As filed with the Securities and
Exchange Commission on August 12, 2019
Registration No. 333-232931
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
DelMar Pharmaceuticals, Inc.
(Exact name
of registrant as specified in its charter)
Nevada
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2834
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99-0360497
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(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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Suite 720-999 West Broadway
Vancouver, British Columbia, Canada V5Z
1K5
(604) 629-5989
(Address, including zip code, and telephone
number, including
area code, of registrant’s principal
executive offices)
Saiid Zarrabian
President and Chief Executive Officer
DelMar Pharmaceuticals, Inc.
Suite 720-999 West Broadway
Vancouver, British Columbia, Canada V5Z
1K5
(604) 629-5989
(Name, address, including zip code, and
telephone number, including area code, of agent for service)
Copies to:
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Steven M. Skolnick, Esq.
Michael J. Lerner, Esq.
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, NY 10020
(212) 262-6700
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Barry L. Grossman
Sarah E. Williams
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas
New York, NY 10105
(212) 370-1300
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Approximate date of commencement of
proposed sale to the public
: As soon as practicable after the effective date of this registration statement.
If any of the securities being registered
on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the
following box. ☒
If this Form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment
filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment
filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration number
of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☒
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Emerging growth company
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☐
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If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
Title
of Securities being Registered
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Proposed Maximum
Aggregate
Offering Price (1) (2)
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Amount of
Registration Fee
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Shares of common stock,
$0.001 par value per share
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$
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9,200,000
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$
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1,115.04
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Warrants to purchase shares of common stock(3)
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Shares of common stock issuable upon exercise
of the Warrants
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$
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9,200,000
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$
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1,115.04
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Pre-Funded Warrants to purchase shares of
common stock
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(4)
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Shares of common stock issuable upon exercise
of the Pre-Funded Warrants(3)
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Underwriter’s warrants(5)
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Common Stock underlying underwriter’s
warrants(5)
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$
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529,000
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$
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64.12
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Total
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$
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18,929,000
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$
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2,294.20
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(1)
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Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended, or the Securities Act.
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(2)
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Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issuable to prevent dilution resulting from stock splits, stock dividends or similar transactions.
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(3)
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No fee is required pursuant to Rule 457(i) under the Securities Act.
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(4)
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The proposed maximum aggregate offering price of the common
stock proposed to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any
Pre-Funded Warrants offered and sold in the offering, and, as such, the proposed maximum aggregate offering price of the common
stock and Pre-Funded Warrants (including the common stock issuable upon exercise of the Pre-Funded Warrants), if any, is $9,200,000.
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(5)
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We
have agreed to issue upon the closing of this offering, warrants to the representatives of the underwriters entitling it to
purchase up to 5% of the aggregate shares of common stock sold in this offering. The exercise price of the warrants is equal
to 115% of the public offering price of the common stock offered hereby. The warrants are exercisable commencing six (6)
months after the date of effectiveness of this Registration Statement and will terminate three (3) years after the date of
effectiveness of this Registration Statement.
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The Registrant hereby amends this registration
statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment
that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities
and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus
is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer
to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS, SUBJECT TO COMPLETION, DATED AUGUST 12, 2019
4,968,944 Shares of Common Stock
Or
Pre-Funded Warrants to Purchase Up
to 4,968,944 Shares of Common Stock
Warrants to Purchase Up to 4,968,944
Shares of Common Stock
DelMar Pharmaceuticals, Inc. is offering 4,968,944 shares
of our common stock and warrants to purchase shares of our common stock. Each share of our common stock is being sold together
with one warrant to purchase one share of our common stock. Each warrant will have an exercise price per share of 100% of the
offering price, will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The
shares of our common stock and warrants are immediately separable and will be issued separately, but will be purchased together
in this offering.
We are also offering to those purchasers, if any, whose purchase
of our common stock in this offering would otherwise result in such purchaser, together with its affiliates and certain related
parties, beneficially owning more than 4.99% of our outstanding common stock immediately following the consummation of this offering,
the opportunity, in lieu of purchasing common stock, to purchase pre-funded warrants to purchase shares of our common stock, or
Pre-Funded Warrants. The purchase price of each Pre-Funded Warrant will equal the price per share at which shares of our common
stock are being sold to the public in this offering, minus $0.01, and the exercise price of each Pre-Funded Warrant will equal
$0.01 per share of common stock. For each Pre-Funded Warrant purchased in this offering in lieu of common stock, we will reduce
the number of shares of common stock being sold in the offering by one. Pursuant to this prospectus, we are also offering the shares
of common stock issuable upon the exercise of the warrants and Pre-Funded Warrants offered hereby.
Each Pre-Funded Warrant is exercisable for one share of our
common stock (subject to adjustment as provided for therein) at any time at the option of the holder until such Pre-Funded Warrant
is exercised in full, provided that the holder will be prohibited from exercising Pre-Funded Warrants for shares of our common
stock if, as a result of such exercise, the holder, together with its affiliates, would own more than 4.99% of the total number
of shares of our common stock then issued and outstanding. However, any holder may increase such percentage to any other percentage
not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice to
us.
Our common stock is listed on The Nasdaq Capital Market
under the symbol “DMPI.” On August 8, 2019, the last reported sale price of our common stock on The Nasdaq Capital
Market was $1.61 per share. There is no established trading market for the warrants or Pre-Funded Warrants and we do not expect
a market to develop. In addition, we do not intend to apply for the listing of the warrants or Pre-Funded Warrants on any national
securities exchange or other trading market. Without an active trading market, the liquidity of the warrants and the Pre-Funded
Warrants will be limited.
You should read this prospectus, together with additional information
described under the heading “Where You Can Find More Information,” carefully before you invest in any of our securities.
Investing in our securities involves a high degree of risk.
See “Risk Factors” beginning on page 8 of this prospectus for a discussion of information that should be considered
in connection with an investment in our securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete.
Any representation to the contrary is a criminal offense.
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Per Share
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Per Pre-Funded Warrant
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Per Warrant
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Total
(No Exercise) (1)
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Total
(Full Exercise) (1)
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Public offering price
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$
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$
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$
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$
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Underwriting discounts and commissions(1)
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Proceeds, before expenses, to us
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$
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$
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$
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$
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(1)
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See “Underwriting” on page 95 for additional disclosure regarding underwriting discounts and commissions and reimbursement of expenses.
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We have granted the underwriters an option for a period
of 45 days from the date of this prospectus to purchase up to an additional 745,341 shares of common stock and/or warrants to
purchase 745,341 shares of common stock at the public offering price, less the underwriting discount.
We anticipate that delivery of the shares, Pre-Funded Warrants
and warrants against payment will be made on or about
, 2019.
Book-Running Manager
Maxim Group LLC
Co-Manager
Dawson James Securities, Inc.
The date of this prospectus is ,
2019.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
We have not, and the underwriters have not, authorized anyone
to provide you with information that is different from that contained in this prospectus or in any free writing prospectus we may
authorize to be delivered or made available to you. When you make a decision about whether to invest in our securities, you should
not rely upon any information other than the information in this prospectus or in any free writing prospectus that we may authorize
to be delivered or made available to you. Neither the delivery of this prospectus nor the sale of our securities means that the
information contained in this prospectus or any free writing prospectus is correct after the date of this prospectus or such free
writing prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy our securities in any circumstances
under which the offer or solicitation is unlawful.
For investors outside the United States: We have not, and the
underwriters have not, taken any action that would permit this offering or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who
come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of
the securities covered hereby and the distribution of this prospectus outside the United States.
Unless otherwise indicated, information
contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and
market position, market opportunity and market share, is based on information from our own management estimates and research, as
well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates
are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge,
which we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have not independently
verified any third-party information. In addition, assumptions and estimates of our and our industry’s future performance
are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk
Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates.
See “Risk Factors”
and
“Special Note Regarding Forward-Looking Statements.”
We further note that the representations, warranties and covenants
made by us in any agreement that is filed as an exhibit to the registration statement of which this prospectus is a part were made
solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the
parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current state of our affairs.
DelMar Pharmaceuticals, Inc. and its consolidated subsidiaries
are referred to herein as “DelMar,” “the Company,” “we,” “us” and “our,”
unless the context indicates otherwise. This prospectus also includes trademarks, tradenames and service marks that are the property
of other organizations. Solely for convenience, trademarks and tradenames referred to in this prospectus appear (after the first
usage) without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert,
to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks
and tradenames.
SUMMARY
This summary highlights information contained
elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our
common stock. You should read this entire prospectus carefully, especially the “Risk Factors” section of this prospectus
before making an investment decision.
On May 8, 2019, we effected a one-for-ten reverse
stock split (the “Reverse Stock Split”) of our issued and outstanding and authorized common stock. All per share amounts
and number of shares of common stock in this prospectus reflect the Reverse Stock Split. The Reverse Stock Split does not affect
our authorized preferred stock of 5,000,000 shares; except that, pursuant to the terms of the Certificate of Designations of Series
B Convertible Preferred Stock for the issued and outstanding shares of our Series B Convertible Preferred Stock, par value $0.001
per share (the “Series B Preferred Stock”), the conversion price at which shares of Series B Preferred Stock may be
converted into shares of common stock will be proportionately adjusted to reflect the Reverse Stock Split.
Our Business
Background
We are a clinical stage, biopharmaceutical company
focused on the development and commercialization of new cancer therapies. Our mission is to benefit patients by developing and
commercializing anti-cancer therapies for patients whose tumors exhibit features that make them resistant to, or unlikely to respond
to, currently available therapies, particularly for orphan cancer indications where patients have failed, or are unlikely to respond
to, currently available therapy.
As of March 31, 2019, we have spent approximately
$38.8 million of shareholder capital in developing VAL-083, a novel, validated, DNA-targeting agent, for the treatment of drug-resistant
solid tumors such as glioblastoma multiforme (“GBM”) and potentially other solid tumors, including ovarian cancer,
non-small cell lung cancer (“NSCLC”), and diffuse intrinsic pontine glioma (“DIPG”). VAL-083 is a first-in-class,
small-molecule, DNA-targeting chemotherapeutic that demonstrated activity against a range of tumor types in prior Phase 1 and Phase
2 clinical studies sponsored by the US National Cancer Institute (“NCI”). As part of our business strategy, we leverage
and build upon these prior NCI investments and data from more than 40 NCI- Phase 1 and Phase 2 clinical studies, which includes
an estimated 1,000 patient safety database, with our own research to identify and target unmet medical needs in modern cancer care.
DNA-targeting agents are among the most successful and widely used treatments for cancer. Their efficacy is based on the ability
to bind with a cancer cell’s DNA and interfere with the process of protein production required for growth and survival of
cancer cells. “First-in-class” means that VAL-083 embodies a unique molecular structure which is not an analogue or
derivative of any approved product, or product under development, for the treatment of cancer.
Our recent research has highlighted the opportunities
afforded by VAL-083’s unique mechanism of action and its potential to address unmet medical needs by focusing our development
efforts on patients whose tumors exhibit biological features that make them resistant to, or unlikely to respond to, currently
available therapies. For example, our research demonstrating VAL-083’s activity in GBM independent of the O6-methyl guanine
methyltransferase (“MGMT”) methylation status allows us to focus patient selection based on this important biomarker.
We are conducting two open-label, biomarker driven
Phase 2 studies in MGMT-unmethylated GBM. MGMT is a DNA-repair enzyme that is associated with resistance to temozolomide, the current
standard-of-care chemotherapy used in the treatment of GBM. Greater than 60% of GBM patients have MGMT-unmethylated tumors and
exhibit a high expression of MGMT, which is correlated with temozolomide treatment failure and poor patient outcomes. Our research
demonstrates that VAL-083’s anti-tumor activity is independent of MGMT expression. In our Phase 2 studies we are using MGMT
as a biomarker to identify patients for treatment with VAL-083 in first-line along with radiation, as adjuvant therapy immediately
following chemoradiation, and in the recurrent treatment setting. If successful, the result of these studies could position VAL-083
for advancement to pivotal clinical studies as a potential replacement for temozolomide in MGMT-unmethylated GBM. We anticipate
presenting data from these studies at peer reviewed scientific meetings during calendar 2019.
With respect to our STAR-3, Phase 3 study, we
have finalized the decision to discontinue this clinical study due to the competitive landscape, patient enrollment rates, and
potential risk of success assessment, and to allow us to focus on enrolling GBM patients in our two biomarker-driven Phase 2 studies.
We have received notice to proceed from the US
Food and Drug Administration (“FDA”) for a phase 1/2, open-label, multicenter study of VAL-083 in patients with
Re
current
P
latinum
R
esistant
Ov
arian Cancer (“REPROVe”). Platinum-based chemotherapy
is the standard-of-care in the treatment of ovarian cancer. Nearly all ovarian cancer patients eventually become resistant to platinum
(“Pt”) based chemotherapy leading to treatment failure and poor patient outcomes. We have demonstrated that VAL-083
is active against Pt-resistant ovarian cancer
in vitro.
However, based on ongoing evaluation and input from our ovarian
cancer advisory board, we are reassessing the development of VAL-083 for the treatment of ovarian cancer. We are in the process
of evaluating the best path forward in ovarian cancer and are evaluating strategic options, including the potential combination
of VAL-083 with PARP inhibitors. At the American Association for Cancer Research (“AACR”) Annual Meeting in 2018 we
presented preclinical data showing that VAL-083 can synergize PARP inhibitors in both a BRACA-proficient and -deficient setting.
In addition to our clinical development activities
in the United States, pursuant to our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. (“Guangxi Wuzhou
Pharmaceutical Company”), we have provided Guangxi Wuzhou Pharmaceutical Company certain commercial rights to VAL-083 in
China where it is approved as a chemotherapy for the treatment of chronic myelogenous leukemia (“CML”) and lung cancer.
Guangxi Wuzhou Pharmaceutical Company is the only manufacturer presently licensed by the China Food and Drug Administration (“CFDA”)
to produce the product for the China market.
We have a broad patent portfolio to protect our
intellectual property. Our patent applications claim composition of matter and methods of use of VAL-083 and related compounds,
synthetic methods, and quality controls for the manufacturing process of VAL-083. We believe that our portfolio of intellectual
property rights provides a defensible market position for the commercialization of VAL-083. In addition, VAL-083 has been granted
protection under the Orphan Drug Act by the FDA and the European Medicines Agency (“EMA”) for the treatment of gliomas,
including GBM. The FDA has also granted Orphan Drug protection to VAL-083 for the treatment of medulloblastoma and ovarian cancer.
Our corporate development strategy is to advance
our drug candidate into multiple clinical studies and then to consider licensing, or acquiring additional product candidates, in
order to establish a product pipeline and to position us for long-term sustainability and growth of shareholder value. We believe
the experience of our clinical development team will position us to efficiently develop drug candidates that we may acquire, or
license, in the future.
We intend to continue to evaluate options for
our strategic direction. These options may include raising additional capital, the acquisition of another company and/or complementary
assets, our sale, or another type of strategic partnership.
Recent Highlights
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As
of August 1, 2019, we provided an update on the first 20 patients enrolled in our ongoing
Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination
with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial, which
is being conducted at the Sun Yat-sen University Cancer Center (“SYSUCC”)
is designed to enroll up to 30 patients to determine whether first-line therapy with
VAL-083 treatment improves progression free survival (“PFS”). The current
standard of care is first-line temozolomide (“TMZ”) with radiation.
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As of August 1, 2019, of the first 20 enrolled
patients, 17 have received at least their first assessment (two patients have not been enrolled long enough to receive their first
assessment and one patient died before their first assessment). “Best Overall Response” for these patients per Investigator
Assessment were:
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Nine
have been assessed as having achieved a complete response (CR) (9/17, or 53%)
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Seven
have been assessed with stable disease (SD), (7/17, or 41%); and
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One
has been assessed as disease progression (PD) (1/17, or 6%).
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Of the 20 patients enrolled, 17 (85%) have received their two-month (post-third cycle) MRI and investigator
assessment, 13 (65%) have received their five-month MRI and investigator assessment, and seven (35%) have received their eight-month
MRI and investigator assessment. Two patients (10%) have not been on the study long enough to reach their first assessment, and
one patient (5%) died before their first assessment. Importantly,
16 of the 20 patients enrolled (80%) were still alive as of the data cut-off date.
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On
July 31, 2019, we announced we had achieved two-thirds enrollment in our ongoing Phase
2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy
in newly-diagnosed MGMT-unmethylated GBM being conducted at SYSUCC in China.
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On
Ju
ly 24, 2019 we announced the enrollment of the first patient in the adjuvant
(pre-temozolomide maintenance) trial arm of our Phase 2, open label study of VAL-083
in MGMT-unmethylated GBM being conducted at the University of Texas MD Anderson Cancer
Center (“MDACC”). The MDACC Institutional Review Board (“IRB”)
had previously approved the addition of up to 24 patients in the pre-TMZ maintenance
setting (i.e. the adjuvant setting). The up to 24 newly-diagnosed patients will have
undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of
standard of care TMZ for adjuvant therapy.
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As of July 24, 2019, we have enrolled 56 of the planned
up to 83 patients in the recurrent arm of our Phase 2, open-label clinical study of VAL-083
in bevacizumab (Avastin®)-naïve, recurrent GBM (“rGBM”) patients
with MGMT-unmethylated status. This study is being conducted at MDACC and is designed
to determine the impact of VAL-083 treatment on overall survival compared to historical
reference control. We previously announced that the MDACC IRB had approved the addition
of up to 35 patients to our rGBM study at a dose of 30 mg/m
2
. As previously
disclosed, we had lowered the dose in this study from 40 mg/m
2
to 30 mg/m
2
to improve tolerance in this patient population and thereby to potentially increase
overall exposure to VAL-083 by increasing the number of cycles of drug patients are able
to receive. Upon completion of the initial 48 patients in this study, 13 will have had
the 30 mg/m
2
dose and 35 will have had the 40 mg/m
2
. Therefore,
potentially adding an additional 35 patients at 30 mg/m
2
would result in a
total of 48 patients receiving the 30 mg/m
2
dose.
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On July 10, 2019 we announced we had initiated the process of relocating our headquarters from Vancouver,
British Columbia to San Diego, CA. The transition to San Diego, which is expected to occur by September 30, 2019, will not
impact our clinical operations which are based in Menlo Park, CA. The Vancouver office will remain open as an
administrative office.
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On June 26, 2019, we amended our articles of incorporation, as amended, to increase the number
of authorized shares of common stock from 7,000,000 to 95,000,000 shares.
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On June 3, 2019, we entered into a securities purchase agreement for the issuance and sale of
an aggregate of 1,170,000 shares of common stock in a registered direct offering (the “RD Offering”) and warrants to
purchase 760,500 shares of common stock in a concurrent private placement, at a combined purchase price of $3.10 per share and
related warrant. The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise
of five years. The closing of the issuance and sale of these securities was consummated on June 5, 2019. The gross proceeds from
the offering, prior to deducting offering expenses and placement agent fees and expenses payable by us, were approximately $3.6
million.
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On May 22, 2019, the Nasdaq Staff notified us that we did not meet the stockholders’ equity
requirements as of March 31, 2019. We submitted a plan to regain compliance with The Nasdaq Capital Market on May 29, 2019. On
June 13, 2019, the Nasdaq Hearings Panel issued a decision granting our request for continued listing, subject to the condition
that on or before October 15, 2019, we shall have issued public disclosure on Form 8-K that we have met the stockholders’
equity requirement and have demonstrated compliance with all other requirements for continued listing. Assuming this offering is
fully subscribed, we expect to utilize the proceeds of this offering to establish compliance.
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On May 20, 2019 we announced the expansion of our Scientific Advisory Board (“SAB”)
with the addition of the following neuro-oncologists:
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o
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Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and a Professor of
Medicine at the Harvard Medical School
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o
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Dr. Timothy Cloughesy, professor of neurology at the David Geffen School of Medicine at the University of California, Los Angeles
and a member of the UCLA Brain Research Institute and Jonsson Comprehensive Cancer Center
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o
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Dr. Nicholas Butowski, a neuro-oncologist practicing at UCSF Medical Center in San Francisco, CA, and director of
translational research in neuro-oncology and a researcher at the Brain Tumor Center
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On April 4, 2019, we announced the formation of an SAB. Its inaugural members are Drs. Napoleone
Ferrara and John de Groot. Dr. John de Groot, Chairman, ad interim of the Department of Neuro-Oncology at the MD Anderson Cancer
Center is an expert in glioma biology and angiogenesis which is the key area of clinical development for VAL-083. Dr. Ferrara is
a world-renowned molecular biologist whose pioneering work on the identification of VEGF, a signal protein produced by cells that
stimulates the formation of blood vessels, led to the development of Genentech Inc.’s Avastin
®
for the treatment
of certain types of cancer, including ovarian cancer and GBM. Dr. Ferrara is also a member of our Board of Directors and he will
serve as the SAB’s Chairman. The SAB will work closely with our management team to optimize the development of VAL-083.
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At the annual meeting of the AACR held March 29 to April 3, 2019, we presented clinical study
updates on both of our Phase 2 studies in MGMT-unmethylated GBM patients, as well as, preclinical presentations on VAL-083 in combination
with Avastin
®
and on the potential to overcome major challenges in the treatment of DIPG.
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China Trial Clinical Update
As of August 1, 2019, we provided an update
on the first 20 patients enrolled in our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination
with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial, which is being conducted at the Sun Yat-sen
University Cancer Center (“SYSUCC”) is designed to enroll up to 30 patients to determine whether first-line therapy
with VAL-083 treatment improves progression free survival (“PFS”). The current standard of care is first-line temozolomide
(“TMZ”) with radiation.
As of August 1, 2019, of the first 20 enrolled patients,
17 have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment
and one patient died before their first assessment). “Best Overall Response” for these patients per Investigator Assessment
were:
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Nine
have been assessed as having achieved a complete response (CR) (9/17, or 53%)
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Seven
have been assessed with stable disease (SD), (7/17, or 41%); and
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One
has been assessed as disease progression (PD) (1/17, or 6%).
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Of the 20 patients enrolled, 17 (85%)
have received their two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI
and investigator assessment, and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%)
have not been on the study long enough to reach their first assessment, and one patient (5%) died before their first assessment.
Importantly, 16 of the 20 patients enrolled (80%) were
still alive as of the data cut-off date.
Clinical Updates Presented at 2019 American
Society of Clinical Oncology
On May 31, 2019, we presented clinical trial
updates from our ongoing first-line and recurrent trials in patients with MGMT-unmethylated GBM at a key opinion leader (“KOL”)
presentation during the 2019 American Society of Clinical Oncology (“ASCO”) annual meeting in Chicago, IL.
At the KOL presentation, we provided an update
on the ongoing Phase 2 clinical study investigating the front-line treatment of VAL-083 with radiation therapy in newly diagnosed
MGMT-unmethylated GBM. This trial is being conducted at SYSUCC in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical
Company. The trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of
first-line temozolomide, improves progression free survival (“PFS”).
As of May 17, 2019, eighteen patients have been
enrolled in the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have
received their post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their
first assessment, and one patient died before their first assessment. Assessments are based on the trial investigator’s clinical
and radiologic assessment, according to the Response Assessment in NeuroOncology (“RANO”) criteria. For the fifteen
patients who have received at least one assessment, eight patients were assessed with a best response of “Complete Response”
(8/15, 53.3% CR) and seven patients were assessed with a best response of “Stable Disease” (7/15, 46.7% SD). Fourteen
of the eighteen patients were still alive at the data cut-off date.
As of July 31, 2019, 20 patients of the
planned 30 have been enrolled in the SYSUCC trial.
We also provided an update on the ongoing recurrent
arm of the Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naïve rGBM. This study
is being conducted in collaboration with MDACC. This biomarker-driven trial (testing for MGMT methylation status) has been amended
to enroll up to 83 patients (35 with a starting dose of 40 mg/m
2
; 48 with a starting dose of 30 mg/m
2
) to
determine the potential of VAL-083 treatment to improve overall survival compared to historical reference control of 7.2 months
with lomustine.
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As of May 5, 2019, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m
2
,
and 16 patients at a starting dose of 30 mg/m
2
.
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For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI:
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9/35
(25.7%) patients initially receiving 40 mg/m
2
exhibited “Stable Disease”
per investigator assessment at the end of cycle 2
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o
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4/12
(33.3%) patients initially receiving 30 mg/m
2
exhibited “Stable Disease”
per investigator assessment at the end of cycle 2
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Additionally, the study protocol has been amended
to include enrollment of up to 24 newly-diagnosed GBM patients who have completed chemoradiation treatment with TMZ and received
no subsequent TMZ maintenance therapy but will receive VAL-083 instead (the adjuvant arm). The adjuvant arm of the study has been
included to explore whether earlier intervention with VAL-083 instead of TMZ maintenance therapy offers clinical benefit and extends
the time to recurrence as compared to TMZ maintenance therapy.
As of July 24, 2019, 56 patients have been enrolled in the recurrent arm of the MDACC study and one patient has been enrolled
in the adjuvant arm of the MDACC study.
Consistent with prior studies, myelosuppression (primarily
thrombocytopenia and neutropenia) is the most common adverse event in both of our ongoing clinical trials.
Risks Affecting Us
Our business is subject to numerous risks described
in the section entitled “Risk Factors” and elsewhere in this prospectus. You should carefully consider these risks
before making an investment. Some of these risks include:
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We have expressed substantial doubt about our ability to continue as a going concern;
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We have a limited operating history and a history of operating losses and expect to incur significant
additional operating losses;
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We will need to raise additional capital;
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We are an early-stage company and may never achieve commercialization of our candidate products
or profitability;
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We are currently focused on the development of a single product candidate;
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Clinical trials for our product candidate are expensive and time consuming, and their outcome
is uncertain; and
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We may not receive regulatory approvals for our product candidate or there may be a delay in obtaining
such approvals.
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Company Information
We are a Nevada corporation formed on June 24, 2009
under the name Berry Only Inc. On January 25, 2013, we entered into and closed an exchange agreement (the “Exchange Agreement”),
with Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”), 0959454 B.C. Ltd. (“Callco”), and 0959456 B.C.
Ltd. (“Exchangeco”) and the security holders of Del Mar (BC). Upon completion of the Exchange Agreement, Del Mar (BC)
became a wholly-owned subsidiary of ours (the “Reverse Acquisition”).
We are the parent company of Del Mar (BC), a British Columbia,
Canada corporation incorporated on April 6, 2010, which is a clinical stage company with a focus on the development of drugs for
the treatment of cancer. We are also the parent company to Callco and Exchangeco which are British Columbia, Canada corporations.
Callco and Exchangeco were formed to facilitate the Reverse Acquisition.
On May 20, 2016, we effected a one-for-four reverse split
of our common stock. All share amounts in this report give effect to the reverse split unless otherwise indicated.
On May 8, 2019, we effected a one-for-ten reverse stock
split (the “Reverse Stock Split”) of our issued and outstanding and authorized common stock. All per share amounts
and number of shares of common stock in this prospectus reflect the Reverse Stock Split. The Reverse Stock Split does not affect
the our authorized preferred stock of 5,000,000 shares; except that, pursuant to the terms of the Certificate of Designations of
Series B Convertible Preferred Stock for the issued and outstanding shares of our Series B Convertible Preferred Stock, par value
$0.001 per share (the “Series B Preferred Stock”), the conversion price at which shares of Series B Preferred Stock
may be converted into shares of common stock will be proportionately adjusted to reflect the Reverse Stock Split.
On June 26, 2019, we amended our articles of incorporation,
as amended, to increase the number of shares of common stock from 7,000,000 to 95,000,000 shares.
Our principal executive offices are located at Suite
720-999 West Broadway, Vancouver, British Columbia, Canada V5Z 1K5 and our telephone number is (604) 629-5989. We have initiated
the process of relocating our headquarters to San Diego, California, which is expected to occur by September 30, 2019. The Vancouver
office will remain open as an administrative office. We maintain an internet website at
www.delmarpharma.com
. We do not
incorporate the information on our website into this prospectus and you should not consider it part of this prospectus.
The Offering
Common stock offered by us
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4,968,944 shares (assuming a combined public offering price of $1.61 per
share and related warrant,
the last reported sale price of our common stock on The Nasdaq Capital
Market on August 8, 2019).
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Pre-Funded Warrants offered by us
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We are also offering to those purchasers, if any,
whose purchase of common stock in this offering would otherwise result in such purchaser, together with its affiliates
and certain related parties, beneficially owning more than 4.99% of our outstanding common stock immediately following
the consummation of this offering, the opportunity, in lieu of purchasing common stock, to purchase Pre-Funded Warrants
to purchase up to 4,968,944 shares of our common stock (assuming a combined public offering price of $1.61 per share and
related warrant, the last reported sale price of our common stock on The Nasdaq Capital Market on August 8, 2019). The
purchase price of each Pre-Funded Warrant will equal the price per share at which the shares of common stock are being
sold to the public in this offering, minus $0.01, and the exercise price of each Pre-Funded Warrant will be $0.01 per
share of common stock. Each Pre-Funded Warrant will be exercisable immediately upon issuance and will not expire. This
prospectus also relates to the offering of the shares of common stock issuable upon exercise of such Pre-Funded Warrants.
See “Description of the Securities We are Offering–Pre-Funded Warrants” for a discussion on the terms
of the Pre-Funded Warrants.
Each Pre-Funded Warrant is exercisable for one share
of our common stock (subject to adjustment as provided therein) at any time at the option of the holder, provided that
the holder will be prohibited from exercising its Pre-Funded Warrant for shares of our common stock if, as a result of
such exercise, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of our
common stock then issued and outstanding. However, any holder may increase such percentage to any other percentage not
in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such
notice to us. For each Pre-Funded Warrant purchased in this offering in lieu of common stock, we will reduce the number
of shares of common stock being sold in the offering by one.
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Warrants offered by us
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Warrants to purchase up to 4,968,944 shares of our common stock (assuming a
combined public offering price of $1.61 per share and related warrant, the last reported sale price of our common stock on
The Nasdaq Capital Market on August 8, 2019). Each share of our common stock is being sold together with one warrant
to purchase one share of our common stock. Each warrant will have an exercise price per share of 100% of the offering price,
will be immediately exercisable and will expire on the fifth anniversary of the original issuance date.
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Common stock outstanding prior to this offering
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3,838,483 shares of common stock.
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Common stock outstanding after this offering
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8,807,427 shares (assuming a combined public offering price of $1.61 per share and related warrant,
the last reported sale price of our common stock on The Nasdaq Capital Market on August 8, 2019) (or 13,776,371 shares if
the warrants sold in this offering are exercised in full). The foregoing assumes only shares of common stock (and no Pre-Funded
Warrants) are sold in this offering and no exercise of the underwriters’ option to purchase additional securities. For each
Pre-Funded Warrant purchased in this offering in lieu of common stock, we will reduce the number of shares of common stock being
sold in the offering by one.
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Use of proceeds
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Based on an assumed combined public offering price
of $1.61 per share and related warrant (the last reported sale price of our common stock on The Nasdaq Capital Market
on August 8, 2019), we estimate that the net proceeds from our sale of shares of our common stock and warrants in
this offering will be approximately $7.1 million ($8.2 million if the underwriters’ option to purchase additional
shares of common stock and/or warrants is exercised in full), after deducting estimated underwriting discounts and commissions
and estimated offering expenses payable by us. We currently expect to use the net proceeds from this offering for our
clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research
and development and other commercial expenditures. In addition, we may use the net proceeds from this offering for investments
in businesses, products or technologies that are complementary to our business. See “Use of Proceeds.”
For additional information please refer to the section
entitled “Use of Proceeds” on page 36 of this prospectus.
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Risk Factors
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Investing in our securities involves a high degree of risk. You should carefully review and consider the “Risk Factors” section of this prospectus for a discussion of factors to consider before deciding to invest in shares of our common stock.
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Market Symbol and trading
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Our common stock is listed on The Nasdaq Capital Market under the symbol “DMPI.” There is no established trading market for the warrants or Pre-Funded Warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the warrants or Pre-Funded Warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the warrants and Pre-Funded Warrants will be limited.
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Unless otherwise stated, all information contained in this
prospectus assumes no investor purchased Pre-Funded Warrants in lieu of common stock sold in this offering.
The number of shares of our common stock to be outstanding
after this offering is based on 3,838,483 shares of our common stock outstanding as of August 8, 2019 and excludes as of such
date:
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288,183 shares of our common stock issuable upon the exercise of stock options, with a weighted-average
exercise price of $22.31 per share;
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1,543,596 shares of our common stock issuable upon the exercise of outstanding warrants,
with a weighted-average exercise price of $12.60 per
share; and
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491,817 other shares of our common stock reserved for future issuance under our 2017 Omnibus
Equity Incentive Plan.
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RISK FACTORS
Investing in our securities involves a high degree of risk.
In determining whether to purchase our common stock, an investor should carefully consider all of the material risks described
below, together with the other information contained in this report before making a decision to purchase our securities. An investor
should only purchase our securities if he or she can afford to suffer the loss of his or her entire investment.
Risks Related to Our Business
We have expressed substantial doubt about our ability
to continue as a going concern.
As discussed in Note 1 to the consolidated financial statements
for the year ended June 30, 2018, our audited financial statements for the fiscal year ended June 30, 2018, include an explanatory
paragraph that such financial statements were prepared assuming that we will continue as a going concern. A going concern basis
assumes that we will continue our operations for the foreseeable future and contemplates the realization of assets and the settlement
of liabilities in the normal course of business.
For the year ended June 30, 2018 and the nine months ended March
31, 2019, we reported a loss of $11,138,312 and $5,465,486, respectively, and a negative cash flow from operations of $9,850,850
and $4,514,674, respectively. We had an accumulated deficit of $57,988,567 as at March 31, 2019. As at March 31, 2019, we had cash
and cash equivalents on hand of $2,152,233. We are in the development stage and have not generated any revenues to date. We do
not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which may
not ever occur. In the near future, we will require additional funding to maintain our clinical studies, research and development
projects, and for general operations. These circumstances indicate substantial doubt exists about our ability to continue as a
going concern.
Consequently, management is pursuing various financing alternatives
to fund our operations so it can continue as a going concern. Management plans to secure the necessary financing through the issue
of new equity and/or the entering into of strategic partnership arrangements. We may tailor our drug candidate development program
based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will
be successful.
The financial statements do not give effect to any adjustments
to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.
Such adjustments could be material.
We have a limited operating history and a history of operating
losses and expect to incur significant additional operating losses.
We are an early stage company and there is limited historical
financial information upon which to base an evaluation of our performance. Our prospects must be considered in light of the uncertainties,
risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. We expect to incur substantial
additional net expenses over the next several years as our research, development and commercial activities increase. The amount
of future losses and when, if ever, we will achieve profitability are uncertain. Our ability to generate revenue and achieve profitability
will depend on, among other things, successful completion of the preclinical and clinical development of our product candidate;
obtaining necessary regulatory approvals from the FDA and international regulatory agencies; successful manufacturing, sales and
marketing arrangements; and raising sufficient funds to finance our activities. If we are unsuccessful at some or all of these
undertakings, our business, prospects and results of operations may be materially adversely affected.
We will need to raise additional capital, which may cause
dilution to our stockholders, restrict our operations or require us to relinquish rights to technologies or product candidates.
Until such time, if ever, as we can generate substantial
product revenues, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings
and/or license and development agreements with collaboration partners. As of March 31, 2019, we had cash and cash equivalents
to fund operations into the middle of calendar 2019. Taking into consideration the net proceeds from the RD Offering of approximately
$3.2 million and the expected net proceeds from this offering of approximately $7.1 million ($8.2 million if the underwriters’
option to purchase additional securities in full), we expect to fund our operations into the fourth calendar quarter of 2020.
We will also need to raise additional capital to fund our operations. We do not have any committed external source of funds. To
the extent that we raise additional capital through the sale of equity or convertible debt securities, then-existing stockholders’
interests may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely
affect their rights as common stockholders. Debt financing and preferred equity financing, if available, may involve agreements
that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making
capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.
In addition, we have retained Oppenheimer & Co. Inc. as
a financial advisor to assist us in our evaluation of a broad range of strategic alternatives to enhance stockholder value, including
additional capital raising transactions, an acquisition, merger, business combination, licensing and/or other strategic transaction
involving us. There is no assurance that the review of strategic alternatives will result in us changing our business plan, pursuing
any particular transaction, or, if we pursue any such transaction, that it will be completed. We do not expect to make further
public comment regarding the strategic review until our Board of Directors has approved a specific transaction or otherwise deems
disclosure of significant developments is appropriate.
If we raise funds through collaborations, strategic partnerships
or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies,
future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If
we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce
or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates
that we would otherwise prefer to develop and market ourselves.
Our inability to obtain additional financing could adversely
affect our ability to meet our obligations under our planned clinical studies and could negatively impact the timing of our clinical
results.
Our ability to meet our obligations and continue the research
and development of our product candidate is dependent on our ability to continue to raise adequate financing. We may not be successful
in obtaining such additional financing in the amount required at any time, or for any period, or, if available, that it can be
obtained on terms satisfactory to us. In the event that we are unable to obtain such additional financing, we may be unable to
meet our obligations under our planned clinical studies and we may have to tailor our drug candidate development programs based
on the amount of funding we raise which could negatively impact the timing of our clinical results. In addition, we could be required
to cease our operations.
Our exploration and pursuit of strategic alternatives
may not be successful.
In September 2018, we announced that we had retained Oppenheimer
& Co. Inc. as a financial advisor to assist us in our evaluation of a broad range of strategic alternatives. Potential strategic
alternatives that may be explored or evaluated as part of this process include the potential for capital raising transactions,
an acquisition, merger, business combination, licensing and/or other strategic transaction involving us. Despite devoting efforts
to identify and evaluate potential strategic transactions, the process may not result in any definitive offer to consummate a strategic
transaction, or, if we receive such a definitive offer, the terms may not be as favorable as anticipated or may not result in the
execution or approval of a definitive agreement. Even if we enter into a definitive agreement, we may not be successful in completing
a transaction or, if we complete such a transaction, it may not enhance stockholder value or deliver expected benefits.
If we fail to regain compliance with the stockholders’
equity requirements of The Nasdaq Capital Market LLC (“Nasdaq”) or other requirements for continued listing, our common
stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
Our common stock is listed for trading on The Nasdaq Capital
Market. On May 22, 2019 and May 23, 2019, we received written notices (collectively, the “Notice”) from the Listing
Qualifications Department of The Nasdaq Stock Market LLC (“The Nasdaq Stock Market”) indicating that, in light of our
having reported stockholders’ equity of $1,259,161 as of March 31, 2019 in our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, we were not in compliance with the $2,500,000 minimum stockholders’ equity requirement set
forth in Nasdaq Listing Rule 5550(b)(1) for continued listing on Nasdaq (the “Stockholders’ Equity Requirement”),
or with any alternative standard under the Nasdaq Listing Rules. The Notice requested that we present a plan to regain compliance
with the above-mentioned deficiency by written submission no later than May 29, 2019, which plan was submitted on such date, in
order to be considered by the Nasdaq Hearings Panel that was, until May 23, 2019, considering our continued listing due to our
previous deficiency with respect to the $1.00 per share bid price requirement, as described below. On June 13, 2019, the Nasdaq
Hearings Panel issued a decision granting our request for continued listing, subject to the condition that on or before October
15, 2019, we shall have issued public disclosure on Form 8-K that we have met the Stockholders’ Equity Requirement and have
demonstrated compliance with all other requirements for continued listing. We will need to raise additional capital to obtain compliance.
As previously disclosed, on June 28, 2018, the Staff of the
Listing Qualifications Department of The Nasdaq Stock Market (the “Nasdaq Staff”) notified the Company that it did
not comply with the minimum $1.00 per share bid price requirement for continued listing, as set forth in Nasdaq Listing Rule 5550(a)(2)
(the “Bid Price Requirement”), and we were therefore granted 180 calendar days, through December 26, 2018, to regain
compliance. On December 27, 2018, the Nasdaq Staff notified us that we had not regained compliance with the Bid Price Requirement,
that our stockholders’ equity as reported in our Quarterly Report on Form 10-Q for the quarter ended September 30,
2018 did not qualify us for an additional 180 calendar day extension period for compliance and that we would therefore be subject
to delisting unless we requested a hearing before a Nasdaq Hearings Panel. Accordingly, we requested a hearing, which was held
on January 31, 2019, at which we presented our plan of compliance. On February 4, 2019, the Nasdaq Hearings Panel issued a decision
granting our request for continued listing of our common stock on The Nasdaq Capital Market pursuant to an extension through June
25, 2019, subject to the condition that we shall have demonstrated a closing bid price of $1.00 per share or more for a minimum
of ten consecutive business days by June 25, 2019. As a result of our previously disclosed one-for-ten reverse stock split effected
on May 8, 2019, on May 23, 2019, we received written notice from Nasdaq that the Company has regained compliance with the Bid Price
Requirement.
Subject to our issuance of public disclosure on Form 8-K that
we have met the Stockholders’ Equity Requirement and our demonstrating compliance for continued listing, our common stock
will continue to be listed on Nasdaq, and our common stock will continue to trade under the symbol “DMPI.” Our receipt
of the Notice does not affect our business, operations or reporting requirements with the SEC.
Notwithstanding, there can be no assurance that we will be able
to regain compliance, and if we are unable to regain compliance with the Stockholders’ Equity Requirement, or if we fail
to meet any of the other continued listing requirements, our securities may be delisted from Nasdaq, which could reduce the liquidity
of our common stock materially and result in a corresponding material reduction in the price of our common stock. In addition,
delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and
may result in the potential loss of confidence by investors, employees and business development opportunities. Such a delisting
likely would impair your ability to sell or purchase our common stock when you wish to do so. Further, if we were to be delisted
from Nasdaq, our common stock may no longer be recognized as a “covered security” and we would be subject to regulation
in each state in which we offer our securities. Thus, delisting from Nasdaq could adversely affect our ability to raise additional
financing through the public or private sale of equity securities, would significantly impact the ability of investors to trade
our securities and would negatively impact the value and liquidity of our common stock.
If we are unable to effectively implement or maintain
a system of internal control over financial reporting, we may not be able to accurately or timely report our financial results
and our stock price could be adversely affected.
Section 404 of the Sarbanes-Oxley Act of 2002 and related regulations
require us to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year, and
to include a management report assessing the effectiveness of our internal control over financial reporting in our Annual Report
on Form 10-K for that fiscal year. Management determined that as of June 30, 2018 and in past periods, our disclosure controls
and procedures and internal control over financial reporting were not effective due to material weaknesses in our internal control
over financial reporting related to our limited number of employees in our accounting department and inadequate segregation of
duties over authorization, review and recording of transactions, as well as the financial reporting of such transactions. Any failure
to implement new or improved controls necessary to remedy the material weaknesses described above, or difficulties encountered
in the implementation or operation of these controls, could harm our operations, decrease the reliability of our financial reporting,
and cause us to fail to meet our financial reporting obligations, which could adversely affect our business and reduce our stock
price.
We are an early-stage company and may never achieve commercialization
of our candidate products or profitability.
We are at an early stage of development and commercialization
of our technologies and product candidate. We have not yet begun to market any products and, accordingly, have not begun or generate
revenues from the commercialization of our product. Our product will require significant additional clinical testing and investment
prior to commercialization. A commitment of substantial resources by ourselves and, potentially, our partners to conduct time-consuming
research and clinical studies will be required if we are to complete the development of our product candidate. There can be no
assurance that our product candidate will meet applicable regulatory standards, obtain required regulatory approvals, be capable
of being produced in commercial quantities at reasonable costs or be successfully marketed. Our product candidate is not expected
to be commercially available for several years, if at all.
We are currently focused on the development of a single
product candidate.
Our product development efforts are currently focused on a single
product, VAL-083, for which we are researching multiple indications. If VAL-083 fails to achieve clinical endpoints or exhibits
unanticipated toxicity or if a superior product is developed by a competitor, our prospects for obtaining regulatory approval and
commercialization may be negatively impacted. In the long-term, we hope to establish a pipeline of product candidates, and we have
identified additional product candidates that we may be able to acquire or license in the future. However, at this time we do not
have any formal agreements granting us any rights to such additional product candidates.
Even if we are able to commercialize any product candidate
that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or
healthcare reform initiatives that could harm our business.
The commercial success of our current or future product candidates
will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidate will be paid
by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government
health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors.
If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our
products. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish and maintain
pricing sufficient to realize a meaningful return on our investment.
There is significant uncertainty related to third-party payor
coverage and reimbursement of newly approved drugs. Marketing approvals, pricing and reimbursement for new drug products vary widely
from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries,
the pricing review period begins after marketing or product licensing approval is granted. In some non-U.S. markets, prescription
pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result,
we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial
launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from
the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or
more product candidates, even if our product candidates obtain marketing approval.
Our ability to commercialize VAL-083 or any other product candidates
will depend in part on the extent to which coverage and reimbursement for these products and related treatments will be available
from government health administration authorities, private health insurers and other organizations. Government authorities and
third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will cover
and establish reimbursement levels. The healthcare industry is acutely focused on cost containment, both in the United States and
elsewhere. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of
reimbursement for particular medications, which could affect our ability to sell our product candidate profitably. These payors
may not view our products, if any, as cost-effective, and coverage and reimbursement may not be available to our customers, or
may not be sufficient to allow our products, if any, to be marketed on a competitive basis. Cost-control initiatives could cause
us to decrease the price we might establish for products, which could result in lower than anticipated product revenues. If the
prices for our products, if any, decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement,
our prospects for revenue and profitability will suffer.
There may also be delays in obtaining coverage and reimbursement
for newly approved drugs, and coverage may be more limited than the indications for which the drug is approved by the FDA or comparable
non-U.S. regulatory authorities. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases
or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Reimbursement rates may
vary, by way of example, according to the use of the drug and the clinical setting in which it is used. Reimbursement rates may
also be based on reimbursement levels already set for lower cost drugs or may be incorporated into existing payments for other
services.
In addition, increasingly, third-party payors are requiring
higher levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged. We
cannot be sure that coverage will be available for any product candidate that we, or they, commercialize and, if available, that
the reimbursement rates will be adequate. Further, the net reimbursement for drug products may be subject to additional reductions
if there are changes to laws that presently restrict imports of drugs from countries where they may be sold at lower prices than
in the United States. An inability to promptly obtain coverage and adequate payment rates from both government-funded and private
payors for any of our product candidates for which we obtain marketing approval could have a material adverse effect on our operating
results, our ability to raise capital needed to commercialize products and our overall financial condition.
We are dependent on obtaining certain patents and protecting
our proprietary rights.
Our success will depend, in part, on our ability to obtain patents,
maintain trade secret protection and operate without infringing on the proprietary rights of third parties or having third parties
circumvent our rights. We have filed and are actively pursuing patent applications for our products. The patent positions of biotechnology,
biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. Thus, there
can be no assurance that any of our patent applications will result in the issuance of patents, that we will develop additional
proprietary products that are patentable, that any patents issued to us or those that already have been issued will provide us
with any competitive advantages or will not be challenged by any third parties, that the patents of others will not impede our
ability to do business or that third parties will not be able to circumvent our patents. Furthermore, there can be no assurance
that others will not independently develop similar products, duplicate any of our products not under patent protection, or, if
patents are issued to us, design around the patented products we developed or will develop.
We may be required to obtain licenses from third parties to
avoid infringing patents or other proprietary rights. No assurance can be given that any licenses required under any such patents
or proprietary rights would be made available, if at all, on terms we find acceptable. If we do not obtain such licenses, we could
encounter delays in the introduction of products or could find that the development, manufacture or sale of products requiring
such licenses could be prohibited.
A number of pharmaceutical, biopharmaceutical and biotechnology
companies and research and academic institutions have developed technologies, filed patent applications or received patents on
various technologies that may be related to or affect our business. Some of these technologies, applications or patents may conflict
with our technologies or patent applications. Such conflict could limit the scope of the patents, if any, that we may be able to
obtain or result in the denial of our patent applications. In addition, if patents that cover our activities are issued to other
companies, there can be no assurance that we would be able to obtain licenses to these patents at a reasonable cost or be able
to develop or obtain alternative technology. If we do not obtain such licenses, we could encounter delays in the introduction of
products, or could find that the development, manufacture or sale of products requiring such licenses could be prohibited. In addition,
we could incur substantial costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits
against others to have such patents declared invalid.
Patent applications in the U.S. are maintained in secrecy and
not published if either: i) the application is a provisional application or ii) the application is filed and we request no publication,
and certify that the invention disclosed “has not and will not” be the subject of a published foreign application.
Otherwise, U.S. applications or foreign counterparts, if any, publish 18 months after the priority application has been filed.
Since publication of discoveries in the scientific or patent literature often lag behind actual discoveries, we cannot be certain
that we or any licensor were the first creator of inventions covered by pending patent applications or that we or such licensor
was the first to file patent applications for such inventions. Moreover, we might have to participate in interference proceedings
declared by the U.S. Patent and Trademark Office to determine priority of invention, which could result in substantial cost to
us, even if the eventual outcome were favorable to us. There can be no assurance that our patents, if issued, would be held valid
or enforceable by a court or that a competitor’s technology or product would be found to infringe such patents.
Moreover, we may be subject to third-party preissuance submissions
of prior art to the USPTO, or become involved in opposition, derivation, reexamination,
inter partes
review, post-grant
review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any
such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize
our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize
products without infringing third-party patent rights.
Even if our patent applications issue as patents, they may not
issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us, or otherwise provide
us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies
or products in a non-infringing manner.
The issuance of a patent is not conclusive as to its inventorship,
scope, validity or enforceability, and our patents may be challenged in courts or patent offices in the United States and abroad.
Such challenges may result in loss of exclusivity or freedom to operate, or in patent claims being narrowed, invalidated or held
unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical
technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time
required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might
expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not
provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
In addition, the protection of intellectual property rights
in China (where our clinical product candidate, VAL-083, is manufactured pursuant to a collaboration agreement with the only manufacturer
presently licensed by the CFDA to manufacture VAL-083 for the China market, and where VAL-083 is approved for the treatment of
CML and lung cancer) is relatively weak compared to the United States, which may negatively affect our ability to generate royalty
revenue from sales of VAL-083 in China.
Much of our know-how and technology may not be patentable. To
protect our rights, we require employees, consultants, advisors and collaborators to enter into confidentiality agreements. There
can be no assurance, however, that these agreements will provide meaningful protection for our trade secrets, know-how or other
proprietary information in the event of any unauthorized use or disclosure. Further, our business may be adversely affected by
competitors who independently develop competing technologies, especially if we obtain no, or only narrow, patent protection.
We may be unable to protect our patents and proprietary
rights
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Our future success will depend to a significant extent on our
ability to:
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obtain and keep patent protection for our products and technologies on an international basis;
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enforce our patents to prevent others from using our inventions;
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maintain and prevent others from using our trade secrets; and
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operate and commercialize products without infringing on the patents or proprietary rights of others.
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We can provide no assurance that our patent rights will afford
any competitive advantages and these rights may be challenged or circumvented by third parties. Further, patents may not be issued
on any of our pending patent applications in the U.S. or abroad. Because of the extensive time required for development, testing
and regulatory review of a product candidate, it is possible that before a product candidate can be commercialized, any related
patent may expire, or remain in existence for only a short period following commercialization, reducing or eliminating any advantage
of the patent.
If we sue others for infringing our patents, a court may determine
that such patents are invalid or unenforceable. Even if the validity of our patent rights is upheld by a court, a court may not
prevent the alleged infringement of our patent rights on the grounds that such activity is not covered by our patent claims.
In addition, third parties may sue us for infringing their patents.
In the event of a successful claim of infringement against us, we may be required to:
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defend litigation or administrative proceedings;
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pay substantial damages;
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stop using our technologies and methods;
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stop certain research and development efforts;
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develop non-infringing products or methods; and
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obtain one or more licenses from third parties.
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If required, we can provide no assurance that we will be able
to obtain such licenses on acceptable terms, or at all. If we are sued for infringement, we could encounter substantial delays
in development, manufacture and commercialization of our product candidates. Any litigation, whether to enforce our patent rights
or to defend against allegations that we infringe third-party rights, will be costly, time consuming, and may distract management
from other important tasks.
As is commonplace in the biotechnology and pharmaceutical industry,
we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors
or potential competitors. To the extent our employees are involved in research areas which are similar to those areas in which
they were involved at their former employers, we may be subject to claims that such employees and/or we have inadvertently or otherwise
used or disclosed the alleged trade secrets or other proprietary information of the former employers. Litigation may be necessary
to defend against such claims, which could result in substantial costs and be a distraction to management and which may have a
material adverse effect on us, even if we are successful in defending such claims.
We are subject to various government regulations.
The manufacture and sale of human therapeutic and diagnostic
products in the U.S., Canada and foreign jurisdictions are governed by a variety of statutes and regulations. These laws require
approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission
containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety
and efficacy of the product for each use sought, including adherence to current cGMP during production and storage, and control
of marketing activities, including advertising and labeling.
VAL-083 and any other products we may develop will require significant
development, preclinical and clinical testing and investment of substantial funds prior to its commercialization. The process of
obtaining required approvals can be costly and time-consuming, and there can be no assurance that we will successfully develop
any future products that will prove to be safe and effective in clinical studies or receive applicable regulatory approvals. Markets
other than the U.S. and Canada have similar restrictions. Potential investors and shareholders should be aware of the risks, problems,
delays, expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.
We may request priority review for our product candidate
in the future. The FDA may not grant priority review for our product candidate. Moreover, even if the FDA designated such product
for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, would not
assure FDA approval.
We may be eligible for priority review designation for our product
candidate if the FDA determines such product candidate offers major advances in treatment or provides a treatment where no adequate
therapy exists. A priority review designation means that the goal for the FDA to review an application is six months, rather than
the standard review period of ten months. The FDA has broad discretion with respect to whether or not to grant priority review
status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or status,
the FDA may decide not to grant it. Thus, while the FDA has granted priority review to other oncology disease products, our product
candidate, should we determine to seek priority review, may not receive similar designation. Moreover, even if our product candidate
is designated for priority review, such a designation does not necessarily mean a faster regulatory review process or necessarily
confer any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does
not guarantee approval within an accelerated timeline or thereafter.
We believe we may in some instances be able to secure
approval from the FDA or comparable non-U.S. regulatory authorities to use accelerated development pathways. If we are unable to
obtain such approval, we may be required to conduct additional preclinical studies or clinical studies beyond those that we contemplate,
which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.
We anticipate that we may seek an accelerated approval pathway
for our product candidate. Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, or FDCA, and
the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed to treat a serious or life-threatening
condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product has an effect
on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers
a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as
irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory
measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself
a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect
on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or
other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available
therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.
If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional
post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail
to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.
Prior to seeking such accelerated approval, we will seek
feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval. There can also be
no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application
(“NDA”), for accelerated approval or any other form of expedited development, review or approval. Similarly, there
can be no assurance that after subsequent FDA feedback that we will continue to pursue or apply for accelerated approval or any
other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit
an application for accelerated approval or under another expedited regulatory designation (e.g., breakthrough therapy designation),
there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval
will be granted on a timely basis, or at all. The FDA or other non-U.S. authorities could also require us to conduct further studies
prior to considering our application or granting approval of any type. A failure to obtain accelerated approval or any other form
of expedited development, review or approval for any of our product candidates that we determine to seek accelerated approval for
would result in a longer time period to commercialization of such product candidate, could increase the cost of development of
such product candidate and could harm our competitive position in the marketplace.
We have conducted, and may in the future conduct, clinical
studies for certain of our product candidates at sites outside the United States, and the FDA may not accept data from studies
conducted in such locations.
We have conducted and may in the future choose to conduct one
or more of our clinical studies outside the United States. Although the FDA may accept data from clinical studies conducted outside
the United States, acceptance of this data is subject to certain conditions imposed by the FDA. For example, the clinical study
must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The study population
must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice
in ways that the FDA deems clinically meaningful. Generally, the patient population for any clinical studies conducted outside
of the United States must be representative of the population for whom we intend to seek approval in the United States. In addition,
while these clinical studies are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination
that the studies also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept
data from studies conducted outside of the United States. If the FDA does not accept the data from any of our clinical studies
that we determine to conduct outside the United States, it would likely result in the need for additional studies, which would
be costly and time-consuming and delay or permanently halt our development of the product candidate.
In addition, the conduct of clinical studies outside the
United States could have a significant impact on us. Risks inherent in conducting international clinical studies include:
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foreign regulatory requirements that could restrict or limit our ability to conduct our clinical studies;
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administrative burdens of conducting clinical studies under multiple foreign regulatory schema;
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foreign exchange fluctuations; and
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diminished protection of intellectual property in some countries.
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If our clinical studies fail to demonstrate safety and
efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays
in completing, or ultimately be unable to complete, the development and commercialization of our product candidate.
We are not permitted to commercialize, market, promote or sell
any product candidate in the United States without obtaining marketing approval from the FDA. Comparable non-U.S. regulatory authorities,
such as the EMA, impose similar restrictions. We may never receive such approvals. We must complete extensive preclinical development
and clinical studies to demonstrate the safety and efficacy of our product candidate in humans before we will be able to obtain
these approvals.
Clinical testing is expensive, difficult to design and implement,
can take many years to complete and is inherently uncertain as to outcome. We have not previously submitted an NDA to the FDA or
similar drug approval filings to comparable non-U.S. regulatory authorities for any product candidate.
Any inability to successfully complete preclinical and clinical
development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory and
commercialization milestones and royalties. In addition, if (1) we are required to conduct additional clinical studies or other
testing of our product candidate beyond the studies and testing that we contemplate, (2) we are unable to successfully complete
clinical studies of our product candidate or other testing, (3) the results of these studies or tests are unfavorable, uncertain
or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition
to incurring additional costs, may:
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be delayed in obtaining marketing approval for our product candidates;
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not obtain marketing approval at all;
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obtain approval for indications or patient populations that are not as broad as we intended or desired;
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obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including
boxed warnings;
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be subject to additional post-marketing testing or other requirements; or
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be required to remove the product from the market after obtaining marketing approval.
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If we experience any of a number of possible unforeseen
events in connection with clinical studies of our product candidates, potential marketing approval or commercialization of our
product candidates could be delayed or prevented.
We may experience numerous unforeseen events during, or as a
result of, clinical studies that could delay or prevent marketing approval of our product candidate, including:
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clinical studies of our product candidate may produce unfavorable or inconclusive results;
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we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;
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the number of patients required for clinical studies of our product candidate may be larger than we anticipate, patient enrollment
in these clinical studies may be slower than we anticipate or participants may drop out of these clinical studies at a higher rate
than we anticipate;
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data safety monitoring committees may recommend suspension, termination or a clinical hold for various reasons, including concerns
about patient safety;
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regulators or IRBs may suspend or terminate the study or impose a clinical hold for various reasons, including noncompliance
with regulatory requirements or concerns about patient safety;
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patients with serious, life-threatening diseases included in our clinical studies may die or suffer other adverse medical events
for reasons that may not be related to our product candidate;
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participating patients may be subject to unacceptable health risks;
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patients may not complete clinical studies due to safety issues, side effects, or other reasons;
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changes in regulatory requirements and guidance may occur, which require us to amend clinical study protocols to reflect these
changes;
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our third-party contractors, including those manufacturing our product candidate or components or ingredients thereof or conducting
clinical studies on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in
a timely manner or at all;
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regulators or institutional review boards, or IRBs may not authorize us or our investigators to commence a clinical study or
conduct a clinical study at a prospective study site;
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we may experience delays in reaching or fail to reach agreement on acceptable clinical study contracts or clinical study protocols
with prospective study sites;
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patients who enroll in a clinical study may misrepresent their eligibility to do so or may otherwise not comply with the clinical
study protocol, resulting in the need to drop the patients from the clinical study, increase the needed enrollment size for the
clinical study or extend the clinical study’s duration;
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we may have to suspend or terminate clinical studies of our product candidate for various reasons, including a finding that
the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of
a product candidate;
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regulators or IRBs may require that we or our investigators suspend or terminate clinical research for various reasons, including
noncompliance with regulatory requirements or their respective standards of conduct, a finding that the participants are being
exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the product candidate or
findings of undesirable effects caused by a chemically or mechanistically similar drug or drug candidate;
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the FDA or comparable non-U.S. regulatory authorities may fail to approve or subsequently find fault with the manufacturing
processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;
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the FDA or comparable non-U.S. regulatory authorities may disagree with our clinical study design or our interpretation of
data from preclinical studies and clinical studies;
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the supply or quality of raw materials or manufactured product candidate or other materials necessary to conduct clinical studies
of our product candidate may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience
interruptions in supply; and
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the approval policies or regulations of the FDA or comparable non-U.S. regulatory authorities may significantly change in a
manner rendering our clinical data insufficient to obtain marketing approval.
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Product development costs for us will increase if we experience
delays in testing or pursuing marketing approvals and we may be required to obtain additional funds to complete clinical studies
and prepare for possible commercialization of our product candidate. We do not know whether any preclinical tests or clinical studies
will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical
study delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidate
or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product
candidate and may harm our business and results of operations. In addition, many of the factors that cause, or lead to, clinical
study delays may ultimately lead to the denial of marketing approval of our product candidate.
If we experience delays or difficulties in the enrollment
of patients in clinical studies, we may not achieve our clinical development on our anticipated timeline, or at all, and our receipt
of necessary regulatory approvals could be delayed or prevented.
We may not be able to initiate or continue clinical studies
for VAL-083 or any other product candidate if we are unable to locate and enroll a sufficient number of eligible patients to participate
in clinical studies. Patient enrollment is a significant factor in the timing of clinical studies, and is affected by many factors,
including:
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the size and nature of the patient population;
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the severity of the disease under investigation;
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the proximity of patients to clinical sites;
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the eligibility criteria for the study;
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the design of the clinical study;
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efforts to facilitate timely enrollment;
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competing clinical studies; and
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clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation
to other available therapies, including any new drugs that may be approved for the indications we are investigating.
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Our inability to enroll a sufficient number of patients for
our clinical studies could result in significant delays or may require us to abandon one or more clinical studies altogether. Enrollment
delays in our clinical studies may result in increased development costs for our product candidate, delay or halt the development
of and approval processes for our product candidate and jeopardize our ability to achieve our clinical development timeline and
goals, including the dates by which we will commence, complete and receive results from clinical studies. Enrollment delays may
also delay or jeopardize our ability to commence sales and generate revenues from our product candidate. Any of the foregoing could
cause our value to decline and limit our ability to obtain additional financing, if needed.
Positive results in previous clinical studies of VAL-083
may not be replicated in future clinical studies, which could result in development delays or a failure to obtain marketing approval.
Positive results in previous clinical studies of VAL-083 may
not be predictive of similar results in future clinical studies. Also, interim results during a clinical study do not necessarily
predict final results. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks
in late-stage clinical studies even after achieving promising results in early-stage development. Accordingly, the results from
the completed preclinical studies and clinical studies for VAL-083 may not be predictive of the results we may obtain in later
stage studies. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require
us, to conduct additional clinical studies. Moreover, clinical data are often susceptible to varying interpretations and analyses,
and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical studies
have nonetheless failed to obtain FDA or EMA, or other regulatory agency, approval for their products.
FDA approval of VAL-083 or future product candidates may
be denied.
There can be no assurance that the FDA will ultimately approve
our NDA. The FDA may deny approval of VAL-083 for many reasons, including:
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we may be unable to demonstrate to the satisfaction of the FDA that our products are safe and effective for its intended uses;
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the FDA may disagree with our interpretation of data from the clinical studies;
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we may be unable to demonstrate that any clinical or other benefits our products outweigh any safety or other perceived risks;
or
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we may not be able to successfully address any other issues raised by the FDA.
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If VAL-083 fails to receive FDA approval, our business and prospects
will be materially adversely impacted.
We expect to rely on orphan drug status to develop and
commercialize our product candidate, but our orphan drug designations may not confer marketing exclusivity or other expected commercial
benefits as anticipated.
Market exclusivity afforded by orphan drug designation is generally
offered as an incentive to drug developers to invest in developing and commercializing products for unique diseases that impact
a limited number of patients. The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. Qualification to maintain
orphan drug status is generally monitored by the regulatory authorities during the orphan drug exclusivity period, currently seven
years from the date of approval in the United States.
We have been granted orphan drug designation in the United States
for GBM, ovarian cancer, and medulloblastoma, and in Europe for GBM. We expect to rely on orphan drug exclusivity for our product
candidate. It is possible that the incidence and prevalence numbers for GBM could change. Should the incidence and prevalence of
GBM patients materially increase, it is possible that the orphan drug designation, and related market exclusivity, in the United
States could be lost. Further, while we have been granted this orphan designation, the FDA can still approve different drugs for
use in treating the same indication or disease, which would create a more competitive market for us and our revenues will be diminished.
Further, it is possible that another company also holding orphan
drug designation for the same product candidate will receive marketing approval for the same indication before we do. If that were
to happen, our applications for that indication may not be approved until the competing company’s period of exclusivity expires.
Even if we are the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which a
competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as if the
later product is shown to be clinically superior to the orphan product, or if the later product is deemed a different product than
ours. Further, the seven-year marketing exclusivity would not prevent competitors from obtaining approval of the same product candidate
as ours for indications other than those in which we have been granted orphan drug designation, or for the use of other types of
products in the same indications as our orphan product.
If the market opportunities for our product candidate
are smaller than we believe they are, our revenues may be adversely affected and our business may suffer. Because the target patient
populations of our product candidate are small, we must be able to successfully identify patients and capture a significant market
share to achieve and maintain profitability.
We focus our research and product development on treatments
for orphan cancer indications. Our projections of both the number of people who have failed other therapies or have limited medical
options, are based on estimates. These estimates may prove to be incorrect and new studies may change the estimated incidence or
prevalence. The number of patients in the United States, Europe and elsewhere may turn out to be lower than expected or may not
be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access
to, all of which would adversely affect our results of operations and our business. Additionally, because our target patient populations
are small, we will be required to capture a significant market share to achieve and maintain profitability.
We may be required to suspend or discontinue clinical
studies due to unexpected side effects or other safety risks that could preclude approval of our products.
Our clinical studies may be suspended at any time for a number
of reasons. For example, we may voluntarily suspend or terminate our clinical studies if at any time we believe that they present
an unacceptable risk to the clinical study patients. In addition, the FDA or other regulatory agencies may order the temporary
or permanent discontinuation of our clinical studies at any time if they believe that the clinical studies are not being conducted
in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to the clinical study patients.
Administering any product candidate to humans may produce undesirable
side effects. These side effects could interrupt, delay or halt clinical studies of our product candidates and could result in
the FDA or other regulatory authorities denying further development or approval of our product candidates for any or all targeted
indications. Ultimately, some or all of our product candidates may prove to be unsafe for human use. Moreover, we could be subject
to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects or even death as a result
of participating in our clinical studies.
We may not receive regulatory approvals for our product
candidate or there may be a delay in obtaining such approvals.
Our product and our ongoing development activities are subject
to regulation by regulatory authorities in the countries in which we or our collaborators and distributors wish to test, manufacture
or market our products. For instance, the FDA will regulate the product in the U.S. and equivalent authorities, such as the EMA,
will regulate in Europe. Regulatory approval by these authorities will be subject to the evaluation of data relating to the quality,
efficacy and safety of the product for its proposed use, and there can be no assurance that the regulatory authorities will find
our data sufficient to support product approval of VAL-083 or any future product candidates.
The time required to obtain regulatory approval varies between
countries. The FDA is required to facilitate the development and expedite the review of drugs and biologics that are intended for
the treatment of a serious or life-threatening disease or condition and which demonstrate the potential to address unmet medical
needs for the condition. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy
that may be potentially better than available therapy. Under the fast track program, the sponsor of a new drug or biologic candidate
may request the FDA to designate the product for a specific indication as a fast track product concurrent with or after the filing
of the IND for the product candidate. The FDA must determine if the product candidate qualifies for fast track designation within
60 days after receipt of the sponsor’s request. In the U.S., for products without “Fast Track” status, it can
take over eighteen (18) months after submission of an application for product approval to receive the FDA’s decision. Even
with Fast Track status, FDA review and decision can take over twelve (12) months.
In December 2017, the FDA granted Fast Track designation for
VAL-083 in rGBM.
Different regulators may impose their own requirements and may
refuse to grant, or may require additional data before granting, an approval, notwithstanding that regulatory approval may have
been granted by other regulators. Regulatory approval may be delayed, limited or denied for a number of reasons, including insufficient
clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not
meeting applicable requirements as well as case load at the regulatory agency at the time.
We may fail to comply with regulatory requirements.
Our success will be dependent upon our ability, and our collaborative
partners’ abilities, to maintain compliance with regulatory requirements, including cGMP, and safety reporting obligations.
The failure to comply with applicable regulatory requirements can result in, among other things, fines, injunctions, civil penalties,
total or partial suspension of regulatory approvals, refusal to approve pending applications, recalls or seizures of products,
operating and production restrictions and criminal prosecutions.
Even if our product candidate receives marketing approval,
it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community
necessary for commercial success and the market opportunity for the product candidate may be smaller than we estimate.
We have never commercialized a product. Even if VAL-083 or any
other product candidate is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to
gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example,
physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or
convenient treatments enter the market. Further, patients often acclimate to the therapy that they are currently taking and do
not want to switch unless their physicians recommend switching products or they are required to switch therapies due to lack of
reimbursement for existing therapies.
Efforts to educate the medical community and third-party payors
on the benefits of our product candidate may require significant resources and may not be successful. If our product candidate
is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not
become profitable. The degree of market acceptance of VAL-083 or any other product candidate, if approved for commercial sale,
will depend on a number of factors, including:
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the efficacy and safety of the product;
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the potential advantages of the product compared to alternative treatments;
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the prevalence and severity of any side effects;
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the clinical indications for which the product is approved;
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whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line
therapy;
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limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;
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our ability to offer the product for sale at competitive prices;
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our ability to establish and maintain pricing sufficient to realize a meaningful return on our investment;
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the product’s convenience and ease of administration compared to alternative treatments;
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the willingness of the target patient population to try, and of physicians to prescribe, the product;
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the strength of sales, marketing and distribution support;
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the approval of other new products for the same indications;
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changes in the standard of care for the targeted indications for the product;
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the timing of market introduction of our approved products as well as competitive products and other therapies;
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availability and amount of reimbursement from government payors, managed care plans and other third-party payors;
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adverse publicity about the product or favorable publicity about competitive products; and
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potential product liability claims.
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The potential market opportunities for our product candidate
are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many assumptions, including
industry knowledge and publications, third-party research reports and other surveys. While we believe that our internal assumptions
are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain
and the reasonableness of these assumptions has not been assessed by an independent source. If any of the assumptions proves to
be inaccurate, the actual markets for our product candidate could be smaller than our estimates of the potential market opportunities.
If our product candidate receives marketing approval and
we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that
were not previously identified, our ability to market the drug could be compromised.
Clinical studies of our product candidate are conducted in carefully
defined subsets of patients who have agreed to enter into clinical studies. Consequently, it is possible that our clinical studies
may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively
fail to identify undesirable side effects. If, following approval of our product candidate, we, or others, discover that the drug
is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following
adverse events could occur:
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regulatory authorities may withdraw their approval of the drug or seize the drug;
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we may be required to recall the drug or change the way the drug is administered;
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additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;
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we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
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regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
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we may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution
to patients;
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we could be sued and held liable for harm caused to patients;
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the drug may become less competitive; and
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our reputation may suffer.
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Any of these events could have a material and adverse effect
on our operations and business and could adversely impact our stock price.
Any product candidate for which we obtain marketing approval,
along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional activities
for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities.
These requirements include submissions of safety and other post-marketing
information, reports, registration and listing requirements, good manufacturing practices, or GMP requirements relating to quality
control, quality assurance and corresponding maintenance of records and documents, and recordkeeping. Even if marketing approval
of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may
be marketed or to conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor
the safety or efficacy of the product. The FDA closely regulates the post-approval marketing and promotion of pharmaceutical products
to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labeling.
In addition, later discovery of previously unknown problems
with our products, manufacturing processes, or failure to comply with regulatory requirements, may lead to various adverse results,
including:
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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restrictions on product distribution or use;
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requirements to conduct post-marketing clinical studies;
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requirements to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval;
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warning letters issued by the FDA or other regulatory authorities;
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withdrawal of the products from the market;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products, fines, restitution or disgorgement of profits or revenue;
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suspension, revocation or withdrawal of marketing approvals;
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refusal to permit the import or export of our products; and
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injunctions or the imposition of civil or criminal penalties.
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If we are unable to establish sales, marketing and distribution
capabilities or enter into acceptable sales, marketing and distribution arrangements with third parties, we may not be successful
in commercializing any product candidates that we develop, if and when those product candidates are approved.
We do not have a sales, marketing or distribution infrastructure
and have limited experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for
any approved product, we must either develop a sales and marketing organization, outsource these functions to third parties, or
license our product candidates to others. If approved, we may seek to license VAL-083 to a large pharmaceutical company with greater
resources and experience than us. We may not be able license the VAL-083 on reasonable terms, if at all. The development of sales,
marketing and distribution capabilities will require substantial resources, will be time-consuming and could delay any product
launch. We expect that we will commence the development of these capabilities prior to receiving approval of our product candidate.
If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and distribution capabilities
is delayed or does not occur for any reason, we could have prematurely or unnecessarily incurred these commercialization costs.
Such a delay may be costly, and our investment could be lost if we cannot retain or reposition our sales and marketing personnel.
In addition, we may not be able to hire or retain a sales force in the United States that is sufficient in size or has adequate
expertise in the medical markets that we plan to target. If we are unable to establish or retain a sales force and marketing and
distribution capabilities, our operating results may be adversely affected. If a potential partner has development or commercialization
expertise that we believe is particularly relevant to our product candidate, then we may seek to collaborate with that potential
partner even if we believe we could otherwise develop and commercialize the product independently.
We expect to seek one or more strategic partners for commercialization
of our product candidate outside the United States. As a result of entering into arrangements with third parties to perform sales,
marketing and distribution services, our product revenues or the profitability of these product revenues may be lower, perhaps
substantially lower, than if we were to directly market and sell products in those markets. Furthermore, we may be unsuccessful
in entering into the necessary arrangements with third parties or may be unable to do so on terms that are favorable to us. In
addition, we may have little or no control over such third parties, and any of them may fail to devote the necessary resources
and attention to sell and market our products effectively.
If we do not establish sales and marketing capabilities, either
on our own or in collaboration with third parties, we will not be successful in commercializing our product candidate.
We face substantial competition from other pharmaceutical
and biotechnology companies and our operating results may suffer if we fail to compete effectively.
The development and commercialization of new drug products is
highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical
companies and biotechnology companies worldwide with respect to VAL-083 and any other product candidates that we may seek to develop
or commercialize in the future. Specifically, due to the large unmet medical need, global demographics and relatively attractive
reimbursement dynamics, the oncology market is fiercely competitive and there are a number of large pharmaceutical and biotechnology
companies that currently market and sell products or are pursuing the development of product candidates for the treatment of cancer.
Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective, have
fewer or more tolerable side effects or are less costly than any product candidates that we are currently developing or that we
may develop, which could render our product candidates obsolete and noncompetitive.
All of the top ten global pharmaceutical companies and many
of the mid-size pharmaceutical companies have a strong research and development and commercial presence in oncology. Smaller companies
also focus on oncology, including companies such as ARIAD Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc., BIND Therapeutics,
Inc., Clovis Oncology, Inc., Endocyte, Inc., Epizyme, Inc., ImmunoGen, Inc., Incyte Corporation, Infinity Pharmaceuticals, Inc.,
MacroGenics, Inc., Merrimack Pharmaceuticals, Inc., OncoMed Pharmaceuticals, Inc., Onconova Therapeutics, Inc., Pharmacyclics,
Inc., Puma Biotechnology, Inc., Seattle Genetics, Inc. and TESARO, Inc.
Several companies are marketing and developing oncology immunotherapy
products. Companies with approved marketed oncology products for GBM are Merck (Temodar
®
) and Genentech (Avastin
®
). Companies with oncology immunotherapy product candidates in clinical development include, but are not limited
to, Northwest Biotherapeutics (DCVax-L), Celldex Therapeutics (Rindopepimut (CDX-110)) and ImmunoCellular Therapeutics (ICT-107).
Our commercial opportunity could be reduced or eliminated if
our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are
more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other marketing
approval for their products before we are able to obtain approval for ours, which could result in our competitors establishing
a strong market position before we are able to enter the market.
Many of our existing and potential future competitors have significantly
greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical
studies, obtaining marketing approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller
or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management
personnel and establishing clinical study sites and patient registration for clinical studies, as well as in acquiring technologies
complementary to, or necessary for, our programs.
If we are unable to or delayed in obtaining state regulatory
licenses for the distribution of our product, we would not be able to sell our product candidate.
The majority of states require manufacturer and/or wholesaler
licenses for the sale and distribution of drugs into that state. The application process is complicated, time consuming and requires
dedicated personnel or a third-party to oversee and manage. If we are delayed in obtaining these state licenses, or denied the
licenses, even with FDA approval, we would not be able to sell or ship product into that state which would adversely affect our
sales and revenues.
We rely on key personnel and, if we are unable to retain
or motivate key personnel or hire qualified personnel, we may not be able to grow effectively.
We are dependent on certain members of our management, scientific
and drug development staff and consultants, the loss of services of one or more of whom could materially adversely affect us.
We currently have two full-time employees, and retain the services
of approximately 15 persons on an independent contractor/consultant and contract-employment basis. Our ability to manage growth
effectively will require us to continue to implement and improve our management systems and to recruit and train new employees.
Although we have done so in the past and expect to do so in the future, there can be no assurance that we will be able to successfully
attract and retain skilled and experienced personnel.
Our success depends in large part upon our ability to attract
and retain highly qualified personnel. We compete in our hiring efforts with other pharmaceutical and biotechnology companies,
as well as universities and nonprofit research organizations, and we may have to pay higher salaries to attract and retain personnel,
which would be very costly.
We may be subject to foreign exchange fluctuation.
Our functional and reporting currency is the United States dollar.
We maintain bank accounts in United States and Canadian dollars. A portion of our expenditures are in foreign currencies, most
notably in Canadian dollars, and therefore we are subject to foreign currency fluctuations, which may, from time to time, impact
our financial position and results. We may enter into hedging arrangements under specific circumstances, typically through the
use of forward or futures currency contracts, to minimize the impact of increases in the value of the Canadian dollar. In order
to minimize our exposure to foreign exchange fluctuations we may hold sufficient Canadian dollars to cover our expected Canadian
dollar expenditures.
Product liability lawsuits against us could divert our
resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
We face an inherent risk of product liability claims as a result
of the clinical testing of our product candidate despite obtaining appropriate informed consents from our clinical study participants.
We will face an even greater risk if we commercially sell any product that we may develop. For example, we may be sued if any product
we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or
sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn
of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under
state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial
liabilities or be required to limit commercialization of our product candidate. Regardless of the merits or eventual outcome, liability
claims may result in:
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decreased demand for our product candidate or products that we may develop;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical study participants;
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significant costs to defend resulting litigation;
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substantial monetary awards to study participants or patients;
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reduced resources of our management to pursue our business strategy; and
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the inability to commercialize any products that we may develop.
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Although we maintain general liability insurance, this insurance
may not fully cover potential liabilities that we may incur. The cost of any product liability litigation or other proceeding,
even if resolved in our favor, could be substantial. We will need to increase our insurance coverage if and when we begin selling
any product candidate that receives marketing approval. In addition, insurance coverage is becoming increasingly expensive. If
we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential
product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate,
which could adversely affect our business, financial condition, results of operations and prospects.
Risks Related to Our Dependence on Third Parties
We rely on third parties to conduct clinical studies for
our product candidate. Any failure by a third-party to meet its obligations with respect to the clinical development of our product
candidate may delay or impair our ability to obtain regulatory approval for our product candidate.
We rely on academic institutions and private oncology centers
to conduct our clinical studies. Our reliance on third parties to conduct clinical studies could, depending on the actions of such
third parties, jeopardize the validity of the clinical data generated and adversely affect our ability to obtain marketing approval
from the FDA or other applicable regulatory authorities.
Such clinical study arrangements provide us with information
rights with respect to the clinical data, including access to and the ability to use and reference the data, including for our
own regulatory filings, resulting from the clinical studies. If investigators or institutions breach their obligations with respect
to the clinical studies of our product candidate, or if the data proves to be inadequate, then our ability to design and conduct
any future clinical studies may be adversely affected.
We rely, and expect to continue to rely, on third parties
to conduct our clinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for
the completion of such studies.
We currently rely on third-party clinical research organizations,
or CROs, to conduct our clinical studies. We expect to continue to rely on third parties, such as CROs, clinical data management
organizations, medical institutions and clinical investigators, to conduct our clinical studies. Our agreements with these third
parties generally allow the third-party to terminate the agreement at any time. If we are required to enter into alternative arrangements
because of any such termination the introduction of our product candidates to market could be delayed.
Our reliance on these third parties for research and development
activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we design
our clinical studies and will remain responsible for ensuring that each of our clinical studies are conducted in accordance with
the general investigational plan and protocols for the study. Moreover, the FDA requires us to comply with standards, commonly
referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical studies to assure
that data and reported results are credible and accurate and that the rights, integrity and confidentiality of study participants
are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements.
We also are required to register ongoing clinical studies and post the results of completed clinical studies on a government-sponsored
database, ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and
criminal sanctions.
Furthermore, these third parties may also have relationships
with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual
duties, meet expected deadlines or conduct our clinical studies in accordance with regulatory requirements or our stated protocols,
we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able
to, or may be delayed in our efforts to, successfully commercialize our product candidates.
We also expect to rely on other third parties to store and distribute
drug supplies for our clinical studies. Any performance failure on the part of our distributors could delay clinical development
or marketing approval of our product candidate or commercialization of our products, producing additional losses and depriving
us of potential product revenue.
We may seek to enter into collaborations with third parties
for the development and commercialization of our product candidate. If we fail to enter into such collaborations, or such collaborations
are not successful, we may not be able to capitalize on the market potential of our product candidate.
We may seek third-party collaborators for development and commercialization
of our product candidate. Our likely collaborators for any marketing, distribution, development, licensing or broader collaboration
arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies, non-profit organizations,
government agencies, and biotechnology companies. We are currently party to a limited number of such arrangements and have limited
control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our
product candidate. Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to
successfully perform the functions assigned to them in these arrangements.
Collaborations involving our product candidate currently pose,
and will continue to pose, the following risks to us:
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collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
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collaborators may not pursue development and commercialization of our product candidate or may elect not to continue or renew
development or commercialization programs based on preclinical or clinical study results, changes in the collaborators’ strategic
focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
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collaborators may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study
or abandon a product candidate, repeat or conduct new clinical studies or require a new formulation of a product candidate for
clinical testing;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with
our product candidate if the collaborators believe that competitive products are more likely to be successfully developed or can
be commercialized under terms that are more economically attractive than ours;
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collaborators with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing
and distribution of such product or products;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in
such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or
expose us to potential litigation;
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collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential
liability;
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disputes may arise between the collaborators and us that result in the delay or termination of the research, development or
commercialization of our product candidate or that result in costly litigation or arbitration that diverts management attention
and resources; and
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collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development
or commercialization of the applicable product candidates.
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Collaboration agreements may not lead to development or commercialization
of our product candidate in the most efficient manner or at all. If a collaborator of ours were to be involved in a business combination,
the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.
If we are not able to establish collaborations, we may
have to alter our development and commercialization plans.
Our drug development programs and the potential commercialization
of our product candidate will require substantial additional cash to fund expenses. We may decide to collaborate with pharmaceutical
and biotechnology companies for the development and potential commercialization of our product candidate.
We face significant competition in seeking appropriate collaborators.
Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s
resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation
of a number of factors. Those factors may include the design or results of preclinical studies or clinical studies, the likelihood
of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product
candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing
products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to
such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may
also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and
whether such a collaboration could be more attractive than the one with us for our product candidate. We may also be restricted
under future license agreements from entering into agreements on certain terms with potential collaborators. Collaborations are
complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations
among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.
We may not be able to negotiate collaborations on a timely basis,
on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of our product candidate, reduce
or delay its development program, delay its potential commercialization or reduce the scope of any sales or marketing activities,
or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase
our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which
may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop
our product candidate or bring it to market and generate product revenue.
We currently manufacture our clinical supplies at a single
location. Any disruption at this facility could adversely affect our business and results of operations.
We have engaged a single manufacturer to produce GMP active
pharmaceutical ingredient and a single manufacturer to produce drug product for our clinical studies. In addition, we have relied
on our manufacturing partner, Guangxi Wuzhou Pharmaceutical Company, for the manufacture of clinical supply of VAL-083 for our
preclinical and Phase 2 clinical studies to-date. If our manufacturer’s facility were damaged or destroyed, or otherwise
subject to disruption, it would require substantial lead-time to replace our clinical supply. In such event, we would be forced
to rely entirely on other third-party contract manufacturers for an indefinite period of time. We do not currently have established
relationships with any back-up manufacturers. At this time no drug product has been manufactured by a third-party back-up manufacturer.
Any disruptions or delays by our third-party manufacturers or Guangxi Wuzhou Pharmaceutical Company or their failure to meet regulatory
compliance could impair our ability to develop VAL-083, which would adversely affect our business and results of operations.
We rely on these third-party manufacturers to provide drug product
supply for our clinical studies. There is no assurance that such a supplier will be able to meet our needs from a technical, timing,
or cost-effective manner. Our failure to enter into appropriate agreements with such a third-party manufacturer would delay, or
halt, our clinical studies.
We may become subject to liabilities related to risks
inherent in working with hazardous materials.
Our discovery and development processes involve the controlled
use of hazardous and radioactive materials. We are subject to federal, provincial and local laws and regulations governing the
use, manufacture, storage, handling and disposal of such materials and certain waste products. Although we believe that our safety
procedures for handling and disposing of such materials comply with the standards prescribed by such laws and regulations, the
risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident,
we could be held liable for any damages that result and any such liability could exceed our resources. We are not specifically
insured with respect to this liability. Although we believe that we are in compliance in all material respects with applicable
environmental laws and regulations and currently do not expect to make material capital expenditures for environmental control
facilities in the near-term, there can be no assurance that we will not be required to incur significant costs to comply with environmental
laws and regulations in the future, or that our operations, business or assets will not be materially adversely affected by current
or future environmental laws or regulations.
Risks Related to Our Common Stock
The market price of our common stock is, and is likely
to continue to be, highly volatile and subject to wide fluctuations.
The market price of our common stock is highly volatile and
could be subject to wide fluctuations in response to a number of factors that are beyond our control, including:
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variations in our quarterly operating results;
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announcements that our revenue or income are below analysts’ expectations;
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general economic slowdowns;
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sales of large blocks of our common stock; and
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announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures or capital
commitments.
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Because we became public by means of a reverse acquisition,
we may not be able to attract, or maintain, the attention of brokerage firms.
Because we became public through a “reverse acquisition”,
securities analysts of brokerage firms may not provide or continue to provide coverage of us since there is little incentive to
brokerage firms to recommend the purchase of our common stock. No assurance can be given that brokerage firms will want to conduct
any follow-on offerings on behalf of us in the future.
Voting power of our shareholders is highly concentrated
by insiders.
Our officers, directors, and 5% shareholders control, either
directly or indirectly, a substantial portion of our voting securities. Therefore, our management may significantly affect the
outcome of all corporate actions and decisions for an indefinite period of time including election of directors, amendment of charter
documents and approval of mergers and other significant corporate transactions.
We do not intend to pay dividends on our common stock
for the foreseeable future.
We have paid no dividends on our common stock to date and we
do not anticipate paying any dividends to holders of our common stock in the foreseeable future. While our future dividend policy
will be based on the operating results and capital needs of the business, we currently anticipate that any earnings will be retained
to finance our future expansion and for the implementation of our business plan. Investors should take note of the fact that a
lack of a dividend can further affect the market value of our common stock, and could significantly affect the value of any investment
in us.
Our articles of incorporation allow for our board to create
new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders
of our common stock.
Our Board of Directors has the authority to fix and determine
the relative rights and preferences of preferred stock. Our Board of Directors has the authority to issue up to 5,000,000 shares
of our preferred stock (of which 1 share has been designated Special Voting Preferred Stock and is issued and outstanding, 278,530
shares have been designated Series A Preferred Stock and are issued and outstanding, and 1,000,000 shares have been designated
as Series B Preferred Stock, of which 648,613 shares are issued and outstanding, as of August 8, 2019) without further stockholder
approval. As a result, our Board of Directors could authorize the issuance of additional series of preferred stock that would
grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are
distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the
redemption of our common stock. In addition, our Board of Directors could authorize the issuance of a series of preferred stock
that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative
voting power of our common stock or result in dilution to our existing stockholders. Although we have no present intention to
issue any additional shares of preferred stock or to create any additional series of preferred stock, we may issue such shares
in the future.
Our issuance of common stock upon exercise of warrants,
Performance Share Units, or options, exchange of Exchangeable Shares, or conversion of Series B Preferred Stock may depress the
price of our common stock.
As of August 8, 2019, we had 3,838,483 shares of common
stock issued and outstanding, 7,813 shares of common stock issuable upon exchange of the Exchangeable Shares of Exchangeco (which
entitle the holder to require Exchangeco to redeem (or, at the option of us or Callco, to have us or Callco purchase) the Exchangeable
Shares, and upon such redemption or purchase to receive an equal number of shares of our common stock) (the Exchangeable Shares
are recognized on an as-exchanged for common stock basis for financial statement purposes), outstanding warrants to purchase 1,543,596
shares of common stock, outstanding Series B convertible preferred shares that are convertible into 162,177 shares of common stock
and outstanding options to purchase 288,183 shares of common stock. All Exchangeable Shares, warrants, and options are convertible
or exercisable into one share of common stock. Each share of Series B preferred stock is convertible into 0.25 shares of common
stock. The issuance of shares of common stock upon exercise of outstanding warrants or options or exchange of Exchangeable Shares
could result in substantial dilution to our stockholders, which may have a negative effect on the price of our common stock.
Risks Related to This Offering
Management will have broad discretion as to the use of
the proceeds from this offering, and we may not use the proceeds effectively.
Our management will have broad discretion in the application
of the net proceeds from this offering, including for any of the purposes described in the section entitled “Use of Proceeds,”
and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. Our
failure to apply these funds effectively could have a material adverse effect on our business and cause the price of our common
stock to decline.
You will experience immediate and substantial dilution
in the net tangible book value per share of the common stock you purchase.
Based on a combined public offering price of $1.61 per share
and related warrant (the last reported sales price of our common stock as of August 8, 2019) and taking into consideration the
securities issued in the RD Offering, if you purchase shares of our common stock and related warrants in this offering, you will
suffer immediate and substantial dilution of $0.40 per share with respect to the net tangible book value of the common stock.
See the section entitled “Dilution” below for a more detailed discussion of the dilution you will incur if you purchase
common stock in this offering.
You may experience future dilution as a result of future
equity offerings and other issuances of our common stock or other securities. In addition, this offering and future equity offerings
and other issuances of our common stock or other securities may adversely affect our common stock price.
In order to raise additional capital, we may in the future
offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices
that may not be the same as the price per share in this offering. We may not be able to sell shares or other securities in any
other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and
investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per
share at which we sell additional shares of our common stock or securities convertible into common stock in future transactions
may be higher or lower than the price per share in this offering. You will incur dilution upon exercise of any outstanding stock
options, warrants or upon the issuance of shares of common stock under our stock incentive programs. In addition, the sale of
shares in this offering and any future sales of a substantial number of shares of our common stock in the public market, or the
perception that such sales may occur, could adversely affect the price of our common stock. We cannot predict the effect, if any,
that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the
market price of our common stock.
Holders of our warrants and Pre-Funded Warrants will have
no rights as a common stockholder until they acquire our common stock.
Until you acquire shares of our common stock upon exercise of
your warrants or Pre-Funded Warrants, you will have no rights with respect to shares of our common stock issuable upon exercise
of your warrants or Pre-Funded Warrants. Upon exercise of your warrants or Pre-Funded Warrants, you will be entitled to exercise
the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
There is no public market for the warrants to purchase
shares of our common stock or Pre-Funded Warrants being offered in this offering.
There is no established public trading market for the warrants
or Pre-Funded Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not
intend to apply to list the warrants or Pre-Funded Warrants on any national securities exchange or other nationally recognized
trading system, including The Nasdaq Capital Market. Without an active trading market, the liquidity of the warrants and Pre-Funded
Warrants will be limited.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on our management’s current beliefs,
expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions
containing these forward-looking statements may be found, among other places, in the Sections entitled “Business,”
“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.
All statements, other than statements of historical fact, included
regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives
are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,”
“believe,” “seek,” “estimate,” “think,” “may,” “could,”
“will,” “would,” “should,” “continue,” “potential,” “likely,”
“opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements
but are not the exclusive means of identifying forward-looking statements. Examples of our forward-looking statements include:
|
●
|
our ability to raise funds for general corporate purposes and operations, including our research activities and clinical trials;
|
|
●
|
our ability to recruit qualified management and technical personnel;
|
|
●
|
the success of our clinical trials;
|
|
●
|
our ability to expand our international business;
|
|
●
|
our ability to obtain and maintain required regulatory approvals for our products;
|
|
●
|
our expectations regarding the use of our existing cash and the expected net proceeds of this offering;
|
|
●
|
our ability to obtain or maintain patents or other appropriate protection for the intellectual property utilized in our current
and planned products; and
|
|
●
|
the other factors discussed in the “Risk Factors” section and elsewhere in this prospectus.
|
Because forward-looking statements are inherently subject to
risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not
rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking
statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking
statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and
it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not
plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
USE OF PROCEEDS
We estimate that the net proceeds of this offering will
be approximately $7.1 million assuming the sale of the shares of our common stock and warrants to purchase shares of
our common stock at an assumed combined public offering price of $1.61 per share and related warrant (the last reported
sale price of our common stock on The Nasdaq Capital Market on August 8, 2019), after deducting the estimated underwriting discounts
and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the warrants.
If the underwriters exercise their option to purchase additional securities in full, we estimate that the net proceeds will be
approximately $8.2 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable
by us, and excluding the proceeds, if any, from the exercise of the warrants.
Each $0.50 increase (decrease) in the assumed combined public
offering price of $1.61 per share would increase (decrease) the net proceeds to us from this offering by approximately $2.3 million,
assuming the number of shares and warrants offered by us, as set forth on the cover page of this prospectus, remains the same,
after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also
increase or decrease the number of shares of our common stock and warrants we are offering. An increase (decrease) of 1,000,000
in the number of shares sold in this offering would increase (decrease) the expected net proceeds of the offering to us by approximately
$1.5 million, assuming that the assumed combined public offering price per share and the related warrant coverage remains
the same.
We intend to use the net proceeds from this offering for our
clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development
and other commercial expenditures. In addition, we may use the net proceeds from this offering for investments in businesses, products
or technologies that are complementary to our business, although we have no present commitments or agreements to make any such
investments as of the date of this prospectus. We expect to use any proceeds we receive from the exercise of Warrants for substantially
the same purposes and in substantially the same manner. Pending these uses, we intend to invest the funds in short-term, investment
grade, interest-bearing securities. It is possible that, pending their use, we may invest the net proceeds in a way that does not
yield a favorable, or any, return for us.
Our management will have broad discretion as to the allocation
of the net proceeds from this offering and could use them for purposes other than those contemplated at the time of commencement
of this offering.
Capitalization
The following table sets forth our cash and cash equivalents
and capitalization as of March 31, 2019:
|
●
|
on an as adjusted basis to give further effect to our sale of 1,170,000 shares of common stock and warrants to purchase 760,500
shares of common stock in the registered direct offering which closed on June 5, 2019 (the “RD Offering”); and
|
|
●
|
on an as adjusted basis to give further effect to
our sale of 4,968,944 shares of common stock and/or pre-funded warrants to purchase 4,968,944
shares of common stock and warrants to purchase 4,968,944 shares of common stock in this
offering at a public offering price of $1.61 per share and warrant, respectively, after
deducting the underwriting discounts and commissions and estimated offering expenses
payable by us, and excluding the proceeds, if any, from the exercise of the common warrants
or pre-funded warrants issued pursuant to this offering.
|
You should read this table together with
our consolidated financial statements and the related notes and the “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” section of this prospectus.
|
|
Actual
(as of March 31,
2019)
|
|
|
As
adjusted (as of the RD Offering)
|
|
|
As
adjusted (including the RD Offering and this
offering
(4)
)
|
|
Cash
and cash equivalents
|
|
$
|
2,152,233
|
|
|
$
|
5,352,233
|
|
|
$
|
12,452,233
|
|
Derivative
liability
(3)
|
|
$
|
265
|
|
|
$
|
925,265
|
|
|
$
|
925,265
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value per share; 5,000,000 shared authorized
|
|
|
|
|
|
|
|
|
|
|
|
|
278,530 Series
A shares
(1)
|
|
|
278,530
|
|
|
|
278,530
|
|
|
|
278,530
|
|
841,113 Series
B shares
(1)
|
|
|
5,867,829
|
|
|
|
5,867,829
|
|
|
|
5,867,829
|
|
1 special voting
share
(1)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Common
stock, $0.001 par value per share
(2)
; 2,620,033 shares
(1)
, 3,790,033 as adjusted for the RD Offering;
8,758,977 as adjusted for the RD Offering and this offering
|
|
|
2,620
|
|
|
|
3,790
|
|
|
|
8,759
|
|
Other equity
(3)
|
|
|
53,098,749
|
|
|
|
55,372,579
|
|
|
|
62,467,610
|
|
Accumulated
deficit
|
|
|
(57,988,567
|
)
|
|
|
(57,988,567
|
)
|
|
|
(57,988,567
|
)
|
Total stockholders’
equity
|
|
$
|
1,259,161
|
|
|
$
|
3,534,161
|
|
|
$
|
10,634,161
|
|
|
(1)
|
Issued and outstanding at March 31, 2019.
|
|
(2)
|
7,000,000 authorized shares of common stock as of March
31, 2019 and 95,000,000 authorized shares of common stock as of August 8, 2019.
|
|
(3)
|
Issued warrants for the RD Offering are assumed to be treated as a derivative liability. The warrants included in this offering have been assumed to be treated as a net increase in equity.
|
|
(4)
|
Excludes the exercise of the underwriters’ option
to purchase additional securities.
|
The foregoing tables and calculations are based 2,620,033 shares
of our common stock outstanding as of March 31, 2019 and excludes as of such date:
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●
|
292,683 shares of our common stock issuable upon the exercise of stock options, with a weighted-average exercise price of $22.40
per share;
|
|
●
|
120,000 shares of our common stock issuable upon the settlement of outstanding performance stock units, which units were cancelled effective as of April 30, 2019;
|
|
●
|
862,503 shares of our common stock issuable upon the exercise of outstanding warrants, with a weighted-average exercise price
of $24.80 per share; and
|
|
|
|
|
●
|
367,317 other shares of our common stock reserved for
future issuance under our 2017 Omnibus Equity Incentive Plan.
|
DILUTION
If you purchase shares of our common stock and warrants in this
offering, you will experience dilution to the extent of the difference between the combined public offering price per share and
related warrant in this offering and our as adjusted net tangible book value per share immediately after this offering assuming
no value is attributed to the warrants. Net tangible book value per share is equal to the amount of our total tangible assets,
less total liabilities, divided by the number of outstanding shares of our common stock. As of March 31, 2019, our net tangible
book value was approximately $1.2 million, or $0.46 per share of our common stock (based upon 2,620,033 shares of our common stock
on an as-exchanged basis with respect to the shares of Exchangeco that can be exchanged for shares of common stock of the Company
and taking into account the one-for-ten reverse stock split effective on May 8, 2019).
Based on the sale by us in the RD Offering of 1,170,000
shares of common stock and, in a concurrent private placement, warrants to purchase 760,500 shares of common stock, at the combined
purchase price of $3.10 per share of common stock and related warrant (assuming no exercise of such warrants), taking into account
the one-for-ten reverse stock split of our common stock effective on May 8, 2019, and net cash proceeds of $3.2 million, less
a resulting increase in derivative liability of $925,000 for a net increase in net tangible book value of $2.3 million, after
deducting estimated offering expenses and placement agent fees and expenses payable by us, our as adjusted net tangible book value
as of March 31, 2019 would have been approximately $3.5 million, or $0.92 per share of our common stock.
After giving effect to the assumed sale by us of
4,968,944 shares of our common stock (assuming no Pre-Funded Warrants in lieu of common stock issued) and warrants to
purchase up to 4,968,944 shares of our common stock in this offering at an assumed combined public offering price of $1.61
per share and related warrant (the last reported sale price of our common stock on The Nasdaq Capital Market on August 8,
2019), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us,
our pro forma, as adjusted net tangible book value as of March 31, 2019 would have been approximately $10.6 million, or
approximately $1.21 per share of our common stock. This represents an immediate increase in net tangible book value of $0.29
per share to existing stockholders and an immediate dilution of $0.40 per share to new investors purchasing shares of our
common stock and related warrants in this offering, attributing none of the assumed combined public offering price to the
warrants offered hereby. The following table illustrates this per share dilution:
Assumed combined public
offering price per share and related warrant
|
|
|
|
|
|
$
|
1.61
|
|
Historical net tangible book value per share
as of March 31, 2019
|
|
$
|
0.46
|
|
|
|
|
|
Increase in net tangible book value as adjusted for the RD Offering
|
|
$
|
0.46
|
|
|
|
|
|
As adjusted net tangible book value per share
as of March 31, 2019
|
|
$
|
0.92
|
|
|
|
|
|
Increase in net tangible book value per share
after this offering
|
|
$
|
0.29
|
|
|
|
|
|
As adjusted net tangible book value per share
after this offering
|
|
|
|
|
|
$
|
1.21
|
|
Dilution per
share to new investors
|
|
|
|
|
|
$
|
0.40
|
|
If the underwriters exercise their option to purchase additional
securities in full, the pro forma, as adjusted net tangible book value per share after this offering would be $1.23 per share,
the increase in net tangible book value per share to existing stockholders would be $0.31 per share and the dilution to new investors
purchasing units in this offering would be $0.38 per share.
A $0.50 increase (decrease) in the assumed combined public
offering price of $1.61 per share and related warrant would result in an increase (decrease) in our pro forma, as adjusted net
tangible book value of approximately $2.3 million or approximately $0.26 per share, and would result in an increase (decrease)
in the dilution to new investors of approximately $0.24 per share, assuming that the number of shares of our common stock and
related warrants sold by us remains the same and that the underwriters do not exercise their option to purchase additional securities,
after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
We may also increase or decrease the number of shares of
common stock and related warrants we are offering from the assumed number of shares of common stock and related warrants set forth
above. An increase of 1,000,000 in the assumed number of shares of common stock and related warrants sold by us in this offering
would result in an increase in our as adjusted net tangible book value of approximately $1.5 million or approximately $0.03 per
share, and would result in a decrease in the dilution to new investors of approximately $0.03 per share, assuming that the assumed
combined public offering price remains the same, after deducting the estimated underwriting discounts and commissions and estimated
offering expenses payable by us. A decrease of 1,000,000 in the assumed number of shares of common stock and related warrants
sold by us in this offering would result in a decrease in our as adjusted net tangible book value of approximately $1.5 million
or approximately $0.04 per share, and would result in an increase in the dilution to new investors of approximately $0.04 per
share, assuming that the assumed combined public offering price remains the same and that the underwriters do not exercise their
option to purchase additional securities, after deducting the estimated underwriting discounts and commissions and estimated offering
expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual public offering
price, the actual number of shares and related warrants sold in this offering and other terms of this offering determined at pricing.
The foregoing discussion and table do not take into account
further dilution to new investors that could occur upon the exercise of outstanding options or warrants having a per share exercise
price less than the per share offering price to the public in this offering. In addition, we may choose to raise additional capital
due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating
plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance
of these securities could result in further dilution to our stockholders.
The foregoing tables and calculations are based 2,620,033
shares of our common stock outstanding as of March 31, 2019 and excludes as of such date:
|
●
|
292,683
shares of our common stock issuable upon the exercise of stock options, with a weighted-average exercise price of $22.40 per
share;
|
|
|
|
|
●
|
120,000
shares of our common stock issuable upon the settlement of outstanding performance stock units, which units were cancelled
effective as of April 30, 2019;
|
|
|
|
|
●
|
862,503
shares of our common stock issuable upon the exercise of outstanding warrants, with a weighted-average exercise price of $24.80
per share; and
|
|
|
|
|
●
|
367,317 other shares of our common stock reserved for future issuance under our 2017 Omnibus Equity Incentive
Plan.
|
DIVIDEND POLICY
We have never declared or paid cash dividends on our common
stock. The holders of the Series A Preferred Stock are entitled to cumulative dividends at the rate of 3% of the stated value of
the Series A Preferred Stock per year, payable quarterly in arrears. The holders of the Series B Preferred Stock are entitled to,
pari passu with the Series A Preferred Stock, cumulative dividends at an annual rate of 9% of the stated value of the Series B
Preferred Stock and any dividends declared and paid on the common stock on an as-converted basis. Dividends on the Series B Preferred
Stock shall be payable solely in shares of common stock, in an amount for each holder equal to the aggregate dividend payable to
such holder with respect to the shares of Series B Preferred Stock held by such holder as of the dividend payment date, divided
by the applicable conversion price as of the dividend payment date.
Except as set forth above, we currently intend to retain our
future earnings, if any, for use in our business and therefore do not anticipate paying cash dividends on our common stock in the
foreseeable future. Payment of future dividends, if any, will be at the discretion of our board of directors after taking into
account various factors, including our financial condition, operating results, and current and anticipated cash needs.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
This Management’s Discussion and Analysis (“MD&A”)
contains “forward-looking statements”, within the meaning of the Private Securities Litigation Reform Act of 1995,
which represent our projections, estimates, expectations, or beliefs concerning, among other things, financial items that relate
to management’s future plans or objectives or to our future economic and financial performance. In some cases, you can identify
these statements by terminology such as “may”, “should”, “plans”, “believe”, “will”,
“anticipate”, “estimate”, “expect” “project”, or “intend”, including
their opposites or similar phrases or expressions. You should be aware that these statements are projections or estimates as to
future events and are subject to a number of factors that may tend to influence the accuracy of the statements. These forward-looking
statements should not be regarded as a representation by us or any other person that our events or plans will be achieved. You
should not unduly rely on these forward-looking statements, which speak only as of the date of this report. Except as may be required
under applicable securities laws, we undertake no obligation to publicly revise any forward-looking statement to reflect circumstances
or events after the date of this report or to reflect the occurrence of unanticipated events.
You should review the factors and risks we describe under “Risk
Factors” and “Forward-Looking Statements” included elsewhere in this prospectus.
Overview
We are a clinical stage, biopharmaceutical company focused on
the development and commercialization of new cancer therapies. Our mission is to benefit patients, by developing and commercializing
anti-cancer therapies for patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently
available therapies, particularly for orphan cancer indications where patients have failed, or are unlikely to respond to, currently
available therapy.
We are developing VAL-083, a novel, validated, DNA-targeting
agent, for the treatment of drug-resistant solid tumors such as glioblastoma multiforme (“GBM”) and potentially other
solid tumors, including ovarian cancer. VAL-083 is a first-in-class, small-molecule, DNA-targeting chemotherapeutic that demonstrated
activity against a range of tumor types in prior Phase 1 and Phase 2 clinical studies sponsored by the US National Cancer Institute
(“NCI”). As part of our business strategy, we leverage and build upon these prior NCI investments and data from more
than 40 NCI- Phase 1 and Phase 2 clinical studies with our own research to identify and target unmet medical needs in modern cancer
care. DNA-targeting agents are among the most successful and widely used treatments for cancer. Their efficacy is based on the
ability to bind with a cancer cell’s DNA and interfere with the process of protein production required for growth and survival
of cancer cells. “First-in-class” means that VAL-083 embodies a unique molecular structure which is not an analogue
or derivative of any approved product, or product under development, for the treatment of cancer.
Corporate History
We are a Nevada corporation formed on June 24, 2009 under the
name Berry Only, Inc. (“Berry’). Prior to a reverse acquisition undertaken on January 25, 2013 Berry did not have any
significant assets or operations. We are the parent company of Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”),
a British Columbia, Canada corporation incorporated on April 6, 2010, that is focused on the development of drugs for the treatment
of cancer. We are also the parent company to 0959454 B.C. Ltd., a British Columbia corporation (“Callco”), and 0959456
B.C. Ltd., a British Columbia corporation (“Exchangeco”). Callco and Exchangeco were formed to facilitate the reverse
acquisition.
Results of Operations
Comparison of the nine months ended March 31, 2019 and March
31, 2018
|
|
Nine months ended
|
|
|
|
|
|
|
|
|
|
March 31,
2019
$
|
|
|
March 31,
2018
$
|
|
|
Change
$
|
|
|
Change
%
|
|
Research and development
|
|
|
2,702,213
|
|
|
|
5,856,197
|
|
|
|
(3,153,984
|
)
|
|
|
(54
|
)
|
General and administrative
|
|
|
2,796,884
|
|
|
|
2,911,538
|
|
|
|
(114,654
|
)
|
|
|
(4
|
)
|
Change in fair value of derivative liability
|
|
|
(852
|
)
|
|
|
(57,839
|
)
|
|
|
56,987
|
|
|
|
(99
|
)
|
Foreign exchange loss
|
|
|
16,754
|
|
|
|
57,406
|
|
|
|
(40,652
|
)
|
|
|
(71
|
)
|
Interest income
|
|
|
(49,513
|
)
|
|
|
(6,241
|
)
|
|
|
(43,272
|
)
|
|
|
693
|
|
Net loss and comprehensive loss
|
|
|
5,465,486
|
|
|
|
8,761,061
|
|
|
|
(3,295,575
|
)
|
|
|
|
|
Research and Development
Research and development expenses decreased to $2,702,213 for
the nine months ended March 31, 2019 from $5,856,197 for the nine months ended March 31, 2018. The decrease was largely attributable
to a decrease in clinical development costs, personnel, preclinical research, intellectual property and travel costs during the
nine months ended March 31, 2019 compared to the nine months ended March 31, 2018. For the nine months ended March 31, 2019 and
2018 non-cash, share-based compensation expense of $74,735 and $135,367 respectively, related to stock option expense and shares
issued for services. During the nine months ended March 31, 2018, we entered into a separation agreement with our former President
and Chief Operating Officer that required the accelerated vesting of certain stock options. The full expense of the accelerated
vesting was recognized during the nine months ended March 31, 2018 resulting in a higher non-cash, share-based compensation expense
for the nine months ended March 31, 2018 compared to the nine months ended March 31, 2019.
Excluding the impact of non-cash, share-based compensation expense,
research and development expenses decreased to $2,627,478 during the current period from $5,720,830 for the prior period. The decrease
in clinical development costs for the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018 was primarily
due to the parking of our STAR-3, Phase 3 study which was announced in February 2018. During the nine months ended March 31, 2018,
we incurred significant study start-up costs. In addition, clinical development costs were higher in the prior period compared
to the current period due to the timing of certain manufacturing activities for the production of GMP material and related stability
studies. Clinical development costs can vary significantly due to the timing of patient enrollment, how a patient reacts to treatment,
and the number of treatment cycles a patient receives.
Personnel costs decreased during the nine months ended March
31, 2019 compared to the nine months ended March 31, 2018 primarily due to amounts recognized pursuant to the settlement agreement
with our former President and Chief Operating Officer. Preclinical research decreased largely due to a decrease in the ongoing
mechanism of action research that we have undertaken in the prior period. Intellectual property costs decreased in the nine months
ended March 31, 2019 compared to the nine months ended March 31, 2018 as we have refined our patent portfolio by focusing on our
most important patent claims in the most important jurisdictions. Patent costs can vary considerably depending on the filing of
new patents, conversion of the provisional applications to PCT applications, foreign office actions, and actual filing costs. Travel
costs have decreased in the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018 as we have focused
on reducing all travel expenses.
General and Administrative
General and administrative expenses were $2,796,884 for the
nine months ended March 31, 2019 compared to $2,911,538 for the nine months ended March 31, 2018. The decrease was largely due
to lower professional fees and travel partially offset by higher personnel and non-cash, share-based compensation expense in the
current period compared to the prior period. In relation to general and administrative expenses during the nine months ended March
31, 2019, we incurred non-cash, share-based compensation expense of $510,661 relating to performance share units, warrants issued
for services, and stock option expense while during the nine months ended March 31, 2018, we incurred non-cash, share-based compensation
expense of $455,331 relating to warrants issued for services and stock option expense. The performance stock units were issued
in April 2018 so no expense for these equity instruments were recognized during the nine months ended March 31, 2018.
Excluding the impact of non-cash, share-based compensation expense,
general and administrative expenses decreased in the nine months ended March 31, 2019 to $2,286,223 from $2,456,207 for the nine
months ended March 31, 2018. The decrease was primarily due to decreased professional fees and travel costs partially offset by
higher personnel costs. Professional fees decreased as a result of certain costs incurred in the prior period that have not been
incurred in the current period. Legal fees have decreased in the nine months ended March 31, 2019 compared to nine months ended
March 31, 2018 in part due to the timing of our annual meeting of stockholders. In the current period, we have not yet incurred
costs for this matter while a portion of these costs was incurred in the prior period. Overall, costs for regulatory filings and
corporate governance matters have been lower in the current nine months compared to the prior nine months. Partially offsetting
lower legal fees are increased public relations and business development costs due to our efforts to expand our outreach to investors
while accounting support has increased due to the complexity of the valuation, and accounting for, our equity instruments. Travel
costs have decreased in the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018 as we have focused
on reducing all travel expenses. Personnel costs have increased during the nine months ended March 31, 2019 compared to the nine
months ended March 31, 2018 primarily due to the appointment of our President and Chief Executive Officer in May 2018.
Change in fair value of derivative liability
Based on the terms of certain warrants issued by us, we have
determined that the warrants were a derivative liability which is recognized at fair value at the date of the transaction and re-measured
at fair value every reporting period with gains or losses on the changes in fair value recorded in the consolidated condensed statement
of loss and comprehensive loss. The balances recognized during the nine months ended March 31, 2019 and 2018 were primarily due
to changes in our common stock price between the date the warrants were last valued on June 30, 2018 and 2017 respectively. These
are the previous valuation dates used for the nine months ended March 31.
We recognized gains of $852 and $57,839 from the change in fair
value of the derivative liability for the nine months ended March 31, 2019 and 2018, respectively.
Foreign Exchange
Our functional currency at June 30, 2018 and March 31, 2019
is the US$ but we incur a portion of our expenses in CA$. The foreign exchange gains and losses are reported in other loss (income)
in the consolidated condensed interim statement of loss and comprehensive loss. We have recognized foreign exchange losses of $16,754
and $57,406 for the nine-month periods ended March 31, 2019 and 2018, respectively. The losses were due to changes in the exchange
rate between the CA$ and the US$ and to varying levels of CA$ cash and accounts payable.
Preferred Share Dividends
For each of the nine-month periods ended March 31, 2019 and
2018 we recorded $6,267 related to the dividend payable to Valent on the Series A preferred stock. The dividend has been recorded
as a direct increase in accumulated deficit for both periods.
During the nine months ended March 31, 2019, we issued 14,430
(2018 — 14,881) shares of common stock as a dividend on the Series B Preferred stock and recognized $75,477 (2018 —
$142,358) as a direct increase in accumulated deficit.
Comparison of the years ended June 30, 2018 and June 30,
2017
|
|
Years ended
|
|
|
|
|
|
|
|
|
|
June 30,
2018
$
|
|
|
June 30,
2017
$
|
|
|
Change
$
|
|
|
Change
%
|
|
Research and development
|
|
|
7,132,952
|
|
|
|
5,003,640
|
|
|
|
2,129,312
|
|
|
|
43
|
|
General and administrative
|
|
|
4,041,711
|
|
|
|
3,317,189
|
|
|
|
724,522
|
|
|
|
22
|
|
Change in fair value of stock option and derivative liabilities
|
|
|
(60,111
|
)
|
|
|
(245,963
|
)
|
|
|
185,852
|
|
|
|
(76
|
)
|
Foreign exchange loss
|
|
|
57,003
|
|
|
|
7,355
|
|
|
|
49,648
|
|
|
|
675
|
|
Interest income
|
|
|
(33,243
|
)
|
|
|
(457
|
)
|
|
|
(32,786
|
)
|
|
|
7,174
|
|
Net loss and comprehensive loss
|
|
|
11,138,312
|
|
|
|
8,081,764
|
|
|
|
3,056,548
|
|
|
|
|
|
Research and Development
Research and development expenses increased to $7,132,952 for
the year ended June 30, 2018 from $5,003,640 for the year ended June 30, 2017. The increase was largely attributable to an increase
in clinical development, personnel, and preclinical research partially offset by lower travel costs. Non-cash, share-based compensation
expense for the year ended June 30, 2018 was $149,452 related to stock option expense and shares issued for services while non-cash,
share-based compensation expense for the year ended June 30, 2017 was $102,828 for stock option expense and warrants issued for
services.
Excluding the impact of non-cash, share-based compensation expense,
research and development expenses increased to $6,983,500 during the current year from $4,900,812 for the prior year. The increase
in clinical development costs for the year ended June 30, 2018 compared to the year ended June 30, 2017 was partially due to manufacturing
costs for GMP material as well as ongoing trial costs for our two Phase 2, biomarker-driven, MGMT-unmethylated, GBM studies. At
June 30, 2017, our Phase 2 study in Avastin-naïve unmethylated GBM patients being conducted at the MD Anderson Cancer Center
had commenced in February 2017 so patient enrollment had just begun. Also, in the prior year, enrollment in our Phase 2 study in
newly diagnosed unmethylated GBM patients in China had not yet started enrollment.
During the year ended June 30, 2018, we undertook site initiation
and enrollment for its now-parked STAR-3, Phase 3 study in GBM. During the year ended June 30, 2018, we recognized certain costs
relating to the parking of the trial. As our two Phase 2, biomarker-driven studies are partially supported through collaboration
arrangements, the ongoing clinical costs for these two studies will be lower than the overall clinical costs incurred by us for
the year ended June 30, 2018.
Personnel costs increased during the current year compared to
the prior year primarily due to amounts recognized for payments made to our former President and Chief Operating Officer pursuant
to a settlement agreement between us and such individual. Preclinical research increased in the year ended June 30, 2018 compared
to the year ended June 30, 2017 largely due our research agreement with Duke University which commenced in April 2017 as well as
due to an increase in the ongoing mechanism of action research that we have undertaken in the current year. Travel costs have decreased
in the year ended June 30, 2018 compared to the year ended June 30, 2017 as we have focused on reducing all but essential travel.
General and Administrative
General and administrative expenses were $4,041,711 for the
year ended June 30, 2018 compared to $3,317,189 for the year ended June 30, 2017. The increase was primarily due to an increase
in professional fees and personnel costs. In relation to general and administrative expenses during the year ended June 30, 2018,
we incurred non-cash, share-based compensation expense of $596,079 relating to warrants issued for services, stock option expense,
and the PSUs while during the year ended June 30, 2017, we incurred non-cash, share-based compensation expense of $667,521 relating
to shares and warrants issued for services, and stock option expense.
Excluding the impact of non-cash, share-based compensation expense,
general and administrative expenses increased in the year ended June 30, 2018 to $3,445,632 from $2,649,668 for the year ended
June 30, 2017. Professional fees incurred during the year ended June 30, 2018 relate to various matters including preparation for
our first annual meeting of stockholders which was held April 11, 2018, completing our 2017 Omnibus Incentive Plan, regulatory
filings, and corporate governance matters. In the year ended June 30, 2017, the costs were incurred related to preparing for our
uplisting of its common stock on the Nasdaq Stock Market as well as fees associated with one-time listing activities, and the filing
of three registration statements with the SEC that were all declared effective in September 2016. Personnel costs increased during
the current year compared to the prior year primarily due to amounts recognized for payments made to our former President and Chief
Operating Officer pursuant to the settlement agreement.
Change in fair value of stock option and derivative liabilities
Based on the terms of certain warrants issued by us, we determined
that such warrants were a derivative liability which is recognized at fair value at the date of the transaction and re-measured
at fair value every reporting period with gains or losses on the changes in fair value recorded in the consolidated statement of
operations and comprehensive loss. The gains recognized during the years ended June 30, 2018 and 2017 were primarily due to changes
in our common stock price between June 30, 2017 and 2016, respectively, and June 30, 2018 and 2017, respectively.
We recognized a gain of $60,111 from the change in fair value
of the derivative liability for the year ended June 30, 2018 and a gain of $331,057 for the year ended June 30, 2017.
Changes in our common stock price can result in significant
volatility in our reported net loss due to its impact on the fair value of the derivative liability. As a result of revaluation
gains and losses, we expect that our reported net income or loss will continue to fluctuate significantly.
Certain of our stock options have been issued in $CA. Of these,
a portion were classified as a stock option liability which is revalued at each reporting date. During the year ended June 30,
2017, we amended 4,375 of these stock options held by five optionees such that the exercise price of the options was adjusted to
be denominated in $USD. No other terms of the stock options were amended. As a result of the amendment, we recognized $85,094 in
stock option liability expense and $260,969 was reclassified to equity during the year ended June 30, 2017.
Foreign Exchange
Our functional currency at June 30, 2018 was the US$, but we
incur a portion of its expenses in CA$. The foreign exchange gains and losses are reported in other loss (income) in the consolidated
statement of operations and comprehensive loss.
We recognized foreign exchange losses of $57,003 and $7,355
for the years ended June 30, 2018 and 2017, respectively. The losses were due to changes in the exchange rate between the CA$ and
the US$ and to varying levels of CA$ cash and accounts payable.
Preferred Share Dividends
For each of the years ended June 30, 2018 and 2017, we recognized
$8,356 related to the dividend payable to Valent on the Series A preferred stock. The dividend has been recorded as a direct increase
in accumulated deficit for both periods.
We issued 19,841 (2017 — 20,045) shares of common stock
on June 30, 2018 as a dividend on the Series B Preferred stock and recognized $176,236 (2017 — $790,454) as a direct increase
in accumulated deficit.
Liquidity and Capital Resources
Nine months ended March 31, 2019 compared to the nine months
ended March 31, 2018
|
|
March 31,
2019
$
|
|
|
March 31,
2018
$
|
|
|
Change
$
|
|
|
Change
%
|
|
Cash flows from operating activities
|
|
|
(4,514,674
|
)
|
|
|
(7,318,012
|
)
|
|
|
2,803,338
|
|
|
|
(38
|
)
|
Cash flows from investing activities
|
|
|
—
|
|
|
|
(12,649
|
)
|
|
|
12,649
|
|
|
|
(100
|
)
|
Cash flows from financing activities
|
|
|
694,912
|
|
|
|
9,251,569
|
|
|
|
(8,556,657
|
)
|
|
|
(92
|
)
|
Operating Activities
Net cash used in operating activities decreased to $4,514,674
for the nine months ended March 31, 2019 from $7,318,012 for the nine months ended March 31, 2018. During the nine months ended
March 31, 2019 and 2018, we reported net losses of $5,465,486 and $8,761,061, respectively. During the nine months ended March
31, 2019, we recorded a gain from the revaluation of the derivative liability of $852 compared to a gain of $57,839 for the nine
months ended March 31, 2018. Excluding the impact of changes in the fair value of the derivative liability, non-cash items relating
to amortization of intangible assets, shares and warrants issued for services, stock option expense, and performance share unit
expense totaled $598,944 for the nine months ended March 31, 2019. Non-cash items relating to amortization of intangible assets,
warrants issued for services, and stock option expense totaled $608,567 for the nine months ended March 31, 2018.
The most significant changes in non-cash working capital for
the nine months ended March 31, 2019 was an increase in cash from a decrease in prepaid expenses and deposits of $794,859 due to
a partial refund of our clinical trial deposit related to our now-parked STAR-3 Phase 3 study. The other significant change in
on-cash working capital in the current period was a decrease in cash from a reduction in accounts payable and accrued liabilities
of $425,383. The most significant changes in non-cash working capital for the nine months ended March 31, 2018 was cash from an
increase of accounts payable and accrued liabilities of $708,634 and cash from a decrease in prepaid expense and deposits of $135,293.
Investing activities
During the nine months ended March 31, 2018, we incurred $12,649
in relation to the development of our website. There were no cash flows from investing activities during the nine months ended
March 31, 2019.
Financing Activities
During the nine months ended March 31, 2019, we received $726,179
in net proceeds from the exercise of warrants pursuant to the Warrant Exercise Agreements. During the nine months ended March 31,
2018, we received $8,945,336 in net proceeds from the completion of a registered direct offering by us of common stock and common
stock purchase warrants. In addition, we recorded $6,267 related to the dividend payable to Valent during each of the nine months
ended March 31, 2019 and 2018 respectively. During the nine months ended March 31, 2019, we also recognized $25,000 in deferred
costs related to our pending financing.
Comparison of the years ended June 30, 2018 and June 30,
2017
|
|
June 30,
2018
$
|
|
|
June 30,
2017
$
|
|
|
Change
$
|
|
|
Change
%
|
|
Cash flows from operating activities
|
|
|
(9,850,850
|
)
|
|
|
(8,019,071
|
)
|
|
|
(1,831,779
|
)
|
|
|
23
|
|
Cash flows from investing activities
|
|
|
(12,649
|
)
|
|
|
(20,956
|
)
|
|
|
8,307
|
|
|
|
(40
|
)
|
Cash flows from financing activities
|
|
|
9,249,480
|
|
|
|
8,468,777
|
|
|
|
780,703
|
|
|
|
9
|
|
Operating activities
Net cash used in operating activities increased to $9,850,850
for the year ended June 30, 2018 from $8,019,071 for the year ended June 30, 2017. During the year ended June 30, 2018 and 2017,
we reported net losses of $11,138,312 and $8,081,764, respectively. During the year ended June 30, 2018, we recorded a gain from
the revaluation of the derivative and stock option liabilities of $60,111 compared to a gain of $245,963 for the year ended June
30, 2017. Excluding the impact of changes in the fair value of the derivative and stock option liabilities, non-cash items relating
to amortization of intangible assets, shares and warrants issued for services, and PSU and stock option expense totaled $770,059
for the year ended June 30, 2018. Non-cash items relating to amortization of intangible assets, shares and warrants issued for
services, and stock option expense totaled $787,032 for the year ended June 30, 2017. The most significant changes in non-cash
working capital for the year ended June 30, 2018 was from an inflow due to increase in accounts payable and accrued liabilities
of $295,774 and from an inflow due to a decrease in prepaid expenses and deposits of $173,192. The most significant changes in
non-cash working capital for the year ended June 30, 2017 was from an outflow from an increase in prepaid expenses and deposits
of $1,063,991 and from an inflow due to an increase in accounts payable and accrued liabilities of $598,310.
As of June 30, 2018, we had cash and cash equivalents
to fund operations into the middle of calendar 2019. We will need to raise additional capital in the near future.
Investing activities
During the years ended June 30, 2018 and 2017, we incurred $12,649
and $20,956, respectively, in relation to the development of our website.
Financing activities
During the year ended June 30, 2018, we received $8,945,336
in net proceeds from the completion of a registered direct offering by us of common stock and common stock purchase warrants. During
the year ended June 30, 2017, we received $7,932,107 in net proceeds from a public offering of its common stock and common stock
purchase warrants.
During the years ended June 30, 2018 and 2017, we received $312,500
and $545,026, respectively, from the exercise of warrants. In addition, we recognized $8,356 related to the dividend payable to
Valent during each of the years ended June 30, 2018 and 2017, respectively.
Going Concern and Capital Expenditure Requirements
Registered Direct Offering and Private Placement
On June 5, 2019, we completed a registered direct offering (the
“RD Offering”) of an aggregate of 1,170,000 shares of common stock and warrants to purchase 760,500 shares of common
stock in a concurrent private placement, at a combined purchase price of $3.10 per share and related warrant. The warrants have
an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five years. The gross proceeds
from the offering, prior to deducting offering expenses and placement agent fees and expenses payable by us, were $3.6 million.
In addition, on April 18, 2019, we filed a registration statement
in connection with a proposed rights offering (the “Rights Offering”), which registration statement was last amended
on June 10, 2019. Due to management’s assessment that market conditions were not conducive to an offering that would be in
the best interests of our shareholders, we terminated the Rights Offering on June 27, 2019 and withdrew the related registration
statement and post-effective amendment thereto that were previously filed with the SEC.
Going Concern
(See note 1 to the consolidated condensed interim financial
statements)
The consolidated condensed interim financial statements have
been prepared on a going concern basis which assumes that we will continue our operations for the foreseeable future and contemplates
the realization of assets and the settlement of liabilities in the normal course of business.
For the nine months ended March 31, 2019, we reported a loss
of $5,465,486 and negative cash flow from operations of $4,514,674. As of March 31, 2019, we had an accumulated deficit of $57,988,567
and cash and cash equivalents on hand of $2,152,233. We are in the development stage and have not generated any revenues to date.
We do not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which
may not ever occur. In the near future, we will require additional funding to maintain our clinical trials, research and development
projects, and for general operations. These circumstances indicate substantial doubt exists about our ability to continue as a
going concern.
Consequently, management is pursuing various financing alternatives
to fund our operations so we can continue as a going concern. Management plans to secure the necessary financing through the issue
of new equity and/or the entering into of strategic partnership arrangements. We may tailor our drug candidate development program
based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will
be successful.
The financial statements do not give effect to any adjustments
to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.
Such adjustments could be material.
Our future funding requirements will depend on many factors,
including but not limited to:
|
●
|
the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development
activities;
|
|
●
|
the costs associated with establishing manufacturing and commercialization capabilities;
|
|
●
|
the costs of acquiring or investing in businesses, product candidates and technologies;
|
|
●
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
|
●
|
the costs and timing of seeking and obtaining FDA and other regulatory approvals;
|
|
●
|
the effect of competing technological and market developments;
|
|
●
|
the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter; and.
|
|
●
|
the impact of us being a public entity.
|
In September 2018, we announced that we had engaged Oppenheimer
& Co. Inc. as our strategic advisor to help manage the exploration and evaluation of a wide range of strategic opportunities.
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect
to finance future cash needs primarily through public or private equity offerings or strategic collaborations. The sale of equity
and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior
to those of our shares of capital stock. If we raise additional funds through the issuance of preferred stock, convertible debt
securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations.
Any other third-party funding arrangement could require us to relinquish valuable rights. Economic conditions may affect the availability
of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at
all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or
more of our clinical trials or research and development programs or make changes to our operating plan. In addition, we may have
to seek a partner for one or more of our product candidate programs at an earlier stage of development, which would lower the economic
value of those programs to us.
Critical Accounting Policies
The preparation of financial statements, in conformity with
generally accepted accounting principles in the United States, requires companies to establish accounting policies and to make
estimates that affect both the amount and timing of the recording of assets, liabilities, revenues and expenses. Some of these
estimates require judgments about matters that are inherently uncertain and therefore actual results may differ from those estimates.
A detailed presentation of all of our significant accounting
policies and the estimates derived therefrom is included in Note 2 to our consolidated financial statements for the year ended
June 30, 2018 contained elsewhere in this prospectus. While all of the significant accounting policies are important to our consolidated
condensed financial statements, the following accounting policies and the estimates derived therefrom are critical:
|
●
|
Warrants and shares
issued for services
|
|
●
|
Performance stock units
|
|
●
|
Clinical trial accruals
|
Warrants and shares issued for services
We have issued equity instruments for services provided by employees
and nonemployees. The equity instruments are valued at the fair value of the instrument granted.
Stock options
We account for these awards under Accounting Standards Codification
(“ASC”) 718, “Compensation — Stock Compensation” (“ASC 718”). ASC 718 requires measurement
of compensation cost for all stock-based awards at fair value on the date of grant and recognition of compensation over the requisite
service period for awards expected to vest. Compensation expense for unvested options to non-employees is revalued at each period
end and is being amortized over the vesting period of the options. The determination of grant-date fair value for stock option
awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of our share price,
the anticipated exercise behavior of its grantee, interest rates, and dividend yields. These variables are projected based on our
historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense
recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures,
using the accelerated attribution method. We recognize forfeitures as they occur. The estimation of stock awards that will ultimately
vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such amounts are
recorded as a cumulative adjustment in the period estimates are revised.
Performance stock units
We also account for performance stock units (PSU’s) under
ASC 718. ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on the date of grant and recognition
of compensation over the requisite service period for awards expected to vest. As vesting of the PSU’s is based on a number
of factors, the determination of the grant-date fair value for PSU’s has been estimated using a Monte Carlo simulation approach
which includes variables such as the expected volatility of our share price and interest rates to generate potential future outcomes.
These variables are projected based on our historical data, experience, and other factors. Changes in any of these variables could
result in material adjustments to the expense recognized for the PSUs. Such value is recognized as expense over the derived service
period using the accelerated attribution method. The estimation of PSUs that will ultimately vest requires judgment, and to the
extent actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment
in the period estimates are revised.
Derivative liability
We account for certain warrants under the authoritative guidance
on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the
understanding that in compliance with applicable securities laws, the warrants require the issuance of securities upon exercise
and do not sufficiently preclude an implied right to net cash settlement. We classify these warrants on our balance sheet as a
derivative liability which is fair valued at each reporting period subsequent to the initial issuance. We have used a binomial
model as well as a Black-Scholes Option Pricing Model (based on a closed-form model that uses a fixed equation) to estimate the
fair value of the share warrants. Determining the appropriate fair-value model and calculating the fair value of warrants requires
considerable judgment. Any change in the estimates (specifically probabilities and volatility) used may cause the value to be higher
or lower than that reported. The estimated volatility of our common stock at the date of issuance, and at each subsequent reporting
period, is based on our historical volatility. The risk-free interest rate is based on rates published by the government for bonds
with a maturity similar to the expected remaining life of the warrants at the valuation date. The expected life of the warrants
is assumed to be equivalent to their remaining contractual term.
Clinical trial accruals
Clinical trial expenses are a component of research and development
costs and include fees paid to contract research organizations, investigators and other service providers who conduct specific
research for development activities on our behalf. The amount of clinical trial expenses recognized in a period related to service
agreements is based on estimates of the work performed on an accrual basis. These estimates are based on patient enrollment, services
provided and goods delivered, contractual terms and experience with similar contracts. We monitor these factors by maintaining
regular communication with the service providers. Differences between actual expenses and estimated expenses recorded are adjusted
for in the period in which they become known. Prepaid expenses or accrued liabilities are adjusted if payments to service providers
differ from estimates of the amount of service completed in a given period.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Changes in and Disagreements with Accountants on
Accounting and Further Disclosure
On July 31, 2019, we received notification from Ernst
& Young LLP (“E&Y”), our independent registered public accounting firm, that, as a result of the relocation
of our headquarters from Vancouver, British Columbia, Canada to San Diego, California, E&Y has declined to stand for re-appointment
as our independent registered public accounting firm with respect to the audit of our consolidated financial statements as of
and for the year ending June 30, 2020. E&Y will complete the audit of our consolidated financial statements for the year ended
June 30, 2019. The decision not to stand for re-appointment was not the result of any disagreements between us and E&Y on
any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures.
Our Audit Committee will accordingly commence the process
of evaluating and selecting a replacement firm to serve as our independent registered public accounting firm.
E&Y’s report on our consolidated financial statements
for fiscal year ended June 30, 2018 contained a paragraph stating that there was substantial doubt about our ability to continue
as a going concern. E&Y’s reports on our financial statements for each of the two most recent fiscal years ended June
30, 2018 and June 30, 2017 did not contain an adverse opinion or a disclaimer of opinion, and neither such report was qualified
or modified as to uncertainty, audit scope, or accounting principle.
During the fiscal years ended June 30, 2018 and June 30,
2017, and the subsequent period through July 31, 2019, (i) there were no disagreements with E&Y on any matter of accounting
principles or practices, financial statement disclosure, or auditing scope or procedures, which disagreement, if not resolved to
the satisfaction of E&Y, would have caused E&Y to make reference thereto in its reports on the financial statements for
such years, and (ii) there were no reportable events as described in paragraph (a)(1)(v) of Item 304 of Regulation S-K, except
as described below.
During the audit for the year ended June 30, 2018, a material
weakness in internal control over financial reporting was identified relating to inadequate segregation of duties over authorization,
review and recording of transactions, as well as the financial reporting of such transactions. During the audit for the year ended
June 30, 2017, a material weakness in internal control over financial reporting was identified relating to inadequate segregation
of duties over authorization, review and recording of transactions.
BUSINESS
Background
We are a clinical stage, biopharmaceutical company focused on
the development and commercialization of new cancer therapies. Our mission is to benefit patients by developing and commercializing
anti-cancer therapies for patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently
available therapies, particularly for orphan cancer indications where patients have failed, or are unlikely to respond to, currently
available therapy.
As of March 31, 2019, we have spent approximately $38.8 million
of shareholder capital in developing VAL-083, a novel, validated, DNA-targeting agent, for the treatment of drug-resistant solid
tumors such as glioblastoma multiforme (“GBM”) and potentially other solid tumors, including ovarian cancer, non-small
cell lung cancer (“NSCLC”), and diffuse intrinsic pontine glioma (“DIPG”). VAL-083 is a first-in-class,
small-molecule, DNA-targeting chemotherapeutic that demonstrated activity against a range of tumor types in prior Phase 1 and Phase
2 clinical studies sponsored by the US National Cancer Institute (“NCI”). As part of our business strategy, we leverage
and build upon these prior NCI investments and data from more than 40 NCI- Phase 1 and Phase 2 clinical studies, which includes
an estimated 1,000 patient safety database, with our own research to identify and target unmet medical needs in modern cancer care.
DNA-targeting agents are among the most successful and widely used treatments for cancer. Their efficacy is based on the ability
to bind with a cancer cell’s DNA and interfere with the process of protein production required for growth and survival of
cancer cells. “First-in-class” means that VAL-083 embodies a unique molecular structure which is not an analogue or
derivative of any approved product, or product under development, for the treatment of cancer.
Our recent research has highlighted the opportunities afforded
by VAL-083’s unique mechanism of action and its potential to address unmet medical needs by focusing our development efforts
on patients whose tumors exhibit biological features that make them resistant to, or unlikely to respond to, currently available
therapies. For example, our research demonstrating VAL-083’s activity in GBM independent of the O6-methyl guanine methyltransferase
(“MGMT”) methylation status allows us to focus patient selection based on this important biomarker.
We are conducting two open-label, biomarker driven Phase 2 studies
in MGMT-unmethylated GBM. MGMT is a DNA-repair enzyme that is associated with resistance to temozolomide, the current standard-of-care
chemotherapy used in the treatment of GBM. Greater than 60% of GBM patients have MGMT-unmethylated tumors and exhibit a high expression
of MGMT, which is correlated with temozolomide treatment failure and poor patient outcomes. Our research demonstrates that VAL-083’s
anti-tumor activity is independent of MGMT expression. In our Phase 2 studies we are using MGMT as a biomarker to identify patients
for treatment with VAL-083 in first-line along with radiation, as adjuvant therapy immediately following chemoradiation, and in
the recurrent treatment setting. If successful, the result of these studies could position VAL-083 for advancement to pivotal clinical
studies as a potential replacement for temozolomide in MGMT-unmethylated GBM. We anticipate presenting data from these studies
at peer reviewed scientific meetings during calendar 2019.
With respect to our STAR-3, Phase 3 study, we have finalized
the decision to discontinue this clinical study due to competitive landscape, patient enrollment rates, and potential risk of success
assessment, and to allow us to focus on enrolling GBM patients in our two biomarker-driven Phase 2 studies.
We have received notice to proceed from the US Food and Drug
Administration (“FDA”) for a phase 1/2, open-label, multicenter study of VAL-083 in patients with
Re
current
P
latinum
R
esistant
Ov
arian Cancer (“REPROVe”). Platinum-based chemotherapy
is the standard-of-care in the treatment of ovarian cancer. Nearly all ovarian cancer patients eventually become resistant to platinum
(“Pt”) based chemotherapy leading to treatment failure and poor patient outcomes. We have demonstrated that VAL-083
is active against Pt-resistant ovarian cancer
in vitro.
However, based on ongoing evaluation and input from our ovarian
cancer advisory board, we are reassessing the development of VAL-083 for the treatment of ovarian cancer. We are in the process
of evaluating the best path forward in ovarian cancer and are evaluating strategic options, including the potential combination
of VAL-083 with PARP inhibitors. At the American Association for Cancer Research (“AACR”) Annual Meeting in 2018 we
presented preclinical data showing that VAL-083 can synergize PARP inhibitors in both a BRACA-proficient and -deficient setting.
In addition to our clinical development activities in the United
States, pursuant to our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. (“Guangxi Wuzhou Pharmaceutical
Company”), we have provided Guangxi Wuzhou Pharmaceutical Company certain commercial rights to VAL-083 in China where it
is approved as a chemotherapy for the treatment of chronic myelogenous leukemia (“CML”) and lung cancer. Guangxi Wuzhou
Pharmaceutical Company is the only manufacturer presently licensed by the China Food and Drug Administration (“CFDA”)
to produce the product for the China market.
We have a broad patent portfolio to protect our intellectual
property. Our patent applications claim composition of matter and methods of use of VAL-083 and related compounds, synthetic methods,
and quality controls for the manufacturing process of VAL-083. We believe that our portfolio of intellectual property rights provides
a defensible market position for the commercialization of VAL-083. In addition, VAL-083 has been granted protection under the Orphan
Drug Act by the FDA and the European Medicines Agency (“EMA”) for the treatment of gliomas, including GBM. The FDA
has also granted Orphan Drug protection to VAL-083 for the treatment of medulloblastoma and ovarian cancer.
Our corporate development strategy is to advance our drug candidate
into multiple clinical studies and then to consider licensing, or acquiring additional product candidates, in order to establish
a product pipeline and to position us for long-term sustainability and growth of shareholder value. We believe the experience of
our clinical development team will position us to efficiently develop drug candidates that we may acquire, or license, in the future.
We intend to continue to evaluate options for our strategic
direction. These options may include raising additional capital, the acquisition of another company and/or complementary assets,
our sale, or another type of strategic partnership.
Registered Direct Offering and Private Placement
On June 3, 2019, we entered into a securities purchase agreement
with the selling stockholders for the issuance and sale of an aggregate of 1,170,000 shares of common stock in a registered direct
offering (the “RD Offering”) and, in a concurrent private placement, warrants to purchase 760,500 shares of common
stock at a combined purchase price of $3.10 per share and related warrant. The warrants have an exercise price of $3.10 per share,
are immediately exercisable and have a term of exercise of five years. The closing of the issuance and sale of these securities
was consummated on June 5, 2019. The gross proceeds from the offering, prior to deducting offering expenses and placement agent
fees and expenses payable by us, were $3.6 million.
Subject to certain ownership limitations, the warrants are exercisable
commencing on the issuance date at an exercise price equal to $3.10 per share of common stock, subject to adjustments as provided
under the terms of the warrants.
China Trial Clinical Update
As of August 1, 2019, we provided an update on the first
20 patients enrolled in our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination with
radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial, which is being conducted at the Sun Yat-sen University
Cancer Center (“SYSUCC”) is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083
treatment improves progression free survival (“PFS”). The current standard of care is first-line temozolomide (“TMZ”)
with radiation.
As of August 1, 2019, of the first 20 enrolled patients,
17 have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment
and one patient died before their first assessment). “Best Overall Response” for these patients per Investigator Assessment
were:
|
●
|
Nine
have been assessed as having achieved a complete response (CR) (9/17, or 53%)
|
|
●
|
Seven
have been assessed with stable disease (SD), (7/17, or 41%); and
|
|
●
|
One
has been assessed as disease progression (PD) (1/17, or 6%).
|
Of the 20 patients enrolled, 17 (85%) have received their
two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI and investigator assessment,
and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%) have not been on the study
long enough to reach their first assessment, and one patient (5%) died before their first assessment. Importantly, 16 of the 20
patients enrolled (80%) were still alive as of the data cut-off date.
Clinical Updates Presented at 2019 American Society of Clinical
Oncology
On May 31, 2019, we provided clinical trial updates from our
ongoing first-line and recurrent trials in patients with MGMT-unmethylated GBM at a KOL presentation during the 2019 ASCO annual
meeting in Chicago, IL.
At the KOL presentation, we provided an update on the ongoing
Phase 2 clinical study investigating the front-line treatment of VAL-083 with radiation therapy in newly diagnosed MGMT-unmethylated
GBM. This trial is being conducted at SYSUCC in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. The
trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of first-line
temozolomide, improves PFS.
As of May 17, 2019, eighteen patients have been enrolled in
the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have received their
post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their first assessment,
and one patient died before their first assessment. Assessments are based on the trial investigator’s clinical and radiologic
assessment, according to the RANO criteria. For the fifteen patients who have received at least one assessment, eight patients
were assessed with a best response of “Complete Response” (8/15, 53.3% CR) and seven patients were assessed with a
best response of “Stable Disease” (7/15, 46.7% SD). Fourteen of the eighteen patients were still alive at the data
cut-off date.
As of July 31, 2019, 20 patients of the planned 30 have
been enrolled in the SYSUCC trial.
We also provided an update on the ongoing recurrent arm of
the Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naïve recurrent GBM. This study is
being conducted in collaboration with MDACC. This biomarker-driven trial (testing for MGMT methylation status) has been amended
to enroll up to 83 patients (35 with a starting dose of 40 mg/m
2
; 48 with a starting dose of 30 mg/m
2
)
to determine the potential of VAL-083 treatment to improve overall survival compared to historical reference control of 7.2 months
with lomustine.
|
●
|
As of May 5, 2019, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m
2
, and 16 patients at
a starting dose of 30 mg/m
2
.
|
|
●
|
For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI:
|
|
o
|
9/35 (25.7%) patients initially receiving 40 mg/m
2
exhibited “Stable Disease” per investigator assessment
at the end of cycle 2
|
|
o
|
4/12 (33.3%) patients initially receiving 30 mg/m
2
exhibited “Stable Disease” per investigator assessment
at the end of cycle 2
|
Additionally, the study protocol has been amended to include
enrollment of up to 24 newly-diagnosed GBM patients who have completed chemoradiation treatment with TMZ and received no subsequent
TMZ maintenance therapy but will receive VAL-083 instead (the adjuvant arm). The adjuvant arm of the study has been included to
explore whether earlier intervention with VAL-083 instead of TMZ maintenance therapy offers clinical benefit and extends the time
to recurrence as compared to TMZ maintenance therapy.
As of July 24, 2019, 56 patients have been enrolled in the recurrent arm of the MDACC study and one patient has been enrolled
in the adjuvant arm of the MDACC study.
Consistent with prior studies, myelosuppression (primarily thrombocytopenia
and neutropenia) is the most common adverse event in both ongoing clinical trials.
VAL-083 Clinical Studies
We are currently developing VAL-083, a novel DNA-targeting agent
for the treatment of GBM and potentially other solid tumors, including ovarian cancer. Our recent research has highlighted the
opportunities afforded by VAL-083’s unique mechanism of action and its potential to address unmet medical needs by focusing
our development efforts on patients whose tumors exhibit biological features that make them resistant to, or unlikely to respond
to, currently available therapies. For example, our research demonstrating VAL-083’s activity in GBM is independent of the
MGMT methylation status allows us to focus patient selection based on this important biomarker.
The evaluation of MGMT promotor methylation status has increasingly
become common practice in the diagnostic assessment of GBM. In September 2017, the National Comprehensive Cancer Network (“NCCN”)
updated guidelines for the standard treatment of GBM based on MGMT methylation status. We believe these recently published guidelines
provide for enhanced opportunities for us to capitalize on VAL-083’s unique mechanism of action by utilizing MGMT methylation
as a biomarker to optimize patient selection for our novel DNA-targeting agent to target the majority of GBM patients who are diagnosed
with MGMT-unmethylated tumors.
Our current priority is to leverage this research and VAL-083’s
unique mechanism of action to efficiently advance our drug candidate for the most promising indications, including:
|
●
|
MGMT-unmethylated GBM, currently comprising two ongoing separate Phase 2 clinical studies for:
|
|
o
|
GBM patients in two study arms at MDACC:
|
|
§
|
as adjuvant therapy immediately following chemoradiation; and
|
|
§
|
in Avastin
®
-naïve rGBM patients;
|
|
o
|
Newly diagnosed GBM patients (ongoing study at SYSUCC); and
|
|
●
|
Potential future indications include ovarian cancer, NSCLC, and other solid tumor indications.
|
MGMT-unmethylated GBM
GBM is the most common and the most lethal form of glioma. According
to the Central Brain Tumor Registry of the United States, GBM occurs with an incidence of 3.20 per 100,000 person-years. Approximately
13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017. Within the GBM patient population,
approximately two-thirds of patients are unmethylated with respect to their MGMT status.
Measurement of MGMT (O6-methyl guanine methyltransferase) methylation
status has become routine in clinical practice as a biomarker that correlates with resistance to the standard-of-care chemotherapy
with temozolomide (Temodar
®
“TMZ”), and patient outcomes in GBM. Greater than 60% of GBM patients’
tumors are characterized as “MGMT-unmethylated” and exhibit a high expression of MGMT, a naturally occurring DNA-repair
enzyme, the activity of which nullifies the chemotherapeutic activity of TMZ. The development of new therapies for MGMT-unmethylated
GBM is a significant unmet medical need. Importantly, the most recent update to NCCN guidelines states that the treatment benefit
of TMZ is likely to be lower in GBM patients with an unmethylated MGMT promoter, and therefore, allows for withholding of TMZ in
the treatment of newly diagnosed GBM patients with MGMT-unmethylated tumors due to lack of efficacy.
We have demonstrated that VAL-083’s anti-tumor mechanism
is active independent from the MGMT status
in vitro
. We believe this suggests the potential of VAL-083 as a replacement
for the current standard-of-care chemotherapy, temozolomide, in MGMT-unmethylated GBM. We are therefore utilizing MGMT-methylation
status to identify GBM patients who are unlikely to respond to temozolomide and instead treat them with VAL-083.
We believe that our research, in the context of the recent amendment
to NCCN guidelines, highlights this unmet need and the opportunity for VAL-083 as a potential new standard-of-care in the treatment
of MGMT-unmethylated GBM.
Phase 2 Study in MGMT-unmethylated GBM in Collaboration
with University of Texas MD Anderson Cancer Center
In February 2017, we initiated a biomarker driven, open-label,
single-arm Phase 2 study in collaboration with MDACC. This biomarker-driven trial (testing for MGMT methylation status) has been
amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m
2
; 48 with a starting dose of 30 mg/m
2
)
to determine the potential of VAL-083 treatment to improve overall survival in GBM patients whose tumors have recurred following
treatment with temozolomide. These patients will not have been treated previously with Avastin
®
. In addition, this
trial has been amended to include 24 patients in the adjuvant patient population. The GBM patients in the adjuvant arm of the study
will have had treatment with TMZ in combination with radiation but rather than then being treated with additional cycles of TMZ,
these patients will begin treatment with VAL-083.
Recurrent Study Arm
As of July 24, 2019, 56 patients had been enrolled in the
recurrent arm of this Phase 2 study. The original starting dose of 40 mg/m
2
of VAL-083 on days 1, 2 and 3, of a
21-day cycle, which was based on the results from our previous Phase 1/2 safety study of VAL-083 in patients with recurrent
glioma (clinicaltrials.gov identifier: NCT01478178), has continued to demonstrate myelosuppression as the principal side
effect of VAL-083, as per prior clinical experience. The safety profile has been well within the existing safety monitoring
guidelines described in the present study protocol. However, in consultation with the principal investigator at MDACC, we
have amended the protocol for this clinical study to modify the starting dose of VAL-083 to 30 mg/m
2
on days 1, 2
and 3, of a 21-day cycle for this specific population previously treated with temozolomide. This modification may improve
tolerance in this patient population and thereby potentially increase overall exposure to VAL-083 by increasing the number of
cycles of drug patients may be able to receive. We have modified the patient screening platelet count, from
100,000/µL to 125,000/µL, for the same reasons.
The historical comparison survival data for the recurrent arm
of the study is lomustine based on a median overall survival of 7.2 months in unmethylated patients. Safety data from this study
will become part of the overall safety dossier to support future filings with the FDA and other regulatory agencies.
On May 31, 2019, we provided a clinical trial update on the
recurrent study arm of our MDACC clinical trial at a KOL presentation during the 2019 ASCO annual meeting in Chicago, IL.
|
●
|
As of May 5, 2019, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m
2
, and 16 patients at
a starting dose of 30 mg/m
2
.
|
|
●
|
For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI:
|
|
o
|
9/35 (25.7%) patients initially receiving 40 mg/m
2
exhibited “Stable Disease” per investigator assessment
at the end of cycle 2
|
|
o
|
4/12 (33.3%) patients initially receiving 30 mg/m
2
exhibited “Stable Disease” per investigator assessment
at the end of cycle 2
|
It is important for this GBM patient population, which has been
heavily pre-treated with temozolomide, to be able to be treated with multiple cycles of VAL-083 without significant hematological
toxicities. We believe the modified dose of VAL-083, in addition to the change in patient eligibility platelet counts, should help
provide for enhanced patient safety. We believe a positive outcome from this study can establish a position for VAL-083 in the
treatment of MGMT-unmethylated rGBM.
A detailed description of this study can be found at clinicatrials.gov,
Identifier Number: NCT02717962.
Adjuvant Study Arm
On July 24, 2019, we announced the enrollment of the first
patient in the adjuvant arm of the Phase 2 study being conducted at MDACC.
As noted above, patients in the recurrent arm of the MDACC clinical
study have been heavily pre-treated with temozolomide. Based on published data from our MDACC and SYSUCC clinical studies, we believe
there is a significant opportunity to treat GBM patients in the pre-temozolomide maintenance stage (i.e., adjuvant). At the AACR’s
annual meeting in April 2019, we reported that myelosuppression (thrombocytopenia and neutropenia) is the most common adverse event
associated with VAL-083. The higher potential for myelosuppression with the 40 mg/m
2
/day of VAL-083 in this study appears
to be correlated with the number of cycles of prior TMZ maintenance therapy (> 5 cycles). These patients will have had
an initial cycle of TMZ following radiation but will not have yet started subsequent cycles of TMZ (i.e. maintenance stage TMZ
patients). The MDACC IRB has approved the addition of up to 24 patients to the adjuvant setting. These patients will have had an
initial cycle of temozolomide following radiation but will not have yet started subsequent cycles of TMZ (i.e. maintenance stage
TMZ patients). The comparison survival data for this study is survival data from Tanguturi et al (2017 Nero-Oncology) for MGMT-unmethylated
patients of 6.9 months.
Phase 2 Study in Newly Diagnosed MGMT-unmethylated
GBM
In September 2017, we initiated a single arm, biomarker driven,
open-label Phase 2 study in newly diagnosed MGMT-unmethylated GBM patients at Sun Yat-sen University Cancer Center (SYSUCC) in
Guangzhou, China. The study is being conducted under our collaboration agreement with Guangxi Wuzhou Pharmaceutical Company.
In this Phase 2 study, VAL-083 is being combined with radiotherapy
as a potential replacement for standard-of-care chemoradiation with temozolomide in patients with MGMT-unmethylated GBM. One goal
of the study will be to confirm the safety of the three-day VAL-083 dosing regimen in combination with radiotherapy and to investigate
outcomes of the combination of VAL-083 and radiotherapy in MGMT-unmethylated GBM patients.
We plan to enroll up to 30 newly-diagnosed, MGMT-unmethylated
GBM patients in this study. The efficacy endpoints of the study include tumor response, as assessed by the Response Assessment
in NeuroOncology (“RANO”), and progression-free survival (“PFS”), progression-free survival at six months
(“PFS6”), and overall survival (“OS”), compared to historical results in the target population. The study
is being conducted in two parts: (1) Dose-confirmation: VAL-083 in cohorts (20, 30 and 40 mg/m
2
/day IV daily x 3 every
21 days) to assess safety and activity when administered concurrently with x-ray therapy (“XRT”) to confirm the maximum
tolerated dose (“MTD”), and (2) Expansion: VAL-083 will be studied in up to 20 additional patients at the target dose,
as determined by the dose-confirmation part of the study, administered concurrently with XRT. Assessments of safety and tolerability
will be used to support further clinical development of VAL-083 in combination with radiotherapy. Pharmacokinetic assessments
of VAL-083 in plasma and cerebral spinal fluid (“CSF”) will be used to correlate drug exposure in the central nervous
system with patient outcomes.
Dose
confirming cohorts studying 20, 30, and 40 mg/m
2
/day x three every 21 days have been completed. Based on the dose confirmation
phase of the study, we have selected 30 mg/m
2
for combination with irradiation for the treatment of newly-diagnosed
MGMT-unmethylated GBM patients.
As of August 1, 2019, of the first 20 enrolled patients,
17 have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment
and one patient died before their first assessment). “Best Overall Response” for these patients per Investigator Assessment
were:
|
●
|
Nine
have been assessed as having achieved a complete response (CR) (9/17, or 53%)
|
|
●
|
Seven
have been assessed with stable disease (SD), (7/17, or 41%); and
|
|
●
|
One
has been assessed as disease progression (PD) (1/17, or 6%).
|
Of the 20 patients enrolled, 17 (85%) have received their
two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI and investigator assessment,
and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%) have not been on the study
long enough to reach their first assessment, and one patient (5%) died before their first assessment. Importantly, 16 of the 20
patients enrolled (80%) were still alive as of the data cut-off date.
Through
our research, and that of the NCI, we have previously demonstrated that VAL-083 crosses the blood brain barrier. New preliminary
data from the SYSUCC study indicate that the concentration of VAL-083 is generally higher in CSF than in plasma at two hours post-infusion.
Concentration of VAL-083 — Two
Hours Post Dose
|
|
|
|
Mean Concentrations (ng/mL)
|
|
Conc. Ratio @ 2 hours
|
Dose (mg/m
2
)
|
|
n
|
|
Plasma (2 hours post dose)
|
|
CSF (2 hours post dose)
|
|
CSF/Plasma
|
20
|
|
1
|
|
110
|
|
154
|
|
1.40
|
30
|
|
3
|
|
97
|
|
134
|
|
1.41
|
40
|
|
3
|
|
170
|
|
190
|
|
1.13
|
By comparison, temozolomide is typically 80% lower in the CSF
than the plasma (Schreck et al. 2018, Oncology (Williston Park)). The reason this is important is that accumulation of VAL-083
in the CSF further validates that VAL-083 crosses the blood-brain-barrier and demonstrates that therapeutic drug concentrations
in the CSF are achievable for extended periods of time.
Ovarian Cancer
In April 2016, the FDA granted orphan drug designation for the
use of VAL-083 in the treatment of ovarian cancer.
In September 2017, we filed an IND for the use of VAL-083 in
ovarian cancer, along with a protocol for a Phase 1/2, open-label, multicenter, study of VAL-083 in patients with
Re
current
P
latinum
R
esistant
Ov
arian Cancer (the REPROVe study).
The FDA has allowed this study to begin enrolling patients,
but based on ongoing evaluation and input from our ovarian advisory board, we are reassessing the ovarian cancer program. We are
in the process of evaluating the best path forward in ovarian cancer and are looking at various strategic options including combination
with PARP inhibitors.
Fast Track Designation
In December 2017, the FDA granted Fast Track designation for
VAL-083 in rGBM.
Fast Track designation is designed to expedite the review of
drugs that show promise in treating life-threatening diseases and address unmet medical needs, with the goal of getting new treatments
to patients earlier. Fast Track designation provides sponsors with an opportunity for increased frequency for communication with
the FDA to ensure an optimal development plan and to collect appropriate data needed to support drug approval. Additional benefits
of the Fast Track designation may include an Accelerated Approval, a Priority Review, and a Rolling Review. Accelerated Approval
is granted to drugs that demonstrate an effect on a surrogate, or intermediate endpoints, reasonably likely to predict clinical
benefit. Priority Review shortens the FDA review process for a new drug from ten months to six months and is appropriate for drugs
that demonstrate significant improvements in both safety and efficacy of an existing therapy. Rolling Review provides a drug company
the opportunity to submit completed sections of its New Drug Application (“NDA”) for review by the FDA. Typically,
NDA reviews do not commence until the drug company has submitted the entire application to the FDA. Through the Fast Track designation,
the FDA attempts to ensure that questions raised during the drug development process are resolved quickly, often leading to earlier
approval and increased access for patients.
Current Treatments for Gliomas and Glioblastoma Multiforme
Gliomas are a type of Central Nervous System (“CNS”)
tumor that arises from glial cells in the brain or spine. Glial cells are the cells surrounding nerves. Their primary function
is to provide support and protection for neurons in the CNS.
GBM is the most common and the most lethal form of glioma. According
to the Central Brain Tumor Registry of The United States, GBM occurs with an incidence of 3.20 per 100,000 person-years. Approximately
13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017.
Common symptoms of GBM include headaches, seizures, nausea,
weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. GBM progresses
quickly and patients’ conditions deteriorate rapidly progressing to death. The outlook for GBM patients is generally poor.
The overall median survival in newly diagnosed GBM patients with best available treatments is less than 15 months, and two-year
and five-year survival rates are approximately 30% and 10%, respectively. Median overall survival in newly-diagnosed, unmethylated
GBM patients is 12.2 months.
In September 2017, the National Comprehensive Cancer Network
(“NCCN”), updated treatment guidelines for GBM. The recommended treatment regimen for GBM includes surgical resection
to remove as much of the tumor as possible (“debulking”) followed by radiotherapy with concomitant and adjuvant chemotherapy
with temozolomide with or without tumor treating fields (“TTF”). GBM patients whose tumors exhibit an unmethylated
promotor for the gene encoding the DNA repair enzyme MGMT, a biomarker correlated with resistance to temozolomide, may be treated
with radiation alone following surgery.
Patients with an unmethylated MGMT promotor have high levels
of MGMT, a naturally-occurring DNA repair enzyme that repairs tumor-fighting lesions induced by TMZ thus allowing a patient’s
tumor to continue to grow despite treatment which leads to poor outcomes. Measurement of MGMT methylation status has become routine
in clinical practice as biomarker that correlates with response to TMZ and patient outcomes in GBM.
Probability of GBM Patient Survival Correlated
to Expression of MGMT Enzyme
(Unmethylated promoter = High MGMT Expression and Significantly Shorter Survival)
TTF (Optune
®
) is a non-invasive technique for
adults with GBM. TTF uses alternating electrical fields to disrupt tumor cell division, or cause cell death, thereby preventing
the tumor from growing or spreading as quickly. A clinical study reported that GBM patients treated with TTF combined with TMZ
experienced longer survival than those treated with TMZ alone.
The majority of GBM patients’ tumors recur within 6 –
12 months of initial treatment. Experimental therapy through clinical studies is recommended under NCCN guidelines for eligible
patients. NCCN guidelines also recommend treatment with systemic chemotherapy, such as lomustine (“CCNU”). For patients
who are eligible for additional surgical debulking, local chemotherapy with carmustine (“BCNU”) wafers may be employed.
CCNU and BCNU target the same DNA-site as TMZ and are also subject to MGMT-related resistance.
Avastin (Avastin
®
, an anti-VEGF antibody) recently
received full approval in the US, Canada, Australia, and Japan as a single agent for patients with recurrent GBM following prior
therapy. Avastin carries an FDA “black-box warning” related to severe, sometimes fatal, side effects such as gastrointestinal
perforations, wound healing complications and hemorrhage. There are no data demonstrating an improvement in disease-related symptoms
or increased survival for GBM patients treated with Avastin.
Recurrent GBM patients, especially those whose tumors progress
following treatment with Avastin, have limited or no treatment options and a very poor prognosis. According to published literature,
the median survival for GBM patients whose tumors progress following Avastin is less than five months.
VAL-083 Mechanism of Action and the Opportunity in the Treatment
of Cancer
Chemotherapy forms the basis of treatment in nearly all cancers.
We believe that VAL-083 may be effective in treating tumors exhibiting biological features that cause resistance to currently available
chemotherapy, particularly for patients who have failed, or become resistant to, other treatment regimens.
Based on published research and our own data, the cytotoxic
functional groups, and the mechanism of action of VAL-083 are functionally different from alkylating agents commonly used in the
treatment of cancer. VAL-083 has previously demonstrated activity in cell-lines that are resistant to other types of chemotherapy.
No evidence of cross-resistance has been reported in published clinical studies.
Our research suggests that VAL-083 attacks cancer cells via
a unique mechanism of action which is distinct from other chemotherapies used in the treatment of cancer. Our data indicate that
VAL-083 forms inter-strand crosslinks at the N
7
position of guanine on the DNA of cancer cells. Our data also indicate
that this crosslink forms rapidly and is not easily repaired by the cancer cell resulting in cell-cycle arrest and lethal double-strand
DNA breaks in cancer cells. VAL-083 readily crosses the blood brain barrier. Published preclinical and clinical research demonstrate
that VAL-083 is absorbed more readily in tumor cells than in normal cells.
In vitro
, our data also demonstrate that VAL-083’s
distinct mechanism may be able to overcome drug resistance against a range of cancers. For example, VAL-083 is active against MGMT-unmethylated
GBM cells which are resistant to treatment with temozolomide and nitrosoureas. VAL-083 also retains a high level of activity in
p53 mutated non-small cell lung cancer (“NSCLC”), ovarian cancer and medulloblastoma cell lines that are resistant
to platinum-based chemotherapy.
Importantly, clinical activity against each of the tumors mentioned
above was established in prior NCI-sponsored Phase 2 clinical studies. We believe that these historical clinical data and our own
research support the development of VAL-083 as a potential new treatment for multiple types of cancer.
The main dose-limiting toxicity (“DLT”) related
to the administration of VAL-083 in previous NCI-sponsored clinical studies and our own clinical studies is myelosuppression, particularly
thrombocytopenia. Myelosuppression, including thrombocytopenia, is a common side effect of chemotherapy. Myelosuppression is the
decrease in cells responsible for providing immunity, carrying oxygen, and causing normal blood clotting. Thrombocytopenia is a
reduction in platelet counts which assist in blood clotting. Modern medicine allows for better management of myelosuppressive side
effects. We believe this offers the potential opportunity to improve upon the drug’s already established efficacy profile
by substantially increasing the dose of VAL-083 that can be safely administered to cancer patients.
There is no evidence of lung, liver, or kidney toxicity even
with prolonged treatment by VAL-083. Data from the Chinese market where the drug has been approved for more than 15 years supports
the safety findings of the NCI studies.
VAL-083 Historical Data
VAL-083 is first-in-class DNA targeting agent that readily crosses
the blood-brain-barrier. Data from prior NCI-sponsored clinical studies with VAL-083 demonstrate activity against GBM and other
CNS tumors. In general, historical NCI-sponsored studies demonstrate that tumor regression in brain cancer was achieved in 40%
of patients treated and stabilization was achieved in an additional 20% to 30% of brain tumor patients following treatment with
VAL-083. In these studies, VAL-083 demonstrated statistically significant improvement in the median survival of high-grade glioma
brain tumors, including GBM when combined with radiation versus radiation alone (p < 0.05) with results similar, or superior
to, other chemotherapies approved for the treatment of GBM.
A Summary of Published Data adapted from
Separate Sources Comparing the Efficacy of VAL-083
and Other Therapies in the Treatment of GBM
|
|
Comparative Therapy
|
|
Median Survival Benefit
vs.
|
Chemotherapy
|
|
Radiation (XRT) Alone
|
|
Radiation + Chemotherapy
|
|
XRT alone
|
VAL-083
(Eagan 1979)
|
|
8.4 months
|
|
16.8 months
|
|
8.4 months
|
Temozolomide (Temodar
®
)
(Stupp 2005)
|
|
12.1 months
|
|
14.6 months
|
|
2.5 months
|
Lomustine (CCNU)
(Walker 1976)
|
|
11.8 months
|
|
13 months
|
|
1.2 months
|
Carmustine (BCNU)
(Reagan 1976)
|
|
10 months
|
|
12.5 months
|
|
2.5 months
|
Semustine (ACNU)
(Takakura 1986)
|
|
12 months
|
|
14 months
|
|
2.0 months
|
VAL-083 is Active Independent of MGMT
We have presented data at several peer reviewed meetings demonstrating
that VAL-083 is active independent of MGMT resistance in GBM cell lines and other CNS tumor cells. Our research, along with that
of others, demonstrates that VAL-083’s unique cytotoxic mechanism forms DNA cross-links at the N
7
position of
guanine and retains cytotoxic activity independent of MGMT expression
in vitro
. Our studies demonstrate that VAL-083 has
more potent activity against brain tumor cells in comparison to TMZ and overcomes resistance associated with MGMT, suggesting the
potential to surpass the current standard-of-care in the treatment of GBM.
A Summary of Our Data Demonstrating that
VAL-083’s Anti-Tumor Mechanism is
Distinct from, and can Overcome, MGMT-Related Chemo resistance in the Treatment of GBM
In addition, historical NCI clinical study data and our own
research support the activity of VAL-083 as a potentiator of radiotherapy. Radiotherapy in combination with temozolomide is the
current standard of care in the treatment of newly diagnosed GBM. Our research demonstrates that temozolomide and radiotherapy
are ineffective against GBM cells exhibiting a high expression of MGMT, whereas VAL-083 potentiates the tumor-killing effect of
radiation independent of MGMT expression. Furthermore, the combination of VAL-083 and radiation has been demonstrated to be active
against GBM cancer stem cells (“CSCs”) in vitro. CSCs are often resistant to chemotherapy and form the basis for tumor
recurrence and metastasis. GBM CSCs display strong resistance to TMZ, even where MGMT expression is low. However, our data demonstrates
that GBM CSCs are susceptible to VAL-083 independent of MGMT expression.
A Summary of Our Data Demonstrating that
VAL-083 Maintains Activity in Both Temozolomide-resistant GBM Cell Lines and Matched Cancer Stem Cells and Potentiates Radiotherapy
We believe that VAL-083’s more potent activity against
brain tumor cells in comparison to TMZ, VAL-083’s ability to overcome MGMT-mediated resistance, and its activity against
GBM CSCs suggests the potential of VAL-083 to surpass the current standard-of-care in the treatment of GBM.
Phase 1 – 2 Clinical Study Overview and Summary of
Results
In an open-label, single arm dose-escalation study designed
to evaluate the safety, tolerability, pharmacokinetics, and anti-cancer activity of VAL-083, we enrolled forty-eight GBM patients
whose disease progressed following prior treatment with temozolomide and Avastin. The study was conducted at five centers in the
United States: the Mayo Clinic in Rochester, Minnesota; the Brain Tumor Center at University of California, San Francisco; the
Sarah Cannon Cancer Research Center in Nashville, Tennessee and Denver, Colorado; and the SCRI affiliate site at the Florida Cancer
Specialist Research Institute in Sarasota, Florida.
Patients received VAL-083 on days 1, 2 and 3 on a 21-day treatment
cycle. The Phase 1 portion of the study involved dose escalation cohorts until a maximum tolerated dose (“MTD”) was
established at 40mg/m
2
. A further 14-patient, Phase 2 expansion was then enrolled at the MTD to gather further safety
data at our chosen therapeutic dose and to further explore the outcomes in this patient population.
In May 2016, we held an end of Phase 2 meeting with the FDA
in which we discussed with the FDA the design of a Phase 3, registration-directed clinical program for VAL-083 in refractory GBM.
Based on the input we received from the FDA, the agency confirmed that it would consider the totality of data available, including
data obtained from our other planned clinical studies in related GBM populations, when assessing the NDA. The FDA also noted that
we may be able to rely on prior NCI studies and historical literature to support nonclinical data required for an NDA filing under
a 505(b)(2) strategy which allows a sponsor to rely on already established safety and efficacy data in support of an NDA.
In summary, the data from our previous Phase 1/2 study are as
follows:
Safety and Tolerability
In the Phase 1 dose escalation regimen, no serious adverse
events (“SAE”) related to VAL-083 were encountered at doses up to 40 mg/m
2
/day.
Increasing frequency of, and higher grade, hematologic toxicities
were observed at doses above 40 mg/m
2
/day. Consistent with the published literature, the observed dose limiting toxicity
for VAL-083 is primarily thrombocytopenia (low platelets). Observed platelet nadir occurred at approximately day 18, and recovery
was rapid and spontaneous following treatment.
Based
on Phase 1 observations, fourteen additional patients were enrolled in a Phase 2 expansion cohort at 40mg/m
2
which
was established as the MTD. Consistent with Phase 1, the dose of VAL-083 of 40 mg/m
2
on days 1, 2 and 3 of a 21-day
cycle was generally well tolerated in Phase 2. At this dose, one subject previously treated with CCNU, a nitrosourea agent, reported
severe (Grade 4) thrombocytopenia. As a result of this observation, the protocol inclusion criterion for platelet count was increased
from 100,000/μL to 150,000/μL for patients receiving prior nitrosoureas within 12 weeks preceding enrollment. No other dose
limiting toxicities were observed.
VAL-083
Safety Observations from Phase 1/2 Clinical Study
Hematologic parameter and CTCAE grade
|
|
dose
|
|
≤30 mg/m
2
|
|
|
40 mg/m
2
|
|
|
45 mg/m
2
|
|
|
50 mg/m
2
|
|
|
|
n =
|
|
20
|
|
|
17
|
|
|
4
|
|
|
7
|
|
Anemia
|
|
≤G2
|
|
|
11
|
|
|
|
55
|
%
|
|
|
2
|
|
|
|
12
|
%
|
|
|
2
|
|
|
|
50
|
%
|
|
|
6
|
|
|
|
86
|
%
|
|
|
G3
|
|
|
2
|
|
|
|
10
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
G4
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukopenia
|
|
≤G2
|
|
|
5
|
|
|
|
25
|
%
|
|
|
2
|
|
|
|
12
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
5
|
|
|
|
71
|
%
|
|
|
G3
|
|
|
1
|
|
|
|
5
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
3
|
|
|
|
43
|
%
|
|
|
G4
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
2
|
|
|
|
50
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neutropenia
|
|
≤G2
|
|
|
4
|
|
|
|
20
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
G3
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
3
|
|
|
|
43
|
%
|
|
|
G4
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
2
|
|
|
|
50
|
%
|
|
|
1
|
|
|
|
14
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenia
|
|
≤G2
|
|
|
9
|
|
|
|
45
|
%
|
|
|
3
|
|
|
|
18
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
3
|
|
|
|
43
|
%
|
|
|
G3
|
|
|
—
|
|
|
|
0
|
%
|
|
|
—
|
|
|
|
0
|
%
|
|
|
1
|
|
|
|
25
|
%
|
|
|
3
|
|
|
|
43
|
%
|
|
|
G4
|
|
|
—
|
|
|
|
0
|
%
|
|
|
1
|
|
|
|
6
|
%
|
|
|
2
|
|
|
|
50
|
%
|
|
|
1
|
|
|
|
14
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DLT Observed
|
|
|
|
|
nil
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
Doses
Achieved
Based
the results of our Phase 1/2 study, we confirmed that we achieved doses of VAL-083 that are higher than were utilized in the original
published NCI-sponsored clinical studies. A summary in comparison to the NCI’s historical regimen is as follows:
Dosing Regimen & Study
|
|
Single Dose
|
|
Acute Regimen
(single cycle)
|
|
Comparative
Cumulative Dose
(@ 35 days)
|
|
Dose Intensity
(dose per week)
|
NCI GBM historical regimen
(Eagan et al)
daily x 5 q 5wks
(cycle = 35 days)
|
|
25 mg/m
2
|
|
x5 days = 125 mg/m
2
|
|
125 mg/m
2
|
|
25 mg/m
2
/wk.
|
DelMar VAL-083 achieved
regimen daily x 3 q 3wks
(cycle = 21 days)
|
|
40 mg/m
2
|
|
x 3 days = 120 mg/m
2
|
|
240 mg/m
2
|
|
40 mg/m
2
/wk.
|
Daily
x 5 q 5wks refers to a dosing regimen of once per day for five consecutive days every five weeks (35-day cycle while daily x 3
q 3wks refers to a dosing regimen of once per day for three consecutive days every three weeks (21-day cycle).
Our
achieved dosing regimen increased the amount of VAL-083 delivered to the CNS over historical regimens without increased toxicity.
Thus, our regimen achieved both a higher maximum concentration and higher overall exposure, which we believe may increase the
likelihood of successful treatment outcomes in glioblastoma and other brain tumors.
Based
on our ongoing Phase 2 study at MDACC, we believe that the safety profile of the 40 mg/m
2
is within the existing safety
monitoring guidelines described in the present study protocol. However, in consultation with the principal investigator at MDACC,
we have amended the protocol for the study to modify the starting dose of VAL-083 to 30 mg/m
2
on days 1, 2 and 3,
of a 21-day cycle for this specific study population which has been previously treated with temozolomide. We believe this modification
may improve tolerance in this patient population and maximize overall exposure to VAL-083 thereby increasing the number of cycles
of drug patients are able to receive. The 30 mg/m
2
dosing regimen is 20% over the historical regimen.
Pharmacokinetics
Pharmacokinetic
(“PK”) analyses showed dose-dependent linear systemic exposure with a short (1-2h) plasma terminal half-life; average
Cmax at 40 mg/m
2
/day was 781 ng/mL (5.3µM). The observed PK profile is comparable to published literature. Prior
NCI-sponsored studies demonstrated that VAL-083 readily crosses the blood brain barrier and has a long (>20 hour) half-life
in the CNS.
We
believe that this PK profile is optimal for the treatment of brain tumors: A long CNS half-life is expected to maximize exposure
of the drug in the brain increasing the likelihood of successful treatment outcomes, while a short plasma half-life is desirable
to minimize systemic side effects.
Observed
pharmacokinetics from VAL-083 Phase 1 clinical study dose vs. AUC
Based
on observed and previously published pharmacokinetics, we believe that therapeutic doses equal to, or above, 20 mg/m
2
daily on days 1, 2 and 3 of a 21-day cycle should deliver sufficient levels of VAL-083 to brain tumors to achieve a therapeutic
benefit. We are currently using a dose of 30 mg/m
2
daily on days 1, 2 and 3 of a 21-day cycle in our two Phase 2 studies
that are currently ongoing.
MGMT
& IDH1
High
expression of MGMT and wild-type form of the enzyme isocitrate dehydrogenase (“IDH1”) have been previously shown to
be diagnostic markers that correlate with resistance to currently available chemotherapies (e.g. temozolomide or nitrosourea)
in the treatment of GBM and poor patient outcomes. Measurement of these biomarkers has become routine in clinical practice.
Notably,
we have previously demonstrated that VAL-083’s anti-tumor mechanism is active independent from the MGMT status
in vitro
.
We believe we will ultimately be able to use such biomarkers in a prognostic fashion to select the patients most likely to respond
to treatment as we expand the clinical development of VAL-083.
Biomarker
|
|
Observation in
Phase 1/2
clinical study
|
|
High MGMT (n=19)
|
|
|
84
|
%
|
IDH-WT (n=11)
|
|
|
90
|
%
|
Tumor
Response and Outcomes
GBM
patients in our Phase 1/2 clinical study were not re-resected prior to treatment with VAL-083 and therefore had a growing recurrent
GBM tumor at the time of enrollment. Patients were monitored for tumor response by MRI.
Consistent
with un-resected GBM, median progression free survival (“PFS”) was short at 1.2 months (range: 0.2 – 20.1 months).
Five GBM patients treated with VAL-083 were reported to have stable disease as their best response following treatment; the remainder
reported progressive disease.
Disease
progression is typical in a refractory GBM population with non-resected tumors. However, we believe that slowed progression may
provide meaningful clinical benefit in this patient population through prolonged overall survival and improved quality of life.
According
to published literature, GBM patients failing Avastin have a poor prognosis with expected survival under five months.
Analysis
of twenty-two patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m
2
) demonstrated median survival
of 8.35 months following Avastin failure.
VAL-083
compared to published literature
Reference
|
|
|
Post
Avastin Salvage Therapy
|
|
Median
Survival following
Avastin Failure
|
Shih
(2016)
|
|
|
VAL-083
|
|
8.35
months
|
Rahman
(2014)
|
|
|
nitrosourea
|
|
4.3
months
|
Mikkelson
(2011)
|
|
|
TMZ
+ irinotecan
|
|
4.5
months
|
Lu
(2011)
|
|
|
dasatinib
|
|
2.6
months
|
Reardon
(2011)
|
|
|
etoposide
|
|
4.7
months
|
Reardon
(2011)
|
|
|
TMZ
|
|
2.9
months
|
Iwomoto
(2009)
|
|
|
various
|
|
5.1
months
|
While
recognizing these data are representative of a relatively small, non-controlled Phase 1/2 clinical study, we believe these outcomes
support the potential of VAL-083 to offer meaningful clinical benefit to GBM patients who have failed Avastin, compared to currently
available therapy.
VAL-083
Historical Data and Our Research in Ovarian Cancer
Ovarian
cancer is the fifth most common cancer in women and is the leading cause of death among women diagnosed with gynecological malignancies.
In 2016, approximately 22,300 women in the US were diagnosed with ovarian cancer and 14,300 died from their disease.
Without
treatment, ovarian cancer spreads within the pelvic region and metastasizes to distant sites such as the lungs, liver, spleen
and, rarely, the brain. The initial symptoms of ovarian cancer such as abdominal bloating, indigestion, pelvic pain, or nausea
are often attributed to symptoms caused by a less serious condition. Therefore, in most cases, ovarian cancer is not diagnosed
until it has progressed to an advanced stage when it is no longer possible to surgically remove all tumor tissue.
When
diagnosed at an advanced stage the 5-year survival rate is less than 40%. Women with ovarian cancer receive chemotherapy following
surgery to treat residual disease.
VAL-083’s
activity against ovarian epithelial adenocarcinoma (“OEA”) and squamous cell carcinoma of the cervix (“SCC”)
was reported in prior NCI-sponsored clinical studies. Importantly, NCI-researchers recommended VAL-083 for further advanced studies
in the treatment of ovarian cancer.
Pt-based
chemotherapy is employed in the treatment of nearly 50% of all cancer patients and is employed in the treatment regimen of nearly
all advanced-stage ovarian cancer patients. Ovarian cancer patients whose tumors are sensitive to Pt-based chemotherapy have the
most favorable outcome. Recently, the approval of PARP inhibitors in the treatment of ovarian cancer patients demonstrated improved
outcomes, particularly patients whose tumors remain sensitive to Pt-based treatments.
Pt-based
chemotherapies function by causing extensive damage to a cancer cell’s DNA. Cancer cells are adept at overcoming DNA damage
or employing mechanisms to repair DNA damage induced by Pt-based chemotherapy. One of the most common obstacles to DNA-damaging
chemotherapy is mutations to a gene called p53. Cellular processes governed by the p53 gene are critical in assessing DNA damage
and determining if a cell should cease from dividing or self-destruct. When p53 does not function properly, cancer cells continue
to divide despite the treatment with DNA-damaging chemotherapy, making these drugs ineffective and leading to treatment resistance.
This occurs in nearly all cases of the most difficult ovarian cancer to treat — high grade serous ovarian cancer (HGSOC)
— which accounts for up to 70% of ovarian cancer cases and approximately 90% of ovarian cancer deaths. P53 mutations are
associated with resistance to Pt-based chemotherapy, which leads to treatment failure and increased mortality. Solving this problem
is a major goal in the development of new treatments for ovarian cancer.
Unfortunately,
the development of resistance to Pt-based agents is nearly inevitable, leading to disease recurrence and increased mortality.
Ultimately, most women with advanced ovarian cancer develop recurrent disease with progressively shorter disease-free intervals.
Those whose tumors recur within 6 months of Pt-based therapy are considered Pt-resistant/refractory and have a very poor prognosis.
The
response rate to second line therapy for Pt-resistant ovarian cancer patients is in the 10-15% range and overall survival is approximately
12 months. The development of new chemotherapies and targeted agents to overcome Pt resistance in ovarian cancer is a significant
unmet medical need.
We
have presented data demonstrating that VAL-083’s distinct mechanism of action allows activity in tumors that are resistant
to other therapies. We have shown that cytotoxicity of VAL-083 against ovarian cancer is independent of sensitivity to cisplatin
or p53 status
in vitro.
We have demonstrated that VAL-083 is active in Pt-resistant ovarian cells harboring a range of
p53-mutations.
Our
research has demonstrated that VAL-083 not only overcomes Pt resistance, but the combination of VAL-083 with Pt-based chemotherapy
displays synergy in multiple models
in vitro
and
in vivo.
This further suggests a distinct mechanism of action and
potential use as part of a VAL-083/Pt-combination therapy.
The
combination of VAL-083 with either cisplatin
(A)
or oxaliplatin
(B)
in the human H460 (WT p53) NSCLC model demonstrated
significant super additivity (p≤0.05) and/or synergism (CI<1) for both combinations. This cytotoxic effect of VAL-083 in
combination with either platinum drug was observed also in A549 (WT p53) and H1975 (mutant p53) NSCLC cells, independently of
p53 status (not shown). Data, where applicable, are shown as mean ± SE; N=7.
While
Pt-based chemotherapy is the standard treatment for ovarian cancer, PARP inhibitors have recently provided a new treatment option
for a subset of patients with platinum-sensitive recurrent ovarian cancer. VAL-083 also demonstrates synergistic activity with
certain PARP inhibitors, including olaparib (Lynparza) and talazoparib
in vitro
, suggesting VAL-083 may have utility in
the treatment of ovarian cancer in combination with PARP inhibitors.
We
believe that these data demonstrate the potential of VAL-083 to treat platinum-resistant ovarian cancers as a single-agent against
platinum-resistant tumors in combination with platinum-based chemotherapeutic regimens or in combination with PARP inhibitors.
Other
Indications for VAL-083 — Potential Future Opportunities
VAL-083
in Lung Cancer
Lung
cancer is a leading cause of cancer death around the world and effective treatment for lung cancer remains a significant global
unmet need despite advances in therapy. Incidence of lung cancer in the United States is approximately 47 per 100,000 with the
majority (85%) being NSCLC, the most common type of lung cancer. Globally, the market for lung cancer treatment may exceed $24
billion by 2033 according to a report published by Evaluate Pharma.
The
activity of VAL-083 against solid tumors, including lung cancer, has been established in both preclinical and human clinical studies
conducted by the NCI. DelMar has developed new nonclinical data to support the utility of VAL-083 in the modern treatment of lung
cancer. In an established murine xenograft model of NSCLC, the activity of VAL-083 was compared to standard platinum-based therapy
with cisplatin against human NSCLC cell lines A549 (TKI-sensitive) and H1975 (TKI-resistant). In the study, VAL-083 demonstrated
superior efficacy and safety in the treatment of TKI-susceptible (A549) tumors and in TKI-resistant (H1975) tumors.
Central
Nervous System Metastases of Solid Tumors
The
successful management of systemic tumors by modern targeted therapies has led to increased incidence of mortality due to CNS metastases
of lung cancer and other solid tumors. In June 2013, we split our Phase 1/2 clinical study protocol into two separate studies:
one focusing solely on refractory GBM and the other focusing on secondary brain cancers caused by other tumors that have spread
to the brain.
Based
on historical clinical activity and our own research, we believe that VAL-083 may be suitable for the treatment of patients with
CNS metastases who currently have limited treatment options. Subject to the availability of financial and operating resources,
we plan to develop a separate protocol for the continued exploration of VAL-083 in patients with secondary brain cancer caused
by a solid tumor spreading to the brain.
Pediatric
Brain Tumors
Tumors
of the brain and spine make up approximately 20 percent of all childhood cancers and they are the second most common form of childhood
cancer after leukemia.
The
activity of VAL-083 against childhood and adolescent brain tumors has been established in both preclinical and human clinical
studies conducted by the NCI. We have presented data indicating that VAL-083 offers potential therapeutic alternatives for the
treatment of pediatric brain tumors including SHH-p53 mutated medulloblastoma. In March 2016, the FDA granted orphan drug designation
for the use of VAL-083 in the treatment of medulloblastoma. Subject to the availability of resources, we intend to collaborate
with leading academic researchers for the continued exploration of VAL-083 as a potential treatment of childhood brain tumors.
Additional
Indications for VAL-083
In
historical studies sponsored by the NCI in the United States, VAL-083 exhibited clinical activity against a range of tumor types
including central nervous system tumors, solid tumors, and hematologic malignancies. We have established new nonclinical data
supporting the activity of VAL-083 in different types of cancer that are resistant to modern targeted therapies and we believe
that the unique cytotoxic mechanism of VAL-083 may provide benefit to patients in a range of indications. We intend to continue
to research these opportunities, and if appropriate, expand our clinical development efforts to include additional indications.
VAL-083
Target Markets
DNA-targeting
agents such as alkylating agents or platinum-based chemotherapy form the mainstay of chemotherapy treatments used in the treatment
of cancers. For example, TMZ had peak annual sales of $1.1 billion in 2010, while bendamustine, had peak annual sales of $0.8
billion in 2014.
Our
product candidate, VAL-083, is a first-in-class DNA targeting agent with a novel mechanism of action. VAL-083’s anti-cancer
activity was established in a range of tumor types in prior NCI-sponsored clinical studies. Based on this novel mechanism, we
have demonstrated that the anti-cancer activity is maintained against tumor cells that are resistant to other DNA-targeting agents.
We believe this positions VAL-083 as a potential chemotherapy-of-choice for patients whose tumors are resistant to current standard-of-care
chemotherapy in orphan and major cancer indications.
Our
ongoing research and development activities are focused on indications where VAL-083 demonstrated promising activity in prior
NCI-sponsored studies and where our research suggests an opportunity to address significant unmet medical needs due to the failure
of existing treatments.
VAL-083 target markets
|
|
2024 Estimated
Global Sales
|
|
Glioblastoma multiforme (GBM)
|
|
$
|
1.5B
|
|
Ovarian Cancer
|
|
$
|
4.2B
|
|
Non-small cell lung cancer (NSCLC)
|
|
$
|
32.6B
|
|
|
|
|
|
|
Source: Evaluate Pharma
|
|
|
|
|
Glioblastoma
Multiforme
GBM
is the most common and the most lethal form of glioma. According to the Central Brain Tumor Registry of The United States, GBM
occurs with an incidence of 3.20 per 100,000 person-years. Approximately 13,000 new cases of GBM were diagnosed in the United
States and 16,000 in Europe during 2017.
Newly
diagnosed patients suffering from GBM are initially treated through invasive brain surgery, although disease progression following
surgical resection is nearly 100%. Temozolomide (Temodar
®
) in combination with radiation is the front-line therapy
for GBM following surgery. Global revenues of branded Temodar reached $1.1 billion in 2010. Approximately 60% of GBM patients
treated with Temodar
®
experience tumor progression within one year. Median overall survival in newly-diagnosed,
unmethylated GBM patients is 12.2 months.
Bevacizumab
(Avastin
®
) has been approved for the treatment of GBM in patients failing Temodar
®
. In clinical
studies, approximately 20% of patients failing Temodar
®
respond to Avastin
®
therapy and no improvement
in median survival was reported.
The
market for refractory (Avastin-failed) GBM is limited to those jurisdictions where Avastin is approved for the treatment of GBM.
The United States, Canada, Australia, Japan and Switzerland represent the major markets where Avastin is used in the treatment
of GBM.
Ovarian
Cancer
The
American Cancer Society estimates that approximately 22,000 women will receive a new diagnosis of ovarian cancer and approximately
14,000 women will die from ovarian cancer in the United States each year. Ovarian cancer ranks fifth in cancer deaths among women,
accounting for more deaths than any other cancer of the female reproductive system.
The
potential of VAL-083 in the treatment of ovarian cancer has been established in prior NCI-sponsored clinical studies and by our
recent research. The FDA has granted orphan drug status to VAL-083 as a potential treatment for ovarian cancer and we have recently
received notice of allowance for our IND to initiate a Phase 1-2 clinical study to investigate the safety and effectiveness of
VAL-083 in patients with recurrent platinum resistant ovarian cancer (VAL-083 REPROVe study).
Ovarian
cancers are commonly treated with a platinum-based chemotherapy regimen. Initial tumor response rates are relatively high. However,
the development of resistance to Pt-based chemotherapy in ovarian cancer patients is nearly inevitable. Our research suggests
that VAL-083 may offer a potential treatment option for ovarian cancer patients who are resistant to platinum-based chemotherapy
and as a potential combination therapy with other agents. We believe the profile of VAL-083 offers the potential to capture meaningful
market share in the multi-billion ovarian cancer market.
Lung
Cancer
Lung
cancer is the most common cancer in the world with 1.8 million cases in 2012, representing 13% of all cancers. According to the
American Lung Association, lung cancer is the leading cancer killer in both men and women in the U.S. During 2018, an estimated
234,030 new cases of lung cancer were expected to be diagnosed.
The
potential of VAL-083 in the treatment of NSLSC has been established in both human clinical studies conducted by the NCI and by
the drug’s commercial approval in China. We believe the profile of VAL-083 offers the potential to capture meaningful market
share in the multi-billion NSCLC market.
VAL-083
Manufacturing
VAL-083
is a small-molecule chemotherapeutic. Chemical synthesis of the active pharmaceutical ingredient (“API”) was initially
established by the NCI. We have made improvements to this process and have obtained patents on these improvements. The current
manufacturing process involves fewer than five synthetic steps.
VAL-083
drug product is a lyophilized (freeze-dried) formulation that is reconstituted for intravenous injection. We anticipate that overall
cost of goods for an eventual commercial product will be similar to other injectable, small-molecule pharmaceuticals.
Until
recently, supply of VAL-083 for our clinical studies has been provided through our collaboration with Guangxi Wuzhou Pharmaceutical
Company. Guangxi Wuzhou Pharmaceutical Company as a manufacturer has established a commercial-scale manufacturing process based
on the North American process originally developed for the NCI that has been licensed by the CFDA for commercial supply of VAL-083
in China. However, to-date, they have not achieved the quality of systems necessary to meet FDA manufacturing standards.
To
address the need to meet FDA standards, we have engaged third-party contract manufacturers with the capabilities to establish
the processes, procedures and quality systems necessary to meet U.S., Canadian, E.U. and other international manufacturing requirements
in accordance with Good Manufacturing Practice (“cGMP”) regulations. We have now received drug supply manufactured
under full cGMP conditions. We intend to use this drug supply for all future clinical studies.
We
have developed and patented certain intellectual property related to quality controls that are used in the release of VAL-083
for our clinical studies in the United States. This intellectual property is also required for product release under CFDA guidelines
and we have granted access to our intellectual property for this purpose.
Research
& Development Collaborations
Guangxi
Wuzhou Pharmaceutical Company
Pursuant
to a memorandum of understanding and collaboration agreement, dated October 25, 2012, we have established a strategic collaboration
with Guangxi Wuzhou Pharmaceutical Company, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group Co., Ltd. (SHG: 600252)
(the “Guangxi Agreement”). VAL-083 is approved for the treatment of chronic myelogenous leukemia (“CML”)
and lung cancer in China and Guangxi Wuzhou Pharmaceutical Company is the only manufacturer licensed by the CFDA to produce the
product for the China market. Through the Guangxi Agreement, we have been provided drug product at the production price for our
VAL-083 clinical studies in the United States and China and we have also secured certain commercial rights in China.
Pursuant
to the Guangxi Agreement, we granted to Guangxi Wuzhou Pharmaceutical Company a royalty-free license to certain of our intellectual
property, as it relates to quality control and drug production methods for VAL-083, and we agreed that Guangxi Wuzhou Pharmaceutical
Company will be our exclusive supplier of VAL-083 for clinical studies and commercial sales, subject to Guangxi Wuzhou Pharmaceutical
Company obtaining and maintaining cGMP certification by the FDA, EMA or other applicable regulatory agencies, and Guangxi Wuzhou
Pharmaceutical Company being able to meet volumes ordered by us. We will continue to work with Guangxi Wuzhou Pharmaceutical Company
to achieve US FDA compliance in order to potentially have them as our future supplier for global sales of VAL-083.
This
Guangxi Agreement also provides us with certain exclusive commercial rights related to drug supply. Specifically, the Guangxi
Agreement establishes an exclusive supply relationship between us and Guangxi Wuzhou Pharmaceutical Company for the Chinese market
and all markets outside China. Guangxi Wuzhou Pharmaceutical Company agreed that it may not sell VAL-083 for markets outside of
China to any other purchaser other than us, provided that, during the first three years following regulatory clearance for marketing
of VAL-083 in a particular country or region, we meet proposed sales volumes set by Guangxi Wuzhou Pharmaceutical Company for
the country or region. In addition, Guangxi Wuzhou Pharmaceutical Company granted us a pre-emptive right in China (subject to
our acceptance of proposed sales volume and prices) to purchase VAL-083 produced by Guangxi Wuzhou Pharmaceutical Company.
The
term of the Guangxi Agreement (except as it relates to the exclusive rights in the China market) is indefinite, subject to termination
upon written agreement of all parties, or if either party breaches any material term and fails to remedy such breach within 30
days of receipt of notice of the breach, or if any action to be taken thereunder is not agreed to by both parties, provided that
such matter is referred to the chief executive officer of both parties, and they are unable to resolve such matter within 90 days.
No payments have been made to date under the Guangxi Agreement.
Duke
University Collaboration
In
April 2017, we entered into a three-year collaboration with Duke University to evaluate VAL-083 as a front-line treatment for
newly diagnosed patients with GBM. Under the terms of the collaboration, we will fund a series of preclinical studies to be conducted
by Duke University’s Glioblastoma Drug Discovery Group to identify molecular characteristics of GBM tumors that are more
likely to respond to VAL-083, and not the standard of care, temozolomide, as a front-line treatment or through combination therapies.
Patents
and Proprietary Rights
Our
success will depend in part on our ability to protect our existing product candidate and the products we acquire or license by
obtaining and maintaining a strong proprietary position. To develop and maintain our position, we intend to continue relying upon
patent protection, orphan drug status, Hatch-Waxman exclusivity, trade secrets, know-how, continuing technological innovations
and licensing opportunities.
We
have filed patent applications claiming the use of, and improvements related to VAL-083. Our patent filings also include proposed
treatment regimens, improvements to the manufacturing process, formulation and composition of the active pharmaceutical ingredient,
and finished dosage forms of VAL-083. We are prosecuting our patent applications in the United States and other jurisdictions
which we deem important for the potential commercial success of VAL-083.
Our
patents and patent applications can be summarized in fourteen series as follows:
|
●
|
Series
I is generally directed to synthesis of VAL-083.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
No. 8,563,758
|
|
Method Of Synthesis
Of Substituted Hexitols Such As Dianhydrogalactitol
|
|
|
United States Patent
No. 8,921,585
|
|
Method Of Synthesis
Of Substituted Hexitols Such As Dianhydrogalactitol
|
|
|
United States Patent
No. 9,085,544
|
|
Method Of Synthesis
Of Substituted Hexitols Such As Dianhydrogalactitol
|
|
|
United States Patent
No. 9,630,938
|
|
Method Of Synthesis
Of Substituted Hexitols Such As Dianhydrogalactitol
|
|
|
PCT Patent Application
Serial No. PCT/US2011/048032
|
|
Method Of Synthesis
Of Substituted Hexitols Such As Dianhydrogalactitol. National phase applications pending and granted in various countries.
|
|
2031
|
|
●
|
Series
II is generally directed to use of VAL-083 to treat a range of diseases and conditions, including but not limited to malignancies.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
No. 9,066,918
|
|
Compositions And
Methods To Improve The Therapeutic Benefit Of Suboptimally Administered Chemical Compounds Including Substituted Hexitols
Such As Dianhydrogalactitol And Diacetyldianhydrogalactitol
|
|
|
United States Patent
No. 9,901,563
|
|
Compositions And
Methods To Improve The Therapeutic Benefit Of Suboptimally Administered Chemical Compounds Including Substituted Hexitols
Such As Dianhydrogalactitol And Diacetyldianhydrogalactitol
|
|
|
|
●
|
Series
III is generally directed to analytical methods for VAL-083.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
No. 9,759,698
|
|
Improved Analytical
Methods For Analyzing And Determining Impurities In Dianhydrogalactitol
|
|
|
United States Patent
No. 10,145,824
|
|
Improved Analytical
Methods For Analyzing And Determining Impurities In Dianhydrogalactitol
|
|
|
United States Patent
No. 9,029,164
|
|
Improved Analytical
Methods For Analyzing And Determining Impurities In Dianhydrogalactitol
|
|
|
PCT Patent Application
Serial No. PCT/IB2013/000793
|
|
Improved Analytical
Methods For Analyzing And Determining Impurities In Dianhydrogalactitol. National phase applications pending and granted in
various countries.
|
|
2033
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
PCT Patent Application
Serial No. PCT/US2014/066087
|
|
Improved Analytical
Methods For Analyzing And Determining Impurities In Dianhydrogalactitol.
|
|
2034
|
|
●
|
Series
IV is generally directed to the use of VAL-083 to treat GBM or medulloblastoma.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 16/242,752
|
|
Use Of Substituted
Hexitols Including Dianhydrogalactitol And Analogs To Treat Neoplastic Disease And Cancer Stem Cells Including Glioblastoma
Multiforme And Medulloblastoma
|
|
|
United States Patent
No. 9,687,466
|
|
Use Of Substituted
Hexitols Including Dianhydrogalactitol And Analogs To Treat Neoplastic Disease And Cancer Stem Cells Including Glioblastoma
Multiforme And Medulloblastoma
|
|
|
United States Patent
No. 10,201,521
|
|
Use Of Substituted
Hexitols Including Dianhydrogalactitol And Analogs To Treat Neoplastic Disease And Cancer Stem Cells Including Glioblastoma
Multiforme And Medulloblastoma
|
|
|
PCT Patent Application
Serial No. PCT/US2013/022505
|
|
Use Of Substituted
Hexitols Including Dianhydrogalactitol And Analogs To Treat Neoplastic Disease And Cancer Stem Cells Including Glioblastoma
Multiforme And Medulloblastoma. National phase applications pending in various countries.
|
|
2033
|
|
●
|
Series
V is generally directed to the veterinary use of VAL-083.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
No. 9,814,693
|
|
Veterinary Use
Of Dianhydrogalactitol, Diacetyldianhydrogalactitol, And Dibromodulcitol To Treat Malignancies
|
|
|
|
●
|
Series
VI is generally directed to the use of VAL-083 to treat tyrosine-kinase-inhibitor-resistant malignancies.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 14/409,909
|
|
Methods For Treating
Tyrosine-Kinase-Inhibitor-Resistant Malignancies In Patients With Genetic Polymorphisms Or Ahi1 Dysregulations Or Mutations
Employing Dianhydrogalactitol, Diacetyldianhydrogalactitol, Dibromodulcitol, Or Analogs Or Derivatives Thereof
|
|
|
PCT Patent Application
Serial No. PCT/US2013/047320
|
|
Methods For Treating
Tyrosine-Kinase-Inhibitor-Resistant Malignancies In Patients With Genetic Polymorphisms Or Ahi1 Dysregulations Or Mutations
Employing Dianhydrogalactitol, Diacetyldianhydrogalactitol, Dibromodulcitol, Or Analogs Or Derivatives Thereof. National phase
applications pending in various countries.
|
|
2033
|
|
●
|
Series
VII is generally directed to the use of VAL-083 to treat recurrent malignant glioma and progressive secondary brain tumor.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 14/682,226
|
|
Use Of Dianhydrogalactitol
And Analogs And Derivatives Thereof To Treat Recurrent Malignant Glioma Or Progressive Secondary Brain Tumor
|
|
|
PCT Application
Serial No. PCT/US2014/040461
|
|
Use Of Dianhydrogalactitol
And Analogs And Derivatives Thereof To Treat Recurrent Malignant Glioma Or Progressive Secondary Brain Tumor. National phase
applications pending and granted in various countries.
|
|
2034
|
|
●
|
Series
VIII is generally directed to the use of VAL-083 to treat non-small-cell lung cancer.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 14/710,240
|
|
Use of Dianhydrogalactitol
and Analogs or Derivatives Thereof in Combination With Platinum-Containing Antineoplastic Agents to Treat Non Small-Cell Carcinoma
of the Lung and Brain Metastases
|
|
|
PCT Patent Application
Serial No. PCT/US2015/024462
|
|
Use of Dianhydrogalactitol
and Analogs or Derivatives Thereof to Treat Non-Small Cell Carcinoma of the Lung and Ovarian Cancer. National phase applications
pending in various countries.
|
|
2035
|
|
●
|
Series
IX is generally directed to the use of VAL-083 and radiation to treat NSCLC and GBM.
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 15/525,933
|
|
Dianhydrogalactitol
Together with Radiation to Treat Non-Small-Cell Carcinoma of the Lung and Glioblastoma Multiforme.
|
|
|
PCT Patent Application
Serial No. PCT/US2015/059814
|
|
Dianhydrogalactitol
Together with Radiation to Treat Non-Small-Cell Carcinoma of the Lung and Glioblastoma Multiforme. National phase applications
pending in various countries.
|
|
2035
|
|
●
|
Series
X is generally directed to the use of VAL-083 in NSCLC and ovarian cancer:
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 15/759,104
|
|
Use of Dianhydrogalactitol
And Derivatives Thereof in the Treatment of Glioblastoma, Lung Cancer and Ovarian Cancer.
|
|
|
|
●
|
Series
XI is generally directed to the use of VAL-083 in the treatment of CNS malignancies:
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 15/624,200
|
|
Use of Dianhydrogalactitol
or Derivatives and Analogs Thereof for Treatment of Pediatric Central Nervous System Malignancies.
|
|
|
United States Patent
Application Serial No. 15/771,631
|
|
Use of Dianhydrogalactitol
or Derivatives and Analogs Thereof for Treatment of Pediatric Central Nervous System Malignancies.
|
|
|
|
●
|
Series
XII is generally directed to the analysis and resolution of VAL-083 preparations:
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
United States Patent
Application Serial No. 15/778,546
|
|
Methods for analysis
and Resolution of Preparations of Dianhydrogalactitol and Derivatives and Analogs Thereof.
|
|
|
PCT Patent Application
Serial No.
PCT/US2016/063362
|
|
Methods for analysis
and Resolution of Preparations of Dianhydrogalactitol and Derivatives and Analogs Thereof. National phase applications pending
in various countries.
|
|
2036
|
|
●
|
Series
XIII is generally directed to combinations:
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
PCT Patent Application
Serial No. PCT/US2018/030391
|
|
Use of Dianhydrogalactitol
and Analogs and Derivatives in Combination VEGF inhibitors to Treat Cancer
|
|
2038
|
Patent or Patent Application
No.
|
|
Title
|
|
Expiry
|
PCT Patent Application
Serial No. PCT/US2018/020314
|
|
Use of Dianhydrogalactitol
and Analogs and Derivatives in Combination with a P53 Modulator or a PARP Inhibitor
|
|
2038
|
|
●
|
Series
XIV is generally directed to DIPG:
|
Patent
or Patent Application No.
|
|
Title
|
|
Expiry
|
PCT
Patent Application Serial No. PCT/IB2018/001357
|
|
Dianhydrogalactitol
for the Treatment of Diffuse Intrinsic Pontine Gliomas
|
|
2038
|
One
of the inventors listed in our Series IX applications is an employee of the University of California, San Francisco. If a patent
issues from a patent application in this series with a claim that the University of California employee conceived of, in whole
or in part, then the Regents of the University of California will share ownership of any such patent with us. Our research agreements
with the University of California address this issue by providing us with an exclusive option, for a limited period of time, to
negotiate a royalty-bearing exclusive license for commercialization of the invention covered by that patent.
In
addition to patent protection, we may also seek orphan drug status whenever it is available. If a product which has an orphan
drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the
product is entitled to orphan exclusivity, meaning that the applicable regulatory authority may not approve any other applications
to market the same drug for the same indication, except in very limited circumstances, for a period of seven years in the U.S.
and Canada, and 10 years in the E.U. Orphan drug designation does not prevent competitors from developing or marketing different
drugs for the same indication or the same drug for a different clinical indication.
VAL-083
has been granted protection under the Orphan Drug Act by the FDA and the European Medicines Agency for the treatment of gliomas,
including GBM. The FDA has also granted Orphan Drug protection to VAL-083 for the treatment of medulloblastoma and ovarian cancer.
In
February 2012, the FDA granted orphan drug status to VAL-083 for the treatment of glioma. In January 2013, the EMA also granted
orphan drug protection to VAL-083 for the treatment of glioma. In the spring of 2016, the FDA Office of Orphan Products Development
granted orphan drug designations to VAL-083 for the treatment of ovarian cancer and medulloblastoma.
In
addition to our patents and orphan drug protection, we intend to rely on the Hatch-Waxman Amendments for five years of data exclusivity
for VAL-083.Under the Hatch-Waxman Amendments, newly approved drugs and indications benefit from a statutory period of non-patent
marketing exclusivity. These amendments provide five-year data exclusivity to the first applicant to gain approval of an NDA for
a new chemical entity, meaning that the FDA has not previously approved any other new drug containing the same active ingredient.
The Hatch-Waxman Amendments prohibit the approval of an abbreviated new drug application, also known as an ANDA or generic drug
application, during the five-year exclusive period if no patent is listed. If there is a patent listed and the ANDA applicant
certifies that the NDA holder’s listed patent for the product is invalid or will not be infringed, the ANDA can be submitted
four years after NDA approval. Protection under the Hatch-Waxman Amendments will not prevent the filing or approval of another
full NDA; however, the applicant would be required to conduct its own pre-clinical studies and adequate and well-controlled clinical
studies to demonstrate safety and effectiveness. The Hatch-Waxman Amendments also provide three years of data exclusivity for
the approval of NDAs with new clinical studies for previously approved drugs and supplemental NDAs, for example, for new indications,
dosages or strengths of an existing drug, if new clinical investigations were conducted by or on behalf of the sponsor and were
essential to the approval of the application. This three-year exclusivity covers only the new changes associated with the supplemental
NDA and does not prohibit the FDA from approving ANDAs for drugs containing the original active ingredient.
We
also rely on trade secret protection for our confidential and proprietary information. We believe that the substantial costs and
resources required to develop technological innovations, such as the manufacturing processes associated with VAL-083, will help
us to protect the competitive advantage of our product candidate.
The
protection of intellectual property rights in China (where our clinical product candidate, VAL-083, is manufactured pursuant to
a collaboration agreement with the only manufacturer presently licensed by the CFDA to produce the product for the China market,
and where VAL-03 is approved for the treatment of CML and lung cancer) is relatively weak compared to the United States, which
may negatively affect our ability to generate revenue from VAL-083 in China.
Our
policy is to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to
execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide
that all confidential information developed or made known to the individual during the course of the individual’s relationship
with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees
and consultants, the agreements provide that all inventions conceived by the individual shall be our exclusive property.
Government
Regulation and Product Approval
Regulation
by governmental authorities in the U.S. and other countries is a significant factor, affecting the cost and time of our research
and product development activities, and will be a significant factor in the manufacture and marketing of any approved products.
Our product candidates will require regulatory approval by governmental agencies prior to commercialization. In particular, our
products are subject to rigorous preclinical and clinical testing and other approval requirements by the FDA and similar regulatory
authorities in other countries. Various statutes and regulations also govern or influence the manufacturing, safety, reporting,
labeling, transport and storage, record keeping and marketing of our products. The lengthy process of seeking these approvals,
and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any
failure by us to obtain, or any delay in obtaining, the necessary regulatory approvals could harm our business.
The
regulatory requirements relating to the testing, manufacturing and marketing of our products may change from time to time and
this may impact our ability to conduct clinical studies and the ability of independent investigators to conduct their own research
with support from us.
The
clinical development, manufacturing and marketing of our products are subject to regulation by various authorities in the U.S.,
the E.U. and other countries, including, in the U.S., the FDA, in Canada, Health Canada, and, in the E.U., the EMA. The Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act in the U.S. and numerous directives, regulations, local laws and guidelines
in Canada and the E.U. govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising
and promotion of our products. Product development and approval within these regulatory frameworks takes a number of years and
involves the expenditure of substantial resources.
Regulatory
approval will be required in all the major markets in which we seek to develop our products. At a minimum, approval requires the
generation and evaluation of data relating to the quality, safety, and efficacy of an investigational product for its proposed
use. The specific types of data required and the regulations relating to this data will differ depending on the territory, the
drug involved, the proposed indication and the stage of development.
In
general, new chemical entities are tested in animals until adequate evidence of safety is established to support the proposed
clinical study protocol designs. Clinical studies for new products are typically conducted in three sequential phases that may
overlap. In Phase 1, the initial introduction of the pharmaceutical into either healthy human volunteers or patients with the
disease (20 to 50 subjects), the emphasis is on testing for safety (adverse effects), dosage tolerance, metabolism, distribution,
excretion and clinical pharmacology. Phase 2 involves studies in a limited patient population (50 to 200 patients) to determine
the initial efficacy of the pharmaceutical for specific targeted indications, to determine dosage tolerance and optimal dosage
and to identify possible adverse side effects and safety risks. Once a compound shows preliminary evidence of some effectiveness
and is found to have an acceptable safety profile in Phase 2 evaluations, Phase 3 studies are undertaken to more fully evaluate
clinical outcomes in a larger patient population in adequate and well-controlled studies designed to yield statistically sufficient
clinical data to demonstrate efficacy and safety.
In
the U.S., specific preclinical data, manufacturing and chemical data, as described above, need to be submitted to the FDA as part
of an IND application, which, unless the FDA objects, will become effective 30 days following receipt by the FDA. Phase 1 studies
in human volunteers may commence only after the application becomes effective. Prior regulatory approval for human healthy volunteer
studies is also required in member states of the E.U. Currently, in each member state of the E.U., following successful completion
of Phase 1 studies, data are submitted in summarized format to the applicable regulatory authority in the member state in respect
of applications for the conduct of later Phase 2 studies. The regulatory authorities in the E.U. typically have between one and
three months in which to raise any objections to the proposed study, and they often have the right to extend this review period
at their discretion. In the U.S., following completion of Phase 1 studies, further submissions to regulatory authorities are necessary
in relation to Phase 2 and 3 studies to update the existing IND.
Authorities
may require additional data before allowing the studies to commence and could demand that the studies be discontinued at any time
if there are significant safety issues. In addition to the regulatory review, studies involving human subjects must be approved
by an independent body. The exact composition and responsibilities of this body will differ from country to country. In the U.S.,
for example, each study will be conducted under the auspices of an independent institutional review board (IRB) at each institution
at which the study is conducted. The IRB considers among other things, the design of the study, ethical factors, the privacy of
protected health information as defined under the Health Insurance Portability and Accountability Act, the safety of the human
subjects and the possible liability risk for the institution. Equivalent rules to protect subjects’ rights and welfare apply
in each member state of the E.U. where one or more independent ethics committees, which typically operate similarly to an IRB,
will review the ethics of conducting the proposed research. Other regulatory authorities around the rest of the world have slightly
differing requirements involving both the execution of clinical studies and the import/export of pharmaceutical products. It is
our responsibility to ensure we conduct our business in accordance with the regulations of each relevant territory.
In
order to gain marketing approval, we must submit a dossier to the relevant authority for review, which is known in the U.S. as
a new drug application (NDA) and in the E.U. as a marketing authorization application (MAA). The format is usually specific and
laid out by each authority, although in general it will include information on the quality of the chemistry, manufacturing and
pharmaceutical aspects of the product as well as the nonclinical and clinical data. Once the submitted NDA is accepted for filing
by the FDA, it undertakes the review process that currently takes on average 10 months, unless an expedited priority review is
granted which takes six months to complete. Approval can take several months to several years, if multiple 10-month review cycles
are needed before final approval is obtained, if at all.
The
approval process can be affected by a number of factors. The NDA may require additional preclinical, manufacturing data or clinical
studies which may be requested at the end of the 10-month NDA review cycle, thereby delaying approval until additional data are
submitted and may involve substantial unbudgeted costs.
In
addition to obtaining approval for each product, in many cases each drug manufacturing facility must be approved. The regulatory
authorities usually will conduct an inspection of relevant manufacturing facilities, and review manufacturing procedures, operating
systems and personnel qualifications. Further inspections may occur over the life of the product. An inspection of the clinical
investigation sites by a competent authority may be required as part of the regulatory approval procedure. As a condition of marketing
approval, the regulatory agency may require post-marketing surveillance to monitor for adverse effects or other additional studies
as deemed appropriate. After approval for the initial indication, further clinical studies may be necessary to gain approval for
any additional indications. The terms of any approval, including labeling content, may be more restrictive than expected and could
affect the marketability of a product.
The
FDA offers a number of regulatory mechanisms that provide expedited or accelerated approval procedures for selected drugs in the
indications on which we are focusing our efforts. These include accelerated approval under Subpart H of the agency’s NDA
approval regulations, fast track drug development procedures, breakthrough drug designation and priority review. At this time,
we have not determined whether any of these approval procedures will apply to our current drug candidate.
By
leveraging existing preclinical and clinical safety and efficacy data, we seek to build upon an existing knowledge base to accelerate
our research. In addition, through our focus on end-stage population which has no current treatment options, regulatory approval
for commercialization may sometimes be achieved in an accelerated manner. Accelerated approval by the FDA in this category may
be granted on objective response rates and duration of responses rather than demonstration of survival benefit. As a result, studies
of drugs to treat end-stage refractory cancer indications have historically involved fewer patients and generally have been faster
to complete than studies of drugs for other indications. We are aware that the FDA and other similar agencies are regularly reviewing
the use of objective endpoints for commercial approval and that policy changes may impact the size of studies required for approval,
timelines and expenditures significantly.
The
U.S., E.U. and other jurisdictions may grant orphan drug designation to drugs intended to treat a “rare disease or condition,”
which, in the U.S., is generally a disease or condition that affects no more than 200,000 individuals. In the E.U., orphan drug
designation can be granted if: the disease is life threatening or chronically debilitating and affects no more than 50 in 100,000
persons in the E.U.; without incentive, it is unlikely that the drug would generate sufficient return to justify the necessary
investment; and no satisfactory method of treatment for the condition exists or, if it does, the new drug will provide a significant
benefit to those affected by the condition. If a product that has an orphan drug designation subsequently receives the first regulatory
approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, meaning that the
applicable regulatory authority may not approve any other applications to market the same drug for the same indication, except
in very limited circumstances, for a period of seven years in the U.S. and 10 years in the E.U. Orphan drug designation does not
prevent competitors from developing or marketing different drugs for the same indication or the same drug for different indications.
Orphan drug designation must be requested before submitting an NDA or MAA. After orphan drug designation is granted, the identity
of the therapeutic agent and its potential orphan use are publicly disclosed. Orphan drug designation does not convey an advantage
in, or shorten the duration of, the review and approval process. However, this designation provides an exemption from marketing
and authorization fees charged to NDA sponsors under the Prescription Drug Act (PDUFA Fees).
Maintaining
substantial compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial
time and financial resources. Drug manufacturers are required to register their establishments with the FDA and certain state
agencies, and after approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance
with ongoing regulatory requirements, including cGMPs. In addition, after approval, some types of changes to the approved product,
such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval.
The FDA may require post-approval testing and surveillance programs to monitor safety and the effectiveness of approved products
that have been commercialized. Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing
regulation by the FDA, including:
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record-keeping
requirements;
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reporting
of adverse experiences with the drug;
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providing
the FDA with updated safety and efficacy information;
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reporting
on advertisements and promotional labeling;
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drug
sampling and distribution requirements; and
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complying
with electronic record and signature requirements.
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In
addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed
on the market. There are numerous regulations and policies that govern various means for disseminating information to health-care
professionals as well as consumers, including to industry sponsored scientific and educational activities, information provided
to the media and information provided over the Internet. Drugs may be promoted only for the approved indications and in accordance
with the provisions of the approved label.
The
FDA has very broad enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative
or judicial sanctions being imposed on us or on the manufacturers and distributors of our approved products, including warning
letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution and disgorgement of profits,
recall or seizure of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to
approve pending applications, and criminal prosecution resulting in fines and incarceration. The FDA and other agencies actively
enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted
off-label uses may be subject to significant liability. In addition, even after regulatory approval is obtained, later discovery
of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product
from the market.
Sales
of our product candidates, if approved, will depend, in part, on the extent to which such products will be covered by third-party
payors, such as government health care programs, commercial insurance and managed healthcare organizations. These third-party
payors are increasingly limiting coverage or reducing reimbursements for medical products and services. In addition, the U.S.
government, state legislatures and foreign governments have continued implementing cost-containment programs, including price
controls, restrictions on reimbursement and requirements for substitution of generic products. Third-party payors decide which
therapies they will pay for and establish reimbursement levels. Third-party payors often rely upon Medicare coverage policy and
payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage
and amount of reimbursement to be provided for any drug candidates that we develop will be made on a payor-by-payor basis. Each
payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy,
and on what tier of its formulary it will be placed. The position on a payor’s list of covered drugs, or formulary, generally
determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such
therapy by patients and physicians. Adoption of price controls and cost-containment measures, and adoption of more restrictive
policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Decreases in third-party
reimbursement for our product candidates or a decision by a third-party payor to not cover our product candidates could reduce
physician usage of our product candidates, once approved, and have a material adverse effect on our sales, results of operations
and financial condition.
Because
of our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party
payors, we will also be subject to healthcare regulation and enforcement by the federal government and the states and foreign
governments in which we will conduct our business, including our clinical research, proposed sales, marketing and educational
programs. Failure to comply with these laws, where applicable, can result in the imposition of significant civil penalties, criminal
penalties, or both. The U.S. laws that may affect our ability to operate, among others, include: the federal Health Insurance
Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical
Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected
health information; certain state laws governing the privacy and security of health information in certain circumstances, some
of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same
effect, thus complicating compliance efforts; the federal healthcare programs’ Anti-Kickback Statute, which prohibits, among
other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly,
in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or
service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; federal false
claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented,
claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; federal criminal laws that
prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report
annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians
(defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and
investment interests held by physicians and their immediate family members; and state law equivalents of each of the above federal
laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including
commercial insurers.
In
addition, many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope
and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Additionally,
to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.
We
are also subject to numerous environmental and safety laws and regulations, including those governing the use and disposal of
hazardous materials. The cost of compliance with and any violation of these regulations could have a material adverse effect on
our business and results of operations. Although we believe that our safety procedures for handling and disposing of these materials
comply with the standards prescribed by state and federal regulations, accidental contamination or injury from these materials
may occur. Compliance with laws and regulations relating to the protection of the environment has not had a material effect on
our capital expenditures or our competitive position. However, we are not able to predict the extent of government regulation,
and the cost and effect thereof on our competitive position, which might result from any legislative or administrative action
pertaining to environmental or safety matters.
Competition
The
development and commercialization of new drug products is highly competitive. We expect that we will face significant competition
from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to
VAL-083 and any other product candidates that we may seek to develop or commercialize in the future. Specifically, due to the
large unmet medical need, global demographics and relatively attractive reimbursement dynamics, the oncology market is fiercely
competitive and there are a number of large pharmaceutical and biotechnology companies that currently market and sell products
or are pursuing the development of product candidates for the treatment of cancer. Our competitors may succeed in developing,
acquiring or licensing technologies and drug products that are more effective, have fewer or more tolerable side effects or are
less costly than any product candidates that we are currently developing or that we may develop, which could render our product
candidates obsolete and noncompetitive.
All
of the top ten global pharmaceutical companies and many of the mid-size pharmaceutical companies have a strong research and development
and commercial presence in oncology. Smaller companies also focus on oncology, including companies such as ARIAD Pharmaceuticals,
Inc., Agios Pharmaceuticals, Inc., BIND Therapeutics, Inc., Clovis Oncology, Inc., Endocyte, Inc., Epizyme, Inc., ImmunoGen, Inc.,
Incyte Corporation, Infinity Pharmaceuticals, Inc., MacroGenics, Inc., Merrimack Pharmaceuticals, Inc., OncoMed Pharmaceuticals,
Inc., Onconova Therapeutics, Inc., Pharmacyclics, Inc., Puma Biotechnology, Inc., Seattle Genetics, Inc. and TESARO, Inc.
Several
companies are marketing and developing oncology immunotherapy products. Companies with approved marketed oncology products for
GBM are Merck (Temodar
®
) and Genentech (Avastin
®
). Companies with oncology immunotherapy product
candidates in clinical development include, but are not limited to, Northwest Biotherapeutics (DCVax-L), Celldex Therapeutics
(Rindopepimut (CDX-110)) and ImmunoCellular Therapeutics (ICT-107).
Our
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more
effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.
Our competitors also may obtain FDA or other marketing approval for their products before we are able to obtain approval for ours,
which could result in our competitors establishing a strong market position before we are able to enter the market.
Many
of our existing and potential future competitors have significantly greater financial resources and expertise in research and
development, manufacturing, preclinical testing, conducting clinical studies, obtaining marketing approvals and marketing approved
products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources
being concentrated among a smaller number of our competitors. Smaller or early stage companies may also prove to be significant
competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete
with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and patient
registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.
We
expect that our ability to compete effectively will depend upon our ability to:
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successfully
and rapidly complete adequate and well-controlled clinical studies that demonstrate statistically significant safety and efficacy
and to obtain all requisite regulatory approvals in a cost-effective manner;
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maintain
a proprietary position for our manufacturing processes and other technology;
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produce
our products in accordance with FDA and international regulatory guidelines;
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attract
and retain key personnel; and
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build
or access an adequate sales and marketing infrastructure for any approved products.
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Failure
to do one or more of these activities could have an adverse effect on our business, financial condition or results of operations.
Research
and Development
During
the nine-month periods ended March 31, 2019 and 2018, we recognized $2,702,213 and $5,856,197, respectively, in research and development
expenses. During the years ended June 30, 2018 and 2017, we recognized $7,132,952 and $5,003,640, respectively, in research and
development expenses.
Employees
We
have two full-time employees and retain the services of approximately 15 persons on an independent contractor/consultant and contract-employment
basis. As such, we currently operate in a “virtual” corporate structure in order to minimize fixed personnel costs.
Legal
Proceedings
There
are no legal proceedings to which we are a party or any of our property is the subject.
Facilities
Our
corporate headquarters are currently located at Suite 720-999 West Broadway, Vancouver, British Columbia, Canada, V5Z 1K5. We
have initiated the process of relocating our headquarters to San Diego, California, which is expected to occur by September 30,
2019. The Vancouver office will remain open as an administrative office. Our clinical operations are managed at 3475 Edison Way,
Suite R, Menlo Park, California, 94025. Our current monthly base rent for our corporate headquarters is $4,022 (CDN $5,375) on
a month-to-month basis. In addition, Valent Technologies, LLC (“Valent”), which is owned by Dr. Dennis Brown, our
Chief Scientific Officer, leases facilities in California and we have access to such facilities pursuant to an informal unwritten
arrangement with Valent. Our leased premises, academic relationships, and access to the Valent facility are sufficient to meet
the immediate needs of our business, research and operations.
MANAGEMENT
Executive
Officers and Directors of DelMar
The
following table sets forth information concerning the DelMar directors and executive officers, including their ages as of July
31, 2019. There are no family relationships among any of the DelMar directors or executive officers.
Name
|
|
Age
|
|
Position
|
Robert E. Hoffman
|
|
53
|
|
Chairman of the
Board
|
Saiid Zarrabian
|
|
66
|
|
President, Chief
Executive Officer and Director
|
Dennis Brown, PhD
|
|
70
|
|
Chief Scientific
Officer
|
Scott Praill, CPA
|
|
53
|
|
Chief Financial
Officer
|
John K. Bell, FCPA,
CPA
|
|
72
|
|
Director
|
Lynda Cranston, BScN, MScN, ICD.D
|
|
72
|
|
Director
|
Napoleone Ferrara,
MD
|
|
63
|
|
Director
|
Robert J. Toth,
Jr., MBA
|
|
56
|
|
Director
|
The
following biographical descriptions set forth certain information with respect to the DelMar directors and executive officers,
based on information furnished to the Company by each individual.
Robert
E. Hoffman
has served as our director since April 11, 2018 and as our Chairman since June 2, 2018. He has served as a member
of Kura Oncology, Inc.’s Board of Directors since March 2015. Mr. Hoffman has served as Senior Vice President and Chief
Financial Officer of Heron Therapeutics, Inc., a publicly-held pharmaceutical company since April 2017. Prior to joining Heron
Therapeutics, Inc., Mr. Hoffman served as Executive Vice President and Chief Financial Officer of Innovus Pharmaceuticals, Inc.,
a publicly-held pharmaceutical company, from September 2016 to April 2017. From July 2015 to September 2016, Mr. Hoffman served
as Chief Financial Officer of AnaptysBio, Inc., a publicly-held biotechnology company. From June 2012 to July 2015, Mr. Hoffman
served as the Senior Vice President, Finance and Chief Financial Officer of Arena Pharmaceuticals, Inc., or Arena, a publicly-held
biopharmaceutical company. From August 2011 to June 2012 and previously from December 2005 to March 2011, he served as Arena’s
Vice President, Finance and Chief Financial Officer and in a number of various roles of increasing responsibility from 1997 to
December 2005. From March 2011 to August 2011, Mr. Hoffman served as Chief Financial Officer for Polaris Group, a biopharmaceutical
drug company. Mr. Hoffman formerly served as a member of the Board of Directors of CombiMatrix Corporation, a molecular diagnostics
company, and MabVax Therapeutics Holdings, Inc., a biopharmaceutical company. Mr. Hoffman serves as a member of the Financial
Accounting Standards Board’s Small Business Advisory Committee and the steering committee of the Association of Bioscience
Financial Officers. Mr. Hoffman formerly served as a director and President, of the San Diego Chapter of Financial Executives
International. Mr. Hoffman holds a B.B.A. from St. Bonaventure University, and is licensed as a C.P.A. (inactive) in the State
of California. Mr. Hoffman’s financial and executive business experience qualifies him to serve on our Board of Directors.
Saiid
Zarrabian
has served as our director since July 7, 2017, Chief Executive Officer since November 3, 2017, and President since
January 1, 2018. From 2014 to 2015 he operated a private personal business. Since October 2016, Mr. Zarrabian has served as an
advisor to Redline Capital Partners, S.A., a Luxembourg based investment firm. From 2012 to 2014 he served as Chairman and member
of the Board of La Jolla Pharmaceutical Company during which time the company transitioned from an OTC listed company to a NASDAQ
listed company. From 2012 to 2013 he served as President of the Protein Production Division of Intrexon Corporation, a synthetic
biology company. He has also previously served as CEO and member of the Board of Cyntellect, Inc., a stem cell processing and
visualization Instrumentation company until its sale in 2012, as President and COO of Senomyx, Inc., a company focused on discovery
and commercialization of new flavor ingredients, and as COO of Pharmacopeia, Inc., a former publicly-traded provider of combinatorial
chemistry discovery services and compounds, where he also served as President & COO of its MSI Division. In addition, Mr.
Zarrabian has served on numerous private and public company boards, including at Immune Therapeutics, Inc., Exemplar Pharma, LLC,
Ambit Biosciences Corporation, eMolecules, Inc., and Penwest Pharmaceuticals CO. His other experience includes COO at Molecular
Simulations, COO of Symbolics, Inc., and as R&D Director at Computervision, Inc. Mr. Zarrabian’s business executive
knowledge and experience qualify him to serve on our Board of Directors.
Dennis
Brown, PhD,
has been our chief scientific officer since January 25, 2013. He also served as our director from February 11,
2013 to April 11, 2018. Dr. Brown is one of our founders and has served as Chief Scientific Officer and director of Del Mar (BC)
since inception. Dr. Brown has more than thirty years of drug discovery and development experience. He has served as Chairman
of Mountain View Pharmaceutical’s Board of Directors since 2000 and is the President of Valent. In 1999 he founded ChemGenex
Therapeutics, which merged with a publicly traded Australian company in 2004 to become ChemGenex Pharmaceuticals (ASX: CXS/NASDAQ:
CXSP), of which he served as President and a Director until 2009. He was previously a co-founder of Matrix Pharmaceutical, Inc.,
where he served as Vice President (VP) of Scientific Affairs from 1985-1995 and as VP, Discovery Research, from 1995-1999. He
also previously served as an Assistant Professor of Radiology at Harvard University Medical School and as a Research Associate
in Radiology at Stanford University Medical School. He received his B.A. in Biology and Chemistry (1971), M.S. in Cell Biology
(1975) and Ph.D. in Radiation and Cancer Biology (1979), all from New York University. Dr. Brown is an inventor of many issued
U.S. patents and applications, many with foreign counterparts.
Scott
Praill, CPA, BSc.
has been our chief financial officer since January 29, 2013 and previously served as a consultant to Del
Mar (BC). From 2004 to 2012 Mr. Praill was an independent consultant providing accounting and administrative services to companies
in the resource industry. Mr. Praill served as CFO of Strata Oil & Gas, Inc. from June 2007 to September 2008. From
November 1999 to October 2003 Mr. Praill was Director of Finance at Inflazyme Pharmaceuticals Inc. Mr. Praill completed his articling
at Price Waterhouse (now PricewaterhouseCoopers LLP) and obtained his Chartered Professional Accountant designation in 1996. Mr.
Praill obtained his Certified Public Accountant (Illinois) designation in 2001. Mr. Praill received a Financial Management Diploma
(Honors), from British Columbia Institute of Technology in 1993, and a Bachelor of Science from Simon Fraser University in 1989.
John
K. Bell, FCPA, FCA, ICD.D
has served as our director since February 11, 2013 and serves as the Chair of the Audit Committee.
Mr. Bell is Chairman of Onbelay Capital Inc., a Canadian based private equity company. Prior to that, from 1996 to 2005, Mr. Bell
was CEO and owner of Polymer Technologies Inc., an automotive parts manufacturer. Prior to that, from 1977 to 1995, Mr. Bell was
founder and owner of Shred-Tech Limited a global manufacturer and supplier of industrial shredders and mobile document shredders.
Mr. Bell served as interim CEO and director of ATS Automation Tooling Systems (TSX-ATA) in 2007. Mr. Bell was a director of Strongco
Corporation (TSX-SQP) from 2008 to 2019 and the Royal Canadian Mint (TSX-MNT) from 2009 to 2018. Mr. Bell is a director of Canopy
Growth Corp. (TSX-WEED) and Canopy Rivers Inc. (TSX-RIV) and Mr. Bell also serves as a member of the audit committee of Canopy
Rivers Inc. Mr. Bell is the past National secretary and board member of The Crohns and Colitis Foundation of Canada. Mr. Bell
is also the past Chairman of Waterloo Regional Police, Cambridge Memorial Hospital, Canada’s Technology Triangle accelerator
network and The Region of Waterloo prosperity counsel. Mr. Bell is a graduate of Western University Ivey School of Business, a
Fellow of the institute of Chartered Accountants of Ontario, a graduate of the Institute of Directors Program of Canada and the
owner’s president program at Harvard and International marketing program at Oxford. Mr. Bell’s financial and executive
business experience qualifies him to serve on our Board of Directors.
Lynda
Cranston BScN, MScN, ICD.D
has served as our director since February 5, 2015 and serves as the Chair of our Nominating and
Corporate Governance Committee. Mrs. Cranston comes to the Board with over 20 years of experience at the CEO level in healthcare.
She is presently Chair of the British Columbia Rapid Transit Company. She previously was, from 2014 to 2016, the National Chair
of the Gastrointestinal Association of Canada. In 2013 she retired from the healthcare industry and her last appointment prior
to her retirement was as the first CEO of the British Columbia Provincial Health Services Authority (2002 to 2013). From 1998-2001,
Mrs. Cranston had been the first CEO of the Canadian Blood Services in Ottawa, ON. Before moving to Ottawa, Mrs. Cranston, as
the CEO of B.C. Women’s Hospital and Healthcare Centre had merged the organization with the BC Children’s Hospital
and the Sunny Hill Health Centre for Children to become the Children’s and Women’s Healthcare Centre of BC. Following
the merger Mrs. Cranston became the first CEO. In 2013, Mrs. Cranston was identified as a member of Diversity 50 by the Canadian
Board Diversity Council as being one of Canada’s most board ready candidates. Mrs. Cranston was awarded the Board Chair
Award of Excellence by the HealthCare Leaders; Association of British Columbia in 2008. In 2007, she was inducted into Canada’s
Most Powerful Women Top 100 Hall of Fame after having been identified in ’04, ’05 & ’06 as one of Canada’s
Most Powerful Women Top 100. Mrs. Cranston is a recipient of the YWCA Women of Distinction Award, the 125
th
Anniversary
of the Confederation of Canada Commemorative Medal for community contributions, and the Queen’s Golden Jubilee Medal for
contribution to Canada and community. Mrs. Cranston is a graduate of the University of Ottawa and the University of Western
Ontario. Mrs. Cranston’s healthcare industry and executive knowledge and experience qualify her to serve on our Board of
Directors.
Napoleone
Ferrara, MD,
has served as our director since June 22, 2018. Since January 2013 he has served as a professor of pathology
and since July 2014 as an adjunct professor of ophthalmology and pharmacology at the University of California, San Diego. Previously,
Dr. Ferrara held increasingly senior positions at Genentech, Inc., over a 24-year period, including fellow, staff scientist and
senior scientist. He is a pioneer in the study of angiogenesis biology and identification of its regulators. Dr. Ferrara’s
lab is responsible for discovering the isolation and cDNA cloning of VEGF and demonstrated that VEGF was a major mediator of tumor
angiogenesis leading to the development of Avastin
®
(bevacizumab). Additionally, his lab’s studies led to
the clinical development of an anti-VEGF antibody fragment, Lucentis
®
(ranibizumab), as a highly effective therapy
preventing vision loss in intraocular neovascular disorders. Dr. Ferrara has been the recipient of over 60 awards/honors, given
more than 300 presentations, authored over 70 patents, and written more than 300 articles, reviews/editorials and published book
chapters. He received his fellowship training and postdoctoral research from the University of California, San Francisco, his
M.D. (cum laude) and residency training from the University of Catania Medical School, and his Maturita’ Classica from Liceo
Classico Mario Cutelli. Dr. Ferrara’s scientific knowledge and experience qualify him to serve on our Board of Directors.
Robert
J. Toth, Jr., MBA
has served as our director since August 20, 2013 and serves as Chair of our Compensation Committee. Since
2005, Mr. Toth has primarily been managing his personal investment portfolio. From 2004-2005, Mr. Toth served as a consulting
analyst to Narragansett Asset Management, a New York-based healthcare-focused hedge fund, where he advised the firm on biotechnology
investments. From 2001-2003, he was the Senior Portfolio Manager for San Francisco-based EGM Capital’s Medical Technology
hedge fund, where he was responsible for managing and maintaining a dedicated medical technology portfolio. Mr. Toth began his
Wall Street career in 1996 as an Equity Research Associate for Vector Securities International, a healthcare-focused brokerage
firm. From 1997-1999 he served as Senior Biotechnology Analyst. He joined Prudential Securities as Senior Vice President and Biotechnology
Analyst where he served from 1999-2001 following Prudential’s acquisition of Vector. His responsibilities included the analysis
of commercial, clinical and scientific fundamentals of oncology and genomics-based biotechnology companies on behalf of institutional
investors. Mr. Toth was named to the Wall Street Journal’s Allstar List for stock picking in 1999. Mr. Toth received an
MBA from the University of Washington and Bachelor of Science degrees in Biological Sciences and Biochemistry from California
Polytechnic State University, San Luis Obispo. Mr. Toth’s financial and biotechnology industry knowledge and experience
quality him to serve on our Board of Directors.
The
Board of Directors and Its Committees
Board
of Directors Operations and Meetings
Our
Board currently consists of six members. Our directors hold office until their successors have been elected and qualified or until
the earlier of their resignation or removal.
We
have no formal policy regarding board diversity. Our priority in selection of board members is identification of members who will
further the interests of our stockholders through their established record of professional accomplishment, the ability to contribute
positively to the collaborative culture among board members, knowledge of our business and understanding of the competitive landscape.
Our
Board met 27 times in fiscal 2018. Each of the directors attended at least 75% of the aggregate of (i) the total number of meetings
of our Board (held during the period for which such directors served on the Board), and (ii) the total number of meetings of all
committees of our Board on which the director served (during the periods for which the director served on such committee or committees).
The
Board oversees our business and monitors the performance of our management. In accordance with our corporate governance procedures,
the Board does not involve itself in the day-to-day operations of DelMar. Our executive officers and management oversee our day-to-day
operations. Our directors fulfill their duties and responsibilities by attending meetings of the Board, which are usually held
on at least a quarterly basis. Our directors also discuss business and other matters with other key executives and our principal
external advisers (legal counsel, auditors, financial advisors and other consultants).
Independent
Directors
Our
Board has determined that Robert Hoffman, John Bell, Lynda Cranston, Napoleone Ferrara and Robert Toth are qualified to serve
as independent directors. Prior to being appointed Chief Executive Officer, Saiid Zarrabian was also determined by our Board to
be independent. The standards relied on by the Board in affirmatively determining whether a director is “independent,”
in compliance with Nasdaq’s rules, are comprised of those objective standards set forth in the rules promulgated by Nasdaq.
The Board is responsible for ensuring that independent directors do not have a relationship that, in the opinion of the Board,
would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
Nasdaq’s
rules, as well as SEC rules, impose additional independence requirements for all members of the Audit Committee. Specifically,
in addition to the “independence” requirements discussed above, “independent” audit committee members
must: (1) not accept, directly or indirectly, any consulting, advisory, or other compensatory fees from DelMar or any subsidiary
of DelMar other than in the member’s capacity as a member of the Board and any Board committee; (2) not be an affiliated
person of DelMar or any subsidiary of DelMar; and (3) not have participated in the preparation of the financial statements of
DelMar or any current subsidiary of DelMar at any time during the past three years. In addition, Nasdaq’s rules require
that all audit committee members be able to read and understand fundamental financial statements, including DelMar’s balance
sheet, income statement, and cash flow statement. The Board believes that the current members of the Audit Committee meet these
additional standards.
Furthermore,
at least one member of the Audit Committee must be financially sophisticated, in that he or she has past employment experience
in finance or accounting, requisite professional certification in accounting, or any other comparable experience or background
which results in the individual’s financial sophistication, including but not limited to being or having been a chief executive
officer, chief financial officer, other senior officer with financial oversight responsibilities. Additionally, the SEC requires
that DelMar disclose whether the Audit Committee has, and will continue to have, at least one member who is a “financial
expert.” The Board has determined that John Bell meets the SEC’s definition of an audit committee financial expert.
Audit
Committee
The
Board has formed an Audit Committee, which currently consists of John K. Bell, Chair, Robert E. Hoffman, and Robert Toth, all
of whom are independent (as that term is defined under the Nasdaq Marketplace Rules) and financially literate (as such qualification
is interpreted by the Board in its business judgment). We are relying upon the exemption in section 6.1 of Canadian National Instrument
52-110 — Audit Committees from Parts 3 and 5 thereof. In addition, our Board has determined that Mr. Bell qualifies as an
audit committee financial expert within the meaning of SEC regulations and The NASDAQ Marketplace Rules.
The
Audit Committee oversees and monitors our financial reporting process and internal control system, reviews and evaluates the audit
performed by our registered independent public accountants and reports to our Board any substantive issues found during the audit.
The Audit Committee will be directly responsible for the appointment, compensation and oversight of the work of our registered
independent public accountants. The Audit Committee reviews and approves all transactions with affiliated parties. The Board has
adopted a written charter for the Audit Committee.
A
copy of the Audit Committee Charter is posted under the “Investors” tab on our website, which is located at
www.delmarpharma.com
.
Compensation
Committee
The
Board has formed a Compensation Committee which consists of Robert Toth, Chair, Napoleone Ferrara, and Robert E. Hoffman, all
of whom are independent (as that term is defined under the Nasdaq Marketplace Rules). The Compensation Committee assists the Board
in fulfilling its oversight responsibilities relating to (i) corporate governance practices and policies and (ii) compensation
matters, including compensation of the directors and senior management of the Company and the administration of compensation plans
of the Company. The Board has adopted a written charter for the Compensation Committee. A copy of the Compensation Committee Charter
is posted under the “Investors” tab on our website, which is located at
www.delmarpharma.com
.
The
Compensation Committee has engaged Marsh & McLennan Agency LLC as its independent compensation consultant. In 2018, Marsh
& McLennan Agency LLC reviewed both executive and director compensation and did not provide us any other services. Marsh &
McLennan Agency LLC reported directly to the Compensation Committee and provided guidance on trends in executive and non-employee
director compensation, the development of specific executive compensation programs, the composition of our compensation peer group
and other matters as directed by the Compensation Committee. In 2017, Marsh & McLennan Agency LLC did not provide any services
to us.
In
2017, the Compensation Committee engaged Hugessen Consulting to provide certain director compensation services, including with
respect to benchmarking, compensation trends and retention practices and Global Advisors to provide advisory services in connection
with the development of our 2017 Omnibus Equity Incentive Plan. In 2017, Hugessen Consulting and Global Advisors did not provide
us any other services.
Nominating
and Corporate Governance Committee
The
Board has formed a Nominating and Corporate Governance Committee, which currently consists of Lynda Cranston, Chair, John Bell,
and Napoleone Ferrara, all of whom are independent (as that term is defined under the Nasdaq Marketplace Rules). The Board has
adopted a written charter for the Nominating and Corporate Governance Committee. A copy of the Nominating and Corporate Governance
Committee Charter is posted under the “Investors” tab on our website, which is located at
www.delmarpharma.com.
Nomination
of Directors
The
Nominating and Corporate Governance Committee of the Board of Directors assesses potential candidates to fill perceived needs
on the Board of Directors for required skills, expertise, independence and other factors. A director candidate recommended by
our stockholders will be considered in the same manner as a nominee recommended by a Board member, management or other sources.
Stockholders wishing to recommend a candidate for nomination should contact our Secretary in writing at the Secretary of DelMar
at Suite 720-999 West Broadway Vancouver, British Columbia, Canada V5Z 1K5. Our Nominating and Corporate Governance Committee
has discretion to decide which individuals to recommend for nomination as directors.
Board
Leadership Structure and Role in Risk Oversight
Robert
E. Hoffman serves as the chairman of our Board of Directors. Saiid Zarrabian serves as our Chief Executive Officer and President.
We have not adopted a formal policy on whether the Chief Executive Officer and Chairman positions should be separated.
Our
Board of Directors is primarily responsible for overseeing our risk management processes. The Board of Directors receives and
reviews periodic reports from management, auditors, legal counsel, and others, as considered appropriate regarding our assessment
of risks. The Board of Directors focuses on the most significant risks facing us and our general risk management strategy, and
also ensures that risks undertaken by us are consistent with the board’s appetite for risk. While the Board of Directors
oversees our risk management, management is responsible for the day-to-day risk management processes. We believe this division
of responsibilities is the most effective approach for addressing the risks we face and that our board leadership structure supports
this approach.
Code
of Ethics
We
have adopted a Code of Ethics and Business Conduct that applies to all of our executive officers, financial and accounting officers,
our directors, our financial managers and all of our employees. The Board of Directors is committed to a high standard of corporate
governance practices and, through its oversight role, encourages and promotes a culture of ethical business conduct. A copy of
our Code of Ethics and Business Conduct is posted under the “Investors” tab under Corporate Governance on our website,
which is located at
www.delmarpharma.com
.
Stockholder
Communication with the Board of Directors and Attendance at Annual Meetings
The
Board maintains a process for stockholders to communicate with the Board and its committees. Stockholders of DelMar and other
interested persons may communicate with the Board or the chair of the Audit Committee, Compensation Committee, and the Nominating
and Corporate Governance Committee by writing to the Secretary of DelMar at Suite 720-999 West Broadway Vancouver, British Columbia,
Canada V5Z 1K5. All communications that relate to matters that are within the scope of the responsibilities of the Board will
be presented to the Board no later than the next regularly scheduled meeting. Communications that relate to matters that are within
the responsibility of one of the Board committees will be forwarded to the chair of the appropriate committee. Communications
that relate to ordinary business matters that are not within the scope of the Board’s responsibilities will be forwarded
to the appropriate officer. Solicitations, junk mail and obviously frivolous or inappropriate communications will not be forwarded,
but will be made available to any director who wishes to review them.
EXECUTIVE
COMPENSATION
The
Board of Directors has formed a Compensation Committee. The Compensation Committee is responsible for reviewing and approving
management compensation, including salaries, bonuses, and equity compensation. We seek to provide competitive compensation arrangements
that attract and retain key talent necessary to achieve our business objectives.
Summary
Compensation Table
The
following table presents information regarding the total compensation awarded to, earned by, or paid to our Chief Executive Officer
and the two most highly-compensated executive officers (other than the Chief Executive Officer) who were serving as executive
officers as of June 30, 2019 and June 30, 2018 for services rendered in all capacities to us for the years ended June 30, 2019
and June 30, 2018, reflecting our one-for-ten reverse stock split occurring on May 8, 2019. These individuals are our Named Executive
Officers for 2019.
SUMMARY
COMPENSATION TABLE
Name
and Principal Position
|
|
Period
|
|
Salary
(US$)
|
|
|
Bonus
Awards
(US$)
|
|
|
Equity
Awards
(US$))
|
|
|
Total
(US$)
|
|
Saiid
Zarrabian,
President and CEO
|
|
Year
Ended
June 30, 2019
|
|
|
470,000
|
(1)
|
|
|
—
|
|
|
|
—
|
|
|
|
470,000
|
|
|
|
Year Ended
June 30, 2018
|
|
|
237,412
|
|
|
|
85,631
|
|
|
|
615,992
|
|
|
|
939,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jeffrey
Bacha,
Former President and CEO
|
|
Year Ended
June 30, 2019
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
Year Ended
June 30, 2018
|
|
|
537,579
|
(2)
|
|
|
—
|
|
|
|
122,338
|
|
|
|
659,917
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dennis
Brown, PhD,
Chief Scientific Officer
|
|
Year Ended
June 30, 2019
|
|
|
200,000
|
(3)
|
|
|
—
|
|
|
|
—
|
|
|
|
200,000
|
|
|
|
Year Ended
June 30, 2018
|
|
|
200,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott
Praill,
Chief Financial Officer
|
|
Year Ended
June 30, 2019
|
|
|
220,000
|
(4)
|
|
|
—
|
|
|
|
30,627
|
|
|
|
250,627
|
|
|
|
Year Ended
June 30, 2018
|
|
|
200,000
|
|
|
|
10,000
|
|
|
|
—
|
|
|
|
210,000
|
|
|
(1)
|
On
July 7, 2017, Mr. Zarrabian was elected to the Board of Directors. Upon his appointment Mr. Zarrabian was granted 3,600 stock
options that are exercisable at $21.10 until July 7, 2027 for total compensation expense of $40,752. Effective April 11, 2018,
he was also issued 20,000 PSUs for total compensation expense of $98,428. The PSUs were cancelled effective April 30, 2019. For
serving as an independent director from July 7, 2017 until November 3, 2017 he was paid $8,750.
|
On
November 3, 2017, Mr. Zarrabian was appointed interim chief executive officer and on January 1, 2018 he was also appointed interim
president. On November 3, 2017 we entered into an agreement with Mr. Zarrabian pursuant to which he will receive an annualized
fee of $280,000 and be eligible to receive a bonus targeted up to 30% of the $280,000 annual fee which may be adjusted by the
Board based on his individual performance and our performance as a whole, with such performance targets to be established by the
Board. Upon execution of the agreement, we paid Mr. Zarrabian an advance of $45,000 of the annual fee. With the $45,000 advance,
Mr. Zarrabian purchased shares of our common stock on the market. For the period from November 3, 2017 to May 20, 2018 we paid
Mr. Zarrabian a total of $243,510 under the consulting agreement which includes the $45,000 advance, $130,134 in consulting fees,
and $68,376 in bonus. Upon his appointment as interim chief executive officer he was granted 12,000 stock options that are exercisable
at $8.70 until November 3, 2027 for total compensation expense of $53,567.
On
May 21, 2018, we entered into an employment agreement with Mr. Zarrabian pursuant to which Mr. Zarrabian was appointed as our
permanent president and chief executive officer. Under the Agreement, Mr. Zarrabian will receive an annual base salary of $470,000
and will be eligible to receive a fiscal year target bonus of up to 50% of base salary (which may be adjusted by the Board to
up to 60% of base salary based on overachievement of bonus targets or other performance criteria). Any bonus earned for a fiscal
year will be payable in cash, but the Board may pay up to 50% of the bonus, as well as any bonus in excess of 50% of base salary,
in the form of stock options granted under our 2017 Omnibus Equity Incentive Plan (or any successor plan). The bonus for our fiscal
year ended June 30, 2019 will be based on the period from the effective date of the agreement (May 21, 2018) through June 30,
2019. Mr. Zarrabian’s bonus for our fiscal year ended June 30, 2019 is to be determined. The employment agreement may be
terminated by us with or without cause (as defined therein). In the event we terminate the employment agreement without cause,
we will be required to pay Mr. Zarrabian continued payment of his base salary for 12 months, a prorated bonus for the year of
termination based on performance through the date of termination, an additional six months of vesting credit for any outstanding
options, and continued health coverage during the severance period. In the event that an involuntary termination occurs during
a period beginning sixty days before a definitive corporate transaction agreement is entered into that would result in a change
in control, or within twelve months following a change in control, the severance period will increase to eighteen months’
severance, Mr. Zarrabian will receive 100% of his target bonus, and his options will be fully vested. During the period from May
21, 2018 to June 30, 2018 Mr. Zarrabian was paid $53,528 under the employment agreement. We have also recorded a pro-rated bonus
of $17,255. Upon his appointment as full-time president and chief executive officer Mr. Zarrabian was granted 83,647 stock options
that are exercisable at $9.825 until May 21, 2028 for total compensation expense of $423,245.
|
(2)
|
On
February 9, 2017, we entered into an employment agreement with Jeffrey Bacha, our former president and chief executive officer.
We paid Mr. Bacha an annual base salary of $250,000 and Mr. Bacha will also be eligible to participate in any bonus plan and long-term
incentive plan established by us for senior executives. On December 22, 2017, we entered into a settlement agreement with Mr.
Bacha pursuant to which, effective January 1, 2018, he would no longer serve as our officer. In addition, Mr. Bacha did not stand
for re-election to the Board of Directors at our 2018 annual meeting of stockholders held on April 11, 2018. Pursuant to the terms
of the settlement agreement and consistent with the terms of the employment agreement between Mr. Bacha and us dated February
9, 2017, as amended, Mr. Bacha was entitled to (i) accrued and unpaid base salary through January 1, 2018, (ii) payment for his
accrued and unused vacation through January 1, 2018, (iii) severance in an amount equal to 13 months of Mr. Bacha’s base
salary, or $270,833, (iv) payment in an amount equal to 12 months’ of coverage under our benefits plans, or $9,600 and (v)
reimbursement for any properly incurred business expenses submitted with appropriate documentation in accordance with our expense
reimbursement policies through December 31, 2017. In addition, all of Mr. Bacha’s unvested stock options were deemed vested
as of January 1, 2018 and will remain exercisable for three years and any unexercised options will expire on December 31, 2020.
In addition, effective January 1, 2018, Mr. Bacha will provide consulting services to us through April 30, 2018 for a consulting
fee of $20,833 per month and subsequent to April 30, 2018 on an hourly basis. The separation agreement and the employment agreement
contain customary post-termination restrictive covenants in favor of us including confidentiality, non-competition and non-solicitation
covenants. As a result of modifying Mr. Bacha’s stock options, a total of $122,338 has been recognized.
|
|
(3)
|
On
January 1, 2015, we entered into a consulting agreement with Dr. Dennis Brown, our chief scientific officer. Subsequent to this
agreement, it has been amended and is now renewed on an annual basis. Under the most recent renewal, Dr. Brown will continue to
serve as our chief scientific officer until December 31, 2019, which period may be extended in accordance with the terms of the
agreement. We will pay Dr. Brown an annual consulting fee of $200,000 during calendar year 2019. We may also pay to Dr. Brown
a bonus and incentive compensation as determined at the discretion of the Board of Directors. The consulting agreement with Dr.
Brown does not specify the amount of time Dr. Brown is required to devote to us, but does require that Dr. Brown provide us with
the full benefit of his knowledge, expertise and ingenuity, and prohibits Dr. Brown from engaging in any business, enterprise
or activity contrary to or that would detract from our business.
|
|
(4)
|
On
February 9, 2017, we entered into an employment agreement with Scott Praill, our chief financial officer. Pursuant to the employment
agreement, Mr. Praill will continue to serve as our chief financial officer for an indefinite period until termination of the
employment agreement in accordance with its terms. We will pay Mr. Praill an annual base salary of $200,000 (which may be adjusted
on an annual basis in the discretion of the Board of Directors) and Mr. Praill will also be eligible to participate in any bonus
plan and long-term incentive plan established by us for senior executives. Mr. Praill’s bonus for our fiscal year ended
June 30, 2019 is to be determined. The employment agreement may be terminated by us with or without cause (as defined therein).
In the event we terminate the employment agreement without cause, we will be required to pay Mr. Praill, any accrued and unpaid
base salary, plus an amount equal to 12 months of Mr. Praill’s base salary plus one additional month’s base salary
for each completed year of service, up to 18 months’ base salary. On November 8, 2018, Mr. Praill was granted 10,000 stock
options that are exercisable at $6.099 until November 8, 2028 for total compensation expense of $30,627.
|
Outstanding
Equity Awards at Fiscal Year-End
The
following table sets forth outstanding equity awards to our named executive officers as of June 30, 2019, reflecting our one-for-ten
reverse stock split occurring on May 8, 2019.
|
|
Option awards
|
|
Stock awards
|
|
Name
|
|
Number of
securities
underlying
unexercised
options (#)
Exercisable
|
|
|
Number of
securities
underlying
unexercised
options (#)
un-exercisable
|
|
|
Equity
incentive plan
awards:
number of
securities
underlying
unexercised
unearned
options
(#)
|
|
|
Option
exercise
price
(US$)
|
|
|
Option
expiration
date
|
|
Equity
incentive plan
awards:
Number of
unearned
shares, units or
other rights
that have not
vested
(#)
|
|
|
Equity
incentive plan
awards: Market
or payout value
of unearned
shares, units or
other rights
that have not
vested
($)
|
|
Saiid Zarrabian
|
|
|
2,100
|
(1)
|
|
|
1,500
|
|
|
|
—
|
|
|
|
21.10
|
|
|
July 7, 2027
|
|
|
—
|
|
|
|
—
|
|
|
|
|
12,000
|
(2)
|
|
|
—
|
|
|
|
—
|
|
|
|
8.70
|
|
|
Nov 3, 2027
|
|
|
|
|
|
|
|
|
|
|
|
30,206
|
(3)
|
|
|
53,441
|
|
|
|
—
|
|
|
|
9.825
|
|
|
May 21, 2028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jeffrey Bacha
|
|
|
3,750
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20.00
|
(5)
|
|
Dec 31, 2020
|
|
|
—
|
|
|
|
—
|
|
|
|
|
8,750
|
|
|
|
—
|
|
|
|
—
|
|
|
|
42.00
|
|
|
Dec 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
9,360
|
|
|
|
—
|
|
|
|
—
|
|
|
|
49.50
|
|
|
Dec 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dennis Brown, PhD
|
|
|
3,750
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20.00
|
(5)
|
|
Feb 1, 2022
|
|
|
—
|
|
|
|
—
|
|
|
|
|
8,750
|
|
|
|
—
|
|
|
|
—
|
|
|
|
42.00
|
|
|
Aug 15, 2023
|
|
|
|
|
|
|
|
|
|
|
|
7,280
|
(4)
|
|
|
2,080
|
|
|
|
—
|
|
|
|
49.50
|
|
|
Feb 17, 2027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott Praill
|
|
|
1,250
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20.00
|
(5)
|
|
Feb 1, 2022
|
|
|
—
|
|
|
|
—
|
|
|
|
|
8,750
|
|
|
|
—
|
|
|
|
—
|
|
|
|
42.00
|
|
|
Aug 15, 2023
|
|
|
|
|
|
|
|
|
|
|
|
2,909
|
(4)
|
|
|
831
|
|
|
|
—
|
|
|
|
49.50
|
|
|
Feb 17, 2027
|
|
|
|
|
|
|
|
|
|
|
|
1,944
|
(6)
|
|
|
8,056
|
|
|
|
—
|
|
|
|
6.099
|
|
|
November 8, 2028
|
|
|
|
|
|
|
|
|
|
(1)
|
Stock
options vest as to 1,200 on June 30, 2018, and 300 options vest each three months thereafter starting September 30, 2018.
|
|
(2)
|
Stock
options vest pro rata monthly until full vesting on November 3, 2018.
|
|
(3)
|
Stock
options vest as to 1/6
th
on November 21, 2018 with the remaining shares vesting in equal monthly installments over
a period of 30 months commencing on December 21, 2018.
|
|
(4)
|
Stock
options vest pro rata monthly until fully vesting on February 17, 2020.
|
|
(5)
|
Original
exercise price was CDN $20.00. Price was amended to USD $20.00 on June 30, 2016. All other terms of the option grants remain unchanged.
|
|
(6)
|
Stock
options vest as to 1/6
th
on May 8, 2019 with the remaining shares vesting in equal monthly installments over a period
of 30 months commencing on June 8, 2019.
|
Director
Compensation
Director
compensation is intended to provide an appropriate level of remuneration considering the responsibilities, time requirements and
accountability of the Directors.
The
following table sets forth director compensation for the fiscal year ended June 30, 2019 (excluding compensation to our executive
officers set forth in the summary compensation table above) paid by us, reflecting our one-for-ten reverse stock split occurring
on May 8, 2019.
Name
|
|
Fees
Earned or
Paid in
Cash
($)
(1)
|
|
|
Stock
Awards
($)
(3)
|
|
|
Option
Awards
($)
(2)
|
|
|
Non-Equity
Incentive Plan
Compensation
($)
|
|
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
|
|
All Other
Compensation
($)
|
|
|
Total
($)
|
|
Robert E. Hoffman
|
|
|
60,000
|
|
|
|
—
|
|
|
|
10,235
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
70,235
|
|
John K. Bell
|
|
|
40,000
|
|
|
|
—
|
|
|
|
10,235
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
50,235
|
|
Lynda Cranston
|
|
|
40,000
|
|
|
|
—
|
|
|
|
10,235
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
50,235
|
|
Napoleone Ferrara, MD
|
|
|
35,000
|
|
|
|
—
|
|
|
|
10,235
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
45,235
|
|
Robert J, Toth, Jr.
|
|
|
40,000
|
|
|
|
—
|
|
|
|
10,235
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
50,235
|
|
|
(1)
|
Our
directors are paid a $35,000 annual retainer, an additional $5,000 annual retainer for chairing a committee, and the chairman
of the board is paid an additional annual retainer of $25,000.
|
|
(2)
|
On
November 8, 2018, independent directors were granted 4,000 stock options at an exercise price of $6.099. The options have a ten-year
term and vest pro rata over one year from the date of grant.
|
|
(3)
|
On
April 30, 2019, the 20,000 Performance Stock Units issued under the 2017 Plan in fiscal 2018 to each of our independent directors
were cancelled.
|
Risk
Management
We
do not believe risks arising from its compensation policies and practices for its employees are reasonably likely to have a material
adverse effect on us.
CERTAIN
RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
We
describe below transactions and series of similar transactions that we were or will be a party to in which (i) an executive officer,
director, nominee for election as a director, beneficial owner of more than 5% of any class of our common stock or any member
of the immediate family of any of the foregoing persons and (ii) the amount involved exceeds $120,000 or one percent of the average
of our total assets at year-end for the last two completed fiscal years.
Other
than as described below, there has not been, nor is there any currently proposed, transactions or series of similar transactions
to which we have been or will be a party.
On
September 12, 2010, Del Mar (BC) entered into a Patent Assignment Agreement (the “Assignment”) with Valent Technologies
LLC pursuant to which Valent assigned to Del Mar (BC) its rights to patent applications and the prototype drug product related
to VAL-083. In accordance with the Assignment the consideration paid by Del Mar (BC) was $250,000 to acquire the prototype drug
product. In accordance with the terms of the Assignment, Valent is entitled to receive a future royalty (in the single digits)
on certain revenues derived from the development and commercialization of VAL-083. In the event that Del Mar (BC) terminates the
agreement, Del Mar (BC) may be entitled to receive royalties from Valent’s subsequent development of VAL-083 depending on
the development milestones Del Mar (BC) has achieved prior to the termination of the Assignment. The Assignment has a term (on
a country-by-country basis), of the later of ten years or until patent rights covered by the Assignment no longer exist, subject
to earlier termination in the event Del Mar (BC) breaches its payment obligations and fails to remedy such breach within 60 days,
or if either party materially beaches any of its obligations and does not cure such breach within 30 days after receipt of notice
thereof.
Pursuant
to a loan agreement dated February 3, 2011, between Del Mar (BC) and Valent, Valent loaned Del Mar (BC) $250,000 for the purchase
of the prototype drug product under the Assignment. The loan is unsecured, bears interest at 3% per year, and is payable on demand.
Effective September 30, 2014, we entered into and closed an agreement with Valent to exchange its loan, including accrued interest
to September 30, 2014, with Valent for 278,530 shares of our Series A preferred stock. The Series A preferred stock has an annual
3% dividend.
One
of our officers, Dr. Dennis Brown, is a principal of Valent and as result Valent is a related party to us.
PRINCIPAL
STOCKHOLDERS
The
following table sets forth certain information, as of July 26, 2019, with respect to the beneficial ownership of the outstanding
common stock, reflecting our one-for-ten reverse stock split occurring on May 8, 2019, by (i) any holder of more than five (5%)
percent; (ii) each of our executive officers and directors; and (iii) our directors and executive officers as a group. Except
as otherwise indicated, each of the stockholders listed below has sole voting and investment power over the shares beneficially
owned.
|
|
Common Stock
|
|
|
Percentage of
Common Stock
|
|
Name of Beneficial Owner
(1)
|
|
Beneficially
Owned
|
|
|
Before Offering
(2)
|
|
|
After Offering
|
|
Directors and Officers:
|
|
|
|
|
|
|
|
|
|
Saiid Zarrabian
|
|
|
57,666
|
(3)
|
|
|
1.5
|
%
|
|
|
*
|
|
Dennis Brown, PhD
|
|
|
90,628
|
(4)
|
|
|
2.4
|
%
|
|
|
*
|
|
Scott Praill
|
|
|
25,573
|
(5)
|
|
|
*
|
|
|
|
*
|
|
Robert E. Hoffman
|
|
|
4,833
|
(6)
|
|
|
*
|
|
|
|
*
|
|
John K. Bell
|
|
|
20,934
|
(7)
|
|
|
*
|
|
|
|
*
|
|
Robert J. Toth, Jr.
|
|
|
10,240
|
(8)
|
|
|
*
|
|
|
|
*
|
|
Lynda Cranston
|
|
|
9,346
|
(9)
|
|
|
*
|
|
|
|
*
|
|
Napoleone Ferrara, MD
|
|
|
5,604
|
(10)
|
|
|
*
|
|
|
|
*
|
|
Jeffrey Bacha
|
|
|
104,063
|
(11)
|
|
|
2.7
|
%
|
|
|
1.0
|
%
|
All officers and directors as a group (9 persons)
|
|
|
328,887
|
|
|
|
8.5
|
%
|
|
|
3.3
|
%
|
|
(1)
|
Except
as otherwise indicated, the address of each beneficial owner is c/o DelMar Pharmaceuticals, Inc., Suite 720 – 999 West Broadway,
Vancouver, British Columbia, Canada V5Z 1K5.
|
|
(2)
|
Applicable
percentage ownership is based on 3,838,483 shares of common stock outstanding as of July
26, 2019, together with securities exercisable or convertible into shares of common stock
within 60 days of July 26, 2019 for each stockholder. Beneficial ownership is determined
in accordance with the rules of the SEC and generally includes voting or investment power
with respect to securities. Shares of common stock that are currently exercisable or
exercisable within 60 days of July 26, 2019 are deemed to be beneficially owned by the
person holding such securities for the purpose of computing the percentage of ownership
of such person, but are not treated as outstanding for the purpose of computing the percentage
ownership of any other person.
|
|
(3)
|
Includes
51,576 shares issuable upon the exercise of vested stock options.
|
|
(4)
|
Includes
53,750 shares held by Valent Technologies, LLC, 20,560 shares issuable upon exercise of vested stock options, 2,125 shares issuable
upon exercise of warrants held by Dr. Brown, and 750 shares issuable upon the conversion of Series B Preferred Stock.
|
|
(5)
|
Includes
15,999 shares issuable upon exercise of vested stock options, 1,250 shares issuable upon exercise of warrants and 938 shares upon
the conversion of Series B Preferred Stock.
|
|
(6)
|
Includes
4,833 shares issuable upon exercise of vested stock options.
|
|
(7)
|
Includes
9,701 shares owned by Onbelay Capital, Inc., 1,250 shares issuable upon exercise of warrants held by Onbelay Capital, Inc., 8,733
shares issuable upon exercise of vested stock options, and 1,250 shares issuable upon the conversion of Series B Preferred Stock
held by Onbelay Capital, Inc.
|
|
(8)
|
Includes
8,733 shares issuable upon exercise of vested stock options and 325 shares issuable upon the conversion of Series B Preferred
Stock.
|
|
(9)
|
Includes
8,733 shares issuable upon exercise of vested options and 313 shares issuable upon the conversion of Series B Preferred Stock.
|
|
(10)
|
Includes
5,604 shares issuable upon exercise of vested stock options.
|
|
(11)
|
Includes
625 shares issuable upon the exchange of Exchangeable Shares held in trust, 21,860 shares issuable upon exercise of vested stock
options, and 1,500 shares issuable upon exercise of warrants.
|
MARKET
PRICE OF OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
Our
common stock is listed on The Nasdaq Capital Market, under the symbol “DMPI”. On August 8, 2019, the closing price
for our common stock as reported on The Nasdaq Capital Market was $1.61 per share. As of June 30, 2019, we had 323
record
holders of our common stock.
DESCRIPTION
OF THE SECURITIES WE ARE OFFERING
General
As of the date of this prospectus, we are authorized to
issue up to 100,000,000 shares of capital stock, including 95,000,000 shares of common stock, par value $0.001 per share, and
5,000,000 shares of preferred stock, par value $0.001 per share. As of August 8, 2019, we had 3,838,483 shares of common stock
278,530 shares of Series A Preferred Stock (as defined below), 648,613 shares of Series B Preferred Stock (as defined below),
and one share of Special Voting Preferred Stock (as defined below) issued and outstanding and 7,813 shares of common stock issuable
upon exchange of Exchangeable Shares of 0959456 B.C. Ltd., a British Columbia corporation (“Exchangeco”) (which shares
are recognized on an as-exchanged for common stock basis for financial statement purposes).
We
are offering 4,968,944 shares of our common stock together with warrants to purchase up to an aggregate of 4,968,944 shares of
our common stock. Each share of our common stock is being sold together with one warrant to purchase one share of common stock.
The shares of our common stock and related warrants will be issued separately. We are also registering the shares of our common
stock issuable from time to time upon exercise of the warrants offered hereby.
The
additional shares of our authorized stock available for issuance may be issued at times and under circumstances so as to have
a dilutive effect on earnings per share and on the equity ownership of the holders of our common stock. The ability of our board
of directors to issue additional shares of stock could enhance the board’s ability to negotiate on behalf of the stockholders
in a takeover situation but could also be used by the board to make a change-in-control more difficult, thereby denying stockholders
the potential to sell their shares at a premium and entrenching current management. The following description is a summary of
the material provisions of our capital stock. You should refer to our articles of incorporation, as amended and bylaws, both of
which are on file with the SEC as exhibits to previous SEC filings, for additional information. The summary below is qualified
by provisions of applicable law.
Common
Stock
Each
outstanding share of common stock entitles the holder to one vote, either in person or by proxy, on all matters submitted to a
vote of stockholders, including the election of directors. There is no cumulative voting in the election of directors. All actions
required or permitted to be taken by stockholders at an annual or special meeting of the stockholders must be effected at a duly
called meeting, with a quorum present of a majority in voting power of the shares entitled to vote thereon. Special meetings of
the stockholders may only be called by our Board of Directors acting pursuant to a resolution approved by the affirmative majority
of the entire Board of Directors. Stockholders may not take action by written consent. A vote by the holders of a majority of
our outstanding shares is required to effectuate certain fundamental corporate changes such as liquidation, merger or an amendment
to our articles of incorporation.
Subject
to preferences which may be applicable to any outstanding shares of preferred stock from time to time, holders of our common stock
have equal ratable rights to such dividends as may be declared from time to time by our Board of Directors out of funds legally
available therefor. In the event of any liquidation, dissolution or winding-up of our affairs, holders of common stock will be
entitled to share ratably in our remaining assets after provision for payment of amounts owed to creditors and preferences applicable
to any outstanding shares of preferred stock. All outstanding shares of common stock are fully paid and nonassessable. Holders
of common stock do not have preemptive rights.
Under
the terms of the warrants issued to the representative of the underwriters in connection with this offering, the holders have
the right to include its shares of common stock underlying the warrants in any registration statement we file. The holders will
have one demand registration right of the underlying shares of common stock at the Company’s expense and one demand registration
right of the underlying shares of common stock at the holder’s expense. Additionally, if we register any securities for
public sale, the holder will have the right to include its shares of common stock in the registration statement, provided that
the underwriters of any such underwritten offering will have the right to limit the number of shares to be included in the registration
statement. These piggyback registration rights expire on the third anniversary of the closing date of this offering.
Pre-Funded
Warrants
The
following summary of certain terms and provisions of the Pre-Funded Warrants that are being offered hereby is not complete and
is subject to, and qualified in its entirety by the provisions of, the Pre-Funded Warrant. Prospective investors should carefully
review the terms and provisions of the form of Pre-Funded Warrant for a complete description of the terms and conditions of the
Pre-Funded Warrants.
The
term “pre-funded” refers to the fact that the purchase price of our common stock in this offering includes almost
the entire exercise price that will be paid under the Pre-Funded Warrants, except for a nominal remaining exercise price of $0.01.
The purpose of the Pre-Funded Warrants is to enable investors that may have restrictions on their ability to beneficially own
more than 4.99% (or, upon election of the holder, 9.99%) of our outstanding common stock following the consummation of this offering
the opportunity to invest capital into the Company without triggering their ownership restrictions, by receiving Pre-Funded Warrants
in lieu of our common stock which would result in such ownership of more than 4.99% (or 9.99%), and receive the ability to exercise
their option to purchase the shares underlying the Pre-Funded Warrants at such nominal price at a later date.
Duration
.
The Pre-Funded Warrants offered hereby will entitle the holders thereof to purchase shares of our common stock at a nominal exercise
price of $0.01 per share, commencing immediately on the date of issuance.
Exercise
Limitation.
A holder will not have the right to exercise any portion of the Pre-Funded Warrant if the holder (together with
its affiliates) would beneficially own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of shares of
our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance
with the terms of the Pre-Funded Warrants. However, any holder may increase or decrease such percentage, provided that any increase
will not be effective until the 61st day after such election.
Exercise
Price.
The Pre-Funded Warrants will have an exercise price of $0.01 per share. The exercise price is subject to appropriate
adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar
events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.
Transferability.
Subject to applicable laws, the Pre-Funded Warrants may be offered for sale, sold, transferred or assigned without our consent.
Exchange
Listing.
There is no established trading market for the Pre-Funded Warrants and we do not expect a market to develop. In addition,
we do not intend to apply for the listing of the Pre-Funded Warrants on any national securities exchange or other trading market.
Without an active trading market, the liquidity of the Pre-Funded Warrants will be limited.
Fundamental
Transactions.
If a fundamental transaction occurs, then the successor entity will succeed to, and be substituted for us, and
may exercise every right and power that we may exercise and will assume all of our obligations under the Pre-Funded Warrants with
the same effect as if such successor entity had been named in the Pre-Funded Warrant itself. If holders of our common stock are
given a choice as to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given
the same choice as to the consideration it receives upon any exercise of the Pre-Funded Warrant following such fundamental transaction.
Rights
as a Stockholder.
Except as otherwise provided in the Pre-Funded Warrants or by virtue of such holder’s ownership of
shares of our common stock, the holder of a Pre-Funded Warrants does not have the rights or privileges of a holder of our common
stock, including any voting rights, until the holder exercises the Pre-Funded Warrant.
Warrants
The
following summary of certain terms and provisions of the warrants offered hereby is not complete and is subject to, and qualified
in its entirety by, the provisions of the warrant, the form of which has been filed as an exhibit to the registration statement
of which this prospectus is a part. Prospective investors should carefully review the terms and provisions of the form of warrant
for a complete description of the terms and conditions of the warrants.
Form.
The warrants will be issued as individual warrant agreements to the investors.
Exercisability.
The warrants are exercisable on the date of issuance, and at any time thereafter up to five years from the initial exercise
date, at which time any unexercised warrants will expire and cease to be exercisable. The warrants will be exercisable, at the
option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration
statement registering the issuance of the shares of common stock underlying the warrants under the Securities Act is effective
and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the
issuance of such shares, by payment in full in immediately available funds for the number of shares of common stock purchased
upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the warrants
under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available
for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the warrant through a cashless exercise,
in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the
formula set forth in the warrant. No fractional shares of common stock will be issued in connection with the exercise of a warrant.
In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise
price.
Exercise
Limitation.
A holder will not have the right to exercise any portion of the warrant if the holder (together with its affiliates)
would beneficially own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of shares of our common stock
outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the
terms of the warrants. However, any holder may increase or decrease such percentage, provided that any increase will not be effective
until the 61st day after such election.
Exercise Price.
The warrants will have an exercise
price of $1.61 (assuming an offering price of $1.61, the last reported sale price of our common stock on The Nasdaq Capital Market
on August 8, 2019 and an exercise price of the warrants equal to 100% of the offering price of the securities in this offering).
The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits,
stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets,
including cash, stock or other property to our stockholders.
Transferability.
Subject to applicable laws, the warrants may be offered for sale, sold, transferred or assigned without our consent.
Exchange
Listing.
There is no established trading market for the warrants and we do not expect a market to develop. In addition, we
do not intend to apply for the listing of the warrants on any national securities exchange or other trading market. Without an
active trading market, the liquidity of the warrants will be limited.
Fundamental
Transactions.
If a fundamental transaction occurs, then the successor entity will succeed to, and be substituted for us, and
may exercise every right and power that we may exercise and will assume all of our obligations under the warrants with the same
effect as if such successor entity had been named in the warrant itself. If holders of our common stock are given a choice as
to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given the same choice
as to the consideration it receives upon any exercise of the warrant following such fundamental transaction.
Rights
as a Stockholder.
Except as otherwise provided in the warrants or by virtue of such holder’s
ownership of shares of our common stock, the holder of a warrant does not have the rights or privileges of a holder of our common
stock, including any voting rights, until the holder exercises the warrant
.
Redemption Rights
.
We may redeem the warrants for $0.001 per warrant if our common stock closes above $
per share for ten consecutive trading days and on each such day the dollar trading volume exceeds $250,000, provided that we may
not do so prior to the first anniversary of the initial exercise date.
As
of August 8, 2019, we had outstanding warrants to purchase up to 1,543,596 shares of common stock, exercisable at prices ranging
from $3.10 per share to $59.30 per share.
Business
Combinations Act
The
Business Combinations Act, Sections 78.411 to 78.444 of the NRS, restricts the ability of a Nevada “resident domestic corporation”
having at least 200 stockholders of record to engage in any “combination” with an “interested stockholder”
for two (2) years after the date that the person first became an interested stockholder, unless the combination meets all of the
requirements of the articles of incorporation of the resident domestic corporation and (i) the purchase of shares by the interested
stockholder is approved by the board of directors before that date or (ii) the combination is approved by the board of directors
of the resident domestic corporation and, at or after that time, the combination is approved at an annual or special meeting of
the stockholders of the resident domestic corporation, and not by written consent, by the affirmative vote of the holders of stock
representing at least sixty percent (60%) of the outstanding voting power of the resident domestic corporation not beneficially
owned by the interested stockholder or the affiliates or associates of the interested stockholder.
If
this approval is not obtained, then after the expiration of the two (2) year period, the business combination may still not be
consummated unless it is a combination meeting all of the requirements of the articles of incorporation of the resident domestic
corporation and either the “fair price” requirements specified in NRS 78.441 to 78.444, inclusive are satisfied or
the combination is (a) a combination or transaction by which the person first became an interested stockholder is approved by
the board of directors of the resident domestic corporation before the person first became an interested stockholder, or (b) a
combination approved by a majority of the outstanding voting power of the resident domestic corporation not beneficially owned
by the interested stockholder, or any affiliate or associate of the interested stockholder.
“Interested
stockholder” means any person, other than the resident domestic corporation or its subsidiaries, who is (a) the beneficial
owner, directly or indirectly, of 10% or more of the voting power of the outstanding voting shares of the resident domestic corporation
or (b) an affiliate or associate of the resident domestic corporation and at any time within two years immediately before the
date in question was the beneficial owner, directly or indirectly, of 10% or more of the voting power of the then outstanding
shares of the resident domestic corporation.
A
“combination” is broadly defined and includes, for example, any merger or consolidation of a corporation or any of
its subsidiaries with (i) an interested stockholder or (ii) any other entity that after and as a result of the merger or consolidation
would be an affiliate or associate of the interested stockholder; or any sale, lease, exchange, pledge, transfer or other disposition
of assets of the corporation, in one transaction or a series of transactions, to or with an interested stockholder having: (x)
an aggregate market value equal to more than 5% of the aggregate market value of the assets of a corporation, (y) an aggregate
market value equal to more than 5% of the aggregate market value of all outstanding voting shares of a corporation, or (z) representing
more than 10% of the earning power or net income of a corporation.
The
provisions of Nevada law, our articles of incorporation and our bylaws could have the effect of discouraging others from attempting
hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our common stock
that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes
in our management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders
may otherwise deem to be in their best interests.
Control
Shares
Nevada
law also seeks to impede “unfriendly” corporate takeovers by providing in Sections 78.378 to 78.3793 of the NRS that
an “acquiring person” shall only obtain voting rights in the “control shares” purchased by such person
to the extent approved by the other shareholders at a meeting. With certain exceptions, an acquiring person is one who acquires
or offers to acquire a “controlling interest” in the corporation, defined as one-fifth or more of the voting power.
Control shares include not only shares acquired or offered to be acquired in connection with the acquisition of a controlling
interest, but also all shares acquired by the acquiring person within the preceding 90 days. The statute covers not only the acquiring
person but also any persons acting in association with the acquiring person.
A
Nevada corporation may elect to opt out of the provisions of Sections 78.378 to 78.3793 of the NRS. We have no provision in our
articles of incorporation pursuant to which we have elected to opt out of Sections 78.378 to 78.3793; therefore, these sections
do apply to us.
Stock
Options
As
of August 8, 2019, we had issued and outstanding options to purchase up to 288,183 shares of common stock, exercisable at prices
ranging from $6.099 per share to $92.00 per share.
Performance
Stock Units
As
of March 31, 2019, we had issued and outstanding performance stock units to acquire up to 120,000 shares of common stock, which
units were cancelled effective as of April 30, 2019.
Potential
Effects of Authorized but Unissued Stock
We
have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these
additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate
corporate acquisitions or payment as a dividend on the capital stock.
The
existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons
friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party
attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity
of our management. In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges
and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences
of each series of preferred stock, all to the fullest extent permissible under the Nevada Revised Statute and subject to any limitations
set forth in our articles of incorporation. The purpose of authorizing the board of directors to issue preferred stock and to
determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote
on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings,
acquisitions and other corporate purposes, could have the effect of making it more difficult for a third-party to acquire, or
could discourage a third-party from acquiring, a majority of our outstanding voting stock.
Transfer
Agent and Warrant Agent
The
transfer agent and registrar for our common stock, preferred stock and the warrant agent for the warrants is Mountain Share Transfer,
Inc.
UNDERWRITING
We
have entered into an underwriting agreement with the underwriters named below with respect to the shares of our common stock and
related warrants and Pre-Funded Warrants and related warrants subject to this offering. Subject to certain conditions, we have
agreed to sell to the underwriters, and the underwriters have agreed to purchase, the number of shares of our common stock, pre-funded
warrants and corresponding warrants provided below opposite each underwriter’s name. Maxim Group LLC and Dawson James Securities,
Inc. are acting as the representatives of the underwriters.
Underwriter
|
|
Number of Shares
|
|
|
Number of Pre-Funded Warrants
|
|
|
Number of Warrants
|
|
Maxim Group LLC
|
|
|
|
|
|
|
|
|
|
|
|
|
Dawson James Securities, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
The
underwriters are offering the shares of our common stock and related warrants and Pre-Funded Warrants and related warrants subject
to their acceptance of our common stock, the Pre-Funded Warrants and the warrants from us and subject to prior sale. The underwriting
agreement provides that the obligations of the underwriters to pay for and accept delivery of the shares of our common stock and
related warrants and Pre-Funded Warrants and related warrants offered by this prospectus are subject to the approval of certain
legal matters by their counsel and to certain other conditions. The underwriters are obligated to take and pay for all of the
shares of our common stock and related warrants and Pre-Funded Warrants and related warrants if any such shares of our common
stock and related warrants or Pre-Funded Warrants and related warrants are taken.
We
have granted the underwriters an option for a period of 45 days from the date of this prospectus to purchase up to an additional 745,341
shares of common stock and/or warrants to purchase 745,341 shares of common stock at the public offering price, less the underwriting
discount.
Underwriter
Compensation
We have agreed to pay the underwriters
an aggregate fee equal to 8.0% of the gross proceeds of this offering and expect the net proceeds from this offering to be approximately
$ after deducting $ in
underwriting commissions and $ in our
other estimated offering expenses. We have also agreed to pay the underwriters an accountable expense allowance for certain of
the underwriters’ expenses relating to the offering up to a maximum aggregate amount of $80,000, including the underwriters’
legal fees incurred in this offering.
Underwriter’s Warrants
We have agreed to grant the representatives of the underwriters
warrants to purchase a number of shares equal to five percent (5%) of the total number of shares of common stock sold in this
offering at an exercise price equal to one hundred fifteen percent (115%) of the public offering price in this offering. The warrants
(the “Underwriter’s Warrants”) will contain a cashless exercise feature. The Underwriter’s Warrants are
exercisable for shares of common stock on a cash or cashless basis at an exercise price of $1.85 per share (or one hundred fifteen
percent (115%) of the price of public offering price in this offering). The Underwriter’s Warrants will be non-exercisable
for one hundred eighty (180) days after the effective date (the “Effective Date”) of the registration statement of
which this prospectus forms a part of this offering, and will expire three years after such Effective Date. The Underwriter’s
Warrants will contain provisions for demand registration of the shares underlying the Underwriter’s Warrants on one occasion
at our expense and unlimited piggyback registration rights for a period of three (3) years after the Effective Date at our expense.
The number of Underwriter’s Warrants outstanding, and the exercise price of those securities, will be adjusted proportionately,
as permitted by FINRA Rule 5110(f)(2)(G). Such Underwriter’s Warrants will be subject to FINRA Rule 5110(g)(1) in that,
except as otherwise permitted by FINRA Rule 5110(g)(2), for a period of 180 days following the Effective Date, the Underwriter’s
Warrants shall not be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative,
put, or call transaction that would result in the effective economic disposition of the securities by any person. The Underwriter’s
Warrants shall be split based on fixed economics of 62.5% to Maxim Group LLC and 37.5% to Dawson James Securities, Inc.
Discounts
and Expenses
The
underwriters have advised us that they propose to offer the shares of our common stock, Pre-Funded Warrants and related warrants
to the public at the respective public offering price set forth on the cover page of this prospectus and to certain dealers at
that price less a concession not in excess of $ per share of
our common stock and related warrant or $ per Pre-Funded Warrants and related
warrants. After this offering, the public offering price and concession to dealers may be changed by the representative. No such
change shall change the amount of proceeds to be received by us as set forth on the cover page of this prospectus. The shares
of our common stock, Pre-Funded Warrants and related warrants are offered by the underwriters as stated herein, subject to receipt
and acceptance by them and subject to their right to reject any order in whole or in part. The underwriters have informed us that
they do not intend to confirm sales to any accounts over which they exercise discretionary authority.
The
following table shows the public offering price, underwriting discount payable to the underwriters by us and proceeds before expenses
to us, assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares of common stock and/or
warrants. The underwriting commissions are equal to the combined public offering price per share, Pre-Funded Warrants and related
warrants, less the amount per share the underwriters pay us for the shares of common stock, Pre-Funded Warrants and warrants:
|
|
Per Share
|
|
|
Per Pre-Funded Warrant
|
|
|
Per Warrant
|
|
|
Total (No Exercise)
|
|
|
Total (Full Exercise)
|
|
Public offering price
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Underwriting discounts and commissions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds, before expenses, to us
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
In addition, we have agreed to reimburse the underwriters
for reasonable out-of-pocket expenses not to exceed $80,000 in the aggregate. We estimate that total expenses payable by us in
connection with this offering, other than the underwriting discount referred to above, will be approximately $258,461.
Indemnification
We
have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act.
Lock-up
Agreements
We,
our officers and directors have agreed, subject to limited exceptions, for a period of 90 days after the closing of this offering,
not to offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of, directly
or indirectly any shares of common stock or any securities convertible into or exchangeable for our common stock either owned
as of the date of the underwriting agreement or thereafter acquired without the prior written consent of Maxim Group LLC and Dawson
James Securities, Inc. Maxim Group LLC and Dawson James Securities, Inc. may, in their sole discretion and at any time or from
time to time before the termination of the lock-up period, without notice, release all or any portion of the securities subject
to lock-up agreements.
Right of First Refusal
Upon the closing of an offering with gross proceeds to the Company of at least $7.5 million, we have granted
the representatives of the underwriters a right of first refusal, for a period of nine (9) months from the commencement of sales
of this offering, at the underwriters sole discretion, to act as underwriter and book runner and/or placement agent for any and
all future public or private equity, equity-linked or debt (excluding commercial bank debt) offerings, during such nine (9) month
period, of the Company, or any successor to or any subsidiary of the Company (the “Right of First Refusal”). The Right
of First Refusal shall be based on fixed economics of 62.5% to Maxim and 37.5% to Dawson James.
Price
Stabilization, Short Positions and Penalty Bids
In
connection with the offering the underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act:
|
●
|
Stabilizing
transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum.
|
|
●
|
Over-allotment
involves sales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase, which
creates a syndicate short position. The short position may be either a covered short position or a naked short position. In a
covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they
may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number
of shares in the over-allotment option. The underwriters may close out any covered short position by either exercising their over-allotment
option and/or purchasing shares in the open market.
|
|
●
|
Syndicate
covering transactions involve purchases of the common stock in the open market after the distribution has been completed in order
to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will
consider, among other things, the price of shares available for purchase in the open market as compared to the price at which
they may purchase shares through the over-allotment option. A naked short position occurs if the underwriters sell more shares
than could be covered by the over-allotment option. This position can only be closed out by buying shares in the open market.
A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on
the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.
|
|
●
|
Penalty
bids permit the underwriters to reclaim a selling concession from a syndicate member when the common stock originally sold by
the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
|
These
stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market
price of our common stock or preventing or retarding a decline in the market price of the common stock. As a result, the price
of our common stock may be higher than the price that might otherwise exist in the open market. These transactions may be discontinued
at any time.
Neither
we nor the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions
described above may have on the price of our shares of common stock. In addition, neither we nor the underwriters make any representation
that the underwriters will engage in these transactions or that any transaction, if commenced, will not be discontinued without
notice.
Electronic
Distribution
This
prospectus in electronic format may be made available on websites or through other online services maintained by the underwriters,
or by their affiliates. Other than this prospectus in electronic format, the information on the underwriters’ websites and
any information contained in any other websites maintained by the underwriters is not part of this prospectus or the registration
statement of which this prospectus forms a part, has not been approved and/or endorsed by us or the underwriters in their capacity
as underwriters, and should not be relied upon by investors.
Other
From
time to time, the underwriters and/or their affiliates have provided, and may in the future provide, various investment banking
and other financial services for us for which services it has received and, may in the future receive, customary fees.
Except
for the services provided in connection with this offering and other than as described below, the underwriters have not provided
any investment banking or other financial services during the 180-day period preceding the date of this prospectus.
On
June 5, 2019, we completed an offering of 1,170,000 shares of our common stock and in a concurrent private placement, we sold
the same purchasers warrants to purchase an aggregate of 760,500 shares of common stock. The purchase price per share of common
stock and related warrant is $3.10. Subject to certain ownership limitations, the warrants are exercisable commencing on the issuance
date at an exercise price equal to $3.10 per share of common stock, subject to adjustments as provided under the terms of the
warrants. The warrants are exercisable for five years from the date of issuance. Maxim Group LLC and Dawson James Securities,
Inc. acted as placement agents in connection with the RD Offering.
In
connection with the RD Offering, we agreed, for a period of four (4) months from the date of the securities purchase agreement,
to grant Maxim Group LLC and Dawson James Securities, Inc. a right of first refusal to act as lead managing underwriter, book
runner and/or lead placement agent, as split between the dealer-managers based on the fixed economics of 62.5% to Maxim Group
LLC and 37.5% to Dawson James Securities, Inc., for 100% of the economics of any and all future equity, equity-linked or debt
(excluding commercial bank debt) offerings undertaken during such period by the Company or any subsidiary of the Company.
LEGAL
MATTERS
The
validity of the securities offered hereby will be passed upon for us by Fennemore Craig, P.C., Reno, Nevada. Certain other matters
are being passed upon for us by Lowenstein Sandler LLP, New York, New York. The underwriters are being represented by Ellenoff
Grossman & Schole LLP, New York, New York.
EXPERTS
The
consolidated financial statements of DelMar Pharmaceuticals, Inc. at June 30, 2018 and 2017, and for the years then ended, appearing
in this Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent registered public accounting
firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial
doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements)
appearing elsewhere herein, and are included in reliance upon such report given on the authority of such firm as experts in accounting
and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock
being offered by this prospectus. This prospectus is part of the registration statement, but the registration statement includes
additional information and exhibits. We file annual, quarterly and current reports, proxy statements and other information with
the SEC. The SEC maintains a web site that contains reports, proxy and information statements and other information regarding
companies, such as ours, that file documents electronically with the SEC. The website address is
www.sec.gov
. The information
on the SEC’s website is not part of this prospectus, and any references to this website or any other website are inactive
textual references only. Additionally, you may access our filings with the SEC through our website at
http://www.delmarpharma.com
.
The information on our website is not part of this prospectus.
DelMar
Pharmaceuticals, Inc.
INDEX
TO FINANCIAL STATEMENTS
Contents
|
Page
|
Unaudited
Consolidated Condensed Interim Financial Statements – March 31, 2019:
|
|
|
|
Consolidated Condensed Interim Balance Sheets as of March 31, 2019 and June 30, 2018
|
F-2
|
Consolidated Condensed Interim Statements of Loss and Comprehensive Loss for the three and nine months ended March 31, 2019 and 2018
|
F-3
|
Consolidated Condensed Interim Statements of Cash Flows for the nine months ended March 31, 2019 and 2018
|
F-4
|
Notes to Consolidated Condensed Interim Financial Statements
|
F-5 – F-19
|
|
|
Consolidated
Financial Statements – June 30, 2018 and 2017:
|
|
|
|
Report of Independent Registered Public Accounting Firm
|
F-20
|
Consolidated Balance Sheets as of June 30, 2018 and 2017
|
F-21
|
Consolidated Statements of Operations and Comprehensive Loss for the years ended June 30, 2018 and 2017
|
F-22
|
Consolidated Statements of Changes in Stockholders’ Equity for the years ended June 30, 2018 and 2017
|
F-23
|
Consolidated Statements of Cash Flows for the years ended June 30, 2018 and 2017
|
F-24
|
Notes to the Consolidated Financial Statements
|
F-25 – F-47
|
DelMar
Pharmaceuticals, Inc.
Consolidated
Condensed Interim Balance Sheets (Unaudited)
|
(expressed
in US dollars unless otherwise noted)
|
|
Note
|
|
March 31,
2019
$
|
|
|
June 30,
2018
$
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
2,152,233
|
|
|
|
5,971,995
|
|
Prepaid expenses and deposits
|
|
|
|
|
240,071
|
|
|
|
1,034,930
|
|
Interest, taxes and other receivables
|
|
|
|
|
9,086
|
|
|
|
39,519
|
|
Deferred financing costs
|
|
7,8
|
|
|
40,873
|
|
|
|
—
|
|
|
|
|
|
|
2,442,263
|
|
|
|
7,046,444
|
|
Intangible assets – net
|
|
|
|
|
14,863
|
|
|
|
28,411
|
|
|
|
|
|
|
2,457,126
|
|
|
|
7,074,855
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
|
|
1,084,460
|
|
|
|
1,478,086
|
|
Related party payables
|
|
|
|
|
113,240
|
|
|
|
160,429
|
|
|
|
|
|
|
1,197,700
|
|
|
|
1,638,515
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liability
|
|
4
|
|
|
265
|
|
|
|
1,117
|
|
|
|
|
|
|
1,197,965
|
|
|
|
1,639,632
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
Authorized
|
|
|
|
|
|
|
|
|
|
|
5,000,000 shares, $0.001 par value
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
278,530 Series A shares at March 31, 2019 (June 30, 2018 – 278,530)
|
|
3,5
|
|
|
278,530
|
|
|
|
278,530
|
|
841,113 Series B shares at March 31, 2019 (June 30, 2018 – 881,113)
|
|
5
|
|
|
5,867,829
|
|
|
|
6,146,880
|
|
1 special voting share at March 31, 2019 (June 30, 2018 – 1)
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
|
|
|
|
|
|
|
|
Authorized
|
|
|
|
|
|
|
|
|
|
|
7,000,000 shares (June 30, 2018 – 7,000,000), $0.001 par value
|
|
|
|
|
|
|
|
|
|
|
2,620,033 issued at March 31, 2019 (June 30, 2018 –
2,296,667)
|
|
5
|
|
|
2,620
|
|
|
|
2,297
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
5
|
|
|
47,022,252
|
|
|
|
43,198,193
|
|
Warrants
|
|
5
|
|
|
6,055,319
|
|
|
|
8,229,482
|
|
Accumulated deficit
|
|
|
|
|
(57,988,567
|
)
|
|
|
(52,441,337
|
)
|
Accumulated other comprehensive income
|
|
|
|
|
21,178
|
|
|
|
21,178
|
|
|
|
|
|
|
1,259,161
|
|
|
|
5,435,223
|
|
|
|
|
|
|
2,457,126
|
|
|
|
7,074,855
|
|
Going
concern, nature of operations, and corporate history
(note 1)
Subsequent
events
(note 8)
The
accompanying notes are an integral part of these consolidated condensed interim financial statements.
DelMar Pharmaceuticals, Inc.
Consolidated Condensed Interim Statements of Loss and Comprehensive Loss (Unaudited)
(expressed
in US dollars unless otherwise noted)
|
|
Note
|
|
Three months ended
March 31,
2019
$
|
|
|
Three months ended
March 31,
2018
$
|
|
|
Nine months ended
March 31,
2019
$
|
|
|
Nine months
ended
March 31,
2018
$
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
5
|
|
|
735,844
|
|
|
|
1,779,609
|
|
|
|
2,702,213
|
|
|
|
5,856,197
|
|
General and administrative
|
|
5
|
|
|
935,530
|
|
|
|
1,155,038
|
|
|
|
2,796,884
|
|
|
|
2,911,538
|
|
|
|
|
|
|
1,671,374
|
|
|
|
2,934,647
|
|
|
|
5,499,097
|
|
|
|
8,767,735
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other loss (income)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of derivative liability
|
|
4
|
|
|
189
|
|
|
|
(2,160
|
)
|
|
|
(852
|
)
|
|
|
(57,839
|
)
|
Foreign exchange loss
|
|
|
|
|
5,819
|
|
|
|
6,420
|
|
|
|
16,754
|
|
|
|
57,406
|
|
Interest income
|
|
|
|
|
(13,397
|
)
|
|
|
(5,850
|
)
|
|
|
(49,513
|
)
|
|
|
(6,241
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,389
|
)
|
|
|
(1,590
|
)
|
|
|
(33,611
|
)
|
|
|
(6,674
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net and comprehensive loss for the period
|
|
|
|
|
1,663,985
|
|
|
|
2,933,057
|
|
|
|
5,465,486
|
|
|
|
8,761,061
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computation of basic loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net and comprehensive loss for the period
|
|
|
|
|
1,663,985
|
|
|
|
2,933,057
|
|
|
|
5,465,486
|
|
|
|
8,761,061
|
|
Series B Preferred stock dividend
|
|
|
|
|
23,202
|
|
|
|
46,626
|
|
|
|
75,477
|
|
|
|
142,358
|
|
Net and comprehensive loss available to common stockholders
|
|
|
|
|
1,687,187
|
|
|
|
2,979,683
|
|
|
|
5,540,963
|
|
|
|
8,903,419
|
|
Basic and fully diluted loss per share
|
|
|
|
|
0.67
|
|
|
|
1.31
|
|
|
|
2.27
|
|
|
|
4.41
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average number of shares
|
|
|
|
|
2,518,452
|
|
|
|
2,283,245
|
|
|
|
2,444,065
|
|
|
|
2,017,977
|
|
The
accompanying notes are an integral part of these consolidated condensed interim financial statements.
DelMar
Pharmaceuticals, Inc.
Consolidated
Condensed Interim Statements of Cash Flows (Unaudited)
|
(expressed
in US dollars unless otherwise noted)
|
|
|
|
Nine months ended
March 31,
|
|
|
|
Note
|
|
2019
$
|
|
|
2018
$
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
|
|
|
|
|
(5,465,486
|
)
|
|
|
(8,761,061
|
)
|
Items not affecting cash
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets
|
|
|
|
|
13,548
|
|
|
|
17,869
|
|
Change in fair value of derivative liability
|
|
4
|
|
|
(852
|
)
|
|
|
(57,839
|
)
|
Shares issued for services
|
|
5
|
|
|
10,269
|
|
|
|
4,821
|
|
Warrants issued for services
|
|
5
|
|
|
36,534
|
|
|
|
155,204
|
|
Stock option expense
|
|
5
|
|
|
355,388
|
|
|
|
430,673
|
|
Performance stock unit expense
|
|
5
|
|
|
183,205
|
|
|
|
—
|
|
Changes in non-cash working capital
|
|
|
|
|
|
|
|
|
|
|
Interest, taxes and other receivables
|
|
|
|
|
30,433
|
|
|
|
14,578
|
|
Prepaid expenses and deposits
|
|
|
|
|
794,859
|
|
|
|
135,293
|
|
Accounts payable and accrued liabilities
|
|
|
|
|
(425,383
|
)
|
|
|
708,634
|
|
Related party payables
|
|
|
|
|
(47,189
|
)
|
|
|
33,816
|
|
|
|
|
|
|
(4,514,674
|
)
|
|
|
(7,318,012
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
Intangible assets – website development costs
|
|
|
|
|
—
|
|
|
|
(12,649
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|
|
(12,649
|
)
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from the issuance of shares and warrants
|
|
5
|
|
|
—
|
|
|
|
8,945,336
|
|
Net proceeds from the exercise and exchange of warrants
|
|
5,7
|
|
|
726,179
|
|
|
|
312,500
|
|
Series A preferred cash dividend
|
|
5
|
|
|
(6,267
|
)
|
|
|
(6,267
|
)
|
Deferred financing costs
|
|
7,8
|
|
|
(25,000
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
694,912
|
|
|
|
9,251,569
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents
|
|
|
|
|
(3,819,762
|
)
|
|
|
1,920,908
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents – beginning of period
|
|
|
|
|
5,971,995
|
|
|
|
6,586,014
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents – end of period
|
|
|
|
|
2,152,233
|
|
|
|
8,506,922
|
|
Supplementary
information
(note 7)
The
accompanying notes are an integral part of these consolidated condensed interim financial statements.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
1
|
Going
concern, nature of operations, and corporate history
|
Going
concern
These
consolidated condensed interim financial statements have been prepared on a going concern basis which assumes that DelMar Pharmaceuticals,
Inc. (the “Company”) will continue its operations for the foreseeable future and contemplates the realization of assets
and the settlement of liabilities in the normal course of business.
For
the nine months ended March 31, 2019, the Company reported a loss of $5,465,486, and a negative cash flow from operations of $4,514,674.
The Company had an accumulated deficit of $57,988,567 as of March 31, 2019. As of March 31, 2019, the Company had cash and cash
equivalents on hand of $2,152,233. The Company is in the development stage and has not generated any revenues to date. The Company
does not have the prospect of achieving revenues until such time that its product candidate is commercialized, or partnered, which
may not ever occur. In the near future, the Company will require additional funding to maintain its clinical trials, research
and development projects, and for general operations. These circumstances indicate substantial doubt exists about the Company’s
ability to continue as a going concern.
Consequently,
management is pursuing various financing alternatives to fund the Company’s operations so it can continue as a going concern.
Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership
arrangements. The Company may tailor its drug candidate development program based on the amount of funding the Company is able
to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
These
financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may
be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.
Nature
of operations
The
Company is a clinical stage drug development company with a focus on the treatment of cancer that is conducting clinical trials
in the United States and China with our product candidate, VAL-083, as a potential new treatment for glioblastoma multiforme,
the most common and aggressive form of brain cancer. The Company has also acquired certain commercial rights to VAL-083 in China
where it is approved as a chemotherapy for the treatment of chronic myelogenous leukemia and lung cancer. In order to accelerate
the Company’s development timelines, the Company leverages existing clinical and commercial data from a wide range of sources.
The Company may seek marketing partnerships in order to potentially generate future royalty revenue.
The
address of the Company’s administrative offices is Suite 720 - 999 West Broadway, Vancouver, British Columbia, Canada, V5Z
1K5 with clinical operations located at 3485 Edison Way, Suite R, Menlo Park, California, 94025.
Corporate
history
The
Company is a Nevada corporation formed on June 24, 2009 under the name Berry Only, Inc. On January 25, 2013, the Company entered
into and closed an exchange agreement (the “Exchange Agreement”), with Del Mar Pharmaceuticals (BC) Ltd. (“Del
Mar (BC)”), 0959454 B.C. Ltd. (“Callco”), and 0959456 B.C. Ltd. (“Exchangeco”) and the security
holders of Del Mar (BC). Upon completion of the Exchange Agreement, Del Mar (BC) became a wholly-owned subsidiary of the Company
(the “Reverse Acquisition”).
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
1
|
Going
concern, nature of operations, and corporate history
(cont.)
|
DelMar
Pharmaceuticals, Inc. is the parent company of Del Mar (BC), a British Columbia, Canada corporation incorporated on April 6, 2010,
which is a clinical stage company with a focus on the development of drugs for the treatment of cancer. The Company is also the
parent company to Callco and Exchangeco which are British Columbia, Canada corporations. Callco and Exchangeco were formed to
facilitate the Reverse Acquisition.
References
to the Company refer to the Company and its wholly-owned subsidiaries, Del Mar (BC), Callco and Exchangeco.
|
2
|
Significant
accounting policies
|
Basis
of presentation
The
consolidated condensed interim financial statements of the Company have been prepared in accordance with United States Generally
Accepted Accounting Principles (“U.S. GAAP”) and are presented in United States dollars. The functional currency of
the Company and each of its subsidiaries is the United States dollar.
The
accompanying consolidated condensed interim financial statements include the accounts of the Company and its wholly-owned subsidiaries,
Del Mar (BC), Callco, and Exchangeco. All intercompany balances and transactions have been eliminated in consolidation.
The
principal accounting policies applied in the preparation of these consolidated condensed interim financial statements are set
out below and have been consistently applied to all periods presented.
Unaudited
interim financial data
The
accompanying unaudited consolidated condensed interim financial statements have been prepared in accordance with the rules and
regulations of the Securities and Exchange Commission for interim financial information. Accordingly, they do not include all
of the information and the notes required by U.S. GAAP for complete financial statements. These unaudited consolidated condensed
interim financial statements should be read in conjunction with the audited financial statements of the Company as at June 30,
2018 included in our Form 10-K. In the opinion of management, the unaudited consolidated condensed interim financial statements
reflect all adjustments, consisting of normal and recurring adjustments, necessary for a fair presentation. The results for three
and nine months ended March 31, 2019 are not necessarily indicative of the results to be expected for the fiscal year ending June
30, 2019 or for any other future annual or interim period.
Use
of estimates
The
preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions about future
events that affect the reported amounts of assets, liabilities, expenses, contingent assets and contingent liabilities as at the
end of, or during, the reporting period. Actual results could significantly differ from those estimates. Significant areas requiring
management to make estimates include the derivative liability, the valuation of equity instruments issued for services, and clinical
trial accruals. Further details of the nature of these assumptions and conditions may be found in the relevant notes to these
consolidated condensed interim financial statements.
Loss
per share
Income
or loss per share is calculated based on the weighted average number of common shares outstanding. For the three- and nine-month
periods ended March 31, 2019 and 2018, diluted loss per share does not differ from basic loss per share since the effect of the
Company’s warrants, stock options, performance stock units, and
convertible preferred shares is anti-dilutive. As of March 31, 2019, potential shares of common stock of 862,502 (2018 –
1,428,128) related to outstanding warrants, 292,683 (2018 – 172,085) relating to stock options, 120,000 (2018 – 0)
relating to performance stock units, and 210,279 (2018 – 220,279) relating to outstanding Series B convertible preferred
shares were excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Recent
accounting pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other
standard setting bodies that are adopted by the Company as of the specified effective date.
Recently
adopted
Accounting
Standards Board (“ASU”) 2017-09 — Compensation — Stock Compensation (Topic 718): Scope of
Modification
Accounting
The
amendments in this update provide guidance about which changes to the terms, or conditions of a stock-based payment award, require
an entity to apply modification accounting in Topic 718. The amendments in ASU 2017-09 are effective for all entities for annual
periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including
adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not
yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available
for issuance. The adoption of ASU 2017-09 did not have a material impact on our results of operations or financial position.
ASU
2016-01 — Financial Instruments — Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial
Liabilities
The
updated guidance enhances the reporting model for financial instruments and requires entities to use the exit price notion when
measuring the fair value of financial instruments for disclosure purposes, and the separate presentation of financial assets and
financial liabilities by measurement category and form of financial asset (i.e., securities or loans and receivables) on the balance
sheet or the accompanying notes to the financial statements. The guidance is effective for annual reporting periods beginning
after December 15, 2017. The adoption of ASU 2016-01 did not have a material impact on our results of operations or financial
position.
Not
yet adopted
ASU
2017-11 — I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral
for Mandatorily Redeemable Financial Instruments of Certain Non-public Entities and Certain Mandatorily Redeemable Noncontrolling
Interests with a Scope Exception
The
amendments in this update are intended to reduce the complexity associated with the accounting for certain financial instruments
with characteristics of liabilities and equity. Specifically, a down round feature would no longer cause a freestanding equity-linked
financial instrument (or an embedded conversion option) to be accounted for as a derivative liability at fair value with changes
in fair value recognized in current earnings. In addition, the indefinite deferral of certain provisions of Topic 480 have been
re-characterized to a scope exception. The re-characterization has no accounting effect. ASU 2017-11 is effective for public business
entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is
permitted. The Company is currently evaluating the potential impact of the adoption of this standard.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
ASU
2016-02 — Leases (Topic 842)
The
new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability
on the consolidated balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance
or operating, with classification affecting the pattern of expense recognition in the consolidated income statement. ASU 2016-02
is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods, with
early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases
existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with
certain practical expedients available. The Company is currently evaluating the potential impact of the adoption of this standard.
ASU
2018-07 — Stock Compensation (Topic 718) Improvements to Nonemployee Shares-based Payment Accounting
The
amendments in this update are intended to the reduce cost and complexity and to improve financial reporting for share-based payments
issued to nonemployees. The ASU expands the scope of Topic 718, Compensation —Stock Compensation, which currently only includes
share-based payments issued to employees, to also include share-based payments issued to nonemployees for goods and services.
The existing guidance on nonemployee share-based payments is significantly different from current guidance for employee share-based
payments. This ASU expands the scope of the employee share-based payments guidance to include share-based payments issued to nonemployees.
By doing so, the FASB improves the accounting of nonemployee share-based payments issued to acquire goods and services used in
its own operations. The amendments in this ASU are effective for public companies for fiscal years beginning after December 15,
2018, including interim periods within that fiscal year. The Company is currently evaluating the potential impact of the adoption
of this standard.
|
3
|
Valent
Technologies, LLC
|
On
September 30, 2014, the Company entered into an exchange agreement (the “Valent Exchange Agreement”) with Valent Technologies,
LLC (“Valent”), an entity owned by Dr. Dennis Brown, the Company’s Chief Scientific Officer, and Del Mar (BC).
Pursuant to the Valent Exchange Agreement, Valent exchanged its loan payable in the outstanding amount of $278,530 (including
aggregate accrued interest to September 30, 2014 of $28,530), issued to Valent by Del Mar (BC), for 278,530 shares of the Company’s
Series A Preferred Stock. The Series A Preferred Stock has a stated value of $1.00 per share (the “Series A Stated Value”)
and is not convertible into common stock. The holder of the Series A Preferred Stock is entitled to dividends at the rate of 3%
of the Series A Stated Value per year, payable quarterly in arrears.
For
the three months ended March 31, 2019 and 2018 respectively, the Company recorded $2,089 related to the dividend payable to Valent.
For the nine months ended March 31, 2019 and 2018 respectively, the Company recorded $6,267 related to the dividend payable to
Valent. The dividends have been recorded as a direct increase in accumulated deficit.
The
Company has issued common stock purchase warrants. Based on the terms of certain of these warrants the Company determined that
the warrants were a derivative liability which is recognized at fair value at the date of the transaction and re-measured at fair
value each reporting period with the changes in fair value recorded in the consolidated condensed interim statement of loss and
comprehensive loss.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
4
|
Derivative
liability
(cont.)
|
The
Company’s derivative liability is summarized as follows:
|
|
Three months ended
March 31,
|
|
|
|
2019
$
|
|
|
2018
$
|
|
Opening balance
|
|
|
76
|
|
|
|
5,549
|
|
Change in fair value of warrants
|
|
|
189
|
|
|
|
(2,160
|
)
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
265
|
|
|
|
3,389
|
|
Less current portion
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
|
|
|
|
|
|
|
Long term portion
|
|
|
265
|
|
|
|
3,384
|
|
|
|
Nine months ended
March 31,
|
|
|
|
2019
$
|
|
|
2018
$
|
|
Opening balance
|
|
|
1,117
|
|
|
|
61,228
|
|
Change in fair value of warrants
|
|
|
(852
|
)
|
|
|
(57,839
|
)
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
265
|
|
|
|
3,389
|
|
Less current portion
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
|
|
|
|
|
|
|
Long term portion
|
|
|
265
|
|
|
|
3,384
|
|
The
derivative liability consists of the following warrants:
|
|
March 31,
2019
|
|
|
|
Number of
warrants
|
|
|
$
|
|
2015 Agent Warrants
|
|
|
2,177
|
|
|
|
265
|
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
2,177
|
|
|
|
265
|
|
Less current portion
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Long-term portion
|
|
|
2,177
|
|
|
|
265
|
|
Preferred
stock
Series
B Preferred Shares
During
the year ended June 30, 2016, the Company issued an aggregate of 902,238 shares of Series B Preferred Stock at a purchase price
of at $8.00 per share. Each share of Series B Preferred Stock is convertible into 0.25 shares of common stock equating to a conversion
price of $32.00 (the “Conversion Price”) and will automatically convert to common stock at the earlier of 24 hours
following regulatory approval of VAL-083 with a minimum closing bid price of $80.00 or five years from the final closing date.
The holders of the Series B Preferred Stock are entitled to an annual cumulative, in arrears, dividend at the rate of 9% payable
quarterly. The 9% dividend accrues quarterly commencing on the date of issue and is payable quarterly on June 30, September 30,
March 31, and March 31 of each year commencing on June 30, 2016. Dividends are payable solely by delivery of shares of common
stock, in an amount for each holder equal to the aggregate dividend payable to such holder with respect to the shares of Series
B Preferred Stock held by such holder divided by the Conversion Price. The Series B Preferred Stock does not contain any repricing
features. Each share of Series B Preferred Stock entitles its holder to vote with the common stock on an as-converted basis.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
In
addition, the Company and the holders entered into a royalty agreement, pursuant to which the Company will pay the holders of
the Series B Preferred Stock, in aggregate, a low, single-digit royalty based on their pro rata ownership of the Series B Preferred
Stock on products sold directly by the Company or sold pursuant to a licensing or partnering arrangement (the “Royalty Agreement”).
Upon
conversion of a holder’s Series B Preferred Stock to common stock, such holder shall no longer receive ongoing royalty payments
under the Royalty Agreement but will be entitled to receive any residual royalty payments that have vested. Rights to the royalties
shall vest during the first three years following the applicable closing date, in equal thirds to holders of the Series B Preferred
Stock on each of the three vesting dates, upon which vesting dates such royalty amounts shall become vested royalties.
Pursuant
to the Series B Preferred Stock dividend, during the three months ended March 31, 2019, the Company issued 4,735 (2018 –
4,960) shares of common stock and recognized $23,202 (2018 – $46,626). During the nine months ended March 31, 2019, the
Company issued 14,430 (2018 – 14,881) shares of common stock and recognized $75,477 (2018 – $142,358). These dividends
have been recognized as a direct increase in accumulated deficit.
During
the nine months ended March 31, 2019, 40,000 Series B Preferred shares were converted to 10,000 shares of common stock. There
were no conversions during the three months ended March 31, 2019 and 2018 or for the nine months ended March 31, 2018. A total
of 841,113 (2018 – 881,113) shares of Series B Preferred Stock are outstanding as of March 31, 2019, such that a total of
210,279 (2018 – 220,279) shares of common stock are issuable upon conversion of the Series B Preferred Stock as at March
31, 2019. Converted shares are rounded up to the nearest whole share.
Series
A Preferred Shares
Effective
September 30, 2014 pursuant to the Company’s Valent Exchange Agreement (note 3), the Company filed a Certificate of Designation
of Series A Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of Nevada. Pursuant
to the Series A Certificate of Designation, the Company designated 278,530 shares of preferred stock as Series A Preferred Stock.
The shares of Series A Preferred Stock have a stated value of $1.00 per share (the “Series A Stated Value”) and are
not convertible into common stock. The holder of the Series A Preferred Stock is entitled to dividends at the rate of 3% of the
Series A Stated Value per year, payable quarterly in arrears. Upon any liquidation of the Company, the holder of the Series A
Preferred Stock will be entitled to be paid, out of any assets of the Company available for distribution to stockholders, the
Series A Stated Value of the shares of Series A Preferred Stock held by such holder, plus any accrued but unpaid dividends thereon,
prior to any payments being made with respect to the common stock.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
Common
stock
|
|
Shares of common stock outstanding
|
|
|
Common stock
|
|
|
Additional paid-in capital
|
|
|
Warrants
|
|
|
Accumulated deficit
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Nine months ended March 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
2,296,667
|
|
|
|
2,297
|
|
|
|
43,198,193
|
|
|
|
8,229,482
|
|
|
|
(52,441,337
|
)
|
Exercise and exchange of warrants
|
|
|
296,667
|
|
|
|
297
|
|
|
|
2,920,695
|
|
|
|
(2,210,697
|
)
|
|
|
—
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
36,534
|
|
|
|
—
|
|
Conversion of Series B preferred stock to common stock
|
|
|
10,000
|
|
|
|
10
|
|
|
|
279,041
|
|
|
|
—
|
|
|
|
—
|
|
Series B Preferred stock dividend
|
|
|
14,430
|
|
|
|
14
|
|
|
|
75,463
|
|
|
|
—
|
|
|
|
(75,477
|
)
|
Shares issued for services
|
|
|
2,269
|
|
|
|
2
|
|
|
|
10,267
|
|
|
|
—
|
|
|
|
—
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
355,388
|
|
|
|
—
|
|
|
|
—
|
|
Performance stock unit expense
|
|
|
—
|
|
|
|
—
|
|
|
|
183,205
|
|
|
|
—
|
|
|
|
—
|
|
Series A Preferred cash dividend
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6,267
|
)
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(5,465,486
|
)
|
Balance – March 31, 2019
|
|
|
2,620,033
|
|
|
|
2,620
|
|
|
|
47,022,252
|
|
|
|
6,055,319
|
|
|
|
(57,988,567
|
)
|
Three months ended March 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – December 31, 2018
|
|
|
2,614,342
|
|
|
|
2,614
|
|
|
|
46,851,817
|
|
|
|
6,046,587
|
|
|
|
(56,299,291
|
)
|
Exercise and exchange of warrants – issue costs
|
|
|
—
|
|
|
|
—
|
|
|
|
(16,186
|
)
|
|
|
—
|
|
|
|
—
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,732
|
|
|
|
—
|
|
Series B Preferred stock dividend
|
|
|
4,735
|
|
|
|
5
|
|
|
|
23,197
|
|
|
|
—
|
|
|
|
(23,202
|
)
|
Shares issued for services
|
|
|
956
|
|
|
|
1
|
|
|
|
3,512
|
|
|
|
—
|
|
|
|
—
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
99,735
|
|
|
|
—
|
|
|
|
—
|
|
Performance stock unit expense
|
|
|
—
|
|
|
|
—
|
|
|
|
60,177
|
|
|
|
—
|
|
|
|
—
|
|
Series A Preferred cash dividend
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,089
|
)
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,663,985
|
)
|
Balance – March 31, 2019
|
|
|
2,620,033
|
|
|
|
2,620
|
|
|
|
47,022,252
|
|
|
|
6,055,319
|
|
|
|
(57,988,567
|
)
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
|
|
Shares of common stock outstanding
|
|
|
Common stock
|
|
|
Additional paid-in capital
|
|
|
Warrants
|
|
|
Accumulated deficit
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Nine months ended March 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2017
|
|
|
1,450,963
|
|
|
|
1,451
|
|
|
|
36,678,344
|
|
|
|
4,570,574
|
|
|
|
(41,118,433
|
)
|
Issuance of shares and warrants
|
|
|
800,000
|
|
|
|
800
|
|
|
|
6,191,785
|
|
|
|
2,752,751
|
|
|
|
—
|
|
Warrants exercised for cash
|
|
|
25,000
|
|
|
|
25
|
|
|
|
312,475
|
|
|
|
—
|
|
|
|
—
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
155,204
|
|
|
|
—
|
|
Series B Preferred stock dividend
|
|
|
14,881
|
|
|
|
15
|
|
|
|
142,343
|
|
|
|
—
|
|
|
|
(142,358
|
)
|
Shares issued for services
|
|
|
407
|
|
|
|
—
|
|
|
|
4,821
|
|
|
|
—
|
|
|
|
—
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
430,673
|
|
|
|
—
|
|
|
|
—
|
|
Series A Preferred cash dividend
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6,267
|
)
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,761,061
|
)
|
Balance – March 31, 2018
|
|
|
2,291,251
|
|
|
|
2,291
|
|
|
|
43,760,441
|
|
|
|
7,478,529
|
|
|
|
(50,028,119
|
)
|
Three months ended March 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – December 31, 2017
|
|
|
2,260,884
|
|
|
|
2,261
|
|
|
|
43,259,228
|
|
|
|
7,321,844
|
|
|
|
(47,046,347
|
)
|
Warrants exercised for cash
|
|
|
25,000
|
|
|
|
25
|
|
|
|
312,475
|
|
|
|
—
|
|
|
|
—
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
156,685
|
|
|
|
—
|
|
Series B Preferred stock dividend
|
|
|
4,960
|
|
|
|
5
|
|
|
|
46,621
|
|
|
|
—
|
|
|
|
(46,626
|
)
|
Shares issued for services
|
|
|
407
|
|
|
|
—
|
|
|
|
4,821
|
|
|
|
—
|
|
|
|
—
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
137,296
|
|
|
|
—
|
|
|
|
—
|
|
Series A Preferred cash dividend
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,089
|
)
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,933,057
|
)
|
Balance – March 31, 2018
|
|
|
2,291,251
|
|
|
|
2,291
|
|
|
|
43,760,441
|
|
|
|
7,478,529
|
|
|
|
(50,028,119
|
)
|
The
issued and outstanding common shares at March 31, 2019 include 9,063 (June 30, 2018 – 91,276) shares of common stock on
an as-exchanged basis with respect to the shares of Exchangeco that can be exchanged for shares of common stock of the Company.
Nine
months ended March 31, 2018
On
September 22, 2017, the Company completed a registered direct offering (the “2018 Registered Offering”) of an aggregate
of 800,000 shares of common stock and warrants to purchase an additional 800,000 shares of common stock at a price of $12.50 per
share and related warrant for gross proceeds of $10.0 million. The warrants have an exercise price of $12.50 per share, are immediately
exercisable and have a term of exercise of five years (the “2018 Investor Warrants”).
The
Company engaged a placement agent for the 2018 Registered Offering. Under the Company’s engagement agreement with the placement
agent, the Company paid $800,000 in cash commission and other fees to the placement agent and issued warrants to purchase 40,000
shares of common stock to the placement agent (the “2018 Agent Warrants”). The 2018 Agent Warrants are exercisable
at a per share price of $12.50 and have a term of exercise of five years.
In
addition to the cash commission and other placement agent fees, the Company also incurred additional cash issue costs of $254,664
resulting in net cash proceeds of $8,945,336.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
2017
Omnibus Incentive Plan
As
approved by the Company’s stockholders at the annual meeting of stockholders held on April 11, 2018, on July 7, 2017, as
amended on February 1, 2018, the Company’s board of directors approved adoption of the Company’s 2017 Omnibus Equity
Incentive Plan (the “2017 Plan”). The board of directors also approved a form of Performance Stock Unit Award Agreement
to be used in connection with grants of performance stock units (“PSUs”) under the 2017 Plan. Under the 2017 Plan,
780,000 shares of Company common stock are reserved for issuance, less the number of shares of common stock issued under the Del
Mar (BC) 2013 Amended and Restated Stock Option Plan (the “Legacy Plan”) or that are subject to grants of stock options
made, or that may be made, under the Legacy Plan. A total of 169,985 shares of common stock have been issued under the Legacy
Plan and/or are subject to outstanding stock options granted under the Legacy Plan, and a total of 122,698 shares of common stock
have been issued under the 2017 Plan and/or are subject to outstanding stock options granted under the 2017 Plan. In addition,
120,000 PSU’s have been issued under the 2017 Plan leaving a potential 367,317 shares of common stock available for issuance
under the 2017 Plan if all such options under the Legacy Plan were exercised and no new grants are made under the Legacy Plan.
The maximum number of shares of Company common stock with respect to which any one participant may be granted awards during any
calendar year is 8% of the Company’s fully diluted shares of common stock on the date of grant (excluding the number of
shares of common stock issued under the 2017 Plan and/or the Legacy Plan or subject to outstanding awards granted under the 2017
Plan and/or the Legacy Plan). No award will be granted under the 2017 Plan on or after July 7, 2027, but awards granted prior
to that date may extend beyond that date.
Performance
stock units
The
Company’s board of directors has granted PSUs under the 2017 Plan to the Company’s directors. The awards represent
the right to receive shares of the Company’s common stock upon vesting of the PSU based on targets approved by the Company’s
board of directors related to the Company’s fully diluted market capitalization. The PSUs vest at various fully diluted
market capitalization levels with full vesting occurring upon the later of one year from the grant date and the Company achieving
a fully diluted market capitalization of at least $500 million for five consecutive business days. The PSUs expire on July 7,
2022. There are 120,000 PSUs outstanding as of March 31, 2019 and June 30, 2018.
The
Company has recognized $60,177 (2018 - $0) and $183,205 (2018 - $0) in expense related to the PSUs during the three and nine months
ended March 31, 2019, respectively, with all of it being recognized as general and administrative expense. As at March 31, 2019
there was $342,936 (2018 - $0) in unrecognized compensation expense that will be recognized over the next 2.47 years.
The
PSUs have been valued using the following assumptions:
|
|
|
Dividend rate
|
|
0%
|
Volatility
|
|
79.0 to 82.5%
|
Risk-free rate
|
|
2.56% to 2.71%
|
Term
–
years
|
|
1.67 to 3.24
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
Stock
Options
The
following table sets forth the stock options outstanding under all plans as of March 31, 2019:
|
|
Number of
stock options
outstanding
|
|
|
Weighted
average
exercise
price
|
|
Balance – June 30, 2018
|
|
|
262,683
|
|
|
|
24.27
|
|
Granted
|
|
|
30,000
|
|
|
|
6.10
|
|
Balance – March 31, 2019
|
|
|
292,683
|
|
|
|
22.40
|
|
The
following table summarizes stock options currently outstanding and exercisable at March 31, 2019 under all plans:
Exercise price
$
|
|
|
Number
Outstanding
|
|
|
Weighted average
remaining
contractual life
(years)
|
|
|
Number
exercisable
|
|
|
6.10
|
|
|
|
30,000
|
|
|
|
9.60
|
|
|
|
6,666
|
|
|
7.00
|
|
|
|
5,451
|
|
|
|
9.23
|
|
|
|
—
|
|
|
8.70
|
|
|
|
12,000
|
|
|
|
8.59
|
|
|
|
12,000
|
|
|
9.83
|
|
|
|
83,647
|
|
|
|
9.14
|
|
|
|
23,235
|
|
|
10.60
|
|
|
|
3,600
|
|
|
|
9.03
|
|
|
|
1,200
|
|
|
11.70
|
|
|
|
30,000
|
|
|
|
3.91
|
|
|
|
30,000
|
|
|
14.98
|
|
|
|
2,500
|
|
|
|
3.17
|
|
|
|
2,500
|
|
|
20.00
|
|
|
|
13,125
|
|
|
|
2.52
|
|
|
|
13,125
|
|
|
21.10
|
|
|
|
15,900
|
|
|
|
7.51
|
|
|
|
8,700
|
|
|
29.60
|
|
|
|
4,500
|
|
|
|
5.84
|
|
|
|
4,500
|
|
|
32.00
|
|
|
|
3,000
|
|
|
|
0.17
|
|
|
|
3,000
|
|
|
37.60
|
|
|
|
4,500
|
|
|
|
6.86
|
|
|
|
4,500
|
|
|
40.00
|
|
|
|
1,250
|
|
|
|
0.50
|
|
|
|
1,250
|
|
|
41.00
|
|
|
|
4,000
|
|
|
|
7.61
|
|
|
|
3,111
|
|
|
42.00
|
|
|
|
41,250
|
|
|
|
3.81
|
|
|
|
41,250
|
|
|
44.80
|
|
|
|
3,000
|
|
|
|
6.86
|
|
|
|
3,000
|
|
|
49.50
|
|
|
|
22,460
|
|
|
|
5.31
|
|
|
|
18,458
|
|
|
53.20
|
|
|
|
8,000
|
|
|
|
7.10
|
|
|
|
7,555
|
|
|
61.60
|
|
|
|
1,500
|
|
|
|
4.00
|
|
|
|
1,500
|
|
|
92.00
|
|
|
|
3,000
|
|
|
|
4.17
|
|
|
|
3,000
|
|
|
|
|
|
|
292,683
|
|
|
|
|
|
|
|
188,550
|
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
Included
in the number of stock options outstanding are 2,500 stock options granted at an exercise price of CA $20.00. The exercise prices
shown in the above table have been converted to US $14.98 using the period ending closing exchange rate. Certain stock options
have been granted to non-employees and will be revalued at each reporting date until they have fully vested. The stock options
granted, and those being re-valued, have been valued using a Black-Scholes pricing model using the following assumptions:
|
|
March
31,
2019
|
Dividend
rate
|
|
0%
|
Volatility
|
|
70.6% to 79.1%
|
Risk-free
rate
|
|
2.1% to 3.2%
|
Term
- years
|
|
0.1 to 3.0
|
The
Company has recognized the following amounts as stock option expense for the periods noted:
|
|
Three months ended
March 31,
|
|
|
Nine months ended
March 31,
|
|
|
|
2019
$
|
|
|
2018
$
|
|
|
2019
$
|
|
|
2018
$
|
|
Research and development
|
|
|
12,889
|
|
|
|
9,145
|
|
|
|
64,466
|
|
|
|
130,546
|
|
General and administrative
|
|
|
86,846
|
|
|
|
128,151
|
|
|
|
290,922
|
|
|
|
300,127
|
|
|
|
|
99,735
|
|
|
|
137,296
|
|
|
|
355,388
|
|
|
|
430,673
|
|
All
of the stock option expense for the periods ended March 31, 2019 and 2018 has been recognized as additional paid in capital. The
aggregate intrinsic value of stock options outstanding at March 31, 2019 was $0 (2018 – $8,400) and the aggregate intrinsic
value of stock options exercisable at March 31, 2019 was $0 (2018 – $2,800). As of March 31, 2019, there was $234,974 in
unrecognized compensation expense that will be recognized over the next 2.61 years. No stock options granted under any plan have
been exercised to March 31, 2019. Upon the exercise of stock options new shares will be issued.
A
summary of the Company’s unvested stock options under all plans is presented below:
|
|
Number of Options
|
|
|
Weighted average
exercise price
$
|
|
|
Weighted average
grant date
fair value
$
|
|
Unvested at June 30, 2018
|
|
|
138,160
|
|
|
|
14.39
|
|
|
|
7.63
|
|
Granted
|
|
|
30,000
|
|
|
|
6.10
|
|
|
|
2.56
|
|
Vested
|
|
|
(64,027
|
)
|
|
|
14.82
|
|
|
|
7.88
|
|
Unvested at March 31, 2019
|
|
|
104,133
|
|
|
|
11.62
|
|
|
|
5.95
|
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
Warrants
Certain
of the Company’s warrants have been recognized as a derivative liability (note 4). The following table summarizes changes
in the Company’s outstanding warrants as of March 31, 2019:
Description
|
|
Number
|
|
Balance – June 30, 2018
|
|
|
1,428,128
|
|
Exercised for cash (i)
|
|
|
(197,500
|
)
|
Cashless exchange (i)
|
|
|
(297,500
|
)
|
Issued for services (ii)
|
|
|
14,000
|
|
Forfeited (iii)
|
|
|
(2,400
|
)
|
Expired (iv)
|
|
|
(82,225
|
)
|
Balance - March 31, 2019
|
|
|
862,503
|
|
|
i)
|
On
November 25, 2018, the Company entered into Warrant Exercise and Exchange Agreements (the “Warrant Exercise Agreements”)
with certain holders (the “Exercising Holders”) of the 2018 Investor Warrants. Pursuant to the Warrant Exercise Agreements,
in order to induce the Exercising Holders to exercise the 2018 Investor Warrants for cash, the Company agreed to reduce the exercise
price from $12.50 to $4.00 per share. Pursuant to the Warrant Exercise Agreements, the Exercising Holders exercised their 2018
Investor Warrants with respect to an aggregate of 197,500 shares of common stock underlying such 2018 Investor Warrants (the “Exercised
Shares”). The Company received net proceeds of $726,481, comprising aggregate gross proceeds of $790,000 net of expenses
of $63,519, from the exercise of the 2018 Investor Warrants.
|
In addition, in order to further induce the Exercising Holders to exercise the 2018 Investor Warrants, the Warrant Exercise Agreements also provided for the issuance of one share of common stock to the Exercising Holders in exchange for every three shares of common stock underlying the 2018 Investor Warrants held by the Exercising Holders that are not being exercised for cash pursuant to the Warrant Exercise Agreements, if any. On November 26, 2018, the Company issued an aggregate of 99,167 shares of common stock in exchange for 297,500 2018 Investor Warrants, resulting in a 198,333 reduction in the Company’s total shares of common stock outstanding on a fully-diluted basis.
|
ii)
|
All
of the warrants issued for services are exercisable at $9.00 with 12,000 expiring on September 15, 2023 and 2,000 expiring on
October 11, 2021. Of the total, 12,000 vest pro rata monthly over twelve months commencing September 15, 2018 and 2,000 are fully
vested as of November 11, 2018.
|
|
iii)
|
Warrants
issued for services exercisable at $11.70 were forfeited upon termination of the underlying agreement.
|
|
iv)
|
Warrants
issued for services exercisable at $70.40 expired September 12, 2018. In addition, warrants exercisable at $31.40 expired March
31, 2019.
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
5
|
Stockholders’
equity
(cont.)
|
The
following table summarizes the Company’s outstanding warrants as of March 31, 2019:
Description
|
|
Number
|
|
Exercise
price
$
|
|
Expiry
date
|
2018
Investor
|
|
280,000
|
|
12.50
|
|
September 22, 2022
|
2017
Investor
|
|
207,693
|
|
35.00
|
|
April 19, 2022
|
2015
Investor
|
|
97,900
|
|
30.00
|
|
July 31, 2020
|
2013
Placement Agent
|
|
126,250
|
|
31.40
|
|
June 30, 2019
|
Issued
for services
|
|
26,500
|
|
30.00
|
|
July 1, 2020 to February
1, 2021
|
Issued
for services
|
|
6,000
|
|
17.80
|
|
January 25, 2023
|
Issued
for services
|
|
33,600
|
|
11.70
|
|
February 27, 2023
|
Issued
for services
|
|
12,000
|
|
9.00
|
|
September 15, 2023
|
Issued
for services
|
|
4,140
|
|
59.30
|
|
February 27, 2020
|
Issued
for services
|
|
2,000
|
|
9.00
|
|
October 11, 2021
|
2018
Agent
|
|
40,000
|
|
12.50
|
|
September 20, 2022
|
2017
Agent
|
|
13,846
|
|
40.60
|
|
April 12, 2022
|
2016
Agent
|
|
10,396
|
|
40.00
|
|
May 12, 2021
|
2015
Agent
|
|
2,178
|
|
30.00
|
|
July 15, 2020
|
|
|
862,503
|
|
24.80
|
|
|
The
Company has financial instruments that are measured at fair value. To determine the fair value, we use the fair value hierarchy
for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs
by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use
to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are
inputs based on assumptions about the factors market participants would use to value an asset or liability. The three levels of
inputs that may be used to measure fair value are as follows:
|
●
|
Level
one — inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities;
|
|
●
|
Level
two — inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either
directly or indirectly such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted
intervals; and
|
|
●
|
Level
three — unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect
those assumptions that a market participant would use.
|
Assets
and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Changes
in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value
hierarchy.
The
Company’s financial instruments consist of cash and cash equivalents, other receivables, accounts payable, related party
payables and derivative liability. The carrying values of cash and cash equivalents, other receivables, accounts payable and related
party payables approximate their fair values due to the immediate or short-term maturity of these financial instruments.
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
6
|
Financial
instruments
(cont.)
|
Derivative
liability
The
Company accounts for certain warrants under the authoritative guidance on accounting for derivative financial instruments indexed
to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities
laws, the warrants require the issuance of securities upon exercise and do not sufficiently preclude an implied right to net cash
settlement. The Company classifies these warrants on its balance sheet as a derivative liability which is fair valued at each
reporting period subsequent to the initial issuance. The Company has used a Black-Scholes Option Pricing Model (based on a closed-form
model that uses a fixed equation) to estimate the fair value of the share warrants. Determining the appropriate fair-value model
and calculating the fair value of warrants requires considerable judgment. Any change in the estimates (specifically probabilities
and volatility) used may cause the value to be higher or lower than that reported. The estimated volatility of the Company’s
common stock at the date of issuance, and at each subsequent reporting period, is based on the historical volatility of the Company.
The risk-free interest rate is based on rates published by the government for bonds with a maturity similar to the expected remaining
life of the warrants at the valuation date. The expected life of the warrants is assumed to be equivalent to their remaining contractual
term.
|
a)
|
Fair
value of derivative liability
|
The
derivative is not traded in an active market and the fair value is determined using valuation techniques. The Company uses judgment
to select a variety of methods to make assumptions that are based on specific management plans and market conditions at the end
of each reporting period. The Company uses a fair value estimate to determine the fair value of the derivative liability. The
carrying value of the derivative liability would be higher, or lower, as management estimates around specific probabilities change.
The estimates may be significantly different from those amounts ultimately recorded in the consolidated financial statements because
of the use of judgment and the inherent uncertainty in estimating the fair value of these instruments that are not quoted in an
active market. All changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss each
reporting period. This is considered to be a Level 3 financial instrument as volatility is considered a Level 3 input.
The
Company has the following liabilities under the fair value hierarchy:
|
|
March 31, 2019
|
|
Liability
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Derivative liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
265
|
|
|
|
June 30, 2018
|
|
Liability
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Derivative liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,117
|
|
DelMar
Pharmaceuticals, Inc
.
Notes to Consolidated Condensed Interim Financial Statements
(Unaudited)
March 31, 2019
|
(expressed
in US dollars unless otherwise noted)
|
7
|
Supplementary
statement of cash flows information
|
|
|
Nine months ended
March 31,
|
|
|
|
2019
$
|
|
|
2018
$
|
|
Series B Preferred share common stock dividend (note 5)
|
|
|
75,477
|
|
|
|
142,358
|
|
Series B Preferred shares converted to common stock (note 5)
|
|
|
279,051
|
|
|
|
—
|
|
Share issuance costs accrued through accounts payable and accrued liabilities
|
|
|
15,884
|
|
|
|
—
|
|
Deferred financing costs accrued through accounts payable and accrued liabilities
|
|
|
15,873
|
|
|
|
—
|
|
Income taxes paid
|
|
|
—
|
|
|
|
—
|
|
Interest paid
|
|
|
—
|
|
|
|
—
|
|
Reverse
Stock Split
On
May 7, 2019, the Company filed a Certificate of Change with the Secretary of State of Nevada that effected a 1-for-10 (1:10) reverse
stock split of its common stock, par value $0.001 per share, which became effective on May 8, 2019. Pursuant to the Certificate
of Change, the Company’s authorized common stock was decreased in the same proportion as the split resulting in a decrease
from 70,000,000 authorized shares of common stock to 7,000,000 shares authorized. The par value of its common stock was unchanged
at $0.001 per share, post-split. All common shares, warrants, stock options, conversion ratios, and per share information in these
consolidated condensed interim financial statements give retroactive effect to the 1-for-10 reverse stock split. The Company’s
authorized and issued preferred stock was not affected by the split.
Rights
Offering
Subsequent
to March 31, 2019, the Company filed a registration statement relating to a rights offering for a maximum gross proceeds of $8.0
million. For every common share of stock owned (including each share of common stock issuable upon exercise of certain outstanding
warrants) as of the record date, the stockholder will receive one basic subscription right, which gives the stockholder the opportunity
to purchase one unit, consisting of one share of the Company’s Series C Preferred Stock and 0.50 warrants, for a price of
$1,000 per Unit. The raising of any funds will not be assured until the closing of the offering which is expected to be in the
first week of June 2019.
Performance
Stock Units
On
April 30, 2019, the Company’s Board of Directors approved the cancellation of all 120,000 PSU’s outstanding at March
31, 2019.
2017
Omnibus Plan
On
April 30, 2019, the Company’s Board of Directors also approved a temporary reduction in the reserve under the Company’s
2017 Plan. As a result, the 367,317 shares of common stock available for issuance under the 2017 Plan as of March 31, 2019 was
reduced to 14,217. If the Company’s authorized common shares are increased at the 2019 annual meeting of stockholders, the
reserve will be increased back to 367,317.
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors of DelMar Pharmaceuticals, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of DelMar Pharmaceuticals, Inc. (the “Company”) as of June
30, 2018 and 2017, the related consolidated statements of operations and comprehensive loss, change in stockholders’ equity
and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated
financial position of the Company as of June 30, 2018 and 2017, and the results of its consolidated operations and its consolidated
cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.
The
Company’s Ability to Continue as a Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations and has stated that
substantial doubt exists about the Company’s ability to continue as a going concern. Management’s evaluation of the
events and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered
with the PCAOB and are required to be independent with respect to the Company in accordance with the US federal securities laws
and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether
due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the consolidated
financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures include
examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the
overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/
Ernst & Young LLP
We
have served as the Company’s auditor since 2016.
Vancouver, Canada
September 21, 2018
except
for Note 11, as to which the date is
May
8, 2019
DelMar
Pharmaceuticals, Inc.
Consolidated Balance Sheets
|
(in
US dollars unless otherwise noted)
|
|
Note
|
|
June 30,
2018
$
|
|
|
June 30,
2017
$
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
5,971,995
|
|
|
|
6,586,014
|
|
Prepaid expenses and deposits
|
|
8
|
|
|
1,034,930
|
|
|
|
1,208,122
|
|
Interest, taxes and other receivables
|
|
|
|
|
39,519
|
|
|
|
76,595
|
|
|
|
|
|
|
7,046,444
|
|
|
|
7,870,731
|
|
Intangible assets – net
|
|
|
|
|
28,411
|
|
|
|
40,290
|
|
|
|
|
|
|
7,074,855
|
|
|
|
7,911,021
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
|
|
1,478,086
|
|
|
|
1,182,312
|
|
Related party payables
|
|
6
|
|
|
160,429
|
|
|
|
88,957
|
|
Current portion of derivative liability
|
|
4
|
|
|
—
|
|
|
|
33,091
|
|
|
|
|
|
|
1,638,515
|
|
|
|
1,304,360
|
|
Derivative liability
|
|
4
|
|
|
1,117
|
|
|
|
28,137
|
|
|
|
|
|
|
1,639,632
|
|
|
|
1,332,497
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
Authorized
|
|
|
|
|
|
|
|
|
|
|
5,000,000 shares, $0.001 par value
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
278,530 Series A shares at June 30, 2018 (June 30, 2017 – 278,530)
|
|
3,5
|
|
|
278,530
|
|
|
|
278,530
|
|
881,113 Series B shares at June 30, 2018 (June 30, 2017 – 881,113)
|
|
5
|
|
|
6,146,880
|
|
|
|
6,146,880
|
|
1 special voting share at June 30, 2018 (June 30, 2017 – 1)
|
|
|
|
|
—
|
|
|
|
—
|
|
Common stock
|
|
|
|
|
|
|
|
|
|
|
Authorized
|
|
|
|
|
|
|
|
|
|
|
7,000,000 shares (June 30, 2017 – 5,000,000), $0.001 par value
|
|
|
|
|
|
|
|
|
|
|
2,296,667 issued at June 30, 2018 (June 30, 2017 – 1,450,963)
|
|
5
|
|
|
2,297
|
|
|
|
1,451
|
|
Additional paid-in capital
|
|
5
|
|
|
43,198,193
|
|
|
|
36,678,344
|
|
Warrants
|
|
5
|
|
|
8,229,482
|
|
|
|
4,570,574
|
|
Accumulated deficit
|
|
|
|
|
(52,441,337
|
)
|
|
|
(41,118,433
|
)
|
Accumulated other comprehensive income
|
|
|
|
|
21,178
|
|
|
|
21,178
|
|
|
|
|
|
|
5,435,223
|
|
|
|
6,578,524
|
|
|
|
|
|
|
7,074,855
|
|
|
|
7,911,021
|
|
Going
concern, nature of operations, and corporate history
(note 1)
Subsequent
events
(note 11)
The
accompanying notes are an integral part of these consolidated financial statements.
DelMar
Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive Loss
|
(in
US dollars unless otherwise noted)
|
|
Note
|
|
Year ended
June 30,
2018
$
|
|
|
Year ended
June 30,
2017
$
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
6
|
|
|
7,132,952
|
|
|
|
5,003,640
|
|
General and administrative
|
|
6
|
|
|
4,041,711
|
|
|
|
3,317,189
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,174,663
|
|
|
|
8,320,829
|
|
|
|
|
|
|
|
|
|
|
|
|
Other loss (income)
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of stock option and derivative liabilities
|
|
4,5
|
|
|
(60,111
|
)
|
|
|
(245,963
|
)
|
Foreign exchange loss
|
|
|
|
|
57,003
|
|
|
|
7,355
|
|
Interest income
|
|
|
|
|
(33,243
|
)
|
|
|
(457
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,351
|
)
|
|
|
(239,065
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net and comprehensive loss for the year
|
|
|
|
|
11,138,312
|
|
|
|
8,081,764
|
|
|
|
|
|
|
|
|
|
|
|
|
Computation of basic loss per share
|
|
|
|
|
|
|
|
|
|
|
Net and comprehensive loss for the year
|
|
|
|
|
11,138,312
|
|
|
|
8,081,764
|
|
Series B Preferred stock dividend
|
|
5
|
|
|
176,236
|
|
|
|
790,454
|
|
|
|
|
|
|
11,314,548
|
|
|
|
8,872,218
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and fully diluted loss per share
|
|
|
|
|
5.42
|
|
|
|
7.36
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average number of shares
|
|
|
|
|
2,086,142
|
|
|
|
1,204,708
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
DelMar
Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
|
(in
US dollars unless otherwise noted)
|
|
Number of
shares
|
|
|
Common
stock
$
|
|
|
Additional
paid-in
capital
$
|
|
|
Accumulated
other
comprehensive
income
$
|
|
|
Preferred
stock
$
|
|
|
Warrants
$
|
|
|
Accumulated
deficit
$
|
|
|
Stockholders’
equity
$
|
|
Balance – June 30, 2016
|
|
|
1,118,702
|
|
|
|
1,119
|
|
|
|
28,843,173
|
|
|
|
21,178
|
|
|
|
6,572,785
|
|
|
|
1,658,382
|
|
|
|
(32,237,859
|
)
|
|
|
4,858,778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares and warrants – net of issue costs
|
|
|
276,923
|
|
|
|
277
|
|
|
|
4,981,093
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,950,737
|
|
|
|
—
|
|
|
|
7,932,107
|
|
Shares issued for services
|
|
|
6,000
|
|
|
|
6
|
|
|
|
563,994
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
564,000
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
81,602
|
|
|
|
—
|
|
|
|
81,602
|
|
Reclassification of stock option liability
|
|
|
—
|
|
|
|
—
|
|
|
|
260,969
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
260,969
|
|
Warrants exercised for cash
|
|
|
23,953
|
|
|
|
24
|
|
|
|
908,399
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(120,147
|
)
|
|
|
—
|
|
|
|
788,276
|
|
Cashless exercise of warrants
|
|
|
59
|
|
|
|
—
|
|
|
|
5,159
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
5,159
|
|
Amendment of warrants (note 4)
|
|
|
—
|
|
|
|
—
|
|
|
|
53,006
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
53,006
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
124,747
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
124,747
|
|
Conversion of Series B preferred stock to common stock
|
|
|
5,281
|
|
|
|
5
|
|
|
|
147,370
|
|
|
|
—
|
|
|
|
(147,375
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Series A preferred cash dividend (note 3)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,356
|
)
|
|
|
(8,356
|
)
|
Series B preferred stock dividend
|
|
|
20,045
|
|
|
|
20
|
|
|
|
790,434
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(790,454
|
)
|
|
|
—
|
|
Loss for the year
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,081,764
|
)
|
|
|
(8,081,764
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2017
|
|
|
1,450,963
|
|
|
|
1,451
|
|
|
|
36,678,344
|
|
|
|
21,178
|
|
|
|
6,425,410
|
|
|
|
4,570,574
|
|
|
|
(41,118,433
|
)
|
|
|
6,578,524
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares and warrants – net of issue costs
|
|
|
800,000
|
|
|
|
800
|
|
|
|
5,371,693
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,572,843
|
|
|
|
—
|
|
|
|
8,945,336
|
|
Shares issued for services
|
|
|
863
|
|
|
|
1
|
|
|
|
8,581
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,582
|
|
Warrants issued for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
192,400
|
|
|
|
—
|
|
|
|
192,400
|
|
Warrants exercised for cash (note 5)
|
|
|
25,000
|
|
|
|
25
|
|
|
|
418,810
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(106,335
|
)
|
|
|
—
|
|
|
|
312,500
|
|
Stock option expense
|
|
|
—
|
|
|
|
—
|
|
|
|
495,925
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
495,925
|
|
Performance stock unit expense
|
|
|
—
|
|
|
|
—
|
|
|
|
48,624
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
48,624
|
|
Series A preferred cash dividend (note 3)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,356
|
)
|
|
|
(8,356
|
)
|
Series B preferred stock dividend
|
|
|
19,841
|
|
|
|
20
|
|
|
|
176,216
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(176,236
|
)
|
|
|
—
|
|
Loss for the year
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(11,138,312
|
)
|
|
|
(11,138,312
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
2,296,667
|
|
|
|
2,297
|
|
|
|
43,198,193
|
|
|
|
21,178
|
|
|
|
6,425,410
|
|
|
|
8,229,482
|
|
|
|
(52,441,337
|
)
|
|
|
5,435,223
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
DelMar
Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
|
(in
US dollars unless otherwise noted)
|
|
|
|
|
Years ended June 30,
|
|
|
|
Note
|
|
|
2018
$
|
|
|
2017
$
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
|
|
|
(11,138,312
|
)
|
|
|
(8,081,764
|
)
|
Items not affecting cash
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets
|
|
|
|
|
|
24,528
|
|
|
|
16,683
|
|
Change in fair value of stock option and derivative liabilities
|
|
4,5
|
|
|
|
(60,111
|
)
|
|
|
(245,963
|
)
|
Shares issued for services
|
|
5
|
|
|
|
8,582
|
|
|
|
564,000
|
|
Warrants issued for services
|
|
5
|
|
|
|
192,400
|
|
|
|
81,602
|
|
Stock option expense
|
|
5
|
|
|
|
495,925
|
|
|
|
124,747
|
|
Performance stock unit expense
|
|
5
|
|
|
|
48,624
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in non-cash working capital
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and deposits
|
|
8
|
|
|
|
173,192
|
|
|
|
(1,063,991
|
)
|
Interest, taxes and other receivables
|
|
|
|
|
|
37,076
|
|
|
|
(58,208
|
)
|
Accounts payable and accrued liabilities
|
|
|
|
|
|
295,774
|
|
|
|
598,310
|
|
Related party payables
|
|
6
|
|
|
|
71,472
|
|
|
|
45,513
|
|
|
|
|
|
|
|
(9,850,850
|
)
|
|
|
(8,019,071
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets – website development costs
|
|
|
|
|
|
(12,649
|
)
|
|
|
(20,956
|
)
|
|
|
|
|
|
|
(12,649
|
)
|
|
|
(20,956
|
)
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from the issuance of shares and warrants
|
|
5
|
|
|
|
8,945,336
|
|
|
|
7,932,107
|
|
Proceeds from the exercise of warrants
|
|
5
|
|
|
|
312,500
|
|
|
|
545,026
|
|
Series A preferred stock dividend
|
|
5
|
|
|
|
(8,356
|
)
|
|
|
(8,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,249,480
|
|
|
|
8,468,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents
|
|
|
|
|
|
(614,019
|
)
|
|
|
428,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents – beginning of year
|
|
|
|
|
|
6,586,014
|
|
|
|
6,157,264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents – end of year
|
|
|
|
|
|
5,971,995
|
|
|
|
6,586,014
|
|
Supplementary
information (note 9)
The
accompanying notes are an integral part of these consolidated financial statements.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
1
|
Going
concern, nature of operations, and corporate history
|
Going
concern
These
consolidated financial statements have been prepared on a going concern basis which assumes that DelMar Pharmaceuticals, Inc.
(the “Company”) will continue its operations for the foreseeable future and contemplates the realization of assets
and the settlement of liabilities in the normal course of business.
For
the year ended June 30, 2018, the Company reported a loss of $11,138,312, and a negative cash flow from operations of $9,850,850.
The Company had an accumulated deficit of $52,441,337 as of June 30, 2018. As of June 30, 2018, the Company has cash and cash
equivalents on hand of $5,971,995. The Company is in the development stage and has not generated any revenues to date. The Company
does not have the prospect of achieving revenues until such time that its product candidate is commercialized, or partnered, which
may not ever occur. In the near future, the Company will require additional funding to maintain its clinical trials, research
and development projects, and for general operations. These circumstances indicate substantial doubt exists about the Company’s
ability to continue as a going concern.
Consequently,
management is pursuing various financing alternatives to fund the Company’s operations so it can continue as a going concern.
Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership
arrangements. The Company may tailor its drug candidate development program based on the amount of funding the Company is able
to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
These
financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may
be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.
Nature
of operations
The
Company is a clinical-stage drug development company with a focus on the treatment of cancer that is conducting clinical trials
in the United States with its product candidate, VAL-083, as a potential new treatment for glioblastoma multiforme, the most common
and aggressive form of brain cancer. The Company has also acquired certain commercial rights to VAL-083 in China where it is approved
as a chemotherapy for the treatment of chronic myelogenous leukemia and lung cancer. In order to accelerate the Company’s
development timelines, the Company leverages existing clinical and commercial data from a wide range of sources. The Company may
seek marketing partnerships in order to generate future royalty revenue.
The
address of the Company’s administrative offices is Suite 720 – 999 West Broadway, Vancouver, British Columbia, V5Z
1K5 with clinical operations located at 3485 Edison Way, Suite R, Menlo Park, California, 94025.
Corporate
history
The
Company is a Nevada corporation formed on June 24, 2009 under the name Berry Only Inc. On January 25, 2013 (the
“Reverse Acquisition Closing Date”), the Company entered into and closed an exchange agreement (the
“Exchange Agreement”), with Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”), 0959454 B.C. Ltd.
(“Callco”), and 0959456 B.C. Ltd. (“Exchangeco”) and the security holders of Del Mar (BC). Upon
completion of the Exchange Agreement, Del Mar (BC) became a wholly-owned subsidiary of the Company (the “Reverse
Acquisition”).
DelMar
Pharmaceuticals, Inc. is the parent company of Del Mar (BC), a British Columbia, Canada corporation incorporated on April 6,
2010, which is a clinical stage company with a focus on the development of drugs for the treatment of cancer. The Company is
also the parent company to Callco and Exchangeco which are British Columbia, Canada corporations. Callco and Exchangeco were
formed to facilitate the Reverse Acquisition.
References to the Company refer to the Company and its wholly-owned
subsidiaries, Del Mar (BC), Callco and Exchangeco.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
|
Reverse
Stock Split
On
May 16, 2016, the Company filed a Certificate of Change with the Secretary of State of Nevada that effected a 1-for-4 (1:4) reverse
stock split of its common stock, par value $0.001 per share. The reverse split became effective on May 20, 2016. Pursuant to the
Certificate of Change, the Company’s authorized common stock was decreased in the same proportion as the split resulting
in a decrease from 20,000,000 authorized shares of common stock to 5,000,000 shares authorized. The par value of its common stock
was unchanged at $0.001 per share, post-split. All common shares, warrants, stock options, conversion ratios, and per share information
in these consolidated financial statements give retroactive effect to the 1-for-4 reverse stock split. The Company’s authorized
and issued preferred stock was not affected by the split.
Basis
of presentation
The
consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting
principles (“US GAAP”) and are presented in United States dollars. The Company’s functional currency is the
United States dollar.
The
principal accounting policies applied in the preparation of these consolidated financial statements are set out below and have
been consistently applied to all years presented.
Consolidation
The
consolidated financial statements of the Company include the accounts of Del Mar (BC), Callco, and Exchangeco as at and for the
years ended June 30, 2018 and 2017. Intercompany balances and transactions have been eliminated in consolidation.
Use
of estimates
The
preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions about future
events that affect the reported amounts of assets, liabilities, expenses, contingent assets and contingent liabilities as at the
end of, or during, the reporting period. Actual results could significantly differ from those estimates. Significant areas requiring
management to make estimates include the derivative liability, the valuation of equity instruments issued for services, and clinical
trial accruals. Further details of the nature of these assumptions and conditions may be found in the relevant notes to these
consolidated financial statements.
Cash
and cash equivalents
Cash
and cash equivalents consist of cash and highly liquid investments with original maturities from the purchase date of three months
or less that can be readily convertible into known amounts of cash. Cash and cash equivalents are held at recognized Canadian
and United States financial institutions. Interest earned is recognized in the consolidated statement of operations and comprehensive
loss.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Foreign
currency translation
The
functional currency of the Company at June 30, 2018 and 2017 is the United States dollar. Transactions that are denominated in
a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any
foreign-currency denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains
or losses recognized as foreign exchange losses or gains in the consolidated statement of operations and comprehensive loss. Non-monetary
assets and liabilities are translated at historical exchange rates. Expenses are translated at average exchange rates during the
period. Exchange gains and losses are included in consolidated statement of operations and comprehensive loss for the period.
Current
and deferred income taxes
The
Company follows the liability method of accounting for income taxes. Under this method, current income taxes are recognized for
the estimated income taxes payable for the current period. Income taxes are accounted for using the asset and liability method
of accounting. Deferred income taxes are recognized for the future income tax consequences attributable to differences between
the carrying values of assets and liabilities and their respective income tax bases and for loss carry-forwards. Deferred income
tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the periods in which
temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities of a change
in tax laws, or rates, is included in earnings in the period that includes the enactment date. When realization of deferred income
tax assets does not meet the more-likely-than-not criterion for recognition, a valuation allowance is provided.
Financial
instruments
The
Company has financial instruments that are measured at fair value. To determine the fair value, the Company uses the fair value
hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable
inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would
use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs
are inputs based on assumptions about the factors market participants would use to value an asset or liability. The three levels
of inputs that may be used to measure fair value are as follows:
|
●
|
Level
one — inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities;
|
|
●
|
Level
two — inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either
directly or indirectly such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted
intervals; and
|
|
●
|
Level
three — unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect
those assumptions that a market participant would use.
|
Assets
and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Changes
in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value
hierarchy.
The
Company’s financial instruments consist of cash and cash equivalents, taxes and other receivables, accounts payable and
accrued liabilities, related party payables and derivative liability. The carrying values of cash and cash equivalents, taxes
and other receivables, accounts payable and accrued liabilities, and related party payables approximate their fair values due
to the immediate, or short-term, maturity of these financial instruments.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Derivative
liability
The
Company accounts for certain warrants under the authoritative guidance on accounting for derivative financial instruments indexed
to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities
laws, the warrants require the issuance of securities upon exercise and do not sufficiently preclude an implied right to net cash
settlement. The Company classifies these warrants on its balance sheet as a derivative liability which is fair valued at each
reporting period subsequent to the initial issuance. The Company has used a binomial model as well as a Black-Scholes Option Pricing
Model (based on a closed-form model that uses a fixed equation) to estimate the fair value of the share warrants. Determining
the appropriate fair-value model and calculating the fair value of warrants requires considerable judgment. Any change in the
estimates (specifically probabilities and volatility) used may cause the value to be higher or lower than that reported. The estimated
volatility of the Company’s common stock at the date of issuance, and at each subsequent reporting period, is based on the
historical volatility of the Company. The risk-free interest rate is based on rates published by the government for bonds with
a maturity similar to the expected remaining life of the warrants at the valuation date. The expected life of the warrants is
assumed to be equivalent to their remaining contractual term.
|
a)
|
Fair
value of derivative liability
|
The
derivative is not traded in an active market and the fair value is determined using valuation techniques. The Company uses judgment
to select a variety of methods to make assumptions that are based on specific management plans and market conditions at the end
of each reporting period. The Company uses a fair value estimate to determine the fair value of the derivative liability. The
carrying value of the derivative liability would be higher, or lower, as management estimates around specific probabilities change.
The estimates may be significantly different from those amounts ultimately recorded in the consolidated financial statements because
of the use of judgment and the inherent uncertainty in estimating the fair value of these instruments that are not quoted in an
active market. All changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss each
reporting period. This is considered to be a Level 3 financial instrument as volatility is considered a Level 3 input.
The
Company has the following liabilities under the fair value hierarchy:
|
|
June 30, 2018
|
|
Liability
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Derivative liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,117
|
|
|
|
June 30, 2017
|
|
Liability
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Derivative liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
61,228
|
|
Intangible
assets
Website
development costs
Website
development costs are stated at cost less accumulated amortization. The Company capitalizes website development costs associated
with graphics design and development of the website application and infrastructure. Costs related to planning, content input,
and website operations are expensed as incurred. The Company amortizes website development costs on a straight-line basis over
three years. At June 30, 2018, the total capitalized cost was $79,910 (2017 – $67,261) and the Company has recognized $24,528
and $16,683, respectively, in amortization expense during the years ended June 30, 2018 and 2017.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Patents
Expenditures
associated with the filing, or maintenance of patents, licensing or technology agreements are expensed as incurred. Costs previously
recognized as an expense are not recognized as an asset in subsequent periods. Once the Company has achieved regulatory approval,
patent costs will be deferred and amortized over the remaining life of the related patent.
Research
and development costs (including clinical trial expenses and accruals)
Research
and development expenses include payroll, employee benefits, stock-based compensation expense, and other headcount-related expenses
associated with research and development. Research and development expenses also include third-party development and clinical
trial expenses noted bel0w. Such costs related to research and development are included in research and development expense until
the point that technological feasibility is reached which, for the Company’s drug candidate, is generally shortly before
the drug is approved by the relevant food and drug administration. Once technological feasibility is reached, such costs will
be capitalized and amortized to cost of revenue over the estimated life of the product.
Clinical
trial expenses are a component of research and development costs and include fees paid to contract research organizations, investigators
and other service providers who conduct specific research for development activities on behalf of the Company. The amount of clinical
trial expenses recognized in a period related to service agreements is based on estimates of the work performed on an accrual
basis. These estimates are based on patient enrollment, services provided and goods delivered, contractual terms and experience
with similar contracts. The Company monitors these factors by maintaining regular communication with the service providers. Differences
between actual expenses and estimated expenses recorded are adjusted for in the period in which they become known. Prepaid expenses
or accrued liabilities are adjusted if payments to service providers differ from estimates of the amount of service completed
in a given period.
Research
and development costs are expensed in the period incurred. As at June 30, 2018 and 2017, all research and development costs have
been expensed.
Shares
for services
The
Company has issued equity instruments for services provided by employees and non-employees. The equity instruments are valued
at the fair value of the instrument granted.
Stock
options
The
Company accounts for these awards under Accounting Standards Codification (“ASC”) 718, “Compensation —
Stock Compensation” (“ASC 718”). ASC 718 requires measurement of compensation cost for all stock-based awards
at fair value on the date of grant and recognition of compensation over the requisite service period for awards expected to vest.
Compensation expense for unvested options to non-employees is revalued at each period end and is being amortized over the vesting
period of the options. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes
model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior
of its grantee, interest rates, and dividend yields. These variables are projected based on the Company’s historical data,
experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized
for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures, using
the accelerated attribution method. The Company recognizes forfeitures as they occur. The estimation of stock awards that will
ultimately vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such
amounts are recorded as a cumulative adjustment in the period estimates are revised.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Performance
stock units
The
Company also accounts for performance stock units (PSU’s) under ASC 718. ASC 718 requires measurement of compensation cost
for all stock-based awards at fair value on the date of grant and recognition of compensation over the requisite service period
for awards expected to vest. As vesting of the PSU’s is based on a number of factors, the determination of the grant-date
fair value for PSU’s has been estimated using a Monte Carlo simulation approach which includes variables such as the expected
volatility of the Company’s share price and interest rates to generate potential future outcomes. These variables are projected
based on the Company’s historical data, experience, and other factors. Changes in any of these variables could result in
material adjustments to the expense recognized for the PSUs. Such value is recognized as expense over the derived service period
using the accelerated attribution method. The estimation of PSUs that will ultimately vest requires judgment, and to the extent
actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment in the
period estimates are revised.
Comprehensive
income
In
accordance with ASC 220, “Comprehensive Income” (“ASC 220”), all components of comprehensive income, including
net loss, are reported in the financial statements in the period in which they are recognized. Comprehensive income is defined
as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net loss
and other comprehensive (income) loss, including foreign currency translation adjustments, are reported, net of any related tax
effect, to arrive at comprehensive income. No taxes were recorded on items of other comprehensive income.
Loss
per share
Income
or loss per share is calculated based on the weighted average number of common shares outstanding. For the years ended June 30,
2018 and 2017 diluted loss per share does not differ from basic loss per share since the effect of the Company’s warrants,
stock options, performance stock units, and convertible preferred shares is anti-dilutive. As at June 30, 2018, potential common
shares of 1,690,810 (2017 – 774,976) related to outstanding warrants and stock options, 120,000 (2017 – 0) relating
to performance stock units, and 220,279 (2017 – 220,279) relating to outstanding Series B convertible preferred shares were
excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive.
Segment
information
The
Company identifies its operating segments based on business activities, management responsibility and geographical location. The
Company operates within a single operating segment being the research and development of cancer indications, and operates primarily
in one geographic area, being North America. The Company is conducting one clinical trial in China but the planned expenses to
be incurred over the course of the study are not expected to be significant. All of the Company’s assets are located in
either Canada or the United States.
Recent
accounting pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other
standard setting bodies that are adopted by the Company as of the specified effective date.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
Recently
adopted
Accounting
Standards Board (“ASU”) 2016-09 — Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment
Accounting
The
amendments in this update change existing guidance related to accounting for employee share-based payments affecting the income
tax consequences of awards, classification of awards as equity or liabilities, and classification on the statement of cash flows.
ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within those
annual periods, with early adoption permitted. The adoption of ASU 2016-09 did not have a material impact on our results of operations
or financial condition.
Not
yet adopted
ASU
2016-01 — Financial Instruments — Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial
Liabilities
The
updated guidance enhances the reporting model for financial instruments and requires entities to use the exit price
notion when
measuring the fair value of financial instruments for disclosure purposes, and the separate presentation of financial assets and
financial liabilities by measurement category and form of financial asset (i.e., securities or loans and receivables) on the balance
sheet or the accompanying notes to the financial statements. The guidance is effective for annual reporting periods beginning
after December 15, 2017. The adoption of ASU 2016-01 is not expected to have a material impact on our results of operations or
financial condition.
ASU
2017-09 — Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting
The
amendments in this update provide guidance about which changes to the terms, or conditions of a stock-based payment award, require
an entity to apply modification accounting in Topic 718. The amendments in ASU 2017-09 are effective for all entities for annual
periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including
adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not
yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available
for issuance. The Company is currently evaluating the potential impact of the adoption of this standard.
ASU
2017-11 — I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral
for Mandatorily Redeemable Financial Instruments of Certain Non-public Entities and Certain Mandatorily Redeemable Noncontrolling
Interests with a Scope Exception
The
amendments in this update are intended to reduce the complexity associated with the accounting for certain financial instruments
with characteristics of liabilities and equity. Specifically, a down round feature would no longer cause a freestanding equity-linked
financial instrument (or an embedded conversion option) to be accounted for as a derivative liability at fair value with changes
in fair value recognized in current earnings. In addition, the indefinite deferral of certain provisions of Topic 480 have been
re-characterized to a scope exception. The re-characterization has no accounting effect. ASU 2017-11 is effective for public business
entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.Early adoption is
permitted. The Company is currently evaluating the potential impact of the adoption of this standard.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
2
|
Significant
accounting policies
(cont.)
|
ASU
2016-02 — Leases (Topic 842)
The
new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability
on the consolidated balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance
or operating, with classification affecting the pattern of expense recognition in the consolidated income statement. ASU 2016-02
is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods, with
early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases
existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with
certain practical expedients available. The Company is currently evaluating the potential impact of the adoption of this standard.
ASU
2018-07 — Stock Compensation (Topic 718) Improvements to Nonemployee Shares-based payment Accounting
The
amendments in this update are intended to the reduce cost and complexity and to improve financial reporting for share-based payments
issued to nonemployees. The ASU expands the scope of Topic 718, Compensation — Stock Compensation, which currently only
includes share-based payments issued to employees, to also include share-based payments issued to nonemployees for goods and services.
The existing guidance on nonemployee share-based payments is significantly different from current guidance for employee share-based
payments. This ASU expands the scope of the employee share-based payments guidance to include share-based payments issued to nonemployees.
By doing so, the FASB improves the accounting of nonemployee share-based payments issued to acquire goods and services used in
its own operations. The amendments in this ASU are effective for public companies for fiscal years beginning after December 15,
2018, including interim periods within that fiscal year. The Company is currently evaluating the potential impact of the adoption
of this standard.
|
3
|
Valent
Technologies LLC agreements
|
One
of the Company’s officers is a principal of Valent Technologies, LLC (“Valent”) and as result Valent is a related
party to the Company.
On
September 12, 2010, the Company entered into a Patent Assignment Agreement (the “Valent Assignment Agreement”) with
Valent pursuant to which Valent transferred to the Company all of its rights, title and interest in and to the patents for VAL-083
owned by Valent. The Company now owns all rights and title to VAL-083 and is responsible for the drug’s further development
and commercialization. In accordance with the terms of the Valent Assignment Agreement, Valent is entitled to receive a future
royalty on all revenues derived from the development and commercialization of VAL-083. In the event that the Company terminates
the agreement, the Company may be entitled to receive royalties from Valent’s subsequent development of VAL-083 depending
on the development milestones the Company has achieved prior to the termination of the Valent Assignment Agreement.
On
September 30, 2014, the Company entered into an exchange agreement (the “Valent Exchange Agreement”) with Valent and
Del Mar (BC). Pursuant to the Valent Exchange Agreement, Valent exchanged its loan payable in the outstanding amount of $278,530
(including aggregate accrued interest to September 30, 2014 of $28,530), issued to Valent by Del Mar (BC), for 278,530 shares
of the Company’s Series A Preferred Stock. The Series A Preferred Stock has a stated value of $1.00 per share (the “Series
A Stated Value”) and is not convertible into common stock. The holder of the Series A Preferred Stock is entitled to dividends
at the rate of 3% of the Series A Stated Value per year, payable quarterly in arrears. For each of the years ended June 30, 2018
and 2017 the Company recorded $8,356 related to the dividend paid to Valent. The dividends have been recorded as a direct increase
in accumulated deficit.
During
the year ended June 30, 2017, Valent exercised 12,500 common stock purchase warrants that had been issued to Valent pursuant to
the Valent Assignment Agreement. The exercised warrants represented all warrants that had been issued to Valent. The warrants
were exercised at $15.40 per share (CA $20.00) for total proceeds of $192,075.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
The
Company has issued common stock purchase warrants. Based on the terms of certain of these warrants the Company determined that
the warrants were a derivative liability which is recognized at fair value at the date of the transaction and remeasured at fair
value each reporting period with the changes in fair value recorded in the consolidated statement of operations and comprehensive
loss.
2013
Investor Warrants
During
the quarter ended March 31, 2013 the Company issued an aggregate of 328,125 units at a purchase price of $32.00 per unit, for
aggregate gross proceeds of $10,500,000. Each unit consisted of one share of common stock and one five-year warrant (the “2013
Investor Warrants”) to purchase one share of common stock at an initial exercise price of $32.00. The exercise price of
the 2013 Investor Warrants is subject to adjustment in the event that the Company issues common stock at a price lower than the
exercise price, subject to certain exceptions. The 2013 Investor Warrants are redeemable by the Company at a price of $0.04 per
2013 Investor Warrant at any time subject to the conditions that (i) the Company’s common stock has traded for twenty (20)
consecutive trading days with a closing price of at least $64.00 per share with an average trading volume of 50,000 shares per
day, and (ii) the underlying shares of common stock are registered for resale.
As
a result of the financing completed by the Company during the three months ended September 30, 2015, the exercise price of all
of the 2013 Investor Warrants was reduced from $32.00 to $31.40. As a result of the financing completed by the Company during
the three months ended September 30, 2017, the exercise price of certain of the 2013 Investor Warrants was further reduced from
$31.40 to $26.80. The change in exercise price did not result in a material change in the fair value of the derivative liability.
All of the 2013 Investor Warrants giving rise to their respective portion of the derivative liability have expired as of June
30, 2018.
2013
Investor Warrant exercises
During
the year ended June 30, 2017, 6,010 of the 2013 Investor Warrants were exercised at an exercise price of $31.40 per share. Also,
500 of the previously amended 2013 Investor Warrants were exercised. The Company received proceeds of $204,659 from these exercises.
The warrants that have been exercised were revalued at their respective exercise dates and then the reclassification to equity
was recorded resulting in $238,474 of the derivative liability being reclassified to equity.
There
were no exercises of 2013 Investor Warrants during the year ended June 30, 2018.
2013
Investor Warrant amendments
During
the year ended June 30, 2017, 1,594 of the 2013 Investor Warrants were amended. As a result, the Company has reclassified $53,006
from the derivative liability to equity. The 2013 Investor Warrants were revalued to their respective amendment dates and were
then reclassified to equity.
There
were no amendments of 2013 Investor Warrants during the year ended June 30, 2018.
2015
Agent Warrants
As
part of the Company’s financing completed in a prior period, the Company issued warrants to purchase 2,348 shares of common
stock to certain placement agents (“2015 Agent Warrants”) and recognized them as a derivative
liability of $29,594 at the time of issuance. The 2015 Agent Warrants are exercisable at a per share price equal to $30.00 until
July 15, 2020. During the year ended June 30, 2017, 68 of the 2015 Agent Warrants were exercised for cash proceeds of $2,040 and
100 of the 2015 Agent Warrants were exercised on a cashless basis for 59 shares of common stock. The total reclassification to
equity subsequent to revaluation at the respective exercise dates was $9,935.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
4
|
Derivative
liability
(cont.)
|
There
were no exercises of the 2015 Agent Warrants during the year ended June 30, 2018.
The
Company’s derivative liability is summarized as follows:
|
|
Years ended
June 30,
|
|
|
|
2018
$
|
|
|
2017
$
|
|
Opening balance
|
|
|
61,228
|
|
|
|
693,700
|
|
Change in fair value of warrants
|
|
|
(60,111
|
)
|
|
|
(331,057
|
)
|
Reclassification to equity upon amendment of warrants
|
|
|
—
|
|
|
|
(53,006
|
)
|
Reclassification to equity upon exercise of warrants
|
|
|
—
|
|
|
|
(248,409
|
)
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
1,117
|
|
|
|
61,228
|
|
Less current portion
|
|
|
—
|
|
|
|
(33,091
|
)
|
|
|
|
|
|
|
|
|
|
Long-term portion
|
|
|
1,117
|
|
|
|
28,137
|
|
The
derivative liability consists of the following warrants as at June 30, 2018 and 2017:
|
|
Year ended
June 30, 2018
|
|
|
|
Number of
warrants
|
|
|
$
|
|
Warrants issued for services
|
|
|
4,375
|
|
|
|
—
|
|
2015 Agent warrants
|
|
|
2,177
|
|
|
|
1,117
|
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
6,552
|
|
|
|
1,117
|
|
Less current portion
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Long-term portion
|
|
|
6,552
|
|
|
|
1,117
|
|
|
|
Year
ended
June 30, 2017
|
|
|
|
Number of
warrants
|
|
|
$
|
|
2013 investor warrants
|
|
|
10,513
|
|
|
|
33,091
|
|
Warrants issued for services
|
|
|
4,375
|
|
|
|
4,468
|
|
2015 Agent warrants
|
|
|
2,177
|
|
|
|
23,669
|
|
|
|
|
|
|
|
|
|
|
Closing balance
|
|
|
17,065
|
|
|
|
61,228
|
|
Less current portion
|
|
|
(10,513
|
)
|
|
|
(33,091
|
)
|
|
|
|
|
|
|
|
|
|
Long-term portion
|
|
|
6,552
|
|
|
|
28,137
|
|
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
|
Preferred
stock
Authorized
5,000,000
preferred shares, $0.001 par value
Issued
and outstanding
Special
voting shares – at June 30, 2018 and 2017 – 1
Series
A shares – at June 30, 2018 – 278,530 (June 30, 2017 – 278,530)
Series
B shares – at June 30, 2018 – 881,113 (June 30, 2017 – 881,113)
Series
B Preferred Shares
During
the year ended June 30, 2016, the Company issued an aggregate of 902,238 shares of Series B Preferred Stock at a purchase price
of at $8.00 per share. Each share of Series B Preferred Stock is convertible into 0.25 shares of common stock equating to a conversion
price of $32.00 (the “Conversion Price”) and will automatically convert to common stock at the earlier of 24 hours
following regulatory approval of VAL-083 with a minimum closing bid price of $80.00 or five years from the final closing date.
The holders of the Series B Preferred Stock are entitled to an annual cumulative, in arrears, dividend at the rate of 9% payable
quarterly. The 9% dividend accrues quarterly commencing on the date of issue and is payable quarterly on June 30, September 30,
December 31, and March 31 of each year commencing on June 30, 2016. Dividends are payable solely by delivery of shares of common
stock, in an amount for each holder equal to the aggregate dividend payable to such holder with respect to the shares of Series
B Preferred Stock held by such holder divided by the Conversion Price. The Series B Preferred Stock does not contain any repricing
features. Each share of Series B Preferred Stock entitles its holder to vote with the common stock on an as-converted basis.
In
addition, the Company and the holders entered into a royalty agreement, pursuant to which the Company will pay the holders of
the Series B Preferred Stock, in aggregate, a low, single-digit royalty based on their pro rata ownership of the Series B Preferred
Stock on products sold directly by the Company or sold pursuant to a licensing or partnering arrangement (the “Royalty Agreement”).
Upon
conversion of a holder’s Series B Preferred Stock to common stock, such holder shall no longer receive ongoing royalty payments
under the Royalty Agreement but will be entitled to receive any residual royalty payments that have vested. Rights to the royalties
shall vest during the first three years following the applicable closing date, in equal thirds to holders of the Series B Preferred
Stock on each of the three vesting dates, upon which vesting dates such royalty amounts shall become vested royalties.
Pursuant
to the Series B Preferred Stock dividend, during the year ended June 30, 2018, the Company issued 19,841 (2017 – 20,045)
shares of common stock and recognized $176,236 (2017 – $790,454) as a direct increase in accumulated deficit. During the
year ended June 30, 2018, a total of 0 (2017 – 21,125) shares of Series B Preferred Stock were converted for an aggregate
0 (2017 – 5,281) shares of common stock.
A
total of 881,113 (2017 – 881,113) shares of Series B Preferred Stock are outstanding as of June 30, 2018, such that a total
of 220,279 (2017 – 220,279) shares of common stock are issuable upon conversion of the Series B Preferred Stock as at June
30, 2018. Converted shares are rounded up to the nearest whole share.
Series
A Preferred Shares
Effective
December 31, 2014 pursuant to the Company’s Valent Exchange Agreement (note 3), the Company filed a Certificate of Designation
of Series A Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of Nevada. Pursuant
to the Series A Certificate of Designation, the Company designated 278,530 shares of preferred stock as Series A Preferred Stock.
The shares of Series A Preferred Stock have a stated value of $1.00 per share (the “Series A Stated Value”) and are
not convertible into common stock. The holder of the Series A Preferred Stock is entitled to dividends at the rate of 3% of the
Series A Stated Value per year, payable quarterly in arrears. Upon any liquidation of the Company, the holder of the Series A
Preferred Stock will be entitled to be paid, out of any assets of the Company available for distribution to stockholders, the
Series A Stated Value of the shares of Series A Preferred Stock held by such holder, plus any accrued but unpaid dividends thereon,
prior to any payments being made with respect to the common stock.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Special
voting shares
In
connection with the Exchange Agreement (note 1), on the Reverse Acquisition Closing Date, the Company, Callco, Exchangeco and
Computershare Trust Company of Canada (the “Trustee”) entered into a voting and exchange trust agreement (the “Trust
Agreement”). Pursuant to the Trust Agreement, Company issued one share of Special Voting Preferred Stock (the “Special
Voting Share”) to the Trustee, and the parties created a trust for the Trustee to hold the Special Voting Share for the
benefit of the holders of the shares of Exchangeco acquired as part of the Reverse Acquisition (the “Exchangeable Shares”)
(other than the Company and any affiliated companies) (the “Beneficiaries”). Pursuant to the Trust Agreement, the
Beneficiaries will have voting rights in the Company equivalent to what they would have had they received shares of common stock
in the same amount as the Exchangeable Shares held by the Beneficiaries.
In
connection with the Exchange Agreement and the Trust Agreement, on January 17, 2013, the Company filed a certificate of designation
of Special Voting Preferred Stock (the “Special Voting Certificate of Designation”) with the Secretary of State of
Nevada. Pursuant to the Special Voting Certificate of Designation, one share of the Company’s blank check preferred stock
was designated as Special Voting Preferred Stock. The Special Voting Preferred Stock votes as a single class with the common stock
and is entitled to a number of votes equal to the number of Exchangeable Shares of Exchangeco outstanding as of the applicable
record date (i) that are not owned by the Company or any affiliated companies and (ii) as to which the holder has received voting
instructions from the holders of such Exchangeable Shares in accordance with the Trust Agreement.
The
Special Voting Preferred Stock is not entitled to receive any dividends or to receive any assets of the Company upon any liquidation,
and is not convertible into common stock of the Company.
The
voting rights of the Special Voting Preferred Stock will terminate pursuant to and in accordance with the Trust Agreement. The
Special Voting Preferred Stock will be automatically cancelled at such time as the share of Special Voting Preferred Stock has
no votes attached to it.
Common
stock
Authorized
7,000,000
as at June 30, 2018 (2017 – 5,000,000) common shares, $0.001 par value
Issued
and outstanding at June 30, 2018 – 2,296,667 (2017 – 1,450,963). The issued and outstanding common shares at June
30, 2018 include 91,276 (2017 –98,276) shares of common stock on an as-exchanged basis with respect to the Exchangeable
Shares.
Public
offering financings
Year
ended June 30, 2018
On
September 22, 2017 the Company completed a registered direct offering (the “2018 Registered Offering”) of an aggregate
of 800,000 shares of common stock and warrants to purchase an additional 800,000 shares of common stock at a price of $12.50 per
share and related warrant for gross proceeds of $10.0 million. The warrants have an exercise price of $12.50 per share, are immediately
exercisable and have a term of exercise of five years (the “2018 Investor Warrants”).
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
The
Company engaged a placement agent for the 2018 Registered Offering. Under the Company’s engagement agreement with the placement
agent, the Company paid $800,000 in cash commission and other fees to the placement agent and issued warrants to purchase 40,000
shares of common stock to the placement agent (the “2018 Agent Warrants”). The 2018 Agent Warrants are exercisable
at a per share price of $12.50 and have a term of exercise of five years.
In
addition to the cash commission and other placement agent fees, the Company also incurred additional cash issue costs of $254,664
resulting in net cash proceeds of $8,945,336.
Year
ended June 30, 2017
On
April 12, 2017 the Company completed a registered public offering (the “2017 Public Offering”) of an aggregate of
276,923 shares of common stock and warrants to purchase an additional 207,692 shares of common stock at a price of $32.50 per
share and related warrant for gross proceeds of approximately $9.0 million. The related warrants have an exercise price of $35.00
per share, are immediately exercisable, and have a term of exercise of five years (the “2017 Investor Warrants”).
The
Company engaged a placement agent for the 2017 Public Offering. Under the Company’s engagement agreement with the placement
agent, the Company agreed to pay up to an 8% cash commission and issue warrants to purchase shares of common stock (the “2017
Agent Warrants”) up to the number of shares of common stock equal to 5% of the aggregate number of shares issued in the
2017 Public Offering. Pursuant to the placement agent agreement the Company issued 13,846 2017 Agent Warrants. The 2017 Agent
Warrants are exercisable at a per share price equal to $40.60 and have a term of exercise of five years.
In
addition to the cash commission the Company also incurred additional cash issue costs of $347,897 resulting in net cash proceeds
of $7,932,107. The 2017 Agent Warrants have been recognized as non-cash issue costs of $424,401. Including the fair value of the
2017 Agent Warrants, total issue costs were $1,492,298.
Shares
issued for services
During
the year ended June 30, 2018, the Company issued 863 (2017 – 6,000) shares of common stock for services resulting in the
recognition of $8,582 (2017 – $564,000) in expense. All of the shares issued for services for the year ended June 30, 2018
have been recognized as general and administrative expense and all of the shares issued for services for the year ended June 30,
2017 have been recognized as research and development expense.
2017
Omnibus Incentive Plan
As
approved by the Company’s stockholders at the annual meeting of stockholders held on April 11, 2018, on July 7, 2017, as
amended on February 1, 2018, the Company’s board of directors approved adoption of the Company’s 2017 Omnibus Equity
Incentive Plan (the “2017 Plan”). The board of directors also approved a form of Performance Stock Unit Award Agreement
to be used in connection with grants of performance stock units (“PSUs”) under the 2017 Plan. Under the 2017 Plan,
780,000 shares of Company common stock are reserved for issuance, less the number of shares of common stock issued under
the Del Mar (BC) 2013 Amended and Restated Stock Option Plan (the “Legacy Plan”) or that are subject to grants of
stock options made, or that may be made, under the Legacy Plan. A total of 169,985 shares of common stock, net of forfeitures,
have been issued under the Legacy Plan and/or are subject to outstanding stock options granted under the Legacy Plan, and a total
of 92,698 shares of common
stock have been issued under the 2017 Plan and/or are subject to outstanding stock options granted under the 2017 Plan. In addition,
120,000 PSU’s have been issued under the 2017 Plan leaving a potential 397,317 shares of common stock available for issuance
under the 2017 Plan if all such options under the Legacy Plan were exercised and no new grants are made under the Legacy Plan.
The maximum number of shares of Company common stock with respect to which any one participant may be granted awards during any
calendar year is 8% of the Company’s fully diluted shares of common stock on the date of grant (excluding the number of
shares of common stock issued under the 2017 Plan and/or the Legacy Plan or subject to outstanding awards granted under the 2017
Plan and/or the Legacy Plan). No award will be granted under the 2017 Plan on or after July 7, 2027, but awards granted prior
to that date may extend beyond that date.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Performance
stock units
The
Company’s board of directors has granted PSUs under the 2017 Plan to the Company’s directors. The awards represent
the right to receive shares of the Company’s common stock upon vesting of the PSU based on targets approved by the Company’s
board of directors related to the Company’s fully diluted market capitalization. The PSUs vest at various fully diluted
market capitalization levels with full vesting occurring upon the later of one year from the grant date and the Company achieving
a fully diluted market capitalization of at least $500 million for five consecutive business days. The PSUs expire on July 7,
2022.
The
following table sets forth the PSUs outstanding under the 2017 Plan as of June 30, 2018:
|
|
Number of
PSUs
outstanding
|
|
Balance – June 30, 2016 and 2017
|
|
|
—
|
|
Granted
|
|
|
140,000
|
|
Forfeited
|
|
|
(20,000
|
)
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
120,000
|
|
The
Company has recognized $48,624 (2017 – $0) in expense related to the PSUs during the year ended June 30, 2018 with all of
it being recognized as general and administrative expense. As at June 30, 2018 there was $526,140 (2017 – $0) in unrecognized
compensation expense that will be recognized over the next 3.24 years.
The
PSUs have been valued using the following assumptions:
|
|
June 30,
2018
|
|
Dividend rate
|
|
|
0
|
%
|
Volatility
|
|
|
79.0 to 82.5
|
%
|
Risk-free rate
|
|
|
2.56% to 2.71
|
%
|
Term
–
years
|
|
|
1.67 to 3.24
|
|
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Stock
options
The
following table sets forth the aggregate stock options outstanding under all plans as of June 30, 2018:
|
|
Number of
stock
options
outstanding
|
|
|
Weighted
average
exercise
price
|
|
Balance – June 30, 2016
|
|
|
85,625
|
|
|
|
37.77
|
|
Granted
|
|
|
26,460
|
|
|
|
48.22
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2017
|
|
|
112,085
|
|
|
|
41.81
|
|
Granted
|
|
|
152,698
|
|
|
|
11.35
|
|
Forfeited
|
|
|
(2,100
|
)
|
|
|
21.10
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
262,683
|
|
|
|
24.27
|
|
The
following table summarizes stock options currently outstanding and exercisable under all plans at June 30, 2018:
Exercise price
$
|
|
|
Number
Outstanding at
June 30,
2018
|
|
|
Weighted
average
remaining
contractual life
(years)
|
|
|
Number
exercisable at
June 30,
2018
|
|
|
7.00
|
|
|
|
5,451
|
|
|
|
9.98
|
|
|
|
—
|
|
|
8.70
|
|
|
|
12,000
|
|
|
|
9.34
|
|
|
|
7,000
|
|
|
9.80
|
|
|
|
83,647
|
|
|
|
9.89
|
|
|
|
—
|
|
|
10.60
|
|
|
|
3,600
|
|
|
|
9.79
|
|
|
|
—
|
|
|
11.70
|
|
|
|
30,000
|
|
|
|
4.66
|
|
|
|
12,500
|
|
|
15.50
|
|
|
|
2,500
|
|
|
|
3.92
|
|
|
|
2,500
|
|
|
20.00
|
|
|
|
13,125
|
|
|
|
3.27
|
|
|
|
13,125
|
|
|
21.10
|
|
|
|
15,900
|
|
|
|
8.26
|
|
|
|
6,300
|
|
|
29.60
|
|
|
|
4,500
|
|
|
|
6.60
|
|
|
|
4,500
|
|
|
32.00
|
|
|
|
3,000
|
|
|
|
0.92
|
|
|
|
3,000
|
|
|
37.60
|
|
|
|
4,500
|
|
|
|
7.61
|
|
|
|
3,499
|
|
|
40.00
|
|
|
|
1,250
|
|
|
|
1.25
|
|
|
|
1,250
|
|
|
41.00
|
|
|
|
4,000
|
|
|
|
8.36
|
|
|
|
2,111
|
|
|
42.00
|
|
|
|
41,250
|
|
|
|
4.56
|
|
|
|
41,250
|
|
|
44.80
|
|
|
|
3,000
|
|
|
|
7.61
|
|
|
|
2,250
|
|
|
49.50
|
|
|
|
22,460
|
|
|
|
6.07
|
|
|
|
15,182
|
|
|
53.20
|
|
|
|
8,000
|
|
|
|
7.85
|
|
|
|
5,556
|
|
|
61.60
|
|
|
|
1,500
|
|
|
|
4.75
|
|
|
|
1,500
|
|
|
92.00
|
|
|
|
3,000
|
|
|
|
4.92
|
|
|
|
3,000
|
|
|
|
|
|
|
262,683
|
|
|
|
|
|
|
|
124,523
|
|
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Included
in the number of stock options outstanding are 2,500 stock options granted at an exercise price of CA $20.00. The exercise prices
for these stock options shown in the above table have been converted to $15.50 US$ using the period ending closing exchange rate.
Certain stock options have been granted to non-employees and will be revalued at each reporting date until they have fully vested.
The
stock options have been valued using a Black-Scholes pricing model using the following assumptions:
|
|
June 30,
2018
|
|
|
June 30,
2017
|
|
Dividend rate
|
|
|
0
|
%
|
|
|
0
|
%
|
Volatility
|
|
|
72.4 to 87.1
|
%
|
|
|
77.5% to 88.7
|
%
|
Risk-free rate
|
|
|
1.49% to 2.86
|
%
|
|
|
1.00% to 1.74
|
%
|
Term
–
years
|
|
|
0.6 to 3.03
|
|
|
|
3.0
|
|
The
Company has recognized the following amounts as stock option expense for the periods noted:
|
|
Years ended June 30,
|
|
|
|
2018
$
|
|
|
2017
$
|
|
Research and development
|
|
|
140,870
|
|
|
|
77,706
|
|
General and administrative
|
|
|
355,055
|
|
|
|
47,041
|
|
|
|
|
|
|
|
|
|
|
|
|
|
495,925
|
|
|
|
124,747
|
|
All
of the stock option expense of $495,925 (2017
–
$124,747) for the years ended June 30, 2018 and 2017 has been recognized
as additional paid in capital. The aggregate intrinsic value of stock options outstanding at June 30, 2018 was $0 (2017
–
$56,783) and the aggregate intrinsic value of stock options exercisable at June 30, 2018 was $0 (2017
–
$56,783).
As at June 30, 2018 there was $527,271 in unrecognized compensation expense that will be recognized over the next 2.9 years. No
stock options granted under the Plan have been exercised to June 30 2018. Upon the exercise of stock options new shares will be
issued.
A
summary of the status of the Company’s unvested stock options as at June 30, 2018 under all plans is presented below:
|
|
Number of
options
|
|
|
Weighted
average
exercise
price
$
|
|
|
Weighted
average
grant date
fair value
$
|
|
Unvested at June 30, 2016
|
|
|
14,102
|
|
|
|
31.71
|
|
|
|
17.25
|
|
Granted
|
|
|
26,460
|
|
|
|
48.22
|
|
|
|
26.11
|
|
Vested
|
|
|
(8,759
|
)
|
|
|
46.81
|
|
|
|
24.83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at June 30, 2017
|
|
|
31,803
|
|
|
|
48.09
|
|
|
|
25.74
|
|
Granted
|
|
|
152,698
|
|
|
|
11.35
|
|
|
|
6.01
|
|
Vested
|
|
|
(44,241
|
)
|
|
|
27.81
|
|
|
|
15.02
|
|
Forfeited
|
|
|
(2,100
|
)
|
|
|
21.10
|
|
|
|
11.32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at June 30, 2018
|
|
|
138,160
|
|
|
|
14.39
|
|
|
|
7.63
|
|
The
aggregate intrinsic value of unvested stock options at June 30, 2018 was $0 (2017
–
$0). The unvested stock options
have a remaining weighted average contractual term of 8.81 (2017 – 9.35) years.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Stock
option modifications
During
the year ended June 30, 2018, certain stock options were modified pursuant to a separation agreement with the Company’s
former President and Chief Operating Officer. A total of 6,760 options had their vesting accelerated such that they became fully
vested on December 22, 2017, resulting in additional stock option expense of $93,777. In addition, a total of 21,860 options were
modified such that their remaining exercise period was increased from one year to three years, resulting in additional stock option
expense of $28,561.
Also,
during the year ended June 30, 2018, certain stock options were modified pursuant to the resignation of the Company’s former
Chairman. A total of 1,500 options had their vesting accelerated such that they became fully vested on June 2, 2018, resulting
in additional stock option expense of $679. In addition, a total of 4,500 (including the 1,500 whose vesting was accelerated)
options were modified such that their remaining exercise period was increased from 90 days to one year, resulting in additional
stock option expense of $2,182.
Stock
option liability
Certain
of the Company’s stock options have been issued in CA$. Of these, a portion was classified as a stock option liability which
was revalued at each reporting date. During the year ended June 30, 2017, the Company amended 4,375 of these stock options held
by five optionees such that the exercise price of the options was adjusted to be denominated in US$. No other terms of the stock
options were amended. As a result of the amendment, the Company recognized $85,094 in stock option liability expense and $260,969
was reclassified to equity during the year ended June 30, 2017.
Warrants
|
|
Number of
warrants
|
|
|
Amount
$
|
|
Balance – June 30, 2016
|
|
|
152,171
|
|
|
|
1,658,382
|
|
|
|
|
|
|
|
|
|
|
Issuance of 2017 Investor Warrants
(i)
|
|
|
207,693
|
|
|
|
2,526,336
|
|
Issuance of 2017 Agent Warrants
(i)
|
|
|
13,846
|
|
|
|
424,401
|
|
Exercise of Valent Warrants
(ii)
|
|
|
(12,500
|
)
|
|
|
(89,432
|
)
|
Exercise of 2015 Investor Warrants
(iii)
|
|
|
(4,875
|
)
|
|
|
(30,715
|
)
|
Warrants issued for services
(iv)
|
|
|
4,140
|
|
|
|
81,602
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2017
|
|
|
360,475
|
|
|
|
4,570,574
|
|
|
|
|
|
|
|
|
|
|
Issuance of 2018 Investor and 2018 Agent Warrants
(v)
|
|
|
840,000
|
|
|
|
3,572,843
|
|
Exercise of 2018 Investor Warrants
(v)
|
|
|
(25,000
|
)
|
|
|
(106,335
|
)
|
Warrants issued for services
(iv)
|
|
|
42,000
|
|
|
|
192,400
|
|
|
|
|
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
1,217,475
|
|
|
|
8,229,482
|
|
|
i)
|
As
part of the financing completed by the Company on April 12, 2017, the Company issued the 2017 Investor Warrants and the 2017 Agent
Warrants. The 2017 Investor Warrants are exercisable at $35.00 until April 19, 2022 and the 2017 Agent Warrants are exercisable
at $40.60 until April 12, 2022.
|
|
ii)
|
The
Valent warrants were exercised at $15.40 (CA$20.00) for proceeds of $192,075.
|
|
iii)
|
The
2015 Investor Warrants are exercisable at a price of $30.00. The warrants expire on July 31, 2020. During the year ended June
30, 2018, nil (2017
–
4,875) warrants were exercised for proceeds of $0 (2017
–
$146,250).
|
|
iv)
|
Warrants
issued for services are exercisable at various prices and expire at the various dates noted in the table below.
|
|
v)
|
As
part of the financing completed by the Company on September 22, 2017, the Company issued the 2018 Investor Warrants and the 2018
Agent Warrants. The 2018 Investor Warrants are exercisable at $12.50 until September 22, 2022 and the 2018 Agent Warrants are
exercisable at $12.50 until September 20, 2022.
|
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
5
|
Stockholders’
equity (deficiency)
(cont.)
|
Certain
of the Company’s warrants have been recognized as a derivative liability (note 4).
The
following table summarizes the changes in the Company’s outstanding warrants as of June 30, 2018:
Description
|
|
Number
|
|
Balance – June 30, 2017
|
|
|
662,891
|
|
|
|
|
|
|
Issuance of 2018 Investor Warrants
|
|
|
800,000
|
|
Exercise of 2018 Investor Warrants
|
|
|
(25,000
|
)
|
Issuance of 2018 Agent Warrants
|
|
|
40,000
|
|
Warrants issued for services
|
|
|
42,000
|
|
Expiry of dividend warrants
|
|
|
(81,250
|
)
|
Expiry of 2013 Investor Warrants
|
|
|
(10,513
|
)
|
|
|
|
|
|
Balance – June 30, 2018
|
|
|
1,428,128
|
|
The
following table summarizes the Company’s outstanding warrants as of June 30, 2018:
Description
|
|
Number
|
|
|
Exercise
price
$
|
|
|
Expiry date
|
2018 Investor
|
|
|
775,000
|
|
|
|
12.50
|
|
|
September 22, 2022
|
2017 Investor
|
|
|
207,693
|
|
|
|
35.00
|
|
|
April 19, 2022
|
2015 Investor
|
|
|
97,900
|
|
|
|
30.00
|
|
|
July 31, 2020
|
2013 Investor – Amended
|
|
|
77,850
|
|
|
|
31.40
|
|
|
March 31, 2019
|
2013 Placement Agent
|
|
|
126,250
|
|
|
|
31.40
|
|
|
June 30, 2019
|
Issued for services
|
|
|
26,500
|
|
|
|
30.00
|
|
|
July 31, 2020 to February 1, 2021
|
Issued for services
|
|
|
6,000
|
|
|
|
17.80
|
|
|
January 25, 2023
|
Issued for services
|
|
|
36,000
|
|
|
|
11.70
|
|
|
February 27, 2023
|
Issued for services
|
|
|
4,375
|
|
|
|
70.40
|
|
|
September 12, 2018
|
Issued for services
|
|
|
4,140
|
|
|
|
59.30
|
|
|
February 27, 2020
|
2018 Agent
|
|
|
40,000
|
|
|
|
12.50
|
|
|
September 20, 2022
|
2017 Agent
|
|
|
13,846
|
|
|
|
40.60
|
|
|
April 12, 2022
|
2016 Agent
|
|
|
10,397
|
|
|
|
40.00
|
|
|
May 12, 2021 to June 8, 2021
|
2015 Agent
|
|
|
2,177
|
|
|
|
30.00
|
|
|
July 15, 2020
|
|
|
|
1,428,128
|
|
|
|
20.80
|
|
|
|
|
6
|
Related
party transactions
|
During
the year ended June 30, 2018, the Company recognized a total expense of $311,683 relating to the settlement agreement with the
Company’s former President and Chief Operating Officer. Amounts owed to related parties, including to the Company’s
former President and Chief Operating Officer, are non-interest bearing and payable on demand.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
7
|
Current
and deferred income taxes
|
For
the years ended June 30, 2018, and 2017, the Company did not record a provision for income taxes due to a full valuation allowance
against our deferred tax assets.
Significant
components of the Company’s future tax assets and deferred tax liabilities are shown below:
|
|
June 30,
2018
$
|
|
|
June 30,
2017
$
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Non-capital losses carried forward
|
|
|
9,416,047
|
|
|
|
7,340,286
|
|
Capital losses carried forward
|
|
|
17,925
|
|
|
|
17,925
|
|
Financing costs
|
|
|
5,512
|
|
|
|
5,512
|
|
Scientific research and development
|
|
|
396,758
|
|
|
|
350,435
|
|
Scientific research and development – ITC
|
|
|
354,411
|
|
|
|
319,528
|
|
|
|
|
10,190,653
|
|
|
|
8,033,686
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Scientific research and development – ITC
|
|
|
(61,230
|
)
|
|
|
(53,841
|
)
|
|
|
|
10,129,423
|
|
|
|
7,979,845
|
|
Valuation allowance
|
|
|
(10,129,423
|
)
|
|
|
(7,979,845
|
)
|
|
|
|
|
|
|
|
|
|
Net future tax assets
|
|
|
—
|
|
|
|
—
|
|
The
income tax benefit of these tax attributes has not been recorded in these consolidated financial statements because of the uncertainty
of their recovery. The Company’s effective income tax rate differs from the statutory income tax rate of 21% (2017
–
34%).
The
differences arise from the following items:
|
|
June 30,
2018
$
|
|
|
June 30,
2017
$
|
|
Tax recovery at statutory income tax rates
|
|
|
(3,063,036
|
)
|
|
|
(2,747,800
|
)
|
Permanent differences
|
|
|
290,722
|
|
|
|
(15,342
|
)
|
Effect of rate differentials between jurisdictions
|
|
|
76,364
|
|
|
|
464,938
|
|
Impact of changes in income tax rates
|
|
|
138,516
|
|
|
|
—
|
|
Scientific research and development – ITC
|
|
|
(354,411
|
)
|
|
|
—
|
|
Other
|
|
|
75,422
|
|
|
|
(62,962
|
)
|
Change in valuation allowance
|
|
|
2,836,423
|
|
|
|
2,361,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|
|
—
|
|
As
of June 30, 2018, the Company had combined US and Canadian net operating loss carryforwards of $34.7 million that begin expiring
in 2029. In addition, the Company has non-refundable Canadian federal investment tax credits of $226,778 that expire between 2029
and 2038 and non-refundable British Columbia investment tax credits of $127,633 that expire between 2019 and 2028.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
7
|
Current
and deferred income taxes
(cont.)
|
The
Tax Cuts and Jobs Act (“2017 Tax Act”) was enacted in December 2017. The 2017 Tax Act, among other things, reduces
the U.S. federal corporate tax rate from 35% to 21%, effective January 1, 2018, requires companies to pay a one-time transition
tax on earnings of certain foreign subsidiaries that were previously tax deferred and creates new taxes on certain foreign earnings.
The Company revalued our deferred tax assets as of June 30, 2018 based on a U.S. federal tax rate of 21%, which resulted in a
reduction to our deferred tax assets of $138,516 fully offset by a reduction to the valuation allowance. The Company is not required
to pay a one-time transition tax on earnings of our foreign subsidiary as the foreign subsidiary has an accumulated deficit.
|
8
|
Commitments
and contingencies
|
The
Company has the following obligations over the next five fiscal years ending June 30, 2023:
Clinical
development
The
Company has entered into contracts for drug manufacturing and clinical study management related to its Phase III clinical trial
for a total of $654,829. While this trial has now been parked, certain costs related to the parking of this trial as well as manufacturing
costs related to drug supply have been committed to by the Company. Pursuant to the commitment for clinical trial management,
the Company has paid a total of $921,027 in deposits related to study initiation and certain study costs. These deposits are available
to be applied against invoices received from the contract research organization but have not been netted against the Company’s
commitments for the fiscal year ended June 30, 2018.
Office
lease
The
Company currently rents its offices on a month-to-month basis at a rate of $4,708 (CA$6,200) per month. During the year ended
June 30, 2018, the Company recorded $58,434 as rent expense (2017 – $35,908).
|
9
|
Supplementary
statement of cash flows information
|
|
|
Year ended
June 30,
2018
|
|
|
Year ended
June 30,
2017
|
|
Series B Preferred Stock common stock dividend (note 5)
|
|
|
176,236
|
|
|
|
790,454
|
|
Non-cash issue costs (note 5)
|
|
|
148,087
|
|
|
|
424,401
|
|
Reclassification of derivative liability to equity upon the exercise of warrants (note 4)
|
|
|
—
|
|
|
|
248,409
|
|
Reclassification of derivative liability to equity upon the amendment of warrants (note 4)
|
|
|
—
|
|
|
|
53,006
|
|
Reclassification of stock option liability to equity upon settlement (note 5)
|
|
|
—
|
|
|
|
260,969
|
|
Conversion of Series B Preferred Stock to common stock (note 5)
|
|
|
—
|
|
|
|
147,375
|
|
Income taxes paid
|
|
|
—
|
|
|
|
—
|
|
Interest paid
|
|
|
—
|
|
|
|
—
|
|
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
10
|
Financial
risk management
|
Market
risk
Market
risk is the risk that changes in market prices, such as foreign exchange rates, interest rates and equity prices will affect the
Company’s income or valuation of its financial instruments.
The
Company is exposed to financial risk related to fluctuation of foreign exchange rates. Foreign currency risk is limited to the
portion of the Company’s business transactions denominated in currencies other than the United Sates dollar, primarily general
and administrative expenses incurred in Canadian dollars. The Company believes that the results of operations, financial position
and cash flows would be affected by a sudden change in foreign exchange rates, but would not impair or enhance its ability to
pay its Canadian dollar accounts payable. The Company manages foreign exchange risk by converting its US$ to CA$ as needed. The
Company maintains the majority of its cash in US$. As at June 30, 2018, Canadian dollar denominated accounts payable and accrued
liabilities exposure in US$ totaled $106,132.
Foreign exchange risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate
because of changes in foreign exchange rates. If foreign exchange rates were to fluctuate within +/-10% of the closing rate at
year-end, the maximum exposure is $6,788.
Balances
in foreign currencies at June 30, 2018 and 2017 are as follows:
|
|
June 30,
2018
balances
CA$
|
|
|
June 30,
2017
balances
CA$
|
|
Trade payables
|
|
|
79,858
|
|
|
|
164,226
|
|
Cash
|
|
|
41,459
|
|
|
|
39,251
|
|
Interest, taxes, and other receivables
|
|
|
14,618
|
|
|
|
99,397
|
|
The
Company is subject to interest rate risk on its cash and cash equivalents and believes that the results of operations, financial
position and cash flows would not be significantly affected by a sudden change in market interest rates relative to the investment
interest rates due to the short-term nature of the investments. As at June 30, 2018, cash and cash equivalents held in by the
Company was $5,971,995. The Company’s cash balance currently earns interest at standard bank rates. If interest rates were
to fluctuate within +/-10% of the closing rate at year end the impact of the Company’s interest-bearing accounts will be
not be significant due to the current low market interest rates.
The
only financial instruments that expose the Company to interest rate risk are its cash and cash equivalents.
Liquidity
risk
Liquidity
risk is the risk that the Company will encounter difficulty in raising funds to meet cash flow requirements associated with financial
instruments. The Company continues to manage its liquidity risk based on the outflows experienced for the period ended June 30,
2018 and is undertaking efforts to conserve cash resources wherever possible. The maximum exposure of the Company’s liquidity
risk is $1,638,515 as at June 30, 2018.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
10
|
Financial
risk management
(cont.)
|
Credit
risk
Credit
risk arises from cash and cash equivalents, deposits with banks, financial institutions, and contractors as well as outstanding
receivables. The Company limits its exposure to credit risk, with respect to cash and cash equivalents, by placing them with high
quality credit financial institutions. The Company’s cash equivalents consist primarily of operating funds with commercial
banks. Of the amounts with financial institutions on deposit, the following table summarizes the amounts at risk should the financial
institutions with which the deposits are held cease trading:
The
maximum exposure of the Company’s credit risk is $39,519 at June 30, 2018 relating to interest, taxes, and other receivables.
The credit risk related to uninsured cash and cash equivalents balances is $5,868,825 at June 30, 2018.
|
|
Cash
and
cash
equivalents
$
|
|
Insured
amount
$
|
|
Non-insured
amount
$
|
|
|
5,971,995
|
|
103,170
|
|
5,868,825
|
Concentration
of credit risk
Financial
instruments that subject the Company to credit risk consist primarily of cash and cash equivalents.
The
Company places its cash and cash equivalents in accredited financial institutions and therefore the Company’s management
believes these funds are subject to minimal credit risk. The Company has no significant off-balance sheet concentrations of credit
risk such as foreign currency exchange contracts, option contracts or other hedging arrangements.
Reverse
Stock Split
On
May 7, 2019, the Company filed a Certificate of Change with the Secretary of State of Nevada that effected a 1-for-10 (1:10) reverse
stock split of its common stock, par value $0.001 per share, which became effective on May 8, 2019. Pursuant to the Certificate
of Change, the Company’s authorized common stock was decreased in the same proportion as the split resulting in a decrease
from 70,000,000 authorized shares of common stock to 7,000,000 shares authorized. The par value of its common stock was unchanged
at $0.001 per share, post-split. All common shares, warrants, stock options, conversion ratios, and per share information in these
consolidated financial statements give retroactive effect to the 1-for-10 reverse stock split. The Company’s authorized
and issued preferred stock was not affected by the split.
Rights
Offering
Subsequent
to June 30, 2018, the Company filed a registration statement relating to a rights offering for a maximum gross proceeds of $8.0
million. For every common share of stock owned (including each share of common stock issuable upon exercise of certain outstanding
warrants) as of the record date, the stockholder will receive one basic subscription right, which gives the stockholder the opportunity
to purchase one unit, consisting of one share of the Company’s Series C Preferred Stock and 0.50 warrants, for a price of
$1,000 per Unit. The raising of any funds will not be assured until the closing of the offering which is expected to be in the
first week of June 2019.
DelMar
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
June 30, 2018
|
(in
US dollars unless otherwise noted)
|
11
|
Subsequent
events
(cont.)
|
Performance
Stock Units
On
April 30, 2019 the Company’s Board of Directors approved the cancellation of all 120,000 PSU’s outstanding at June
30, 2018.
2017
Omnibus Plan
On
April 30, 2019 the Company’s Board of Directors also approved a temporary reduction in the reserve under the Company’s
2017 Plan. As a result, the 367,317 shares of common stock available for issuance under the 2017 Plan as of March 31, 2019 was
reduced to 14,217. If the Company’s authorized common shares are increased at the 2019 annual meeting of stockholders, the
reserve will be increased back to 367,317.
4,968,944
Shares of Common Stock
or
Pre-Funded
Warrants to Purchase up to 4,968,944 Shares of Common Stock
Warrants
to Purchase Up to 4,968,944 Shares of Common Stock
PROSPECTUS
Book-Running Manager
Maxim Group LLC
Co-Manager
Dawson James Securities, Inc.
, 2019
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13.
|
Other Expenses of Issuance and Distribution
|
The
following table sets forth the costs and expenses, other than underwriting discounts, payable by DelMar Pharmaceuticals, Inc.,
or the Registrant, in connection with the sale and distribution of the securities being registered. All amounts are estimated
except the SEC registration fee.
Item
|
|
Amount
|
|
SEC registration fee
|
|
$
|
2,294.20
|
|
Legal fees and expenses
|
|
|
192,500.00
|
|
Accounting fees and expenses
|
|
|
40,000.00
|
|
Printing and engraving expenses
|
|
|
20,000.00
|
|
Transfer agent
and registrar fees and expenses
|
|
|
3,500. 00
|
|
Miscellaneous
|
|
|
166.80
|
|
Total
|
|
$
|
258,461.00
|
|
Item 14.
|
Indemnification of Directors and Officers
|
Neither our Articles of Incorporation or our Bylaws prevent
us from indemnifying our officers, directors and agents to the extent permitted under the Nevada Revised Statute (“NRS”).
NRS Section 78.7502 provides that a corporation shall indemnify any director, officer, employee or agent of a corporation against
expenses, including attorneys’ fees, actually and reasonably incurred by him in connection with any the defense to the extent
that a director, officer, employee or agent of a corporation has been successful on the merits or otherwise in defense of any action,
suit or proceeding referred to Section 78.7502(1) or 78.7502(2), or in defense of any claim, issue or matter therein.
NRS Section 78.7502(1) provides that a corporation may indemnify
any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative, except an action by or in the right of the corporation, by reason of
the fact that he is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise,
against expenses, including attorneys’ fees, judgments, fines and amounts paid in settlement actually and reasonably incurred
by him in connection with the action, suit or proceeding if he: (a) is not liable pursuant to NRS Section 78.138; or (b) acted
in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful.
NRS Section 78.7502(2) provides that a corporation may indemnify
any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by
or in the right of the corporation to procure a judgment in its favor, by reason of the fact that he is or was a director, officer,
employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or other enterprise against expenses, including amounts paid in
settlement and attorneys’ fees actually and reasonably incurred by him in connection with the defense or settlement of the
action or suit if he: (a) is not liable pursuant to NRS Section 78.138; or (b) acted in good faith and in a manner which he reasonably
believed to be in or not opposed to the best interests of the corporation. Indemnification may not be made for any claim, issue
or matter as to which such a person has been adjudged by a court of competent jurisdiction, after exhaustion of all appeals there
from, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent that
the court in which the action or suit was brought or other court of competent jurisdiction determines upon application that in
view of all the circumstances of the case, the person is fairly and reasonably entitled to indemnity for such expenses as the court
deems proper.
NRS Section 78.747 provides that except as otherwise provided
by specific statute, no stockholder, director or officer of a corporation is individually liable for a debt or liability of the
corporation, unless the director or officer acts as the alter ego of the corporation. The court as a matter of law must determine
the question of whether a director or officer acts as the alter ego of a corporation.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933, as amended (the “Securities Act”), may be permitted to directors, officers or controlling persons
of ours, pursuant to the foregoing provisions, or otherwise, we have been informed that, in the opinion of the SEC, such indemnification
is against public policy as expressed in the Securities Act and is therefore unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such a director, officer or
controlling person in connection with the securities being registered, we will, unless in the opinion of our counsel the matter
has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by us is against public policy as expressed hereby in the Securities Act and we will be governed by the final adjudication of such
issue.
Item 15.
|
Recent Sales of Unregistered Securities.
|
On May 8, 2019, we effected a one-for-ten reverse stock split
(the “Reverse Stock Split”) of our issued and outstanding and authorized common stock. All per share amounts and number
of shares of common stock, in this Item 15 reflect the Reverse Stock Split. The Reverse Stock Split does not affect the our authorized
preferred stock of 5,000,000 shares; except that, pursuant to the terms of the Certificate of Designations of Series B Convertible
Preferred Stock for the issued and outstanding shares of our Series B Convertible Preferred Stock, par value $0.001 per share (the
“Series B Preferred Stock”), the conversion price at which shares of Series B Preferred Stock may be converted into
shares of common stock will be proportionately adjusted to reflect the Reverse Stock Split.
Investment Warrants
On June 5, 2019, we completed a registered direct offering (the
“RD Offering”) with certain institutional investors of an aggregate of 1,170,000 shares of common stock and, in a concurrent
private placement, warrants to purchase 760,500 shares of common stock at a combined purchase price of $3.10 per share and related
warrant. The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five
years (the “RD Warrants”). We have filed a registration statement on Form S-1 for the registration of the shares underlying
the RD Warrants, which was declared effective on July 16, 21019. The gross proceeds from the offering, prior to deducting offering
expenses and placement agent fees and expenses payable by us, were $3.6 million. We issued additional warrants to purchase 46,800
shares of common stock at an exercise price of $3.875 pursuant a placement agency agreement by and among us, Maxim Group LLC and
Dawson James Securities, Inc. for services provided in connection with the RD Offering.
On November 25, 2018 we issued an aggregate of 99,167 shares
of common stock in exchange for 297,500 exchanged warrants, pursuant to Warrant Exercise and Exchange Agreements, dated as of November
25, 2018 with certain institutional investors.
On September 20, 2017, we issued warrants to purchase 800,000
shares of common stock at an exercise price equal to $12.50 per whole share of common stock, pursuant to a securities purchase
agreement with certain institutional investors, and we issued additional warrants to purchase 40,000 shares of common stock at
an exercise price equal to $12.50 pursuant an engagement letter by and between us and H.C. Wainwright & Co, LLC for services
provided in connection with a securities offering of common stock and warrants.
On April 12, 2017, we issued warrants to purchase 207,692 shares
of common stock at an exercise price equal to $35.00 per whole share of common stock, pursuant to a securities purchase agreement
with certain institutional investors, and we issued additional warrants to purchase 13,846 shares of common stock at an exercise
price equal to $40.60 per whole share of common stock pursuant to an engagement letter by and between us and Rodman & Renshaw,
a unit of H.C. Wainwright & Co, LLC for services provided in connection with a securities offering of common stock and warrants.
Series B Preferred and Dividends
From April 29, 2016 through June 8, 2016, we issued a total
of 902,238 shares of our Series B Preferred Shares which are convertible into 225,560 for gross proceeds of $7,217,904.
During the three-year period ended June 30, 2018, we issued
42,921 shares of common stock as dividends on our outstanding shares of Series B Preferred Stock
Exchangeable Shares
During the three-year period ended June 30, 2018, 15,125 shares
of common stock upon exchange of Exchangeable Shares of 0959456 B.C. Ltd., a British Columbia corporation, and our subsidiary.
Warrant Exercises
During the three-year period ended June 30, 2018, we issued
20,960 shares of common stock upon exercise of warrants at an exercise price of $31.40.
During the three-year period ended June 30, 2018, we issued
9,110 shares of common stock upon exercise of warrants at an exercise price of $30.00.
During the three-year period ended June 30, 2018, we issued
62 shares of common stock upon the cashless exercise of 103 warrants with an exercise price of $30.00.
During the three-year period ended June 30, 2018, we issued
12,500 shares of common stock upon exercise of warrants at an exercise price of $15.40.
Compensatory Issuances
During the three-year period ended June 30, 2018, we issued
9,613 shares of common stock in relation to services received by us.
During the three-year period ended June 30, 2018, we granted
options pursuant to our 2017 Omnibus Incentive Plan to purchase 92,698 shares of our common stock at an exercise price of $9.70
per share.
During the three-year period ended June 30, 2018, we granted
140,000 performance stock units pursuant to our 2017 Omnibus Incentive Plan.
During the three-year period ended June 30, 2018, we granted
options pursuant to our Amended and Restated 2003 Employee Stock Option Plan to purchase 230,448 shares of our common stock at
an exercise price of $14.20 per share.
During the three-year period ended June 30, 2018, we issued
warrants to purchase an aggregate of 72,640 shares of our common stock at an exercise price of $21.60 for service to be rendered
by consultants to us.
Except as indicated above, in connection with the issuance of
the above unregistered securities we relied on the exemption from registration afforded by Section 4(a)(2) and Regulation D (Rule
506) of the Securities Act of 1933, as amended, based on representations to the Company made by the Exercising Holders that they
are “accredited investors” as such term is defined under Regulation D of the Securities Act. Until registered, the
Exchange Shares are restricted and may not be offered or sold in the United States absent registration or availability of an applicable
exemption from registration.
Item 16.
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Exhibits and Financial Statement Schedules.
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(a) Exhibits
The following exhibits are being filed with this Registration
Statement:
Exhibits:
|
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Description
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1.1*
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Form of Underwriting Agreement
|
3.1
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Articles of Incorporation of the Company (incorporated by reference to Exhibit 3.1 of the Company’s Registration Statement on Form S-1 filed with the SEC on August 17, 2010)
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3.2
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Articles of Merger of the Company (incorporated by reference to Exhibit 3.1(b) of the Company’s Current Report on Form 8-K filed with the SEC on January 23, 2013)
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3.3
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Certificate of Designation of Special Voting Preferred Stock of the Company (incorporated by reference to Exhibit 3.1(a) of the Company’s Current Report on Form 8-K filed with the SEC on January 23, 2013)
|
3.4
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Bylaws of the Company (incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S-1 filed with the SEC on August 17, 2010)
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3.5
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Amendment to Bylaws of the Company (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 14, 2013)
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3.6
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Certificate of Designation of Series A Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014)
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3.7
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Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 7, 2013)
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3.8
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Certificate of Change (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2016)
|
3.9
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|
Certificate of Designation of Series B Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 5, 2016)
|
3.10
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The Certificate of Amendment to the Articles of Incorporation, as amended, of DelMar Pharmaceuticals Inc., dated April 11, 2018 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2018)
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3.11
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Certificate of Correction to the Company’s articles of incorporation, filed with the Secretary of State of the State of Nevada on April 17, 2019 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 17, 2019)
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3.12
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|
Certificate of Change of DelMar Pharmaceuticals, Inc., dated May 7, 2019 and effective May 8, 2019 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 8, 2019)
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3.13
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Certificate of Amendment to the Articles of Incorporation, as amended, of DelMar Pharmaceuticals Inc., dated June 26, 2019 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 28, 2019)
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4.1
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Specimen Common Stock Certificate, $.001 par value (incorporated by reference to Exhibit 4 of the Company’s Registration Statement on Form 8-A filed with the SEC on September 14, 2012)
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4.2
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Form of Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Registration Statement on Form S-1/A filed with the SEC on July 9, 2015)
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4.3
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Form of Investor Warrant (incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
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4.4
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Form of Dividend Warrant (incorporated by reference to Exhibit 10.7 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
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4.5
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Form of Election to Exercise Warrants (incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 9, 2014)
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4.6
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Form of Investor Warrant Amendment (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2014)
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4.7
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Form of Dividend Warrant Amendment (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2014)
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4.8
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Form of Placement Agent Warrant Amendment (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 31, 2015)
|
4.9
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Form of Placement Agent Warrant (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on May 5, 2016)
|
4.10
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Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2017)
|
4.11
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Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on September 21, 2017)
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4.12*
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Form of Warrant Certificate
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4.13*
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Form of Pre-Funded Warrant Certificate
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4.14*
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|
Form of Underwriter’s Warrant
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4.15*
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Form of Warrant Agency Agreement
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5.1*
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Legal opinion of Fennemore Craig, P.C.
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5.2*
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Legal opinion of Lowenstein Sandler LLP
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10.1
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Form of Placement Agent Agreement (incorporated by reference to Exhibit 1.1 of the Company’s Registration Statement on Form S-1/A filed with the SEC on July 15, 2015)
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10.2
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Intercompany Funding Agreement, dated January 25, 2013, between the Company and Exchangeco (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
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10.3
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Support Agreement, dated January 25, 2013, among the Company, Exchangeco and Callco (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
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10.4
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Voting and Exchange Trust Agreement, dated January 25, 2013, among the Company, Callco, Exchangeco, and the Trustee (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
|
10.5†
|
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Memorandum of Understanding and Collaboration Agreement between Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. and Del Mar (BC) (incorporated by reference to Exhibit 10.8 of the Company’s Current Report on Form 8-K filed with the SEC on January 31, 2013)
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10.6†
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Patent Assignment Agreement, dated September 12, 2010, between Del Mar (BC) and Valent (incorporated by reference to Exhibit 10.9 of the Company’s Current Report on Form 8-K/A filed with the SEC on March 14, 2013)
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10.7†
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Amendment, dated January 21, 2013, to Patent Assignment Agreement, dated September 12, 2010, between Del Mar (BC) and Valent (incorporated by reference to Exhibit 10.10 of the Company’s Current Report on Form 8-K/A filed with the SEC on March 14, 2013)
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10.8
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Form of Exchange Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 7, 2015)
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10.9†
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Consulting Agreement, effective January 1, 2015 between Del Mar (BC) and Jeffrey Bacha (incorporated by reference to Exhibit 10.16 of the Company’s Registration Statement on Form S-1 filed with the SEC on April 10, 2015)
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10.10†
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Consulting Agreement, effective January 1, 2015 between Del Mar (BC) and Dennis Brown (incorporated by reference to Exhibit 10.17 of the Company’s Registration Statement on Form S-1 filed with the SEC on April 10, 2015)
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10.11†
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Consulting Agreement, effective January 1, 2015 between Del Mar (BC) and Scott Praill (incorporated by reference to Exhibit 10.18 of the Company’s Registration Statement on Form S-1 filed with the SEC on April 10, 2015)
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10.12
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Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 5, 2016)
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10.13
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Form of Royalty Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on May 5, 2016)
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10.14
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Form of Securities Purchase Agreement, dated April 12, 2017 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2017)
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10.15
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Engagement Letter Agreement, dated January 24, 2017 between DelMar Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2017)
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10.16
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Amendment No. 1 to letter agreement between DelMar Pharmaceuticals, Inc. H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2017)
|
10.17
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Amendment No. 2 to letter agreement between DelMar Pharmaceuticals, Inc. H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed with the SEC on April 13, 2017)
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10.18†
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Employment agreement among Delmar Pharmaceuticals Inc., Delmar Pharmaceuticals (BC) Ltd. and Jeffrey Bacha (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 10, 2017)
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10.19†
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Employment agreement among Delmar Pharmaceuticals Inc., Delmar Pharmaceuticals (BC) Ltd. and Scott Praill (incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 10, 2017)
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10.20†
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Amendment to consulting agreement between Delmar Pharmaceuticals (BC) Ltd. and Dennis Brown (incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 10, 2017)
|
10.21†
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2017 Omnibus Equity Incentive Plan (As Amended and Restated Effective as of February 1, 2018) (incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 14, 2018)
|
10.22
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|
Form of Performance Share Unit Award Agreement (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 12, 2017)
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10.23
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Engagement Letter Agreement, dated September 17, 2017 between DelMar Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on September 21, 2017)
|
10.24
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|
Form of Securities Purchase Agreement, dated September 20, 2017 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on September 21, 2017)
|
10.25†
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Settlement Agreement, dated January 1, 2018, between Delmar Pharmaceuticals, Inc. and Jeffrey Bacha (incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 14, 2018
|
10.26†
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Agreement, effective as of November 3, 2017 between the Company and Mr. Zarrabian (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 8, 2017
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10.27†
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Employment agreement, effective as of May 21, 2018 between the Company and Mr. Zarrabian (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 22, 2018
|
10.28
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Placement Agency Agreement, dated June 3, 2019, among the Company, Maxim Group LLC and Dawson James Securities, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 3, 2019)
|
10.29
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|
Form of Purchase Agreement, dated as of June 3, 2019 among the Company and the purchasers thereunder (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on June 3, 2019)
|
21.1
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|
Subsidiaries (incorporated by reference to Exhibit 21 of the Company’s Registration Statement on Form S-1 filed with the SEC on June 14, 2013)
|
23.1*
|
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Consent of Ernst & Young, LLP
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23.2*
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Consent of Fennemore Craig, P.C. (included in Exhibit 5.1)
|
23.3*
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Consent of Lowenstein Sandler LLP (included in Exhibit 5.2)
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24.1**
|
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Power of Attorney (included on the signature page of the registration statement filed on August 1, 2019)
|
EX-101.INS
|
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XBRL Instance Document**
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EX-101.SCH
|
|
XBRL Taxonomy Extension Schema Document**
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EX-101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase**
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EX-101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase*
*
|
EX-101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase*
*
|
EX-101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase**
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†
|
Indicates management contract or compensatory plan.
|
|
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*
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Filed herewith.
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|
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**
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Previously filed.
|
(b) Financial Statement Schedules
No financial statement schedules are provided because the information
called for is not required or is shown either in the financial statements or the notes thereto.
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales
are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of
the Securities Act;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually
or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding
the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would
not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation
of Registration Fee” table in the effective registration statement;
(iii) To include any material information with respect
to the plan of distribution not previously disclosed in the registration statement or any material change to such information in
the registration statement.
(2) That, for the purpose of determining any liability
under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide
offering
thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under
the Securities Act to any purchaser: each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance
on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede
or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or
made in any such document immediately prior to such date of first use.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities Act, the
Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized,
in the City of Vancouver, British Columbia, Canada, on the 12
th
day of August 2019.
|
DELMAR PHARMACEUTICALS, INC.
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|
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By:
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/s/ Scott Praill
|
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Scott Praill
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|
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Chief Financial Officer
|
Pursuant to the requirements of the Securities Act, this Registration
Statement has been signed by the following persons in the capacities and on the dates indicated.
Signature
|
|
Title
|
|
Date
|
|
|
|
/s/ Saiid
Zarrabian
|
|
Chief
Executive Officer and Director
(Principal
Executive Officer)
|
|
August 12, 2019
|
Saiid Zarrabian
|
|
|
|
|
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/s/ Scott
Praill
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
|
August 12, 2019
|
Scott Praill
|
|
|
|
|
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*
|
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Director
|
|
August 12, 2019
|
John K. Bell
|
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|
|
|
|
|
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*
|
|
Director
|
|
August 12, 2019
|
Lynda Cranston
|
|
|
|
|
|
|
|
*
|
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Director
|
|
August 12, 2019
|
Napoleone Ferrara
|
|
|
|
|
*
|
|
Director
|
|
August 12, 2019
|
Robert E. Hoffman
|
|
|
|
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*
|
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Director
|
|
August 12, 2019
|
Robert J. Toth
|
|
*By:
|
/s/
Scott Praill
|
|
|
Scott Praill
|
|
|
Attorney-in-Fact
|
|
II-8
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