VANCOUVER and HOUSTON, Dec. 19,
2019 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the
"Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company
focused on developing novel therapies for the treatment of prostate
cancer, today provided a corporate update and reported financial
results for the fiscal year ended September
30, 2019. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"This past year was ESSA's most significant year of progress
towards its goal of developing a novel prostate cancer therapy. Our
discovery efforts led to the selection of a next generation
N-terminal domain inhibitor of the androgen receptor ("aniten"),
EPI-7386, that was nominated as the IND candidate. Preclinically,
this potent compound exhibits a long half-life, and excellent
pharmaceutical properties, while also demonstrating on-target
specificity and anti-tumor activity against prostate cancer cell
lines and animal models resistant to currently used anti-androgens.
Preparations for an IND filing continue to advance and we remain on
track to file the IND in the first quarter of 2020 with an
initiation of the Phase 1 study of EPI-7386 expected in the first
half of 2020," stated David
Parkinson, MD, President and CEO of ESSA.
Dr. Parkinson continued, "With the $56
million raised through the acquisition of Realm
Therapeutics, plc and the subsequent private placement, the Company
has sufficient funds to complete the Phase 1 monotherapy
dose-escalation study and an expansion phase to that study. In
addition, the Company believes it is funded to be able to conduct a
combination study of EPI-7386 with currently utilized antiandrogens
in prostate cancer patients with earlier stages of the disease.
2020 will be another important year as we commence clinical
development of EPI-7386 as a single agent in advanced prostate
cancer as well as in combination with standard of care
anti-androgens in earlier lines of therapy. The Phase I clinical
trial will be conducted in men whose tumors are progressing (and
therefore PSA levels are rising) despite therapy with one of the
latest generation anti-androgen therapies. While patients will be
selected for the trial on the basis of clinical considerations, a
series of biological studies will characterize their individual
tumor biology. In addition, we will continue the characterization
of other aniten molecules in our pre-clinical pipeline."
Clinical and Corporate Highlights for 2019 Fiscal
Year
- On March 28, 2019, the Company
nominated EPI-7386 as the lead clinical candidate for the treatment
of metastatic castration-resistant prostate cancer ("mCRPC")
- On July 15, 2019, the Company
appointed Dr. Alessandra Cesano as
Chief Medical Officer
- On July 31, 2019, the Company
completed the acquisition of Realm Therapeutics, plc ("Realm"),
which provided the Company with approximately $20M in additional funds
- On August 23, 2019, the Company
closed an equity financing for gross proceeds of $36 million
- In October, the Company paid off the balance of its
$3.6M debt facility, leaving the
Company with no outstanding debt
- Throughout the year, at multiple scientific conferences, the
Company presented preclinical data characterizing the preclinical
profile of EPI-7386 in various prostate cancer preclinical
models
Summary Financial Results
- Net Income (Loss). ESSA recorded a net loss of
$10.4 million ($1.24 loss per common share based on 8,433,441
weighted average common shares outstanding) for the year ended
September 30, 2019, compared to a net
loss of $11.6 million ($2.55 loss per common share based on 4,566,519
weighted average common shares outstanding) for the year ended
September 30, 2018. The net loss for
the fourth quarter ended September 30,
2019 was $1.0 million compared
to a net loss of $2.3 million for the
fourth quarter ended September 30,
2018.
- Research and Development ("R&D") expenditures.
R&D expenditures for the year ended September 30, 2019 were $6.7 million compared to $4.9 million for the year ended September 30, 2018. For the fourth quarter ended
September 30, 2019, R&D
expenditures were $2.0 million (net
and gross), as compared to $0.9
million net of grants ($1.2
million gross) for the fourth quarter ended September 30, 2018. The increase in R&D
expenditures for the full year and fourth quarter were primarily
related to ESSA's efforts in preparing an Investigational New Drug
("IND") application for its recently nominated clinical candidate,
EPI-7386. Costs in the comparative period included preclinical
research related to the Company's next-generation aniten
compounds.
- General and administration ("G&A") expenditures.
G&A expenditures for the year ended September 30, 2019 were $5.5 million compared to $5.9 million for the year ended September 30, 2018. For the fourth quarter ended
September 30, 2018, G&A
expenditures were $1.3 million,
compared to $1.2 million for the
fourth quarter ended September 30,
2018. The decrease in the full year is the result of a
reduction in share-based payments, rent expense, and professional
fees. The increase in the fourth quarter is a result of increased
corporate activity following the acquisition of Realm, including
directors fees, investor relations, and regulatory fees.
Liquidity and Outstanding Share Capital
Cash on
hand at September 30, 2019 was
$53.3 million, with working capital
of $48.7 million, reflecting the
aggregate gross proceeds of the completed August 2019 financing of $36 million, the acquisition of Realm which
provided the Company with $22.2
million in cash, less operating expenses in the intervening
period.
As of September 30, 2019, the
Company had 20,762,374 common shares issued and outstanding.
In addition, as of September 30,
2019 there were 12,393,092 common shares issuable upon the
exercise of warrants and broker warrants. This includes 11,919,404
prefunded warrants at an exercise price of $0.0001, and 473,688 other warrants at a weighted
average exercise price of $34.36.
There are 5,314,000 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$3.19 per common share.
About ESSA Pharma Inc.
ESSA is a pharmaceutical
company focused on developing novel and proprietary therapies for
the treatment of castration-resistant prostate cancer in patients
whose disease is progressing despite treatment with current
therapies. ESSA's proprietary "aniten" compounds bind to the
N-terminal domain of the androgen receptor ("AR"), inhibiting AR
driven transcription and the AR signaling pathway in a unique
manner which bypasses the drug resistance mechanisms associated
with current anti-androgens. The Company is currently progressing
IND-enabling studies and expects to file an IND with the U.S. Food
and Drug Administration ("FDA") for EPI-7386 in the first calendar
quarter of 2020. For more information, please visit
www.essapharma.com or follow us on Twitter under
@ESSAPharma.
About Prostate Cancer
Prostate cancer is the
second-most commonly diagnosed cancer among men and the fifth most
common cause of male cancer death worldwide (Globocan, 2018).
Adenocarcinoma of the prostate is dependent on androgen for tumor
progression and depleting or blocking androgen action has been a
mainstay of hormonal treatment for over six decades. Although
tumors are often initially sensitive to medical or surgical
therapies that decrease levels of testosterone, disease progression
despite castrate levels of testosterone generally represents a
transition to the lethal variant of the disease, mCRPC, and most
patients ultimately succumb to the illness. The treatment of mCRPC
patients has evolved rapidly over the past five years. Despite
these advances, additional treatment options are needed to improve
clinical outcomes in patients, particularly those who fail existing
treatments including abiraterone or enzalutamide, or those who have
contraindications to receive those drugs. Over time, patients with
mCRPC generally experience continued disease progression, worsening
pain, leading to substantial morbidity and limited survival rates.
In both in vitro and in vivo animal studies, ESSA's novel approach
to blocking the androgen pathway has been shown to be effective in
blocking tumor growth when current therapies are no longer
effective.
Forward-Looking Statement Disclaimer
This release
contains certain information which, as presented, constitutes
"forward-looking information" within the meaning of the Private
Securities Litigation Reform Act of 1995 and/or applicable Canadian
securities laws. Forward-looking information involves statements
that relate to future events and often addresses expected future
business and financial performance, containing words such as
"anticipate", "believe", "plan", "estimate", "expect", and
"intend", statements that an action or event "may", "might",
"could", "should", or "will" be taken or occur, or other similar
expressions and includes, but is not limited to, statements
regarding the preparation and expected timing of an IND filing with
the FDA for EPI-7386, a Phase 1 study of EPI-7386, a combination
study of EPI-7386 and other statements surrounding the Company's
clinical evaluation of EPI-7386.
Forward-looking statements and information are subject to
various known and unknown risks and uncertainties, many of which
are beyond the ability of ESSA to control or predict, and which may
cause ESSA's actual results, performance or achievements to be
materially different from those expressed or implied thereby. Such
statements reflect ESSA's current views with respect to future
events, are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while
considered reasonable by ESSA as of the date of such statements,
are inherently subject to significant medical, scientific,
business, economic, competitive, political and social uncertainties
and contingencies. In making forward looking statements, ESSA may
make various material assumptions, including but not limited to (i)
the accuracy of ESSA's financial projections; (ii) obtaining
positive results of clinical trials; (iii) obtaining necessary
regulatory approvals; and (iv) general business, market and
economic conditions.
Forward-looking information is developed based on assumptions
about such risks, uncertainties and other factors set out herein
and in ESSA's Annual Report on Form 20-F dated December 19, 2019 under the heading "Risk
Factors", a copy of which is available on ESSA's profile on the
SEDAR website at www.sedar.com, ESSA's profile on EDGAR at
www.sec.gov, and as otherwise disclosed from time to time on ESSA's
SEDAR profile. Forward-looking statements are made based on
management's beliefs, estimates and opinions on the date that
statements are made and ESSA undertakes no obligation to update
forward-looking statements if these beliefs, estimates and opinions
or other circumstances should change, except as may be required by
applicable Canadian and United
States securities laws. Readers are cautioned against
attributing undue certainty to forward-looking statements.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
(Unaudited)
Amounts in thousands of United States dollars
|
|
|
|
|
|
|
September
30, 2019
|
|
September
30, 2018
|
|
|
|
|
|
Cash
|
$
|
53,323
|
|
$
|
14,829
|
Prepaid and other
assets
|
|
1,451
|
|
1,188
|
|
|
|
|
|
Total
assets
|
$
|
54,774
|
|
$
|
16,017
|
|
|
|
|
|
Current
liabilities
|
|
5,575
|
|
3,344
|
Long-term
debt
|
|
-
|
|
3,501
|
Derivative
liability
|
|
18
|
|
20
|
Shareholders'
deficiency
|
|
49,181
|
|
9,152
|
|
|
|
|
|
Total liabilities and
shareholders' deficiency
|
$
|
54,774
|
|
$
|
16,017
|
ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
Amounts in thousands of United States dollars, except share and per
share data
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September 30,
2019
|
|
Three months
ended
September 30,
2018
|
|
Year ended
September 30,
2019
|
|
Year ended
September 30,
2018
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
2,005
|
|
$
|
927
|
|
$
|
6,696
|
|
$
|
4,873
|
Financing
costs
|
|
119
|
|
207
|
|
603
|
|
912
|
General and
administration
|
|
1,251
|
|
1,211
|
|
5,473
|
|
5,929
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
(3,375)
|
|
(2,345)
|
|
(12,772)
|
|
(11,714)
|
|
|
|
|
|
|
|
|
|
Gain (loss) on
derivative liability
|
|
(10)
|
|
21
|
|
1
|
|
151
|
Gain on acquisition of
Realm
|
|
2,333
|
|
-
|
|
2,333
|
|
-
|
Other items
|
|
52
|
|
53
|
|
35
|
|
(39)
|
|
|
|
|
|
|
|
|
|
Net loss before
taxes
|
|
(1,000)
|
|
(2,271)
|
|
(10,403)
|
|
(11,602)
|
Income tax
expense
|
|
-
|
|
(5)
|
|
(38)
|
|
(27)
|
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
$
|
(1,000)
|
|
$
|
(2,276)
|
|
$
|
(10,441)
|
|
$
|
(11,629)
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share
|
$
|
(0.07)
|
|
$
|
(0.39)
|
|
$
|
(1.24)
|
|
$
|
(2.55)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of
common shares
outstanding
|
|
14,665,230
|
|
5,776,098
|
|
8,433,441
|
|
4,566,519
|
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SOURCE ESSA Pharma Inc