As filed with the Securities and Exchange
Commission on April 8, 2020
Registration
No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Outlook Therapeutics, Inc.
(Exact name of registrant as specified in
its charter)
Delaware
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2836
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38-3982704
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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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7 Clarke Drive
Cranbury, New Jersey 08512
(609) 619-3990
(Address, including zip code, and telephone
number, including
area code, of registrant’s principal
executive offices)
Lawrence A.
Kenyon
President, Chief
Executive Officer and Chief Financial Officer
Outlook Therapeutics,
Inc.
7 Clarke Drive
Cranbury, New
Jersey 08512
(609) 619-3990
(Name, address,
including zip code, and telephone number, including area code, of agent for service)
Copies to:
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Yvan-Claude Pierre
Marianne C. Sarrazin
Pia Kaur
Cooley LLP
55 Hudson Yards
New York, New York 10001
(212) 479-6275
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Approximate date of commencement of
proposed sale to the public: As soon as practicable after this registration statement becomes effective.
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. x
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 statement
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:
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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x
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Smaller reporting company
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x
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Emerging growth company
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x
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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. x
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
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Amount to be
Registered (1)
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Proposed Maximum Offering Price Per
Share (2)
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Proposed Maximum
Aggregate
Offering Price (2)
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Amount of
Registration Fee
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Common stock, $0.01 par value per share, issuable upon exercise of common stock purchase warrants
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3,799,213(3)
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$0.575
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$2,184,547.48
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$283.55
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Common stock, $0.01 par value per share, issuable upon exercise of placement agent’s warrants to purchase common stock
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531,890(4)
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$0.575
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$305,836.75
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$39.70
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Total
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4,331,103
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$2,490,384.23
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$323.25
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(1)
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Pursuant to Rule 416(a) of the Securities Act of 1933, as amended, or the Securities Act, this Registration Statement also covers any additional shares of common stock that may become issuable to prevent dilution from stock splits, stock dividends and similar events.
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(2)
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This estimate is made pursuant to Rule 457(c) of the Securities Act solely for purposes of calculating the registration fee. The price per share and aggregate offering price are based upon the average of the high and low prices of the Registrant’s common stock on April 6, 2020, as reported on The Nasdaq Capital Market.
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(3)
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Represents shares of common stock issuable upon the exercise of warrants to purchase common stock at an exercise price of $0.9535 per share issued by the Registrant in a private placement on February 26, 2020.
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(4)
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Represents shares of common stock issuable upon the exercise of warrants to purchase common stock at an exercise price of $1.27 per share issued to the placement agent on February 26, 2020.
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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 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. The selling stockholders 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 the
selling stockholders are not soliciting offers to buy these securities, in any state where the offer or sale of these securities
is not permitted.
SUBJECT
TO COMPLETION, DATED APRIL 8, 2020
PROSPECTUS
4,331,103 Shares
of Common Stock
This prospectus
relates to the resale by the selling stockholders identified in this prospectus of up to 4,331,103 shares of our common stock that
are issuable upon the exercise of certain outstanding warrants, or the warrants, to purchase shares of our common stock, or the
warrant shares.
We are not selling
any shares of common stock and will not receive any proceeds from the sale of the warrant shares by the selling stockholders under
this prospectus. Upon the exercise of the warrants for all 4,331,103 shares of our common stock by payment of cash, however, we
will receive aggregate gross proceeds of approximately $4.3 million.
We have agreed
to bear all of the expenses incurred in connection with the registration of these warrant shares. The selling stockholders will
pay or assume brokerage commissions and similar charges, if any, incurred for the sale of the warrant shares.
The selling stockholders
identified in this prospectus may offer the shares from time to time through public or private transactions at fixed prices, at
prevailing market prices, at varying prices determined at the time of sale, or at privately negotiated prices. We provide more
information about how the selling stockholders may sell their shares of common stock in the section titled “Plan of Distribution”
beginning on page 9 of this prospectus. We will not be paying any underwriting discounts or commissions in connection with any
offering of warrant shares under this prospectus.
Our common stock
is listed on The Nasdaq Capital Market under the ticker symbol “OTLK.” On April 6, 2020, the last reported sale price
per share of our common stock was $0.57 per share.
You should read
this prospectus, together with additional information described under the headings “Incorporation of Certain Information
by Reference” and “Where You Can Find More Information,” carefully before you invest in any of our securities.
We are an “emerging
growth company” under the federal securities laws and are subject to reduced public company reporting requirements for this
prospectus and future filings.
Investing
in our securities involves a high degree of risk. See “Risk Factors” on page 4 of this prospectus.
Neither the
Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this
prospectus is ,
2020.
TABLE OF CONTENTS
This prospectus is part of a registration
statement on Form S-1 that we filed with the Securities and Exchange Commission, or the SEC. We incorporate by reference important
information into this prospectus. You may obtain the information incorporated by reference without charge by following the instructions
under “Where You Can Find More Information.” You should carefully read this prospectus as well as additional information
described under “Incorporation of Certain Information by Reference,” before deciding to invest in our common shares.
We are responsible for the information
contained in this prospectus. We have not authorized anyone to provide you with different information, and we take no responsibility
for any other information others may give you. If anyone provides you with different or inconsistent information, you should not
rely on it. We are not, and the selling stockholders are not, making an offer to sell these securities in any jurisdiction where
the offer or sale is not permitted. You should not assume that the information contained in this prospectus is accurate as of any
date other than the date on the front of this prospectus.
Except as otherwise indicated or unless
the context otherwise requires, references to “company,” “we,” “us,” “our” or “Outlook
Therapeutics,” refer to Outlook Therapeutics, Inc. and its consolidated subsidiaries. Our name “Outlook Therapeutics,”
the Outlook Therapeutics logo, LYTENAVA and other trademarks or service marks of Outlook Therapeutics, Inc. appearing in this prospectus
supplement, the accompanying prospectus and any related free writing prospectus and the information incorporated by reference herein
or therein are the property of Outlook Therapeutics, Inc. Other trademarks, service marks or trade names appearing in this prospectus
supplement, the accompanying prospectus and any related free writing prospectus and the information incorporated by reference herein
or therein are the property of their respective owners. We do not intend our use or display of other companies’ trade names,
trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and the documents incorporated by reference
herein and therein, contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Securities Exchange Act of 1934, as amended, or the Exchange Act, about us and our industry that involve substantial risks
and uncertainties. All statements, other than statements of historical facts contained in this prospectus and the documents incorporated
by reference herein and therein, including statements regarding our future financial condition, business strategy and plans, and
objectives of management for future operations, are forward-looking statements. In some cases you can identify these statements
by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “could,” “would,” “project,” “plan,”
“expect” or the negative or plural of these words or similar expressions. These forward-looking statements include,
but are not limited to, statements concerning the following:
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the timing and the success of the design of the clinical trials and
planned clinical trials of our lead product candidate, ONS-5010;
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whether the results of our clinical trials will be sufficient to support
domestic or global regulatory approvals;
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our ability to obtain and maintain regulatory approval for ONS-5010
in the United States and other markets if we successfully complete clinical trials;
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our expectations regarding the potential market size and the size
of the patient populations for our product candidates, if approved, for commercial use;
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our ability to fund our working capital requirements;
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the rate and degree of market acceptance of our current and future
product candidates;
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the implementation of our business model and strategic plans for our
business and product candidates;
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developments or disputes concerning our intellectual property or other
proprietary rights;
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our ability to maintain and establish collaborations or obtain additional
funding;
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our expectations regarding government and third-party payor coverage
and reimbursement;
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our ability to compete in the markets we serve;
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the factors that may impact our financial results; and
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our estimates regarding the sufficiency of our cash resources and
our need for additional funding.
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These statements reflect our current views with respect to future
events and are based on assumptions and are subject to risks and uncertainties, including risks associated with the global COVID-19
pandemic, and uncertainty regarding the effects it may have on our clinical trials and otherwise. Given these uncertainties, you
should not place undue reliance on these forward-looking statements. We discuss in greater detail many of these risks under the
heading “Risk Factors” contained in our most recent annual report on Form 10-K, which is incorporated by reference
into this prospectus supplement in its entirety, as well as any amendments thereto reflected in subsequent filings with the SEC.
Also, these forward-looking statements represent our estimates and assumptions only as of the date of the document containing the
applicable statement. Unless required by law, we undertake no obligation to update or revise any forward-looking statements to
reflect new information or future events or developments. Thus, you should not assume that our silence over time means that actual
events are bearing out as expressed or implied in such forward-looking statements. You should read this prospectus together with
the documents we have filed with the SEC that are incorporated by reference herein and therein and any free writing prospectus
that we may authorize for use in connection with this offering completely and with the understanding that our actual future results
may be materially different from what we expect. We qualify all of the forward-looking statements in the foregoing documents by
these cautionary statements.
This prospectus and the documents incorporated by reference
herein and therein contain market data and industry statistics and forecasts that are based on independent industry publications
and other publicly available information. Although we believe that these sources are reliable, we do not guarantee the accuracy
or completeness of this information and we have not independently verified this information. Although we are not aware of any misstatements
regarding the market and industry data presented in this prospectus and the documents incorporated by reference herein and therein,
these estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under
the heading “Risk Factors” contained in this prospectus supplement and any related free writing prospectus, and under
similar headings in the other documents that are incorporated by reference into this prospectus supplement and the accompanying
prospectus. Accordingly, investors should not place undue reliance on this information.
PROSPECTUS SUMMARY
This
summary does not contain all of the information you should consider before investing in our securities. You should read this
entire prospectus carefully, including the risks of investing in our securities discuss under the heading “Risk
Factors” beginning on page 4 of this prospectus and under similar headings in the documents incorporated by reference
herein.
Overview
We are a late clinical-stage biopharmaceutical
company working to develop the first ophthalmic formulation of bevacizumab approved by the U.S. Food and Drug Administration, or
FDA, for use in retinal indications. Our goal is to launch the first and only approved bevacizumab in the United States, Europe,
Japan and other markets for the treatment of wet age-related macular degeneration, or wet AMD, diabetic macular edema, or DME,
and branch retinal vein occlusion, or BRVO.
ONS-5010 (LYTENAVA (bevacizumab-vikg)) is an
investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the
treatment of wet AMD and other retinal diseases. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth
Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. The study design for our
Phase 3 clinical program to evaluate ONS-5010 as an ophthalmic formulation of bevacizumab was reviewed at an end of Phase 2 meeting
with the FDA in April 2018, and we filed our investigational new drug application with the FDA in the first quarter of calendar
2019.
Our Phase 3 program for ONS-5010 in wet AMD
involves two clinical trials, which we refer to as NORSE 1 and NORSE 2, evaluating ONS-5010 against ranibizumab (LUCENTIS). Enrollment
in the NORSE 1 study is complete with 61 patients enrolled, all in Australia. The endpoint for NORSE 1 is the difference in mean
change from baseline in visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to LUCENTIS dosed using the alternative
PIER clinical trial dosing regimen of three-monthly doses followed by quarterly dosing. While not designed as a pivotal study,
NORSE 1 is one of two studies agreed upon with the FDA in April 2018 and will provide initial safety and efficacy data relating
to ONS-5010 in wet AMD patients. We expect to report top line data from NORSE 1 in August 2020.
The NORSE 2 study began enrolling wet AMD patients
in July 2019. NORSE 2 is expected to enroll a total of at least 220 patients and is being conducted in the United States. The primary
endpoint for NORSE 2 is the difference in proportion of participants who gain at least 15 letters in the best corrected visual
acuity, or BCVA, at 11 months for ONS-5010 dosed on a monthly basis compared to LUCENTIS dosed using the alternative PIER clinical
trial dosing regimen. Enrollment in NORSE 2 is scheduled to be completed no later than the end of May 2020, but we are currently
assessing the potential impact of the COVID-19 outbreak on NORSE 2 enrollment, if any.
In addition, we have received agreements from
the FDA on three Special Protocol Assessments, or SPAs, for three additional registration clinical trials for our ongoing Phase
3 program for ONS-5010. These SPAs cover the protocols for NORSE 4, a registration clinical trial to treat branch retinal vein
occlusion, or BRVO, and NORSE 5 and NORSE 6, two registration clinical trials to treat DME.
Currently, the cancer drug Avastin (bevacizumab)
is used off-label for the treatment of wet AMD and other retinal diseases such as DME and BRVO even though Avastin has not been
approved by regulatory authorities for use in these diseases. If the ONS-5010 clinical program is successful, it will support our
plans to submit for regulatory approval in multiple markets in 2021 including the United States, Europe and Japan, as well as other
markets. Because there are no approved bevacizumab products for the treatment of retinal diseases in such major markets, we are
developing ONS-5010 as a standard Biologics License Application and not using the biosimilar drug development pathway that would
be required if Avastin were an approved drug for the targeted diseases. If approved, we believe ONS-5010 has potential to mitigate
risks associated with off-label use of bevacizumab. Off-label use of bevacizumab is currently estimated to account for at least
50% of all wet AMD prescriptions in the United States.
Risks Associated with our Business
Our business is subject to numerous risks, as described under
the heading “Risk Factors” contained herein, and under similar headings in the documents that are incorporated by reference
into this prospectus.
Additional Information
For additional information related to our business and operations,
please refer to the reports incorporated herein by reference, including our Annual Report on Form 10-K for the year ended September
30, 2019 as filed with the SEC on December 19, 2019, our Quarterly Report on Form 10-Q for the quarter ended December 31, 2019
as filed with the SEC on February 14, 2020 and our other Quarterly Reports and our Current Reports on Form 8-K as filed with the
SEC, as described in the section titled “Incorporation of Certain Information by Reference.”
Implications of Being an Emerging Growth Company
We are an “emerging growth company,” as defined
in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For so long as we remain an emerging growth
company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including
not being required to have our internal control over financial reporting audited by our independent registered public accounting
firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation
in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive
compensation and any golden parachute payments not previously approved.
We may take advantage of these reporting exemptions until we
are no longer an emerging growth company. We will remain an emerging growth company until the earlier of (1) September 30, 2021
(the last day of the fiscal year in which the fifth anniversary of our initial public offering occurs), (2) the last day of the
fiscal year in which we have total annual gross revenue of at least $1.07 billion, (3) the last day of the fiscal year in which
we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates
exceeds $700 million as of the prior June 30th, and (4) the date on which we have issued more than $1.0 billion in non-convertible
debt during the prior three-year period. We may choose to take advantage of some or all of these available exemptions and we have
taken advantage of some reduced reporting requirements in our public filings. Accordingly, the information that we provide stockholders
may be different than the information you receive from other public companies in which you hold stock.
Company Information
We initially incorporated in January 2010 in New Jersey, in
October 2015, reincorporated in Delaware by merging with and into a Delaware corporation, changed our name to Outlook Therapeutics,
Inc. in November 2018. Our headquarters are located at 7 Clarke Drive, Cranbury, New Jersey, 08512, and our telephone number at
that location is (609) 619-3990. Our website address is www.outlooktherapeutics.com. The information contained on, or that can
be accessed through, our website is not part of, and is not incorporated by reference into this prospectus and should not be considered
to be part of this prospectus.
The Offering
The selling stockholders identified under the section titled
“Selling Stockholders,” or the selling stockholders, may offer and sell up to 4,331,103 shares of our common stock.
Our common stock is currently listed on The Nasdaq Capital Market under the symbol “OTLK.” Shares of common stock that
may be offered under this prospectus will be fully paid and non-assessable. We will not receive any of the proceeds of sales by
the selling stockholders of any of the common stock covered by this prospectus. Throughout this prospectus, when we refer to the
shares of our common stock being registered on behalf of the selling stockholders for offer and sale, we are referring to the shares
of common stock issuable upon exercise of the warrants sold to the selling stockholders, as described below under the section titled
“Selling Stockholders.”
RISK FACTORS
An investment in our securities involves a high degree of
risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties discussed
below, as well as those under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended
September 30, 2019, as filed with the SEC, and as incorporated by reference in this prospectus, as the same may be amended, supplemented
or superseded by the risks and uncertainties described under similar headings in the other documents that are filed by us after
the date hereof and incorporated by reference into this prospectus. Additional risks not currently known to us or that we currently
believe are immaterial may also significantly impair our business operations. Please also read carefully the section above titled
“Special Note Regarding Forward-Looking Statements.”
Our business could
be adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, in regions where
we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other
business operations, or materially affect our operations, including at our headquarters in New Jersey, which is currently subject
to a state executive order mandating shelter-in-place, and at our clinical trial sites, as well as the business or operations of
our manufacturers, CROs or other third parties with whom we conduct business.
Our business could
be adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared
by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of
the disease, including a New Jersey executive order, and several other state and local orders across the country, which, among
other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease
non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential
travel. As a result of these recent developments, we have implemented work-from-home policies for all our employees. The effects
of these orders, government-imposed quarantines and our work-from-home policies may negatively impact productivity, disrupt our
business and could delay our ONS-5010 clinical programs and timelines, the magnitude of which will depend, in part, on the length
and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and
similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial
condition.
Quarantines, shelter-in-place
and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations
could occur, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in
the United States and other countries, or the availability or cost of materials, which could disrupt our supply chain.
In
addition, our ongoing clinical trials are likely to be affected by the recent COVID-19 outbreak. Patient enrollment and recruitment
may be delayed due to local clinical trial site protocols designed to protect staff and patients from COVID-19 infection, and some
patients may not be able to comply with clinical trial protocols if quarantines or other restrictions impede patient movement or
interrupt healthcare services. Similarly, our ability to retain principal investigators
and site staff who, as healthcare providers, may have heightened exposure to COVID-19, could be disrupted, which would adversely
impact our clinical trial operations.
The spread of COVID-19,
which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by,
and the duration of, the COVID-19 pandemic, may be difficult to assess or predict, it is currently resulting in significant disruption
of global financial markets. This disruption, if sustained or recurrent, could make it more difficult for us to access capital,
which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting from the spread
of COVID-19 could materially affect our business and the value of our common stock.
The global pandemic
of COVID-19 continues to rapidly evolve. The ultimate impact of the recent COVID-19 outbreak or a similar health pandemic or epidemic
is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our
clinical trials, healthcare systems or the global economy as a whole. These effects could have a material impact on our operations,
and we will continue to monitor the COVID-19 situation closely.
Our common stock may be delisted
from Nasdaq and begin trading in the over-the-counter markets if we are not successful in regaining compliance with Nasdaq’s
continued listing standards, which may negatively impact the price of our common stock and our ability to access the capital markets.
On March 27, 2020, we received written
notification from The Nasdaq Stock Market LLC, or Nasdaq, indicating that as of March 27, 2020, we were not in compliance with
Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the minimum bid price of our listed securities
was less than $1.00 per share for the previous 30 consecutive business days. Under Nasdaq Listing Rule 5810(c)(3)(A), we have a
period of 180 calendar days, or until September 23, 2020, to regain compliance with the rule. To regain compliance, during this
180-day compliance period, the minimum bid price of our listed securities must close at $1.00 per share or more for a minimum of
10 consecutive business days. If we are unable to regain compliance during the 180-day period, we anticipate that we will receive
a delisting determination from Nasdaq, following which we anticipate requesting a hearing to remain on The Nasdaq Capital Market.
If granted, such request will ordinarily suspend such delisting determination until a decision by Nasdaq subsequent to the hearing.
We intend to actively monitor the minimum bid price of our listed securities and, as appropriate, will consider available options
to resolve the deficiencies and regain compliance with the Nasdaq Listing Rules, including effecting a reverse stock split.
If we are not successful in regaining
compliance, we anticipate that our common stock would begin trading on the over-the-counter market. Delisting from Nasdaq and trading
on the over-the-counter market could adversely affect the liquidity of our common stock. Stocks traded on the over-the-counter
market generally have limited trading volume and exhibit a wider spread between the bid/ask quotation, as compared to securities
listed on a national securities exchange. Consequently, you may not be able to liquidate your investment in the event of an emergency
or for any other reason.
If our common stock is delisted from
the Nasdaq, we could face significant material adverse consequences, including:
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A limited availability of market quotations
for our common stock;
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A reduced amount of news and analyst coverage
for our company;
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A decreased ability to issue additional
securities or obtain additional financing in the future;
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Reduced liquidity for our stockholders;
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Potential loss of confidence by partners
and employees; and
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Loss of institutional investor interest
and fewer business development opportunities.
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USE OF PROCEEDS
We are filing the registration statement of which this prospectus
forms a part to permit the holders of certain outstanding warrants to purchase shares of our common stock described in the section
titled “Selling Stockholders” to resell such shares of common stock issuable upon exercise of such warrants, or the
warrant shares. The selling stockholders will receive all of the net proceeds from sales of the warrant shares sold pursuant to
this prospectus and we will not receive any proceeds from the resale of any warrant shares offered by this prospectus by the selling
stockholders. However, upon the exercise of the warrants for 4,331,103 shares of our common stock by payment of cash, we will receive
aggregate gross proceeds of approximately $4.3 million. Any proceeds from the exercise of the warrants will be used for working
capital, and general corporate purposes, including in support of our ONS-5010 development program. We cannot predict when or if
the warrants will be exercised, and it is possible that the warrants may expire and never be exercised.
Selling
Stockholders
On February 24, 2020, we entered into a securities purchase
agreement with certain institutional and accredited investors, pursuant to which we agreed to sell and issue, in a registered direct
offering, offered pursuant to an effective shelf registration statement on Form S-3 an aggregate of 7,598,426 shares of common
stock, for aggregate gross proceeds of approximately $7.72 million, before deducting fees to the placement agents and other estimated
offering expenses payable by us.
In a concurrent private placement, pursuant to the purchase
agreement, we offered and sold to the investors common stock purchase warrants to purchase an aggregate of 3,799,213 shares of
our common stock. The purchase warrants have an exercise price per share equal to $0.9535, are immediately exercisable and expire
four years from the issuance date.
Pursuant to a letter agreement dated as of December 10, 2019,
we engaged H.C. Wainwright & Co., LLC, or Wainwright, to act as the exclusive placement agent in connection with the registered
direct and private placement transaction. We issued placement agent warrants to purchase an aggregate of 531,890 shares of our
common stock, or the placement agent warrants. The placement agent warrants have an exercise price of $1.27 per share, are immediately
exercisable and expire five years from the issuance date. The shares of common stock underlying the placement agent warrants and
the purchase warrants are referred to collectively as the warrant shares.
Pursuant to the purchase agreements, we agreed to file the registration
statement of which this prospectus is a part to cover the resale of the shares of common stock underlying the purchase warrants
and to keep such registration statement effective until the date that is six months after no selling stockholder owns any warrants.
We are registering the resale of the warrant shares to permit
each of the selling stockholders identified below to resell or otherwise dispose of the warrant shares in the manner contemplated
under “Plan of Distribution” in this prospectus (as may be supplemented and amended). Throughout this prospectus, when
we refer to the shares of our common stock being registered on behalf of the selling stockholders, we are referring to the warrant
shares, and when we refer to the selling stockholders in this prospectus, we are referring to the purchasers of the warrants.
The selling stockholders may sell some, all or none of their
warrant shares. We do not know how long the selling stockholders will hold the warrant shares before selling them, and we currently
have no agreements, arrangements or understandings with the selling stockholders regarding the sale or other disposition of any
of the warrant shares. The warrant shares covered hereby may be offered from time to time by the selling stockholders.
The following table sets forth the name of each selling stockholder,
the number and percentage of our outstanding shares of common stock beneficially owned by the selling stockholders as of March
31, 2020, the number of warrant shares that may be offered under this prospectus, and the number and percentage of our outstanding
shares of common stock beneficially owned by the selling stockholders assuming all of the warrant shares covered hereby are sold.
Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect
to our common stock. Generally, a person “beneficially owns” shares of our common stock if the person has or shares
with others the right to vote those shares or to dispose of them, or if the person has the right to acquire voting or disposition
rights within 60 days. The number of shares in the column “Shares of Common Stock being Offered” represents all of
the warrant shares that a selling stockholder may offer and sell from time to time under this prospectus.
All information contained in the table below and the footnotes
thereto is based upon information provided to us by the selling stockholders. The selling stockholders may have sold or transferred,
in transactions exempt from the registration requirements of the Securities Act, some or all of their warrant shares or other securities
since the date on which the information in the table below if presented. Information about the selling stockholders may change
over time. The percentage of shares owned after the offering is based on 89,751,192 shares of common stock outstanding as of March
31, 2020.
|
|
|
|
|
|
|
|
Beneficial
Ownership
After this Offering (1)
|
|
Name
|
|
Shares
of Common Stock Beneficially Owned Prior to this
Offering
|
|
|
Shares
of Common Stock Offered Hereby
|
|
|
Number
of
Shares
|
|
|
%
|
|
Intracoastal Capital, LLC (2)
|
|
|
48,178
|
|
|
|
2,500
|
|
|
|
45,678
|
|
|
|
*
|
|
Rosalind Master Fund L.P. (3)
|
|
|
738,172
|
|
|
|
246,046
|
|
|
|
492,126
|
|
|
|
*
|
|
Armistice Capital Master Fund Ltd. (4)
|
|
|
3,271,232
|
|
|
|
1,476,378
|
|
|
|
1,794,854
|
|
|
|
2.0
|
%
|
Sabby Volatility Warrant Master Fund, Ltd. (5)
|
|
|
4,595,596
|
|
|
|
1,476,378
|
|
|
|
3,119,218
|
|
|
|
3.4
|
%
|
Noam Rubinstein (6)(7)
|
|
|
315,183
|
|
|
|
315,183
|
|
|
|
0
|
|
|
|
*
|
|
Craig Schwabe (6)(8)
|
|
|
17,951
|
|
|
|
17,951
|
|
|
|
0
|
|
|
|
*
|
|
Michael Vasinkevich (6)(9)
|
|
|
341,075
|
|
|
|
341,075
|
|
|
|
0
|
|
|
|
*
|
|
Charles Worthman (6)(10)
|
|
|
5,319
|
|
|
|
5,319
|
|
|
|
0
|
|
|
|
*
|
|
_____________________________
*
(1)
|
Less than one percent
Assumes the exercise in full of the warrants
and sale of all warrant shares registered pursuant to this prospectus, although the selling stockholders are under no obligation
known to us to sell any shares of common stock at this time.
|
(2)
|
Before offering includes (i) 45,678 shares of common stock and (ii) purchase warrants to purchase 2,500 shares of common stock, all of which are held directly by Intracoastal Capital, LLC (“Intracoastal”). Mitchell P. Kopin and Daniel B. Asher, each of whom are managers of Intracoastal, have shared voting control and investment discretion over the securities reported herein that are held by Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be deemed to beneficially own the securities held by Intracoastal. The address of each of Mr. Kopin and Intracoastal is 245 Palm Trail, Delray Beach, Florida 33483. The address of Mr. Asher is 111 W. Jackson Boulevard, Suite 2000, Chicago, Illinois 60604.
|
(3)
|
Before offering includes (i) 492,126 shares of common stock and (ii) purchase warrants to purchase 246,046 shares of common stock, all of which are held directly by Rosalind Master Fund L.P. (“Rosalind Fund”). Mr. Steven Salamon is the Portfolio Manager and President of Rosalind Advisors, Inc., which is the investment advisor of Rosalind Fund. As a result, Mr. Salamon may be deemed to beneficially own the securities held by Rosalind Fund. The address of each of Rosalind Fund, Rosalind Advisors, Inc. and Mr. Salamon is c/o TD Waterhouse, 77 Bloor Street West, 3rd Floor, Toronto, ON M5S 1M2, Canada.
|
(4)
|
Before offering includes (i) 1,794,854 shares of common stock and (ii) purchase warrants to purchase 1,476,378 shares of common stock, all of which are held directly by Armistice Capital Master Fund Ltd. (“Armistice Fund”). Steven Boyd is the Managing Member of Armistice Capital, LLC, which acts as the investment manager of Armistice Fund. As a result, Mr. Boyd may be deemed to beneficially own the securities held by Armistice Fund. The address of Armistice Fund is c/o dms Corporate Services ltd., 20 Genesis Close, P.O. Box 314, Grand Cayman KY1-1104, Cayman Islands, and the address of each of Armistice Capital LLC and Mr. Boyd is 510 Madison Avenue, 7th Floor, New York, NY 10022.
|
(5)
|
Before offering includes (i) 3,104,349 shares of common stock, (ii) purchase warrants to purchase 1,476,378 shares of common stock and (iii) other warrants to purchase 14,869 shares of common stock, all of which are held directly by Sabby Volatility Warrant Master Fund, Ltd. (“SVWMF”). Hal Mintz is the manager of Sabby Management, LLC, which acts as the investment manager of SVWMF. As a result, Mr. Mintz may be deemed to beneficially own the securities held by SVWMF. The address of each of SVWMF, Sabby Management LLC and Mr. Mintz is c/o Sabby Management, LLC, 10 Mountainview Road, Suite 205, Upper Saddle River, New Jersey 07458.
|
(6)
|
The selling stockholder is an affiliate of a registered broker-dealer.
|
(7)
|
Before the offering includes (i) purchase warrants to purchase 147,638 shares of common stock and (ii) placement agent warrants to purchase 167,545 shares of common stock. The address of Mr. Rubinstein is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.
|
(8)
|
Before the offering reflects placement agent warrants to purchase 17,951 shares of common stock. The address of Mr. Schwabe is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.
|
(9)
|
Before the offering reflects placement agent warrants to purchase 341,075 shares of common stock. The address of Mr. Vasinkevich is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.
|
(10)
|
Before the offering reflects placement agent warrants to purchase 5,319 shares of common stock. The address of Mr. Worthman is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022.
|
Other Relationships with the Selling
Stockholders
Messrs. Rubinstein, Schwabe, Vasinkevich, and Worthman, selling
stockholders, are each affiliated with H.C. Wainwright, which acted as the placement agent in the concurrent private placement
of the purchase warrants for which we are registering the underlying shares in the registration statement of which this prospectus
forms a part, and received the placement agent warrants for which we are registering the underlying shares in the registration
statement of which this prospectus forms a part as compensation in connection therewith. Mr. Rubinstein also participated as in
investor in the concurrent private placement. From time to time, H.C. Wainwright may provide in the future various advisory, investment
and commercial banking and other services to us in the ordinary course of business, for which they have received and may continue
to receive customary fees and commissions. H.C. Wainwright acted as exclusive financial advisor for our December 2019 warrant restructuring
transaction, for which it received compensation. Except with respect to the foregoing, none of the selling stockholders has, or
within the past three years has had, any position, office or other material relationship with us.
Plan
of Distribution
We are registering the warrant shares issuable to the selling
stockholders to permit the resale of these shares of common stock by the selling stockholders from time to time from after the
date of this prospectus. We will not receive any of the proceeds from the sale by the selling stockholders of the warrant shares.
We will bear the fees and expenses incident to our obligation to register the shares of common stock, however the selling stockholders
will bear legal and advisor fees, commissions and discounts, if any, attributable to their respective sales of the warrant shares.
Each selling stockholder may, from time to time, sell any or
all of its warrant shares covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on
which the shares can be traded or in private transactions. These sales may be at fixed prices, at prevailing market prices at the
time of the sale, at varying prices determined at the time of sale, or privately negotiated prices. A selling stockholder may use
any one or more of the following methods when selling shares:
|
·
|
ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block trades in which the broker-dealer will attempt to sell the shares
as agent but may position and resell a portion of the block as principal to facilitate the transaction;
|
|
·
|
purchases by a broker-dealer as principal and resale by the broker-dealer
for its account;
|
|
·
|
an exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately negotiated transactions;
|
|
·
|
underwritten transactions;
|
|
·
|
settlement of short sales, to the extent permitted by law;
|
|
·
|
in transactions through broker-dealers that agree with the selling
stockholders to sell a specified number of such shares at a stipulated price per share;
|
|
·
|
through the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
|
|
·
|
through the distribution of the common stock by any selling stockholder
to its partners, members or stockholders;
|
|
·
|
a combination of any such methods of sale; or
|
|
·
|
any other method permitted pursuant to applicable law.
|
The selling stockholders may also sell the shares of common
stock under Rule 144 under the Securities Act, if available, rather than under this prospectus.
If underwriters are used in the sale, the shares of common stock
will be acquired by the underwriters for their own account and may be resold from time to time in one or more transactions, including
negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale. In connection with
any such underwritten sale of shares of common stock, underwriters may receive compensation from the selling stockholders, for
whom they may act as agents, in the form of discounts, concessions or commissions. If the selling stockholders use an underwriter
or underwriters to effectuate the sale of shares of common stock, we and/or they will execute an underwriting agreement with those
underwriters at the time of sale of those shares of common stock. To the extent required by law, the names of the underwriters
will be set forth in a prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that
includes the prospectus supplement and the accompanying prospectus used by the underwriters to sell those securities. The obligations
of the underwriters to purchase those shares of common stock will be subject to certain conditions precedent, and unless otherwise
specified in a prospectus supplement, the underwriters will be obligated to purchase all the shares of common stock offered by
such prospectus supplement if any of such shares of common stock are purchased. Any public offering price and any discounts or
concessions allowed or re-allowed or paid to dealers may be changed from time to time.
Broker-dealers engaged by the selling stockholders may arrange
for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders
(or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated, but, except
as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission
in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440-1.
In connection with the sale of the shares of common stock or
interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the shares of common stock in the course of hedging the positions they assume. The selling
stockholders may also sell the shares of common stock short and deliver these securities to close out their short positions or
to return borrowed shares in connection with such short sales, or loan or pledge the shares of common stock to broker-dealers that
in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers
or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or
other financial institution of shares of common stock offered by this prospectus, which shares such broker-dealer or other financial
institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Each selling stockholder
has informed us that it does not have any agreement or understanding, directly or indirectly, with any person to distribute the
common stock
The selling stockholders and any broker-dealers or agents that
are involved in selling the shares of common stock may be deemed to be “underwriters” within the meaning of the Securities
Act in connection with such sales. In such event, any commissions received by such selling stockholders, broker-dealers or agents
and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the
Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act
will be subject to the prospectus delivery requirements of the Securities Act and may be subject to certain statutory liabilities
of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act
of 1934, as amended, or the Exchange Act. The selling stockholders have advised us that there is no underwriter or coordinating
broker acting in connection with the proposed sale of the resale securities by the selling stockholders.
We are required to pay certain fees and expenses incurred by
us incident to the registration of the shares of common stock of the selling stockholders. We have also agreed to indemnify the
selling stockholders holding purchase warrants against losses, claims, damages and liabilities, including liabilities under the
Securities Act, with respect to the registration statement of which this prospectus forms a part.
The selling stockholders will be subject to the prospectus delivery
requirements of the Securities Act, including Rule 172 thereunder, unless an exemption therefrom is available.
We agreed to cause the registration statement of which this
prospectus is a part to remain effective until the date on which no selling stockholder owns any purchase warrants or common stock
issuable upon exercise thereof. The shares of common stock will be sold only through registered or licensed brokers or dealers
if required under applicable state securities laws. In addition, in certain states, the shares of common stock covered hereby may
not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration
or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act,
any person engaged in the distribution of the shares of common stock may not simultaneously engage in market making activities
with respect to the shares of common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement
of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the
rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of shares of common
stock by the selling stockholders or any other person. We will make copies of this prospectus available to the selling stockholders
and have informed them of the need to deliver a copy of this prospectus at or prior to the time of the sale (including by compliance
with Rule 172 under the Securities Act).
The selling stockholders may decide not to sell any or all of
the shares of common stock we registered on behalf of the selling stockholders pursuant to the registration statement of which
this prospectus forms a part.
Once sold under the registration statement of which this prospectus
forms a part, the shares of common stock will be freely tradable in the hands of persons other than our affiliates.
LEGAL MATTERS
The validity of the securities being offered by this prospectus
will be passed upon for us by Cooley LLP.
EXPERTS
The consolidated financial statements of Outlook Therapeutics,
Inc. as of September 30, 2019 and 2018, and for the years then ended, have been incorporated by reference in this prospectus in
reliance upon the report of KPMG LLP, independent registered public accounting firm, incorporated by reference herein, and upon
the authority of said firm as experts in accounting and auditing. The audit report covering the consolidated financial statements
for the year ended September 30, 2019 contains an explanatory paragraph that states that the Company has incurred recurring losses
and negative cash flows from operations and has stockholders’ deficit of $16.1 million, $6.7 million of convertible senior
secured notes that become due on December 22, 2019, $3.6 million of unsecured indebtedness due on demand and $1.0 million of unsecured
indebtedness also due on demand, but subject to a forbearance agreement through March 2020, that raise substantial doubt about
the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments
that might result from the outcome of that uncertainty.
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 does not contain all of the information in the registration statement and its exhibits. For further information with
respect to us and the common stock offered by this prospectus, we refer you to the registration statement and its exhibits. Statements
contained in this prospectus as to the contents of any contract or any other document referred to are not necessarily complete,
and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement.
Each of these statements is qualified in all respects by this reference. You can read our SEC filings, including the registration
statement, over the Internet at the SEC’s website at www.sec.gov.
We are subject to the information and
periodic reporting requirements of the Exchange Act, and we file periodic reports, proxy statements and other information with
the SEC. These periodic reports, proxy statements and other information are available for inspection and copying at the website
of the SEC referred to above. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC
free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished
to, the SEC. The information contained in, or that can be accessed through, our website is not incorporated by reference in, and
is not part of, this prospectus.
INCORPORATION OF CERTAIN INFORMATION
BY REFERENCE
The SEC allows us to incorporate by reference the information
and reports we file with it, which means that we can disclose important information to you by referring you to these documents.
The information incorporated by reference is an important part of this prospectus. We incorporate by reference, as of their respective
dates of filing, the documents listed below that we have filed with the SEC and any documents that we file with the SEC pursuant
to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to the termination of the
offering of securities under this prospectus (except in each case the information contained in such documents to the extent “furnished”
and not “filed”):
|
·
|
our
Annual Report on Form
10-K for the fiscal year ended September 30, 2019, filed with the SEC on December
19, 2019;
|
|
·
|
our
Quarterly Report on Form
10-Q for the quarter ended December 31, 2019, filed with the SEC on February 14,
2020;
|
|
·
|
our
Current Reports on Form 8-K filed with the SEC on December
6, 2019, December
19, 2019, December
23, 2019, January
23, 2020, January
31, 2020, February
14, 2020, February
24, 2020, March
24, 2020, and April
2, 2020.
|
|
·
|
the
description of our common stock set forth in our registration statement on Form
8-A, filed with the SEC on April 29,2016, as amended on May 11, 2016, including any
further amendments thereto or reports filed for the purposes of updating this description.
|
We also incorporate by reference any future filings (other than
Current Reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items
unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act, including those made after the date of the initial Registration Statement of which this prospectus is a part and
prior to the effectiveness of the Registration Statement). These documents include period reports, such as Annual Reports on Form
10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as proxy statements.
This prospectus is part of a registration statement we filed
with the SEC. We have incorporated exhibits into this registration statement. You should read the exhibits carefully for provisions
that may be important to you.
You should rely only on the information incorporated by reference
or provided in this prospectus or any prospectus supplement. We have not authorized anyone to provide you with different information.
We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the information
in this prospectus or in the documents incorporated by reference is accurate as of any date other than the date on the front of
this prospectus or those documents.
We will furnish without charge to you, upon written or oral
request, a copy of any or all of the documents incorporated by reference into this prospectus supplement and the accompanying prospectus,
including exhibits that are specifically incorporated by reference into such documents. You should direct any requests for documents
to Outlook Therapeutics, Inc., Attention: Corporate Secretary, 7 Clarke Drive, Cranbury, New Jersey 08512. Our phone number is
(609) 619-3990. You may also view the documents that we file with the SEC and incorporate by reference in this prospectus supplement
and the accompanying prospectus on our corporate website at www.outlooktherapeutics.com. The information on our website is not
incorporated by reference and is not a part of this prospectus supplement.
4,331,103 Shares
Common Stock
_____________________
PROSPECTUS
____________________
,
2020
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
|
Item
13.
|
Other
Expenses of Issuance and Distribution
|
The following table sets forth the
estimated costs and expenses payable by the registrant in connection with the common stock being registered. The selling stockholders
will not bear any portion of such expenses. All the amounts shown are estimates, except for the SEC registration fee.
Item
|
|
Amount
|
|
SEC registration fee
|
|
$
|
323.25
|
|
Legal fees and expenses
|
|
|
35,000.00
|
|
Accounting fees and expenses
|
|
|
20,000.00
|
|
Printing and miscellaneous fees and expenses
|
|
|
10,676.75
|
|
Total
|
|
$
|
66,000.00
|
|
|
Item
14.
|
Indemnification
of Directors and Officers
|
As permitted by Section 102 of the Delaware General Corporation
Law, we have adopted provisions in our amended and restated certificate of incorporation and amended and restated bylaws that limit
or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care
generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all
material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders
for monetary damages for breach of fiduciary duty as a director, except for liability for:
|
·
|
any breach of the director’s duty of loyalty to us or our stockholders;
|
|
·
|
any act or omission not in good faith or that involves intentional
misconduct or a knowing violation of law;
|
|
·
|
any act related to unlawful stock repurchases, redemptions or other
distributions or payment of dividends; or
|
|
·
|
any transaction from which the director derived an improper personal
benefit.
|
These limitations of liability do not affect the availability
of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes
us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.
|
·
|
As permitted by Section 145 of the Delaware General Corporation Law,
our amended and restated bylaws provide that:
|
|
·
|
we may indemnify our directors, officers and employees to the fullest
extent permitted by the Delaware General Corporation Law, subject to limited exceptions;
|
|
·
|
we may advance expenses to our directors, officers and employees in
connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited
exceptions; and
|
|
·
|
the rights provided in our bylaws are not exclusive.
|
Our amended and restated certificate of incorporation and bylaws,
which are filed as Exhibits 3.1 and 3.6, each as amended, provide for the indemnification provisions described above and elsewhere
herein. We have entered into separate indemnification agreements with our directors and officers that may be broader than the specific
indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require
us, among other things, to indemnify our officers and directors against liabilities that may arise by reason of their status or
service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also
generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as
to which they could be indemnified. In addition, we have purchased a policy of directors’ and officers’ liability insurance
that insures our directors and officers against the cost of defense, settlement or payment of a judgment in some circumstances.
These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our
officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933,
as amended, or the Securities Act.
We have entered into indemnification agreements with our directors
and executive officers, in addition to the indemnification provided for in our amended and restated certificate of incorporation
and amended and restated bylaws, and intend to enter into indemnification agreements with any new directors and executive officers
in the future. We have purchased and currently intend to maintain insurance on behalf of each and every person who is or was a
director or officer of our company against any loss arising from any claim asserted against him or her and incurred by him or her
in any such capacity, subject to certain exclusions.
|
Item
15.
|
Recent
Sales of Unregistered Securities.
|
The following is a summary of all securities
that we have sold within the past three years without registration under the Securities Act. All share and per share amounts have
been adjusted to reflect a 1-for-8 reverse stock split that we effected on March 15, 2019.
|
(1)
|
In April and May 2017, we issued and sold and accredited investor an aggregate 37,500 shares of
common stock for total cash proceeds of $659,790 pursuant to a March 2017 purchase agreement.
|
|
(2)
|
Between September and October 2017, we issued and sold an aggregate 250,000 shares of our Series
A convertible preferred stock and warrants to acquire 2,093,750 shares of our common stock at an initial exercise price of
$7.20 per share, which had an eight year term, for an aggregate cash purchase price of $25.0 million to BioLexis
Pte. Ltd., or BioLexis, an accredited investor. Prior to conversion and/or exchange for other securities (see (4) below), we issued
BioLexis an additional aggregate 11,045 shares of Series A convertible preferred stock as quarterly dividends thereon in accordance
with its terms.
|
|
(3)
|
Between May and June 2018, we issued and sold an aggregate 1,594,345 shares of common stock and
warrants to purchase 2,564,102 shares of common stock at an exercise price of $7.80 per share, which had an eight
year term, to BioLexis for an aggregate purchase price of approximately $15.0 million in cash.
|
|
(4)
|
In July 2018, we exchanged all 58,735 outstanding shares of our Series A convertible preferred
stock held by BioLexis for 58,735 shares of newly-created Series A-1 convertible preferred stock, which Series A-1 convertible
preferred stock earned 10% quarterly dividends. Accordingly, we issued an aggregate 9,377 additional shares of Series A-1 convertible
preferred to BioLexis as quarterly dividends thereon, prior to such shares of Series A-1 convertible preferred stock being converted
in full into an aggregate 29,358,621 shares of our common stock in March 2020 following amendment of the conversion terms.
|
|
(5)
|
In November 2018, we issued and sold an aggregate of 2,680,390 shares of our common stock to BioLexis
at $7.46 per share, for aggregate gross cash proceeds of $20.0 million.
|
|
(6)
|
Between September and December 2019, we issued an aggregate 1,848,146 shares of our common stock
upon exchange of certain outstanding unsecured notes having an aggregate principal and accrued interest of $2.0 million.
|
|
(7)
|
In December 2019, we issued $7.6 million aggregate principal amount of new senior secured convertible
notes to an accredited investor in exchange for $7.3 million outstanding principal amount of senior secured notes originally issued
December 2016, which new senior secured notes are convertible beginning April 1, 2020, into shares of our common stock, at a conversion
price equal to 90% of the two lowest closing bid prices in the twenty trading days immediately preceding such conversion, subject
to a beneficial ownership cap, and a floor price of $0.232 per share.
|
|
(8)
|
In January 2020, we issued BioLexis 4,657,852 shares of our common stock upon exercise in full
of remaining outstanding warrants issued October 2017, May 2018, and June 2018 for cash payment of approximately $1.1 million,
which warrants were amended prior to exercise thereof to reduce the exercise price to $0.232 per share.
|
|
(9)
|
In February 2020, we entered into securities purchase agreements with certain institutional and
accredited investors pursuant to which we issued, in a concurrent private placement, warrants to purchase 3,799,213 shares of our
common stock, which warrants are immediately exercisable at an exercise price of $0.9535 per share and expire four years from the
issuance date.
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|
(10)
|
In February 2020, we issued H.C. Wainwright warrants to acquire an aggregate 531,890 shares of
our common stock at an exercise price of $1.27 per share, which expire five years from the issuance date pursuant to a letter agreement
dated as of December 10, 2019.
|
|
(11)
|
In February 2020, we issued GMS Ventures and Investments, an affiliate of BioLexis, 2,460,630 shares
of our common stock and warrants to purchase up to an aggregate of 1,230,315 shares of our common stock at an exercise price of
$0.9535 per share at a purchase price per share and accompanying warrant of $1.016, for aggregate gross cash proceeds of approximately
$2.5 million.
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|
(12)
|
In March 2020, we issued the four principals of MTTR LLC an aggregate of 7,244,739 shares of our
common stock in connection with the termination of a strategic license agreement and effectiveness of their respective consulting
agreements with our company.
|
We claimed exemption from registration under the Securities
Act for the sale and issuance of securities in the transactions described above by virtue of Sections 3(a)(9), 4(a)(2) and/or Regulation
D promulgated thereunder as transactions not involving any public offering. All of the purchasers of unregistered securities for
which we relied on Section 4(a)(2) and/or Regulation D represented that they were accredited investors as defined under the Securities
Act. We claimed such exemption on the basis that (i) the purchasers in each case represented that they intended to acquire the
securities for investment only and not with a view to the distribution thereof and that they either received adequate information
about the registrant or had access, through employment or other relationships, to such information and (ii) appropriate legends
were affixed to the stock certificates issued in such transactions.
|
Item
16.
|
Exhibits
and Financial Statement Schedules.
|
(a) Exhibits
The following
exhibits are being filed with this Registration Statement:
Exhibit
Number
|
|
Description
|
3.1
|
|
Amended
and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s current report
on Form 8-K filed with the SEC on May 19, 2016).
|
3.2
|
|
Certificate
of Designation of Series A-1 Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s
current report on Form 8-K filed with the SEC on July 19, 2018).
|
3.3
|
|
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s
current report on Form 8-K filed with the SEC on December 6, 2018).
|
3.4
|
|
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s
current report on Form 8-K filed with the SEC on March 18, 2019).
|
3.5
|
|
Certificate
of Amendment to the Certificate of Designation of Series A-1 Convertible Preferred Stock (incorporated by reference to Exhibit
3.1 to the Registrant’s current report on Form 8-K filed with the SEC on March 24, 2020).
|
3.6
|
|
Amended
and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s current report on Form 8-K filed with
the SEC on May 19, 2016).
|
3.7
|
|
Amendment
to the Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant’s current report on Form
8-K filed with the SEC on November 29, 2016).
|
5.1
|
|
Opinion of Cooley
LLP.
|
10.1
|
|
2011
Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s registration statement on Form S-1
(File No. 333-209011) filed with the SEC on January 15, 2016).
|
10.2
|
|
Form
of Amended and Restated Performance Stock Unit Agreement for 2011 Stock Incentive Plan (incorporated by reference to Exhibit
10.29 to the Registrant’s registration statement on Form S-1 (File No. 333-209011) filed with the SEC on April 27, 2016).
|
10.3
|
|
2015
Equity Incentive Plan, as amended (incorporated by reference to Exhibit 99.1 to the Registrant’s current report on Form
8-K filed with the SEC on September 13, 2019).
|
10.4
|
|
Forms
of agreements and award grant notices for 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s
registration statement on Form S-1 (File No. 333-209011) filed with the SEC on January 15, 2016).
|
10.5
|
|
2016
Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s registration statement on
Form S-1 (File No. 333-209011) filed with the SEC on February 12, 2016).
|
10.6
|
|
Form
of Indemnity Agreement, by and between the Registrant and each of its directors and executive officers (incorporated by reference
to Exhibit 10.12 to the Registrant’s registration statement on Form S-1 (File No. 333-209011) filed with the SEC on
January 15, 2016).
|
10.7
|
|
Executive
Employment Agreement between the Registrant and Lawrence A. Kenyon, dated October 22, 2018 (incorporated by reference to
Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on October 26, 2018).
|
10.8**
|
|
Consulting
Agreement between the Company and The Dagnon Group LLC (Dagnon), dated as of January 27 2020 (incorporated by reference to
Exhibit 10.4 to the Registrant’s current report on Form 8-K filed with the SEC on January 31, 2020).
|
10.9**
|
|
Consulting
Agreement between the Company and Scott Three Consulting, LLC (Evanson), dated as of January 27, 2020 (incorporated by reference
to Exhibit 10.5 to the Registrant’s current report on Form 8-K filed with the SEC on January 31, 2020).
|
10.10†
|
|
ONS-1045
Commercial License Agreement by and between the Registrant and Selexis SA effective as of April 11, 2013, as amended effective
as of May 21, 2014 (incorporated by reference to Exhibit 10.15 to the Registrant’s registration statement on Form S-1
(File No. 333-209011) filed with the SEC on January 15, 2016).
|
10.11
|
|
Termination
Agreement and Mutual Release between the Company and MTTR LLC, dated as of January 27, 2020 (incorporated by reference to
Exhibit 10.3 to the Registrant’s current report on Form 8-K filed with the SEC on January 31, 2020).
|
10.12
|
|
Warrant
Agreement by and between the Registrant and American Stock Transfer & Trust Company LLC, as Warrant Agent dated May 18,
2016 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC
on June 27, 2016).
|
10.13
|
|
Amendment
to the Warrant Agreement dated May 18, 2016 by the Registrant and American Stock Transfer & Trust Company LLC, as Warrant
Agent, dated February 6, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form
8-K filed with the SEC on February 6, 2017).
|
10.14
|
|
Amendment
#2 to the Warrant Agreement dated May 18, 2016 by and between the Registrant and American Stock Transfer & Trust Company
LLC, as Warrant Agent, dated February 9, 2018 (incorporated by reference to Exhibit 10.1 to the Registrant’s current
report on Form 8-K filed with the SEC on February 9, 2018).
|
10.15
|
|
Amendment
#3 to the Warrant Agreement dated May 18, 2016 by and between the Registrant and American Stock Transfer & Trust Company
LLC, as Warrant Agent, dated January 22, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s current
report on Form 8-K filed with the SEC on January 22, 2019).
|
10.16
|
|
Form
of Series A warrant certificate (included in Exhibit 10.15).
|
10.17
|
|
Form
of Warrant (incorporated by reference to Exhibit B to the Note and Warrant Purchase Agreement by and between the Registrant
and the Purchasers named therein dated December 22, 2016 filed as Exhibit 10.1 to the Registrant’s current report on
Form 8-K filed with the SEC on December 23, 2016 filed as Exhibit 10.20).
|
10.18
|
|
Exchange
Agreement, dated December 20, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on
Form 10-Q filed with the SEC on December 23, 2019).
|
10.19
|
|
Form
of Senior Secured Note (incorporated by reference to Exhibit 10.2 to the Registrant’s current report on Form 8-K filed
with the SEC on December 23, 2019).
|
10.20
|
|
Global
Amendment to senior secured notes issued December 20, 2019, dated as of January 29, 2020 (incorporated by reference to Exhibit
10.6 to the Registrant’s current report on Form 8-K filed with the SEC on January 31, 2020).
|
10.21
|
|
Security
Agreement by and between the Registrant and the Secured Parties named therein dated December 22, 2016 (incorporated by reference
to Exhibit 10.4 to the Registrant’s current report on Form 8-K filed with the SEC on December 23, 2016).
|
10.22
|
|
Intellectual
Property Security Agreement by and between the Registrant and the Secured Parties named therein dated December 22, 2016 (incorporated
by reference to Exhibit 10.5 to the Registrant’s current report on Form 8-K filed with the SEC on December 23, 2016).
|
10.23
|
|
Investor
Rights Agreement by and between the Registrant and BioLexis Pte. Ltd. (formerly GMS Tenshi Holdings Pte. Limited), dated September
11, 2017 (incorporated by reference to Exhibit 10.3 to the Registrant’s current report on Form 8-K filed with the SEC
on September 11, 2017).
|
10.24
|
|
Amendment
to Investor Rights Agreement by and between the Registrant and BioLexis Pte. Ltd. (formerly GMS Tenshi Holdings Pte. Limited),
dated May 11, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s current report on Form 8-K filed with
the SEC on May 15, 2018).
|
10.25
|
|
Second
Amendment to Investor Rights Agreement by and between the Registrant, and BioLexis Pte. Ltd. (formerly GMS Tenshi Holdings
Pte. Limited), dated July 18, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s current report on
Form 8-K filed with the SEC on July 19, 2018).
|
10.26
|
|
Third
Amendment to Investor Rights Agreement by and between the Registrant and BioLexis Pte. Ltd. (formerly GMS Tenshi Holdings
Pte. Limited), dated November 5, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s current report
on Form 8-K filed with the SEC on November 9, 2018).
|
10.27
|
|
Fourth
Amendment to Investor Rights Agreement dated September 11, 2017 by and between the Company and BioLexis Pte. Ltd. (formerly
GMS Tenshi Holdings Pte. Limited), by and between the Company, BioLexis and GMS Ventures and Investments dated February 24,
2020 (incorporated by reference to Exhibit 10.4 to the Registrant’s current report on Form 8-K filed with the SEC on
February 24, 2020).
|
10.28
|
|
Form
of Securities Purchase Agreement, dated February 24, 2020, by and among the Company and the purchasers named therein (incorporated
by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed with the SEC on February 24, 2020).
|
10.29
|
|
Form
of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s current report on Form
8-K filed with the SEC on February 24, 2020).
|
10.30
|
|
Securities
Purchase Agreement by and between the Company and GMS Ventures and Investments dated February 24, 2020 (incorporated by reference
to Exhibit 10.2 to the Registrant’s current report on Form 8-K filed with the SEC on February 24, 2020).
|
10.31
|
|
Form
of GMS Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s current report on Form 8-K
filed with the SEC on February 24, 2020).
|
10.32
|
|
Engagement
letter dated December 10, 2019 by and between the Company and H.C. Wainwright & Co. LLC (incorporated by reference to
Exhibit 10.3 to the Registrant’s current report on Form 8-K filed with the SEC on February 24, 2020).
|
10.33
|
|
Form
of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 to the Registrant’s current report on Form 8-K
filed with the SEC on February 24, 2020).
|
23.1
|
|
Consent of independent
registered public accounting firm.
|
23.2
|
|
Consent of Cooley
LLP (included in Exhibit 5.1).
|
24.1
|
|
Power
of Attorney (included on the signature page hereto)
|
†
Confidential treatment has been granted for certain information contained in this document pursuant to an order of the SEC. Such
information (indicated by asterisks) has been omitted and been filed separately with the SEC.
**Certain portions of this exhibit
(indicated by “[***]”) have been omitted because they are both (i) not material and (ii) would be competitively harmful
if publicly disclosed.
(b) Financial Statement Schedules
All schedules have been omitted because
either they are not required, are not applicable or the information is otherwise set forth in the financial statements and related
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 of 1933; (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; provided, however, that paragraphs (1)(i),
(ii), and (iii) of this section do not apply if the information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section
15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in the registration statement,
(2) That, for the purpose of determining any liability under
the Securities Act of 1933, 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 of 1933 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.
(5) That, for purposes of determining any liability under the
Securities Act of 1933, each filing of the registrant's annual report pursuant to section 13(a) or section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to section 15(d)
of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement 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.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 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
Exchange Act of 1934, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the
undersigned, thereunto duly authorized, in Cranbury, New Jersey, on April 8, 2020.
|
OUTLOOK THERAPEUTICS, INC.
|
|
|
|
|
By:
|
/s/ Lawrence A. Kenyon
|
|
|
Lawrence A. Kenyon
|
|
|
Chief Executive Officer and Chief Financial Officer (Principal Executive, Accounting, and Financial Officer)
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints Lawrence A. Kenyon and Ralph H. Thurman, and each of them, individually, as his true
and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and
stead in any and all capacities, in connection with this registration statement, including to sign in the name and on behalf of
the undersigned, this registration statement and any and all amendments thereto, including post-effective amendments and registrations
filed pursuant to Rule 462(b) under the Securities Act of 1933, and to file the same, with all exhibits thereto, and other documents
in connection therewith, with the Securities and Exchange Commission, granting unto such attorneys-in-fact and agents full power
and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully
to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents, or his substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933,
this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Ralph
H. Thurman
|
|
Executive Chairman
|
|
April 8, 2020
|
Ralph H. Thurman
|
|
|
|
|
|
|
|
|
|
/s/ Lawrence
A. Kenyon
|
|
President and Chief Executive Officer, Chief Financial Officer,
|
|
April 8, 2020
|
Lawrence A. Kenyon
|
|
Treasurer, Secretary and Director
(Principal Executive and Accounting and
Financial Officer)
|
|
|
|
|
|
|
|
/s/ Yezan
Haddadin
|
|
Director
|
|
April 8, 2020
|
Yezan Haddadin
|
|
|
|
|
|
|
|
|
|
/s/ Kurt
J. Hilzinger
|
|
Director
|
|
April 8, 2020
|
Kurt J. Hilzinger
|
|
|
|
|
|
|
|
|
|
/s/ Faisal
Sukhtian
|
|
Director
|
|
April 8, 2020
|
Faisal Sukhtian
|
|
|
|
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