false
0001649989
0001649989
2026-03-13
2026-03-13
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): March 13, 2026
Outlook Therapeutics,
Inc.
(Exact name of registrant as specified in its charter)
| Delaware |
001-37759 |
38-3982704 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
111
S. Wood Avenue, Unit
#100
Iselin, New Jersey |
08830 |
| (Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including area code:
(609) 619-3990
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities pursuant to Section 12 (b) of the Act:
| Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on Which
Registered |
| Common Stock |
|
OTLK |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
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 13(a) of the Exchange Act. ¨
| Item 1.01 | Entry into a Material Definitive Agreement. |
On March 16, 2026, Outlook Therapeutics, Inc. (the “Company”)
entered into a Note Purchase Agreement (the “NPA”) with Atlas Sciences, LLC, a Utah limited liability company (the “Investor”),
pursuant to which the Company agreed to issue to the Investor an unsecured promissory note with an original principal balance of $18,360,000
(the “Note”). The Note was issued with an original issue discount of $1,360,000, resulting in a purchase price of $17,000,000.
The Company is required to use the proceeds from the issuance of the Note solely for the partial repayment of $17,000,000 of the Company’s
existing convertible promissory note with Avondale Capital, LLC (“Avondale”), dated March 13, 2025, with an original principal
balance of $33,100,000 (the “Avondale Note”), and for no other purpose. Following the payment on the Avondale Note, there
will be $10,806,991 in remaining obligations under the Avondale Note. The closing of the transactions (“Closing”) contemplated
by the NPA and the Note occurred on March 16, 2026.
Note Purchase Agreement
The NPA contains customary representations, warranties, and covenants
of the Company and the Investor and customary closing conditions. Until amounts due under the Note are paid in full, the Company has agreed,
among other things, to: (i) timely make all filings under the Securities Exchange Act of 1934, as amended, (ii) maintain the listing
of the Company’s common stock on The Nasdaq Capital Market (or other applicable stock exchange), (iii) not encumber, mortgage, pledge
or grant a security interest in any of its assets, including intellectual property, subject to certain exceptions, (iv) subject to certain
exceptions for exempt issuances, not make any Restricted Issuance (as defined in the NPA) without the Investor’s prior consent,
(v) not enter into any agreement that would restrict the Company’s ability to enter into variable rate transactions with, or issue
securities to, the Investor or its affiliates.
The Note contains customary events of default, subject to customary
cure periods, including for failure to pay amounts when due, bankruptcy-related events, the occurrence of certain fundamental transactions
without the Investor’s consent, breach of certain covenants, and material misrepresentations.
Note
The Note bears interest at the prime rate (as published in The Wall
Street Journal) plus 3% (subject to a floor of 9.5%). The Note is scheduled to mature 15 months after the Closing. Beginning on the six-month
anniversary of the Closing, the Investor will have the right to redeem up to $3,000,000 of the outstanding balance per calendar quarter.
All payments made by the Company in cash, including prepayments, redemptions, or repayment at maturity, will be subject to an exit fee
of 7.5%.
The foregoing summary of the NPA and Note is qualified in its entirety
by reference to the NPA and the Note, which are filed herewith as Exhibits 10.1 and 10.2, respectively and are incorporated by reference
herein.
Amendment of Avondale Note
In connection with the entry into the Note, we and Avondale entered
into an amendment to the Avondale Note (the “Note Amendment”) to extend the maturity thereof to December 31, 2026.
The foregoing summary of the Note Amendment is qualified in its entirety
by reference to the Note Amendment, which is filed herewith as Exhibit 10.3 and is incorporated by reference herein.
| Item 2.03 | Creation of a Direct Financial Obligation or an Obligation
under an Off-Balance Sheet Arrangement of a Registrant. |
The disclosure under Item 1.01 of this Current Report on Form 8-K is
incorporated into this Item 2.03 by reference.
In connection with entry into the Note, the Company is providing supplemental
risk factors, which are filed herewith as Exhibit 99.1 and are incorporated by reference herein.
Forward-Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1, which has
been filed herewith and incorporated by reference herein, contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Words such as “anticipate,” “expect,” “intend,” “may,”
“will,” “would,” and similar expressions (as well as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking statements. All statements other than statements of historical fact contained
in this Current Report on Form 8-K are forward-looking statements, including without limitation statements regarding the anticipated proceeds
of the Note and the use thereof, the Company’s expectations regarding the duration of its cash runway, the potential of ONS-5010/LYTENAVA™
as a treatment for retina diseases, the potential for ONS-5010 to receive approval from the FDA, and other statements that are not historical
fact. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Current Report
on Form 8-K. These forward-looking statements are subject to risks and uncertainties that could cause results and events to differ significantly
from those expressed or implied by the forward-looking statements, including risks associated with closing a securities offering. Additional
factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements
in this Current Report on Form 8-K are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including
under “Risk Factors” in the Company’s annual report on Form 10-K for the year ended September 30, 2025 and future filings
by the Company. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein
to reflect any change in expectations, even as new information becomes available.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. |
|
Description |
| 10.1 |
|
Note Purchase Agreement, dated March 16, 2026, by and between the Company and Atlas Sciences,
LLC.* |
| 10.2 |
|
Note issued to Atlas Sciences, LLC, dated March 16, 2026. |
| 10.3 |
|
Second Amendment, dated March 13, 2026, to the Convertible Promissory Note, dated March 13, 2025,
by and between the Company and Avondale Capital, LLC. |
| 99.1 |
|
Supplemental Risk Factors. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL
document)
|
* Certain of the exhibits and schedules to
this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted
exhibits and schedules to the Securities and Exchange Commission upon its request.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Outlook Therapeutics, Inc. |
| |
|
| |
|
| Date: March 16, 2026 |
By: |
/s/ Lawrence A. Kenyon |
| |
|
Lawrence A. Kenyon |
| |
|
Chief Financial Officer |
Exhibit 99.1
Supplemental Risk Factors
Except as set forth below, as of March 16, 2026,
there have been no material changes to the risk factors that were previously disclosed in Item 1A in the Company’s Annual Report
on Form 10-K for the year ended September 30, 2025 filed with the Securities and Exchange Commission on December 19, 2025.
There is substantial doubt about our ability
to continue as a going concern. We will continue to need to raise substantial additional funding to complete the development of ONS-5010/LYTENAVA outside
the European Union, or EU, and United Kingdom, or UK, and support our operations until we are able to generate sufficient revenue
from the sales of ONS-5010/LYTENAVA in the EU and UK. This additional funding may not be available on acceptable terms or at all.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other
operations.
Developing product candidates
is an expensive, risky and lengthy process. We have received a marketing authorization from the European Commission and the UK Medicines
and Healthcare products Regulatory Agency, or MHRA, for ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration,
or wet AMD, in the EU and UK, respectively. We are currently advancing ONS-5010/LYTENAVA through the regulatory approval process
in the United States, which may ultimately require additional clinical and/or non-clinical studies. Our expenses may increase in connection
with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and
seek marketing approval for, ONS-5010/LYTENAVA outside the EU and UK.
As of December 31, 2025, our cash and cash equivalents
balance was $8.7 million. We estimate that our cash and cash equivalents as of December 31, 2025, together with $2.4 million in net proceeds
from the sale of shares of common stock under an at-the-market sales program since December 31, 2025, will not be sufficient to fund our
operations through at least the next 12 months from the date of our Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2025. On March
13, 2025, we issued a $33.1 million promissory note, or the March 2025 Note, to Avondale Capital, LLC, or Avondale. The March 2025 Note
bears interest at the prime rate plus 3%, with a minimum rate of 9.5%, matures on July 1, 2026 and is convertible into common stock. We
must repay at least $3.0 million (by cash or conversions into common stock) of the outstanding balance on the March 2025 Note each quarter
starting in the second calendar quarter of 2025 (subject to adjustments for conversions and to payment of a 7.5% exit fee), or the Quarterly
Debt Reduction Obligations. Any amount converted by Avondale during a given calendar quarter in excess of the Quarterly Debt Reduction
Obligations will be credited toward meeting the Quarterly Debt Reduction Obligations for the next quarter or quarters. See “Raising
additional capital, including modifications to our existing convertible securities, may cause dilution to our securityholders, restrict
our operations or require us to relinquish rights to our technologies and product candidates” for additional information
on the effects of an event of default under the terms of the March 2025 Note. On December 31, 2025, we did not satisfy the required $3.0
million Quarterly Debt Reduction Obligation, which constituted a Major Trigger Event under the March 2025 Note. Subsequent to December
31, 2025, Avondale converted $6.3 million of principal and accrued interest on the March 2025 Note into shares of common stock at a weighted
average conversion price of $0.47. While this Major Trigger Event has not resulted in an Event of Default under the March 2025 Note, as
a result of our financial position, we may be unable to satisfy our future repayment obligations under the March 2025 Note which could
result in continued conversions at prices significantly below the initial $2.26 Conversion Price or, ultimately, an Event of Default,
in which case Avondale could accelerate our obligations, and otherwise pursue remedies available to it, under the March 2025 Note. On
March 16, 2026, we entered into a Note Purchase Agreement with Atlas Sciences, LLC (“Atlas”), pursuant to which we agreed
to issue to Atlas an unsecured promissory note with an original principal balance of $18,360,000 (the “March 2026 Note”),
which we agreed to use for the partial repayment of $17 million of the March 2025 Note. Following the repayment on the March 2025 Note,
there will be approximately $10.8 million in remaining obligations under the March 2025 Note.
We do not believe our cash and cash equivalents
will be adequate to fund our currently planned operations through at least the next 12 months from the date the Quarterly Report on Form
10-Q for the quarter ended December 31, 2025. As a result, there is substantial doubt about our ability to continue as a going concern.
We will require substantial additional capital to continue to operate as a going concern. Although we continue to pursue discussions with
additional potential strategic partners for ONS-5010/LYTENAVA outside of the United States, there is no guarantee that we will be successful
in reaching any such agreement, nor that such agreement, if successful, will cover the anticipated commercialization costs for ONS-5010/LYTENAVA.
Moreover, on December 31, 2025, we reported that we had received a third Complete Response Letter, or CRL, with respect to our Biologics
License Application, or BLA, for ONS-5010, and the U.S. Food and Drug Administration, or FDA, has again recommended that confirmatory
evidence of efficacy be submitted to support the application. However, the FDA did not indicate in the CRL what type of confirmatory evidence
would be acceptable, and it is possible that we may need to conduct additional clinical and/or non-clinical studies of ONS-5010 in order
to satisfy the FDA’s requirements, which would require substantial resources, which may be difficult to obtain or which may be unavailable
to us on acceptable terms or at all. Our operating plan may also change as a result of many factors currently unknown to us, and we will
continue to actively seek substantial additional capital, through public or private equity or debt financings, third-party funding, marketing
and distribution arrangements, as well as through other collaborations, strategic alliances and licensing arrangements, or a combination
of these approaches. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital
if market conditions are favorable or if we have specific strategic considerations. Additionally, we may not achieve the expected benefits
of these cost reduction measures and other cost reduction plans on the anticipated timeline, or at all, which could otherwise accelerate
our liquidity needs and could force us to further curtail or suspend our operations. If we are unable to obtain the substantial additional
funding needed to operate our business, our business and prospects would be materially and adversely affected, and we may be required
to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you
may lose all or part of your investment.
Any additional fundraising
efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize
our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable
to us, if at all. We may experience difficulties in accessing the capital markets due to external factors beyond our control, such as
volatility in the equity markets for emerging biotechnology companies and general economic and market conditions both in the United States
and abroad. For example, our ability to raise additional capital may be adversely impacted by global economic conditions and disruptions
to and volatility in the credit and financial markets in the United States and worldwide, such as has been experienced recently due in
part to, among other things, the impacts of inflation, geopolitical instability and uncertainty, and disruptions in access to bank deposits
and lending commitments due to bank failure. In addition, our financial position may make it more difficult for us to secure additional
funding. We cannot be certain that we will be able to obtain financing on terms acceptable to us, or at all. Our failure to obtain adequate
and timely funding will adversely affect our business and our ability to develop our technology and products candidates. Moreover, the
terms of any financing may negatively impact the holdings or the rights of our stockholders, and the issuance of additional securities,
whether equity or debt, by us or the possibility of such issuance may cause the market price of our securities to decline. The incurrence
of indebtedness could result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants,
such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property
rights and other operating restrictions that could adversely impact our ability to conduct our business. We may be required to relinquish
rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, in order to obtain necessary funding,
any of which may harm our business, operating results and prospects. Even if we believe we have sufficient funds for our current or future
operating plans, we may seek additional capital if market conditions are favorable or for specific strategic considerations. If we are
unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our development
programs or the commercialization of ONS-5010/LYTENAVA or any product candidates, if approved. We may also be unable to expand our operations
or otherwise capitalize on our business opportunities, as desired, which could harm our business, financial condition and results of operations.
We are highly dependent on the success of
ONS-5010/LYTENAVA, our only product that has been approved in the EU and UK. If ONS-5010/LYTENAVA does not receive regulatory approval
outside the EU and UK, or is not successfully commercialized, our business may be harmed.
We currently have one product,
ONS-5010/LYTENAVA, that is approved for commercial sale in the EU and UK. We may never be able to obtain regulatory
approval for ONS-5010/LYTENAVA outside the EU or UK, commercialize ONS-5010/LYTENAVA in the EU or UK, or develop other
marketable products. We expect that a substantial portion of our efforts and expenditures in the foreseeable future will be devoted to
the advancement of ONS-5010/LYTENAVA, our only approved product and only product candidate in active development. We also expect that
we will need to devote significant effort to the commercialization of ONS-5010/LYTENAVA in the EU, UK, and other markets following
regulatory approval, if received. There is no assurance that we will be able to successfully obtain regulatory approval of ONS-5010/LYTENAVA outside
of the EU and UK and develop sufficient commercial capabilities for ONS-5010/LYTENAVA if and when necessary. Accordingly, our
business currently depends heavily on the successful regulatory approval of ONS-5010/LYTENAVA outside the EU and UK, and commercialization
of ONS-5010/LYTENAVA.
We cannot be certain that
ONS-5010/LYTENAVA will receive regulatory approval outside of the EU or UK, or be successfully commercialized even in the EU or UK,
or any other targeted market in which we receive regulatory approval. The research, testing, manufacturing, labeling, approval, sale,
marketing and distribution of products are, and will remain, subject to extensive regulation by the FDA and other regulatory authorities
in the United States and other countries that each have differing regulations. We are not permitted to market ONS-5010/LYTENAVA in
the United States until we receive approval from the FDA, or in any foreign country until we receive the requisite approvals from the
appropriate authorities in such countries for marketing authorization.
Obtaining approval from the
FDA or similar regulatory approval is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or other foreign
regulatory authorities may delay, limit or deny approval of ONS-5010/LYTENAVA for many reasons, including:
| · | we may not be able to demonstrate that ONS-5010/LYTENAVA is effective as a treatment for any of our currently
targeted indications to the satisfaction of the FDA or other relevant regulatory authorities; |
| · | the relevant regulatory authorities may require additional pre-approval studies or clinical trials, which
would increase our costs and prolong our development timelines; |
| · | the results of our clinical trials may not meet the level of statistical or clinical significance required
by the FDA or other relevant regulatory authorities for marketing approval; |
| · | the FDA or other relevant regulatory authorities may disagree with the number, design, size, conduct or
implementation of our clinical trials; |
| · | the FDA or other relevant regulatory authorities may not find the data from nonclinical studies or clinical
trials sufficient to demonstrate that the clinical and other benefits of these products outweigh their safety risks; |
| · | the FDA or other relevant regulatory authorities may disagree with our interpretation of data or significance
of results from the nonclinical studies and clinical trials of ONS-5010/LYTENAVA and any future product candidate, or may require that
we conduct additional trials; |
| · | the FDA or other relevant regulatory authorities may require development of a risk evaluation and mitigation
strategy, or REMS, or its equivalent, as a condition of approval; |
| · | the FDA or other relevant regulatory authorities may require additional post-marketing studies, which
would be costly; |
| · | the FDA or other relevant regulatory authorities may identify deficiencies in the manufacturing processes
or facilities of our third-party manufacturers; or |
| · | the FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations. |
There can be no assurance
that our BLA or marketing authorization applications of ONS-5010/LYTENAVA for wet AMD, or planned future, clinical trials for other retina
indications, will ultimately meet the requirements sufficient for us to receive regulatory approval outside of the EU and UK. For example,
in May 2022, we voluntarily withdrew our BLA to provide additional information requested by the FDA. We re-submitted the BLA to the FDA
for ONS-5010/LYTENAVA in August 2022 and in August 2023, we received a CRL in which the FDA concluded it could not approve the BLA during
this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial
evidence. At subsequent Type A meetings with the FDA, we learned that the FDA required the successful completion of an additional adequate
and well-controlled clinical trial evaluating ONS-5010/LYTENAVA, as well as additional requested CMC data indicated in the CRL to approve
ONS-5010/LYTENAVA for use in wet AMD. We received agreement from FDA under the special protocol assessment, or SPA, for the NORSE EIGHT
trial protocol and in November 2024, we reported that ONS-5010/LYTENAVA did not meet the pre-specified non-inferiority endpoint at week
8 set forth in the SPA.
However, the preliminary
data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety
profile for ONS-5010. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, we resubmitted the BLA application
for ONS-5010/LYTENAVA on February 27, 2025 and received a CRL on August 28, 2025. In September 2025, we conducted a Type A meeting with
the FDA at which we received feedback on resubmitting the BLA. On November 3, 2025 we resubmitted the ONS-5010/LYTENAVA BLA and on December
31, 2025, we reported that we had received a third CRL in which the FDA noted that the additional mechanistic and natural history data
information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled
study demonstrated efficacy, and the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application.
However, the FDA did not indicate in the CRL what type of confirmatory evidence would be acceptable. In March 2026, we conducted a Type
A meeting with the FDA to discuss the CRL and potential regulatory pathways for ONS-5010, however there can be no assurance that we will
be able to address the deficiencies identified in the CRL without performing additional clinical and/or non-clinical studies which would
require substantial additional time and funding, and which may ultimately not be successful.
Raising additional capital, including modifications
to our existing convertible securities, may cause dilution to our securityholders, restrict our operations or require us to relinquish
rights to our technologies or product candidates.
Until such time, if ever,
as we can generate sufficient product revenues, we expect to finance our cash needs through a combination of equity and debt financings,
as well as selectively continuing to enter into collaborations, strategic alliances and licensing arrangements. We do not currently have
any committed external source of funding. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that
adversely affect your rights as a securityholder.
We are obligated to repay
a minimum of $3.0 million of the outstanding balance of the March 2025 Note each calendar quarter starting with the second calendar quarter
of 2025, subject to adjustments for conversions by Avondale and the payment of an exit fee of 7.5%. Any amount converted by Avondale during
a given calendar quarter in excess of the Quarterly Debt Reduction Obligations will be credited toward meeting the Quarterly Debt Reduction
Obligations for the next quarter or quarters.
Avondale may convert any
portion of the March 2025 Note into common stock at a conversion price of $2.26, as further described in the March 2025 Note. In addition,
we may convert the March 2025 Note if our stock trades at or above $3.00 per share for 30 consecutive days with an average daily trading
volume of at least $1.0 million. Trigger Events (e.g., payment default, covenant breaches) may increase the Note balance by 5-10%. Unresolved
issues after 10 trading days trigger default, accelerating the Note with 22% interest. If the Conversion Price drops below $0.404, conversions
must be paid in cash. Conversions of amounts outstanding under the March 2025 Note may result in the issuance of a substantial number
of shares of common stock. On December 31, 2025, we did not satisfy the required $3.0 million Quarterly Debt Reduction Obligation, which
constituted a Major Trigger Event under the March 2025 Note. Subsequent to December 31, 2025, Avondale converted $6.3 million of principal
and accrued interest on the March 2025 Note into shares of common stock at a weighted average conversion price of $0.47. If we are unable
to satisfy future repayment obligations under the March 2025 Note, Avondale may continue to effectuate conversions at prices significantly
below the initial $2.26 Conversion Price (as defined in the March 2025 Note), with such Conversion Price to be determined in accordance
with the terms set out in the March 2025 Note. Such conversion could result in significant dilution.
Additional debt financing,
if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring
additional debt, making capital expenditures or declaring dividends, and may be secured by all or a portion of our assets. If we secure
development funds for ONS-5010/LYTENAVA or any future product candidate through entering into collaborations, strategic alliances or licensing
arrangements with third parties, we may have to relinquish additional valuable rights to our technologies, future revenue streams, research
programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds
when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts, including for
ONS-5010/LYTENAVA, or grant rights to develop and market ONS-5010/LYTENAVA or other product candidates that we would otherwise
prefer to develop and market ourselves, terminate product development or future commercialization efforts, including for ONS-5010/LYTENAVA, or
to cease operations altogether.
