Full Press Release Details
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
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