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| PART I. FINANCIAL INFORMATION | | |
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| Item 1. Financial Statements (Unaudited) | | 1 |
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| Consolidated Balance Sheets as of December 31, 2025 and September 30, 2025 | | 1 |
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| Consolidated Statements of Operations for the Three Months Ended December 31, 2025 and 2024 | | 2 |
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| Consolidated Statements of Stockholders’ Deficit for the Three Months Ended December 31, 2025 and 2024 | | 3 |
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| Consolidated Statements of Cash Flows for the Three Months Ended December 31, 2025 and 2024 | | 4 |
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| Notes to Unaudited Interim Consolidated Financial Statements | | 5 |
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| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 21 |
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| Item 3. Quantitative and Qualitative Disclosures About Market Risk | | 32 |
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| Item 4. Controls and Procedures | | 33 |
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| PART II. OTHER INFORMATION | | 34 |
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| Item 1. Legal Proceedings | | 34 |
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| Item 1A. Risk Factors | | 34 |
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| Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | | 34 |
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| Item 3. Defaults Upon Senior Securities | | 34 |
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| Item 4. Mine Safety Disclosures | | 35 |
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| Item 5. Other Information | | 35 |
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| Item 6. Exhibits | | 35 |
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| SIGNATURES | | 36 |
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In this report, unless otherwise stated or as the context otherwise requires, references to “Outlook Therapeutics,” “Outlook,” “the Company,” “we,” “us,” “our” and similar references refer to Outlook Therapeutics, Inc. and its consolidated subsidiaries. The Outlook logo, LYTENAVA and other trademarks or service marks of Outlook Therapeutics, Inc. appearing in this report are the property of Outlook Therapeutics, Inc. This report also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders. 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.
References to ONS-5010 and/or LYTENAVA refer to an ophthalmic formulation of bevacizumab for use in retinal indications which, as the context requires: (i) is currently commercially available in Germany and in the United Kingdom as LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) and (ii) is currently the subject of a Biologics License Application under review by the U.S. Food and Drug Administration.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this report, 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 forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “seek,” “should,” “will,” “would,” or the negative of these terms or similar expressions in this report.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled “Risk Factors” contained in our Annual Report on Form 10-K for the year ended September 30, 2025, filed with the Securities and Exchange Commission (“SEC”) on December 19, 2025, and in Part II, Item 1A. “Risk Factors” of this Quarterly Report, including, among other things, risks associated with:
| ● | our ability to obtain and maintain regulatory approval for ONS-5010/LYTENAVA in the United States and other markets; |
| ● | our ability to successfully commercialize and generate revenues from the sale of LYTENAVA™ (bevacizumab gamma) in the United Kingdom and European Union; |
| ● | the rate and degree of market acceptance of our current and future product candidates, including our commercialization strategy and manufacturing capabilities for ONS-5010/LYTENAVA; |
| ● | our ability to fund our working capital requirements, the sufficiency of our current cash resources and our need for additional funding; |
| ● | our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved, for commercial use; |
| ● | whether the results of our clinical trials will be sufficient to support domestic or global regulatory approvals; |
| ● | the initiation, timing, progress and results of our clinical trials of our lead product candidate, ONS-5010/LYTENAVA; |
| ● | our reliance on our contract manufacturing organizations and other vendors; |
| ● | the implementation of our business model and strategic plans for our business and product candidates; |
| ● | developments or disputes concerning our intellectual property or other proprietary rights; |
| ● | our ability to maintain and establish collaborations or obtain additional funding; |
| ● | our expectations regarding government and third-party payor coverage and reimbursement; |
| ● | our ability to compete in the markets we serve; and |
| ● | the factors that may impact our financial results. |
These risks are not exhaustive. Additional factors could harm our business and financial performance, such as risks associated with the current macroeconomic environment, including as a result of the impacts of fluctuations in inflation, and interest rates, tariffs and trade tensions, current or potential future bank failures or geopolitical instability and uncertainty. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 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. We qualify all of the forward-looking statements in this report by these cautionary statements.
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