Financial Analysis

9. Commitments and Contingencies Selexis Commercial License Agreements In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS-3010, ONS-1045 and ONS-1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense. The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Companys affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to terminate its royalty payment obligation by providing written notice to Selexis and paying Se …

CommitmentsAndContingenciesDisclosureTextBlock · excerpt; the full note is in the filing

8. Debt Debt consists of: September 30, 2025 September 30, 2024 Unsecured convertible promissory note (measured at fair value) $ 29,947,000 $ 29,440,000 Less: current portion (29,947,000) (29,440,000) Long-term debt $ $ December 2022 Note On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued an unsecured promissory note (the December 2022 Note) with a face amount of $31,820,000 to Streeterville Capital, LLC (the Lender), the holder of the Companys unsecured promissory note issued in November 2021 (the November 2021 Note). The December 2022 Note had an original issue discount of $1,820,000. The Company received net proceeds of $18,052,461 upon the closing on December 28, 2022 after deducting the Lenders transaction costs in connection with the issuance and a full payment of the remaining outstanding principal and accrued interest on the November 2021 Note. In December 2023, the Company extended the maturity of the December 2022 Note from January 1, 2024 to April 1, 2024. The Company incurred a $475,000 extension fee, which was expensed and included in interest expense in the consolidated statement of operations for the year ending September 30, 2024. On January 22, 2024, the Company entered into an amendment to the December 2022 Note (the Note Amendment) with the Lender, which became effective on April 1, 2024 after satisfaction of certain conditions, including various required stockholder approvals and the closing of the private placement o …

DebtDisclosureTextBlock · excerpt; the full note is in the filing

11. Stock-Based Compensation 2024 Equity Incentive Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the 2015 Plan). The 2015 Plan provided for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. In August 2024, the Companys stockholders approved the amendment and restatement of the 2015 Plan and, in connection with amending and restating the 2015 Plan, the name of the 2015 Plan was updated to the Outlook Therapeutics, Inc. 2024 Equity Incentive Plan (the 2024 Plan). The 2024 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Companys 2024 Plan is 7,293,901. As of September 30, 2025, 4,357,084 shares remained available for grant under the 2024 Plan. Stock options and RSUs granted under the Company's 2024 Plan generally vest over a period of one to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period. The Company recorded stock-based compensation expense in the following expense categories of its consolid …

DisclosureOfCompensationRelatedCostsShareBasedPaymentsTextBlock · excerpt; the full note is in the filing

4. Fair Value Measurements The following table presents the Companys liabilities that are measured at fair value on a recurring basis: September 30, 2025 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ $ $ 29,947,000 Warrant liability 4,768,438 Total $ $ $ 34,715,438 September 30, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ $ $ 29,440,000 Warrant liability 59,099,013 Total $ $ $ 88,539,013 The table presented below is a summary of changes in the fair value of the Companys Level 3 valuation for the warrant liability and the unsecured convertible promissory notes for the years ended September 30, 2025 and 2024: Unsecured Convertible Promissory Notes Warrants Balance at October 1, 2023 $ 35,551,000 $ 6,219 Issued in connection with sale of common stock 97,730,836 Promissory note maturity extension fee added to outstanding balance 2,681,847 Principal and accrued interest converted to common stock (11,250,000) Loss (gain) from change in fair value 2,457,153 (38,638,042) Balance at September 30, 2024 29,440,000 59,099,013 Fair value of unsecured convertible promissory note issued 33,100,000 Principal and accrued interest converted to common stock (2,525,000) Loss (gain) from change in fair value 6,074,586 (43,015,831) Loss from change in fair value from warrant inducement 1,948,057 Reclassification of fair value of common stock warrants exercised to equity (13,262,801) Repayment (36,142,586) Balance at Sep …

FairValueDisclosuresTextBlock · excerpt; the full note is in the filing

13. Income Taxes Income tax benefit for the years ended September 30, 2025 and 2024 consists of the following: Year ended September 30, 2025 2024 State tax $ 2,800 $ 2,800 Foreign tax provision (1,554,629) $ (1,551,829) $ 2,800 A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year ended September 30, 2025 2024 U.S. federal statutory rate (21.0) % (21.0) % State taxes, net of federal benefit (0.1) (6.2) Change in state rate 8.5 Deferred true-up 0.2 0.2 Foreign withholding tax (2.4) Permanent differences (0.9) 2.5 Foreign tax credits 0.3 1.7 Research and development credit 2.2 (2.4) Change in valuation allowance 11.1 25.3 Other (0.3) (0.1) Effective income tax rate (2.4) % 0.0 % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2025 2024 Deferred tax assets: Net operating loss carryforwards $ 110,272,674 $ 102,906,140 Capitalized research and development costs 13,720,059 15,200,918 Stock-based compensation 6,612,848 6,463,068 Lease liability 52,366 83,720 Research and development credit carryforward 12,370,887 13,748,600 Foreign tax credits 100,000 290,188 Accruals and others 2,799,707 144,079 Gross deferred tax assets 145,928,541 138,836,713 Less: valuation allowance (145,880,866) (138,759,510) 47,675 77,203 Deferred tax liabilities: Right-of-use assets (47,675) (77,203) Net deferred tax assets $ $ As of Se …

IncomeTaxDisclosureTextBlock · excerpt; the full note is in the filing

Recently issued accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . ASU 2023-07, which is applicable to entities with a single reportable segment and will primarily require enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning after December 31, 2024, with early adoption permitted. The Company adopted ASU 2023-07 during fiscal year 2025, as the standard became effective for public entities for fiscal years beginning after December 15, 2023. For further details regarding the adoption and its impact, refer to the discussion above within Notes 3 and 14. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . ASU 2023-09 which is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Compan …

NewAccountingPronouncementsPolicyPolicyTextBlock · excerpt; the full note is in the filing

14. Segment Information Operating segments are components of an enterprise for which discrete financial information is available and reviewed by the chief operating decision maker (CODM) to allocate resources and assess performance. The Company has one reportable segment, which consists of the development and commercialization of ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Companys CODM is its Chief Executive Officer, who evaluates and manages the business on a consolidated basis for purposes of resource allocation and performance assessment. The accounting policies of the Companys single segment are the same as those described in the summary of significant accounting policies. To date, the Company has generated insignificant product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The CODM uses budget versus forecasted expense and cash forecast models in making decisions. Such models are reviewed to assess the entity-wide operating results and performance, including how long cash is expected to be sufficient. The measure of segment assets is reported on the consolidated balance sheet as total assets. T …

SegmentReportingDisclosureTextBlock · excerpt; the full note is in the filing

"10. Stockholders Equity Common stock On March 7, 2024, following receipt of stockholder approval at the Companys 2024 annual meeting of stockholders, the number of authorized shares of common stock under the Companys Certificate of Incorporation was increased from 21,250,000 shares to 60,000,000 shares. On March 11, 2025, following receipt of stockholder approval at the Companys 2025 annual meeting of stockholders, the number of authorized shares of common stock under the Companys Certificate of Incorporation was increased from 60,000,000 shares to 260,000,000 shares. On March 18, 2024, in a private placement (the Private Placement) pursuant to a securities purchase agreement entered in January 2024 with certain institutional and accredited investors, including GMS Ventures and Investments (GMS Ventures), the Companys largest stockholder, the Company issued an aggregate of 8,571,423 shares of common stock and warrants to purchase an aggregate of 12,857,133 shares of common stock at a purchase price per share of $7.00 per share (the Private Placement Warrants) and accompanying warrant to purchase one and one -half shares of common stock for $55,498,311 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 2,305,714 shares of common stock and warrants to purchase an aggregate of 3,458,571 shares of common stock in the Private Placement. The Warrants have an exercise price of $7.70 per share of common stock and wi …

StockholdersEquityNoteDisclosureTextBlock · excerpt; the full note is in the filing

8. Commitments and Contingencies Litigation On November 3, 2023, a securities class action lawsuit was filed against the Company and certain of its officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by the Company related to the Companys BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that the Company violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time the Companys BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve the Companys BLA, and that the Companys stock price dropped when such information was disclosed. The plaintiffs in the class action seek damages and interest, and an award of reasonable costs, including attorneys fees. On December 23, 2025, the court dismissed the plaintiffs second amended complaint in part with prejudice and in part with leave to amend. The deadline for the plaintiffs to file a third amended complaint is February 27, 2026. On October 10, 2024, certain of the Companys …

CommitmentsAndContingenciesDisclosureTextBlock · excerpt; the full note is in the filing

7. Debt Debt consists of: December 31, 2025 September 30, 2025 Unsecured convertible promissory note (measured at fair value) $ 36,660,000 $ 29,947,000 Less: current portion (36,660,000) (29,947,000) Long-term debt $ $ March 2025 Note On March 13, 2025, the Company issued the March 2025 Note for $33,100,000 to Avondale pursuant to a Securities Purchase Agreement (Purchase Agreement) dated January 31, 2025. Certain terms of the March 2025 Note were approved at the Companys annual meeting of stockholders on March 11, 2025.The net proceeds from the March 2025 Note were used to repay the Companys unsecured convertible promissory note issued on December 22, 2022 (the December 2022 Note). The March 2025 Note bears interest at the prime rate plus 3% (subject to a floor of 9.5%), is scheduled to mature on July 1, 2026, and is convertible into common stock. The Company must repay at least $3,000,000 (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) (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. During the three months ended December 31, 2025, Avondale converted $30,736 of accrued interest o …

DebtDisclosureTextBlock · excerpt; the full note is in the filing

10. Stock-Based Compensation 2024 Equity Incentive Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the 2015 Plan). The 2015 Plan provided for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units (RSUs) awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. In August 2024, the Companys stockholders approved the amendment and restatement of the 2015 Plan, at which time, the name of the 2015 Plan was updated to the Outlook Therapeutics, Inc. 2024 Equity Incentive Plan (the 2024 Plan). The 2024 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Companys 2024 Plan is 7,293,901. As of December 31, 2025, there were 1,573,065 shares available for grant under the 2024 Plan. Stock options and RSUs are granted under the Companys 2024 Plan and generally vest over a period of one to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and RSU over its vesting period. The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim consolidate …

DisclosureOfCompensationRelatedCostsShareBasedPaymentsTextBlock · excerpt; the full note is in the filing

4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The assets or liabilitys fair value measurement level within the fair value hierarchy is based on the …

FairValueDisclosuresTextBlock · excerpt; the full note is in the filing

Recently issued accounting pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The ASU requires greater disaggregation of income tax disclosures primarily on the income tax rate reconciliation and income taxes paid. This authoritative guidance will be effective for fiscal years beginning after December 15, 2024, and for interim periods within fiscal years beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the effect of this new standard on the Company's disclosures. In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses . ASU 2024-03 requires additional disclosure of specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The requirements will be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.

NewAccountingPronouncementsPolicyPolicyTextBlock

11. Segment Information Operating segments are components of an enterprise for which discrete financial information is available and reviewed by the chief operating decision maker (CODM) to allocate resources and assess performance. The Company has one reportable segment, which consists of the development and commercialization of ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Companys CODM is its Chief Executive Officer, who evaluates and manages the business on a consolidated basis for purposes of resource allocation and performance assessment. The accounting policies of the Companys single segment are the same as those described in the summary of significant accounting policies. To date, the Company has generated insignificant product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The CODM uses budget versus forecasted expense and cash forecast models in making decisions. Such models are reviewed to assess the entity-wide operating results and performance, including how long cash is expected to be sufficient. The measure of segment assets is reported on the consolidated balance sheet as total assets. T …

SegmentReportingDisclosureTextBlock · excerpt; the full note is in the filing

9. Common Stock and Stockholders Equity Preferred Stock The number of authorized shares of preferred stock under the Companys Certificate of Incorporation is 10,000,000 shares. Common stock On March 11, 2025, following receipt of stockholder approval at the Companys 2025 annual meeting of stockholders, the number of authorized shares of common stock under the Companys Certificate of Incorporation increased from 60,000,000 shares to 260,000,000 shares. BTIG, LLC At-the-Market Offering Agreement On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG as sales agent (as amended, the ATM Agreement or the ATM Offering), under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000,000 from time to time through BTIG. The Company incurred financing costs of $353,688 in connection with the execution of the ATM Agreement, which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of December 31, 2025, the remaining balance under the ATM Agreement was $64,460,655 and $227,987 of unamortized deferred costs are included in other assets on the unaudited interim consolidated balance sheets. Under the ATM Agreement, the Company pays BTIG a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the ATM Agreement. The offering of common stock pursuant to the ATM Agr …

StockholdersEquityNoteDisclosureTextBlock · excerpt; the full note is in the filing