Outlook Therapeutics Inc 2025年度报告

CORPORATEANNUALREPORT202 Securities Registered Pursuant to Section 12(g) of the Act: None Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period than the registrant was required to file such reports), and (2) has beensubject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuantto Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and“emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness ofits internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered publicaccounting firm that prepared or issued its audit report.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ The aggregate market value of the registrant’s common stock, held by non-affiliates of the registrant as of March 31, 2025 (which is thelast business day of registrant’s most recently completed second fiscal quarter) based upon the closing market price of such stock on TheNasdaq Capital Market on that date, was approximately $26.9 million. As of December 16, 2025, the registrant had outstanding 64,114,399 shares of common stock, par value $0.01 per share. DOCUMENTS INCORPORATED BY REFERENCE Part III of this report incorporates information by reference from the Company’s definitive proxy statement, which proxy statement isdue to be filed with the Securities and Exchange Commission not later than 120 days after September 30, 2025. OUTLOOK THERAPEUTICS, INC.ANNUAL REPORT ON FORM 10-K TABLE OF CONTENTS PageCautionary Note Regarding Forward-Looking Statements and Industry Data. . . . . . . . . . .iiSelected Risks Affecting Our Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iiiPART I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ITEM 1.Business. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ITEM 1A.Risk Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27ITEM 1B.Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82ITEM 1C.Cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82ITEM 2.Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83ITEM 3.Legal Proceedings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83ITEM 4.Mine Safety Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84PART II. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85ITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters, and IssuerPurchases of Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85ITEM 6.Reserved.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85ITEM 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86ITEM 7A.Quantitative and Qualitative Disclosures about Market Risk . . . . . . . . . . . . . . . . . . .103ITEM 8.Consolidated Financial Statements and Supplementary Data. . . . . . . . . . . . . . . . . .104ITEM 9.Changes in and Disagreem