Outlook Therapeutics Inc 2023年度报告

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware38-3982704(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☐ 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 Exchange Actof 1934 during the preceding 12 months (or for such shorter period than the registrant was required to file such reports), and (2) has been subjectto 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 pursuant toRule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was requiredto 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” inRule 12b-2 of the Exchange Act. Accelerated filerSmaller reporting company☐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 Large accelerated filer☐Non-accelerated filer 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 of itsinternal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accountingfirm that prepared or issued its audit report. ☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant includedin the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensationreceived 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, 2024 (which is the lastbusiness day of registrant’s most recently completed second fiscal quarter) based upon the closing market price of such stock on The NasdaqCapital Market on that date, was approximately $180.4 million. As of December 24, 2024, the registrant had outstanding 24,905,635 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 is due to befiled with the Securities and Exchange Commission not later than 120 days after September 30, 2024. OUTLOOK THERAPEUTICS, INC.ANNUAL REPORT ON FORM 10-KTABLE OF CONTENTS PageCautionary Note Regarding Forward-Looking Statements and Industry DataiiSelected Risks Affecting Our BusinessiiiPART I1ITEM 1.Business1ITEM 1A.Risk Factors27ITEM 1B.Unresolved Staff Comments83ITEM 1C.Cybersecurity83ITEM 2.Properties84ITEM 3.Legal Proceedings84ITEM 4.Mine Safety Disclosures85PART II86ITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchasesof Equity Securities86ITEM 6.Reserved.86ITEM 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations87ITEM 7A.Quantitative and Qualitative Disclosures about Market Risk101ITEM 8.Consolidated Financial Statements and Supplementary Data102ITEM 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure129ITEM 9A.Controls and Procedures129ITEM 9B.Other Information129PART III131ITEM 10.Directors, Executive Officers and Corporate Governance131ITEM 11.Executive Compensation131ITEM 12.Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters132ITEM 13.Certain Relationships and Related Transactions, and Director Independence132ITEM 14.Principal Accounting Fees and Services132PART IV133IT