Outlook Therapeutics Inc 2025年季度报告

(Mark One) ☒QUARTERLYREPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 For the quarterly period endedJune 30, 2025or ☐TRANSITIONREPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or15(d)of the Securities Exchange Act of 1934 during the preceding 12months (or for such shorter period that theregistrant was required to file such reports), and (2)has been subject to such filing requirements for the past90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required tobe submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months(or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acceleratedfiler, a smaller reporting company, or an emerging growth company. See the definitions of “large acceleratedfiler,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of theExchange Act. Largeacceleratedfiler☐ Acceleratedfiler Non-accelerated filer☒ Smallerreportingcompany☒Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extendedtransition period for complying with any new or revised financial accounting standards provided pursuant toSection13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ The number of shares of the registrant’s common stock, $0.01 par value per share, outstanding as of August 11,2025 was44,419,529. Outlook Therapeutics, Inc.Table of Contents PageNumberPART I. FINANCIAL INFORMATIONItem 1. Financial Statements (Unaudited)1Consolidated Balance Sheets as ofJune 30, 2025 and September 30, 20241Consolidated Statements of Operations for theThree and Nine Months Ended June 30, 2025and 20242Consolidated Statements of Stockholders’ Deficit for the Three and Nine Months Ended June30, 2025 and 20243Consolidated Statements of Cash Flows for the Nine Months Ended June 30, 2025 and 20244Notes to Unaudited Interim Consolidated Financial Statements5Item 2. Management’s Discussion and Analysis of Financial Condition and Results ofOperations24Item 3. Quantitative and Qualitative Disclosures About Market Risk40Item 4. Controls and Procedures41PART II. OTHER INFORMATION42Item 1. Legal Proceedings42Item 1A. Risk Factors42Item 2. Unregistered Sales of Equity Securities and Use of Proceeds47Item 3. Defaults Upon Senior Securities47Item 4. Mine Safety Disclosures47Item 5. Other Information47Item 6. Exhibits47SIGNATURES48In 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 OutlookTherapeutics, Inc. and its consolidated subsidiaries. The Outlook logo, LYTENAVA and othertrademarks or service marks of Outlook Therapeutics, Inc. appearing in this report are the property ofOutlook Therapeutics, Inc. This report also contains registered marks, trademarks and trade names ofother companies. All other trademarks, registered marks and trade names appearing in this report arethe property of their respective holders. We do not intend our use or display of other companies’ tradenames, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of usby, these other companies. References to ONS-5010 and/or LYTENAVA refer to an ophthalmic formulation of bevacizumab foruse in retinal indications which, as the context requires: (i) is currently commercially available inGermany and in the United Kingdom as LYTENAVA™ (bevacizumab gamma) for the treatment ofwet age-related macular degeneration (wet AMD) and (ii) is currently the subject of a BiologicsLicensing 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 substantialrisks 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, andobjectives of management for future operations, are forward-looking statements. In some cases, youcan 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