Opus Genetics Inc 2025年度报告

FORM 10-K ☒Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2025or Commission File No. 001-34079 Opus Genetics, Inc. (Exact name of registrant as specified in its charter) 11-3516358(I.R.S. EmployerIdentification No.) 27713(Zip Code) 8 Davis Drive, Suite 220Durham, NC(Address of principal executive offices) Registrant’s telephone number, including area code: (984) 884-6030 N/A (Former name or former address, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: Title of each classTrading SymbolName of each exchange on which registeredCommon Stock, $0.0001 par value per shareIRDThe Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None 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 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 SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject 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 submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant 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-accelerated filer, a smallerreporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Accelerated filer☐ Large accelerated filer☐ Smaller reporting company☒Emerging growth company☐ Non-accelerated filer☒ 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 theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered public accounting firm that prepared or issued its audit report. Yes☐ If securities are registered pursuant toSection 12(b)of the Act, indicate by check mark whether the financial statements of theregistrant included in 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 compensation 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 the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐No☒ The aggregate market value of the common equity held by non-affiliates of the registrant on June 30, 2025, the last business dayof the registrant’s most recently completed second fiscal quarter, based on the closing price on that date of $0.9421, was approximately$45.9 million. As of March 5, 2026, there were 71,149,045 shares of the registrant’s common stock outstanding. Documents Incorporated by Reference Portions of the registrant’s Definitive Proxy Statement to be filed with the Commission pursuant to Regulation 14A in connection withthe registrant’s 2026 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.Such Definitive ProxyStatement will be filed with the Securities and Exchange Commission not later than 120 days after the conclusion of the registrant’sfiscal year ended December 31, 2025. Opus Genetics, Inc.Form 10-K TABLE OF CONTENTS ITEM 1.BUSINESS5ITEM 1A.RISK FACTORS46ITEM 1B.UNRESOLVED STAFF COMMENTS88ITEM 1C.CYBERSECURITY88ITEM 2.PROPERTIES89ITEM 3.LEGAL PROCEEDINGS89ITEM 4.MINE SAFETY DISCLOSURES89 ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERSAND ISSUER PURCHASES OF EQUITY SECURITIES89ITEM 6.[RESERVED]90ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS90ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK108ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA108ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING ANDFINANCIAL DISCLOSURE108ITEM 9A.CONTROLS AND PROCEDURES108ITEM 9B.OTHER INFORMATION109ITEM 9C.DISCLOSURE