Opus Genetics Inc 2024年度报告

FORM10-K ☒Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Commission File No.001-34079 Opus Genetics, Inc. (Exact name of registrant as specified in its charter) 11-3516358(I.R.S. EmployerIdentification No.) 27709(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 shareIRDTheNasdaqStock 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 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 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 definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and“emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐ 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 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. Yes☐ If securities are registered pursuant toSection 12(b)of the Act, indicate by check mark whether the financial statements of the registrantincluded 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-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 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 28, 2024, the last business day of theregistrant’s most recently completed second fiscal quarter, based on the closing price on that date of $1.53, was approximately $38.7million. Asof March 27, 2025, there were45,483,823shares 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 with theregistrant’s 2025 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.Such Definitive Proxy Statementwill be filed with the Securities and Exchange Commission not later than 120 days after the conclusion of the registrant’s fiscal year endedDecember 31, 2024. Opus Genetics, Inc.Form 10-K TABLE OF CONTENTS ITEM 1.BUSINESS5ITEM 1A.RISK FACTORS51ITEM 1B.UNRESOLVED STAFF COMMENTS95ITEM 1C.CYBERSECURITY95ITEM 2.PROPERTIES96ITEM 3.LEGAL PROCEEDINGS96ITEM 4.MINE SAFETY DISCLOSURES97 ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS ANDISSUER PURCHASES OF EQUITY SECURITIES97ITEM 6.[RESERVED]98ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS98ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK112ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA112ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING ANDFINANCIAL DISCLOSURE112ITEM 9A.CONTROLS AND PROCEDURES112ITEM 9B.OTHER INFORMATION113ITEM 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS113