MetaVia Inc 2024年度报告

(Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year endedDecember 31, 2024 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934For the transition period fromto Commission file number001-37809 (Exact name of Registrant as specified in its charter) (Registrant’s telephone number, including area code) SecuritiesregisteredpursuanttoSection12(g)oftheAct: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 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 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. Large accelerated filer☐Non-accelerated filer☒Emerging growth company☐ 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.☐ If securities are registered pursuant to Section 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-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 12(b)-2 of the Act). Yes☐No☒ As of June 30, 2024, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant wasapproximately$13.8million, based on the closing price on the Nasdaq Capital Market on the last business day of the registrant’s mostrecently completed second fiscal quarter. As of March 17, 2025, the registrant had8,654,869shares of common stock, $0.001 par value per share, outstanding. METAVIA INC. Table of Contents Special Note Regarding Forward-Looking Statements2Summary Risk Factors3Part IItem 1.Business5Item 1A.Risk Factors31Item 1B.Unresolved Staff Comments63Item 1C.Cybersecurity63Item 2.Properties64Item 3.Legal Proceedings64Item 4.Mine Safety Disclosures64Part IIItem 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities64Item 6.[Reserved]64Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations64Item 7A.Quantitative and Qualitative Disclosures About Market Risk72Item 8.Financial Statements and Supplementary Data72Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure72Item 9A.Controls and Procedures72Item 9B.Other Information74Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevents Inspections74Part IIIItem 10.Directors, Executive Officers and Corporate Governance74Item 11.Executive Compensation78Item 12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholderMatters82Item 13.Certain Relationships and Related Transactions, and Director Independence84Item 14.Principal Accountant Fees and Services86Part IVItem 15.Exhibits and Financial Statement Schedules86Item 16.Form 10-K Summary89Signatures90 Unless the context requires otherwise, references in this Annual Report on Form 10-K for the fiscal year endedDecember 31, 2024 (this “Annual Report” or “Report”) to “we,” “us,” “the Company,” “MetaVia” and“our” refer to MetaVia Inc. (the “Company”) and its