MetaVia Inc 2026年季度报告

Form 10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19346For the quarterly period ended June 30, 2026 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period fromto (857) 702-9600(Registrant’s telephone number, including area code) Not applicable(Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: Name of Each Exchange On Which RegisteredThe Nasdaq Stock Market LLC 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 pursuantto Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas 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 smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany” 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of August 3, 2026, the registrant had 6,588,101 shares of common stock, $0.001 par value per share, issued and outstanding. METAVIA INC. Table of Contents Special Note Regarding Forward-Looking Statements2Part IFinancial Information3Item 1.Financial Statements (Unaudited)3Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025(Unaudited)3Condensed Consolidated Statements of Operations for the three and six months ended June30, 2026 and 2025 (Unaudited)4Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and sixmonths ended June 30, 2026 and 2025 (Unaudited)5Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026and 2025 (Unaudited)6Notes to the Condensed Consolidated Financial Statements (Unaudited)7Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations18Item 3.Quantitative and Qualitative Disclosures about Market Risk25Item 4.Controls and Procedures25Part IIOther Information26Item 1.Legal Proceedings26Item 1A. Risk Factors26Item 2.Unregistered Sales of Equity Securities and Use of Proceeds26Item 3.Defaults Upon Senior Securities26Item 4.Mine Safety Disclosures26Item 5.Other Information26Item 6.Exhibits26Signatures28 Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q for the quarterlyperiod ended June 30, 2026 (this “Report”) to “we,” “us,” “the Company,” “MetaVia,” “the Registrant” and“our” refer to MetaVia Inc. and its subsidiaries. Special Note Regarding Forward-Looking Statements This Report contains “forward-looking statements” within the meaning of the safe harbor provisions of Section27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the SecuritiesExchange Act of 1934, as amended (the “Exchange Act”). All statements that address future operatingperformance, events or developments that we expect or anticipate will occur in the future are forward-lookingstatements, including without limitation, our expectations regarding our ability to execute our commercialstrategy; our expectations regarding the sufficiency of our existing cash and cash equivalents on hand to fundour operations; the timeline for regulatory submissions, regulatory steps and potential regulatory approval ofour current and future product candidates; the ability to realize the benefits of the license agreement withDong-A ST Co., Ltd., a related party (“Dong-A ST”), including the impact on our future financial andoperating results; the ability to integrate the product candidates into our business in a timely and cost-efficientmanner; the cooperation of our contract manufacturers, clinical study partners and others involved in thedevelopment of our current and future product candidates; our ability to initiate clinical trials on a timely basis;our planned clinical trials and our ability to recruit subjects for our clinical trials; the