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    MetaVia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

    5/7/25 7:00:21 AM ET
    $MTVA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $MTVA alert in real time by email
    0001638287false00016382872025-05-072025-05-07

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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

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    FORM 8-K

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    CURRENT REPORT

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    Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

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    Date of Report (Date of earliest event reported): May 7, 2025

    Graphic

    METAVIA INC.

    (Exact name of Registrant as Specified in Its Charter)

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    Delaware

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    001-37809

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    47-2389984

    (State or other jurisdiction

    of incorporation)

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    (Commission

    File Number)

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    (IRS Employer

    Identification No.)

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    545 Concord Avenue, Suite 210

    Cambridge, Massachusetts

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    02138

    (Address of principal executive offices)

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    (Zip Code)

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    (857) 702-9600

    (Registrant’s telephone number, including area code)

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    Not applicable

    (Former name or former address, if changed since last report)

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    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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    ☐

    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

    ☐

    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

    ☐

    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

    ☐

    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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    Securities registered pursuant to Section 12(b) of the Act:

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    Title of each class

        

    Trading

    Symbol(s)

        

    Name of each exchange on which registered

    Common Stock, par value $0.001 per share

     

    MTVA

     

    The Nasdaq Stock Market LLC

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    Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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    Emerging growth company ☐

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    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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    Item 7.01.Regulation FD Disclosures.

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    On May 7, 2025, MetaVia Inc. (the “Company”) issued a press release announcing that the Company presented data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis, demonstrating both hepatoprotective and glucose-regulating effects. The data was presented in late-breaking poster presentation at the European Association for the Study of the Liver Congress 2025, taking place May 7-10, 2025, in Amsterdam, the Netherlands. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (the "Report").

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    Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.

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    The information in this Report, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

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    Forward-Looking Statements

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    Exhibit 99.1 attached hereto contain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

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    Item 9.01.Financial Statements and Exhibits.

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    (d) Exhibits

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    Exhibit
    Number

        

    Exhibit Description

    99.1

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    Press Release dated May 7, 2025.

    104

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    Cover Page Interactive Data File (embedded within Inline XBRL document).

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    SIGNATURES

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    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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    METAVIA INC.

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    Date: May 7, 2025

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    By:

    /s/ Hyung Heon Kim

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    Hyung Heon Kim

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    President and Chief Executive Officer

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    ​

    ​

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