METAVIA INC._September 9, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported): September 9, 2026

METAVIA INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-37809

47-2389984

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

545 Concord Avenue, Suite 210

Cambridge, Massachusetts

02138

(Address of principal executive offices)

(Zip Code)

(857) 702-9600

(Registrant’s telephone number, including area code)

Not applicable

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

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:


☐	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))

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

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

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).

Emerging growth company ☐

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. ☐

Item 7.01. Regulation FD Disclosures.

On September 9, 2026, MetaVia Inc. (the “Company”) issued a press release announcing results from a preclinical tissue distribution study (the “DA-1726 Study”) demonstrating that DA-1726-derived radioactivity is slowly absorbed and extensively distributed throughout the body following subcutaneous administration, with broad tissue distribution and the highest tissue exposure observed in adipose (fat) tissue. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated herein by reference.

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.

The information in Item 7.01 of this Report, including Exhibit 99.1 attached hereto, is furnished 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.

Item 8.01. Other Events.

On September 9, 2026, the Company announced results from its DA-1726 Study, demonstrating that DA-1726-derived radioactivity is slowly absorbed and extensively distributed throughout the body following subcutaneous administration, with broad tissue distribution and the highest tissue exposure observed in adipose (fat) tissue. The DA-1726 Study showed that tissue-to-plasma ratios increased over time, indicating prolonged retention of DA-1726-derived radioactivity in tissues relative to plasma. Consistent with this finding, the DA-1726 Study also showed that the greatest exposure outside of the injection site occurred in abdominal, subcutaneous and brown fat, as well as the liver. The DA-1726 Study also demonstrated prolonged retention of DA-1726-derived radioactivity in tissues through the final 144-hour assessment, consistent with the prolonged pharmacokinetic profile supporting once-weekly dosing of DA-1726. In addition, the DA-1726 Study demonstrated that only minimal radioactivity was detected in the central nervous system, consistent with the limited brain penetration typically observed with peptide-based therapies.

Forward-Looking Statements

This Report, including Exhibit 99.1 attached hereto, contains 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 that the Company has filed with the Securities and Exchange Commission, including that results from preclinical studies are not necessarily predictive of future clinical results.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Exhibit Description
99.1		Press Release dated September 9, 2026.
104		Cover Page Interactive Data File (embedded within Inline XBRL document).

Signatures

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.


	METAVIA INC.


Date: September 9, 2026	By:	/s/ Hyung Heon Kim
		Hyung Heon Kim
		President and Chief Executive Officer