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): March 1826, 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 2.02.Results of Operations and Financial Condition.

On March 26, 2026, MetaVia Inc. issued a press release announcing its financial results for the year ended December 31, 2025 and providing a corporate update. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

The information in this Report, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 2.02 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..

Forward-Looking Statements

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.

Item 9.01.Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Exhibit Description
99.1		Press Release dated March 26, 2026.
104		Cover Page Interactive Data File (embedded within Inline XBRL document).

Signatures

~~Item~~Pursuant ~~7.01. Regulation~~to FDthe ~~Disclosures~~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.

On March 18, 2026, MetaVia Inc. (the “Company”) issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. 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.


	METAVIA INC.


Date: March 26, 2026	By:	/s/ Hyung Heon Kim
		Hyung Heon Kim
		President and Chief Executive Officer

On March 18, 2026, the Company issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. The Phase 1 Part 3 trial will enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics of DA-1726. Primary endpoints include monitoring adverse events (“AEs”), serious adverse events, treatment-emergent adverse events, and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index, and other cardiometabolic measures. The Company plans to initiate initial dosing in April 2026, with data expected in the fourth quarter of 2026.

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 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.

~~Item 9.01. Financial Statements and Exhibits.~~

~~(d) Exhibits~~

ExhibitNumber		Exhibit Description
99.1		Press Release dated March 18, 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: March 18, 2026	By:	/s/ Hyung Heon Kim
		Hyung Heon Kim
		President and Chief Executive Officer

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