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Rhea-AI Filing Summary

MetaVia Inc. Form 8-K — Regulation FD disclosure (Aug 6, 2025)

MetaVia furnished a press release announcing an extension of the 48 mg multiple ascending dose (MAD) cohort in the Phase 1 clinical trial of DA-1726 from 4 weeks to 8 weeks and reporting that a fifth weekly dose was administered to the first patient. DA-1726 is described as a novel dual oxyntomodulin (OXM) analog agonist acting at GLP1R and GCGR for obesity treatment.

• Date: August 6, 2025
• Action: Cohort duration extended to 8 weeks (from 4 weeks)
• Dosing update: Fifth weekly dose given to first patient
• Exhibit: Press release furnished as Exhibit 99.1 (information furnished, not filed)

Positive

• 48 mg MAD cohort extended to 8 weeks, indicating a defined protocol update
• First patient received fifth weekly dose, showing continued dosing activity in the Phase 1 trial
• Press release furnished as Exhibit 99.1, providing timely disclosure under Item 7.01

Negative

• None.

Insights

Financial Analyst

TL;DR: Clinical trial schedule update and dosing milestone disclosed; limited immediate financial impact evident from the filing.

The 8-K furnishes a press release that documents a procedural change in the Phase 1 DA-1726 MAD cohort (extension from 4 to 8 weeks) and a dosing milestone (fifth weekly dose administered). The filing emphasizes that the press release is furnished, not filed, and contains forward-looking statements. There are no financial metrics, guidance, or safety data provided in this Report; therefore, investors have confirmation of operational progress but lack outcome or timeline detail to reprice valuation.

Clinical Development Specialist

TL;DR: Protocol adjustment and an additional administered dose reported; the filing provides procedural updates without clinical results.

MetaVia states that the 48 mg MAD cohort duration has been extended to 8 weeks and that the first patient has received a fifth weekly dose of DA-1726, a dual OXM analog targeting GLP1R and GCGR. The disclosure does not state the reason for the extension, safety findings, pharmacodynamic or efficacy data, or any changes to enrollment or overall timelines. As presented, this is a trial operational update rather than clinical outcome data.

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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): August 6, 2025

METAVIA INC.

(Exact name of Registrant as Specified in Its Charter)

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Delaware	​	001-37809	​	47-2389984
(State or other jurisdiction of incorporation)	​	(Commission File Number)	​	(IRS Employer Identification No.)

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545 Concord Avenue, Suite 210 Cambridge, Massachusetts ​	​	02138
(Address of principal executive offices)	​	(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 August 6, 2025, MetaVia Inc. issued a press release announcing an extension to 8 weeks from 4 weeks of the 48 mg, multiple ascending dose (MAD) cohort of the Phase 1 clinical trial of DA-1726, and has administered a fifth weekly dose to the first patient. DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

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 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.

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.

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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	​	Press Release dated August 6, 2025.
104	​	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: August 6, 2025	​	By:	/s/ Hyung Heon Kim
​	​	​	Hyung Heon Kim
​	​	​	President and Chief Executive Officer

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FAQ

What did MetaVia disclose in the August 6, 2025 Form 8-K?

MetaVia furnished a press release stating the 48 mg MAD cohort of the DA-1726 Phase 1 trial was extended from 4 weeks to 8 weeks and that a fifth weekly dose was administered to the first patient.

What is DA-1726 as described in the filing?

DA-1726 is described as a novel, dual oxyntomodulin (OXM) analog agonist that functions as a GLP1R and GCGR agonist for the treatment of obesity.

When was the press release dated and how was it submitted to the SEC?

The press release is dated August 6, 2025 and is furnished as Exhibit 99.1 to the Form 8-K (information furnished, not filed).

Does the 8-K disclose clinical safety or efficacy data for DA-1726?

No. The 8-K reports a cohort extension and a dosing update but does not provide safety, efficacy, or detailed clinical data.

Who signed the Form 8-K for MetaVia?

The report was signed by /s/ Hyung Heon Kim, President and Chief Executive Officer, dated August 6, 2025.