Current Report · Items 2.02, 7.01, 9.01 · 8-K

MetaVia Inc.

MTVANASDAQEQUITYCurrent

Results of Operations and Financial Condition · Regulation FD Disclosure

Item 2.02. Results of Operations and Financial Condition . On August 6, 2026, MetaVia Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2026 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”).

Filed Aug 6, 2026Accepted Aug 6, 2026, 4:05 PM EDTCIK 1638287Accession 0001104659-26-091981

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Company context

MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists such as semaglutide. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose and lipid control, and also proved differentiated hepatic benefits reducing hepatic steatosis, hepatic inflammation, and liver fibrosis regardless independent of metabolic improvement. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.

Current securities

MTVANASDAQ · EQUITY · Current

Historical securities (1)

NRBOOTC · EQUITY · Historical · closed Nov 27, 2024

Recent company filings

Disclosure sections

Items 2.02, 7.01, 9.01

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Item 2.02Item 2.02 - Results of Operations

Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure . On August 6, 2026, the Company posted an updated corporate presentation to its website at https://ir.metaviatx.com/events-presentations/presentations, which the Company may use from time to time in connection with presentations, investor communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.2 to this Report and is incorporated herein by reference. Information contained on or accessible through any website reference in the press release or the corporate presentation 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 and the corporate presentation is as inactive textual references only. The information in this Report, including Exhibits 99.1 and 99.2 attached hereto, are furnished pursuant to Item 2.02 and Item 7.01, respectively, 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 Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2 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.

Filed exhibits (2)

EX-99.1 (by filename) mtva-20260806xex99d1.htm

EX-99.1 2 mtva-20260806xex99d1.htm EX-99.1 Exhibit 99.1 MetaVia Reports Second Quarter 2026 Financial Results and Provides Corporate Update All Active Patients Successfully Reached Highest Planned Dose Levels of 48 mg and 64 mg in Ongoing Phase 1 Part 3 Study of DA-1726 16-Week Topline Data Expected in the Fourth Quarter of 2026 CAMBRIDGE, Mass., August 6, 2026 - MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate strategic update. “During the second quarter of 2026, and subsequently, we continued to execute across both of our clinical development programs while further strengthening the differentiated profile of DA-1726 as a dual GLP-1/glucagon receptor agonist,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “Most recently, all active patients in both cohorts of our ongoing Phase 1 Part 3 study successfully reached the highest planned dose levels of 48 mg and 64 mg, representing an important execution milestone as we prepare for our 16-week topline data readout, expected in the f…

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EX-99.2 (by filename) mtva-20260806xex99d2.htm

EX-99.2 3 mtva-20260806xex99d2.htm EX-99.2 Exhibit 99.2 1 MetaVia Inc. Transforming Cardiometabolic Diseases Investor Presentation August 2026 www.metaviatx.com Nasdaq: MTVA ───────────────────────────────── 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “believes”, “expects”, “anticipates”, “may”, “will”, “should”, “seeks”, “approximately”, “intends”, “projects”, “plans”, “estimates” or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, but are not limited to, statements regarding the market size and potential growth opportunities…

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