Form 8-K

8-K — MetaVia Inc.

Accession: 0001104659-26-066631

Filed: 2026-05-27

Period: 2026-05-27

CIK: 0001638287

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — mtva-20260527x8k.htm (Primary)

EX-99.1 (mtva-20260527xex99d1.htm)

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8-K

8-K (Primary)

Filename: mtva-20260527x8k.htm · Sequence: 1

METAVIA INC._May 27, 2026

0001638287false00016382872026-05-272026-05-27

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): May 27, 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 May 27, 2026, MetaVia Inc. (the “Company”) issued a press release announcing the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026), being held May 27–30 in Barcelona, Spain. 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 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

Exhibit Description

99.1

Press Release dated May 27, 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: May 27, 2026

By:

/s/ Hyung Heon Kim

Hyung Heon Kim

President and Chief Executive Officer

EX-99.1

Filename: mtva-20260527xex99d1.htm · Sequence: 2

Exhibit 99.1

MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASH

48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau

Exploratory FibroScan Assessments Demonstrated Early Liver-Related Improvements

Ongoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at Higher-Dose Levels

CAMBRIDGE, Mass., May 27, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026), being held May 27–30 in Barcelona, Spain.

The data highlighted favorable safety and tolerability, clinically meaningful reductions in body weight and waist circumference at the 48 mg dose without titration, and exploratory, noninvasive liver-related findings supporting continued evaluation in metabolic dysfunction-associated steatohepatitis (MASH).

“These late-breaking Phase 1 findings presented at EASL 2026 continue to reinforce DA-1726’s differentiated metabolic profile as a dual GLP-1 and glucagon receptor agonist with meaningful effects on both body weight, waist circumference and liver-related parameters,” said Hyung Heon Kim, Chief Executive Officer of MetaVia. “Importantly, DA-1726 demonstrated robust and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, while maintaining favorable tolerability even in the absence of dose titration. We are also encouraged by the exploratory FibroScan findings, which demonstrated early and consistent improvements across multiple noninvasive liver biomarkers, including liver stiffness, CAP and FAST scores. These findings further illustrate the potential of DA-1726 in obesity and MASH, where metabolic and hepatic dysfunction are closely linked. Based on these findings, we continue to advance the ongoing Phase 1 Part 3a/3b titration studies designed to evaluate longer-term dosing strategies, optimize tolerability at higher exposures, and further assess durability of metabolic and liver-related effects.”

The late-breaking poster presentation reported results from the 48 mg cohort of the randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose (MAD) study evaluating DA-1726 in obese but otherwise healthy adults. Subjects received once-weekly subcutaneous DA-1726 or placebo for four weeks without titration in a 2:1 randomization ratio. Of the nine subjects enrolled in the 48 mg cohort, six entered an optional four-week extension phase at the same dose.

DA-1726 was generally well tolerated up to the 48 mg dose level, with no serious adverse events or treatment-related discontinuations observed. Gastrointestinal adverse events were primarily mild-to-moderate and transient in nature, even without dose titration. In addition, despite glucagon receptor

activation, no clinically meaningful changes in cardiovascular parameters, including heart rate and QTcF, were observed.

Clinically meaningful reductions in body weight and waist circumference were observed in the 48 mg cohort. Participants achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54 (p < 0.05 vs placebo at Day 26), with no evidence of a plateau through Week 8. Waist circumference was reduced by 5.8 cm at Day 26 and 9.8 cm at Day 54 (p < 0.05 vs placebo at Day 26).

Exploratory noninvasive liver assessments using FibroScan also suggested liver-related improvements at Day 54, including a reduction in controlled attenuation parameter (CAP) of −20.0 dB/m in the 48 mg group compared with +24.0 dB/m with placebo. Improvements in liver stiffness were also observed, with a −10.3% change from baseline by vibration-controlled transient elastography (VCTE) versus +13.8% with placebo. In addition, directional improvements from baseline were observed in FibroScan-aspartate aminotransferase (FAST) score, supporting further long-term evaluation of DA-1726 in obesity-associated liver disease and MASH.

Presentation Details:

● Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment

● Presenting Author: Chris Fang, Chief Medical Officer, MetaVia

● Abstract Number: LB26-5204

● Final Abstract ID: LBP-010

● Session: Late Breaking Posters

● Presentation Date: Wednesday, May 27, 2026

● Presentation Start: 8:30 am CET

A copy of the poster will be available on the Posters section of the MetaVia website after the presentation.

About DA-1726

DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction.

About MetaVia

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 GLP1R 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 novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.

For more information, please visit www.metaviatx.com.

Forward Looking Statements

Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", “potential”, "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) are intended to identify forward-looking statements. 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. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia’s ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia

Marshall H. Woodworth

Chief Financial Officer

+1-857-299-1033

marshall.woodworth@metaviatx.com

Rx Communications Group

Michael Miller

+1-917-633-6086

mmiller@rxir.com

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