# EDGAR Filing Document

**Accession Number:** 0001638287
**File Stem:** 0001104659-26-063059
**Filing Date:** 2026-5
**Character Count:** 16184
**Document Hash:** 4ef7e4e3e59421256c2ef1dd660dcdd2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-26-063059.hdr.sgml**: 20260518

**ACCESSION NUMBER**: 0001104659-26-063059

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260518

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260518

**DATE AS OF CHANGE**: 20260518

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MetaVia Inc.
- **CENTRAL INDEX KEY:** 0001638287
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 472389984
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37809
- **FILM NUMBER:** 26990962

**BUSINESS ADDRESS:**
- **STREET 1:** 545 CONCORD AVENUE
- **STREET 2:** SUITE 210
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02138
- **BUSINESS PHONE:** (857) 702-9600

**MAIL ADDRESS:**
- **STREET 1:** 545 CONCORD AVENUE
- **STREET 2:** SUITE 210
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02138

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** NeuroBo Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20191231

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Gemphire Therapeutics Inc.
- **DATE OF NAME CHANGE:** 20150331

?xml version='1.0' encoding='ASCII'? METAVIA INC._May 18, 2026

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**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 18, 2026**

![Graphic](mtva-20260518x8k001.jpg)

**METAVIA INC.**

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-37809** | **47-2389984** |
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (IRS Employer<br>Identification No.) |

---

---

| | |
|:---|:---|
| **545 Concord Avenue, Suite 210**<br>**Cambridge, Massachusetts** <br>| **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:

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| | | |
|:---|:---|:---|
| Title of each class | Trading<br>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).

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. ☐

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**Item 7.01.** **Regulation FD Disclosures.**

On May 18, 2026, MetaVia Inc. (the "Company") issued a press release announcing that three late-breaking abstracts highlighting its cardiometabolic assets, DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors for the treatment of obesity, and vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, have been accepted for poster presentations at the American Diabetes Association's (ADA) 2026 Scientific Sessions. The ADA will be held June 5-8, 2026 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. 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**

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| | |
|:---|:---|
| Exhibit<br>Number | Exhibit Description |
| 99.1 | [Press Release dated May 18, 2026.](mtva-20260518xex99d1.htm) |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |

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**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.

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| | | |
|:---|:---|:---|
|  | **METAVIA INC.** | **METAVIA INC.** |
| Date: May 18, 2026 | By:  | /s/ Hyung Heon Kim |
|  |  | Hyung Heon Kim |
|  |  | *President and Chief Executive Officer* |

---

## Exhibit 99.1

![Graphic](mtva-20260518xex99d1001.jpg)

**Exhibit 99.1**

**MetaVia to Present Obesity Data at the American Diabetes Association's (ADA) 2026 Scientific Sessions**

*Three Late-Breaking Posters Highlight DA-1726, a GLP-1/Glucagon Dual Agonist, and Vanoglipel, a GPR119 Agonist*

**CAMBRIDGE, Mass., May 18, 2026 – MetaVia Inc.** (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that three late-breaking abstracts highlighting its cardiometabolic assets, DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors for the treatment of obesity, and vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, have been accepted for poster presentations at the American Diabetes Association's (ADA) 2026 Scientific Sessions. The ADA will be held June 5-8, 2026 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

"Having three late-breaking abstracts accepted for poster presentations at the prestigious ADA conference is a testament to the strength of our cardiometabolic portfolio," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 has the potential to be a differentiated obesity treatment and is currently being evaluated in a 16-week Phase 1 Part 3 titration study designed to reach higher therapeutic doses with improved tolerability. We look forward to reporting data from this trial in the fourth quarter of this year. Our second asset, vanoglipel, has demonstrated broad therapeutic potential across liver and metabolic diseases. The two preclinical posters focused on vanoglipel explore combination therapies with current treatments for metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes."

● **Title:** *Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort Results* 

● **Presenting Author:** Weikai "Chris" Fang, Chief Medical Officer, MetaVia

● **Abstract Control Number:** 3102-LB

● **Session:** 23-B Obesity—Human

● **Presentation Date:** Sunday, June 7, 2026

● **Presentation Time:** 12:30-1:30 pm ET

● **Title:** *Synergistic Hepatoprotective and Weight-Loss Effects of Vanoglipel and Resmetirom Combination Therapy in a Diet-Induced Obese, Biopsy-Confirmed Mouse Model of MASH* 

● **Presenting Author:** Tae Hyoung Kim, Lead Research Scientist, Dong-A ST Research Center

● **Abstract Control Number:** 3043-LB

● **Session:** 22-C Integrated Physiology—Liver

● **Presentation Date:** Sunday, June 7, 2026

● **Presentation Time:** 12:30-1:30 pm ET

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

● **Title:** *Synergistic Effects of Vanoglipel and Metformin on Glycemic Control and Body Weight Reduction in a Diet-Induced Obese Mouse Model* 

● **Presenting Author:** Yuna Chae, Lead Research Scientist, Dong-A ST Research Center

● **Abstract Control Number:** 2856-LB

● **Session:** 12-D Clinical Therapeutics—Other Therapeutic Agents

● **Presentation Date:** Sunday, June 7, 2026

● **Presentation Time:** 12:30-1:30 pm ET

A copy of the posters 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 Vanoglipel (DA-1241)**

Vanoglipel is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.

**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 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 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,

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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 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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