# EDGAR Filing Document

**Accession Number:** 0001638287
**File Stem:** 0001558370-25-010415
**Filing Date:** 2025-8
**Character Count:** 13872
**Document Hash:** 4c2909c896201d22438288387f8c76e1
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001558370-25-010415.hdr.sgml**: 20250806

**ACCESSION NUMBER**: 0001558370-25-010415

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20250806

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250806

**DATE AS OF CHANGE**: 20250806

**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:** 251187770

**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

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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): August 6, 2025**

![Graphic](mtva-20250806x8k001.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.) |

---

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| | |
|:---|:---|
| **545 Concord Avenue, Suite 210**<br>**Cambridge, Massachusetts** <br>| **02138** |
| (Address of principal executive offices) | (Zip Code) |

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**(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 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.

**Item 9.01.** **Financial Statements and Exhibits.**

**(d) Exhibits**

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| | |
|:---|:---|
| Exhibit<br>Number | Exhibit Description |
| 99.1 | [Press Release dated August 6, 2025.](mtva-20250806xex99d1.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: August 6, 2025 | By:  | /s/ Hyung Heon Kim |
|  |  | Hyung Heon Kim |
|  |  | *President and Chief Executive Officer* |

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## Exhibit 99.1

![Graphic](mtva-20250806xex99d1001.jpg)

**Exhibit 99.1**

**MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726** 

**for the Treatment of Obesity to 8 Weeks and** 

**Announces Fifth Weekly Dose in First Patient**

*Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose*

*Top-Line Data Expected in the Fourth Quarter of 2025*

**CAMBRIDGE, Mass., August 6, 2025 –** MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has extended to 8 weeks from 4 weeks, the 48 mg, multiple ascending dose (MAD) cohort of its 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. The extension is designed to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Top-line data is expected in the fourth quarter of 2025.

"Extending DA-1726 administration by an additional 4 weeks—for a total of 8 weeks—in the 48 mg cohort represents a meaningful step forward as we seek to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "After reviewing the original trial design and previous results, we feel confident that the 4-week extension can potentially provide more robust data, which we believe may position DA-1726 more strongly against current treatments and those in late-stage clinical trials. By extending exposure to the drug, we aim to more fully evaluate DA-1726's therapeutic profile across primary, secondary and exploratory endpoints—including safety, tolerability, body weight, waist circumference, and body mass index (BMI), among others—and to further unlock its full therapeutic potential. Previously reported data from the 32 mg dose demonstrated strong weight loss effects (mean: 4.3%, max: 6.3% by Day 26), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. These findings, along with favorable glycemic and cardiovascular safety and a mild, transient GI profile, suggest that DA-1726-may offer a superior tolerability profile compared to existing GLP-1 therapies."

Mr. Kim added, "We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20–30% within the first month and up to 70% within a year. We look forward to reporting top-line data from the extended 48 mg cohort later this year, which may further validate DA-1726's longer-term safety, early efficacy and differentiated tolerability profile compared to current GLP-1 therapies."

The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index (BMI) between 30 – 45 kg/m<sup>2</sup>. Nine subjects in each cohort are randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort

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will add 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.

For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.

**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®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared 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 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 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. 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. DA-1241 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, DA-1241 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, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.

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

**Contacts:**

MetaVia

Marshall H. Woodworth

Chief Financial Officer

+1-857-299-1033

marshall.woodworth@metaviatx.com

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**Rx Communications Group**

Michael Miller

+1-917-633-6086

mmiller@rxir.com

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