MetaVia Pushes MASH, Obesity Drugs Amidst Mounting Losses

Ticker: MTVA · Form: 10-K · Filed: Mar 26, 2026 · CIK: 0001638287

Metavia INC. 10-K Filing Summary
FieldDetail
CompanyMetavia INC. (MTVA)
Form Type10-K
Filed DateMar 26, 2026
Risk Levelhigh
Pages15
Reading Time18 min
Key Dollar Amounts$0.001
Sentimentbearish

Complexity: moderate

Sentiment: bearish

Topics: Biotechnology, Clinical Stage, MASH, Obesity, Drug Development, Net Losses, Capital Intensive

TL;DR

**MTVA is a high-risk bet on two early-stage drugs in competitive markets, and without revenue, they're burning cash fast; avoid until a clear path to profitability emerges.**

AI Summary

MetaVia Inc. (MTVA) reported continued net losses for the fiscal year ended December 31, 2025, as it remains a clinical-stage biotechnology company without revenue. The company's primary focus is on two cardiometabolic programs: vanoglipel (DA-1241) for MASH and Type 2 Diabetes Mellitus, and DA-1726 for obesity. Vanoglipel (DA-1241) completed its Phase 2a clinical trial in November 2024, with positive topline 16-week results announced in December 2024 and presented at EASL 2025 and AASLD The Liver Meeting 2025. The Clinical Study Report for vanoglipel (DA-1241) is expected in the first half of 2026. DA-1726, an oxyntomodulin analog, showed positive topline data from its Phase 1 SAD Part 1 in September 2024 and MAD cohort Part 2 in April 2025. A higher-dose 48 mg MAD cohort was extended to eight weeks in July 2025, with positive topline data announced on January 5, 2026. MTVA plans to start Part 3a and 3b of the DA-1726 Phase 1 trial in April 2026, with data expected in Q4 2026. The company's market value of common stock held by non-affiliates was approximately $3.0 million as of June 30, 2025, and it had 5,090,936 shares outstanding as of March 20, 2026. MetaVia requires additional capital to fund its operations and advance its pipeline.

Why It Matters

MetaVia's continued net losses and reliance on external capital highlight the high-risk, high-reward nature of clinical-stage biotech. For investors, the success of vanoglipel (DA-1241) and DA-1726 is paramount, as these are the company's only active programs with significant potential to generate future revenue. Employees and customers are directly impacted by the company's ability to secure funding and advance its drug candidates, particularly in competitive fields like obesity and MASH where giants like Novo Nordisk and Eli Lilly are already dominant. The broader market will watch for clinical trial readouts, which could signal a new contender in the lucrative cardiometabolic space or another cautionary tale of biotech burn rates.

Risk Assessment

Risk Level: high — MetaVia Inc. is a clinical-stage biotechnology company that has incurred net losses since inception and anticipates continued losses for the foreseeable future, explicitly stating, "We do not generate any revenue." The aggregate market value of common stock held by non-affiliates was only approximately $3.0 million as of June 30, 2025, indicating a small market capitalization and limited financial cushion. The company explicitly states, "We require additional capital to accomplish our business plan and the failure to obtain necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations."

Analyst Insight

Investors should exercise extreme caution and consider MetaVia Inc. a highly speculative investment. Monitor closely for successful capital raises and significant positive clinical trial data, particularly the upcoming Q4 2026 data readout for DA-1726 Part 3a and 3b, before considering any position.

Financial Highlights

debt To Equity
N/A
revenue
$0
operating Margin
N/A
total Assets
Not Disclosed
total Debt
Not Disclosed
net Income
Net Loss
eps
N/A
gross Margin
N/A
cash Position
Not Disclosed
revenue Growth
N/A

Key Numbers

Key Players & Entities

Forward-Looking Statements

FAQ

What are MetaVia Inc.'s primary drug candidates and their current development status?

MetaVia Inc. is primarily focused on vanoglipel (DA-1241) for MASH and Type 2 Diabetes Mellitus, which completed its Phase 2a clinical trial in November 2024 with positive topline results announced in December 2024. Its second candidate, DA-1726 for obesity, is in Phase 1 clinical trials, with positive topline data from a 48 mg MAD cohort announced on January 5, 2026, and further Phase 1 parts (3a and 3b) planned for April 2026.

Has MetaVia Inc. generated any revenue from its operations?

No, MetaVia Inc. has not generated any revenue from its operations. The company explicitly states it has incurred net losses since inception and anticipates continuing to incur net losses for the foreseeable future, relying on capital raises to fund its business plan.

What is the market value of MetaVia Inc.'s common stock?

As of June 30, 2025, the aggregate market value of MetaVia Inc.'s common stock held by non-affiliates was approximately $3.0 million. As of March 20, 2026, the company had 5,090,936 shares of common stock outstanding.

What are the key risks for investors in MetaVia Inc.?

Key risks for MetaVia Inc. investors include the company's consistent net losses and dependence on additional capital, potential dilution from future fundraising, the inherent uncertainties and high failure rates of clinical trials, and intense competition in the cardiometabolic disease market. The company also faces risks related to regulatory approvals and the ability to successfully commercialize any approved products.

When can investors expect more data from MetaVia Inc.'s DA-1726 clinical trials?

MetaVia Inc. plans to start Part 3a and Part 3b of the Phase 1 clinical trial for DA-1726 in April 2026. The data readout for both Part 3a and Part 3b is planned for the fourth quarter of 2026, which will provide further insights into higher doses and titration strategies.

What is vanoglipel (DA-1241) designed to treat?

Vanoglipel (DA-1241) is a novel GPR119 agonist being developed primarily for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM). It aims to promote the release of key gut peptides like GLP-1, GIP, and PYY to improve glucose and lipid metabolism and aid in weight loss.

What is DA-1726 designed to treat and how does it work?

DA-1726 is a novel oxyntomodulin (OXM) analog functioning as a GLP-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist for the treatment of obesity. It is designed to be administered once weekly subcutaneously, with weight loss achieved by GLP1R reducing appetite and GCGR increasing energy expenditure.

What is MetaVia Inc.'s strategy for its legacy therapeutic programs?

MetaVia Inc. is not planning to advance development on its four legacy therapeutic programs: ANA001, NB-01, NB-02, and Gemcabene. The company has, or continues to consider, out-licensing and divestiture opportunities for these programs, such as the exclusive out-license agreement for NB-01 with MThera Pharma Co., LTD. in July 2024.

What is the significance of the 48 mg MAD cohort for DA-1726?

The 48 mg multiple-ascending dose (MAD) cohort for DA-1726 is significant because it was extended to eight weeks from four weeks in July 2025 to further explore the non-titrated maximum tolerated dose, evaluate safety, and assess longer-term early efficacy. Positive topline data from this cohort was announced on January 5, 2026, informing future dose escalation strategies.

Where is MetaVia Inc. incorporated and where are its principal executive offices located?

MetaVia Inc. is incorporated in Delaware. Its principal executive offices are located at 545 Concord Avenue, Suite 210, Cambridge, Massachusetts 02138.

Risk Factors

Industry Context

MetaVia operates in the highly competitive and rapidly evolving biotechnology sector, specifically focusing on cardiometabolic diseases like MASH and obesity. The market is characterized by significant unmet needs and intense R&D efforts from both large pharmaceutical companies and smaller biotech firms. Key trends include the development of novel mechanisms of action, combination therapies, and the increasing focus on metabolic health.

Regulatory Implications

As a clinical-stage biotechnology company, MetaVia faces significant regulatory hurdles. The development and approval process for new drugs is lengthy, costly, and subject to stringent requirements from regulatory bodies like the FDA. Any delays or setbacks in clinical trials or regulatory submissions for vanoglipel and DA-1726 could materially impact the company's future prospects.

What Investors Should Do

  1. Monitor upcoming clinical trial data readouts for DA-1726 (Q4 2026) and the final CSR for vanoglipel (H1 2026).
  2. Assess the company's ability to secure additional funding.
  3. Evaluate the competitive landscape for MASH and obesity treatments.
  4. Track any updates on the vanoglipel Phase 2a clinical study report (CSR).

Key Dates

Glossary

MASH
Metabolic dysfunction-associated steatohepatitis, a severe form of fatty liver disease characterized by inflammation and liver cell damage. (MetaVia's vanoglipel (DA-1241) is being developed as a potential treatment for MASH.)
T2DM
Type 2 Diabetes Mellitus, a chronic condition that affects the way the body processes blood sugar (glucose). (Vanoglipel (DA-1241) is also being explored for its potential in treating T2DM.)
GPR119 agonist
A substance that activates the G protein-coupled receptor 119, which plays a role in the release of gut hormones like GLP-1 and GIP, influencing glucose and lipid metabolism and potentially aiding weight loss. (Vanoglipel (DA-1241) is a GPR119 agonist, forming the basis of its therapeutic approach.)
Oxyntomodulin (OXM) analog
A synthetic version of the natural hormone oxyntomodulin, which acts on both GLP-1 and glucagon receptors. (DA-1726 is an OXM analog designed to promote weight loss by reducing appetite and increasing energy expenditure.)
GLP-1 receptor (GLP1R)
The receptor for glucagon-like peptide-1, a hormone that stimulates insulin secretion and inhibits glucagon secretion, thereby lowering blood glucose levels and promoting satiety. (DA-1726 is a dual agonist targeting the GLP1R, contributing to its appetite-suppressing effects.)
Glucagon receptor (GCGR)
The receptor for glucagon, a hormone that raises blood glucose levels by stimulating the liver to release stored glucose. (DA-1726 also targets the GCGR, which is believed to increase energy expenditure, contributing to weight loss.)
Clinical Study Report (CSR)
A comprehensive document detailing the design, conduct, and results of a clinical trial. (The final CSR for vanoglipel's Phase 2a trial is expected in H1 2026 and is critical for understanding the full trial outcomes.)
MAD cohort
Multiple Ascending Dose cohort, a part of a Phase 1 clinical trial where participants receive multiple doses of the study drug over a period to assess safety, tolerability, and pharmacokinetics. (MetaVia has completed MAD cohorts for DA-1726 and is extending them to assess longer-term effects.)

Year-Over-Year Comparison

As MetaVia is a clinical-stage company without revenue, year-over-year comparisons primarily focus on pipeline progression and financial burn rate. The company has advanced its key programs, with vanoglipel (DA-1241) completing Phase 2a and DA-1726 progressing through Phase 1 trials with positive data readouts. However, the company continues to incur net losses, underscoring its ongoing need for capital. New risks related to the specific outcomes of these advanced clinical trials and the ongoing need for substantial funding are likely to be more prominent compared to the previous filing.

Filing Stats: 4,521 words · 18 min read · ~15 pages · Grade level 14.9 · Accepted 2026-03-26 08:45:45

Key Financial Figures

Filing Documents

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 38 Item 1B. Unresolved Staff Comments 69 Item 1C . Cybersecurity 69 Item 2.

Properties

Properties 70 Item 3.

Legal Proceedings

Legal Proceedings 70 Item 4. Mine Safety Disclosures 70 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 70 Item 6. [Reserved] 71 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 71 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 80 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 80 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 80 Item 9A.

Controls and Procedures

Controls and Procedures 80 Item 9B. Other Information 81 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevents Inspections 81 Part III Item 10. Directors, Executive Officers and Corporate Governance 81 Item 11.

Executive Compensation

Executive Compensation 85 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 89 Item 13. Certain Relationships and Related Transactions, and Director Independence 91 Item 14. Principal Accountant Fees and Services 93 Part IV Item 15. Exhibits and Financial Statement Schedules 94 Item 16. Form 10-K Summary 96

Signatures

Signatures 97 1 Table of Contents Unless the context requires otherwise, references in this Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (this "Annual Report" or "Report") to "we," "us," "the Company," "MetaVia" and "our" refer to MetaVia Inc. (the "Company") and its subsidiaries. Special Note Regarding Forward-Looking Statements This Annual Report contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations regarding our ability to execute our commercial strategy; our expectations regarding the sufficiency of our existing cash and cash equivalents on hand to fund our operations; the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co., Ltd., a related party ("Dong-A ST"), including the impact on our future financial and operating results; the ability to integrate the product candidates into our business in a timely and cost-efficient manner; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate clinical trials on a timely basis; our planned clinical trials and our ability to recruit subjects for our clinical trials; the costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the changes in applicable laws or regulations; and the effects of changes to ou

Business

Item 1. Business Overview We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis ("MASH") and obesity. Vanoglipel (DA-1241) is a novel GPR119 ("GPR119") agonist with development optionality as a standalone or combination therapy for both MASH and Type 2 Diabetes Mellitus (" T2DM"). Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide-1 (" GLP-1"), glucagon-dependent insulinotropic polypeptide receptor ("GIP"), and peptide YY ("PYY") . These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel (DA-1241) has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies. o In Phase 1a and 1b human clinical trials, vanoglipel (DA-1241) was well tolerated in both healthy volunteers and those with T2DM. o We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel (DA-1241) in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel (DA-1241). In November 2024, we completed the last patient last visit for the Phase 2a clinical trial. o In December 2024, we an nounced positive topline 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. o In May 2025, we presented the topline 16-week results from the two-part Phase 2a clinical trial at the European Association for the Study of the Liver ("EASL") 2025. o In November 2025, we presented sub-group analysis on glucose control in prediabetes and diabetes subjects and additional data on inflammation and lipidomic profiles at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting 2025. o We

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