10-K: MetaVia Advances MASH, Obesity Programs Amidst Funding Needs

Sentiment:

Annual Report 26 March 2026 8:45 AM

MetaVia Inc. reported positive clinical trial results for its MASH and obesity drug candidates, vanoglipel (DA-1241) and DA-1726, but faces substantial doubt about its ability to continue as a going concern due to recurring net losses and a need for additional capital.

Capital raiseIn May 2025, closed a private placement offering with Dong-A ST and Dong-A Holdings, receiving net proceeds of $9.1 million.In November 2025, entered into an At The Market Offering Agreement (ATM Sales Agreement) for up to $2.3 million, selling 106,788 shares for $0.9 million net proceeds.In January 2026, closed an underwritten public offering, issuing Class A and Class B Units for gross proceeds of approximately $9.3 million.The company explicitly states it plans to continue to fund operations through equity offerings, debt financing, the exercise of existing warrants, or other sources, including collaborations, out-licensing, and similar arrangements.

Worse than expectedThe company has incurred net losses since inception and continues to do so, with an accumulated deficit of $148.8 million as of December 31, 2025.The independent registered public accounting firm has issued an opinion stating substantial doubt about the company's ability to continue as a going concern within the next twelve months.Despite recent capital raises, the company explicitly states it requires additional capital to accomplish its business plan and fund operations beyond Q4 2026.

Summary

MetaVia is a clinical-stage biotechnology company focused on cardiometabolic diseases, primarily MASH and obesity, with two main drug candidates: vanoglipel (DA-1241) and DA-1726.
Vanoglipel (DA-1241), a GPR119 agonist for MASH and Type 2 Diabetes Mellitus (T2DM), completed its Phase 2a clinical trial in November 2024, with positive topline 16-week results announced in December 2024.
DA-1726, an oxyntomodulin analog (GLP-1R and GCGR dual agonist) for obesity, completed its Phase 1 SAD Part 1 in September 2024 and MAD Part 2 (up to 32 mg dose) in April 2025, with positive topline data from the non-titrated 48 mg MAD cohort announced on January 5, 2026.
The company incurred a net loss of $13.0 million in 2025, a significant improvement from $27.6 million in 2024, and has an accumulated deficit of $148.8 million as of December 31, 2025.
Cash and cash equivalents stood at $10.3 million as of December 31, 2025, with management believing existing cash plus proceeds from a January 2026 public offering will fund operations into Q4 2026.
A one-for-eleven reverse stock split was completed in December 2025, and the company raised $9.1 million net from a private placement in May 2025 and $0.9 million net from an At The Market (ATM) Program in November 2025.
An underwritten public offering in January 2026 generated gross proceeds of approximately $9.3 million.
MetaVia has four legacy therapeutic programs (ANA001, NB-01, NB-02, Gemcabene) that it is not planning to advance and is considering for out-licensing or divestiture, with NB-01 already out-licensed in July 2024.

Sentiment

Score: 4

Explanation: StockSavvy.ai views this as a mixed filing. While clinical trial results for key drug candidates are positive and show promise, the significant ongoing net losses and the 'going concern' warning from auditors present a substantial financial risk, overshadowing the scientific progress.

Positives

Vanoglipel (DA-1241) Phase 2a clinical trial achieved its primary efficacy endpoint, showing statistically significant reductions in ALT levels at Weeks 4 and 8 (p = 0.0159 and p = 0.0342, respectively) and near statistical significance at Week 16 (p = 0.0506) compared to placebo.
Vanoglipel (DA-1241) 50 mg showed statistically significant improvement in ALT normalization compared to placebo (odds ratio of 10.500, p = 0.0487).
Vanoglipel (DA-1241) 100 mg and combination therapy showed significant improvements in CAP score (p=0.0308 and p=0.0452, respectively) and the combination showed a statistically significant reduction in FAST score (p = 0.0416).
Vanoglipel (DA-1241) 100 mg and combination therapy showed significant reductions in HbA1c from baseline at Week 16 compared to placebo (p = 0.0179 and p = 0.0050, respectively).
Vanoglipel (DA-1241) demonstrated a strong safety signal with mostly mild adverse events and no drug-related serious adverse events or discontinuations.
DA-1726 Phase 1 MAD cohort (48 mg) showed robust early weight loss, with a statistically significant reduction of 6.1% (14.6 lbs.) mean weight loss at Day 26 compared to placebo (p = 0.003), and 9.1% (21.2 lbs.) weight reduction by Day 56.
DA-1726 48 mg showed statistically significant waist circumference reduction of 5.8 cm (2.3 inches) on Day 26 (p = 0.006) and 9.8 cm (3.8 inches) on Day 56 (p = 0.022) compared to placebo.
DA-1726 48 mg demonstrated strong improvements in glucose control, with a 12.3 mg/dL reduction in fasted glucose and normalization of HbA1c from 6.0% to 5.5% in one prediabetic subject over eight weeks.
DA-1726 48 mg showed a significant 23.7% reduction in liver stiffness (VCTE) in eight weeks, from 5.9 kPa to 4.5 kPa.
DA-1726 Phase 1 data demonstrated favorable safety and tolerability with mild to moderate gastrointestinal adverse events and no treatment-related discontinuations up to a non-titrated 48 mg dose level.
Strengthened global intellectual property position for DA-1726 with 39 granted and pending patents providing protection at least through 2041.
Comprehensive global intellectual property portfolio supporting vanoglipel with 48 granted and pending patents providing protection into 2035.
Net loss decreased from $27.6 million in 2024 to $13.0 million in 2025, and R&D expenses decreased by 68.4% ($14.8 million) in 2025 compared to 2024.

Negatives

Incurred net losses since inception, with a net loss of $13.0 million in 2025 and an accumulated deficit of $148.8 million as of December 31, 2025.
Experienced negative cash flows from operating activities since inception, with $15.7 million used in operating activities in 2025.
Independent registered public accounting firm issued an opinion stating substantial doubt about the company's ability to continue as a going concern within twelve months from the financial statements' issuance date.
Requires additional capital to accomplish its business plan, and failure to obtain necessary capital could force delays, reductions, or termination of operations.
Raising additional capital may cause material dilution to existing stockholders and could include restrictive covenants.
Future sales, or the perception of future sales, by the company or its securityholders could cause the market price of common stock to decline.
The company has a small number of employees (eight full-time as of December 31, 2025) and may experience difficulties managing future growth.
The company relies exclusively on Dong-A ST as the sole manufacturer for vanoglipel (DA-1241) and DA-1726, posing supplier risk if issues arise or alternative sources are not found.

Risks

Incurred net losses since inception and anticipates continued net losses for the foreseeable future, requiring additional capital.
Dependent on working capital to fund its business plan, and raising additional capital may cause dilution, restrict operations, or require relinquishing rights to technologies.
Future sales, or the perception of future sales, by the company or its securityholders could cause the market price of common stock to decline.
Adverse global economic conditions could materially adversely affect business, results of operations, financial condition, and liquidity.
May expend limited resources on a particular product candidate or indication and fail to capitalize on more profitable opportunities.
Public opinion and scrutiny of treatments for obesity, overweight patients, MASH, and MASH patients may impact public perception and business plans.
May be required to make significant payments under the 2022 License Agreement (milestones, royalties) for which sufficient funds may not be available.
Even with favorable clinical results, may not obtain regulatory approval for, or successfully commercialize vanoglipel (DA-1241) and DA-1726.
Preliminary, interim, and topline data from clinical trials may change as more patient data become available and are subject to audit and verification.
Results of earlier clinical trials may not be predictive of later-stage clinical trials.
Product candidates may cause undesirable side effects that could delay or prevent marketing approval, limit commercial profile, or result in negative consequences post-approval.
Efforts to discover drug candidates beyond current ones may not succeed, and candidates recommended for clinical development may not begin trials.
Delays in clinical trials may lead to delayed marketing approval applications and jeopardize ability to receive approvals and generate revenues.
Developing product candidates in combination with other therapies exposes the company to additional risks.
Any future collaboration arrangement may not be successful, adversely affecting ability to develop and commercialize drug candidates.
Enrollment and retention of patients in clinical trials is expensive, time-consuming, and difficult due to factors like diagnosing MASH/obesity and competition.
Faces substantial competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies.
Commercial success depends on attaining significant market acceptance of product candidates, if approved, among hospitals, physicians, patients, and healthcare payors.
May engage in strategic transactions that could impact liquidity, increase expenses, and distract management.
Product liability lawsuits could cause substantial liabilities and limit commercialization.
Failure to comply with environmental, health, and safety laws and regulations could result in fines or penalties.
Relies on third-party clinical research organizations (CROs) and manufacturers; failure by these parties could substantially harm the business.
Inability to obtain and maintain sufficient intellectual property rights could harm competitive position.
May not be able to protect or practice intellectual property rights throughout the world.
May become involved in lawsuits to protect or enforce intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
Trade secrets are difficult to protect, and loss of confidentiality would harm business and competitive position.
Small number of employees; future success depends on ability to retain executive officers and attract/retain qualified personnel.
Price of common stock may be volatile and fluctuate substantially, resulting in losses for stockholders.
Two largest stockholders (Dong-A ST and Dong-A Holdings) may use their significant interest to take actions not supported by other stockholders.
Provisions in corporate charter documents and Delaware law may make an acquisition more difficult and prevent attempts to replace management.
Nasdaq has proposed enhanced listing standards, which could adversely affect ability to maintain Nasdaq listing and access to capital markets.
Business and operations may suffer in the event of system failures or other unplanned events, including cybersecurity incidents.
Inadequate funding of the FDA and other government agencies could hinder their ability to review and approve products.

Future Outlook

MetaVia plans to advance vanoglipel (DA-1241) through the FDA regulatory process for MASH, including seeking initiation of a Phase 2b clinical trial as monotherapy or in combination. The company also intends to advance DA-1726 through the FDA process for obesity, including expediting clinical trials and conducting non-clinical studies, with Phase 1 Part 3a and 3b titration studies planned for April 2026 and data readout expected in Q4 2026. MetaVia aims to explore additional clinical-stage product candidates and technologies to diversify its pipeline.

Management Comments

"We believe that our existing cash, together with the proceeds from the underwritten public offering in January 2026, will be sufficient to fund our operations into the fourth quarter of 2026."
"We plan to continue to fund our operations through equity offerings, debt financing, the exercise of existing warrants, or other sources, potentially including collaborations, out-licensing and other similar arrangements."
"We expect dose-dependent exploratory weight loss and other early signals in the exploratory endpoints with potential for best-in-class safety and tolerability [for DA-1726 Phase 1 Part 3a and 3b]."

Industry Context

StockSavvy.ai notes that MetaVia operates in highly competitive pharmaceutical and biotechnology industries characterized by rapid technological advancements. For MASH, MetaVia's vanoglipel (DA-1241) competes with Madrigal Pharmaceuticals' approved thyroid hormone receptor beta agonist and numerous candidates in Phase 3 or earlier development from companies like Novo Nordisk (semaglutide), Eli Lilly (tirzepatide), Akero Therapeutics (efruxifermin), and 89 Bios (pegaozafermin). In obesity, DA-1726 faces strong competition from approved products like Novo Nordisk's semaglutide (WEGOVY) and Eli Lilly's tirzepatide (Zepbound), as well as other GLP1R/GCGR dual and triple agonists in development from companies such as Boehringer Ingelheim, Merck/Hanmi Pharmaceutical, AstraZeneca, Altimmune, and Amgen. The company acknowledges that MASH is a complex disease unlikely to have a single optimal therapeutic option, and commercial success in obesity will depend on demonstrating benefits over existing standards of care.

Comparison to Industry Standards

DA-1726 demonstrated superior body weight loss compared to semaglutide in HF-DIO mice in preclinical studies, suggesting a potential competitive advantage.
DA-1726 showed similar glycemic control and excellent weight loss to semaglutide in obese mice with hyperglycemia, without hypoglycemia risk in overnight fasted normal mice, unlike semaglutide.
DA-1726 showed similar body weight reduction to tirzepatide in HF-DIO MASH mice while consuming significantly more food, and also reduced plasma clinical chemistry parameters (ALT, AST, ALP, T-BIL, glucose, and cholesterol) and hepatic fat accumulation, indicating a potentially differentiated profile.
The furthest stage of development for oxyntomodulin analogs (like DA-1726) are survudutide and mazdutide, which are in Phase 3 clinical trials in the U.S. (mazdutide approved in China) and Phase 2 clinical trials in the U.S. for obesity and MASH, positioning MetaVia's DA-1726 in an earlier stage of development compared to some competitors but with promising early data.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Board Classification	The Board is divided into three classes, with members serving staggered three-year terms. Terms for Class I, Class II, and Class III directors expire at annual meetings in 2026, 2027, and 2028, respectively.	N/A	This classified board structure, along with other provisions, could make it more difficult for stockholders to replace a majority of directors and may discourage hostile takeovers.
Director Removal and Vacancies	Removal of directors requires a stockholder vote of at least 66 2/3% of outstanding voting stock and only for cause. Board vacancies can be filled by a majority of directors then in office, and the authorized number of directors can only be changed by Board resolution.	N/A	These provisions make it more difficult for stockholders to replace a majority of directors, potentially entrenching current management and board members.
Special Stockholder Meetings	Special stockholder meetings may only be called by a resolution adopted by a majority of the Board or by the Chair of the Board.	N/A	Limits stockholders' ability to call special meetings, reducing their power to initiate certain corporate actions.
Stockholder Advance Notice Procedure	Bylaws establish advance notice procedures for stockholder nominations of directors or other business at annual meetings, requiring written notice within specific timeframes and detailed information.	N/A	Ensures orderly meetings and provides the company time to review proposals, but can make it more challenging for dissident stockholders to introduce items.
Undesignated Preferred Stock	The Board may, without stockholder action, fix the rights, preferences, privileges, and restrictions of up to 10,000,000 shares of Preferred Stock in one or more series.	N/A	The issuance of Preferred Stock could adversely affect common stockholders' voting power, dividend rights, and liquidation preferences, and could delay, defer, or prevent a change of control.
Delaware Anti-Takeover Statute (Section 203 DGCL)	The company is subject to Section 203 of the Delaware General Corporation Law, which generally prohibits business combinations with an interested stockholder (owning 15% or more of voting stock) for three years, unless certain conditions are met.	N/A	This statute can deter hostile takeovers by making it more difficult for an interested stockholder to complete a business combination.
Insider Trading Policy	The Board adopted an Insider Trading Compliance Policy prohibiting speculative trading and hedging transactions involving common stock by directors, officers, employees, and other specified persons.	N/A	Aims to promote compliance with insider trading laws and prevent improper conduct, enhancing corporate integrity.
Audit Committee Financial Experts	Mark A. Glickman and D. Gordon Strickland qualify as audit committee financial experts.	N/A	Ensures strong financial oversight and expertise on the audit committee, which is crucial for financial reporting reliability.

Legal Proceedings

Not currently a party to any claims or legal proceedings that are likely to have a material adverse effect on the business and consolidated financial statements.

Related Party Transactions

In May 2025, MetaVia closed a private placement offering with Dong-A ST and Dong-A Holdings (affiliates), receiving net proceeds of $9.1 million from the issuance of common stock and pre-funded warrants.
Dong-A ST and Dong-A Holdings beneficially owned 17.8% and 16.9%, respectively, of MetaVia's voting rights as of March 20, 2026, giving them significant influence.
MetaVia has an exclusive global license (excluding Republic of Korea) for vanoglipel (DA-1241) and DA-1726 from Dong-A ST, under which Dong-A ST is eligible for regulatory milestone payments (up to $178.0 million for DA-1726, $138.0 million for vanoglipel) and single-digit royalties on net sales.
Dong-A ST manufactures clinical quantities of vanoglipel (DA-1241) and DA-1726 under a Shared Services Agreement. MetaVia incurred R&D expenses of $3.4 million in 2025 and $4.9 million in 2024 under this agreement.
The aggregate payable to Dong-A ST under the Shared Services Agreement was $3.3 million as of December 31, 2025, including $2.0 million with extended payment terms and $1.3 million in clinical trial accrued liabilities.

Stakeholder Impact

Shareholders face potential material dilution from future equity offerings needed to fund operations.
Existing stockholders may experience volatility in stock price due to the company's financial condition, need for capital, and the influence of major stockholders (Dong-A ST and Dong-A Holdings).
Employees may be impacted by the company's ability to attract, retain, and motivate qualified personnel in a competitive industry, especially given the small current workforce.
Customers (future patients) could benefit from the successful development and commercialization of novel treatments for MASH and obesity, but face risks of delays or failure to obtain regulatory approval.
Creditors face risks due to the company's recurring net losses and the 'going concern' uncertainty, which could affect its ability to meet financial obligations.
Suppliers and contract research organizations (CROs) are critical to MetaVia's operations, and their ability to meet commitments could be strained by adverse economic conditions or MetaVia's financial challenges.

Next Steps

Finalize the Clinical Study Report (CSR) of the vanoglipel (DA-1241) Phase 2a clinical trial in the first half of 2026.
Seek initiation of a Phase 2b clinical trial for vanoglipel (DA-1241) as monotherapy or in combination with GLP1R or other therapeutic candidates.
Start Part 3a and Part 3b of the Phase 1 clinical trial for DA-1726 in April 2026, with Part 3a being a one-step titration (16 mg for 4 weeks, 48 mg for 12 weeks) and Part 3b being a two-step titration (16 mg for 4 weeks, 32 mg for 4 weeks, 64 mg for 8 weeks).
Plan for data readout for both Part 3a and Part 3b of the DA-1726 Phase 1 clinical trial in the fourth quarter of 2026.
Explore various avenues to advance DA-1726 through the FDA approval process, including seeking ways to expedite clinical trials and conducting non-clinical studies.
Explore adding clinical stage product candidates or other technologies to diversify and enrich the pipeline.
Continue to consider out-licensing and divestiture opportunities for legacy therapeutic programs (ANA001, NB-02, Gemcabene).

Key Dates

Date	Description
September 14, 2022	Entered into the Investor Rights Agreement and 2022 Registration Rights Agreement with Dong-A ST Co. Ltd.
November 2022	The 2022 License Agreement with Dong-A ST became effective.
August 2023	Hyung Heon Kim appointed as President and Chief Executive Officer.
September 2023	Lease for corporate headquarters in Cambridge, Massachusetts commenced.
October 25, 2023	Marshall Woodworth appointed as Acting Chief Financial Officer.
March 1, 2024	Marshall Woodworth appointed as Chief Financial Officer.
June 2024	Entered into a Securities Purchase Agreement with Dong-A and another institutional investor, raising $20.0 million gross proceeds.
June 23, 2024	Entered into the 2024 Registration Rights Agreement with Dong-A and Armistice Capital Master Fund Ltd.
July 2024	Entered into an exclusive out-license agreement with MThera Pharma Co., LTD. for NB-01.
September 2024	Announced positive topline data from the single ascending dose (SAD) Part 1 of the Phase 1 clinical trial for DA-1726.
November 2024	Completed the last patient last visit for the vanoglipel (DA-1241) Phase 2a clinical trial.
December 2024	Announced positive topline 16-week results from the two-part Phase 2a clinical trial for vanoglipel (DA-1241).
April 2025	Announced positive topline data from the up to 32 mg, MAD cohort Part 2 of the Phase 1 clinical trial for DA-1726.
May 8, 2025	Entered into the 2025 Registration Rights Agreement with Dong-A and Dong-A Socio Holdings Co., Ltd. and experienced an ownership change under Section 382 of the Code.
May 2025	Closed on a private placement offering with Dong-A ST and Dong-A Holdings, receiving $9.1 million net proceeds.
May 2025	Presented topline 16-week results from the vanoglipel (DA-1241) Phase 2a clinical trial at EASL 2025.
June 2025	Began enrollment for a higher-dose MAD cohort for DA-1726.
July 2025	Dosed the first patient in the non-titrated 48 mg, MAD cohort of the DA-1726 Phase 1 clinical trial.
November 2025	Presented new Phase 1 and pre-clinical data on DA-1726 at ObesityWeek 2025.
November 2025	Presented sub-group analysis on glucose control and additional data on inflammation and lipidomic profiles for vanoglipel (DA-1241) at AASLD The Liver Meeting 2025.
November 2025	Entered into an At The Market Offering Agreement (ATM Sales Agreement) for up to $2.3 million and sold 106,788 shares for $0.9 million net proceeds.
December 2025	Completed a one-for-eleven reverse stock split of common stock.
December 31, 2025	Fiscal year end for the annual report.
January 5, 2026	Announced positive topline data from the non-titrated 48 mg, MAD cohort 5 Part 2 of the Phase 1 clinical trial for DA-1726.
January 2026	Closed an underwritten public offering for gross proceeds of approximately $9.3 million.
February 2026	Announced positive AI-modeling results from collaboration with Syntekabio, Inc. for vanoglipel.
February 2026	Strengthened global intellectual property position for DA-1726.
March 2026	Announced a comprehensive global intellectual property portfolio supporting vanoglipel.
March 2026	Received IRB approval for the Phase 1 Part 3 16-week titration study of DA-1726.
March 20, 2026	Date for shares of common stock outstanding (5,090,936 shares) and beneficial ownership reporting.
March 26, 2026	Filing date of the Annual Report on Form 10-K.
April 2026	Planning to start Part 3a and Part 3b of the Phase 1 clinical trial for DA-1726.
First half of 2026	Expecting to finalize the Clinical Study Report (CSR) of the vanoglipel (DA-1241) Phase 2a clinical trial.
Fourth quarter of 2026	Planned data readout for both Part 3a and Part 3b of the DA-1726 Phase 1 clinical trial.
Fourth quarter of 2026	Expected period for existing cash and January 2026 offering proceeds to fund operations.
August 2028	Expiration of the corporate headquarters lease.

Recommendation

hold

MetaVia presents a high-risk, high-reward profile. The positive clinical data for vanoglipel (DA-1241) in MASH and DA-1726 in obesity are significant and could drive substantial value if regulatory approvals are achieved. However, the company's recurring net losses, accumulated deficit, and the 'going concern' warning from auditors indicate severe financial instability and a strong dependence on future capital raises. While recent funding provides a short runway, the long-term viability is uncertain without sustained financing. Existing investors might hold to see if the promising clinical pipeline can attract further funding or a strategic partnership, but new investors should approach with extreme caution due to the substantial financial risks.

Keywords

Biotechnology, Cardiometabolic Diseases, MASH, Obesity, Vanoglipel, DA-1241, DA-1726, GPR119 Agonist, GLP-1R Agonist, GCGR Agonist, Clinical Trials, Phase 2a, Phase 1, Drug Development, SEC Filing, 10-K, Financial Reporting, Going Concern, Biopharmaceutical

Disclaimer:The information provided here is for general informational purposes only and does not constitute financial advice, recommendation, or endorsement of any kind. It may contain errors or omissions. You should not rely on this information to make financial decisions. Always seek the advice of a qualified financial professional before making any investment or financial decisions. Use of this information is at your own risk.