Form 8-K

8-K — MetaVia Inc.

Accession: 0001104659-26-035238

Filed: 2026-03-26

Period: 2026-03-26

CIK: 0001638287

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — mtva-20260326x8k.htm (Primary)

EX-99.1 (mtva-20260326xex99d1.htm)

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8-K

8-K (Primary)

Filename: mtva-20260326x8k.htm · Sequence: 1

METAVIA INC._March 26, 2026

0001638287false00016382872026-03-262026-03-26

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): March 26, 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 Disclosure.

On March 26, 2026, MetaVia Inc. (the “Company”) posted an updated corporate presentation to its website at https://ir.metaviatx.com/events-presentations/presentations, which the Company may use from time to time in connection with presentations, investor communications or conferences. A copy of the corporate presentation 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 corporate presentation 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 corporate presentation is as inactive textual references only.

The information in this Report, including Exhibit 99.1 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 contains 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

Exhibit

Number

Exhibit Description

99.1

Corporate Presentation, March 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: March 26, 2026

By:

/s/ Hyung Heon Kim

Hyung Heon Kim

President and Chief Executive Officer

EX-99.1

Filename: mtva-20260326xex99d1.htm · Sequence: 2

Exhibit 99.1

MetaVia Inc.

Transforming

Cardiometabolic

Diseases

Investor Presentation

March 2026 www.metaviatx.com

Nasdaq: MTVA

Forward-Looking Statements

This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or

current facts and can be identified by the use of words such as “believes”, “expects”, “anticipates”, “may”, “will”, “should”, “seeks”, “approximately”, “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). 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. These forward-looking statements include, but are not limited to, statements regarding the market size and

potential growth opportunities of our current product candidates; the safety, efficacy, tolerability and other potential benefits, such as weight loss, associated with our current product candidates; the competitive differentiators

of our current product candidates; our planned clinical trial activities for our current product candidates; and the expected timeline for topline data release dates. Many factors could cause actual future events to differ

materially from the forward-looking statements in this presentation, including, without limitation, those risks associated our history of net losses, the sufficiency of our existing cash on hand to fund operations and raising

additional capital; adverse global economic conditions; our ability to execute on our commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of our

current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd. (the "License Agreement"), including the impact on our future financial and operating results; the

cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; potential negative interactions between our product candidates and any

other products with which they are combined for treatment; our ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for its clinical trials; whether we receive results from our 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; and the effects of changes to our stock price. These forward-looking statements are based on information currently available to us and our

current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements expressed or implied by the

forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, and our other filings with the

Securities and Exchange Commission.

While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we

believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as

representing our views as of any date subsequent to this presentation.

This presentation also may contain estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and

limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are

necessarily subject to a high degree of uncertainty and risk.

Market Opportunity: Obesity and MASH

MetaVia is Positioned to Pursue Two Fast-Growing, Multi-Billion Dollar Markets

• Obesity: A Massive Global Therapeutic Market

o 650M+ adults worldwide are clinically obese

o Market expected to grow from ~$10B today to $80B–$130B+ annually by 2030

• MASH: Emerging Multi-Billion Dollar Category

o An estimated 5–6% of adults globally may have MASH, especially in obesity & diabetes populations

o Until recently, no approved drug therapies

o Analysts forecast a $20B–$35B+ annual market as treatments enter the clinic and gain coverage

o Combination therapies expected to be standard, increasing lifetime value per patient

Clinical Stage Biotech Focused on Cardiometabolic Diseases

Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics

• DA-1726:

 Potential best-in-class profile for weight loss, glucose control, direct liver benefit and safety shown in Phase 1 studies

 At 48 mg (no titration) (at Day 54) -9.1% weight loss, -3.8-inch reduction in waist, -0.22 HbA1c, and -23.7% liver stiffness

(VCTE), mostly mild to moderate side effects

 Well-tolerated at 48 mg; now optimizing tolerability with planned stepwise titration up to 64 mg

 Part 3a (One-step): 16 mg (4 weeks) → 48 mg (12 weeks)

 Part 3b (Two-step): 16 mg (4 weeks) → 32 mg (4 weeks) → 64 mg (8 weeks)

o Data expected by YE 2026

• Vanoglipel (DA-1241)

 Phase 2a in presumed MASH met primary endpoint and demonstrated direct liver benefit

 Significant HbA1c reductions at 100 mg vs placebo at Week 16

o Additional exploratory endpoints including MRI-PDFF to be presented at major medical conferences

o Actively seeking combination/licensing partner

Strong Leadership Team

Executive Management

Hyung Heon Kim, Chief Executive Officer

Robert Homolka, SVP Clinical Operations

Marshall H. Woodworth, Chief Financial Officer

Mi-Kyung Kim, Ph.D., RPh, Chief Scientific Officer

 20+ years of experience in M&A, financing and corporate governance

 10+ years of licensing, M&A and compliance with Dong-A Group

 Former General Counsel/SVP at Dong-A ST and Dong-A Socio Group

 BA Soonghsil University, JD Washington University School of Law

 25+ years in drug discovery research at Dong-A ST

 Specialized in diabetes, obesity, MASH, immune-mediated diseases

 Ph.D., RPh, College of Pharmacy, Ewha Womans University

 35+ years in pharmaceutical and biotech development

 Sr. director of clinical operations in Adiso Therapeutics

 Director of clinical operations at Shire/Takeda pharmaceuticals

 Director of experimental trial management at AstraZeneca

 35+ years of financial experience

 20+ years working with life science investors and analysts

 CFO of Nevakar Inc., Braeburn Pharmaceuticals Inc., Aerocrine AB and Furiex

Pharmaceuticals Inc.

 BS University of Maryland, MBA Indiana University

Chris Fang, MD, Advisor/Consulting Chief Medical Officer

 20+ years of experience in clinical development, R&D and medical affairs

 Career focused on obesity, MASH, diabetes and other indications

 Held key roles at Eli Lilly, IQVIA, Acer Health and Johnson & Johnson

 BA UCLA, Master of Health Science John Hopkins, MD Cornell, MBA

Wharton

Non-Executive Management

Multiple Near-Term Catalysts to Drive Shareholder Value

2026

Vanoglipel

(DA-1241)

H1 2026

Meeting with FDA

DA-1726

*These milestones assume regulatory and clinical success, which is not guaranteed

*Gray boxes are prospective future studies, the timing and occurrence of which are subject to various factors

√ Q2/Q3 2025

Phase 1

Additional SAD/MAD Studies

√ Q4 2025

Phase 1

Additional

SAD/MAD data

To explore maximum tolerated dose

2025

Obese Otherwise

Healthy

2027

Obese with MASH

1H 2027*

Phase 2

Obesity MASH

Study Initiation

Q1 2026

Phase 1

Part 3

Initiation

1H 2027*

Phase 2

Obesity Otherwise

Healthy Study Initiation

Q4 2026

Phase 1

Part 3 Data

Readout

DA-1726

A Novel GLP1R/GCGR

Dual Agonist for the

Treatment of Obesity

DA-1726 (Oxyntomodulin Analogue)

• Mimics a natural gut hormone released after

meals

Dual-Acting Therapy Leveraging the GLP-1 and Glucagon Pathways (3:1 Ratio)

GLP1R/GCGR: glucagon-like peptide 1 receptor/glucagon receptor); GLP-1:glucagon-like peptide 1

1. Pocai A. Mol Metab.2014;3:241-51.

Physiological effects of oxyntomodulin1

DA-1726: Mechanism of Action - Reduces Appetite & Boosts Burning

of Calories

GLP-1 Receptor Activation (3x)

• Reduces appetite

• Decreases food intake

Glucagon Receptor Activation (1x)

• Increases energy expenditure

• Boosts calorie burning

Combined Effect: Superior Weight Loss Potential

Competitive Landscape – Efficacy

DA-1726 Pemvidutide1 Mazdutide2 Survodutide3 Retatrutide5

Developer MetaVia Altimmune Innovent/Lilly Boehringer Ingelheim/Zealand Lilly

Status Phase 1 Phase 3 ready Phase 2 in US Phase 3 Phase 3

Action GLP-1R/GCGR

(3:1)

GLP-1R/GCGR

(1:1)

GLP-1R/GCGR

(Unknown)

GLP-1R/GCGR

(8:1)

GLP-1/GCGR/GIP

(1.3:1:29.7)

Administration Once weekly injection Once weekly injection Once weekly injection Once weekly injection Once weekly injection

Current Titration No titration in Phase 1 No titration in Phase 1 5 Step (1.5, 3, 6, 9, 12, 16mg) 7 Step (0.3, 0.6, 0.9, 1.2, 1.8, 2.4,

3.3, 4.2, 4.8mg) 3 Step (2, 4, 8, 12mg)

Body Weight Loss in

Phase 1 MAD

Phase 1 8 weeks (Day 54) (no titration)

9.1% (48 mg)

Phase 1b 12 weeks (no titration)

10.3% (1.8mg)

9% (2.4mg)

Phase 2 48 weeks

-22.3%

Week 8: less than 5%

Week 16: between 9~10%

Placebo adjusted

Phase 2 46 weeks

-16.7%

Week 8: less than -6%

Phase 2 48 weeks

-24.2% (12mg)

Week 8: between 9~10%

Fasting Glucose

(mg/dL)

-12.3 mg/dL HbA1c @ 8 weeks

(Day 54) (48 mg) -0.8 mg/dL @ 12 weeks (2.4mg)

Phase 2 48 weeks

(obese Healthy, 16mg)

-12.3 mg/dL, HbA1c -0.6%

Week 8 glucose: nominal change

from baseline

Phase 1 6 weeks did not show any

treatment effect at any time point

Max -8.7 mg/dL,@ day 107

(close to week 16)

Phase 2 48 weeks

(Obese Healthy, 12mg)

-10.6 mg/dL

HbA1c -0.4%

Waist Circumference

(cm) -9.8 cm @ 8 weeks (Day 54) (48 mg) -10.2cm @ 24 weeks (2.4mg)

Phase 2 48 weeks

-16.6cm (16mg)

Week 8: Less than 5cm (16mg)

Up to -16cm @ 46 weeks

Phase 2 48 week 12mg

-19.6cm

Week 8: less than 9cm

 Data in the above table were gathered from publicly available company reports, scientific journals and posters. As each clinical study presented above vary in protocol design, study population, baseline characteristics,

duration, titration scheme and dose levels, this table is not intended to provide direct comparison nor a result of head-to-head study. This is only to show potential trends not direct comparison.

1. Company presentations, including, Stephen A. Harrison et al., 2022 EASL Conference, Pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist, achieves rapid and potent reductions in body weight and liver fat: Results of a placebo controlled, double blinded, first-in-human (FIH) clinical trial

2. Company presentation, Stanley H. Hsia et al., Obesity Week 2025, Mazdutide (LY3305677) in Participants With Obesity or Overweight: A Phase 2 Dose-Finding Study

3. Arvid Jungnik et al., 2022, Wiley, DOI: 10.1111/dom.14948, Matthias Blüher et al., 2023, Diabetologia DOI: 10.1007/s00125-023-06053-9, Carel W le Roux et al., Lancet Diabetes Endocrinol 2024; 12: 162-73

4. Tamer Coskun et al., 2018, Molecular Metabolism 18, DOI: 10.1016/j.molmet.2018.09.009, Juan Pablo Frias et al., 2020, Wiley, DOI: 10.1111/dom.13979

5. Shweta Urva et al., Lancet 2022; 400: 1869-81, Ania M. Jastreboff et al., N Engl J Med 2023; 389:514-26

Competitive Landscape – Adverse Events

DA-1726 Pemvidutide1 Mazdutide2 Survodutide3 Retatrutide5

Developer MetaVia Altimmune Innovent/Lilly Boehringer Ingelheim/Zealand Lilly

Status Phase 1 Phase 3 ready Phase 2/3 Phase 3 Phase 3

Action GLP-1R/GCGR

(3:1)

GLP-1R/GCGR

(1:1)

GLP-1R/GCGR

(Unknown)

GLP-1R/GCGR

(8:1)

GLP-1R/GCGR/GIP

(1.3:1:29.7)

Administration Once weekly injection Once weekly injection Once weekly injection Once weekly injection Once weekly injection

Current Titration No titration in Phase 1 No titration in Phase 1 5 Step (1.5, 3, 6, 9, 12, 16mg) 7 Step (0.3, 0.6, 0.9, 1.2, 1.8,

2.4, 3.3, 4.2, 4.8mg) 3 Step (2, 4, 8, 12mg)

Adverse Events

Phase 1 (48 mg) @ 8 weeks (Day 54) Phase 1 MAD (2.4mg) @ 12 weeks Phase 2 (16mg) @ 48 weeks

92.2% with at least 1 TEAE

Phase 2 @ 46 weeks

91% TEAEs

Phase 2 (12mg) @ 48 weeks

92% with any AEs

83.3% mild or moderate vomiting 72.8% mild or moderate vomiting 45.1% vomiting 24% vomiting 19% vomiting

50% mild or moderate nausea 91% mild or moderate nausea 60.8% nausea 59% nausea 45% nausea

0% constipation 18.2% constipation 35.3% Constipation 24% constipation 16% constipation

16.7% mild diarrhea 18.2% diarrhea 25.5% diarrhea 17% diarrhea 15% diarrhea

Discontinuations Due to

AEs

Phase 1 @ 8 weeks (Day 54) , no

discontinuations

Phase 1 MAD @ 12 weeks, no

discontinuations

19.6% @ 48 weeks

19.6% discontinuation

2 cases of SAEs

Phase 1 @ 6 weeks 7.5%

Phase 2 @ 46 weeks 24.6%

Phase 2 (12mg) @ 48 weeks 16%

2 cases of SAEs

AE of Special Interest

Hypersensitivity 13%

Antidrug antibody 18%

Cardiac arrhythmia 11%

duration, titration scheme and dose levels, this table is not intended to provide direct comparison nor a result of head-to-head study. This is only to show potential trends not direct comparison.

2. Company presentation, Stanley H. Hsia et al., Obesity Week 2025, Mazdutide (LY3305677) in Participants With Obesity or Overweight: A Phase 2 Dose-Finding Study

3. Arvid Jungnik et al., 2022, DOI: 10.1111/dom.14948, Matthias Blüher et al., 2023, Diabetologia DOI: 10.1007/s00125-023-06053-9, Carel W le Roux et al., Lancet Diabetes Endocrinol 2024; 12: 162-73

4. Tamer Coskun et al., 2018, Molecular Metabolism 18, DOI: 10.1016/j.molmet.2018.09.009

5. Shweta Urva et al., Lancet 2022; 400: 1869-81, Ania M. Jastreboff et al., N Engl J Med 2023; 389:514-26

Recent Obesity Drug Transactions

Companies Date Stage Description Drug Deal Structure Deal Terms

Pfizer / Metsera November 2025

Phase 3

Ready

(Lead

asset)

GLP-1,

Amylin analog,

Oral peptide GLP-1

MET-097i

MET-233i

MET-224o

MET-097o

M&A ~$7 billion

Novo Nordisk /

Septerna May 2025 Pre-IND

Oral Small Molecules Directed to

GPCR Targets, Including GLP-1, GIP

and Glucagon

UBT251 Exclusive Global Collaboration

and License

$200 million up front and near-term

milestone payments, with up to $2.0

billion in milestone payments

Novo Nordisk /

United

Biotechnology

March 2025 Phase 1

Ready GLP-1, GIP and Glucagon UBT251

Global License, excluding

Chinese mainland, Hong Kong,

Macau, or Taiwan

$200 million up front, with up to $1.8

billion in milestone payments

AbbVie / Gubra March 2025 Phase 1 Long-acting amylin analog GUB01429 Global License $350 million up front, with potential

milestone payments up to $1.875 billion

Roche / Zealand

Pharma March 2025 Phase 2

Amylin analogue,

as stand-alone therapy & in

combination with Roche’s incretin,

CT-388

Petrelintide

(ZP8396)

Collaboration,

Co-Development and

Co-Commercialization

$1.65 billion up front, with

$1.2 billion in milestones linked to Phase 3

and sales-based milestones of $2.4 billion

Carmot

Therapeutics /

Roche

January 2024 Phase 1

GLP-1/GIP agonist

GLP-1

GLP-1/GIP

CT-388

CT-996

CT-868

M&A $2.7 billion

Big Pharma has Committed Over $15 Billion in Obesity/MASH Licensing Deals in the Past 12 Months

DA-1726: Program Summary & Path Forward

DA-1726: Differentiated efficacy with best-in-class potential across weight loss, glucose control, liver

health, and safety

48 mg Key Takeaways

Potential best-in-class metabolic profile

• Strong efficacy without titration: (at Day 54)

o –9.1% body weight

o –3.8 inches waist circumference

o –0.22 HbA1c

o –23.7% liver stiffness (VCTE)

• Broad benefit profile: weight loss, glucose

control, and direct liver impact

• Well-tolerated at 48 mg, supporting further

dose optimization

Next Steps

Advancing dose optimization

• Tolerability optimization with stepwise titration up to

64 mg

o Part 3a (One-step): 16 mg (4 wks) → 48 mg (12 wks)

o Part 3b (Two-step): 16 mg (4 wks) → 32 mg (4 wks) →

64 mg (8 wks)

• Data readout expected by YE 2026

• 16-week study in obese patients

o First patient in targeted 1H 2026

Vanoglipel

(DA-1241)

Orally Available, Potential

First-in-Class GPR119

Agonist for the Treatment of

Metabolic Dysfunction-Associated

Steatohepatitis (MASH)

Vanoglipel (DA-1241): Targeting MASH at Its Source

Harrison et al., Clinical Gastroenterology and Hepatology, 2023;21(8):2001-2014

GPR119 Activation

• Found on key liver and immune cells driving

MASH

• Acts directly in the liver, not just indirectly

Potential Benefits in MASH and Metabolism

• Reduce liver fat and inflammation

• Slow or reverse liver scarring (fibrosis)

• Post-meal blood sugar lowering in type 2

diabetes (Phase 1 data)

Combination Potential

• Can potentially be used with other MASH

treatments to enhance efficacy

Vanoglipel: Liver Protection and Blood Sugar Benefits in MASH

Key Phase 2a Results (randomized, double-blind, 16 weeks, placebo-controlled):

Liver function improved: ALT reduced by 22.8 U/L

Inflammation & fibrosis markers improved: suggesting liver health benefits

Enhanced glucose control in patients with type 2 diabetes

Well-tolerated: no treatment-related discontinuations (only 1 in placebo)

Safe in combination therapy

Vanoglipel Combos with SEMA or EFX Boost Liver Benefits in Mouse

MASH Model

Support the therapeutic potential of combining GPR119 agonists with GLP-1 RAs or

FGF-21 analogues for the treatment of MASH:

 Combination therapy improved liver health—ALT, cholesterol, fat, inflammation, and

fibrosis—more than single drugs

 94% of combo-treated mice showed significant liver score improvement

 Reduced liver and blood inflammatory markers with Vanoglipel alone and with EFX

 Tissue and gene analyses confirmed stronger anti-inflammatory and anti-fibrotic

effects

 Additional anti-fibrotic potential suggested by Hhip upregulation

 Vanoglipel didn’t cause extra weight loss—remained weight-neutral

Vanoglipel: Summary & Next Steps

Clinical Rationale & Opportunity

• Vanoglipel is a novel GPR119 therapy for MASH and metabolic diseases

• Demonstrated liver protection and glucose control in Phase 1 & 2a

• Safe and well tolerated, including in combination therapy

• Large market opportunity: MASH ~$20B by 2032; growing interest in combination therapies (Madrigal, Novo Nordisk,

Roche)

Key Clinical Highlights

• ALT & liver enzymes improved; HbA1c lowered

• Additive benefits in combination therapy in preclinical models

• Strong IP protection, including composition-of-matter patents

Next Steps

• Additional exploratory endpoints including MRI-PDFF to be presented at major medical conferences

• MetaVia has begun partnering discussions, seeking early indications of interest

Clinical Data Supports Development as Monotherapy or in Combination: High Unmet Need

Financials

and

Capitalization

Cash Balance and Capitalization Table

Financial Snapshot As of December 31, 2025

Cash and cash equivalents $10.3 million

Debt None

Capitalization Table as of December 31, 2025 Common Stock Equivalents

Common Stock(1)(2) 2,308,294

Warrants (WAEP $63.13)(1)(3) 722,644

Options (WAEP $4,240.22) 420

Restricted Stock Units 29,295

Fully Diluted (1)(2)(3) 3,060,653

1. In January 2026, we closed on an underwritten public offering, pursuant to which we issued and sold, (i) 1,006,870 Class A Units, with each Class A Unit consisting of (A) one share of common stock, (B) 1.5 Series C Common

Warrants to purchase 1.5 shares of common stock, and (C) 1.5 Series D Common Warrants to purchase 1.5 shares of common stock, at a price of $3.10 per Class A Unit, and (ii) 1,998,704 Class B Units, with each Class B Unit

consisting of (A) one pre-funded warrant to purchase one share of common stock, (B) 1.5 Series C Common Warrants to purchase 1.5 shares of common stock, and (C) 1.5 Series D Common Warrants to purchase 1.5 shares of

common stock, at a purchase price of $3.099 per Class B Unit. Each pre-funded warrant has an exercise price of $0.001 per share and is immediately exercisable and will expire when exercised in full. Each Series C Common

Warrant and Series D Common Warrant has an exercise price of $3.10 per whole share of common stock, subject to certain adjustments, are immediately exercisable, and will expire on January 16, 2031 and January 16, 2028,

respectively. We received gross proceeds of $9.3 million, prior to deducting underwriting discounts and commissions and offering expenses. The Series C and Series D Common Warrants are fixed priced and do not contain any

variable pricing features or alternative exercise provisions. Subsequently, 1,630,964 pre-funded warrants have been exercised for an equivalent number of shares of common stock.

2. In March 2026, we sold 216,625 shares of common stock under an At The Market sale of shares of common stock program and received net proceeds of $0.3 million, net of sales agent commission and related offering expenses.

3. Includes (i) 2024 Series B milestone-based warrants to purchase 693,962 shares with an exercise price of $43.23 per share; (ii) 2024 Placement Agent warrants to purchase 11,564 shares of with an exercise price of $54.0375 per

share; (iii) 2022 Series B warrants to purchase 16,176 shares with an assumed exercise price of $0.00 per share; and (iv) 2021 and prior warrants to purchase a total of 942 shares with a weighted average exercise price of

$15,919.20 per share. No ratchets, price resets or anti-dilution provisions.

Strong Clinical Progress Across Two High-Impact Programs

Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics

• DA-1726:

 Potential best-in-class profile for weight loss, glucose control, direct liver benefit and safety shown in Phase 1 studies

 At 48 mg (no titration) (at Day 54)-9.1% weight loss, -3.8-inch reduction in waist, -0.22 HbA1c, and -23.7% liver

stiffness (VCTE), mostly mild to moderate side effects

 Well-tolerated at 48 mg; now optimizing tolerability with planned stepwise titration up to 64 mg

 Part 3a (One-step): 16 mg (4 weeks) → 48 mg (12 weeks)

 Part 3b (Two-step): 16 mg (4 weeks) → 32 mg (4 weeks) → 64 mg (8 weeks)

o Data expected by YE 2026

• Vanoglipel (DA-1241)

 Phase 2a in presumed MASH met primary endpoint and demonstrated direct liver benefit

 Significant HbA1c reductions at 100 mg vs placebo at Week 16

o Additional exploratory endpoints including MRI-PDFF to be presented at major medical conferences

o Actively seeking combination/licensing partner

Positioned for Value Creation in Two High-Growth Markets

• High-Impact Clinical Programs

o DA-1726: Obesity program in a rapidly expanding drug class

o Vanoglipel: Novel oral therapy targeting MASH

• Large, Growing Addressable Populations

o Obesity: broad population with increasing treatment adoption

o MASH: high unmet need, growing clinical recognition and screening

o Big pharma validating space via major acquisitions and licensing deals

• Multiple Paths to Shareholder Value

o Upcoming clinical milestones can meaningfully de-risk valuation

o Potential partnership/licensing opportunities

o Expanding regulatory clarity in both indications

Thank You!

Investor Contacts:

Rx Communications Group

Michael Miller

+1 917.633.6086

mmiller@rxir.com

MetaVia

Marshall Woodworth

+1 919.749.8748

marshall.woodworth@metaviatx.com

Appendix

DA-1726

A Novel GLP1R/GCGR

Dual Agonist for the

Treatment of Obesity

DA-1726: Phase 1 Clinical Program

Carefully planned to evaluate safety and efficacy of DA-1726 and dosing strategy to inform Phase 2 design

Main Optional Extension for

48mg Cohort

Part 3

Titration Dosing Strategy

(16-week Duration)

48 mg 48 mg

Q1 2026 Initiation

Additional

4 weeks

16 mg

4 mg

8 mg

Single Ascending Dose (SAD) 32 mg

16 mg

1 mg

2 mg

4 mg

8 mg

Completed

32 mg

A total of 8-week treatment

Part 2

Part 1

Part 3a: One step titration

16 mg x 4 wks → 48 mg x 12 wks

Part 3b: Two step titration

16 mg x 4 wks → 32 mg x 4 wks

→ 64 mg x 8 wks

-0.9%

-3.2%

-1.7%

-3.0%

-4.3%

-6.1%

-7%

-6%

-5%

-4%

-3%

-2%

-1%

Change from Baseline

(Day 26)

Baseline body weight (kg) 96.7 84.4 89.3 96.0 90.4 110.4

Compelling, dose-dependent body weight loss seen in doses > 8 mg

Pooled

Placebo

(n=14)

4 mg

(n=6)

8 mg

(n=5)

16 mg

(n=6)

32 mg

(n=6)

48 mg

(n=6)

DA-1726

DA-1726 Phase 1 MAD Study: Body Weight Loss on Day 26

*p<0.05 vs. placebo; **p<0.001 vs. placebo

Mean Body Weight Mean Body Weight Change from Baseline

Baseline Day 26 Day 54

DA-1726 48 mg 110.4 kg -6.1% (-6.6 kg) -9.1% (-9.6 kg)

Placebo 109.0 kg -0.2% (-0.3 kg) -2.8% (-3.1 kg)*

Placebo adjusted -5.9% -6.3%

Placebo adjusted

excluding outlier* -5.1% -7.7%

*One placebo subject in the extension period reported implementing no carbohydrate diet while participating in the study

which may have led to a substantial weight loss.

Potentially best-in-class weight loss seen in 48 mg DA-1726 with

no titration

64 mg DA-1726 with 2-step titration dosing

to be evaluated in Part 3

DA-1726 Phase 1 MAD Study:

Body Weight Loss in 48 mg Cohort

-6.1%

-9.1% -10%

-8%

-6%

-4%

-2%

Mean Body Weight Change (%) from

Baseline in 48 mg DA-1726

†p<0.05 from Baseline; *p<0.05 vs. placebo

†*

†

-5.8 cm

-9.8 cm

-12

-10

-8

-6

-4

-2

Mean Waist Circumference (cm)

Change from Baseline in 48 mg DA-1726

†*

†p<0.05 from Baseline; *p<0.05 vs. placebo

Mean Waist

Circumference

Mean Waist Circumference

Change from Baseline

Baseline Day 26 Day 54

DA-1726 48 mg 118.7 cm -5.0% (-5.8 cm) -8.5% (-9.8 cm)

Placebo 122.7 cm -0.3% (-0.3 cm) -1.2% (-1.5 cm)*

Placebo adjusted -4.7% -7.3%

Placebo adjusted

excluding outlier* -3.7% -7.7%

*One placebo subject in the extension period reported implementing no carbohydrate diet while participating in the study

which may have led to a substantial weight loss.

DA-1726 Phase 1 MAD Study:

Waist Circumference Change in 48 mg Cohort

The placebo outlier on no carbohydrate diet did not have a

substantial reduction in waist circumference (-1.7% [-2 cm])

relative to the subject’s weight loss (-4.3% [-4.4 kg]) on Day 54

Indicator of DA-1726’s effect on reducing

waist circumference

Baseline Day 54

DA-1726 48 mg 105.3 mg/dL 93 mg/dL

Placebo 91.3 mg/dL 83 mg/dL

100

110

Day 1 Predose Day 54

Mean Fasting Glucose (mg/dL)

in 48 mg DA-1726

mean

Mean Fasting Glucose

Baseline Day 54

DA-1726 48 mg 5.6% 5.4%

Placebo 5.4% 5.3%

Mean HbA1c

5.0

5.2

5.4

5.6

5.8

Day 1 Predose Day 54

Mean HbA1c (%) in 48 mg DA-1726

mean

DA-1726 Phase 1 MAD Study:

Glucose Control in 48 mg Cohort (Day 54)

Potentially best-in-class glucose control with mean HbA1c change by -0.22% point in

non-diabetic subjects after 8 weeks of 48 mg DA-1726 treatment

Pre-diabetic subjects with mean HbA1c of 6% at baseline was

reduced to 5.5% by Day 54

Baseline Day 54

DA-1726 48 mg 5.9 kPa 4.5 kPa

Placebo 5.1 kPa 6 kPa

3.0

3.5

4.0

4.5

5.0

5.5

6.0

6.5

Day -1 Day 54

Mean VCTE (kPa) in 48 mg DA-1726

mean

DA-1726 Phase 1 MAD Study:

VCTE in 48 mg Cohort (Day 54)

Mean VCTE

VCTE=vibration controlled transient elastography

VCTE (FibroScan®) is the most widely used imaging-based

non-invasive test for liver stiffness, with <6.0 kPa being

F0-F1 in fibrosis. FDA indicated that VCTE can be a non-invasive

biomarker in development of MASH drugs.

Regardless of the placebo outlier, 8 weeks of DA-1726

treatment showed significant reduction in VCTE indicating its

effects in liver inflammation and stiffness.

Vanoglipel

(DA-1241)

Orally Available, Potential

First-in-Class GPR119

Agonist for the Treatment of

Metabolic Dysfunction-associated

Steatohepatitis (MASH)

Phase 2a, 16-week, Randomized Double-blind, Placebo-controlled in

Patients with Presumed MASH

Primary Endpoint:

Change from baseline in

ALT level at Week 16

50 mg Vanoglipel (n=12)

100 mg Vanoglipel (n=25)

Placebo (n=12)

Part 1

Placebo (n=12)

Part 2

100 mg Vanoglipel + 100 mg Sitagliptin (n=25)

Patients with presumed

MASH

• 7 kPa ≤ VCTE < 14 kPa,

• CAP ≥ 290 dB/m,

• BMI > 23 kg/m2, and

• 40 IU/L ≤ ALT < 200 IU/L

Double-blind

Screening

W0 W4 W8 W12 W16 W20

EoT EoS/

Follow up

ALT=alanine aminotransferase; BMI=body mass index; CAP=controlled attenuation parameter; EoT=end of treatment; EoS=end of study; MASH=metabolic dysfunction

associated steatohepatitis; VCTE=vibration controlled transient elastography; W=week

Vanoglipel Monotherapy vs. Placebo

Vanoglipel Reduced CAP Indicating Liver Fat Reduction and

Improved At-risk MASH Biomarkers Including FAST and NIS-4 Scores

-1.4

-16.9

-23.0

Placebo

DA-1241

50 mg

DA-1241

100 mg

LSM of CFB

CAP (dB/m) at W16

† †

-0.082

-0.216

-0.196

Placebo

DA-1241

50 mg

DA-1241

100 mg

LSM of CFB

FAST Score at W16

†

0.04

-0.2

-0.14

Placebo

DA-1241

50 mg

DA-1241

100 mg

LSM of CFB

NIS-4 Score at W16

†

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CAP=controlled attenuation parameter; CFB=change from baseline; CI=confidence interval; FAST=Fibroscan-AST;

NIS-4=; LSM=least square mean

Loomba R, et al. EASL 2025.

In subjects with 40 ≤ ALT < 200 U/L at baseline: Placebo (n=21); DA-1241 50 mg (n=9); DA-1241 100 mg (n=17)

†95% CI not crossing 0

†* †* †*

†*

-0.6

-0.4

-0.2

0.2

W0 W4 W8 W16

LSM of CFB:

HbA1c (%p) Over Time

Placebo

DA-1241 50 mg

DA-1241 100 mg

0.1

-0.55 -0.54

Placebo

DA-1241

50 mg

DA-1241

100 mg

LSM of CFB:

HbA1c (%p) at W16

†* †*

BL (%):6.74 6.36 6.99

Vanoglipel Monotherapy vs. Placebo

Significant, Rapid Reduction in HbA1c was Observed With Vanoglipel

Monotherapy Suggesting Favorable Improvement in Glucose Control

Vanoglipel 100 mg significantly

decreased HbA1c as early as

Week 4 in presumed MASH

patients

Both doses of Vanoglipel

significantly improved HbA1c at

Week 16

In subjects with 40 ≤ ALT < 200 U/L at baseline: Placebo (n=21); DA-1241 50 mg (n=9); DA-1241 100 mg (n=17)

†95% CI not crossing 0

ALT=alanine aminotransferase; BL=baseline; CFB=change from baseline; CI=confidence interval; LSM=least square mean; W=Week

Loomba R, et al. EASL 2025.

0.1

-0.55 -0.54

-0.66

Placebo

DA-1241

50 mg

DA-1241

100 mg Combo

LSM of CFB:

HbA1c (%p) at W16

†* †*

BL (%):

6.74 6.36 6.99 6.61

Vanoglipel 100 mg + Sitagliptin 100 mg Combination vs. Placebo

Enhanced Incretin Action With the Combination Therapy Augmented

Glucose Control Leading to a Significant Reduction in HbA1c at Week 16

ALT=alanine aminotransferase; BL=baseline; CFB=change from baseline; CI=confidence interval; LSM=least square mean; W=Week

Loomba R, et al. EASL 2025.

In subjects with 40 ≤ ALT < 200 U/L at baseline: Placebo (n=21); DA-1241 50 mg (n=9); DA-1241 100 mg (n=17)

†95% CI not crossing 0

†* †* †*

†*

-0.8

-0.6

-0.4

-0.2

0.2

W0 W4 W8 W16

LSM of CFB:

HbA1c (%p) Over Time

Placebo

DA-1241 50 mg

DA-1241 100 mg

Combo

†* †*

HbA1c reduction was enhanced

at Week 16 when Vanoglipel

100 mg was combined with

sitagliptin 100 mg in patients

with presumed MASH

†* †*

Vanoglipel 100 mg + Sitagliptin 100 mg Combination vs. Placebo

Vanoglipel Efficiently Controlled Plasma Glucose in Diabetic Subjects

With Presumed MASH

CFB=change from baseline; LSM=least square mean

Loomba R, et al. EASL 2025.

†*

Greater Improvement of Glucose

Control was Observed in Patients

with Type 2 Diabetes

†* †*

†*

0.12

0.24

-0.29 -0.18

-0.4

-0.99

-0.45

-0.66

-1.08

-0.18 -0.24

-1.08

-1.5

-1

-0.5

Week 4 Week 8 Week 16

LSM of CFB: HbA1c (%p) in

Diabetic Patients (≥6.5%)

Placebo (N=8) DA, 50mg (N=3) DA, 100mg (N=9) Combo (N=9)

BL: 7.0~7.9%

Vanoglipel Showed a Favorable Safety & Tolerability Profile With

No TEAE Leading to IP Discontinuation in Patients w/Presumed

MASH

n (%)

Placebo

(N=32)

Vanoglipel 50 mg

(N=14)

Vanoglipel 100 mg

(N=26)

Vanoglipel 100 mg

+ Sitagliptin 100 mg

(N=36)

Subjects with any Treatment

Related AE

Mild

Moderate

Severe

9 (28.1%)

8 (25.0%)

1 (3.1%)

4 (28.6%)

9 ( 34.6%)

8 (30.8%)

1 (3.8%)

10 (27.8%)

9 (25.0%)

1 (2.8%)

Subjects with any Treatment

related SAE 0 0 0 0

Subjects with any TEAE leading to

study discontinuation 0 0 0 1 ( 3.1%)

Subjects with any TEAE leading to

study drug discontinuation 1 ( 3.1%) 0 0 0

Similar safety profile of the combination arm compared to placebo indicates

combinability of vanoglipel with other drugs

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dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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