MetaVia Reports Year End 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

MetaVia (Nasdaq: MTVA) reported year-end 2025 results and a corporate update highlighting positive clinical progress and a tightened cash runway. DA-1726 48 mg Phase 1 showed ~9.1% weight loss, improved glucose control and reduced liver stiffness. IRB approval received for Part 3 titration study; dosing expected April 2026 with data in Q4 2026. Vanoglipel Phase 2a showed clinically meaningful metabolic and liver improvements. Cash and equivalents were $10.3M at year-end; January 2026 gross offering proceeds of ~$9.3M are expected to fund operations into Q4 2026.

Positive

• DA-1726 48 mg showed ~9.1% weight loss in Phase 1
• IRB approval for Phase 1 Part 3 dosing expected April 2026
• Vanoglipel Phase 2a demonstrated glucose and liver improvements over 16 weeks
• Public offering raised gross proceeds of approximately $9.3M

Negative

• Cash and cash equivalents declined to $10.3M at 12/31/2025
• Company expects runway only into Q4 2026 with offering proceeds
• Net loss was $13.0M for year ended 12/31/2025

News Market Reaction – MTVA

+1.54%

1 alert

+1.54% Session close to close

+2.9% Peak Tracked

$4.36M Market Cap

0.1x Rel. Volume

In the Mar 26 session, MTVA gained 1.54%, reflecting a mild positive market reaction. Argus tracked a peak move of +2.9% during that session.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines positive Phase 1 obesity data for DA-1726, supportive Phase 2a MASH resul...

Analysis

This announcement combines positive Phase 1 obesity data for DA-1726, supportive Phase 2a MASH results for vanoglipel, and a substantial year-over-year reduction in operating expenses to $13.7M. Cash of $10.3M plus January 2026 offering proceeds is expected to fund operations into the fourth quarter of 2026. Investors may focus on clinical execution, future financing needs, and progress toward Phase 1 Part 3 and an end-of-Phase 2 FDA meeting.

Key Figures

Weight loss at 48 mg: 9.1% weight loss DA-1726 dose level: 48 mg High-dose regimen: 64 mg +5 more

8 metrics

Weight loss at 48 mg 9.1% weight loss Phase 1 extended 8-week, non-titrated 48 mg cohort for DA-1726

DA-1726 dose level 48 mg Phase 1 non-titrated cohort and planned 1-step titration arm

High-dose regimen 64 mg Planned 2-step titration regimen in Phase 1 Part 3 study

Year-end cash $10.3 million Cash and cash equivalents as of December 31, 2025

R&D expenses 2025 $6.8 million Year ended 2025 vs $21.6 million in 2024

Total operating expenses $13.7 million Year ended 2025 vs $28.8 million in 2024

Net loss 2025 $13.0 million Year ended 2025 vs $27.6 million in 2024

Public offering proceeds $9.3 million Gross proceeds from January 2026 underwritten public offering

Previous Earnings Reports

4 past events · Latest: Nov 06 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	24h Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	-15.0%	Q3 2025 results with strong DA-1726 and vanoglipel clinical updates and cash detail.
Aug 07	Q2 2025 earnings	Positive	+3.0%	Q2 2025 results plus DA-1726 obesity data, Syntekabio AI collaboration, and cash runway.
May 14	Q1 2025 earnings	Positive	+1.3%	Q1 2025 results with positive DA-1726 and DA-1241 data and reduced net loss.
Mar 20	FY 2024 earnings	Neutral	-2.5%	2024 results showing higher R&D spend, larger net loss, and cash funding into Q3 2025.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings and corporate updates have often been met with modest downside moves despite generally constructive clinical and cash updates.

Recent Company History

Recent earnings events for MetaVia have consistently paired clinical progress with constrained balance sheet commentary. Prior reports highlighted advancing DA-1726 obesity data and positive DA-1241 MASH findings, alongside cash levels in the low tens of millions and ongoing net losses. Market reactions around these 2025 earnings dates were mixed but skewed slightly negative on average, with one sharp -15% drop. Today’s full-year 2025 results continue that pattern of pipeline advancement plus reduced expenses and net loss, against a still-limited cash runway.

Key Terms

phase 1, phase 2a, g-protein-coupled receptor 119 (gpr119), institutional review board (irb), +3 more

7 terms

phase 1 medical

"48 mg Phase 1 Data Demonstrate Potential Best-in-Class Profile for DA-1726"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

phase 2a medical

"advance vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, with the presentation of positive Phase 2a data"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

g-protein-coupled receptor 119 (gpr119) medical

"vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist"

G-protein-coupled receptor 119 (GPR119) is a protein on the surface of certain cells that acts like a lock receiving chemical signals that change how the cell behaves, especially in controlling blood sugar and appetite. Investors watch it because drugs that activate or block this receptor are being explored to treat diabetes, obesity and related conditions; successful drug candidates can transform a biotech company's value much like finding a more efficient engine can change a carmaker's prospects.

institutional review board (irb) regulatory

"Having recently received Institutional Review Board (IRB) approval from the Clinical Pharmacology of Miami"

An institutional review board (IRB) is an independent committee that reviews and approves research involving people to make sure studies are safe, ethical, and that participants give informed consent. For investors, IRB approval is like a safety inspection for a company’s clinical program: it can reduce regulatory risk, affect how quickly trials start or proceed, and influence whether study results will be accepted by regulators, all of which can change a company’s value and outlook.

pre-funded warrants financial

"public offering of shares of common stock, pre-funded warrants, Series C Common Warrants"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

multiple-ascending-dose medical

"8-week (extended from four weeks) non-titrated 48 mg MAD cohort of the Phase 1 clinical trial"

A multiple-ascending-dose (MAD) study is a type of clinical trial where groups of volunteers take the same drug repeatedly while subsequent groups receive progressively higher doses, to track how the drug builds up in the body and whether side effects emerge or worsen over time. For investors it matters because MAD results set safe and effective dose ranges, reveal early safety and drug‑behavior signals, and materially affect the likelihood and cost of later, larger trials—like slowly turning up the heat on a recipe to find the right balance without burning it.

pharmacokinetic (pk) medical

"a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing"

Pharmacokinetic (pk) describes how a substance, such as a medication or chemical, moves through and is processed by the body over time. It includes how the substance is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps assess the potential effectiveness, safety, and market success of new drugs or treatments.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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48 mg Phase 1 Data Demonstrate Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit

Planned Phase 1 Part 3 16-Week Titration Study to Evaluate 48 mg (1-Step) and 64 mg (2-Step) Regimen Receives IRB Approval; Initiation Expected in April of 2026 with Data Anticipated in the Fourth Quarter

$10.3 Million in Cash and Cash Equivalents at End of Year and Proceeds From January 2026 Public Offering is Expected to Fund the Company Into the Fourth Quarter of 2026

CAMBRIDGE, Mass., March 26, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate strategic update.

"We made significant progress advancing our cardiometabolic portfolio during the year, punctuated by the positive data, released in January of this year, from the Phase 1 extended 8-week, non-titrated 48 mg cohort of lead asset DA-1726, 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 and related metabolic disorders," stated Hyung Heon Kim, Chief Executive Officer of MetaVia. "These results demonstrated robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, all achieved without titration and with a favorable safety and tolerability profile. We believe this combination of weight loss, glycemic control, direct hepatic benefit and tolerability meaningfully differentiates DA-1726 and supports its potential to deliver a best-in-class profile in obesity and broader cardiometabolic disease. Importantly, DA-1726 is supported by a growing intellectual property estate comprising 39 granted and pending patents in the United States and internationally, providing protection at least through 2041."

"On the heels of the positive Phase 1 data, we strengthened our balance sheet in January with gross proceeds of $9.3 million from an underwritten public offering, providing additional capital to advance the DA-1726 program. Having recently received Institutional Review Board (IRB) approval from the Clinical Pharmacology of Miami, we expect to initiate dosing in our Phase 1 Part 3, 16-week titration studies evaluating escalation to 48 mg in a single step and 64 mg using a two-step regimen in April, with data anticipated in the fourth quarter of 2026."

Mr. Kim continued, "Beyond DA-1726, we continued to advance vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, with the presentation of positive Phase 2a data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025, highlighting clinically meaningful improvements in glucose control, liver health and plasma lipidomic profiles over 16 weeks. In parallel, results from our collaboration with Syntekabio using the DeepMatcher® artificial intelligence (AI) platform confirmed strong inflammatory and cardiometabolic target engagement, further supporting development of vanoglipel in MASH and, potentially, in type 2 diabetes. We believe both programs position MetaVia at the forefront of next-generation cardiometabolic innovation as we move into 2026."

Fourth Quarter 2025 and Subsequent Highlights

• March 2026: Received IRB approval from Clinical Pharmacology of Miami for the Phase 1 Part 3 16-week titration study of DA-1726, enabling higher-dose evaluation in obese, otherwise healthy adults.
• March 2026: Announced a comprehensive global intellectual property portfolio supporting vanoglipel with 48 granted and pending patents across three patent families in the U.S., Europe, Japan, China and other countries, providing protection into 2035, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the patent portfolio provides broad protection for vanoglipel itself, how it is manufactured, and its potential use across a range of serious metabolic and liver conditions.
• February 2026: Strengthened global intellectual property position for DA-1726 with 39 granted and pending patents in the U.S. and internationally, providing protection through at least 2041, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the portfolio broadly covers DA-1726's novel peptide structure, its long-acting dual-incretin design, and therapeutic use across obesity, metabolic disease, and related cardiometabolic conditions.
• February 2026: Announced positive AI-modeling results from the ongoing collaboration with Syntekabio, Inc., an AI-driven drug discovery company, leveraging their proprietary DeepMatcher® platform. The results confirmed vanoglipel's strong inflammatory and cardiometabolic target engagement, supporting development in MASH and, potentially, type 2 diabetes.
• January 2026: Closed an underwritten public offering of shares of common stock, pre-funded warrants, Series C Common Warrants and Series D Common Warrants for gross proceeds of approximately $9.3 million, prior to deducting underwriting discounts and commissions and offering expenses and excluding any potential future proceeds from the exercise of warrants.
• January 2026: Announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg MAD cohort of the Phase 1 clinical trial of DA-1726. The results showed robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile.
• November 2025: Presented positive new data from the Phase 2a clinical trial evaluating vanoglipel as a potential treatment for MASH in a poster presentation at the AASLD The Liver Meeting® 2025. The data highlight vanoglipel's differentiated dual activity across both hepatic and metabolic pathways, demonstrating clinically meaningful improvements in glucose control, liver health, and plasma lipidomic profiles following 16 weeks of treatment.
• November 2025: Presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek® 2025. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy.

Anticipated Clinical Milestones

• DA-1726 in Obesity:
  • Dosing of the first patient in the company's Phase 1 Part 3, 16-week titration studies, evaluating titration to 48 mg in one step and 64 mg via a two-step regimen, is expected in April of 2026.
  • Data readout for these Phase 1 studies is expected in the fourth quarter of 2026.
• Vanoglipel (DA-1241) in MASH:
  • The Company is currently working to schedule an end-of-Phase 2 meeting with the FDA.

Fourth Quarter Financial and Operating Results

• Research and Development (R&D) Expenses were approximately $6.8 million for the year ended December 31, 2025, as compared to approximately $21.6 million for the year ended December 31, 2024. The decrease of approximately $14.8 million was primarily attributable to (i) $10.8 million in lower direct R&D expenses related to vanoglipel (DA-1241) product development, (ii) $3.9 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.2 million in lower direct other R&D costs. These decreases were partially offset by $0.1 million in higher indirect consulting expenses and a slight increase in indirect employee compensation and benefits. Included in direct R&D costs were expenses totaling $3.4 million and $4.9 million for 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).

• General and Administrative (G&A) Expenses were approximately $6.9 million for the year ended December 31, 2025, as compared to approximately $7.3 million for the year ended December 31, 2024. The approximately $0.4 million decrease was primarily attributable to (i) $0.7 million in lower consulting expenditures, (ii) $0.1 million in lower insurance, and (iii) $0.2 million in lower other G&A expenses. These decreases were partially offset by $0.5 million in higher legal and professional fees and $0.1 million in higher employee compensation and benefits.

• Total Operating Expenses were approximately $13.7 million for the year ended December 31, 2025, compared to approximately $28.8 million for the year ended December 31, 2024. The approximately $15.1 million decrease was primarily attributable to lower R&D expenses and G&A expenses.

• Total Other Income was approximately $0.7 million for the year ended December 31, 2025, compared to approximately $1.2 million for the year ended December 31, 2024. The approximately $0.5 million decrease was primarily attributable to (i) $0.4 million in lower interest income, net, due to lower cash balances and lower interest rates, and (ii) $0.1 million in lower gain related to the change in fair value of warrant liabilities due to the impact of the Company's common stock's volatile stock price during the last few years.

• Net Loss was $13.0 million, or $7.35 per basic and diluted share, for the year ended December 31, 2025 based on 1,766,026 weighted average shares of common stock outstanding, compared with a net loss of $27.6 million, or $39.13 per basic and diluted share, based on 705,193 weighted average shares of common stock outstanding for the year ended December 31, 2024.

• Cash and cash equivalents was $10.3 million as of December 31, 2025, compared with $16.0 million as of December 31, 2024. With these funds and proceeds from the January 2026 public offering, the company expects its cash position will be adequate to fund operations into the fourth quarter of 2026.

About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective 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. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.

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

Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@metaviatx.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

- Tables to Follow -

 

MetaVia Inc. Consolidated Balance Sheets (Unaudited - In thousands, except share and per share amounts)
		As of December 31,
		2025			2024
Assets
Current assets
Cash and cash equivalents		$	10,278		$	16,017
Prepaid expenses and other current assets			597			55
Total current assets			10,875			16,072
Property and equipment, net			17			34
Right-of-use asset			210			133
Other assets			21			21
Total assets		$	11,123		$	16,260
Liabilities and stockholders' equity
Current liabilities
Accounts payable		$	1,060		$	3,879
Clinical trial accrued liabilities			79			1,696
Accrued expenses and other current liabilities			993			785
Warrant liabilities			136			361
Related party payable			3,312			1,472
Lease liability, short-term			68			78
Total current liabilities			5,648			8,271
Lease liability, long-term			142			58
Total liabilities			5,790			8,329
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized and no shares issued or outstanding as of December 31, 2025 and 2024			—			—
Common stock, $0.001 par value per share, 100,000,000 shares authorized as of December 31, 2025 and 2024; 2,308,294 and 785,194 shares issued and outstanding as of December 31, 2025 and 2024, respectively			2			1
Additional paid–in capital			154,161			143,787
Accumulated deficit			(148,830)			(135,857)
Total stockholders' equity			5,333			7,931
Total liabilities and stockholders' equity		$	11,123		$	16,260

 

MetaVia Inc. Consolidated Statements of Operations (Unaudited - In thousands, except share and per share amounts)
		Year Ended December 31,
		2025			2024
Operating expenses
Research and development		$	6,802		$	21,553
General and administrative			6,906			7,256
Total operating expenses			13,708			28,809
Loss from operations			(13,708)			(28,809)
Other income
Gain from change in fair value of warrant liabilities			225			297
Interest income			510			920
Total other income			735			1,217
Loss before income taxes			(12,973)			(27,592)
Provision for income taxes			—			—
Net loss			(12,973)			(27,592)
Loss per share of common stock, basic and diluted		$	(7.35)		$	(39.13)
Weighted average shares of common stock, basic and diluted			1,766,026			705,193

 

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SOURCE MetaVia Inc.

FAQ

What did MetaVia (MTVA) report about DA-1726 Phase 1 48 mg results?

DA-1726 48 mg produced approximately 9.1% weight loss with improved glucose and liver stiffness. According to the company, the non-titrated 8-week cohort showed robust weight loss, significant waist reductions, favorable safety, and meaningful hepatic benefit.

When will MetaVia (MTVA) start the Phase 1 Part 3 titration study for DA-1726?

Dosing is expected to begin in April 2026 for Phase 1 Part 3, per the company. The study will evaluate 48 mg (one-step) and 64 mg (two-step) regimens with data anticipated in Q4 2026.

How strong is MetaVia's cash runway reported on March 26, 2026 for MTVA?

Cash and equivalents were $10.3M as of December 31, 2025, with ~$9.3M gross from January 2026 offering. According to the company, these funds are expected to finance operations into Q4 2026.

What did MetaVia (MTVA) report about vanoglipel (DA-1241) Phase 2a data?

Vanoglipel Phase 2a showed clinically meaningful improvements in glucose control, liver health, and plasma lipidomics over 16 weeks. According to the company, results were presented at AASLD 2025 supporting development in MASH and possibly type 2 diabetes.

What were MetaVia's 2025 financial results that impact MTVA shareholders?

Total operating expenses were approximately $13.7M and net loss was $13.0M for 2025. According to the company, operating expenses fell due to lower R&D and G&A versus 2024, while cash declined to $10.3M.

What upcoming data milestones should investors watch for MetaVia (MTVA)?

Investors should watch for Phase 1 Part 3 DA-1726 readout expected in Q4 2026. According to the company, dosing begins April 2026 and vanoglipel regulatory planning includes an end-of-Phase 2 meeting with FDA.