MetaVia Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Rhea-AI Summary

MetaVia (MTVA) reported a wider third-quarter net loss and interim DA-1726 clinical results supporting its planned liver-disease development program. Third-quarter 2026 net loss was $4.623 million, versus $3.377 million a year earlier; basic and diluted loss per share narrowed to $0.69 from $1.52 as weighted-average shares increased. Cash and equivalents were $8.778 million at September 30, versus $10.278 million at year-end 2025.

DA-1726 Phase 1 Part 3B interim results at Day 109 showed placebo-adjusted reductions of 68.1% in liver fat and 13.5% in body weight. MetaVia expects full Parts 3A/3B data in first-quarter 2027 and targets a 48-week Phase 2 study in up to 150 participants with metabolic dysfunction and alcohol-associated liver disease or alcohol-associated liver disease in second-half 2027. A vanoglipel/resmetirom Phase 2a study is targeted for first-half 2027. Sarah Browne joined as chief medical officer in October.

9 points · 0 major

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2 major · 11 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointDA-1726 Phase 1 Part 3B interim data showed 68.1% placebo-adjusted liver-fat reduction at Day 109.
• Moderate point. Forward-looking: it has not happened yet and may not happen.MetaVia targets a 48-week Phase 2 study in up to 150 subjects in second-half 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.MetaVia targets a randomized 12-week vanoglipel/resmetirom Phase 2a study in first-half 2027.
• Minor pointDA-1726 interim data showed 13.5% placebo-adjusted weight loss at Day 109.
• Minor pointAll five participants with baseline liver-fat accumulation achieved MRI-measured liver fat below 5% in interim results.

4 minor points

• Minor pointDA-1726 reduced uric acid by 1.47 mg/dL versus placebo after 16 weeks (p<0.001).
• Minor pointDA-1726 interim findings included reduced abdominal fat and relative preservation of lean tissue.
• Minor pointAll active patients completed dose escalation to planned 48 mg and 64 mg DA-1726 levels.
• Minor point. Forward-looking: it has not happened yet and may not happen.MetaVia expects full DA-1726 Phase 1 Parts 3A/3B data in first-quarter 2027.

Negative

• Major pointThird-quarter net loss widened to $4.623 million from $3.377 million year over year; loss/share narrowed to $0.69 from $1.52.
• Major pointOutstanding common shares increased to 6,742,889 at September 30, 2026, from 2,308,294 at year-end 2025.
• Moderate pointCash and equivalents fell to $8.778 million at September 30, 2026, from $10.278 million at year-end 2025.
• Minor pointNine-month net loss widened to $13.762 million from $11.043 million year over year; loss/share narrowed to $2.36 from $6.93.
• Minor pointThird-quarter research and development expenses rose to $2.589 million from $1.914 million a year earlier.

6 minor points

• Minor pointNine-month research and development expenses rose to $8.168 million from $6.561 million a year earlier.
• Minor pointThird-quarter general and administrative expenses rose to $2.104 million from $1.561 million a year earlier.
• Minor pointNine-month general and administrative expenses rose to $5.935 million from $5.101 million a year earlier.
• Minor pointThird-quarter other income declined to $70,000 from $98,000 a year earlier.
• Minor pointNine-month other income declined to $341,000 from $619,000 a year earlier.
• Minor pointStockholders' equity fell to $2.411 million at September 30, 2026, from $5.333 million at year-end 2025.

News Explained

At September 30, 2026, MetaVia reported 6,742,889 common shares issued and outstanding, up from 2,308,294 at December 31, 2025; the increase reduces an existing holder’s percentage ownership absent offsetting changes.

Key Figures

Placebo-adjusted liver fat reduction: 68.1% Placebo-adjusted weight loss: 13.5% Placebo-adjusted uric acid reduction: 1.47 mg/dL; p<0.001 +4 more

Placebo-adjusted liver fat reduction

68.1%

DA-1726 Phase 1 Part 3B interim data, after approximately 16 weeks

Placebo-adjusted weight loss

13.5%

DA-1726 Phase 1 Part 3B interim data

Placebo-adjusted uric acid reduction

1.47 mg/dL; p<0.001

DA-1726 after 16 weeks of treatment

Planned Phase 2 study

48 weeks; up to 150 subjects

MetALD and ALD; targeted to begin in the second half of 2027

Full Phase 1 Parts 3A and 3B data

Expected in the first quarter of 2027

DA-1726

Net loss

$4.6 million

Third quarter ended September 30, 2026

Cash and cash equivalents

$8.8 million

As of September 30, 2026

Previous Earnings Reports

1 past event · Latest: Aug 06

Same Type 1 event

1. Aug 06

   Q2 earnings

   24h Move

   +2.8%

   Reported $12.6 million cash and expected funding through 2026 alongside DA-1726 clinical progress.

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

Key Terms

mri-pdff, glp-1 receptor, g-protein-coupled receptor 119

3 terms

mri-pdff medical

"all five of the participants with baseline steatosis achieving MRI-PDFF below 5%"

MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction) is a medical imaging technique that measures the amount of fat within the liver or other tissues. For investors, it provides a precise way to assess health risks related to fat buildup, which can impact healthcare costs and the valuation of related companies. Its accuracy helps in monitoring treatment progress and predicting potential medical expenses, making it relevant for healthcare decision-making and investment considerations.

glp-1 receptor medical

"dual GLP-1/glucagon receptor agonist"

A GLP-1 receptor is a protein on the surface of certain cells that works like a lock for the body’s GLP-1 hormone key, helping control blood sugar and appetite by signaling the pancreas and brain. It matters to investors because drugs that activate or block this receptor can treat diabetes and obesity, creating large market opportunities, regulatory milestones, and patent-driven competitive value.

g-protein-coupled receptor 119 medical

"our G-protein-coupled receptor 119 (GPR119) agonist"

A G-protein-coupled receptor 119 (GPR119) is a protein located on the surface of certain cells that senses specific chemical signals and triggers internal responses, acting much like a doorbell that alerts a cell to act. Investors care because medicines that activate or block this receptor can change blood sugar and appetite control, so successful drugs or trial results tied to GPR119 can materially affect a biotech or pharmaceutical company's value.

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

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Positive DA-1726 16-Week Phase 1 Part 3 Interim Data Support Planned Phase 2 Development in MetALD and ALD

Appointed Sarah Browne, M.D., as Chief Medical Officer to Help Lead the Next Stage of Clinical Development for DA-1726 and Vanoglipel

Full Data From the Phase 1 Parts 3A and 3B Expected in the First Quarter of 2027

CAMBRIDGE, Mass., Nov. 13, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming liver-related cardiometabolic diseases, today announced financial results for the third quarter ended September 30, 2026, and provided a corporate strategic update.

"The positive interim results from our Phase 1 Part 3B study of DA-1726, a novel oxyntomodulin (OXM) analog and dual GLP-1/glucagon receptor agonist, were recently highlighted in an oral presentation at the Precision Liver Symposium. We believe these findings provide important clinical support for DA-1726's potential to treat metabolic dysfunction and alcohol-associated liver disease (MetALD), as well as alcohol-associated liver disease (ALD)," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Most notably, after approximately 16 weeks, we observed a 68.1% placebo-adjusted reduction in liver fat, with all five of the participants with baseline steatosis achieving MRI-PDFF below 5%. These findings were accompanied by 13.5% placebo-adjusted weight loss, significant reductions in adipose tissue and relative preservation of lean tissue. Recently reported additional interim data also demonstrated a statistically significant 1.47 mg/dL placebo-adjusted reduction in uric acid after 16 weeks of treatment, further supporting DA-1726's liver-focused cardiometabolic profile. Based on these results, we are planning a 48-week Phase 2 study in up to 150 subjects with MetALD and ALD, targeted to begin in the second half of 2027. We also recently hosted an invitation-only KOL dinner during AASLD's The Liver Meeting 2026 featuring Dr. Rohit Loomba, a member of our Scientific Advisory Board. The event provided a valuable opportunity to gather leading experts in the field to discuss the evolving treatment landscape in MetALD and the significant unmet medical need we hope to address."

Mr. Kim continued, "Last month, we also expanded our clinical leadership team with the appointment of Sarah Browne, M.D., as Chief Medical Officer. Sarah brings more than 20 years of experience spanning clinical development, regulatory science and clinical medicine, including leading the development of pemvidutide, a dual GLP-1/glucagon receptor agonist, through Phase 2 and establishing Phase 3 development strategies. Her extensive experience developing therapies for metabolic and liver diseases will be particularly valuable as we prepare to move DA-1726 into Phase 2 development in MetALD and ALD. In parallel, we continue to advance vanoglipel, our G-protein-coupled receptor 119 (GPR119) agonist, in combination with resmetirom for MASH, with a Phase 2a proof-of-concept study targeted to begin in the first half of 2027."

Third Quarter 2026 and Subsequent Highlights

• November 2026: Announced additional positive Phase 1 Part 3B interim data demonstrating a statistically significant 1.47 mg/dL placebo-adjusted reduction in uric acid after 16 weeks of treatment with DA-1726 (p<0.001), further supporting its liver-focused cardiometabolic profile.
• November 2026: Announced the presentation of preclinical data on DA-1726 at ObesityWeek 2026 in a poster entitled, DA-1726 Demonstrates Comparable Weight Loss and Distinct Metabolic Profile Compared With Retatrutide.
• November 2026: Presented positive DA-1726 Phase 1 Part 3B interim data in an oral presentation at the Precision Liver Symposium, demonstrating a 68.1% placebo-adjusted reduction in liver fat and 13.5% placebo-adjusted weight loss at Day 109, with all five participants with baseline steatosis achieving MRI-PDFF below 5%. Announced plans to initiate a 48-week Phase 2 study in MetALD and ALD.
• October 2026: Appointed Sarah Browne, M.D., as Chief Medical Officer to provide clinical and regulatory leadership as MetaVia advances DA-1726 and vanoglipel through their next stages of development.
• September 2026: Announced preclinical tissue distribution findings for DA-1726 showing the highest exposure in adipose tissue and prolonged tissue retention, providing biological support for the reductions in waist circumference observed clinically and DA-1726's once-weekly dosing profile.
• July 2026: Announced the completion of dose titration in the 16-week Phase 1 Part 3 study of DA-1726, with all active patients successfully reaching the highest planned dose levels of 48 mg and 64 mg.

Anticipated Clinical Milestones

• DA-1726 in MetALD and ALD:
  • Full data from Phase 1 Parts 3A and 3B expected in the first quarter of 2027.
  • Initiation of a 48-week, non-biopsy Phase 2 study in up to 150 subjects with MetALD and ALD is targeted for the second half of 2027.
• Vanoglipel (DA-1241) in MASH:
  • MetaVia is currently working to schedule an End-of-Phase 2 meeting with the FDA before the end of 2026 to discuss the clinical development pathway for vanoglipel in combination with resmetirom.
  • Initiation of a randomized, 12-week Phase 2a non-biopsy proof-of-concept study of vanoglipel in combination with resmetirom is targeted for the first half of 2027.

Third Quarter Financial and Operating Results

• Research and Development (R&D) Expenses were approximately $2.6 million for the third quarter ended September 30, 2026, as compared to approximately $1.9 million for the third quarter ended September 30, 2025. The increase of approximately $0.7 million was primarily attributable to higher direct R&D expenses related to DA-1726 product development, partially offset by $0.2 million in lower indirect consulting expenses.
  
  R&D expenses were approximately $8.2 million for the nine months ended September 30, 2026, as compared to approximately $6.6 million for the nine months ended September 30, 2025. The approximately $1.6 million increase was primarily attributable to $2.0 million in higher direct R&D expenses related to DA-1726 product development, partially offset by (i) $0.2 million in lower indirect consulting expenditures and (ii) $0.2 million in lower direct R&D expenses related to vanoglipel product development.
  
  
• General and Administrative (G&A) Expenses were approximately $2.1 million for the third quarter ended September 30, 2026, as compared to approximately $1.6 million for the third quarter ended September 30, 2025. The approximately $0.5 million increase was primarily attributable to (i) $0.2 million in higher legal and professional fees, (ii) $0.2 million in higher consulting expenditures and (iii) $0.1 million in higher employee compensation and benefits. 
  
  G&A expenses were approximately $5.9 million for the nine months ended September 30, 2026, as compared to approximately $5.1 million for the nine months ended September 30, 2025. The approximately $0.8 million increase was primarily attributable to (i) approximately $0.3 million in higher consulting expenditures, (ii) approximately $0.2 million in higher legal and professional fees, (iii) approximately $0.1 million in higher employee compensation and benefits costs and (iv) $0.2 million in higher other G&A expenses, which was primarily related to higher franchise tax expenses.
  
  
• Total Operating Expenses were approximately $4.7 million for the third quarter ended September 30, 2026, compared to approximately $3.5 million for the third quarter ended September 30, 2025. The approximately $1.2 million increase was primarily attributable to higher R&D and G&A expenses.
  
  Total operating expenses were approximately $14.1 million for the nine months ended September 30, 2026, compared to approximately $11.7 million for the nine months ended September 30, 2025. The approximately $2.4 million increase was primarily attributable to higher R&D and G&A expenses for the nine months ended September 30, 2026.
  
  
• Total Other Income was approximately $0.1 million for the third quarter ended September 30, 2026, unchanged from the third quarter ended September 30, 2025.
  
  Total other income was approximately $0.3 million for the nine months ended September 30, 2026, as compared to approximately $0.6 million for the nine months ended September 30, 2025. The approximately $0.3 million decrease was primarily attributable to (i) $0.1 million in lower gain from change in fair value of warrant liabilities and (ii) $0.2 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates.
  
  
• Net Loss was $4.6 million, or $0.69 per basic and diluted share, for the third quarter ended September 30, 2026, based on 6,679,250 weighted average shares of common stock outstanding, compared with a net loss of $3.4 million, or $1.52 per basic and diluted share, based on 2,219,625 weighted average shares of common stock outstanding for the third quarter ended September 30, 2025.
  
  Net loss was approximately $13.8 million, or $2.36 per basic and diluted share for the nine months ended September 30, 2026, based on 5,830,258 weighted average shares of common stock outstanding, compared with a net loss of approximately $11.0 million, or $6.93 per basic and diluted share, based on 1,592,484 weighted average shares of common stock outstanding for the nine months ended September 30, 2025.
  
  
• Cash and cash equivalents was $8.8 million as of September 30, 2026, compared with $10.3 million as of December 31, 2025.

About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming liver-related cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of various cardiometabolic conditions, with potential in both Metabolic Dysfunction and Alcohol-Associated Liver Disease (MetALD) and Alcohol-Associated Liver Disease (ALD), and is advancing vanoglipel (DA-1241) in combination with resmetirom 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, engineered with a 3:1 GLP1R:GCGR potency ratio. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure. In a Phase 1 Part 3B interim analysis at Day 109, DA-1726 demonstrated placebo-adjusted reductions of 13.5% in body weight and 68.1% in liver fat, along with reductions in visceral and subcutaneous adipose tissue and relatively preserved lean mass. A Phase 2, 48-week, non-biopsy study of DA-1726 in MetALD and ALD, is targeted to begin in the second half of 2027. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). It acts directly in the liver on pathways involved in steatosis, inflammation and fibrosis, while GPR119 activation in the pancreas and gut also supports glucose and metabolic regulation. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. MetaVia is advancing vanoglipel in combination with resmetirom as a once-daily oral combination therapy for MASH, with a Phase 2a proof-of-concept study targeted to begin in the first half of 2027.

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 obtain, maintain, protect and/or enforce sufficient intellectual property rights to execute its commercial strategy; 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 preclinical 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 and subsequent Quarterly Reports on Form 10-Q. 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.
Condensed Consolidated Balance Sheets
(Unaudited - In thousands, except share and per share amounts)
		As of
		September 30, 2026			December 31, 2025
Assets
Current assets
Cash and cash equivalents		$	8,778		$	10,278
Prepaid expenses and other current assets			575			597
Total current assets			9,353			10,875
Property and equipment, net			22			17
Right-of-use asset			158			210
Other assets			21			21
Total assets		$	9,554		$	11,123
Liabilities and stockholders' equity
Current liabilities
Accounts payable		$	2,478		$	1,060
Clinical trial accrued liabilities			1,579			79
Accrued expenses and other current liabilities			782			993
Warrant liabilities			25			136
Related party payable			2,119			3,312
Lease liability, short-term			77			68
Total current liabilities			7,060			5,648
Lease liability, long-term			83			142
Total liabilities			7,143			5,790
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 September 30, 2026 and December 31, 2025			—			—
Common stock, $0.001 par value per share, 100,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 6,742,889 and 2,308,294 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively			7			2
Additional paid–in capital			164,996			154,161
Accumulated deficit			(162,592)			(148,830)
Total stockholders' equity			2,411			5,333
Total liabilities and stockholders' equity		$	9,554		$	11,123

 

MetaVia Inc.
Condensed Consolidated Statements of Operations
(Unaudited - In thousands, except share and per share amounts)
		Three Months Ended September 30,						Nine Months Ended September 30,
		2026			2025			2026			2025
Operating expenses
Research and development		$	2,589		$	1,914		$	8,168		$	6,561
General and administrative			2,104			1,561			5,935			5,101
Total operating expenses			4,693			3,475			14,103			11,662
Loss from operations			(4,693)			(3,475)			(14,103)			(11,662)
Other income (expense)
(Loss) gain from change in fair value of warrant liabilities			(2)			(53)			111			194
Interest income, net			72			151			230			425
Total other income			70			98			341			619
Loss before income taxes			(4,623)			(3,377)			(13,762)			(11,043)
Provision for income taxes			—			—			—			—
Net loss			(4,623)			(3,377)			(13,762)			(11,043)
Loss per share of common stock, basic and diluted		$	(0.69)		$	(1.52)		$	(2.36)		$	(6.93)
Weighted average shares of common stock, basic and diluted			6,679,250			2,219,625			5,830,258			1,592,484

 

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SOURCE MetaVia Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did MetaVia's DA-1726 interim trial results show?

Phase 1 Part 3B interim results at Day 109 showed placebo-adjusted reductions of 68.1% in liver fat and 13.5% in body weight. All five participants with baseline liver-fat accumulation achieved MRI-measured liver fat below 5%.

What were MetaVia's third-quarter 2026 financial results?

MetaVia reported a $4.623 million net loss, compared with $3.377 million a year earlier. Basic and diluted loss per share narrowed to $0.69 from $1.52, while weighted-average common shares increased to 6,679,250 from 2,219,625.

What FDA meeting is MetaVia seeking for vanoglipel?

MetaVia is working to schedule an End-of-Phase 2 meeting with the FDA before the end of 2026. The planned discussion concerns the clinical development pathway for vanoglipel in combination with resmetirom.