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MetaVia (Nasdaq: MTVA) posts Phase 1 DA-1726 obesity and MASH data

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Rhea-AI Filing Summary

MetaVia Inc. furnished an update on its obesity and liver-disease candidate DA-1726, sharing new Phase 1 results from a 48 mg cohort presented at EASL 2026. DA-1726 is a once-weekly dual GLP1R/GCGR agonist being developed for obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH).

In obese but otherwise healthy adults, once-weekly 48 mg DA-1726 without dose titration was generally well tolerated, with no serious adverse events, no treatment-related discontinuations and mainly mild-to-moderate, transient gastrointestinal side effects. No clinically meaningful changes in cardiovascular measures, including heart rate and QTcF, were seen despite glucagon receptor activation.

Participants on 48 mg DA-1726 achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54, along with notable waist reductions. Exploratory FibroScan measures showed early, noninvasive signals of liver-related improvement versus placebo, supporting further evaluation of DA-1726 in obesity and MASH as ongoing Phase 1 titration studies continue.

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Insights

Early Phase 1 data for DA-1726 show encouraging weight loss and liver signals with acceptable safety.

MetaVia reports higher-dose Phase 1 results for DA-1726, a dual GLP1R/GCGR agonist for obesity and MASH. In a multiple ascending dose design, nine obese but otherwise healthy adults received once-weekly 48 mg for four weeks, some continuing four more weeks at the same dose.

DA-1726 was generally well tolerated up to 48 mg, with no serious adverse events or treatment-related discontinuations and mostly mild-to-moderate, transient gastrointestinal events. Cardiovascular parameters, including heart rate and QTcF, did not show clinically meaningful changes despite glucagon receptor activation, which is an important safety focus for this mechanism.

Clinically meaningful mean weight reductions of 6.1% at Day 26 and 9.1% at Day 54, plus nearly 10 cm lower waist circumference at Day 54, position DA-1726 as a competitive obesity candidate if later-stage data are consistent. Exploratory FibroScan metrics (CAP and VCTE) and FAST score movement suggest early liver improvements relevant to MASH, but confirmation will depend on longer-term Part 3a/3b titration data and subsequent trials.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Mean weight loss Day 54 9.1% body-weight reduction 48 mg DA-1726 cohort, Day 54 of Phase 1 study
Mean weight loss Day 26 6.1% body-weight reduction 48 mg DA-1726 cohort, Day 26 of Phase 1 study
Waist reduction 9.8 cm decrease Waist circumference change at Day 54, 48 mg cohort
CAP change with DA-1726 −20.0 dB/m FibroScan CAP at Day 54, 48 mg group vs baseline
CAP change placebo +24.0 dB/m FibroScan CAP at Day 54, placebo group vs baseline
Liver stiffness change −10.3% vs +13.8% VCTE percent change from baseline, DA-1726 vs placebo
Cohort size 9 subjects Phase 1 48 mg multiple ascending dose cohort
Metabolic Dysfunction-Associated Steatohepatitis (MASH) medical
"for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH)"
Metabolic dysfunction-associated steatohepatitis (MASH) is a liver condition characterized by inflammation and fat buildup caused by metabolic issues like obesity and insulin resistance. It can lead to liver damage over time, similar to rust gradually weakening metal. Because it is linked to widespread health problems such as diabetes and heart disease, MASH is becoming an important factor in overall health risks and healthcare costs, which can impact economic and investment considerations.
GLP1R/GCGR dual agonist medical
"DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist"
multiple ascending dose (MAD) study medical
"the randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose (MAD) study evaluating DA-1726"
FibroScan medical
"Exploratory noninvasive liver assessments using FibroScan also suggested liver-related improvements"
A FibroScan is a noninvasive medical scan that measures how stiff and fatty a liver has become by sending painless pulses into the body and reading the response, similar to tapping a fruit to judge ripeness. For investors, FibroScan matters because demand, regulatory approvals, and reimbursement for the device and its tests affect revenue prospects for manufacturers and clinics, and widespread use can change market estimates for liver-disease diagnostics and related treatments.
vibration-controlled transient elastography (VCTE) medical
"a −10.3% change from baseline by vibration-controlled transient elastography (VCTE)"
Vibration-controlled transient elastography (VCTE) is a noninvasive scan that sends a gentle vibration into the liver and measures how fast the resulting shear wave travels, which reveals tissue stiffness and fat content. Like tapping a fruit to judge ripeness, VCTE provides a quick, painless estimate of liver scarring and disease without a biopsy; investors care because its use affects demand for diagnostic equipment, clinical trial design, treatment monitoring, and reimbursement trends in healthcare.
FibroScan-aspartate aminotransferase (FAST) score medical
"directional improvements from baseline were observed in FibroScan-aspartate aminotransferase (FAST) score"

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FAQ

What did MetaVia (MTVA) report about DA-1726 in its latest 8-K?

MetaVia reported new Phase 1 data for DA-1726, a dual GLP1R/GCGR agonist, from a 48 mg cohort in obese adults. The results showed meaningful weight loss, waist reduction and exploratory liver improvements, with generally favorable safety and tolerability up to eight weeks.

How much weight loss did DA-1726 achieve in MetaVia’s Phase 1 48 mg cohort?

Participants receiving 48 mg DA-1726 once weekly saw mean body-weight reductions of 6.1% at Day 26 and 9.1% at Day 54. These reductions occurred without dose titration and with no evidence of a plateau through Week 8, supporting continued investigation in obesity.

How was DA-1726 tolerated at the 48 mg dose in MetaVia’s Phase 1 study?

DA-1726 was generally well tolerated up to 48 mg, with no serious adverse events or treatment-related discontinuations reported. Gastrointestinal side effects were mostly mild-to-moderate and transient, and there were no clinically meaningful changes in heart rate or QTcF despite glucagon receptor activation.

What ongoing studies is MetaVia (MTVA) conducting with DA-1726?

MetaVia is running Phase 1 Part 3a/3b titration studies of DA-1726 to evaluate longer-term dosing strategies at higher exposures. These studies aim to optimize tolerability and further assess durability of metabolic and liver-related effects in obesity and MASH populations over extended treatment periods.

What other pipeline program does MetaVia (MTVA) mention alongside DA-1726?

MetaVia also highlights vanoglipel (DA-1241), a GPR119 agonist in development for MASH. In pre-clinical and Phase 2a data, vanoglipel showed favorable effects on liver inflammation, lipid metabolism, weight, glucose control and multiple markers of hepatic steatosis, inflammation and fibrosis.
0001638287false00016382872026-05-272026-05-27

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): May 27, 2026

Graphic

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 Disclosures.

On May 27, 2026, MetaVia Inc. (the “Company”) issued a press release announcing the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026), being held May 27–30 in Barcelona, Spain. A copy of the press release 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 press release 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 press release is as inactive textual references only.

The information in Item 7.01 of this Report, including Exhibit 99.1 attached hereto, is furnished 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit
Number

 

Exhibit Description

99.1

Press Release dated May 27, 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: May 27, 2026

By:

/s/ Hyung Heon Kim

Hyung Heon Kim

President and Chief Executive Officer

Graphic

Exhibit 99.1

MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASH

48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau

Exploratory FibroScan Assessments Demonstrated Early Liver-Related Improvements

Ongoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at Higher-Dose Levels

CAMBRIDGE, Mass., May 27, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026), being held May 27–30 in Barcelona, Spain.

The data highlighted favorable safety and tolerability, clinically meaningful reductions in body weight and waist circumference at the 48 mg dose without titration, and exploratory, noninvasive liver-related findings supporting continued evaluation in metabolic dysfunction-associated steatohepatitis (MASH).

“These late-breaking Phase 1 findings presented at EASL 2026 continue to reinforce DA-1726’s differentiated metabolic profile as a dual GLP-1 and glucagon receptor agonist with meaningful effects on both body weight, waist circumference and liver-related parameters,” said Hyung Heon Kim, Chief Executive Officer of MetaVia. “Importantly, DA-1726 demonstrated robust and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, while maintaining favorable tolerability even in the absence of dose titration. We are also encouraged by the exploratory FibroScan findings, which demonstrated early and consistent improvements across multiple noninvasive liver biomarkers, including liver stiffness, CAP and FAST scores. These findings further illustrate the potential of DA-1726 in obesity and MASH, where metabolic and hepatic dysfunction are closely linked. Based on these findings, we continue to advance the ongoing Phase 1 Part 3a/3b titration studies designed to evaluate longer-term dosing strategies, optimize tolerability at higher exposures, and further assess durability of metabolic and liver-related effects.”

The late-breaking poster presentation reported results from the 48 mg cohort of the randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose (MAD) study evaluating DA-1726 in obese but otherwise healthy adults. Subjects received once-weekly subcutaneous DA-1726 or placebo for four weeks without titration in a 2:1 randomization ratio. Of the nine subjects enrolled in the 48 mg cohort, six entered an optional four-week extension phase at the same dose.

DA-1726 was generally well tolerated up to the 48 mg dose level, with no serious adverse events or treatment-related discontinuations observed. Gastrointestinal adverse events were primarily mild-to-moderate and transient in nature, even without dose titration. In addition, despite glucagon receptor


activation, no clinically meaningful changes in cardiovascular parameters, including heart rate and QTcF, were observed.

Clinically meaningful reductions in body weight and waist circumference were observed in the 48 mg cohort. Participants achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54 (p < 0.05 vs placebo at Day 26), with no evidence of a plateau through Week 8. Waist circumference was reduced by 5.8 cm at Day 26 and 9.8 cm at Day 54 (p < 0.05 vs placebo at Day 26).

Exploratory noninvasive liver assessments using FibroScan also suggested liver-related improvements at Day 54, including a reduction in controlled attenuation parameter (CAP) of −20.0 dB/m in the 48 mg group compared with +24.0 dB/m with placebo. Improvements in liver stiffness were also observed, with a −10.3% change from baseline by vibration-controlled transient elastography (VCTE) versus +13.8% with placebo. In addition, directional improvements from baseline were observed in FibroScan-aspartate aminotransferase (FAST) score, supporting further long-term evaluation of DA-1726 in obesity-associated liver disease and MASH.

Presentation Details:

Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment
Presenting Author: Chris Fang, Chief Medical Officer, MetaVia
Abstract Number: LB26-5204
Final Abstract ID: LBP-010
Session: Late Breaking Posters
Presentation Date: Wednesday, May 27, 2026
Presentation Start: 8:30 am CET

A copy of the poster will be available on the Posters section of the MetaVia website after the presentation.

About DA-1726

DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction.

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 such as semaglutide. 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


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