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 $9.3 million from an underwritten public offering, providing additional capital to advance the DA-1726 program. Having recently received Institutional Review Board (IRB) approval from the Clinical Pharmacology of Miami, we expect to initiate dosing in our Phase 1 Part 3, 16-week titration studies evaluating escalation to 48 mg in a single step and 64 mg using a two-step regimen in April, with data anticipated in the fourth quarter of 2026."
Mr. Kim continued, "Beyond DA-1726, we continued to advance vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, with the presentation of positive Phase 2a data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting$(R)$ 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(R) 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(R) 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(R) 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(R) 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.
(END) Dow Jones Newswires
March 26, 2026 08:31 ET (12:31 GMT)