US Market News
3日前
MetaVia Presents New Late-Breaking Obesity and Metabolic Data at the ADA 2026 Scientific Sessions Supporting DA-1726 Differentiation and Vanoglipel Combination PotentialJune 8, 2026 8:31 AM
PR Newswire (US) DA-1726 Phase 1, 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of PlateauVanoglipel Combined with Resmetirom Demonstrated Synergistic Hepatoprotective and Weight-Loss Effects in Preclinical MASH ModelVanoglipel Combined with Metformin Demonstrated Enhanced Glycemic Control and Body Weight Reduction Versus Monotherapy in a Preclinical T2D ModelCAMBRIDGE, Mass., June 8, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new late-breaking data highlighting its obesity and metabolic disease portfolio at the American Diabetes Association's (ADA) 2026 Scientific Sessions, held June 5–8 in New Orleans, Louisiana. The presentations included new Phase 1 higher-dose cohort results for DA-1726, a novel dual agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), as well as preclinical data supporting combination treatment potential for vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, in metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2D) and obesity. The data highlighted favorable safety, tolerability and clinically meaningful reductions in body weight and waist circumference for DA-1726 at the 48 mg dose level, while the vanoglipel presentations demonstrated synergistic metabolic, liver-related effects and weight loss when combined with current standards of care, supporting potential combination strategies across MASH, T2D and obesity."The late-breaking ADA 2026 data further reinforces the differentiated and complementary potential of our cardiometabolic pipeline," said Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 demonstrated clinically meaningful and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, along with consistent reductions in waist circumference and BMI in a once-weekly regimen without titration. Importantly, the data also demonstrates a sustained and progressive metabolic effect through Day 54, supporting continued advancement of higher-dose evaluation in our ongoing Phase 1 Part 3 titration studies designed to assess higher-dose exposure and durability of metabolic response, with results expected in the fourth quarter of 2026.""In parallel, preclinical vanoglipel combination data demonstrated synergistic effects across liver and metabolic disease models, including meaningful improvements in hepatic steatosis, liver injury markers, fibrosis-related biomarkers, glycemic control, and body weight. Importantly, when combined with resmetirom, vanoglipel's ability to unlock synergistic benefits highlights its potential as a combination strategy for MASH. In addition, when combined with metformin, vanoglipel improved glycemic control and reduced body weight to a greater extent than either monotherapy, further supporting its potential as a therapeutic combination strategy for additional metabolic benefit in T2D. Taken together, these findings further support DA-1726 as a differentiated obesity therapy and vanoglipel as a versatile metabolic backbone for combination approaches in MASH and type 2 diabetes."Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort ResultsPresenting Author: Weikai "Chris" Fang, Chief Medical Officer, MetaViaAbstract Control Number: 3102-LBSession: 23-B Obesity—HumanThe late-breaking poster presentation of DA-1726 reported interim results from a randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose study evaluating once-weekly subcutaneous administration in obese but otherwise healthy adults. In the 48 mg cohort, DA-1726 was generally well tolerated, with predominantly mild-to-moderate and transient gastrointestinal adverse events and no treatment-related discontinuations or serious adverse events. Pharmacokinetic (PK) analysis demonstrated sustained exposure with dose-proportional behavior.DA-1726 produced a 6.1% reduction in body weight at Day 26 and a 9.1% reduction at Day 54 (p
US Market News
2週前
MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASHMay 27, 2026 8:31 AM
PR Newswire (US) 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of PlateauExploratory FibroScan Assessments Demonstrated Early Liver-Related ImprovementsOngoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at Higher-Dose LevelsCAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- 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, MetaViaAbstract Number: LB26-5204Final Abstract ID: LBP-010Session: Late Breaking PostersPresentation Date: Wednesday, May 27, 2026Presentation Start: 8:30 am CETA 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-presents-higher-dose-phase-1-results-for-da-1726-at-easl-congress-2026-supporting-potential-in-obesity-and-mash-302782740.htmlSOURCE MetaVia Inc. Original: MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASH
US Market News
3週前
MetaVia to Present Obesity Data at the American Diabetes Association's (ADA) 2026 Scientific SessionsMay 18, 2026 8:31 AM
PR Newswire (US) Three Late-Breaking Posters Highlight DA-1726, a GLP-1/Glucagon Dual Agonist, and Vanoglipel, a GPR119 AgonistCAMBRIDGE, Mass., May 18, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that three late-breaking abstracts highlighting its cardiometabolic assets, DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors for the treatment of obesity, and vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, have been accepted for poster presentations at the American Diabetes Association's (ADA) 2026 Scientific Sessions. The ADA will be held June 5-8, 2026 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. "Having three late-breaking abstracts accepted for poster presentations at the prestigious ADA conference is a testament to the strength of our cardiometabolic portfolio," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 has the potential to be a differentiated obesity treatment and is currently being evaluated in a 16-week Phase 1 Part 3 titration study designed to reach higher therapeutic doses with improved tolerability. We look forward to reporting data from this trial in the fourth quarter of this year. Our second asset, vanoglipel, has demonstrated broad therapeutic potential across liver and metabolic diseases. The two preclinical posters focused on vanoglipel explore combination therapies with current treatments for metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes."Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort ResultsPresenting Author: Weikai "Chris" Fang, Chief Medical Officer, MetaViaAbstract Control Number: 3102-LBSession: 23-B Obesity—HumanPresentation Date: Sunday, June 7, 2026Presentation Time: 12:30-1:30 pm ETTitle: Synergistic Hepatoprotective and Weight-Loss Effects of Vanoglipel and Resmetirom Combination Therapy in a Diet-Induced Obese, Biopsy-Confirmed Mouse Model of MASHPresenting Author: Tae Hyoung Kim, Lead Research Scientist, Dong-A ST Research CenterAbstract Control Number: 3043-LBSession: 22-C Integrated Physiology—LiverPresentation Date: Sunday, June 7, 2026Presentation Time: 12:30-1:30 pm ETTitle: Synergistic Effects of Vanoglipel and Metformin on Glycemic Control and Body Weight Reduction in a Diet-Induced Obese Mouse ModelPresenting Author: Yuna Chae, Lead Research Scientist, Dong-A ST Research CenterAbstract Control Number: 2856-LBSession: 12-D Clinical Therapeutics—Other Therapeutic AgentsPresentation Date: Sunday, June 7, 2026Presentation Time: 12:30-1:30 pm ETA copy of the posters 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 Vanoglipel (DA-1241)
Vanoglipel is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.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 GLP-1 receptor 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 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-to-present-obesity-data-at-the-american-diabetes-associations-ada-2026-scientific-sessions-302773824.htmlSOURCE MetaVia Inc. Original: MetaVia to Present Obesity Data at the American Diabetes Association's (ADA) 2026 Scientific Sessions
US Market News
4週前
MetaVia Reports First Quarter 2026 Financial Results and Provides Corporate UpdateMay 14, 2026 4:05 PM
PR Newswire (US) 48 mg Phase 1 Data Demonstrated Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Key Milestone Achieved with Dosing of the First Patient in Phase 1 Part 3 16-Week Titration Study Evaluating 48 mg (1-Step) and 64 mg (2-Step) Regimens; Data Expected in Fourth Quarter 2026CAMBRIDGE, Mass., May 14, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate strategic update. "We continued to build strong momentum in the first quarter of 2026 and most recently, as highlighted by the on-time dosing of the first patient in Part 3 of our Phase 1 clinical trial of DA-1726 for obesity, which followed closely on the heels of receiving IRB approval," said Hyung Heon Kim, Chief Executive Officer of MetaVia. "In this part of the trial, we are evaluating higher doses through optimized titration regimens, including a one-step escalation to 48 mg and a two-step escalation to 64 mg. This strategy is intended to safely reach higher therapeutic doses with improved tolerability, which could represent a meaningful advantage compared to currently marketed therapies that require longer, more gradual titration. Our January financing provides the capital to support the execution of this study, and we look forward to reporting data from Part 3 in the fourth quarter of 2026.""This trial is designed to build on the compelling results reported in January from the 8-week, non-titrated 48 mg cohort, which demonstrated robust early weight loss of 9.1%, statistically significant reductions in waist circumference, meaningful improvements in glucose control and direct liver benefit, all with a favorable safety and tolerability profile. Based on these results, we believe DA-1726 has the potential to establish a best-in-class profile in obesity and broader cardiometabolic disease, driven by its differentiated dual GLP-1/glucagon mechanism. We also look forward to presenting additional data from the Phase 1 48 mg dose cohort on the direct liver benefit of DA-1726 at the European Association for the Study of the Liver (EASL) Congress 2026."First Quarter 2026 and Subsequent HighlightsMay 2026: Announced the presentation of additional data from the 48 mg Phase 1 trial of DA-1726 at the EASL Congress 2026 in a poster entitled, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment.April 2026: Dosed the first patient in Part 3 of the Phase 1 clinical trial evaluating DA-1726 in obese, otherwise healthy adults, consisting of two 16-week titration cohorts designed to evaluate one-step dose titration to 48 mg and two-step dose titration to 64 mg, designed to safely achieve higher target doses and further optimize tolerability.March 2026: Received IRB approval from Clinical Pharmacology of Miami for the Phase 1 Part 3 16-week titration study of DA-1726.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.Anticipated Clinical MilestonesDA-1726 in Obesity: Data readout from 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 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.First Quarter Financial and Operating ResultsResearch and Development (R&D) Expenses were approximately $2.1 million for the first quarter ended March 31, 2026, as compared to approximately $2.3 million for the first quarter ended March 31, 2025. The decrease of approximately $0.2 million was primarily attributable to (i) $0.1 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. Included in direct R&D costs were expenses totaling $0.7 million and $1.1 million for the three months ended March 31, 2026 and 2025, 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 $1.9 million for the first quarter ended March 31, 2026, as compared to approximately $1.6 million for the first quarter ended March 31, 2025. The approximately $0.3 million increase was primarily attributable to (i) approximately $0.1 million in higher consulting expenditures, (ii) approximately $0.1 million in higher franchise tax expenses, and (iii) $0.1 million in higher legal and professional fees.Total Operating Expenses were approximately $4.0 million for the first quarter ended March 31, 2026, compared to approximately $3.9 million for the first quarter ended March 31, 2025. The approximately $0.1 million increase was primarily attributable to higher G&A expenses and was partially offset by lower R&D expenses.Total Other Income was approximately $0.2 million for the first quarter ended March 31, 2026, consistent with the corresponding period in 2025.Net Loss was $3.8 million, or $0.79 per basic and diluted share, for the first quarter ended March 31, 2026 based on 4,859,567 weighted average shares of common stock outstanding, compared with a net loss of $3.7 million, or $3.93 per basic and diluted share, based on 933,109 weighted average shares of common stock outstanding for the first quarter ended March 31, 2025.Cash and cash equivalents was $13.7 million as of March 31, 2026, compared with $10.2 million as of December 31, 2025. 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.comRx 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
March 31, 2026
December 31, 2025Assets
Current assets
Cash and cash equivalents
$13,731
$10,278 Prepaid expenses and other current assets
431
597Total current assets
14,162
10,875Property and equipment, net
12
17Right-of-use asset
193
210Other assets
21
21Total assets
$14,388
$11,123Liabilities and stockholders' equity
Current liabilities
Accounts payable
$1,007
$1,060Clinical trial accrued liabilities
627
79Accrued expenses and other current liabilities
456
993Warrant liabilities
19
136Related party payable
3,012
3,312Lease liability, short-term
71
68Total current liabilities
5,192
5,648Lease liability, long-term
123
142Total liabilities
5,315
5,790Commitments 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 March 31, 2026 and
December 31, 2025
—
—Common stock, $0.001 par value per share, 100,000,000 shares
authorized as of March 31, 2026 and December 31, 2025; 5,164,370 and
2,308,294 shares issued and outstanding as of March 31, 2026 and
December 31, 2025, respectively
5
2Additional paid–in capital
161,721
154,161Accumulated deficit
(152,653)
(148,830)Total stockholders' equity
9,073
5,333Total liabilities and stockholders' equity
$14,388
$11,123 MetaVia Inc.Condensed Consolidated Statements of Operations(Unaudited - In thousands, except share and per share amounts)
Three Months Ended March 31,
2026
2025Operating expenses
Research and development
$2,101
$2,327General and administrative
1,924
1,559Total operating expenses
4,025
3,886Loss from operations
(4,025)
(3,886)Other income
Gain from change in fair value of warrant liabilities
117
87Interest income, net
85
128Total other income
202
215Loss before income taxes
(3,823)
(3,671)Provision for income taxes
—
—Net loss
(3,823)
(3,671)Loss per share of common stock, basic and diluted
$(0.79)
$(3.93)Weighted average shares of common stock, basic and diluted
4,859,567
933,109 View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302772529.htmlSOURCE MetaVia Inc. Original: MetaVia Reports First Quarter 2026 Financial Results and Provides Corporate Update
US Market News
1月前
MetaVia to Present Data Highlighting DA-1726, a GLP-1/Glucagon Dual Agonist, in a Late-Breaking Poster Presentation at the EASL Congress 2026May 11, 2026 8:31 AM
PR Newswire (US) CAMBRIDGE, Mass., May 11, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that a late-breaking abstract highlighting DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors for the treatment of obesity, has been accepted for a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2026, being held May 27–30, 2026 in Barcelona, Spain. "Having a late-breaking abstract on DA-1726 accepted for a poster presentation at the prestigious EASL Congress underscores the strength of this asset," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 continues to demonstrate potential for a differentiated, best-in-class profile and is currently being evaluated in a 16-week Phase 1 Part 3 titration study designed to optimize higher dose levels and tolerability, with data expected in the fourth quarter of this year."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, MetaViaAbstract Number: LB26-5204Final Abstract ID: LBP-010Session: Late Breaking PostersPresentation Date: Wednesday, May 27, 2026Presentation Start: 8:30 am CETA copy of the poster will be available on the Posters section of the MetaVia website after the presentation.About DA-1726DA-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 MetaViaMetaVia 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 StatementsCertain 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-to-present-data-highlighting-da-1726-a-glp-1glucagon-dual-agonist-in-a-late-breaking-poster-presentation-at-the-easl-congress-2026-302767663.htmlSOURCE MetaVia Inc. Original: MetaVia to Present Data Highlighting DA-1726, a GLP-1/Glucagon Dual Agonist, in a Late-Breaking Poster Presentation at the EASL Congress 2026
US Market News
2月前
MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of ObesityApril 10, 2026 8:30 AM
PR Newswire (US)
16-Week Study Evaluates One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise Healthy AdultsCAMBRIDGE, Mass., April 10, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the first patient has been dosed in Part 3 of its Phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors. Part 3 of the Phase 1 program consists of two 16-week titration cohorts designed to evaluate one-step and two-step dose-escalation strategies to safely achieve higher target doses and further optimize tolerability.
"Dosing the first patient in these higher-dose cohorts is an exciting milestone that moves us closer to unlocking the full potential of DA-1726," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "We have already seen compelling results, including approximately 9% weight loss at the 48 mg dose, along with meaningful reductions in waist circumference, improved glycemic control, and early signals of direct liver benefit, all with a favorable tolerability profile. We believe these results highlight the potential of our dual GLP-1/glucagon approach. Importantly, Part 3 is designed to reach higher therapeutic doses with improved tolerability, which could represent a meaningful advantage compared to currently marketed therapies that require longer, more gradual titration. With data expected in the fourth quarter of 2026, we are focused on further demonstrating DA-1726's potential to deliver differentiated efficacy and a more streamlined path to optimal dosing."The Phase 1 Part 3 trial is expected to enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726. Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI), and other cardiometabolic measures.For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.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 GLP-1 receptor 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 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-doses-the-first-patient-in-higher-dose-phase-1-study-of-da-1726-its-glp-1-and-glucagon-dual-agonist-for-the-treatment-of-obesity-302738622.htmlSOURCE MetaVia Inc.
Original: MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of Obesity
US Market News
3月前
MetaVia Reports Year End 2025 Financial Results and Provides Corporate UpdateMarch 26, 2026 8:31 AM
PR Newswire (US)
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 2026CAMBRIDGE, 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 HighlightsMarch 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 MilestonesDA-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 ResultsResearch 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.comRx 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
2024Assets
Current assets
Cash and cash equivalents
$10,278
$16,017 Prepaid expenses and other current assets
597
55Total current assets
10,875
16,072Property and equipment, net
17
34Right-of-use asset
210
133Other assets
21
21Total assets
$11,123
$16,260Liabilities and stockholders' equity
Current liabilities
Accounts payable
$1,060
$3,879Clinical trial accrued liabilities
79
1,696Accrued expenses and other current liabilities
993
785Warrant liabilities
136
361Related party payable
3,312
1,472Lease liability, short-term
68
78Total current liabilities
5,648
8,271Lease liability, long-term
142
58Total liabilities
5,790
8,329Commitments 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
1Additional paid–in capital
154,161
143,787Accumulated deficit
(148,830)
(135,857)Total stockholders' equity
5,333
7,931Total 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
2024Operating expenses
Research and development
$6,802
$21,553General and administrative
6,906
7,256Total operating expenses
13,708
28,809Loss from operations
(13,708)
(28,809)Other income
Gain from change in fair value of warrant liabilities
225
297Interest income
510
920Total other income
735
1,217Loss 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-year-end-2025-financial-results-and-provides-corporate-update-302725141.htmlSOURCE MetaVia Inc.
Original: MetaVia Reports Year End 2025 Financial Results and Provides Corporate Update
US Market News
3月前
MetaVia Expands Global Patent Protection for Vanoglipel, Supporting Metabolic and Liver Disease Therapy Through 2035March 12, 2026 9:01 AM
PR Newswire (US)
Patent Portfolio Includes 48 Granted and Pending Patents in the U.S., Europe, Japan, China and other Countries, Providing Protection Into 2035, Unless Extended FurtherCAMBRIDGE, Mass., March 12, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced a comprehensive global intellectual property portfolio supporting vanoglipel (DA-1241), its novel, orally available G-protein-coupled receptor 119 (GPR119) agonist. This currently includes 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.
MetaVia's patent portfolio, exclusively licensed from Dong-A ST Co., Ltd., provides broad protection for vanoglipel itself, how it is manufactured, and its potential use across a range of serious metabolic and liver conditions. Collectively, the patents cover both the core compound and pharmaceutical compositions designed to treat diseases linked to metabolic dysfunction, including Metabolic Dysfunction-Associated Steatohepatitis (MASH) and diabetes."Maintaining and expanding a strong intellectual property position is a core element of our strategy to maximize the long-term value potential of vanoglipel," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "These patents reflect the broad therapeutic opportunity for DA-1241 across liver and metabolic diseases and reinforce our commitment to advancing innovative oral treatments for patients who currently have limited options."About Vanoglipel (DA-1241)
Vanoglipel (DA-1241) is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.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 ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; 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 or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-expands-global-patent-protection-for-vanoglipel-supporting-metabolic-and-liver-disease-therapy-through-2035-302712075.htmlSOURCE MetaVia Inc.
Original: MetaVia Expands Global Patent Protection for Vanoglipel, Supporting Metabolic and Liver Disease Therapy Through 2035
US Market News
4月前
MetaVia Builds Comprehensive Global Patent Protection for DA-1726, Securing Exclusive Rights to Novel Obesity and Metabolic Therapy Through 2041February 13, 2026 8:31 AM
PR Newswire (US)
Intellectual Property Portfolio Includes 39 Granted and Pending Patents in the U.S. and Internationally, Providing Protection Into 2041, Unless Extended FurtherCAMBRIDGE, Mass., Feb. 13, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced a strong global intellectual property portfolio supporting 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. This currently includes 39 granted and pending patents in the U.S. and internationally, providing protection into 2041, unless extended further.
MetaVia's patent portfolio, exclusively licensed from Dong-A ST Co., Ltd., provides broad protection covering the novel peptide structure of DA-1726 as well as its design as a long-acting dual-incretin therapy. Together, these protect both the core molecule and its therapeutic use in obesity, metabolic disease, and associated cardiometabolic conditions, strengthening the company's long-term development and commercialization position in one of the fastest-growing areas of medicine."Building a strong and durable patent foundation is essential as we advance DA-1726 as a potential best-in-class therapy for obesity and metabolic disease," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Our intellectual property estate protects the unique design of this dual GLP-1/glucagon agonist and supports the long-term value of the program. As importantly, our recent clinical data reinforce the promise of DA-1726. At the 48 mg dose, we saw meaningful weight loss of about 9%, significant reductions in waist size, improvements in blood sugar levels, and early signs of direct liver benefit, all with a favorable safety profile."Mr. Kim continued, "Looking ahead, our planned 16-week titration studies to 48 mg and 64 mg reflect our confidence in the therapy's tolerability and its potential to offer an advantage over the slower dose-escalation schedules required by current GLP-1 treatments. With results expected in the fourth quarter of 2026, we believe we are well positioned to unlock additional value as we advance DA-1726 into later-stage development."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®). 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. 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 ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; 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 or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; 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.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 ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; 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 or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; 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.comRx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-builds-comprehensive-global-patent-protection-for-da-1726-securing-exclusive-rights-to-novel-obesity-and-metabolic-therapy-through-2041-302687014.htmlSOURCE MetaVia Inc.
Original: MetaVia Builds Comprehensive Global Patent Protection for DA-1726, Securing Exclusive Rights to Novel Obesity and Metabolic Therapy Through 2041
subslover
7月前
Thank you, glenn MetaVia Presents Positive New Phase 2a Data on Vanoglipel (DA-1241) in Patients with Presumed MASH at the AASLD The Liver Meeting® 2025
Oral GPR119 Agonist Demonstrated Clinically Meaningful Reductions in HbA1c, Improvements in Liver Inflammation and Fibrosis, and Favorable Changes in Plasma Lipidomic Profiles
CAMBRIDGE, Mass., Nov. 7, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of positive new data from its Phase 2a clinical trial evaluating vanoglipel (DA-1241), a potent and selective G protein-coupled receptor 119 (GPR119) agonist, as a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH). 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. The data will be presented in a poster presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025, taking place November 7-11, in Washington D.C.
The Phase 2a randomized, placebo-controlled trial evaluated vanoglipel as a potential treatment for MASH, both as monotherapy and in combination with a dipeptidyl peptidase-4 inhibitor (DPP4i) to augment endogenous GLP-1 action. GPR119 agonists directly stimulate GLP-1 secretion, thereby increasing total GLP-1 levels; when combined with a DPP4 inhibitor, the treatment can extend the action, not only of basal endogenous GLP-1, but also of the secreted GLP-1 induced by GPR119 activation. A total of 109 subjects with presumed MASH and qualifying baseline alanine transaminase (ALT) and imaging analyses were randomized to receive placebo, vanoglipel 50 mg, vanoglipel 100 mg alone, or vanoglipel 100 mg with a DPP4 inhibitor once daily for 16 weeks in a 2:1:2:2 ratio.
"The encouraging additional Phase 2a results, presented at AASLD, highlight vanoglipel's differentiated mechanism and its potential to target both hepatic and metabolic drivers of MASH in a single oral therapy," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "In addition to improvements in liver inflammation, fibrosis, and steatosis, vanoglipel demonstrated meaningful reductions in HbA1c among patients with type 2 diabetes and prediabetes, as well as favorable shifts in plasma lipidomic profiles, reducing disease-associated glycerolipids and glycerophospholipids linked to hepatic injury. These data reinforce vanoglipel's potential to address the complex interplay between metabolic dysfunction and liver disease. Following 16 weeks of treatment, vanoglipel showed consistent biochemical, imaging, and metabolic improvements, supporting its continued development as both a monotherapy and combination therapy for MASH and related metabolic disorders."
Following 16 weeks of treatment, vanoglipel demonstrated rapid and sustained improvements in glycemic control, with reductions in glycated hemoglobin (HbA1c) observed from the fourth week of treatment. At Week 16, mean HbA1c decreased by –0.54%p with vanoglipel monotherapy and –0.66%p with combination therapy, reflecting enhanced incretin action. In the study, patients treated with vanoglipel showed clinically meaningful HbA1c reductions of 0.37%p, 0.41%p, and 0.54%p at weeks 4, 8, and 16, from a baseline of 6.99%, despite nearly half of participants being non-diabetic (p ? 0.05 vs. PBO). These findings highlight vanoglipel's ability to improve glucose control independently of weight loss, suggesting its mechanism is differentiated from other metabolic liver disease therapies.
In addition to its glycemic effects, vanoglipel significantly decreased plasma ALT levels in subjects with baseline ALT between 40 and 200 U/L. The reduction in ALT was not further enhanced by co-administration with a DPP4 inhibitor, suggesting that vanoglipel monotherapy drives the majority of the observed hepatoprotective effects. Vanoglipel improved liver steatosis as measured by controlled attenuation parameter (CAP) and reduced liver stiffness by vibration-controlled transient elastography (VCTE). Non-invasive assessments, including FAST and NIS-4 scores, also improved from baseline, reinforcing vanoglipel's potential to address both hepatic and metabolic components of MASH.
Vanoglipel treatment reduced circulating biomarkers associated with cell death (CK18F/M30), inflammation (hs-CRP, CCL2), and fibrosis (TIMP1), consistent with its proposed hepatoprotective mechanism. Additionally, Vanoglipel 100 mg reduced pathogenic lipids in plasma lipidomic profiles, including glycerolipids (DG36:4, TG52:4) and glycerophospholipids (PE38:4, PE38:5), suggesting favorable remodeling of lipid metabolism.
Vanoglipel was well tolerated across all treatment groups, with no treatment-emergent adverse events leading to discontinuation, except for one in the placebo group.
Presentation Details:
Title: Vanoglipel (DA-1241), a GPR119 Agonist, Demonstrates Hepatoprotective Effects Through Improving Inflammation and Metabolism in the Liver: A 16-week Randomized Placebo-Controlled Trial in Presumed MASH Patients
Presenting Author: Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief, Division of Gastroenterology and Hepatology at the University of California at San Diego.
Poster Number: 4012
Session: Monday Poster Presenters Hall Hour
Poster Date: Monday, November 10, 2025
Poster Time: 1:00-2:00 pm ET
Poster Location: Convention Center: Hall DE (Posters & Exhibits), Level 2
A copy of the poster is available on the Posters section of the MetaVia website.
About Vanoglipel (DA-1241)
Vanoglipel (DA-1241) is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.
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 th
tw0122
2年前
NeuroBo Pharmaceuticals Announces up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
PUBLISHED
JUN 24, 2024 8:01AM EDT
$20 million upfront with up to an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-linked Series Warrants are expected to provide cash runway to complete the Phase 1 Part 3 clinical trial
CAMBRIDGE, Mass., June 24, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) (NeuroBo), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced that it has entered into definitive agreements for the issuance and sale in a private placement of 4,325,701 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $3.93 per share (or per pre-funded warrant in lieu thereof). In a concurrent registered direct offering, NeuroBo has agreed to issue and sell 763,359 shares of its common stock at the same purchase price per share as in the private placement. In addition, NeuroBo has agreed to issue in the offerings unregistered Series A warrants to purchase up to 5,089,060 shares of common stock and unregistered Series B warrants to purchase up to 7,633,591 shares of common stock (all the warrants, collectively, the "Series Warrants"). The Series Warrants will have an exercise price of $3.93 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Series Warrants (the "Stockholder Approval"). The Series A warrants will expire on the earlier of the twelve months anniversary of the Stockholder Approval and within 60 days following the public announcement of NeuroBo receiving positive Phase 1 multiple ascending dose (MAD) data readout for DA-1726 and the Series B warrants will expire on the earlier of the five years anniversary of the Stockholder Approval and within six months following the public announcement of NeuroBo receiving positive Phase 1 Part 3 data readout for DA-1726. The private placement and the registered direct offering were priced at-the-market under Nasdaq rules. The closing of the offerings is expected to occur on or about June 25, 2024, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.
The aggregate gross proceeds to NeuroBo from the offerings are expected to be approximately $20 million before deducting the placement agent's fees and other offering expenses payable by NeuroBo. NeuroBo currently intends to use the net proceeds from the offerings for working capital and general corporate purposes, as well as to continue the clinical development of DA-1726 for the treatment of obesity. The potential additional gross proceeds to NeuroBo from the Series Warrants, if fully exercised on a cash basis, will be approximately $50 million and will be utilized to fund the Phase 1 Part 3 clinical trial of DA-1726. No assurance can be given that any of the Series Warrants will be exercised.
The shares of common stock offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the warrants issued in the private placement) are being offered and sold by NeuroBo pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-278646), including a base prospectus, previously filed with the Securities and Exchange Commission ("SEC") on April 12, 2024 and declared effective by the SEC on April 23, 2024. The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may be obtained on the SEC's website at http://www.sec.gov and may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
The offer and sale of the securities in the private placement and the Series Warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants issued in the private placement, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the Series Warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement with the SEC or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. NeuroBo has agreed to file an initial registration statement with the SEC covering the resale of the securities to be issued in the private placement.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About NeuroBo PharmaceuticalsNeuroBo Pharmaceuticals, 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 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. DA-1241 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, DA-1241 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.