Core Insights - MetaVia Inc. announced positive results from its Phase 1 clinical trial of DA-1726, a dual oxyntomodulin analog for obesity treatment, showing significant weight loss and metabolic improvements [1][3][6] Group 1: Clinical Trial Results - In the non-titrated 48 mg cohort, patients achieved a statistically significant average weight reduction of 9.1% (21.2 lbs) and a waist circumference reduction of 9.8 cm (3.8 inches) by Day 54 [2][3] - The trial demonstrated a 12.3 mg/dL reduction in fasted glucose levels, indicating strong glycemic response [1][3] - A 23.7% reduction in liver stiffness was observed, suggesting a significant direct hepatic effect from DA-1726 [1][2] Group 2: Safety and Tolerability - No treatment-related discontinuations were reported, and gastrointestinal events were mild to moderate in severity [2][3] - The favorable safety profile supports the potential for DA-1726 as a best-in-class treatment option [3][4] Group 3: Future Development Plans - MetaVia plans to conduct 16-week titration studies to further evaluate DA-1726's tolerability and efficacy, with results expected in Q4 2026 [3][4] - The company aims to leverage the competitive advantage of DA-1726's dosing regimen compared to existing GLP-1 drugs [3][4] Group 4: Mechanism of Action - DA-1726 functions as a dual agonist of GLP-1 and glucagon receptors, leading to weight loss through appetite reduction and increased energy expenditure [6][7] - Pre-clinical studies indicate that DA-1726 may provide superior weight loss compared to other treatments like semaglutide and tirzepatide [6][7]

Core Insights - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases [2] - The company is developing two key products: DA-1726 for obesity and vanoglipel for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [2] Product Development - DA-1726 is a novel oxyntomodulin (OXM) analogue acting as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), showing best-in-class potential for weight loss, glucose control, and waist reduction in Phase 1 trials [2] - Vanoglipel is a G-protein-coupled receptor 119 (GPR119) agonist that enhances the release of gut peptides GLP-1, GIP, and PYY, demonstrating positive effects on liver inflammation, lipid metabolism, and glucose control in pre-clinical studies and Phase 2a clinical studies [2] Conference Participation - MetaVia will participate in and sponsor the 10th Annual MASH-TAG 2026 Conference from January 8-10, 2026, in Park City, Utah, with members from its business development and clinical teams attending [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Group 1: Premarket Gainers - AlphaTime Acquisition Corp (ATMC) has seen a remarkable increase of 602%, trading at $104.70 [3] - Exicure, Inc. (XCUR) is up 70%, currently priced at $8.98 [3] - Vor Biopharma Inc. (VOR) has risen by 53%, trading at $12.83 [3] - Other notable gainers include AlphaVest Acquisition Corp (ATMV) up 20% at $9.45, Mama's Creations, Inc. (MAMA) up 16% at $13.00, and Ares Management Corporation (ARES) up 8% at $178.34 [3] Group 2: Premarket Losers - Top Wealth Group Holding Limited (TWG) has experienced a significant decline of 48%, trading at $11.31 [4] - Cemtrex, Inc. (CETX) is down 16%, currently at $5.86 [4] - Gulf Resources, Inc. (GURE) has decreased by 14%, trading at $4.70 [4] - Other notable losers include JX Luxventure Group Inc. (JXG) down 10% at $4.58, HWH International Inc. (HWH) down 10% at $2.08, and MetaVia Inc. (MTVA) down 8% at $10.50 [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]

Core Viewpoint - MetaVia Inc. announced a 1-for-11 reverse stock split of its common stock, effective December 4, 2025, to comply with Nasdaq's continued listing requirements [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every 11 shares of common stock into one share, maintaining the par value of $0.001 per share [2][3]. - Following the split, the number of outstanding shares will decrease from approximately 25.4 million to about 2.3 million, while the authorized shares will remain at 100 million [4]. Group 2: Impact on Stock Options and Warrants - The reverse stock split will proportionately reduce the number of shares issuable upon conversion of restricted stock units, stock options, and warrants, while increasing their conversion and exercise prices accordingly [3]. Group 3: Company Overview - MetaVia Inc. is focused on transforming cardiometabolic diseases, currently developing DA-1726 for obesity treatment and vanoglipel (DA-1241) for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [6]. - DA-1726 is a dual agonist that has shown best-in-class potential for weight loss and glucose control in Phase 1 trials [6]. - Vanoglipel has demonstrated positive effects on liver inflammation and glucose metabolism in pre-clinical studies and Phase 2a clinical trials [6].

Core Insights - MetaVia Inc. announced positive results from its Phase 2a clinical trial of vanoglipel (DA-1241), a GPR119 agonist, showing significant improvements in glucose control, liver health, and plasma lipid profiles in patients with metabolic dysfunction-associated steatohepatitis (MASH) [1][3][9] Clinical Trial Details - The Phase 2a trial was randomized and placebo-controlled, involving 109 subjects with presumed MASH, who received either placebo, vanoglipel 50 mg, vanoglipel 100 mg alone, or vanoglipel 100 mg with a DPP4 inhibitor for 16 weeks [2][4] - Vanoglipel demonstrated rapid and sustained improvements in glycemic control, with mean HbA1c reductions of -0.54% with monotherapy and -0.66% with combination therapy at Week 16 [3][4] Mechanism of Action - Vanoglipel acts as a GPR119 agonist, stimulating GLP-1 secretion, which enhances glucose metabolism and lipid profiles [2][9] - The treatment showed significant reductions in plasma ALT levels and improvements in liver steatosis and stiffness, indicating hepatoprotective effects [4][5] Biomarker Improvements - Treatment with vanoglipel resulted in decreased biomarkers associated with cell death, inflammation, and fibrosis, supporting its hepatoprotective mechanism [5] - Favorable changes in plasma lipidomic profiles were observed, including reductions in disease-associated glycerolipids and glycerophospholipids [5] Tolerability and Safety - Vanoglipel was well tolerated across all treatment groups, with no treatment-emergent adverse events leading to discontinuation, except for one in the placebo group [6] Company Overview - MetaVia Inc. is focused on developing therapies for cardiometabolic diseases, with vanoglipel being a key candidate for treating MASH and type 2 diabetes [10][12]

Core Insights - MetaVia Inc. has initiated the first patient dosing in the 8-week 48 mg MAD cohort of its Phase 1 clinical trial for DA-1726, targeting obesity, with top-line data expected by the end of 2025 [1][2] - The company reported $14.3 million in cash at the end of Q3 2025, which is anticipated to fund operations into 2026 [1][12] Company Developments - The Phase 1 data for DA-1726 presented at ObesityWeek® 2025 indicated a strong safety and tolerability profile, with participants experiencing up to a 6.3% mean body-weight reduction and waist circumference decreases of up to 3.9 inches [2][5] - The pharmacokinetic data for DA-1726 showed a linear, dose-proportional exposure and an approximately 80-hour half-life, supporting the feasibility of once-weekly dosing [2] - MetaVia is preparing for an end-of-Phase 2 meeting with the FDA in the first half of 2026 regarding vanoglipel (DA-1241), which has shown meaningful reductions in liver fat and inflammation in Phase 2a trials [2][7] Financial Performance - Research and Development (R&D) expenses for Q3 2025 were approximately $1.9 million, down from $4.5 million in Q3 2024, primarily due to lower direct R&D expenses related to both DA-1241 and DA-1726 [6][7] - General and Administrative (G&A) expenses for Q3 2025 were approximately $1.6 million, slightly down from $1.7 million in Q3 2024 [6][7] - The net loss for Q3 2025 was $3.4 million, or $0.14 per share, compared to a net loss of $5.7 million, or $0.55 per share, in Q3 2024 [12][14]

Core Insights - MetaVia Inc. announced new Phase 1 and pre-clinical data for DA-1726, a dual oxyntomodulin analog, showing favorable safety, tolerability, and clinically meaningful weight loss without dose titration [1][2][12] - The Phase 1 trial demonstrated a significant body weight reduction of up to 6.3% from baseline and a waist circumference decrease of up to 3.9 inches after four weeks of treatment [2][4] - DA-1726 exhibited superior lipid-lowering effects compared to pemvidutide in pre-clinical models, indicating its potential as a differentiated treatment for obesity [7][9] Phase 1 Trial Results - The Phase 1 trial was randomized, double-blind, and placebo-controlled, assessing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in obese adults with a BMI of 30–45 kg/m² [4] - At the highest tested dose of 32 mg, participants experienced an average weight reduction of 4.3% at Day 26, with effects sustained for two weeks post-treatment [2][3] - DA-1726 demonstrated a mean half-life of approximately 80 hours, supporting once-weekly dosing [3][12] Pre-clinical Data Insights - In pre-clinical studies, DA-1726 showed comparable weight loss to pemvidutide while achieving greater reductions in total cholesterol and LDL-C [7][9] - The drug promoted weight reduction by suppressing appetite and increasing energy expenditure without increased physical activity [8][12] - DA-1726's metabolic profile suggests broader and more durable benefits for patients with obesity compared to other dual agonists [7][9] Future Directions - MetaVia has extended the Phase 1 study to evaluate a 48 mg dose over eight weeks to assess longer-term efficacy and patient exposure [2][4] - Results from the extended cohort are expected later this year, which may provide further insights into DA-1726's potential as a treatment for obesity [2][4]

Core Insights - MetaVia Inc. announced that an abstract on Vanoglipel (DA-1241), a GPR119 agonist, has been accepted for presentation at the AASLD Liver Meeting 2025 [1] Company Overview - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing DA-1726 for obesity and Vanoglipel (DA-1241) for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [4] - DA-1726 is a novel oxyntomodulin analogue that acts as a dual agonist for GLP1R and GCGR, showing potential for superior weight loss and glucose control [4] Product Details - Vanoglipel (DA-1241) promotes the release of gut peptides GLP-1, GIP, and PYY, which are involved in glucose and lipid metabolism, as well as weight loss [3] - Preclinical studies have shown that DA-1241 reduces hepatic steatosis, inflammation, and fibrosis while improving glucose control [3] - In Phase 1a, 1b, and 2a trials, DA-1241 was well tolerated in both healthy volunteers and those with type 2 diabetes mellitus (T2DM) [3] Upcoming Presentation - The poster presentation titled "Vanoglipel (DA-1241), a GPR119 Agonist, Demonstrates Hepatoprotective Effects Through Improving Inflammation and Metabolism in the Liver" will be presented by Dr. Rohit Loomba at the AASLD meeting on November 10, 2025 [6]

Core Insights - MetaVia Inc. announced the acceptance of two abstracts for poster presentations at ObesityWeek® 2025, focusing on DA-1726, a novel dual oxyntomodulin analog agonist targeting cardiometabolic diseases [1][3]. Company Overview - MetaVia Inc. is a clinical-stage biotechnology company dedicated to transforming cardiometabolic diseases, currently developing DA-1726 for obesity treatment and Vanoglipel (DA-1241) for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [4]. Product Details - DA-1726 is a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), administered once weekly subcutaneously, aimed at weight loss through appetite reduction and increased energy expenditure [3]. - In pre-clinical studies, DA-1726 showed superior weight loss compared to semaglutide and cotadutide, while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide [3]. - The Phase 1 multiple ascending dose trial indicated that the 32 mg dose of DA-1726 has best-in-class potential for weight loss, glucose control, and waist circumference reduction [3][4]. Upcoming Presentations - The poster presentations will take place on November 4, 2025, at Exhibit Hall A1, featuring topics on the safety, tolerability, and pharmacokinetics of DA-1726, as well as its potential as a therapy for obesity and related metabolic disorders [6].