MetaVia Inc Stock Price, News & Analysis

MetaVia (MTVA) announced the acceptance of a pre-clinical data abstract on DA-1241, their novel GPR119 agonist, for poster presentation at the American Diabetes Association's 85th Scientific Sessions. The presentation, titled 'Additive Hepatoprotective Effects of DA-1241, a GPR119 Agonist, in Combination with Efruxifermin in a Diet-Induced Obese and Biopsy-Confirmed Mouse Model of MASH', will be delivered by Dong-A ST Research Center's Lead Research Scientist Yuna Chae. The presentation is scheduled for June 22, 2025, from 12:30-1:30 pm CT at Chicago's McCormick Place Convention Center. The poster will be made available on MetaVia's website and published in the journal Diabetes®.

MetaVia (NASDAQ: MTVA) reported significant progress in Q1 2025 with positive clinical trial results for its obesity treatment DA-1726. The Phase 1 MAD trial demonstrated a maximum weight reduction of 6.3% and mean reduction of 4.3% at 32mg dose, with strong safety profile and minimal side effects. The company also presented promising 16-week Phase 2a results for DA-1241 in MASH treatment, showing reduced liver injury markers and improved glycemic control. Financially, MetaVia reported Q1 net loss of $3.7 million ($0.36 per share), reduced from $6.7 million year-over-year. R&D expenses decreased to $2.3 million from $4.9 million in Q1 2024. The company successfully completed a $10 million private placement, ending Q1 with $11.2 million cash, which combined with the placement proceeds is expected to fund operations into 2026.

MetaVia (NASDAQ: MTVA) has announced a $10.0 million private placement priced at-the-market under Nasdaq rules. The offering includes 9,479,345 shares of common stock at $0.71 per share and 4,605,162 pre-funded warrants at $0.709 with an exercise price of $0.001. The clinical-stage biotech company plans to use the proceeds for working capital and continued clinical development of DA-1726 for obesity treatment. The private placement, exclusively placed by Ladenburg Thalmann & Co. Inc., is expected to close around May 12, 2025. The securities are being offered to institutional accredited investors under Section 4(a)(2) of the Securities Act and will require registration with the SEC for resale.

MetaVia (NASDAQ: MTVA) announced positive Phase 2a clinical trial results for DA-1241, a novel GPR119 agonist, in treating presumed metabolic dysfunction-associated steatohepatitis (MASH). The trial involved 109 subjects over 16 weeks, demonstrating significant hepatoprotective and glucose-regulating effects. Key findings include: • ALT levels decreased by 22.8 U/L with 100mg dose • Liver fat (CAP score) reduced by 23.0 dB/m • FAST score improved from 0.559 to 0.371 • HbA1c reduced by 0.54%p overall, and 1.08%p in diabetic patients • Significant reductions in inflammation and fibrosis biomarkers The drug showed a favorable safety profile with no treatment-related discontinuations. The company plans to meet with the FDA in H1 2025 to discuss further development as both monotherapy and combination therapy for MASH and metabolic diseases.

MetaVia (Nasdaq: MTVA) announced that data from its Phase 2a clinical trial of DA-1241, a novel GPR119 agonist, will be presented as a late-breaking poster at the EASL Congress 2025 in Amsterdam (May 7-10, 2025). The presentation will focus on the drug's hepatoprotective and glucose-regulating effects in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH) from a 16-week randomized placebo-controlled trial.

The presentation titled 'DA-1241, a GPR119 Agonist, Demonstrates Hepatoprotective and Glucose-Regulating Effects in a 16-week Randomized Placebo-Controlled Trial in Presumed MASH Patients' will be delivered by Dr. Rohit Loomba from the University of California, San Diego. The poster will be available on MetaVia's website following the presentation.

MetaVia (Nasdaq: MTVA) reported additional positive top-line results from Phase 1 Multiple Ascending Dose (MAD) study of DA-1726, its novel 3:1 ratio GLP-1 and glucagon dual receptor agonist for obesity treatment. The 28-day, 36-subject trial demonstrated:

- Dose-dependent body weight reduction across 8-32mg range, with maximum -6.3% and mean -4.3% weight loss at 32mg dose by Day 26

- No significant cardiovascular effects observed, with most treatment groups showing slight decrease in heart rate

- Strong safety profile with only mild gastrointestinal adverse events in 4/6 subjects at 32mg dose, resolving within 24 hours

The drug showed promising results compared to current GLP-1 agonists, with early satiety observed in 83% of subjects at 32mg dose. Additional cohorts are being added to determine maximum tolerated dose, and a Phase 1 Part 3 study is planned to evaluate DA-1726 in patients who discontinued Wegovy®.

MetaVia (NASDAQ: MTVA) announced positive results from its 4-week Phase 1 multiple ascending dose (MAD) trial of DA-1726, a novel dual receptor agonist for obesity treatment. The 32mg dose cohort demonstrated a maximum weight loss of 6.3% and mean weight loss of 4.3% at Day 26 (p=0.0005), with no titration required.

Key findings include:

• Maximum waist circumference reduction of 3.9 inches and mean reduction of 1.6 inches at Day 33
• Maximum lowering of fasted glucose of -18 mg/dL and mean lowering of -5.3 mg/dL
• 25% of subjects experienced mostly mild gastrointestinal adverse events
• No treatment-related discontinuations or serious adverse events

The company plans to conduct Phase 1 Part 3 study investigating DA-1726 on Wegovy early drop-out patients, aiming to demonstrate superior tolerability and safety. Additional cohorts will be added to determine maximum tolerated dose.

MetaVia (NASDAQ: MTVA) announced its 2024 financial results and corporate updates. The company reported significant progress in its cardiometabolic drug development programs:

Key highlights include positive Phase 2a trial results for DA-1241 in MASH treatment, showing ALT level reduction and improved HbA1C levels. The company expects top-line data from Phase 1 MAD Part 2 trial of DA-1726 for obesity treatment in April 2025.

Financial results show:

• R&D expenses increased to $21.6M from $9.2M in 2023
• Net loss of $27.6M ($3.56 per share) compared to $12.5M in 2023
• Cash position of $16.0M, expected to fund operations into Q3 2025

MetaVia (NASDAQ: MTVA) announced it will hold an Advisory Committee meeting at the 9th Annual MASH-TAG 2025 Conference to discuss previously announced positive top-line 16-week results from their Phase 2a clinical trial. The trial evaluated DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH).

The conference is being held from January 9-11 at the Chateaux Deer Valley in Park City, Utah. MetaVia's management and clinical team will be available in the Exhibit Hall to discuss the trial results, and the presentation will be accessible on the company's website.