Metavia Inc. · NASDAQ:MTVA
Metavia — Investor Presentation (April 2025)
26 slides from Metavia's investor presentation, Apr 15, 2025
Slide 1: MetaVia Inc. NASDAQ: MTVA
December 2023 NASDAQ: NRBO 1 April 2025 MetaVia Inc. NASDAQ: MTVA
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use o
Slide 3: Risk Factors
3 Risk Factors Investing in our securities includes a high degree of risk. You should consider carefully the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2024, including specific factors discussed below, together with all of the other information contained
Slide 4: A Clinical Stage Biotech Focused on Cardiometabolic Diseases
4 A Clinical Stage Biotech Focused on Cardiometabolic Diseases Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics A novel GLP1R/GCGR Dual Agonist with GLP-1R:GCGR = 3:1 Safety and Tolerability No treatment-related discontinuations with mild GI related events Weight Loss (26th
Slide 5: Multiple Near-Term Milestones: Targeting to Increase Shareholder Value
5 Multiple Near-Term Milestones: Targeting to Increase Shareholder Value 2026 DA-1241 H1 2025 Meeting with FDA April 2025 Phase 1 MAD Top Line Results DA-1726 Q3 2025 Phase 1 Part 3 First Patient In Q2 2025 Phase 1 Part 3 IND Amend Submission H1 2026 Phase 1 Part 3 Interim Data Readout * These mil
Slide 6: DA-1726: A Novel GLP1R/GCGR Dual Agonist for the Treatment of Obesity
December 2023 NASDAQ: NRBO 6 DA -1726 A Novel GLP1R/GCGR Dual Agonist for the Treatment of Obesity
Slide 7: DA-1726: Mechanism of Action
7 DA-1726: Mechanism of Action DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/Glucagon Receptor); GLP-1 (Glucagon-Like Peptide 1) 1. Pocai A. Mol Metab.2014;3:241-51 ▪ Oxyntomodulin •
Slide 8: DA-1726: Phase 1 MAD Clinical Study Design and Subject Disposition
8 A Single Site, Randomized, Double-Blind, Placebo-Controlled, Parallel, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DA-1726 in Obese Otherwise Healthy Subjects Primary Objective To evaluate the safety and tolerability of DA-1726 in obese but otherwise healthy patients NCT Numb
Slide 9: DA-1726: Phase 1 MAD Clinical Study Baseline Characteristics
9 DA-1726: Phase 1 MAD Clinical Study Baseline Characteristics 4mg 8mg 16mg 32mg Pooled PBO Overall Baseline Weight (kg) n 6 6 6 6 12 36 Mean 84.35 89.32 95.95 90.43 96.65 92.23 Min, Max 71.2, 97.0 74.7, 105.9 84.3, 111.0 75.5, 109.3 72.7, 121.9 71.2, 121.9 Baseline Body Mass Index (kg/m2) N 6 6 6 6
Slide 10: DA-1726: Phase 1 Safety Highlights (32 mg Dose)
10 DA-1726: Phase 1 Safety Highlights (32 mg Dose) • Safety & Tolerability ✓ Most GI related AEs occurred after the 1st dose and resolved within 24 hours from occurrence ✓ No treatment-related discontinuations ✓ Mild vomiting occurred with 3 subjects but resolved within 9 hours, 2 subjects after 1st
Slide 11: DA-1726: Phase 1 MAD Safety GI Treatment Emergent Adverse Events
11 DA-1726: Phase 1 MAD Safety GI Treatment Emergent Adverse Events, by Severity GI Treatment Emergent Adverse Events Number of subjects reporting (%) Pooled PBO n = 12 Pooled DA1726 n = 24 4 mg n = 6 8 mg n = 6 16 mg n = 6 32 mg n = 6 Gastrointestinal disorders 1 (8.3%) 6 (25.0%) 1 (16.7%) 0 1 (16.
Slide 12: DA-1726: Phase 1 MAD Topline Body Weight Loss
12 DA-1726: Phase 1 MAD Topline Body Weight Loss • Day 26 shown dose dependent and compelling BWL shown in 8 mg, 16 mg and 32 mg -4.5% -4.0% -3.5% -3.0% -2.5% -2.0% -1.5% -1.0% -0.5% 0.0% % Change from Baseline Maximum Change in BW -2.9% -6.9% -6.1% -6.0% -6.3% % Change in mean BW -1.1% -3.2% -1.7%
Slide 13: DA-1726: Key Secondary and Exploratory Results (32mg Dose)
13 DA-1726: Phase 1 MAD Key Secondary and Exploratory Results (32mg Dose) • Glucose Lowering ✓ With mean baseline of 97.8 mg/dL, mean -5.3 mg/dL at Day 26 with maximum -18 mg/dL at Day 26 ✓ No sign of increase of glucose despite the dual MOA in any cohorts ❖ Signs of very strong GLP-1 efficacy with
Slide 14: DA-1726: Comparative Study with Survodutide on Fat Mass Loss
14 DA-1726: Comparative Study with Survodutide on Fat Mass Loss • DA-1726 demonstrated superior weight loss efficacy compared to Survodutide in HF-DIO mice under similar dietary intake conditions • DA-1726 demonstrated superior body fat mass reduction and lean body mass relative preservation compare
Slide 15: DA-1726 vs Semaglutide in DIO-NASH Mice
15 6.75 5* 3.88* 3.63* 0 1 2 3 4 5 6 7 NASH Control Semaglutide 250 nmol/kg* DA-1726 100 nmol/kg* DA-1726 200 nmol/kg* Score • DA-1726 further improved hepatic steatosis, inflammation, and fibrosis compared to semaglutide ▪ Animals: male DIO-NASH mice ▪ Regimen: Every three days S.C. injection ▪ Dos
Slide 16: Recent Obesity Drug Transactions
16 Recent Obesity Drug Transactions Companies Date Stage Description Drug Deal Structure Deal Terms Novo Nordisk / United Biotechnology March 2025 Phase 1 Ready GLP-1, GIP and Glucagon UBT251 Global License, excluding Chinese mainland, Hong Kong, Macau, or Taiwan $200 million up front, with up to $1
Slide 17: DA-1241: Orally Available, Potential First-in-Class GPR119 Agonist for MASH
December 2023 NASDAQ: NRBO 17 DA-1241 Orally Available, Potential First-in-Class GPR119 Agonist for the Treatment of MASH
Slide 18: DA-1241: Mode of Action
18 ▪ DA-1241 is a synthetic drug that binds to GPR119 expressed on the cell surface of liver cells, immune cells (Kupfer cells, macrophages, monocytes), and hepatic astrocytes. ▪ Multiple effects are expected by direct action on representative cells involved in pathogenesis. Harrison et al., Clinica
Slide 19: DA-1241: Phase 2a Top-Line Results Primary Efficacy Endpoint
19 Placebo (N=23) DA-1241 50 mg (N=12) DA-1241 100 mg (N=22) DA-1241 100mg + Sitagliptin 100 mg (N=34) Number of Subjects, n < 30, n (%) 1 (4.3%) 4 (33.3%) 4 (18.2%) 3 (8.8%) Odds Ratio (p value) 10.500 (0.0487) 5.600 (0.1402) 2.423 (0.4576) DA-1241: Phase 2a Top-Line Results Primary Efficacy Endpoi
Slide 20: DA-1241: Phase 2a Top-Line Results LS Mean ALT Changes
20 DA-1241: Phase 2a Top-Line Results LS Mean ALT Changes from Baseline (U/L) -4.7 -16.81 -18.09 -8.24 -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 Alanine Aminotransferase CFB @ W16 (U/L) 68.4 65.8 57.2 63.2 -4.7 -16.81 -18.09 -8.24 -23 -18 -13 -8 -3 2 PBO 50mg 100mg Combi ALT CFB vs. Time (U/L) Week 4 We
Slide 21: DA-1241: Phase 2a Secondary Efficacy Endpoints
21 DA-1241: Phase 2a Top-Line Results LS Mean CAP, FAST, HbA1c score Changes from Baseline at Week 16 Select Secondary Efficacy Endpoint * p < 0.05 vs. placebo * -0.09 -0.17 -0.2 -0.19 -0.19 -0.18 -0.16 -0.14 -0.12 -0.1 -0.08 -0.06 -0.04 -0.02 0 PBO 50mg 100mg Combi FAST Score CFB 347.4 347.3 336.0
Slide 22: DA-1241: Phase 2a Safety Assessment
22 DA-1241: Phase 2a Top-Line Results Safety Assessment Overall TEAE Summary N (%) Placebo (N=32) DA-1241 50 mg (N=14) DA-1241 100 mg (N=26) DA-1241 100mg + Sitagliptin 100 mg (N=36) Subjects with any Treatment Related AE Mild Moderate Severe 9 ( 28.1%) 8 ( 25.0%) 1 ( 3.1%) 0 4 ( 28.6%) 4 ( 28.6%) 0
Slide 23: Financials and Capitalization
December 2023 NASDAQ: NRBO 23 Financials and Capitalization
Slide 24: Cash Balance and Capitalization Table
24 Cash Balance and Capitalization Table Financial Snapshot As of December 31, 2024 Cash $16.0 million Debt None Capitalization Table as of December 31, 2024 Common Stock Equivalents Common Stock 8,637,132 Warrants (WAEP $5.54)(1) 14,483,792 Options (WAEP $398.30) 4,700 Restricted Stock Units 175,08
Slide 25: Investment Opportunity Targeting Obesity and MASH
25 Compelling Investment Opportunity Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics ▪ Aiming to increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones • DA-1726 ✓ With strong weight loss at 4 weeks, potentially best-in-class tolerability and com
Slide 26: Thank You! Investor Contacts
December 2023 NASDAQ: NRBO 26 Thank You! Investor Contacts: Rx Communications Group Michael Miller +1 917.633.6086 mmiller@rxir.com MetaVia Marshall Woodworth +1 919.749.8748 marshall.woodworth@metaviatx.com