Metavia Inc. · NASDAQ:MTVA
Metavia — NeuroBo Pharmaceuticals — Investor Presentation (December 2023)
25 slides from Metavia's investor presentation, Dec 7, 2023
Slide 1: NeuroBo Pharmaceuticals, Inc. December 2023
NASDAQ: NRBO December 2023 NeuroBo Pharmaceuticals, Inc.
Slide 2: Forward-looking statements
2 This presentation may contain 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 of words such as “believe
Slide 3: Strong Leadership Team
3 Hyung Heon Kim, Chief Executive Officer Robert Homolka, SVP Clinical Operations Stephen Harrison, M.D., Consulting Chief Medical Officer Sung-Jin Kim, Pharmacist, Director of Corporate Strategy Mi-Kyung Kim, Ph.D, RPh, Chief Scientific Officer Marshall H. Woodworth, Acting Chief Financial Officer
Slide 4: Compelling Investment Opportunity
4 ▪ Aiming to Increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones o DA-1241 ✓ Open IND for Treatment of MASH and Type 2 Diabetes ✓ Actively recruiting into a Phase 2a for DA-1241 in subjects with presumed MASH ✓ Completed SAD and MAD studies (in healthy volunteers and s
Slide 5: Pipeline
5 Pipeline Asset Preclinical Phase 1 Phase 2 DA-1241 (GPR119 Agonist) DA-1726 (GLP1R/GCGR Dual Agonist) 2a 2b OBESITY Indication Phase 3 MASH Obesity
Slide 6: Multiple Near-Term Milestones: Targeting to Increase Shareholder Value
6 Investments in the current DA-1241 Phase 2a and planned DA-1726 Phase 1 have the potential for significant returns in the event of clinical and regulatory success H1 2025 Meeting with FDA Multiple Near-Term Milestones: Targeting to Increase Shareholder Value 2024 2025 H2 2025 Phase 2b Protocol Sub
Slide 7: DA-1241 Orally Available, Potential First-in-Class GPR119 Agonist for MASH
DA-1241 Orally Available, Potential First-in-Class GPR119 Agonist for the Treatment of MASH
Slide 8: Resmetirom vs DA-1241 comparison
https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-announces-positive-topline-results-pivotal-phase-3 8 Resmetirom DA-1241 Developer Madrigal NeuroBo Indication MASH MASH Status Phase 3 completed NDA Submitted Phase 2 Action THR (Thyroid hormone receptor) β agonist GPR119 agon
Slide 9: DA-1241 Effect on Pathogenesis in MASH as a Monotherapy
9 DAMPs : danger-associated molecular patterns PAMPs: pathogen-associated molecular patterns ECM: extracellular matrix Steatosis Steatohepatitis Fibrosis GPR119 activation: ▪ Macrophage activation ▪ Monocyte recruitment ▪ Macrophage differentiation Stellate cell activation De novo lipogenesis Dietar
Slide 10: GPR119 in Glucose Control when Co-Administered with Other Therapies
10 GPR119 in Glucose Control when Co-Administered with Other Therapies ▪ Effectively decreased hepatic inflammation ▪ Reduced systemic inflammation and fibrosis biomarkers ▪ Reduced hepatic lipid and collagen deposition in the liver of MASH mice Activation of GLP1 Receptor Effects ▪ Pancreas • Incre
Slide 11: DA-1241 improves hepatic and systemic inflammation
11 ▪ DA-1241 was shown to improve BOTH hepatic and systemic inflammation effectively ▪ Co-administered with a DPP4 potentiated the anti-inflammatory effect 38 100 84 68 58 103 0 20 40 60 80 100 120 Change in Plasma Inflammatory Cytokine & Chemokines after 8-week treatment in DIO-MASH mice (2,3) CCL2
Slide 12: DA-1241 combined with DPP4 inhibitor in DIO-MASH mice
12 ▪ Increased plasma active GLP-1 in DIO-MASH mice ▪ Augmented improvement in steatosis, inflammation, and fibrosis compared to monotherapy ▪ Inhibited stellate cell activation (αSMA+ area) further in the liver ▪ Improved Fibrosis-related biomarkers (PINP and TIMP-1) in plasma accordingly C57BL/6 m
Slide 13: DA-1241: Ongoing Phase 2a in MASH
13 DA-1241: Ongoing Phase 2a in MASH Notes: FPFV (First Patient First Visit); LPO (Last Patient Last Visit) Study Design Study Overview: ▪ A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with pr
Slide 14: DA-1241: Potential Advantages in MASH
14 ▪ GPR119 therapeutic target is to inhibit steatosis, inflammation and fibrosis and the treatment or progression of MASH ▪ DA-1241 is an advanced GPR119 agonist with proven enhanced efficacy in animal models ▪ Its effect is enhanced when combined with a DPP4 inhibitor DA-1241: Potential Advantages
Slide 15: DA-1726 A Novel GLP1R/GCGR Dual Agonist for the Treatment of Obesity
DA-1726 A Novel GLP1R/GCGR Dual Agonist for the Treatment of Obesity
Slide 16: Obesity competitive landscape
16 Survodutide Mazdutide DA-1726 Semaglutide (Wegovy®) Tirzepatide (Mounjaro®) Developer Boehringer Ingelheim Innovent Biologics Lilly NeuroBo Novo Nordisk Lilly Indication Obesity Obesity Obesity Obesity Obesity Status Phase 2 completed Phase 3 (China) Phase 1 (USA) Phase 1 IND in 2H 2023 Marketed
Slide 17: DA-1726: Mechanism of Action
17 ▪ Oxyntomodulin • a gut hormone released from intestinal L-cells after meal ingestion resulting in dual agonism of the GLP-1 receptor and glucagon receptor ▪ Reduces food intake (GLP-1 R) and increases energy expenditure (GCGR) in humans, potentially resulting in superior body weight lowering Not
Slide 18: DA-1726 vs Semaglutide body weight loss in mice
18 BWL in HF-DIO Obese Mice DA-1726 vs Semaglutide (1,3) *Statistically significant compared to control Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/ Glucagon Receptor); HF-DIO (High Fat-Diet Induced Obesity); GLP-1 (Glucagon-Like Peptide 1). 1. Dong-A Study Report 104561. All treatments give
Slide 19: DA-1726: Therapeutic Potential in Obesity - Tirzepatide Comparison
19 DA-1726: Therapeutic Potential in Obesity (1,2) - Tirzepatide Comparison DA-1726 shows similar weight loss while consuming more food compared to Tirzepatide (Mounjaro™) Cumulative Food intake in HF-DIO Obese Mice DA-1726 vs Tirzepatide (1,2) Plasma Biochemistry Analysis DA-1726 vs Tirzepatide (1,
Slide 20: DA-1726: Phase 1 Study to Evaluate PK/PD and Safety
20 DA-1726: Phase 1 Study to Evaluate PK/PD and Safety Notes: MAD (Multiple Ascending Dose); SAD (Single Ascending Dose); PK (Pharmacokinetic); PD (Pharmacodynamic); FPFV (First Patient First Visit); LPLV (Last Patient Last Visit). Phase I Study overview: • 2-part study o Part 1—Single ascending dos
Slide 21: Financials and Capitalization
Financials and Capitalization
Slide 22: Financials and Capitalization Table
22 Financials and Capitalization Table Financial Overview As of September 30, 2023 Cash $25.8 million Debt none Capitalization as of September 30, 2023 Common Stock Equivalents Common Stock 38,429,185 Warrants (WAEP $13.00)(1) 2,458,576 Options (WAEP $59.21) 40,272 Common Stock Shares Available for
Slide 23: Investment Thesis
fA) NeuroBo OBHARMACEUTICALS Investment Thesis
Slide 24: Compelling Investment Opportunity
24 Compelling Investment Opportunity • Aiming to Increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones o DA-1241 ✓ Open IND for Treatment of MASH and Type 2 Diabetes ✓ Actively recruiting into a Phase 2a for DA-1241 in subjects with presumed MASH ✓ Completed SAD and MAD s
Slide 25: Thank You! Investor Contacts
THANK YOU! INVESTOR CONTACTS: RX COMMUNICATIONS GROUP NEUROBO PHARMACEUTICALS MICHAEL MILLER MARSHALL WOODWORTH +1 917-633-6086 +1 919-749-8748 MMILLER@RXIR.COM MARSHALL.WOODWORTH@NEUROBOPHARMA.COM
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