Metavia Inc. · NASDAQ:MTVA
Metavia — NeuroBo Pharmaceuticals — Investor Presentation (September 2023)
34 slides from Metavia's investor presentation, Sep 22, 2023
Slide 1: NeuroBo Pharmaceuticals, Inc. September 2023
NeuroBo Pharmaceuticals, Inc. NASDAQ: NRBO September 2023
Slide 2: Forward Looking Statements
0.66” 0.66” 2 Forward Looking Statements 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 identifi
Slide 3: Company is Reborn: Transformed Company, Compelling Investment Opportunity
0.66” 0.66” 3 Company is Reborn November 2022 • Licensed DA-1241 (GPR119) and DA-1726 (GLP1R/GCGR) • New focus: NASH and obesity • IND for DA-1241 Phase 2 filed and cleared by FDA Executing on Milestones • Initiation of DA-1241 Phase 2a clinical study • IND for DA-1726 Value Drivers in 2023 • Invest
Slide 4: Committed Partner Provides Financial and R&D Support
0.66” 0.66” 4 Committed Partner Provides Financial and R&D Support Dong-A Socio Group Revenue: $1.8B in 2022 Revenue $470M in 2022 Our strategic partner and largest shareholder, Dong-A ST Co. Ltd., is part of Dong-A Socio Group of companies established in 1932 and based in South Korea. The company h
Slide 5: Focused on Chronic Liver and Related Metabolic Diseases
0.66” 0.66” 5 Focused on Chronic Liver and Related Metabolic Diseases Product Preclinical Phase 1 Phase 2 Upcoming Catalysts DA-1241 (GPR119 Agonist) • 2H 2023: initiation of Part 2 of Phase 2a in NASH • 2H 2024: Phase 2a NASH data readout DA-1726 (GLP1R/GCGR Dual Agonist) • 2H 2023: Phase 1 IND sub
Slide 6: Multiple Near-Term Milestones: Driving Shareholder Value
0.66” 0.66” 6 Multiple Near-Term Milestones: Driving Shareholder Value 2023 2024 1Q 2023 √ Phase 2a IND submitted and cleared 2H 2023 Phase 1 IND submission 2H 2024 Phase 1b data readout 2H 2024 Phase 2a NASH data readout DA-1726 DA-1241 1H 2024 Phase 2a Last patient last visit 3Q 2023 √ Phase 2a Fi
Slide 7: DA-1241 Orally Available, Potential First-in-Class GPR119 Agonist for NASH
DA-1241 Orally Available, Potential First-in-Class GPR119 Agonist for the Treatment of NASH
Slide 8: DA-1241: A Unique Mechanism of Action
0.66” 0.66” 8 DA-1241: A Unique Mechanism of Action DA-1241 is a novel chemical entity activating G protein-coupled receptor 119 (GPR119) with clinically confirmed glucose-lowering activity & inflammation reduction ➢ GPR119 activation in hepatocytes, macrophages, and hepatic stellate cells inhibits
Slide 9: DA-1241: Direct Effect on Innate Immune Cells Versus Current NASH Landscape
0.66” 0.66” 9 DA-1241: Direct Effect on Innate Immune Cells Versus Current NASH Landscape The Highlights of DA-1241’s Anti-NASH Effects GPR119 GPR119 GPR119 DA-1421 Efruxifermin Lanifibranor Resmetirom Notes: TG (triglycerides); LDL-C (low density lipoprotein cholesterol); HDL-C (high density lipopr
Slide 10: DA-1241: Differentiated Anti-Inflammatory Effect in NASH Mice
0.66” 0.66” 10 DA-1241: Differentiated Anti-Inflammatory Effect (1-3) in NASH Mice DA-1241 was shown to effectively improve BOTH hepatic and systemic inflammation Combination with Sitagliptin potentiated the anti-inflammatory effect of DA-1241 monotherapy 38 100 84 68 58 103 0 20 40 60 80 100 120 Ch
Slide 11: DA-1241: Pre-Clinical Highlights
0.66” 0.66” 11 DA-1241: Pre-Clinical Highlights DA-1241 Encouraging Pre-Clinical Findings ➢ DA-1241 has a higher intrinsic activity compared to preexisting GPR119 agonists and triggers unique balanced signaling paths. Therefore, DA-1241 shows an improved in vivo efficacy with sustained anti-diabetic
Slide 12: Clinical Outcomes Study
0.66” 0.66” 12 Clinical Outcomes Study ▪ Phase 1a, First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose and Interactions with Metformin Study (n=60) ▪ Phase Ib, Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose Study (n=108) ➢ Study treated 24 healt
Slide 13: DA-1241: Ongoing Phase 2a in NASH
0.66” 0.66” 13 DA-1241: Ongoing Phase 2a in NASH 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 subj
Slide 14: DA-1241: Potential for Best-In-Class Efficacy
0.66” 0.66” 14 DA-1241: Potential for Best-In-Class Efficacy ▪ Novel, first-in-class GPR119 agonist for NASH ▪ Small molecule oral, once-daily administration ▪ Multimodal mechanism ▪ Proven preclinical anti-NASH effects ▪ Positive effects in animals on hepatic steatosis, fibrogenesis/fibrosis, hepat
Slide 15: DA-1241: Competitive Analysis
0.66” 0.66” 15 DA-1241: Competitive Analysis Notes: 1. https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-announces-positive-topline-results-pivotal-phase-3 Resmetirom DA-1241 Developer Madrigal NeuroBo Indication NASH NASH Status Phase 3 completion NDA Submitted Phase 2a IND
Slide 16: 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 17: DA-1726: Mechanism of Action
0.66” 0.66” 17 DA-1726: Mechanism of Action DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the treatment of Obesity ➢ Oxyntomodulin is a gut hormone released from intestinal L-cells after meal ingestion and represents dual agonism of the GLP-1 receptor and glu
Slide 18: DA-1726: Mechanism of Action of Body Weight Loss
0.66” 0.66” 18 5 7 9 11 13 15 17 19 21 6 12 18 24 30 36 42 48 54 60 66 72 Energy Expenditure (kcal/kg/hr) Time (hours) HF Control Pair-Fed DA-1726*# DA-1726: Mechanism of Action of Body Weight Loss (1,2) ▪ DA-1726 was superior to the pair-fed group in the body weight loss, indicating that reduced fo
Slide 19: DA-1726: Therapeutic Potential in Obesity – Semaglutide Comparison
0.66” 0.66” 19 DA-1726 :Therapeutic Potential in Obesity (1-3) – Semaglutide Comparison DA-1726 out-performed Semaglutide (WEGOVY™), a GLP-1 agonist, in mouse models of obesity BWL in HF-DIO Obese Mice DA-1726 vs Semaglutide (1,3) Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/ Glucagon Recepto
Slide 20: DA-1726: Therapeutic Potential in Obesity – Tirzepatide Comparison
0.66” 0.66” 20 DA-1726: Therapeutic Potential in Obesity (1,2) – Tirzepatide Comparison DA-1726 shows similar efficacy while consuming more food compared to Tirzepatide (Mounjaro™) in mouse models of obesity and more effective in improving plasma metabolic parameters Cumulative Food intake in HF-DIO
Slide 21: DA-1726: Pre-Clinical Highlights
0.66” 0.66” 21 GLP1R/GCGR dual agonist for the treatment of Obesity A novel oxyntomodulin analogue, once-weekly subcutaneous administration DA-1726: Pre-Clinical Highlights • DA-1726 induces balanced activation between GLP-1 and glucagon receptors • DA-1726 showed reduced food intake via activating
Slide 22: DA-1726 Planned Phase 1a to Evaluate PK/PD and Safety in Obesity
0.66” 0.66” 22 DA-1726 Planned Phase 1a to Evaluate PK/PD and Safety in Obesity 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: ▪ 12-week SAD/MAD,
Slide 23: DA-1726: Competitive Differentiation
0.66” 0.66” 23 DA-1726: Competitive Differentiation Survodutide Mazdutide DA-1726 Semaglutide (Wegovy®) Tirzepatide (Maunjaro®) Developer Boehringer Ingelheim Innovent Biologics Lilly NeuroBo Novo Nordisk Lilly Indication Obesity Obesity Obesity Obesity Obesity Status Phase 2 completed Phase 3 (Chin
Slide 24: Corporate Overview
fA) NeuroBo OBHARMACEUTICALS Corporate Overview
Slide 25: Broad Intellectual Property Portfolio
0.66” 0.66” 25 Broad Intellectual Property Portfolio DA-1241 DA-1726 U.S. ▪ One patent: both composition of matter and process of making the composition - Expected to expire in 2035* ▪ One U.S. non-provisional patent application: both composition of matter and use of the composition ▪ One U.S. paten
Slide 26: Strong Leadership Team
0.66” 0.66” 26 Strong Leadership Team Management Team Hyung Heon Kim, Chief Executive Officer ▪ 35+ years on the pharmaceutical and biotech development ▪ Sr. director of clinical operations in Adiso therapeutics ▪ Director of clinical operations in Shire/Takeda pharmaceuticals ▪ Director of experime
Slide 27: Experienced Board of Directors
0.66” 0.66” 27 Experienced Board of Directors ▪ 20+ years in executive management, at various levels ▪ Executive Vice President and General Counsel at Medifast Inc. ▪ U.S. Army Veteran; direct-commissioned Judge Advocate in U.S. Army’s (JAG) Corps. ▪ BS Bethune-Cookman University, J.D. North Carolin
Slide 28: Supported By Scientific Advisory Board
0.66” 0.66” 28 Supported By Scientific Advisory Board Scientific Advisory Board ▪ Prof. of Neurology, Harvard Medical School ▪ Director, Center for Autonomic and Peripheral Nerve Disorders ▪ Boston, MA Roy Freeman, MBChB ▪ Associate Prof. of Medicine, Colorado University School of Medicine ▪ Divisio
Slide 29: Financials and Capitalization Table
0.66” 0.66” 29 Financials and Capitalization Table 1. No ratchets, price resets or anti-dilution provisions. Presumes $0 exercise price for each warrant exchangeable for one share of common stock. Financial Overview As of June 30, 2023 Cash $28.9 million Debt none Capitalization as of June 30, 2023
Slide 30: Compelling Investment Summary
0.66” 0.66” 30 Compelling Investment Summary Targeting NASH and Obesity With a Pipeline of Next Generation Therapeutics • Driving Shareholder Value though Multiple, Near-Term, Value Creating Milestones ✓ IND Submission for Phase 2a Trial of DA-1241 for the Treatment of NASH ✓ Initiation of Phase 2a
Slide 31: Thank You! Investor Contact
THANK YOU! INVESTOR CONTACT: RX COMMUNICATIONS GROUP MICHAEL MILLER +1-917-633-6086 MMILLER@RXIR.COM
Slide 32: Appendix
fA) NeuroBo OBHARMACEUTICALS Appendix
Slide 33: Opportunity and Challenge in NASH
0.66” 0.66” 33 Opportunity and Challenge in NASH Select NASH Comparables in Phase 2(3) Company Drug Target Dev. Stage Akero Efruxifermin FGF-21 Phase 2 ongoing Altimmune Pemvidutide GLP-1 Phase 2b mid-2023 CytoDyn Leronlimab CCR5 Phase 2b planned Galectin Belapectin Galectin-3 Phase 2b planned NGM P
Slide 34: Tangible Universe of Successful, Early-Stage Comparables in Obesity
0.66” 0.66” 34 Tangible Universe of Successful, Early-Stage Comparables in Obesity Select Obesity Comparables in Phase 2 Company Drug Target Dev. Stage Altimmune Pemvidutide GLP/GCGR Phase 2 Hanmi Pharmaceuticals Efinopegdutide GLP/GCGR Phase 2 Jiangsu Hansoh Noliglutide GLP1 analog Phase 2 Rhythm S
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