Metavia Inc. · NASDAQ:MTVA
Metavia — NeuroBo Pharmaceuticals — Investor Presentation (March 2021)
27 slides from Metavia's investor presentation, Mar 5, 2021
Slide 1: Company Presentation March 2021
Company Presentation Confidential March 2021
Slide 2: Disclaimers
2 Disclaimers This presentation includes forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amende d, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in th is present
Slide 3: NeuroBo Pharmaceuticals
3 NeuroBo Pharmaceuticals Developing and commercializing multimodal disease - modifying therapies for viral, neuropathic and neurodegenerative diseases
Slide 4: Pipeline Programs Overview
4 ANA001 — COVID - 19 Trial • Compelling in - vitro data showing evidence of efficacy, with 50+ years of safety data • Shows great broad - spectrum antiviral activity • Data suggests effectiveness against other viruses such as influenza • Likely effective against novel SARS - CoV - 2 variants • Show
Slide 5: Development Pipeline
5 Development Pipeline *Due to constraints on initiating and conducting clinical studies during pandemic Enrolling Disease Indication Stage of Development Discovery Preclinical Phase 1 Phase 2 Phase 3 ANA001 COVID - 19 Moderate to Severe Patients Gemcabene COVID - 19 Acute NB - 01 Neuropathic Pain N
Slide 6: Proven Leadership Team
6 Proven Leadership Team • Founder of JK BioPharma Solutions and senior management at companies in immuno - oncology and natural products • Visiting Fellow at NIH and senior research experience in host - disease pathogen interactions • Co - Founder and CEO of ANA Therapeutics • Co - Founder and CEO
Slide 7: Expert Scientific Advisory Boards
7 Expert Scientific Advisory Boards Roy Freeman, M.D. Expert in peripheral nerve disorders and neurodegenerative diseases • Professor of Neurology, Harvard Medical School • Director of the Center for Autonomic and Peripheral Nerve Disorders NEUROPATHIC PAIN SCIENTIFIC CHAIR Warner Greene, M.D., Ph.D
Slide 8: ANA001 Targeting
ANA001 Targeting COVID - 19
Slide 9: What is Niclosamide?
9 What is Niclosamide? Background • On World Health Organization’s (WHO) list of essential medicines • Safely treated millions of patients • Currently used to treat tapeworm Safety Profile • Well - established drug: oral administration known to be safe for 50+ years • Very few, non - severe side eff
Slide 10: ANA001
10 ANA001 A cquired proprietary capsule formulation of niclosamide for COVID - 19 treatment and prophylaxis • ANA001 being studied in U.S. Phase 2/3 trial ( currently enrolling patients) • Generic niclosamide used safely for 50+ years globally as a treatment for tapeworm infections • Niclosamide pre
Slide 11: Broad Coverage Across Viral Homology is Important
11 Broad Coverage Across Viral Homology is Important Niclosamide is effective against diverse virus families in vitro . Mutations / Another Corona Virus / Influenza Source: https:// pubs.acs.org / doi /10.1021/acsinfecdis.0c00052
Slide 12: Evidence: In-Vitro Efficacy Related to Inhibition of SARS-CoV-2
12 Evidence: In - Vitro Efficacy Related to COVID - 19 Inhibition of SARS - CoV - 2 replication (Jeon et al., 2020, Antimicrob . Agents Chemother. doi:10.1128/AAC. 00819 - 20) Studies highlighting properties of niclosamide as COVID - 19 treatment ANTI - INFLAMMATORY: STAT3 INHIBITION BRONCHODILATION
Slide 13: Niclosamide as Prophylaxis
13 Niclosamide as COVID - 19 Prophylaxis • VeroFM cells were pre - treated with spermidine ( spd , 100 μ M), niclosamide ( nic , 5 μ M) or control ( veh ) 24 h prior to infection with SARS - CoV - 2 • Spermidine is a natural enhancer of autophagy to protect the body • 24 h after infection, viral rep
Slide 14: ANA001 and Clinical Program
ANA001 and COVID - 19 Clinical Program
Slide 15: Update on ANA001 Phase 1 Study
15 Update on ANA001 - 002 (Phase 1 study) SAD n=30 (8 subjects on ANA001, 2 on placebo / per cohort) Date Outcomes Cohort 1: 1,000 mg Nov 17, 2020 no AEs Cohort 2: 2,000 mg Nov 20, 2020 no AEs Cohort 3: 3,000 mg Nov 24, 2020 no AEs
Slide 16: Clinical Trial Design: Phase 2/3
16 Clinical Trial Design: Phase 2/3 Continue to PH3 Regiment 1 (n=30) Placebo (n=30) Criteria: ✓ Age >18 ✓ Moderate/Severe COVID - 19 ✓ Confirmed by RT - PCR ✓ Not on a ventilator random Screen incoming PTs (n=60) 4 days 7 days 60 days Primary Objective: Evaluate effect of dosing regimen on clinical
Slide 17: Competitive Activity in Clinical Development for Niclosamide
17 Competitive Activity in Clinical Development for Niclosamide We believe NRBO is the lead program to NDA for niclosamide capsule formulation in the U.S. Company Name NCT Phase Start End Formulation Sites N ANA Therapeutics NCT04603924 2 & 3 Oct - 20 Nov - 22 O 20 sites 436 Imuneks Farma ilac San.
Slide 18: Timeline for ANA001 Commercial Development
18 COVID - 19: Timeline Slide for ANA001 Commercial Development 2 nd potential EUA Request (Jun - July) PH 3 Data Read (Jun - July) Fast Track Approval (Dec) Submit NDA (Aug - Sep) PH 2 Data (Early Sept) 1 st potential EUA Request EoP2 Meeting (Oct) Launch PH 3 Trial (Q4) Q1 – Q2 Q4 Q3 DMC 24 patien
Slide 19: ANA001 and The Changing Landscape
ANA001 and COVID - 19 The Changing Landscape
Slide 20: Potential Markets
20 Potential Markets 1. COVID - 19 Associated Hospitalization Surveillance Network (COVID - NET) Mar - Dec 2020 2. Johns Hopkins Coronavirus Resource Center Mar - Dec 2020 3. Statista: 16.5% of 331M 4. Center for Economic and Policy Research (CEPR) April 2020 COVID - 19 Hospitalized Patients (1M in
Slide 21: Vaccines are Just One Tool
21 • RNA Vaccine — Ultra Cold storage • Manufacturing: scale - up capacity • Most vaccines are 2 doses • Willingness of population to get vaccinated • Mutation of viral sequence may require new vaccines • Long - term efficacy • Efficacy in diverse populations • Safety — Side effects • Vaccinated ind
Slide 22: Recent Deals for COVID Antivirals
22 Recent Deals for COVID Antivirals
Slide 23: Corporate Highlights
Corporate Highlights
Slide 24: Hatch-Waxman Exclusivity and Intellectual Property
24 Hatch - Waxman Exclusivity and Intellectual Property • NRBO is pursuing an abbreviated regulatory pathway using A 505(b)(2) New Drug Application (NDA). • This allows for referencing all the safety data from niclosamide’s original approval. • A 505(b)(2) New Drug Application (NDA) provides 3 years
Slide 25: Financials & Cap Structure
25 Financials & Cap Structure • Shares outstanding : 22.2 M • Cash position: $12.9M as of 9/30/20 • $10M Raise in January 2021 • Debt position: No debt
Slide 26: Upcoming Targeted Milestones
26 Upcoming Targeted Milestones • PK Data (SAD and MAD) (2Q 21) • Complete Phase 2 enrollment of ANA001 in m oderate to severe COVID - 19 patients (Jun/Jul 21) • Topline data from Phase 2 ANA001 in moderate to severe COVID - 19 patients (Sep 21) • Potential consideration for EUA based on Phase 2 top
Slide 27: Thank You
Thank You
NeuroBo Pharmaceuticals — Investor Presentation (March 2021) on 6ix