Metavia Inc. · NASDAQ:MTVA

Metavia — NeuroBo Pharmaceuticals — Investor Presentation (January 2021)

28 slides from Metavia's investor presentation, Jan 8, 2021

  1. Slide 1: Company Presentation

    Company Presentation January 8, 2021 Confidential ​ ​

  2. Slide 2: Disclaimers

    DISCLAIMERS This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation

  3. Slide 3: Company Overview and Merger with ANA Therapeutics

    Company Overview and Merger with ANA Therapeutics NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases. Repurposing ANA-001 as a rapid COVID-19 tr

  4. Slide 4: Proven Leadership Team

    Proven Leadership Team Richard J. Kang, PhD President & CEO Akash Bakshi, MsC. Chief Operating Officer Nikki Shannon, RegN, BA VP, Clinical Operations Founder of JK BioPharma Solutions and senior management at companies including NeoImmuneTech in immuno-oncology Visiting Fellow at NIH and senior res

  5. Slide 5: NeuroBo Development Pipeline

    NeuroBo Development Pipeline Disease Indication Stage of Development Discovery Preclinical Phase I Phase 2 Phase 3 ANA-001 COVID-19 Moderate to Severe Patients NB-01 Neuropathic Pain NB-02 Alzheimer’s Disease Gemcabene COVID-19 (Acute) Postponed Enrolling Assessing Program IND Ready ​ ​

  6. Slide 6: ANA-001 Targeting Covid-19

    ANA-001 Targeting Covid-19 First indication: Moderate/Severe Covid-19 ​ ​

  7. Slide 7: ANA founded, IND submitted, first patient, merger

    ANA founded IND Submitted First Patient Merger ​ ​

  8. Slide 8: Background: What is Niclosamide?

    Background • On World Health Organization’s (WHO) list of essential medicines • Safely treated millions of patients • Currently used to treat tapeworm Niclosamide • Well-established drug: oral administration known to be safe for 50+ years • Very few, non-severe side effects • Appealing characteristi

  9. Slide 9: ANA-001

    ANA-001 ANA Therapeutics has developed a proprietary capsule formulation of niclosamide for COVID-19 treatment and prophylaxis ANA-001 is being studied in a Phase 2/3 trial in the US that is currently enrolling patients Generic niclosamide has been used safely for 50 years globally as a treatment fo

  10. Slide 10: Evidence: In-Vitro Efficacy Related to COVID-19

    Niclosamide Remdesivir Anti-Inflammatory: STAT3 inhibition Bronchodilation Anti-Viral Shi et al., 2020, unpublished Miner et al., 2019, Front Pharmacol. doi:10.3389/fphar.2019.00051 Ren et al., 2010, ACS Med Chem Lett. doi: 10.1021/ml100146z Concentration [log µM] IC50 = 11.41 Concentration [log µM]

  11. Slide 11: Niclosamide as COVID-19 Prophylaxis

    Gassen et al., 2020, Preprint from bioRxiv, doi: 10.1101/2020.04.15.997254 Niclosamide as COVID-19 Prophylaxis VeroFM cells were pre-treated with spermidine (spd, 100 μM), niclosamide (nic, 5 μM) or control (veh) 24 h prior to infection with SARS-CoV-2 Spermidine is a natural enhancer of autophagy t

  12. Slide 12: Broad Coverage Across Viral Homology is Important

    Source: https://pubs.acs.org/doi/10.1021/acsinfecdis.0c00052 Broad Coverage Across Viral Homology is Important Mutations/Another Corona Virus / Influenza ​ ​

  13. Slide 13: Potential Markets

    COVID-19 Infected Individuals (20M in US) National Stockpile (25% of US population) Potential Markets COVID-19 Hospitalized Patients (1M in US) Prophylaxis Over 65 (55M in US) Front Line Healthcare (16M in US) COVID-19 Associated Hospitalization Surveillance Network (COVID-NET) Mar-Dec 2020 Johns Ho

  14. Slide 14: Competitive Activity in Clinical Development for niclosamide

    Competitive Activity in Clinical Development for niclosamide 10 total studies listed in ClinicalTrial.gov for niclosamide Currently Active Programs We believe ANA is estimated to be the lead program to NDA for niclosamide capsule formulation in the U.S. ​ ​

  15. Slide 15: Landscape of Vaccines and Therapeutics

    Landscape of Vaccines and Therapeutics Prevention (Vaccines) Therapeutics (Treatment) Pfizer – RNA / 2 shots Hydroxychloroquine AstraZeneca – Viral Vector / 2 shots Convalescent Plasma Moderna – RNA / 2 shots Antibody- Regeneron / Lilly Novavax – Protein Subunit / 2 shots Remdesivir – Gilead $875M i

  16. Slide 16: Vaccines are an Important Tool in Battling COVID-19 However There are Challenges

    Vaccines are an Important Tool in Battling COVID-19 However There are Challenges to Overcome RNA Vaccine - Ultra Cold storage (-100° F) and “cold chain” distribution scale-up Manufacturing: scale-up capacity Essential supply of vials, syringes, etc. 2 administrations necessary 28 days apart Willingn

  17. Slide 17: Pharma is still hungry for Antivirals

    Pharma is still hungry for Antivirals ​ ​

  18. Slide 18: ANA-001 and COVID-19 Clinical Program

    18 ANA-001 and COVID-19 Clinical Program ​ ​

  19. Slide 19: Clinical Trial Design: Phase 2

    Continue to PH3 Regiment 1 (n=30) Placebo (n=30) Criteria: ✓ ✓ ✓ ✓ random Screen incoming PTs (n=60) Primary objective: Primary Endpoint: Follow-up assessment Outcomes: Clinical Trial Design: Phase 2 19 ​ ​

  20. Slide 20: Update on ANA001-002 Phase 1 study

    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 COMPLETED ​ ​

  21. Slide 21: ANA-001 and COVID-19 Regulatory Approval

    21 ANA-001 and COVID-19 Regulatory Approval ​ ​

  22. Slide 22: Emergency Use Authorization

    Emergency Use Authorization The primary mechanism of FDA approval of therapeutics during the COVID-19 pandemic has been Emergency Use Authorization (EUA) EUA requires a lower level of evidence than the "effectiveness" standard that FDA uses for standard product approvals. None of the existing therap

  23. Slide 23: EUA Definition & Criteria

    EUA Definition & Criteria What is EUA? During a public health emergency, the FDA may authorize the introduction of a drug into interstate commerce, including one which is not yet (or currently) approved under 505 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Per Section 564 of the FD&C Act, EU

  24. Slide 24: ANA-001 and COVID-19 IP and Exclusivity

    24 ANA-001 and COVID-19 IP and Exclusivity ​ ​

  25. Slide 25: Hatch-Waxman Exclusivity and Intellectual Property

    Hatch-Waxman Exclusivity and Intellectual Property NRBO is pursuing an abbreviated regulatory 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 of market exclusiv

  26. Slide 26: ANA-001 and COVID-19 Clinical

    26 ANA-001 and COVID-19 Clinical ​ ​

  27. Slide 27: COVID-19: Timeline Slide for ANA-001

    COVID-19: Timeline Slide for ANA-001 Commercial Development PH 2 Data (Early Sept) 1st EUA Request (Sept) EoP2 Meeting (Sept-Oct) 2nd EUA Request (Jun-July) Launch PH 3 Trial (Sept-Oct) PH 3 Data Read (Jun-July) Submit NDA (July-Aug) Fast Trak Approval Fast Track Approval (Dec) Q1 2021 Q2 2021 Q3 20

  28. Slide 28: Thank You

    28 Thank You ​

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