Metavia Inc. · NASDAQ:MTVA
Metavia — NeuroBo Pharmaceuticals — Investor Presentation (January 2020)
26 slides from Metavia's investor presentation, Jan 13, 2020
Slide 1: Novel Treatments for Neurodegenerative and Cardiometabolic Conditions
Novel Treatments for Neurodegenerative and Cardiometabolic Conditions Multi-modal, disease-modifying therapies
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT 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 pre
Slide 3: Company Overview
3 Company Overview Clinical-stage biopharmaceutical company with three drug programs to impact a range of indications in neurodegenerative and cardiometabolic disease Multiple Drug Programs; One Phase 3-Ready Large Therapeutic Markets with High Unmet Need Staged Financing Strategy with Experienced T
Slide 4: Proven Leadership Team and Advisors
Robert H. Dworkin, PhD Leader in Neuropathic Pain Clinical Trials Professor of Anesthesiology, Neurology, Psychiatry, and Experimental Therapeutics at the University of Rochester School of Medicine Director of the Anesthesiology Clinical Research Center Allan Basbaum, PhD, FRS Leader in Pain Researc
Slide 5: NeuroBo Development Pipeline
5 NeuroBo Development Pipeline Disease Indication Stage of Development Discovery Preclinical Phase I Phase 2 Phase 3 NB-01 Painful Diabetic Neuropathy (PDN): Phase 3 initiation H1 2020 NB-02 (IND-ready) Alzheimer’s Disease Gemcabene HoFH SHTG 5 HoFH = Homozygous Familial Hypercholesterolemia SHTG =
Slide 6: NB-01 Targeting neuropathic pain
6 NB-01 Targeting neuropathic pain First indication: PDN
Slide 7: Painful Diabetic Neuropathy Overview
PAINFUL DIABETIC Neuropathy OVERVIEW 7 Diabetes is among the leading causes of neuropathic pain A disorder known as painful diabetic neuropathy (PDN) PDN affects 8.4M people worldwide representing global drug sales of $3.56B (2018, GlobalData) Pain can be severe and debilitating, impairing sleep, li
Slide 8: FDA Warning on Gabapentinoids
8 8 FDA WARNING ON GABapentinOIDS for serious breathing problems We are requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. We have also required the drug manufacturers to conduct clinical trials to further evaluate their
Slide 9: NB-01 Demonstrated Pain Reduction in US Phase 2 Study
9 NB-01 Demonstrated Pain Reduction in US Phase 2 Study 9 CSR DA9801-DN-001 Table 11-10 * * * ** ** **
Slide 10: 50% Response Rates - Comparison of NB-01 to Approved Therapies
10 10 50% response rates - Comparison of NB-01 to approved therapies Freedman, Diabetes Care 22008;31 Pritchett, Pain Med 2007;8:397-409
Slide 11: Treatment-Emergent Adverse Events Comparison
11 11 Source: DA9801-DN-001 (USA) Table 14.3.1.1A Incident on NB-01 N=96 Incident on Placebo N=32 Difference in Incident NB-01 from Placebo Constipation 5.2% 0.0% 5.2% Sinusitis 5.2% 0.0% 5.2% Back pain 6.3% 3.1% 3.1% Myalgia 3.1% 0.0% 3.1% Pain in extremity 3.1% 0.0% 3.1% Arthralgia 5.2% 3.1% 2.1%
Slide 12: Distinct Multi-Target Approach: Pre-clinical Data
12 Distinct Multi-Target Approach: Pre-clinical Data Nerve growth and repair Reducing cell damage 12 NGF restored to normal endogenous levels in STZ model AGE Reduction in STZ model Reduction IL-6 Expression in STZ model Note: DA-9801 is now NB-01 * Data on file NeuroBo * Preclinical rodent models h
Slide 13: PDN Treatment Paradigm
PDN Treatment Paradigm *Source: GlobalData Confirmed painful diabetic neuropathy First Line Second Line Third Line Tricyclic antidepressants Serotonin-norepinephrine reuptake inhibitors Voltage-gated calcium channel α2δ ligands No Effect Partial Effect Try another first-line drug Try combination of
Slide 14: Phase 3 PDN Trial Design
NB-01 200mg orally TID (600mg/day) PHASE 3 PDN TRIAL Double-Blind, Placebo-Controlled; Safety, Efficacy, & Tolerability Primary Endpoint: Change from baseline in weekly mean of daily average pain score Secondary Endpoints: Responders on Patient Global Impression of Change Responders on PI-NRS Change
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Slide 16: Significant opportunity for safe, disease-modifying therapies
Significant opportunity for safe, disease-modifying therapies that restore cognitive function 16 Alzheimer’s disease & other dementias GlobalData PharmaPoint: Painful Diabetic Neuropathy Report, 2018 16 Alzheimer’s disease Alzheimer’s disease (AD) affects 27.3M people globally (2018, Global Data) Ap
Slide 17: NB-02: Our Distinct, Multiple Pathway Approach
17 NB-02: Our Distinct, Multiple pathway Approach Inhibits Acetylcholinesterase (AChE) Restores Disrupted Ca++ Homeostasis Inhibits Tau Phosphorylation 18 Prevents Amyloid-β Plaque Deposition Amyloid plaque burden 8-week treatment DA-9803 is NB-02 Pagnier et al., 2018 Alzheimer Research & Therapy DA
Slide 18: IND-Ready: Extensive Preclinical Studies
18 IND-Ready: Extensive preclinical studies NB-02 impacts multiple pathways implicated in neurodegenerative disease Efficacy demonstrated in extensive cognitive and behavioral studies Y-Maze, Morris Water Maze, and Novel Object Recognition studies show improved cognitive endpoints in transgenic mous
Slide 19: Patent Protection for NB-01 and NB-02
19 19 Patent Protection for NB-01 and NB-02 IP Protection for Indications and Long-Term Runway for Commercialization 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 NB-01 NB-01 NB-02 NB-02 Use in Multiple Neuropathy Drug Composition and use in
Slide 20: Intellectual Property Portfolio & Future Expansion Plans
Intellectual Property Portfolio & Future Expansion Plans Granted patents in US, EU, and Asia on use of plant species in treating multiple neuropathy – Expires 2026 Granted patents in US, EU and Asia, for composition and use in peripheral neuropathy – Expires 2031 20 Patents in prosecution for US, EU
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Slide 22: Gemcabene: Near-term catalyst may provide financial upside
22 Gemcabene: Near-term catalyst may provide financial upside 22 Gemcabene: a Phase 2b asset acquired in the reverse merger Provides potential financial upside (subject to contingent rights[CVR] payments to pre-merger Gemphire stockholders) PPAR (peroxisome proliferation activated receptor) agonist
Slide 23: Gemcabene: Phase 2b Asset with Signed Partnership
23 Gemcabene: PHASE 2B Asset with signed partnership 23 25 completed Phase 1 and Phase 2 studies and > 1,110 subjects treated with gemcabene with multiple cardiometabolic indications studied, including Severe Hypertriglyceridemia ASCVD, Hypercholesterolemia, and Familial Partial Lipodystrophy, with
Slide 24: Pipeline and Potential Milestones with Additional Assets
24 Pipeline and Potential Milestones with Additional Assets 24 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NB-01 First patient enrolled FDA Meeting MOA Assay New IP Complete enrollment NB-02 Publications Gemcabene HOFH First patient BD Deal: Sale/ Licensing IND Submission Phase 1 Launch Readout PCH Lifted Rea
Slide 25: NASDAQ Global Market: NRBO Capitalization
25 25 NASDAQ GLOBAL MARKET Symbol NRBO Market Cap1 $140M Price Per Share1 $9.00 Shares Outstanding2 15.6M Combined Cash at 6/30/19 $28.2M NEUROBO CAPITALIZATION TABLE 01/08/2020 Fully diluted shares outstanding = 16.6M as of 12/30/19
Slide 26: NeuroBo Pharmaceuticals
Y NeuroBo PHARMACEUTICALS
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