Metavia Inc. · NASDAQ:MTVA
Metavia — Gemphire Therapeutics — Merger or Acquisition (September 2019)
23 slides from Metavia's merger presentation, Sep 24, 2019
Slide 1: Disclaimer
DISCLAIMER Forward-Looking Statements—All statements in this presentation other than statements of historical facts, including statements regarding the proposed transaction with Gemphire Therapeutics, Inc. (“Gemphire”) and other contemplated transactions, expected future results of operations and fi
Slide 2: Additional Information & Where You Can Find It
ADDITIONAL INFORMATION & WHEREYOU CAN FIND IT Important Additional Information Will be Filed with the SEC. In connection with the proposed transaction, Gemphire intends to file relevant materials with the SEC, including a registration statement on Form S-4 that will contain a proxy statement/prospec
Slide 3: Company Summary
COMPANY SUMMARY C l i ni cal - s t ag e bi op h a r m a c e u t i ca l com pa n y w i t h t w o dr ug pr ogr a m s t o i m p ac t a r a n g e o f i n di c at i ons i n n eur odegener at i vedi s ease • • • NB-01: Phase 3-ready; targeting neuropathic pain (NP) NB-02: IND-ready; targeting Alzheimer’s
Slide 4: NeuroBo Development Pipeline
NEUROBO DEVELOPMENT PIPELINE 5 CONFIDENTIAL INFORMATION Disease Indication Stage of Development Discovery Preclinical Phase I Phase 2 Phase 3 NB-01 (Ph III-ready) Painful Diabetic Neuropathy (PDN) Chemotherapy-induced Neuropathic Pain Other peripheral neuropathy NB-02 (IND-ready) Alzheimer’s Disease
Slide 5: NB-01 Targeting neuropathic pain
NB-01 T ar get i n g neur o p a t h i c pai n F i r s t i n d ic a tio n :P DN 6
Slide 6: Painful Diabetic Neuropathy Overview
PAINFULDIABETIC NEUROPATHY OVERVIEW • PDN affects 8.4M people worldwide representing global drug sales of $3.05B (2018, GlobalData) • Diabetes and cancer are amongst the leading causes of neuropathic pain • Symptoms range from dull and tingling to debilitating pain; limiting mobility, negatively imp
Slide 7: Painful Diabetic Neuropathy (PDN) 2018 Market Overview
PAINFUL DIABETIC NEUROPATHY (PDN) 2018 MARKET OVERVIEW FIRST INDICATION OF NB-01 Prevalence 8.4M 2.4M Drug Sales Global U.S. $3.1B $2.2B •Prevalence ofdiabetes •Majority of patientsare continues to increase globally 55-70yearsofage; PDN affects men and women equally •1/3of PDN patientsare refractory
Slide 8: PDN Patient Journey
PDN PATIENT JOURNEY Confirmed painful diabetic neuropathy First Line • Pregabalin • Gabapentin • • Duloxetine Venlafaxine • Amitriptyline No Effect Partial Effect Second Line Or asses and combination therapy fail Third Line 9 Source: GlobalData, adapted from Callahan et al., 2012 ©GlobalData Opioids
Slide 9: NB-01 Treatment Paradigm
NB-01 TREATMENT PARADIGM Confirmed painful diabetic neuropathy NB-01 has thepotentialtoimprove first-linetherapysafety andeffectiveness 10 Source: GlobalData, adapted from Callahan et al., 2012 ©GlobalData NB-01
Slide 10: Our Distinct, Multi-Target Approach
OUR DISTINCT, MULTI-TARGET APPROACH com pl ex pat hop h y si o l o g y • • N e u r opat hi c p ai n i s a m u l t i - t a r g e t di se a se w i t h a NB - 01 has di se a se - m o d i fy in g p o te n tia l with e ffe c ts o n m u l ti p le p a th wa y s and IL-6 End-Products • • Demonstrated effect
Slide 11: NB-01 Achieves Multi-Target Effects from Multiple Compounds
12 NB-01 ACHIEVES MULTI-TARGET EFFECTS FROM COMBINED ACTION OF MULTIPLE COMPOUNDS IN ORAL FORMULATION Saponins (Glycosteroids) Anti-inflammatory effects Anti-neuroinflammatory Anti-oxidant effects effects Curcumins Reduction of Advanced Glycation End-Products Rosmarinic Acids • • • • 60 compounds is
Slide 12: NB-01 Adheres to FDA Guidelines for Natural Product-Based Drug Mixtures
NB-01 ADHERES TO REQUIRED FDA DRUG GUIDELINES FOR NATURAL PRODUCT-BASED DRUGMIXTURES Clinicaltrialsofbotanical drugs areno more difficult thannon-botanical Sau (Larry) Lee, FDA, 2015 drugs Raw Material • Good Agricultural (GACP) in place Drug Substance (API) & Drug Product and Collection Practices •
Slide 13: NB-01 Demonstrated Pain Reduction in US Phase 2 Study
NB-01 DEMONSTRATED PAIN REDUCTION IN US PHASE 2 STUDY 16 US sites, 128 subjects, 3 doses vs. placebo (600mg and 300mg doses shown here) 3.5 * * * * * 2.5 Reduction from Baseline in NRS Score NRS: 11-point numeric scale* <0.05, <0.01 rating P values are baseline 1.5 0.5 0 1 2 3 4 5 6 7 8 9 10 11 12 W
Slide 14: NB-01 Well-Tolerated in Two Phase 2 Studies
NB-01 SHOWNTOBEWELL-TOLERATED INTWOPHASE2STUDIES: SAFETY & TOLERABILITY IS A SIGNIFICANT DIFFERENTIATOR Placebo NB-01 30% 25% Average incidence adverse events of 20% 15% ranges 15-30% over placebo of approved 10% treatments for PDN 5% 0% Constipation Sinusitis Headache Back pain Adverse events inclu
Slide 15: Planned Phase 2 Study: Efficacy & Disease Modification
PLANNED PHASE 2 STUDY: DEMONSTRATION OF EFFICACY & DISEASE MODIFICATION NB-01-203 (US) • Designed to demonstrate pain alleviation, effects on pathway potential disease modification biomarkers, and • 200 patient study with PDN • Single high dose of 600mg daily compared with placebo • Measurement of N
Slide 16: Phase 3-Ready Studies in PDN Planned
PHASE 3-READY STUDIES IN PDN PLANNED: POWERED FOR EFFICACY AND SAFETY NB-01-301 (US-NA) ANCHOR – PIVOTAL STUDY CSR TAL STUDY UDY • Two End of Phase 2 (EOP2) meetings completed with FDA • Endpoint: Change from baseline in weekly mean of daily pain scores 17 Year 1Year 2Year 3Year 4Year 5 Interim anal
Slide 17: NB-02 Targeting Alzheimer's Disease & Tauopathies
NB-02 T a r g e t i ng A l z hei m er ’ s d i s e ase & T a u o pat hi es 18
Slide 18: Alzheimer's & Tau-Related Diseases (Tauopathies)
ALZHEIMER’S &TAU-RELATED DISEASES (TAUOPATHIES) • Alzheimer’s disease affects 10.6M people globally (2016, Global Data) • Approved treatments focus on symptomatic management and largely on acetyl cholinesterase (AChE) inhibition • 650+ drug trials underway targeting Tau inhibition, amyloid plaque in
Slide 19: Extensive IND-Ready Preclinical Studies
EXTENSIVE IND-READY PRECLINICAL STUDIES: NB-02 is a multi-component drug compound mixture designed to impact multiple pathways involved in neurodegenerative disease Extensive cognitive and behavioral pre-clinical studies Y-Maze, Morris Water Maze, and Novel Object Recognition studies show improved c
Slide 20: Intellectual Property Portfolio
INTELLECTUAL PROPERTY PORTFOLIO • Granted patents in US, EU, and Asia on combination of plant species for drug composition – Expires 2027 • Granted patents in EU, Asia, and allowance in US for composition and use in peripheral neuropathy – Expires 2031 • Patents being prosecuted on other quality ass
Slide 21: Proven Leadership Team
PROVEN LEADERSHIP TEAM John L. Brooks III, BBA, MSBA President & CEO Nandan Padukone, PhD, MBA SVP, Business Development Mark Versavel, MD, PhD, MBA Chief Medical Officer • • Experienced biotech, device, and healthcare executive Former President & CEO of Joslin Diabetes Center • • Experienced execut
Slide 22: Proven Leadership Team
PROVEN LEADERSHIP TEAM John L. Brooks Ill, BBA, MSBA President & CEO Experienced biotech, device, and healthcare executive Former President & CEO of Joslin Diabetes Centor Nicola Shannon, RegN, BA VP, Clinical Operations Experienced senior executive in clinical operations Former Vice President of Cl
Slide 23: NeuroBo Pharmaceuticals
PHARMACEUTICALS
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