Metavia Inc. · NASDAQ:MTVA
Metavia — Gemphire Therapeutics — Merger or Acquisition (July 2019)
16 slides from Metavia's merger presentation, Jul 25, 2019
Slide 1: NeuroBo Pharmaceuticals & Gemphire Therapeutics Merger
NeuroBo Pharmaceuticals & Gemphire Therapeutics Merger Building a pipeline of treatment candidates for neurodegenerative diseases that affect millions of patients worldwide Novel Treatment Candidates for Neurodegenerative Conditions July 2019
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements—All statements in this presentation other than statements of historical facts, including statements regarding the proposed transaction and other contemplated transactions, expected future results of operations and financial position of NeuroBo, its business or s
Slide 3: Additional Information and Where You Can Find It
Additional Information and Where You 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/pros
Slide 4: NeuroBo Summary
NeuroBo Summary NB-01, the lead drug candidate, is Phase 3-ready in Diabetic Neuropathic Pain (DNP). Additional pain indications and a second IND-ready drug candidate in neurodegenerative disease, NB-02, are being developed. Robust Drug Pipeline Large Market DNP estimated to affect up to 22% of all
Slide 5: The NeuroBo Management Team
The NeuroBo Management Team Mark Versavel, MD, PhD, MBA Chief Medical Officer John L. Brooks III, MSBA, BBA President & CEO Experienced biotech, device, and healthcare executive Senior medical and clinical drug development experience Nandan Padukone, PhD Senior Vice President, Business Development E
Slide 6: Scientific Advisory Board Members
Roy Freeman, MD Founder and Chair of SAB Scientific Advisory Board Members Robert H. Dworkin, Ph.D. Leading Clinician in Neuropathy Bob Rappaport, MD Regulatory Expert Professor at Harvard Medical School and Physician at Beth Israel Leahy Health Former Division Director of Anesthesia, Analgesia and
Slide 7: Diabetic Neuropathic Pain Background
Diabetic Neuropathic Pain (DNP) arises due to hyperglycemia and other diabetes-related factors. Up to 22% of all patients with diabetes suffer from DNP Most common pain symptoms are reported to be numbness, tingling, burning, sharp, and dull ache, which are often localized to the extremities, impact
Slide 8: Diabetic Neuropathic Pain Market Overview
~10.8M ~5.5M ~$7.1B (~3.4M U.S.) (~1.9M U.S.) (~$4.8B U.S.) Prevalent Population Total Diagnosed and Treated Population Market Sales Diabetic Neuropathic Pain Market Overview 2018 DNP Global Market: ~8.4M ~4M ~$3.6B (~2.4M U.S.) (~1.2M U.S.) (~$2.6B U.S.) Prevalent Population Total Diagnosed and Tre
Slide 9: Development Pipeline In Neuropathic Pain and Neurodegenerative Disease
Disease Indication Current Stage of Development Discovery Preclinical Phase 1 Phase 2 Phase 3 NB-01 Diabetic Neuropathic Pain (DNP) Chemotherapy-induced Neuropathic Pain Post-traumatic Neuropathic Pain Diabetic Neuropathy NB-02 Alzheimer’s Disease Tauopathies Development Pipeline In Neuropathic Pain
Slide 10: 50% Responder Rates: NB-01 Shows Equivalent Efficacy to Approved Drugs
50% Responder Rates: NB-01 Shows Equivalent Efficacy to Approved Drugs Despite Higher Placebo Effect in Phase 2 Study NB-01 Duloxetine Pregabalin 10 Moore et al, 2009; Lunn et al, 2014 0 10 20 30 40 50 60 PGB-Placebo PGB-300mg DLX-Placebo DLX-120mg NB-01 Placebo NB-01-600mg Percentage of 50% Respond
Slide 11: Adverse Events of NB-01 from Phase Studies Observed within 2-3% of Placebo
Adverse Events of NB-01 from Phase 2 Studies Observed within 2-3% of Placebo Safety data compiled from two Phase 2 studies (US and Korea) Average incidence of AEs over Placebo of Approved Treatments for DNP 11 Range: 15-30% 0% 5% 10% 15% 20% 25% 30% 35% Constipation Sinusitis Headache Back pain Plac
Slide 12: NB-01 Improved Pain Scores in US Phase 2 Study of DNP
• • Change from Baseline in NRS Score 0.5 1.5 2.5 3.5 0 1 2 3 4 5 6 7 8 9 10 11 12 Weeks * * * * * * * * * * NRS: 11-point numeric rating scale * <0.05, ∗∗ <0.01 NB-01 300mg NB-01 600mg Placebo 16 US sites, 128 subjects, 3 doses vs. placebo (600mg and 300mg doses shown here) ClinicalTrials.gov NCT01
Slide 13: Three Phase 3 Studies in DNP Powered For Efficacy and Safety
2019 2020 2021 2022 2023 Three Phase 3 Studies in DNP Powered For Efficacy and Safety NB-01 ANCHOR Study: North American Pivotal Study N=717; 2 doses – 300mg and 600mg daily vs. placebo Primary endpoint: Change from baseline to week 12 in the weekly mean of the average daily pain score measured by t
Slide 14: Summary
Summary Planned merger of NeuroBo Pharmaceuticals and Gemphire Therapeutics NeuroBo has a strong team, a late-stage clinical candidate (NB-01), and a recent $24M investment of capital NB-01 targets diabetic neuropathic pain (DNP); NB-01 Phase 3 clinical trial in DNP expected to begin this year Post-
Slide 15: Intellectual Property Portfolio
Intellectual Property Portfolio (with current year of expiration) Granted patents in US, EU, and Asia on combination of plant species for drug composition – 2027 Granted patents in EU, Asia, and allowance in US for composition and use in peripheral neuropathy - 2031 Patents being prosecuted on drug
Slide 16: High Level Terms and Conditions of NeuroBo-Gemphire Merger
High Level Terms and Conditions of NeuroBo-Gemphire Merger Definitive agreement for all-stock merger announced on July 24, 2019 Expected to be completed 2H 2019; shares of common stock of post-merger combined company expected to trade on Nasdaq under new symbol NRBO Requires NeuroBo and Gemphire sto
Gemphire Therapeutics — Merger or Acquisition (July 2019) on 6ix