Reviva Pharmaceuticals Holdings, Inc. · NASDAQ:RVPH
Reviva Pharmaceuticals — SPAC Merger (July 2020)
28 slides from Reviva Pharmaceuticals's SPAC merger presentation, Jul 29, 2020
Slide 1: Business Combination with Tenzing Acquisition Corp.
Reviva Pharmaceuticals, Inc. Business Combination with Tenzing Acquisition Corp. (NASDAQ: TZAC/TZACW) July 2020 Confidential
Slide 2: Disclaimer and Other Important Information
Disclaimer and Other Important Information Disclaimer and Other Important Information This presentation (the “Presentation”) is for informational purposes only and has been prepared to assist interested parties in making their own evaluation with respect to a potential business combination between T
Slide 3: Transaction Overview – 1/2
1. See slide 8 for details and assumptions ; assuming no redemptions by Tenzing shareholders and assuming no other equity issuances by Tenzing . 2. Assumes $ 34 . 4 million in primary funding from cash in trust and no redemptions from Tenzing public shareholders ; excludes approximately 6 . 8 mm out
Slide 4: Transaction Overview – 2/2: Ownership, Management & Governance
Ownership • Current Reviva equity holders r olling 100 % of equity in exchange for approximately 5 . 8 mm shares valued at $ 62 . 4 million 1 • Reviva shareholders will have the ability to earn an additional 1 . 0 mm shares after the closing, if a stock price milestone ( $ 15 . 00 per share for any
Slide 5: Leadership Team
Leadership Team Board of Directors Current/Previous Affiliation Parag Saxena 1 (Chairman) Laxminarayan Bhat, PhD (CEO) Richard Margolin, MD 1 Purav Patel 1. At closing of Merger with Tenzing . Other Senior Management Current/Previous Affiliation Marc Cantillon, MD (Chief Medical Officer) 5
Slide 6: Board of Advisors
Board of Advisors 1 Current/Previous Affiliation Daphne Karydas John M. Kane, MD Senior Vice President, Behavioral Health Services, Northwell Health Chair, Psychiatry, Zucker Hillside Hospital Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Leslie Citrome , MD, M
Slide 7: Financing & Transaction Structure
Financing & Transaction Structure 7
Slide 8: Transaction Overview Pro Forma Equity Ownership
Reviva Rollover Shareholders 52.4% Public Shareholders 28.9% Tenzing Sponsor 18.8% Transaction Overview Pro Forma Equity Ownership 2 3 4 1. Based on $ 34 . 4 million cash in trust and 3 , 194 , 490 public shares outstanding . 2. Excludes Reviva’s outstanding options and warrants to acquire capital s
Slide 9: Current Financing Round & Use of Proceeds
Current Financing Round & Use of Proceeds 1. Projected amounts for debt financing and licensing deals based on estimates and goals of Reviva management . Such figures are based on assumptions and not on contractual terms and, therefore, are inherently uncertain, and no assurance can be given regardi
Slide 10: Comparable Companies in Neuroscience Space
Comparable Companies in Neuroscience Space 1. Reviva : post Merger with Tenzing - assuming no redemptions by Tenzing shareholders and assuming no other equity issuances by Tenzing . 2. See slide 8 for details and assumptions ; assuming no redemptions by Tenzing shareholders and assuming no other equ
Slide 11: R&D Focus and Product Pipeline
R&D Focus and Product Pipeline 11
Slide 12: Product Pipeline: Overview
Product Pipeline: Overview Therapeutic Areas of Focus ▪ Focused on development of next generation Platform Therapies using chemical genomics driven discovery approach and proprietary drug molecules ▪ Therapeutic areas of focus are the CNS, inflammatory and cardiometabolic diseases ▪ Company has 2 ne
Slide 13: Clinical Development of Brilaroxazine (RP5063)
Clinical Development of Brilaroxazine (RP5063) Neuropsychiatric and Pulmonary Diseases Neuropsychiatric Diseases Pulmonary Diseases • Schizophrenia (ready for phase 3) • Pulmonary Arterial Hypertension (ready for phase 2) • Bipolar Disorder (ready for phase 2) • Idiopathic Pulmonary Fibrosis (ready
Slide 14: U.S. Regulatory Status
U.S. Regulatory Status Successful End of Phase 2 (EOP2) meeting with U.S. FDA FDA guidance for p otential “Superior Safety” label claim FDA waived the requirement of CYP2D6 drug interaction clinical study FDA reviewed the phase 3 protocol, CMC, and long - term toxicology package ▪ New chemic
Slide 15: Prevalence
15 Prevalence • Schizophrenia : Worldwide prevalence of schizophrenia is approximately 1 . 1 % with about 20 million people globally and 3 . 5 million in USA . Schizophrenia commonly starts earlier among men and is one of the leading causes of disability worldwide . 1 , 2 • Bipolar Disorder : Global
Slide 16: Why Are New Antipsychotics Needed for Schizophrenia?
1. Suboptimal efficacy for residual symptoms 1 2 • Negative symptoms • Cognitive deficits • Mood symptoms 2. Poor tolerability / High Side effects 2 • Neurological (EPS, akathisia) • Metabolic (obesity, diabetes, cholesterol) • Endocrine (sexual dysfunction) 3 . High Discontinuation / Non - complian
Slide 17: Phase 1B Clinical Study in Stable Schizophrenia
x Efficacy further supported by the phase 2 study in acute schizophrenia patients 2 x Cognition improvement supported by pharmacology profile, and translational studies data in rodents 3 1. Cantillon M. et al. Clinical & Translational Science 2018, 11: 387 - 396. 2. Cantillon, M. et al. Schizophreni
Slide 18: Phase 2 Clinical Efficacy for Acute Schizophrenia
Efficacy for Schizophrenia (PANSS reduction: – 20 points) Decrease in Positive Symptoms (PANSS) Effect Size: 0.44* Improvement in Social Functioning (PANSS) Effect Size: 0.54** Decrease in Negative Symptoms (PANSS) Effect Size: 0.53* PANSS Total, Reduction from Baseline Effect Size: 0.5* MMRM - ITT
Slide 19: Brilaroxazine Has an Extremely Clean Side Effect Profile
Extrapyramidal Side Effect (%) Ari: Aripiprazole; RP: Brilaroxazine (RP5063) Change in Prolactin (mIU/L) Body Weight Increase (%) Diabetes/Blood Sugar (mmol/L) Lipids/Triglycerides (mmol/L) Akathisia (%) CNS / Neuroleptic Side Effects Endocrine Side Effects Metabolic Side Effects Change in Thyroid -
Slide 20: Therapeutic Benefits
Therapeutic Benefits • First - line therapy for schizophrenia • Robust Efficacy for acute schizophrenia, and comorbid positive symptoms : negative symptoms, and social inhibition . Promising efficacy for depression and cognitive deficits . • Superior Safety & Tolerability - During the phase 2 clinic
Slide 21: Brilaroxazine vs Standard of Care Antipsychotics
Assuming timeline and successful completion of phase 3 clinical trials, anticipated U.S. market entry of Brilaroxazine Schizophrenia 2025 BD & MDD 2026 2 Brilaroxazine vs Standard of Care Antipsychotics Antipsychotic Schizophrenia Bipolar Disorder BD - I BD - II MDD Brilaroxazine (RP5063)* 2 x
Slide 22: Overview of Brilaroxazine Respiratory Programs
• A novel MOA, first - in - class, potentially disease modifying therapy for PAH and IPF • A new chemical entity (NCE) with granted U.S. and European patents • Demonstrated efficacy in preclinical translational animal models for PAH and IPF • Clinical phase 2 study stage programs for PAH and IPF : x
Slide 23: PAH and IPF Prevalence and Unmet Need
PAH IPF • Global prevalence of PAH 6 . 6 – 26 . 0 per million with 1 . 1 – 1 . 76 incidence per million adults per year . 1 • PAH is frequently diagnosed in older patients, i . e . 65 years and older . PAH occurs 3 - 5 times more frequently in females as in males, and it tends to affect females betw
Slide 24: Pathophysiology and Pathobiology of PAH and IPF
Pathophysiology of PAH and IPF: • Lung vascular/alveoli remodeling due to inflammation, proliferation of fibrosis, and microthrombi/blood clots, and pulmonary hypertension are morphological hallmarks in patients with PAH and IPF Pathobiology of PAH and IPF: • Elevated plasma serotonin (5 - HT) level
Slide 25: Brilaroxazine Efficacy in Rodent Models of PAH
RP5063 Decreases Pulmonary Pressure RP5063 Mitigates Vascular Remodeling A: PLs in SuHx - only B: PLs in SuHx + RP5063 RP - Brilaroxazine Oral10mg/kg, [MOA: 5 - HT 2A/2B/7 ] B - Bosentan Oral 100mg/kg, [MOA: ERA] S - Sildenafil Oral 50mg/kg, [MOA: PDE - 5] T - Treprostinil I. V.100ng/kg/min, [MOA: P
Slide 26: Brilaroxazine Mitigates Lung Fibrosis and Inflammation in IPF
RP5063 Mitigates lung fibrosis/collagen (Decrease in Hydroxyproline) Increase in hydroxyproline is an indicator of collagen deposition which is an underlying pathophysiology in IPF Brilaroxazine demonstrated robust efficacy for IPF compared to standard of care, nintedanib (Ofev) and pirfenidone
Slide 27: Brilaroxazine Improves Survival Rate in IPF
Bhat et al., European J Pharmacology 2019 (in peer review) Mitigates Respiratory Resistance Improves Oxygen Saturation Improves Survival Rate 62% >95% Brilaroxazine (RP5063) Improves Survival Rate in IPF Bleomycin (BLM) Induced IPF Rodent Model 27
Slide 28: Brilaroxazine's Translational Data for PAH & IPF
Brilaroxazine’s Translational Data for PAH & IPF x Mitigation of pulmonary hypertension x Mitigation of vascular / alveoli fibrosis x Mitigation of thrombus / blood clot x Mitigation of lung inflammation x Mitigation of respiratory resistance x Improvement in oxygen saturation x Improvement in survi