Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — IPO Roadshow (November 2020)
26 slides from Dogwood Therapeutics's IPO roadshow presentation, Nov 25, 2020
Slide 1: HSV-1 Virus New Scientific Paradigm: Investor Update
HSV - 1 Virus New Scientific Paradigm Exploring HSV - 1 Virus Activation as Potential Underlying Cause of Fibromyalgia and Other Chronic Conditions Investor Update Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated November 25, 2020 File No.: 333 - 248447
Slide 2: Forward Looking Statements and Free Writing Prospectus Disclaimer
Statements in this presentation contain “forward - looking statements” that are subject to substantial risks and uncertainties. Forward - looking statements contained in this presentation may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estim
Slide 3: Offering Summary
Offering Summary 3 Issuer Virios Therapeutics, Inc. Expected Offering Size $30,000,000 Expected Price Range $9.00 - $11.00 Shares Offered 3,000,000 (450,000 over - allotment option) Listing / Symbol Nasdaq / VIRI Use of Proceeds • Execute IMC - 1 fibromyalgia Phase 2b clinical trial • IMC - 1 chroni
Slide 4: Virios Therapeutics Overview
Virios Therapeutics Overview 4 The Fibromyalgia (FM) Market is Large but Dissatisfied Lead Candidate, Oral IMC - 1, Demonstrated Significant Pain Reduction and Tolerability Benefits in P2a FM Clinical Trial Market Analysis Shows Significant Commercial Potential for a New, Differentiated FM Product V
Slide 5: Proven Executive Team with Experience in Fibromyalgia Development and Commercialization
Proven Executive Team with Experience in Fibromyalgia (FM) Development and Commercialization 5 Management Directly Involved In Launch of Lyrica® and Savella ® for FM Greg Duncan Chairman & CEO Rick Burch President* R. Michael Gendreau MD, PhD CMO Ralph Grosswald VP of Operations Angela Walsh VP of F
Slide 6: Experienced Board of Directors
Experienced Board of Directors, Including Expertise Developing & Commercializing Leading Antiviral Therapies 6 Rich Whitely, MD Abel De La Rosa, PhD John Thomas, CPA Rick Keefer Skip Pridgen, MD Founder • Distinguished Professor Loeb Scholar Chair in Pediatrics, and Professor of Microbiology, Medici
Slide 7: Scientific Advisory Board Includes Top Global FM Thought Leaders
Scientific Advisory Board Includes Top Global FM Thought Leaders 7 Daniel J. Clauw, MD Chair: Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry at the University of Michigan Director of the Chronic Pain and Fatigue Research Center Lesley M. Arnold, MD Professor of Psychiatry and Be
Slide 8: Fibromyalgia Disease Overview
Fibromyalgia Disease Overview 8 • FM is a Chronic Disease that Affects up to 8% of the US Population • Hallmark Characteristics are Widespread Chronic Pain and Severe Fatigue – Symptoms Present for ≥ 3 Months • Other Symptoms May Include GI, Sleep, Mood Disorder and Headache Devastating Impact • Pat
Slide 9: The Fibromyalgia Market is Large and Poised for Growth
0 50 100 150 200 250 300 Asia Africa Europe Latin America 3% Prevalence 6% Prevalence 10.0 M 3.6 M 2.0 M Total FM Patients Diagnosed Patients Treated Patients The Fibromyalgia Market is Large and Poised for Growth if Better Therapeutic Options Emerge 9 Worldwide FM Prevalence Ranges From 3% - 6% of
Slide 10: Polypharmacy and Unapproved Therapies Demonstrate Significant Unmet Need
Polypharmacy and Utilization of Unapproved Therapies Demonstrates Significant Unmet Need 10 Approved FM Medications Not Approved for FM 75% 25% 26.8% 24.5% 8.9% 0% 10% 20% 30% 40% Cymbalta (duloxetine) Lyrica (pregablin) Savella Approved Medicines 39.5% Opioid Therapy • 2.0M Rx Treated FM Patients •
Slide 11: A New Treatment Could Have Significant Commercial Potential in the US Market
A New Treatment for Fibromyalgia Could Have Significant Commercial Potential in the US Market Alone 11 3.6 M Dx 10.0 M Prevalence Total Projected US FM Community 500 K Lyrica 25% Patient Share Approximately 500 K Patients 2.0 M Tx @ $16/day with 60% Compliance FM Sales Est. $1.752 B FM Costs US $12
Slide 12: Virios Discovery: Reactivation of Latent HSV-1 Triggers Overactive Immune Response
HSV - 1 virus Virios Discovery – Reactivation of Latent HSV - 1 Virus Triggers Overactive Immune Response, and Manifestation of FM
Slide 13: Dormant HSV-1 Reactivation Triggers Immune Response and Fibromyalgia
Discovery Implicates Dormant HSV - 1 Reactivation Triggers Immune Response and Manifestation of Fibromyalgia 13 More Than 3.7 Billion People Under the Age of 50 – or 67% of the Population are infected with Herpes Simplex Virus Type 1 (HSV - 1), According to WHO
Slide 14: Synergistic Antiviral Mechanism Basis for Proposed Treatment Effect
IMC - 1’s Synergistic Antiviral Mechanism Serves as Basis for Proposed Fibromyalgia Treatment Effect 14 IMC - 1 is a Proprietary Fixed Dose Combination of Famciclovir and Celecoxib that Cannot be Replicated Using Available Generics IMC - 1 Inhibits HSV - 1 Virus, FM Pain Reduced
Slide 15: Antiviral Mechanism Corroborated by GI Biopsy Research
15 Viral GI Tissue Study: Patient population: • 30 Patients who Presented with Both FM and a Chronic GI Disorder • 15 Control Patients, No FM or GI Disorder GI Biopsies were Evaluated for Herpesvirus Infection: • Analysis for ICP8 Viral Protein • ICP8 Only Present During Active HSV - 1 Infection • P
Slide 16: Potential Identified in Statistically Significant Phase 2a Trial Results
HSV - 1 virus IMC - 1’s Potential Identified in Statistically Significant Phase 2a Trial Results
Slide 17: Phase 2a Clinical Proof of Concept Trial Design
Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 IMC - 1 N = 69 Placebo N = 74 17 Design Summary: • Randomized, Double - blind, Multi - center, Placebo - controlled • IMC - 1 (famciclovir + celecoxib) vs Placebo, Dosed BID • Famciclovir Dose Not Optimized • Diagnosis of Fibromyalgia Using 2010 ACR, Asses
Slide 18: Statistically Significant Reduction in Pain in Phase 2a Trial
IMC - 1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a Clinical Trial 18 - 1.9 - 2.2 - 1.1 - 0.92 -2.5 -2 -1.5 -1 -0.5 0 NRS 24-hour Recall FIQ-R 7-day Recall IMC - 1 Placebo p = 0.031 p = 0.001 Decrease in Pain Analysis at 16 Week Endpoint
Slide 19: Consistent Treatment Effects Across Fibromyalgia Endpoints
IMC - 1 Treatment Resulted in Consistent Treatment Effects at 16 Weeks Across Spectrum of Fibromyalgia Endpoints 19 Secondary Endpoints P Value PROMIS (NIH) Fatigue Assessment p=0.001 PGIC - Patient’s Global Impression of Change P=0.040 FIQ - R - Revised Fibromyalgia Impact Questionnaire Total Score
Slide 20: Lower Discontinuation Rate Versus Placebo in Phase 2a Study
IMC - 1 Had a Lower Discontinuation Rate Versus Placebo in Fibromyalgia Phase 2a Study 20 Category Placebo IMC - 1 IMC - 1 Difference Randomized 74 69 Completed 16 weeks on study drug 45 (60.8%) 57 (82.6%) 22% Discontinuation reasons: Adverse event 12 (16.2%) 4 (5.8%) 2.8X reduction Therapeutic fail
Slide 21: Phase 2b Design Using Optimized Dosage
IMC - 1 Phase 2b Design Using Optimized IMC - 1 Dosage 21 Secondary Endpoints: Change in fatigue, sleep disturbance, global health status, and patient functionality FM Patients 2016 ACR criteria Age 18 - 70 Sample Size 460 (~230/arm) Treatments IMC - 1 vs Placebo Daily Assessments 16 Weeks Design: R
Slide 22: Pipeline Potential Extends to Other Functional Somatic Syndromes
IMC - 1 Pipeline Potential Extends to Other Functional Somatic Syndromes 22 HSV - 1 Infects 67% of People < Age 50 • IMC - 1 Statistically Significant P2a FM data • FDA Fast Track Review Designation FIBROMYALGIA • Univ. of AL GI Biopsy Data Confirm Active HSV - 1 in IBS • ROME IV Criteria Places Inc
Slide 23: Issued Patents Provide Protection to 2033
23 Issued Patents (Expire 6 Feb 2033): Virios Has 20 Existing Patents that All Provide Protection to 2033 Issued US IMC - 1 Patents • U.S. “Composition of Matter” Patents (US 8,809,351 & US 10,034,846) Drug - combination of famciclovir + celecoxib • U.S. “Method - of - Use” Patent (US 9,040,546) Fam
Slide 24: Capitalization Table - Pro Forma Pre-Offering
Capitalization Table - Pro Forma Pre - Offering 24 Common Shares 1 5,125,000 Warrants 2 134,663 Options 3 528,125 1 Includes underlying shares for conversion of convertible notes and 292 , 500 of vested non - qualified options assuming a $ 10 . 00 offering price, the mid - point of the expected pric
Slide 25: Virios Therapeutics Summary
Virios Therapeutics Summary 25 Virios Team Has Extensive Experience in Developing and Commercializing FM and Antiviral Therapies FM Market Very Dissatisfied – Significant Commercial Potential for Differentiated New Product in US Market Alone Two Components of IMC - 1 (famciclovir & celecoxib) Have B
Slide 26: Q&A
HSV - 1 virus Q&A