Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — Corporate Update (May 2021)
18 slides from Dogwood Therapeutics's corporate update, May 14, 2021
Slide 1: New Scientific Paradigm Exploring HSV-1 Virus Activation in Fibromyalgia
HSV-1 virus Virios Therapeutics, Inc. (Nasdaq: “VIRI”) New Scientific Paradigm Exploring Herpes Simplex 1 (HSV-1) Virus Activation as Potential Underlying Cause of Fibromyalgia and Other Chronic Conditions Corporate Update Q2 2021 1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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,” “wil
Slide 3: Virios Therapeutics Summary
Virios Therapeutics Summary 3 Virios Team and Board of Directors Have Led Development or Commercialization for Two of Three Approved FM Medicines The Fibromyalgia (FM) Market is Large, but Dissatisfied – Highlighting Significant Commercial Potential for a Differentiated New FM Treatment Unique IMC-1
Slide 4: Proven Leadership Team with Experience in Fibromyalgia Development and Commercialization
Proven Leadership Team with Experience in Fibromyalgia (FM) Development and Commercialization 4 Pharma Brand Development & Commercialization Experience Includes Management of: Greg Duncan Chairman & CEO R. Michael Gendreau MD, PhD CMO Ralph Grosswald VP of Operations Angela Walsh SVP of Finance E X
Slide 5: Fibromyalgia Disease Overview
Fibromyalgia Disease Overview 5 • 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 6: 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 10.0M 3.6M 2.0M Total FM Patients Diagnosed Patients Treated Patients The Fibromyalgia Market is Large and Poised for Growth if Better Therapeutic Options Emerge 6 Worldwide FM Prevalence Ranges From 3%-6% of the P
Slide 7: Polypharmacy and Utilization of Unapproved Therapies Demonstrate Significant Unmet Need
Polypharmacy and Utilization of Unapproved Therapies Demonstrate Significant Unmet Need 7 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 • 2.0M Rx Treated FM Patients • Avg 2.6 Rx per Patient
Slide 8: A New Treatment for Fibromyalgia Could Have Significant Commercial Potential in the US Market
A New Treatment for Fibromyalgia Could Have Significant Commercial Potential in the US Market Alone 8 Existing Market of 3.6M Dx Full Market Potential: 10.0M Total Projected US FM Community 500K 25% Patient Share of Treated FM Population @ 500K Unique Patients Lyrica @ $16/day in 2019, Est. 60% Comp
Slide 9: Discovery Implicates Dormant HSV-1 Reactivation in Fibromyalgia
Discovery Implicates Dormant HSV-1 Reactivation Triggers Immune Response and Manifestation of Fibromyalgia 9 The World Health Organization Estimates That 3.7 Billion People Under the Age of 50 – or 67% of the Population are infected with Herpes Simplex Virus Type 1 (HSV-1), a Life-long Infection Sou
Slide 10: IMC-1's Synergistic Antiviral Mechanism
IMC-1’s Synergistic Antiviral Mechanism Serves as Basis for Proposed Fibromyalgia Treatment Effect 10 IMC-1 Inhibits HSV-1 Virus, FM Pain Reduced Source: P.A. Bond, Medical Hypotheses, 1993,; R. A Vere Hodge and Y.-G. Cheng, Antiviral Chemistry & Chemotherapy, 1993; Liu Y, et al, Scientific World Jo
Slide 11: IMC-1: Completed Phase 2a Clinical Proof of Concept Trial
Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 IMC-1 N = 69 Placebo N = 74 11 Design Summary: • Randomized, Double-blind, Multi-center, Placebo-controlled • IMC-1 (famciclovir + celecoxib) vs Placebo, Dosed Twice Daily • Diagnosis of Fibromyalgia Using 2010 American College of Rheumatology, Assessments
Slide 12: IMC-1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a
12 30% Response FIQ-R Pain Responder Analysis IMC-1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a Clinical Trial Source: Pridgen et al, Journal of Pain Research, 2017, Virios Therapeutics, Inc.
Slide 13: Key Secondary Outcomes
Key Secondary Outcomes at 16 Weeks 13 Source: Pridgen et al, Journal of Pain Research, 2017, 2017, Virios Therapeutics, Inc. FIQ-R Symptom Domain Improvement Endpoints P Value PROMIS (NIH) Fatigue Assessment p=0.001 Patient’s Global Impression of Change P=0.040 Fibromyalgia Impact Questionnaire p=0.
Slide 14: IMC-1 Had a Lower Discontinuation Rate Versus Placebo
IMC-1 Had a Lower Discontinuation Rate Versus Placebo in Fibromyalgia Phase 2a Study 14 Placebo IMC-1 IMC-1 Difference Discontinuation reasons: Adverse event 12 (16.2%) 4 (5.8%) 2.8X reduction Therapeutic failure 12 (16.2%) 5 (7.2%) 2.3X reduction Other 5 (6.8%) 3 (4.4%) 1.5X reduction (p=0.012) Sou
Slide 15: IMC-1 Phase 2b Design Using Optimized Dosage
IMC-1 Phase 2b Design to be Conducted Using Optimized IMC-1 Dosage 15 Secondary Endpoints: Fatigue, sleep, global health status, and patient functionality FM Patients 2016 ACR criteria Age 18 - 65 Sample Size 460 (~230/arm) Treatments IMC-1 vs Placebo Daily Assessments 16 Weeks Primary Endpoint: Red
Slide 16: IMC-1 Pipeline Potential Extends to Other Functional Somatic Syndromes
IMC-1 Pipeline Potential Extends to Other Functional Somatic Syndromes 16 • IMC-1 Statistically Significant Reduction in Pain P2a • FDA Fast Track Review Designation, Progressing to P2b FIBROMYALGIA • Univ. of AL GI Biopsy Data Confirm Active HSV-1 in IBS • ROME IV IBS Assessment Criteria Places Inc
Slide 17: Capital Table as of May 12th 2021
Capital Table as of May 12th 2021 17 Listing/Symbol Nasdaq/VIRI Common Shares Outstanding 8,330,390 Underwriters Warrants* (Exercisable at $12.50/share) 172,500 Stock Options (Employees, Directors & Officers)** 874,397 Fully Diluted Shares Outstanding 9,377,287 Management Ownership on a Fully Dilute
Slide 18: Virios Therapeutics Summary
Virios Therapeutics Summary 18 Virios Team and Board of Directors Have Led Development or Commercialization for Two of Three Approved FM Medicines The Fibromyalgia (FM) Market is Large, but Dissatisfied – Highlighting Significant Commercial Potential for a Differentiated New FM Treatment Unique IMC-