Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — Investor Presentation (March 2021)
19 slides from Dogwood Therapeutics's investor presentation, Mar 23, 2021
Slide 1: New Scientific Paradigm Exploring HSV-1 Activation as Potential Cause of 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 (FM) and Other Chronic Conditions Investor Update Q1 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,” “will,
Slide 3: Virios Therapeutics Summary
Virios Therapeutics Summary 3 Virios Team and Board of Directors Have Deep Experience in Developing and Commercializing FM and Antiviral Medicines The FM Market is Large, but Dissatisfied – Significant Commercial Potential for Differentiated New FM Treatment Unique IMC-1 Antiviral Combination (famci
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 if Better Therapeutic Options Emerge
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: Discovery Implicates Dormant HSV-1 Reactivation Triggers Immune Response and Manifestation of Fibromyalgia
Discovery Implicates Dormant HSV-1 Reactivation Triggers Immune Response and Manifestation of Fibromyalgia 8 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 9: IMC-1's Synergistic Antiviral Mechanism Serves as Basis for Proposed Fibromyalgia Treatment Effect
IMC-1’s Synergistic Antiviral Mechanism Serves as Basis for Proposed Fibromyalgia Treatment Effect 9 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 Jou
Slide 10: Viral GI Tissue Study
10 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 • PCR
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 • Famciclovir Dose Not Optimized • Diagnosis of Fibromyalgia Using 2010 American Col
Slide 12: IMC-1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a Clinical Trial
IMC-1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a Clinical Trial 12 p = 0.031 p = 0.001 Source: Pridgen et al, Journal of Pain Research, 2017
Slide 13: IMC-1 Treatment Resulted in Consistent Treatment Effects at 16 Weeks
IMC-1 Treatment Resulted in Consistent Treatment Effects at 16 Weeks Across Spectrum of Fibromyalgia Endpoints 13 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 p=0.
Slide 14: IMC-1 Had a Lower Discontinuation Rate Versus Placebo in Phase 2a Study
IMC-1 Had a Lower Discontinuation Rate Versus Placebo in Fibromyalgia Phase 2a Study 14 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 failure 12
Slide 15: IMC-1 Phase 2b Design to be Conducted Using Optimized IMC-1 Dosage
IMC-1 Phase 2b Design to be Conducted Using Optimized IMC-1 Dosage 15 Secondary Endpoints: Change in fatigue, sleep disturbance, 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
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 P2a FM data • 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 Increasing Fo
Slide 17: 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 17 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% Com
Slide 18: Capital Table as of February 28th 2021
Capital Table as of February 28th 2021 18 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 D
Slide 19: Virios Therapeutics Summary
Virios Therapeutics Summary 19 Virios Team and Board of Directors Have Deep Experience in Developing and Commercializing FM and Antiviral Medicines The FM Market is Large, but Dissatisfied – Significant Commercial Potential for Differentiated New FM Treatment Unique IMC-1 Antiviral Combination (famc
Virios Therapeutics — Investor Presentation (March 2021) on 6ix