Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — Corporate Update (October 2021)
22 slides from Dogwood Therapeutics's corporate update, Oct 12, 2021
Slide 1: New Scientific Paradigm Exploring HSV-1 Virus 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 and Other Chronic Conditions Corporate Update Q4, 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 FDA Approved FM Medicines The Fibromyalgia (FM) Market is Large, but Dissatisfied – Highlighting Significant Commercial Potential for a Differentiated New FM Treatment Novel Co
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 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 Total Projected US FM Community FM Market Est. to Have 5x Current Potential Lyrica Price was $16/day in 2019, Compliance Rate Est @60% Fortune Business Insights Report, the FM Market Sales at $1.9B
Slide 9: Dormant HSV-1 Reactivation Triggers Immune Response and Manifestation of 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 Serves as Basis for Proposed Treatment Effect
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
Slide 11: Viral GI Tissue Study
11 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 12: IMC-1: Completed Phase 2a Clinical Proof of Concept Trial
Week12345678910111213141516 IMC-1 N = 69 Placebo N = 74 12 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 at Weeks 6, 12
Slide 13: IMC-1 Demonstrated Statistically Significant Reduction in Pain in Phase 2a
13 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 14: 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 14 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 15: Key Secondary Outcomes at Weeks
Key Secondary Outcomes at 16 Weeks 15 Source: Pridgen et al, Journal of Pain Research, 2017, 2017, Virios Therapeutics, Inc.
Slide 16: IMC-1 Had a Lower Discontinuation Rate Versus Placebo
IMC-1 Had a Lower Discontinuation Rate Versus Placebo in Fibromyalgia Phase 2a Study 16 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 17: IMC-1 Phase 2b Design to be Conducted Using Optimized Dosage
IMC-1 Phase 2b Design to be Conducted Using Optimized IMC-1 Dosage 17 Secondary Endpoints: Fatigue, sleep, global health, and patient functionality FM Diagnosis using 2016 ACR criteria Daily Assessments: 16 Weeks Primary Endpoint: Reduction in pain as measured by NRS 24 Hour Recall via daily electro
Slide 18: IMC-1 Regulatory Considerations
IMC-1 Regulatory Considerations 18 By combining proprietary doses of two approved drugs, our fixed dose combination development candidates has the advantage of being eligible for submission to the FDA for approval under Section 505(b)(2) IMC-1 Composition of Matter “Synergy” intellectual propert
Slide 19: IMC-1 Pipeline Potential Extends to Other Functional Somatic Syndromes
IMC-1 Pipeline Potential Extends to Other Functional Somatic Syndromes 19 • 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 20: Combination Antiviral Pipeline Includes 21 Issued Patents
Virios Therapeutics Inc Combination Antiviral Pipeline Includes 21 Issued Patents 20 Issued US IMC-1 Patents • U.S. “Composition of Matter” Patents (US 8,809,351 & US 10,034,846) Drug-combination of famciclovir and celecoxib • U.S. “Method-of-Use” Patent (US 9,040,546) Famciclovir + celecoxib for th
Slide 21: Capital Table as of June 30th 2021
Capital Table as of June 30th 2021 21 Listing/Symbol Nasdaq/VIRI Common Shares Outstanding 8,330,390 Underwriters Warrants* (Exercisable at $12.50/share) 172,500 Stock Options (Employees, Directors & Officers)** 1,041,647 Fully Diluted Shares Outstanding 9,544,537 Management Ownership*** on a Fully
Slide 22: Virios Therapeutics Summary
Virios Therapeutics Summary 22 Virios Team and Board of Directors Have Led Development or Commercialization for Two of Three FDA Approved FM Medicines The Fibromyalgia (FM) Market is Large, but Dissatisfied – Highlighting Significant Commercial Potential for a Differentiated New FM Treatment Novel C
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