Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — IPO Roadshow (September 2022)
29 slides from Dogwood Therapeutics's IPO roadshow presentation, Sep 19, 2022
Slide 1: New Scientific Paradigm Exploring Herpes Virus Activation as Potential Cause of Fibromyalgia
New Scientific Paradigm Exploring Herpes Virus Activation as Potential Underlying Cause of Fibromyalgia, Long COVID and Other Chronic Conditions Nasdaq: VIRI September 2022 Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated September 19, 2022 File No. 333 - 263700
Slide 2: Forward Looking Statements
NASDAQ: VIRI Forward Looking Statements 2 • Statements in this presentation contain “forward - looking statements” that are subject to substantial risks and uncertainties. Fo rward - looking statements contained in this presentation may be identified by the use of words such as “anticipate,” “expect
Slide 3: Free Writing Prospectus
NASDAQ: VIRI Free Writing Prospectus 3 • This presentation highlights basic information about us and the proposed offering. Because it is a summary, it does not conta in all of the information that you should consider before investing. We have filed a registration statement (including a preliminary
Slide 4: Proven Leadership Team with Extensive Experience in Drug Development and Commercialization
NASDAQ: VIRI Proven Leadership Team with Extensive Experience in Drug Development and Commercialization 4 Pharma Brand Development & Commercialization Experience Includes Management of: Greg Duncan Chairman & CEO R. Michael Gendreau MD, PhD CMO Ralph Grosswald SVP of Operations Angela Walsh SVP of F
Slide 5: Fibromyalgia Syndrome Overview
NASDAQ: VIRI Fibromyalgia Syndrome Overview 5 • American College of Rheumatology Estimates 2 - 4% of Population has FM • Hallmark Characteristics are Widespread Chronic Pain and Severe Fatigue • Symptoms Present for ≥ 3 Months • Other Symptoms May Include GI, Sleep, Mood Disorder and Headache • High
Slide 6: The Global Fibromyalgia Market is Large but Dissatisfied, Poised for Growth
NASDAQ: VIRI The Global Fibromyalgia Market is Large but Dissatisfied, Poised for Growth if Better Therapeutic Options Emerge 6 Significant Global FM Commercial Opportunity Source: Verified Market Research, FM Report, 2021 Anti - epileptics and Anti - depressants are Dominant Treatments Global FM Ma
Slide 7: Hypothesis Implicates Dormant Herpes Virus Reactivation Triggering Dysfunctional Immune Response
NASDAQ: VIRI Hypothesis Implicates Dormant Herpes Virus Reactivation Triggering Dysfunctional Immune Response and/or FM Severity 7 Source: P.A. Bond, Medical Hypotheses , 1993; R. A Vere Hodge and Y. - G. Cheng, Antiviral Chemistry & Chemotherapy , 1993; Kaufman et al, IOVS, 2005; Liu Y, et al, Scie
Slide 8: Synergistic Antiviral Mechanism Serves as Basis for Proposed Treatment
NASDAQ: VIRI Synergistic Antiviral Mechanism Serves as the Basis for Proposed Fibromyalgia and Long COVID Treatment Effect 8 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 Journal, 2014; Higak
Slide 9: Purposeful Research Approach Focused on Herpes Virus Inhibition Demonstrates IMC-1 Clinical Potential
NASDAQ: VIRI Purposeful Research Approach Focused on Herpes Virus Inhibition Demonstrates IMC - 1 Clinical Potential in FM 9 GI Biopsy Study Confirms Herpes Infection in Somatic Syndrome Disorders Phase 2a Clinical Study Identifies Potential of IMC - 1 Source: C. Duffy, et al, Infection , 2022; W. P
Slide 10: Oral IMC-1 Demonstrated Clinical Benefits on a Variety of FM Related Outcomes Measures
NASDAQ: VIRI Oral IMC - 1 Demonstrated Clinical Benefits on a Variety of FM Related Outcomes Measures 10 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=0.002 FI
Slide 11: FORTRESS Clinical Trial Design
NASDAQ: VIRI FORTRESS Clinical Trial Design 11 • 425 Female Patients Enrolled 18 - 65 Years of Age, 422 ITT population • 1:1 IMC - 1 (675mg famciclovir + 180mg celecoxib) vs Placebo, Dosed BID • Double - blind, 41 US Research Centers • Diagnosis of Fibromyalgia Using 2016 ACR Criteria Design Summary
Slide 12: FORTRESS Disposition
NASDAQ: VIRI FORTRESS Disposition 12 Placebo IMC - 1 Total (N=209) (N=216) (N=425) Randomized 209 (100.0%) 216 (100.0%) 425 (100.0%) Completed 161 (77.0%) 176 (81.5%) 337 (79.3%) Discontinued Early 48 (23.0%) 40 (18.5%) 88 (20.7%) Reason for Discontinuation Adverse Event 17 (8.1%) 10 (4.6%) 27 (6.4%
Slide 13: FORTRESS Adverse Events
NASDAQ: VIRI FORTRESS Adverse Events 13 AEs in >2% of IMC - 1 Patients Placebo IMC - 1 Total Preferred Term (N=208) (N=216) (N=424)* 110 (52.9%) 121 (56.0%) 231 (54.5%) COVID - 19 17 ( 8.2%) 20 ( 9.3%) 37 ( 8.7%) Nausea 4 ( 1.9%) 8 ( 3.7%) 12 ( 2.8%) Headache 12 ( 5.8%) 8 ( 3.7%) 20 ( 4.7%) Sinusiti
Slide 14: FM Treatment Tolerability: TEAEs > 5% from PIs
NASDAQ: VIRI FM Treatment Tolerability: TEAEs > 5% from PIs* 14 0 5 10 15 20 25 30 35 40 0 5 10 15 20 25 30 35 40 0 5 10 15 20 25 30 35 40 0 5 10 15 20 25 30 35 40 Savella n=1557 Cymbalta n=6020 Lyrica n=1517 IMC - 1 (FORTRESS) n=216 https://www.accessdata.fda.gov/drugsat fda_docs/label/2012/022256s
Slide 15: Primary Endpoint: Diary Pain Improvement Over Time
NASDAQ: VIRI Primary Endpoint: Diary Pain Improvement Over Time 15
Slide 16: PROMIS Fatigue Improvement - Full Dataset
NASDAQ: VIRI PROMIS Fatigue Improvement - Full Dataset 16 P=NS
Slide 17: FIQR Symptoms & Function Improvement
NASDAQ: VIRI 17 FIQR Symptoms & Function Improvement FIQR Symptom Domain FIQR Function Domain
Slide 18: Enrollment Timing and COVID-Variants
NASDAQ: VIRI Enrollment Timing and COVID - 19 Variants 18 https://www.nytimes.com/interactive/2021/health/coronavirus - variant - tracker.html Cohort 1 Jun 2021 – Nov 2 nd 2021 Cohort 2 Nov 3 rd 2021 - Apr 2022
Slide 19: Cohort Versus Cohort Analyses
NASDAQ: VIRI Cohort 1 Versus Cohort 2 Analyses 19 Primary Endpoint Enrollment Dates Placebo Baseline Placebo Week 14 IMC - 1 Baseline IMC - 1 Week 14 CFB P Value Cohort 1 n=208 June ’21 - Nov 2 nd , ‘21 6.14 4.59 6.25 4.77 0.18 (PBO) - 0.484 Cohort 2 n=214 Nov 3 rd , ‘21 - April 15 th ‘22 6.28 4.98
Slide 20: Primary Efficacy Daily Pain Score By Treatment Week in Cohorts 1 & 2
NASDAQ: VIRI Primary Efficacy Daily Pain Score By Treatment Week in Cohorts 1 & 2 20
Slide 21: PROMIS Fatigue T-Score Improvement By Treatment Week For Cohorts 1 & 2
NASDAQ: VIRI PROMIS Fatigue T - Score Improvement By Treatment Week For Cohorts 1 & 2 21 P=NS P=0.007 P=0.005 P=0.006 P=0.24
Slide 22: FIQR Symptom Domain Scores Over Weeks of Treatment: IMC-1 vs. Placebo
NASDAQ: VIRI FIQR Symptom Domain Scores Over 16 Weeks of Treatment: IMC - 1 vs. Placebo For Cohorts 1 & 2 22 P=0.015
Slide 23: Mean Change in HADS Depression Score by Cohort at Week 23
NASDAQ: VIRI Mean Change in HADS Depression Score by Cohort at Week 14 23
Slide 24: FORTRESS Summary
NASDAQ: VIRI FORTRESS Summary 24 □ Virios management strongly believes this mechanism has potential to improve FM patient care – Positive Phase 2a clinical study results – IMC - 1 in Cohort 2 delivered statistically significant improvement in FM patient pain, fatigue, depression and overall health s
Slide 25: Long Covid Prevalence is Significant
NASDAQ: VIRI Long Covid Prevalence is Significant 25 □ Approximately 30% of patient infected with the Covid virus will experience post - COVID symptoms — up to six months after recovering □ COVID - 19 long - haulers experience an array of widespread and debilitating symptoms even after the virus cle
Slide 26: Potential Link Between Long-COVID and Herpes Virus Reactivation
NASDAQ: VIRI COVID19 Infection □ Immune Dysregulation □ Direct Effect on Neurons □ Psychological Stress □ Fever Potential Link Between Long - COVID and Herpes Virus Reactivation 26 Herpes Reactivation □ Upregulation of Lytic Genes □ Herpes virus reactivation from latency Latent Herpes Virus
Slide 27: Strong IP Portfolio with Issued Patents to 2033
NASDAQ: VIRI Strong IP Portfolio with 21 Issued Patents to 2033 27 Four Issued US IMC - 1 P atents • Two “Composition of M a tter” P a tents • Drug - combin a tion of famcicl o vir and c e lec o xib • Synergistic combination for total daily dose of famciclovir and celecoxib • Two “Method - of - Use”
Slide 28: Capitalization Table
NASDAQ: VIRI Capitalization Table 28 Common Shares Outstanding 8,330,390 Warrants* 172,500 Stock Options** (Employees, Directors & Officers) 1,304,147 Fully Diluted Shares Outstanding 9,807,037 Management Ownership on a Fully Diluted Basis*** 22.6% Cash balance as of 9/18/22 $5.3M Capitalization tab
Slide 29: Thank You!
THANK YOU! www.virios.com For Additional Information, Contact: Kirin Smith : ksmith@pcgadvisory.com or ir@virios.com