Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — Investor Presentation (November 2022)
27 slides from Dogwood Therapeutics's investor presentation, Nov 16, 2022
Slide 1: New Scientific Paradigm Exploring Herpes Virus Activation as Potential Cause of Chronic Conditions
New Scientific Paradigm Exploring Herpes Virus Activation as Potential Underlying Cause of Fibromyalgia, Long COVID and Other Chronic Conditions Nasdaq: VIRI November 2022
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: Proven Leadership Team with Extensive Experience in Drug Development and Commercialization
NASDAQ: VIRI Proven Leadership Team with Extensive Experience in Drug Development and Commercialization 3 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 4: Fibromyalgia Disease Overview
NASDAQ: VIRI Fibromyalgia Disease Overview 4 • 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 • Highe
Slide 5: The Global Fibromyalgia Market is Large but Dissatisfied
NASDAQ: VIRI The Global Fibromyalgia Market is Large but Dissatisfied, Largely Due to Poor Tolerability of the Approved Medicines 5 Significant Global FM Commercial Opportunity Source: Verified Market Research, FM Report, 2021 Anti - epileptics and Anti - depressants are Dominant Treatments Global F
Slide 6: Dormant Herpes Virus Reactivation Hypothesized to Trigger Dysfunctional Immune Response
NASDAQ: VIRI Dormant Herpes Virus Reactivation Hypothesized to Trigger Dysfunctional Immune Response, Disease Symptoms 6 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, Scientific Wor
Slide 7: Synergistic Antiviral Mechanism Serves as Basis for Proposed FM Treatment Effect
NASDAQ: VIRI Synergistic Antiviral Mechanism Serves as the Basis for Proposed FM Treatment Effect 7 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; Higaki S, et al Current Eye Re
Slide 8: Purposeful Research Approach Focused on Herpes Virus Inhibition
NASDAQ: VIRI Purposeful Research Approach Focused on Herpes Virus Inhibition As A Novel Approach to FM Treatment 8 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. Pridgen et
Slide 9: FORTRESS Phase 2b Clinical Trial Design
NASDAQ: VIRI FORTRESS Phase 2b Clinical Trial Design 9 • 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
Slide 10: FORTRESS FM Phase 2b Study Disposition
NASDAQ: VIRI FORTRESS FM Phase 2b Study Disposition 10 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%) Discontinuation due to Adverse Events 17 (8.1%) 10
Slide 11: FM Treatment Tolerability: TEAEs > 5%
NASDAQ: VIRI FM Treatment Tolerability: TEAEs > 5% from PIs* 11 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 12: FORTRESS Primary Pain Reduction Result
NASDAQ: VIRI -2.0 -1.8 -1.6 -1.4 -1.2 -1.0 -0.8 -0.6 -0.4 -0.2 0.0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 NRS Diary Pain Placebo (n= 207) IMC-1 (n=215 ) FORTRESS Primary Pain Reduction Result 12 Change from Baseline LS Mean NRS Score Study Week p=0.302
Slide 13: Treatment Effect Similar in Both Cohorts, Early Enrollee Placebo Effect
NASDAQ: VIRI IMC - 1 Treatment Effect Similar in Both Cohorts, Early Enrollee Placebo Effect at Levels Previously Unseen 13 4 4.5 5 5.5 6 6.5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Cohort 2 Placebo (n=108) IMC-1 (n=106) p=0.030 4 4.5 5 5.5 6 6.5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Cohort 1 Pl
Slide 14: Assessment of Enrollment Timing and COVID Variants Impacting Placebo Response
NASDAQ: VIRI Original Assessment of Enrollment Timing and COVID - 19 Variants Potentially Impacting Placebo Response 14 Source: NYTimes .. com, 2021; USA Facts , 2022; CDC COVID Tracker , 2022 Cohort 1: Jun 2021 – Oct 2021 Cohort 2: Nov 2021 - Apr 2022 ❖ Significant Quarantining ❖ Research Site Staf
Slide 15: Factors Explored During Data Analysis
NASDAQ: VIRI Factors Explored During Data Analysis 15 ❖ Cohort 1 v Cohort 2 - Study entry date ❖ Recruitment by advertising – not previously involved in prior site trials ❖ Lifetime usage of FM treatment drugs (including washout) ❖ Recruitment at purely clinical research sites vs “mixed” (practice &
Slide 16: Advertising-Recruited Patients Compared To Patients From Prior Trials
NASDAQ: VIRI Advertising - Recruited Patients (“New”) Compared To Patients From Prior Trials, Databases and Clinical Practice (“Existing”) 16 New vs Existing Patients N Placebo Change from Baseline @ Week 14 IMC - 1 Change from Baseline @ Week 14 Contrast @ Week 14 P Value Existing 247 - 1.843 - 1.5
Slide 17: New Patient Cohort Demonstrates Pain Reduction Consistent with Savella Phase 3
NASDAQ: VIRI “New” Patient Cohort Treated with IMC - 1 Demonstrates Pain Reduction Consistent with Savella Phase 3 Patients 17 p=0.016 Mean NRS Score Savella Phase 3 4.0 4.5 5.0 5.5 6.0 6.5 0 1 2 3 4 5 6 7 8 9 19 11 12 13 14 15 16 New Patients Placebo (n=80) IMC-1 (n=95) IMC - 1 Phase 2b --- Savella
Slide 18: New FM Patients Demonstrate Treatment Effect on Key Secondary Outcomes
NASDAQ: VIRI New FM Patients Demonstrate IMC - 1 Treatment Effect on Key Secondary Outcomes - Entire Study Interval 18 Overall n=175: Placebo n=80, IMC - 1 n=95 FIQ - R New Patients PGIC New Patients Promise - Fatigue New Patients
Slide 19: New FM Patients Demonstrate Improved Mood-Related Endpoints
NASDAQ: VIRI New FM Patients Demonstrate Improved Mood - Related Endpoints - Entire Study Interval 19 HADS Depression Score 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 0 2 4 6 12 14 16 HADS Depression Placebo (n=80) IMC-1 (n=95) p=0.0016 HADS Anxiety Score 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0
Slide 20: Site Recruitment: Research-Only Sites Compared to Mixed Sites
NASDAQ: VIRI Site Recruitment: Research - Only Sites Compared to Mixed Research/Practice - Entire Study Interval 20 Research Site Or Not n Placebo Change from Baseline @ Week 14 IMC - 1 Change from Baseline @ Week 14 Contrast @ Week 14 P Value Research Sites 198 - 1.445 - 1.885 - 0.439 0.050 Mixed S
Slide 21: Optimal Patient Response Observed in 104 Total Patients
NASDAQ: VIRI Result Order of Importance, Optimal Patient Response Observed in 104 Total Patients 21 Defining the Optimal Patient: ❖ Recruited at tail end of pandemic (after November 2021) ❖ Simulate no pandemic effects ❖ Recruited through social media advertising (more naïve patients) ❖ Bias towards
Slide 22: FM Program Summary
NASDAQ: VIRI IMC - 1 FM Program Summary 22 ❖ Mechanistic link between herpes virus activation and FM ❖ Positive Phase 2a clinical study results ❖ Phase 2b Trial Results: FM patients who were new to the research sites demonstrated clinically and statistically significant reductions in: – Pain, fatigu
Slide 23: Potential Link Between Long COVID and Herpes Virus Reactivation
NASDAQ: VIRI Potential Link Between Long - COVID and Herpes Virus Reactivation Drives Valacyclovir/Celecoxib Exploratory Trial 23 Herpes Reactivation ❖ As many as 30% of COVID patients will experience post - COVID symptoms ❖ SARS - CoV - 2 infection is a potent trigger for reactivation of latent her
Slide 24: Strong IP Portfolio with Issued Patents to 2033
NASDAQ: VIRI Strong IP Portfolio with 21 Issued Patents to 2033 24 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 25: Combination Antiviral Research Pipeline Provides Rich Milestone Progression
NASDAQ: VIRI Combination Antiviral Research Pipeline Provides Rich Milestone Progression Pipeline Candidates Disease Pre - Clinical Phase 1 Exploratory Phase 2 Phase 3 IMC - 1: (famciclovir + celecoxib) FM Phase IMC - 1: (famciclovir + celecoxib) IBS IMC - 2: (valacyclovir + celecoxib) Long COVID* E
Slide 26: Virios Therapeutics Summary
NASDAQ: VIRI Virios Therapeutics Summary 26 ❖ First - in - Class Combination Antiviral Development Candidates Target Two Significant Commercial Opportunities: • Fibromyalgia (FM) impacts 2%+ of the population, novelty of approach garners FDA “Fast Track” review designation • Long - Covid sequelae im
Slide 27: Thank You
THANK YOU! www.virios.com For Additional Information, Contact: Kirin Smith : ksmith@pcgadvisory.com or ir@virios.com
Virios Therapeutics — Investor Presentation (November 2022) on 6ix