Dogwood Therapeutics, Inc. · NASDAQ:DWTX

Dogwood Therapeutics — Technical Presentation (September 2022)

21 slides from Dogwood Therapeutics's technical presentation, Sep 19, 2022

  1. Slide 1: FORTRESS Study Summary

    FORTRESS STUDY SUMMARY Topline Results September 19, 2022 1 HSV-1 virus

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements • 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,

  3. Slide 3: Fibromyalgia Disease Overview

    Fibromyalgia Disease Overview Syndrome Devastating Impact Characteristics • American College of Rheumatology • Patients with FM > 3x Risk of Estimates 2-4% of Population has FM Committing Suicide v. General Population • Hallmark Characteristics are Widespread Chronic Pain and Severe • High Healthcar

  4. Slide 4: The Global Fibromyalgia Market is Large but Dissatisfied, Poised for Growth

    The Global Fibromyalgia Market is Large but Dissatisfied, Poised for Growth if Better Therapeutic Options Emerge Significant Global FM Anti-epileptics and Anti-depressants Global FM Market Estimated to Reach Commercial Opportunity are Dominant Treatments $2.46B in 2030 GLOBAL FM SALES GLOBAL SALES B

  5. Slide 5: Purposeful Research Approach Focused on Herpes Virus Inhibition Demonstrates IMC-1 Clinical Potential in FM

    Purposeful Research Approach Focused on Herpes Virus Inhibition Demonstrates IMC-1 Clinical Potential in FM GI Biopsy Study Confirms Herpes Phase 2a Clinical Study Identifies Potential Infection in Somatic Syndrome Disorders of IMC-1 Source: C. Duffy, et al, Infection, 2022; W. Pridgen et al, Journa

  6. Slide 6: FORTRESS Study Highlights

    FORTRESS Study Highlights  Overall, IMC-1 did not achieve statistical significance on the primary efficacy endpoint of change from baseline to Week 14 in the weekly average of daily self-reported pain scores comparing IMC-1 and placebo (p=0.302)  Bifurcation of response based on the timing of pati

  7. Slide 7: FORTRESS Clinical Trial Design

    FORTRESS Clinical Trial Design Design Summary: Primary Endpoints: Reduction in Pain • 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 Key Secondary Endpoints: • Diagnosi

  8. Slide 8: FORTRESS Disposition

    FORTRESS Disposition 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%) Lost to follow-u

  9. Slide 9: FORTRESS Adverse Events

    FORTRESS Adverse Events 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%) Sinusitis 7 ( 3.4%) 7 ( 3.2%)

  10. Slide 10: FM Treatment Tolerability: TEAEs > 5% from PIs

    FM Treatment Tolerability: TEAEs > 5% from PIs* 40 40 35 35 30 Savella https://www.accessdata.fda.gov/drugsat 30 Cymbalta fda_docs/label/2012/022256s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda 25 n=1557 25 n=6020 _docs/label/2010/022516lbl.pdf 20 20 15 15 10 10 5 5 0 0 40 35 40 Lyrica https

  11. Slide 11: Primary Endpoint: Diary Pain Improvement Over Time

    Primary Endpoint: Diary Pain Improvement Over Time 11

  12. Slide 12: PROMIS Fatigue Improvement- Full Dataset

    PROMIS Fatigue Improvement- Full Dataset P=NS 12

  13. Slide 13: FIQR Symptoms & Function Improvement

    FIQR Symptoms & Function Improvement FIQR Symptom Domain FIQR Function Domain 13

  14. Slide 14: Enrollment Timing and COVID-19 Variants

    Enrollment Timing and COVID-19 Variants Cohort 1 Cohort 2 Jun 2021 – Nov 2nd 2021 Nov 3rd 2021 - Apr 2022 https://www.nytimes.com/interactive/2021/health/coronavirus-variant-tracker.html 14

  15. Slide 15: Cohort Versus Cohort Analyses

    Cohort 1 Versus Cohort 2 Analyses Primary Enrollment Dates Placebo Placebo IMC-1 IMC-1 CFB P Value Endpoint Baseline Week 14 Baseline Week 14 Cohort 1 June ’21 - Nov 6.14 4.59 6.25 4.77 0.18 -0.484 n=208 2nd, ‘21 (PBO) Cohort 2 Nov 3rd, ‘21 - 6.28 4.98 6.05 4.42 -0.56 0.030 n=214 April 15th ‘22 15

  16. Slide 16: Primary Efficacy Daily Pain Score By Treatment Week in Cohorts 1 & 2

    Primary Efficacy Daily Pain Score By Treatment Week in Cohorts 1 & 2 16

  17. Slide 17: PROMIS Fatigue T-Score Improvement By Treatment Week For Cohorts 1 & 2

    PROMIS Fatigue T-Score Improvement By Treatment Week For Cohorts 1 & 2 P=0.007 P=0.005 P=0.006 P=0.24 P=NS 17

  18. Slide 18: FIQR Symptom Domain Scores Over Weeks of Treatment

    FIQR Symptom Domain Scores Over 16 Weeks of Treatment: IMC-1 vs. Placebo For Cohorts 1 & 2 P=0.015 18

  19. Slide 19: Mean Change in HADS Depression Score by Cohort at Week 14

    Mean Change in HADS Depression Score by Cohort at Week 14 Cohort 1 Cohort 2 0 0 -0.2 -0.2 -0.4 -0.4 -0.6 p=0.015 -0.6 -0.8 -0.8 -1 -1 p=NS -1.2 -1.2 -1.4 -1.4 -1.6 -1.6 Placebo IMC-1

  20. Slide 20: FORTRESS Summary

    FORTRESS Summary  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 status – IMC-1 in C

  21. Slide 21: Thank You!

    THANK YOU! For Additional Information, Contact: Kirin Smith: ksmith@pcgadvisory.com or ir@virios.com www.virios.com HSV-1 virus

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