Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Virios Therapeutics — Merger or Acquisition (October 2024)
19 slides from Dogwood Therapeutics's merger presentation, Oct 7, 2024
Slide 1: Virios and Wex Announce Business Combination to Form Dogwood Therapeutics
Virios Therapeutics, Inc. and Wex Pharmaceuticals, Inc. Announce Business Combination to Form Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) October 7, 2024 The renaming of Virios Therapeutics, Inc. to Dogwood Therapeutics, Inc. is effective on October 9, 2024. The information in this presentation was
Slide 2: Forward-Looking Statements
Forward-Looking Statements ➢ Statements in this presentation contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, conta
Slide 3: Business Combination to Form Dogwood Therapeutics: Key Terms
Virios Therapeutics, Inc. and Wex Pharmaceuticals, Inc. Announce Business Combination to Form Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) ➢ Expanded pipeline includes a potential first-in-class non-opioid, NaV1.7 inhibition pain treatment, Halneuron® , currently in Phase 2b development for chemother
Slide 4: Dogwood Therapeutics Pipeline has Significant Value Creation Potential
Dogwood Therapeutics, Inc. Pipeline has Significant Value Creation Potential Target Indication Candidate/ Target Preclinical Phase 1 Phase 2 Phase 3 CINP Halneuron® NaV 1.7 Cancer Related Pain Halneuron® NaV 1.7 Acute Pain Halneuron® NaV 1.7 Ocular Pain Contact Lens NaV 1.7 Fibromyalgia IMC-1 Long C
Slide 5: WEX Pharmaceuticals Inc. Overview
WEX Pharmaceuticals Inc. Overview ➢ WEX Pharmaceuticals (“WEX”), headquartered in Canada, is a pharmaceutical company focused on the development of Halneuron® , a non-opioid pain medication to treat moderate to severe pain ➢ WEX was a wholly owned subsidiary of CK Life Sciences Int'l., (Holdings) In
Slide 6: Halneuron is a Voltage-Gated Sodium Channel Modulator
Halneuron® is a Voltage-Gated Sodium Channel Modulator ➢ Halneuron® (TTX) works to reduce pain by inhibiting NAV 1.7, a sodium channel on neurons responsible for pain transmission ➢ Halneuron® inhibits NAV 1.7 which is known to reduce pain signal transmission1,2 Pain signals are nerve impulses that
Slide 7: Halneuron Demonstrated Superiority over Duloxetine in Preclinical Neuropathic Pain Model
Halneuron® Demonstrated Superiority over Duloxetine Treatment in Preclinical Oxaliplatin-induced Neuropathic Pain Model ➢ Halneuron®, at 8 g/kg, sc, significantly increased the PWT in rats with oxaliplatin-induced neuropathy ➢ Duloxetine (positive control) at 30 mg/kg, q.d., increased the PWT in ra
Slide 8: Previous Clinical Trials Investigating Halneuron
Previous Clinical Trials Investigating Halneuron® CINP Phase 2a Signal Seeking Study • Tested for efficacy and safety of Halneuron® for moderate to severe inadequately controlled CRP • Randomized, double-blind, placebo-controlled, parallel-design, multicenter, trial • Patients enrolled: 165 • Primar
Slide 9: Phase 2 CRP Study: Pain Measurement Outcome
Phase 2 CRP Study: Pain Measurement Outcome ➢There was a statistically significant improvement in pain outcomes for Halneuron® ❖51% of patients receiving Halneuron® experienced a ≥30% reduction in pain; vs ❖35% of patients in the placebo group recorded a ≥30% reduction in pain Notes: 1. Halneuron® +
Slide 10: Cancer Related Pain Study: Global Impression of Pain Change
Cancer Related Phase 2 Pain Study: Global Impression of Pain Change Patients in the Halneuron® group reported an improvement in pain compared to the placebo group 0 % 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Placebo Halneuron® Missing Very much worse Much worse Minimally worse Not changed Minimally
Slide 11: Cancer Related Pain Study: Long Duration of Pain Relief for Responders
Cancer Related Phase 2 Pain Study: Long Duration of Pain Relief for Responders Duration of response assessed for initial responders (30% or greater reduction): ➢ After a single cycle of treatment, Halneuron® initial responders (50.8%) showed a greater duration of pain reduction as compared to placeb
Slide 12: Halneuron Five-arm Study: CINP Phase 2a Trial Conclusions
Halneuron Five-arm Study, Assessing Three Doses and Two Dose Regimens: ➢ Halneuron® high doses delivered greater pain reduction as compared to low doses ➢ Halneuron® QD dose pain reduction comparable to BID dose, but exhibited better tolerability ➢ Halneuron® pain relief evident four weeks post trea
Slide 13: Halneuron has the Potential to Address a Large Market Opportunity
Halneuron® has the Potential to Address a Large Market Opportunity Notes 1. Delveinsight December 2018, Chemotherapy-Induced Peripheral Neuropathy, Market insights, Epidemiology and Market Forecast 2018-2027 2. Allied Market Research December 2018, Global Cancer Pain Market, Opportunity Analysis and
Slide 14: Halneuron - A Novel Non-opioid Pain Development Candidate
Halneuron® - A Novel Non-opioid Pain Development Candidate Lead indication: CINP Represents a Large Market Opportunity o Currently there are no treatments approved for Chemotherapy-Induced Neuropathic Pain Validated Mechanism: Pain blocking process well-validated by decades of scientific research o
Slide 15: Novel Combination Antiviral Program
Novel Combination Antiviral Program 15 ➢ Two novel, late-stage clinical stage development assets: ➢ IMC-1 (famciclovir + celecoxib) ready for Phase 3 development as treatment for FM: ➢ Phase 2a and Phase 2b in Fibromyalgia (“FM”) ➢ FDA agreement to enter Phase 3 post EoP2 meeting ➢ Exploring Phase 3
Slide 16: IMC-1 Phase 3 Study Designs Agreed To By FDA
IMC-1 Phase 3 Study Designs Agreed To By FDA I. Pharmacokinetic/Food Effect Study II. Study 1: Head-to-Head IMC-1 vs Placebo (n=320) ❖ 1:1 Randomization – 160 in each group ❖ Primary Endpoint – Reduction in Pain at 12 Weeks III. Study 2: Multifactorial Study of IMC-1 vs Placebo vs Famciclovir vs Cel
Slide 17: IMC-2 Long-COVID Exploratory Study Demonstrates Treatment Effect
IMC-2 Long-COVID Exploratory Study Demonstrates Treatment Effect on Long-COVID Symptoms 17 Valacyclovir + Celecoxib Treated Patients (n=22) Matched Controls (n=17) • All female, mean age = 43, mean duration of Long-COVID symptoms at enrollment = 2.0 years • 86% SARS CoV2 vaccination rate • Washed ou
Slide 18: Bateman Horne Center Follow-Up PASC Study
Bateman Horne Center Follow-Up 202 PASC Study ➢ Study also run by Bateman Horne Center, Salt Lake City, Utah ➢ Second IRB approved study supported by Virios via unrestricted, investigator-initiated grant ➢ Dr. Lucinda Bateman, MD, a recognized leader in both Long-COVID and fatigue related clinical r
Slide 19: Business Combination to Form Dogwood Therapeutics: Summary
Virios Therapeutics, Inc. and Wex Pharmaceuticals, Inc. Announce Business Combination to Form Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) ➢ Expanded pipeline includes a potential first-in-class non-opioid, NaV1.7 inhibition pain treatment, Halneuron® , currently in Phase 2b development for chemother
Virios Therapeutics — Merger or Acquisition (October 2024) on 6ix