Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Corporate Update (October 2024)
19 slides from Dogwood Therapeutics's corporate update, Oct 9, 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”) Q4, 2024 The renaming of Virios Therapeutics, Inc. to Dogwood Therapeutics, Inc. is effective on October 9, 2024. The information in this presentation was prepare
Slide 2: Forward-Looking Statements and Disclaimers
Forward-Looking Statements and Disclaimers 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, othe
Slide 3: Business Combination to Form Dogwood Therapeutics (Nasdaq: DWTX)
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 chemothera
Slide 4: Dogwood Therapeutics Pipeline has Significant Value Creation Potential
Dogwood Therapeutics, Inc. Pipeline has Significant Value Creation Potential Candidate/ Target Indication Preclinical Phase 1 Phase 2 Phase 3 Target 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) Inc
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 Effect of TTXHalneuron® v duloxetine on 1h PWT in Oxaliplatin v placebo induced pain model rats Placebo 1 ml/kg, sc TTX 8ug/kg, sc Duloxetine 30 mg/kg, po 14 Dosing, qd. 12 *** ***
Slide 8: Previous Clinical Trials Investigating Halneuron
Previous Clinical Trials Investigating Halneuron® Cancer Related Pain (CRP) Phase 2 Study CINP Phase 2a Signal Seeking Study • Tested for efficacy and safety of • Primarily a dose finding trial but also Halneuron® for moderate to severe evaluating potential efficacy and inadequately controlled CRP s
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 Pain Outcome – Co-Prim
Slide 10: Cancer Related Phase 2 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 100% No. of times Halneuron® 1 Placebo 2 better than 90% Placebo Missing 80% Very Much Improved 12% 2% 6X Very much worse 70% Much Improv
Slide 11: Cancer Related Phase 2 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: CINP 4-week Phase 2a Signal Seeking Study: Trial Conclusions
CINP 4-week Phase 2a Signal Seeking Study: 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 toler
Slide 13: Halneuron has the Potential to Address a Large Market Opportunity
Halneuron® has the Potential to Address a Large Market Opportunity There are no FDA approved treatments for CINP ~ 57% of the Global Pain Market is comprised of opioid use Approximately one-in-three CINP patients exhibit neuropathic pain six months post treatment It is estimated that there a
Slide 14: Halneuron - A Novel Non-opioid Pain Development Candidate
Halneuron® - A Novel Non-opioid Pain Development Candidate Novel Nav 1.7 voltage-gated sodium channel inhibitor therapeutic o Highly differentiated, non-opioid mechanism of action to treat pain Validated Mechanism: Pain blocking process well-validated by decades of scientific research o Halneuron® p
Slide 15: Novel Combination Antiviral Program
Novel Combination Antiviral Program 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 pa
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 Valacyclovir + Celecoxib Matched Controls Treated Patients (n=22) (n=17) • All female, mean age = 43, mean duration of Long- • Matched controls based on treatment group COVID symptoms at enrollment = 2.0 years e
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 (Nasdaq: DWTX)
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 chemothera
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