Dogwood Therapeutics, Inc. · NASDAQ:DWTX
Dogwood Therapeutics — Investor Presentation (February 2025)
24 slides from Dogwood Therapeutics's investor presentation, February 2025
Slide 1: Developing a Non-opioid, Nav1.7 Specific Sodium Channel Inhibitor to Treat Pain
Developing a Non-opioid, Nav1.7 Specific Sodium Channel Inhibitor to Treat Pain INVESTOR PRESENTATION February 2025 NASDAQ: DWTX
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, other
Slide 3: Executive Team with Extensive Drug Development and Commercialization Experience
Dogwood is Led by an Executive Team with Extensive Drug Development and Commercialization Experience Management’s Brand Development & DWTX Executive Team Commercialization Experience Includes: Greg Duncan Chairman & CEO R. Michael Gendreau Angela Walsh MD, PhD CMO CFO Ralph Grosswald Meng Zhou SVP o
Slide 4: Dogwood Therapeutics: An Advanced Clinical-Stage Pharmaceutical Company
Dogwood Therapeutics: An Advanced Clinical-Stage Pharmaceutical Company • Lead candidate Halneuron® in late-stage clinical development for CINP, a $1.5B global opportunity ⎼ Phase 2b trial in CINP initiated in February 2025, interim data expected 4Q25 ⎼ Proof of efficacy already in Phase 2 trial in
Slide 5: Pipeline Summary
Pipeline Summary • A late-stage, clinical development company advancing novel pain management and antiviral therapies that are poised to address today’s unmet medical needs: Target Indication Candidate/Target Preclinical Phase 1 Phase 2 Phase 3 Chemotherapy-Induced Halneuron® Nav1.7 Neuropathic Pain
Slide 6: Halneuron - A Potential Opioid-free Therapy for Pain Management
Halneuron® - A Potential Opioid-free Therapy for Pain Management NASDAQ: DWTX 6
Slide 7: Vicious Cycle With Opioid Pain Therapies
Vicious Cycle With Opioid Pain Therapies Current Problem: Increase Dosage: Manage Pain and Worsen Taking Opioids to While effective at managing pain, opioids Withdrawal Symptoms Manage Pain have numerous concerning issues: • Highly addictive, a recognized public health crisis • Severe side effects L
Slide 8: Navs are Crucial to Pain Signal Transmission and Nav1.7 is Associated with Certain Neuropathies
Navs are Crucial to Pain Signal Transmission and Nav1.7 is Associated with Certain Neuropathies Halneuron®: Loss of Nav1.7 Function Halneuron® inhibits sodium Erythromelalgia: Sodium Leads to Congenital channels, including Nav1.7, channels remain open Insensitivity to Pain thus reducing pain signal
Slide 9: Halneuron - Fulfills Many Requirements Of An Ideal Analgesic
Halneuron® - Fulfills Many Requirements Of An Ideal Analgesic Novel, non-opioid Nav1.7 Reduced pain in both Long-lasting relief, with No evidence of mechanism of action to Cancer Related Pain and responders exhibiting almost addiction, euphoria or treat pain CINP clinical trial of two months of pain
Slide 10: Our Approach - What is Halneuron?
Our Approach - What is Halneuron®? • Halneuron® is Tetrodotoxin (TTX), a sodium channel blocker and potent small molecule found in puffer fish and several other marine animals (not a peptide or protein) • Halneuron® works as a painkiller by blocking Nav1.7, a sodium channel responsible for pain sign
Slide 11: Halneuron is a Voltage-Gated Sodium Channel Modulator Selective to Nav1.7
Halneuron® is a Voltage-Gated Sodium Channel Modulator that is Selective to Nav1.7 Halneuron® Nav1.7 Selectivity Suzetrigine is selective for Nav1.8 versus Channel TTX Sensitivity Predominant Distribution Nav1.7 EC50 = 24.5 nM PNS (DRG) Nav1.8 EC50 = 60,000 nM PNS (DRG) Nav1.9 EC50 = 40,000 nM PNS (
Slide 12: Halneuron Therapy Demonstrated Reduction of Pain in CRP and CINP Patients
Halneuron® Therapy Demonstrated Reduction of Pain in CRP and CINP Patients CRP Phase 2 Study CINP Phase 2a Signal-Seeking (n=165) Study (n=125) • Tested for efficacy and safety of Halneuron® for • Primarily a dose-finding trial evaluating potential moderate to severe inadequately controlled CRP effi
Slide 13: Halneuron Demonstrated Statistically Significant Pain Reduction in Phase 2 CRP Study
Halneuron® Demonstrated Statistically Significant Pain Reduction (p-value = 0.046) in Phase 2 CRP Study Treatment Long term Screening Baseline Early Follow-Up Late Follow-up Injections Follow-Up Days -28 to -7 Days -7 to 0 Days 1-4 Days 5-8 visits Days 15 Every other week CRP Phase 2 Pain Outcome –
Slide 14: Halneuron Treated Patients Reported an Improvement in Pain Compared to Placebo
Halneuron® Treated Patients Reported an Improvement in Pain Compared to Placebo-Treated Patients 100% No. of times ®1 2 Halneuron Placebo better than 90% Placebo Missing 80% Very Much Improved 12% 2% 6X Very much worse 70% Much Improved 20% 10% 2X Much worse 60% Minimally improved 23% 12% 2X 50% Min
Slide 15: Cancer Related Pain Phase 2 Study: Long Duration of Pain Relief for Initial Responders
Cancer Related Pain Phase 2 Study (n=165): Long Duration of Pain Relief for Initial Responders Duration of response assessed for initial responders (30% or greater reduction): • After a single cycle of treatment, Halneuron® initial responders (50.8% of treated) showed a greater duration of pain redu
Slide 16: Current Phase 2b Trial Builds on Halneuron Phase 2a Treatment Effect Size
Current Phase 2b Trial Builds on Halneuron® Phase 2a Treatment Effect Size Halneuron® CINP Phase 2a (n=125) Dose-Ranging Study Highlights CINP Phase 2a Study Assessing Three Doses and Two Dose Regimens Demonstrated: • Halneuron® high doses delivered greater pain reduction as compared to low doses •
Slide 17: Halneuron Exhibits an Acceptable Safety Profile
Halneuron® Exhibits an Acceptable Safety Profile Phase 2 Cancer Related Pain Study Clinical Safety Most Frequent Adverse Events from Previous (n=165): CINP Study with BID Dosing (n=25/ group) • Majority of AEs were mild-to-moderate in severity • Most common AEs were expected and resolved naturally •
Slide 18: Current Halneuron 4-Week Phase 2b CINP Study
Current Halneuron® 4-Week Phase 2b CINP Study Baseline Week 1 Week 2 Week 3 Week 4 Run-in Period Avg. of Primary Endpoint 8 Halneuron® injections spaced over 2 weeks Days -7 to -1 End of Study • Primary Objective of the 4-Week Phase 2b study ⎼ To explore the safety and efficacy of Halneuron® in the
Slide 19: Ability to Effectively Treat CINP Opens a Large Market Opportunity
Ability to Effectively Treat CINP Opens a Large Market Opportunity Current Problem Is Significant • Chemotherapy is effective, but common side effects include fever, fatigue, infection, hair loss. and both acute and chronic pain • Chemotherapy expected to increase by 54% by 2024 • Platinum/taxane ch
Slide 20: Intellectual Property & Drug Manufacturing
Intellectual Property & Drug Manufacturing New Synthetic API for • Target Filing Mid-2025 Phase 3 and • Potential Extension to 2045+ Commercialization • Target Filing Mid-2025 Manufacturing Process and Trade Secrets • Potential Extension to 2045 • CINP to 2030 Method of Use • Ophthalmic filed in 202
Slide 21: Combination Antiviral Programs
Combination Antiviral Programs 21
Slide 22: Novel Combination Antiviral Program Targets Two Areas of Unmet Medical Need
Novel Combination Antiviral Program Targets Two Areas of Unmet Medical Need Two novel, late-stage clinical stage development assets: • IMC-1 (famciclovir + celecoxib) ready for Phase 3 development as treatment for fibromyalgia: ⎼ FDA agreement to enter Phase 3 post End-of-Phase 2 meeting; ⎼ Pharmaco
Slide 23: 2025 Milestones and Catalysts
2025 Milestones and Catalysts Candidate/Target Target Indication Next Key Milestone Q1: First Patient Dosed in Phase 2b trial Halneuron® Nav1.7 CINP Q2/Q3: New Synthetic IP Filed Q4: Phase 2b Interim Data Redout IMC-1 Antiviral Fibromyalgia Phase 3 Partnership Update 1H IMC-2 Antiviral Long-COVID/ P
Slide 24: Investor Relations Email: [email protected]
Investor Relations Email: [email protected] NASDAQ: DWTX
Dogwood Therapeutics — Investor Presentation (February 2025) on 6ix