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NASDAQ: DWTX Developing First-in-Class, Non-opioid Medicines to Deliver Life-Changing Relief from Pain & Neuropathy Corporate Overview Q1 2026
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NASDAQ: DWTX 2 Forward-Looking Statements and Disclaimers 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, contained in this presentation are forward-looking statements. Forward-looking statements contained in this presentation may be identified by the use of words such as “anticipate, ” “believe, ” “contemplate, ” “could, ” “estimate, ” “ e x p e c t ,” “intend, ” “seek, ” “ m a y,” “might, ” “ p l a n ,” “potential, ” “ p r e d i c t ,” “project, ” “suggest, ” “target, ” “ a i m ,” “should, ” " w i l l ,” “ w o u l d ,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the current expectations of Dogwood Therapeutics, Inc. (“Dogwood”) and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Forward-looking statements contained in this presentation are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law. Dogwood’s Investor Relations at IR@dwtx.com or (866) 620-8655.
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NASDAQ: DWTX 3 Dogwood is Led by an Executive Team with Extensive Drug Development and Commercialization Experience DWTX Executive Team Greg Duncan Chairman & CEO R. Michael Gendreau MD, PhD CMO Ralph Grosswald SVP of Operations Angela Walsh CFO Management’s Brand Development & Commercialization Experience Includes:
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NASDAQ: DWTX 4 Developing First-in-Class, Non-opioid Medicines to Deliver Life-Changing Relief from Pain & Neuropathy 68% 60% 30% 0% 10% 20% 30% 40% 50% 60% 70% 80% 1 Month Post Chemo Tx 3 Months Post Chemo Tx 6 Months Post Chemo Tx Neuropathy Prevalence Post Chemotherapy Treatment Two Potential Solutions to Address Significant Unmet Neuropathic Medical Need Halneuron® Nav 1.7 Inhibition: Phase 2b Moderate-to-severe neuropathic pain Pain Synergy Numbness, tingling, muscle weakness, and loss of coordination SP16 LRP1 agonism: Phase 1b • Highly Targeted Call Point: Oncology referrals to hospital outpatient pain clinics, community neurologists/pain centers • Bundled protocols/formularies with major cancer centers/providers • Together deeper penetration into the global CIPN treatment opportunity ~$1.5B market, expand into larger ~$5B CRP market
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NASDAQ: DWTX 5 First-in-Class Pain and Neuropathy Therapeutics Pipeline Target Indication Candidate Preclinical Phase 1 Phase 2 Phase 3 Phase 2b CINP Halneuron® Injection General Cancer Pain Halneuron® Injection Acute Surgical Pain Halneuron® Injection Chemo Induced Pain & Peripheral Neuropathy (CIPPN) SP16 Intravenous FDA Fast-Track Designation: Ongoing P2b Completed P2 National Cancer Institute Funded P 1b
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NASDAQ: DWTX 6 Milestones and Catalysts • Halneuron® (TTX) = Nav1.7 channel blocker, analgesic → best for treating established CINP pain ⎼ Halneuron® is in Phase 2b development for CINP ⎼ Opportunity to expand ⎼ Nav1.7 channel blocker should have utility on cancer related pain, as well as post surgical pain • SP16 = LRP1-agonist, anti-inflammatory, neuroprotection → best for attenuation of CIPN during chemo; ⎼ SP16 is in early clinical stage development and may enable neuroprotection, may preserve full chemo regimen and potential to synergistically complement Halneuron® in treating pain post chemotherapy ⎼ SP16 Phase 1b development for CIPN ⎼ Program is fully funded by NCI through next clinical milestone Key 2026 Milestones Q1 ‘26: Anticipated Filing of SP16 IND to Advance to Phase 1b Safety Study Q2 ‘26: Projected SP16 Phase 1b Enrollment Begins Q3 ‘26: Halneuron Phase 2b Fully Recruited Q3 ‘26: Projected Final Data Patient Phase 2b CINP Q4 ‘26: Planned Halneuron End of Phase 2 FDA Clinical Submission
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Halneuron® CINP Program Overview
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NASDAQ: DWTX 8 Halneuron® is Selective for the Nav1.7 Channel in Peripheral Tissues • Nav1.7 through 1.9 are found in the peripheral nervous system (PNS) and are involved in regulating pain signaling • Halneuron’s low affinity for cardiac sodium channels (Nav1.5) provides 200X safety margin, avoiding limitations of previous approaches to modulating Nav1.7 • Halneuron does not cross the blood-brain barrier, minimizing central nervous system adverse events Source: Catterall WA, Goldin AL, Waxman SG. International Union of Pharmacology. XLVII. Nomenclature and structure-function relationships of voltage-gated sodium channels. Pharmacol Rev. 2005 Dec;57(4):397-409J; Channels 2(6): 407-412, 2008. Lee et al.; Osteen et al, Pain Ther, 2025 Target TTX Sensitivity (EC50s) Predominant Distribution Nav1.7 EC50 = 24.5 nM Peripheral nervous system (PNS) Nav1.8 EC50 = 60,000 nM PNS & dorsal root ganglion (DRG) Nav1.9 EC50 = 40,000 nM PNS & DRG Nav1.5 EC50 = 5,700 nM Cardiac
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NASDAQ: DWTX 9 Halneuron® Comparison to SiteOne and Vertex Compounds Asset Target IC50 Source Halneuron® Nav1.7 ~36nM https://www.tocris.com/products/tetrodotoxin_1078?utm_source=chatgpt.com SiteOne ST-2262 Nav1.7 ~72nM https://www.nature.com/articles/s41598-020-71135-2.pdf?utm_source=chatgpt.com Halneuron® Nav1.8 ~1uM https://www.tocris.com/products/tetrodotoxin_1078?utm_source=chatgpt.com SiteOne ST-004 Nav1.8 <1nM https://reporter.nih.gov/project-details/10694726?utm_source Vertex VX-548 (Suzetrigine) Nav1.8 0.68nM https://probechem.com/products_VX-548.html?utm_source=chatgpt.com
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NASDAQ: DWTX 10 The Chemotherapy Induced Neuropathic Pain (CINP) Commercial Opportunity is Substantial and Projected to Grow by 53% Over the Next Decade Sources: American Cancer Society: Discovery Dundee: Neurology Advisor: CancerWorld2019: Lancet, Oncology, 2019; Delveinsight December 2018; Chemotherapy- Induced Peripheral Neuropathy, Market insights, Epidemiology and Market Forecast 2018-2027; Allied Market Research December 2018; Global Cancer Pain Market, Opportunity Analysis and Industry Forecast 2018-2025; LP Information December 2019, Global Pain Management Drugs Market growth 2019 -2024; Windbank, Annals pf Neurol, Naurol, 2017; Cancer facts & Figures 2021, CA: A Cancer Journal for Clinician Current treatment paradigm: Nothing is approved by FDA to treat CINP Eleven of twelve prior CINP trials failed Duloxetine recommended by ASCO for CINP , despite mixed clinical results Off label used chronic drugs have proven ineffective CINP market opportunity for Halneuron: Current opportunity: ~1.15 million patients represents a ~$3B US opportunity. Refractory market opportunity: ~360,000 patients inadequately controlled Worldwide incidence of cancer is projected to 26 million by 2040 (+53%) Halneuron granted fast-track review designation by FDA as a treatment for CINP: Treats serious or life-threatening disease US Pool of Persistent, Painful CINP Patients Projection Methodology Jan 1, 2025, there are ~18.6M cancer survivors in the U.S ~ 40% percent of cancer patients receive chemotherapy Among those, assume ~30% have persistent CIPN Among CIPN patients, ~41% have chronic painful neuropathy
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NASDAQ: DWTX 11 Halneuron® - Logical Approach Fulfills Many Requirements Of An Ideal Analgesic Halneuron® Therapeutic Profile Demonstrated in Clinical Research to-date Halneuron’s® Nav1.7 Inhibition Mechanism Supported by Real World Patient Experience
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NASDAQ: DWTX 12 Halneuron® Demonstrated Statistically Significant Pain Reduction Phase 2 CRP Study (n=165) 51% of cancer patients on Halneuron® experienced a ≥30% reduction in pain vs. 35% on Placebo TTX 1 Placebo 2 Difference Responder 3 33 51% 29 35% 16% Non-Responder 32 49% 55 65% Total 65 84 95% C. I. 0.4 - 32.1 p-value 0.046 Cancer Related Pain – 8 Injections over 4 days – long term follow-up every 15 days after primary endpoint A “Responder” was defined as a patient who had a mean reduction in pain intensity of ≥ 30%; or ≥ 50% reduction in opioid use
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NASDAQ: DWTX 13 Phase 2 CRP Study: Long Duration of Pain Relief Halneuron® Responders Responders to Halneuron® Responders to Placebo Placebo response was temporary 0 10 20 30 40 50 60 70 80 90 100 150 200 250 300 350 400 450 500 550 Days • A “Responder” is defined as a patient who had a mean reduction in pain intensity of ≥30% or a decrease of at least 50% of opioid use at endpoint • One-in-four (27%) Halneuron ® responders had pain relief for >30 days after 4 days of treatment Mean Pain Response For Halneuron® Responders Was 57.7 Days Vs 10.5 Days For Placebo Responders
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NASDAQ: DWTX 14 Phase 2a Dose CINP Finding Study (n=125) Signal-Seeking Study to Determine Phase 2b Dose and Administration Regimen • Randomized, double-blind, dose-finding, placebo-controlled, multicenter study evaluating efficacy and safety of Halneuron® in CINP patients ⎼ Tested 7.5 ug, 15 ug and 30 ug sub-Q injections in patients with neuropathic pain ⎼ Compared 30 ug BID x 4 days to 30 ug QD x 4 days • Results: ⎼ 30 ug results superior to lower doses and placebo ⎼ 30 ug BID vs QD showed comparable efficacy (with half the total amount of drug delivered) ⎼ 30 ug QD demonstrated a superior adverse event profile to BID dosing ⎼ Halneuron® showed an acceptable safety profile in CINP patients, similar to that seen in CRP • Conclusion: 30 ug dosed 1x day selected to advance to Phase 2b studies in CINP ⎼ Determined treatment ‘effect size’ used to power the Phase 2b study (i.e 0.4 units)
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NASDAQ: DWTX 15 Halneuron® Adverse Event Rates Across CINP Studies Adverse Event CINP 201 TTX 30 µg QD x 4 days N=25 N (%) CINP-201 Placebo x 4 days N=25 N (%) CINP-203 Blinded Summary: TTX 30µg QD + Placebo N=125 (%) Paresthesia oral (tingling or sensation in oral region) 10 (40.0%) 3 (12.0%) 51 (41%) Hypoesthesia oral (numbness or decreased sensation in oral region) 6 (24.0%) 3 (12.0%) 24 (19%) Paresthesia (tingling or sensation in extremities) 5 (20.0%) 6 (24.0%) 23 (18%) Headache 1 (4.0%) 5 (20.0%) 17 (14%) Nausea 1 (4.0%) 6 (24.0%) 16 (13%) Fatigue 5 (20.0%) 4 (16.0%) 9 (7%) Dizziness 3 (12.0%) 5 (20.0%) 6 (5%) Dysgeusia (taste distortion) 2 (8.0%) 0 (0%) 4 (3%) Pain in extremity 4 (16.0%) 2 (8.0%) 2 (1.6%) Burning sensation 1 (4.0%) 2 (8.0%) 2 (1.6%) Back pain 1 (4.0%) 3 (12.0%) 0 (0%)
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NASDAQ: DWTX 16 Ongoing Phase 2b CINP Study (HALT-CINP-203): 4-week Study Screening & Randomization Baseline Week 1 Week 2 Week 3 Week 4 Run-in Period Avg. of Days -7 to -1 8 Halneuron® or placebo treatment injections spaced over 2 weeks Primary Endpoint End of Study Primary Objective of the 4-Week Phase 2b study • To explore the safety and efficacy of Halneuron® in the treatment of patients with moderate-to-severe CINP Completed Phase 2b interim analysis for sample size and to choose the analytical method for the primary analysis for the statistical analysis plan • Committee consists of two senior statisticians not otherwise involved with our study • Interim analysis is based on change in pain from baseline compared to placebo • Statistical methodology based on >50% responder analysis • Sample size required to maintain 80-85% statistical power ranges from 210 to 240 patients Final HALT-CINP-203 Data Projected in Q3 2026
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17 Key Highlights from Phase 2b Interim Analysis (n=97) 97 patients completing Phase 2b study demonstrates that Halneuron Is separating from placebo, responders exhibit durable treatment pattern o Second cancer related pain trial exhibiting pain reduction via responder analysis o Halneuron treatment effect +/- concomitant pain meds also > placebo o Halneuron drop out rate (~4.4%) far below other compounds: duloxetine (20+%), pregabalin (30-40%) First randomized control clinical trial to demonstrate pain reduction effect in CINP patients conducted under FDA chronic pain guidance Halneuron treatment effect noteworthy given: o 5-year (mean) duration of moderate-to-severe neuropathic pain for Ph2b enrollees o Includes refractory CINP patients treated with other chronic pain medicines (67%) Next Steps: Dogwood plans on enrolling between 210 and 240 patients by the end of July 2026; this sample size would provide 80+% power to achieve a stat sig outcome via responder analysis.
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NASDAQ: DWTX 18 Halneuron® Intellectual Property Patent Name Type App/Patent # Date Filed Anticipated Expiry Stable Pharmaceutical Composition of Freeze-Dried Tetrodotoxin Powder Composition of Matter 8,124,608 7/14/2004 8/4/2028 Use of Sodium Channel Blockers for the Treatment of Neuropathic Pain Developing as a Consequence of Chemotherapy Method of Use 9,018,222 3/26/2007 3/18/2030 Sodium Channel Blocking Compounds Tetrodotoxin Galactopyranosides Composition/Method of Use 8,486,901 3/26/2010 4/7/2030 Tetrodotoxin Liquid Formulations Composition of Matter 18/556,683 4/22/2022 2042 Process For the Extraction and Purification of Tetrodotoxin Process 18/880,674 4/26/2023 2043 Process for the Synthesis of Tetrodotoxin and Intermediates Therefor Synthetic Mfg Process 63/672,146 11/28/2025 2046 Intermediates and Process for the synthesis of Tetrodotoxin Composition of Matter/Process 11/28/2025 2046
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SP16 IV Chemotherapy Induced Pain & Peripheral Neuropathy (CIPPN) Program Overview
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NASDAQ: DWTX 20 SP16 Target Background • Alpha 1 antitrypsin (A1AT) is a member of the serpin (serine protease inhibitor family) that plays a critical role in protecting the body from the damaging effects of powerful enzyme proteases, including neutrophil elastase • Neutrophil elastase is released by white blood cells, particularly during infection and inflammation, to help fight off pathogens and remove damaged cells ⎼ A1AT acts as an "off switch" or inhibitor for proteases including neutrophil elastase, preventing them from damaging healthy tissue • Serpin the company has discovered the active portion of A1AT responsible for this activity ⎼ SP16 is a 17 amino acid peptide containing the active portion of A1AT activating LRP1 ⎼ Isolated only the anti-inflammatory portion of A1AT (removed pro- inflammatory sequences) for higher potency (300x) • SP16 administered via IV formulation with two hypothesized actions: ⎼ Anti-inflammatory (analgesic) action via reduction of IL-6, IL-8, IL- 1β and TNF-alpha ⎼ Repairs tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation, and survival • Human PoC is the next stage of SP16 development
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NASDAQ: DWTX 21 SP16 LRP1 Mechanism of Action
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NASDAQ: DWTX 22 Preclinical Research Demonstrates SP16 Analgesic Effects Von Frey Mechanical Hypersensitivity Thermal Allodynia SP16 Reduced Both Mechanical and Cold Sensitivity in a Murine Model of Paclitaxel Induced Neuropathy
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NASDAQ: DWTX 23 SP16 Inhibits Pain Responses and Inflammation in Peripheral Nerve Injury Model Systemically administered SP16 treatment blocks the development of mechanical hypersensitivity • Tactile allodynia develops after peripheral nerve ligation and are sustained for 14 days • SP16(2μg/g) delivered daily (S.C.) significantly prevented the development of tactile allodynia for 9 days post-injury (**p<0.01)
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NASDAQ: DWTX 24 SP16 LRP1 Agonism Exhibits Potential to Prevent and/or Repair Nerve Damage Associated Chemotherapy • In collaboration with Dr. Wendy Campana at the University of California San Diego, SP16 was tested for its regenerative effects on neurons • Neurotrophic effects of SP16 and associated increase in regenerative genes in neurons [Wang, 2022] • SP16 was neuroprotective, activating neurite survival and growth, pro- regenerative genes and proteins, and protective signaling pathways • SP16 significantly increased neurite growth in the presence of paclitaxel Source: Wang et al., 2021 FASEB J Reparative Function of SP16
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NASDAQ: DWTX 25 In-vitro Assays in Several Cancer Types Shows SP16 Does Not Interfere with Common Chemotherapy Regimes In-vitro assays in breast and colon cancer shows SP16 does not interfere with the effectiveness of either platinum or taxane drugs In-vitro assays in pancreatic cancer cells shows SP16 does not interfere with the effectiveness of a topoisomerase 1 inhibitor
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26 NCI Funded SP16 Research Plan to be Finalized with FDA and Executed at University of VA Baseline Chemotherapy SP16 Low Dose n=6 SP16 Mid Dose n=6 SP16 High Dose n=6Placebo n=6 SP16 IV Phase 1b SP16 IV Phase 2a Eligible for NCI Funding Phase 1b Study Endpoints: • SP 16 Safety • SP 16 Prevention of CIPN • SP16 Pharmacokinetics • Chemotherapy Adherence NCI Funded Trial in collaboration with UVA Patient Population Up to 32 Metastatic Cancer Patients Experiencing Neuropathy from their Concurrent Chemotherapy SP-16 Placebo