Dogwood Therapeutics (DWTX) investor relations material

Halneuron Phase 2b Study Update

• Halneuron, a Nav1.7 sodium channel inhibitor, is in an ongoing Phase 2b trial for chemotherapy-induced neuropathic pain (CINP), with FDA Fast Track designation and a target enrollment of 200 patients; interim analysis is expected in Q4 or December 2025.

• Over 82 patients have been enrolled, with more than 50 completing the study and only two dropouts, indicating a strong safety profile.

• The study assesses pain reduction and global health metrics, with primary endpoint being change in pain intensity at week 4 and secondary endpoints including fatigue, sleep, and neuropathic pain symptom inventory.

• Halneuron has shown pain reduction in previous Phase 2 studies, with responders experiencing mean pain relief of about 2 months and no evidence of addiction, euphoria, or tolerance in over 700 patients.

• Both assets are positioned for independent and combination development, with multiple revenue pathways possible.

SP16 Program and Clinical Development

• SP16 is a first-in-class LRP1 agonist with anti-inflammatory and analgesic effects, licensed via an exclusive, worldwide, royalty-free, all-stock transaction.

• The Phase 1b trial for SP16, fully funded by the National Cancer Institute, will enroll up to 32 metastatic cancer patients with neuropathy, with IND filing planned for Q4 2025 and patient dosing in 1H 2026.

• Preclinical studies show SP16 reduces cytokine-driven inflammation, promotes cell survival and nerve regeneration, and does not interfere with chemotherapy efficacy or promote tumor growth.

• SP16 has been tested in other human studies for different indications, with two open INDs at Serpin.

• The transaction grants Serpin Pharma 7.31% of the company's common stock, subject to shareholder approval.

Strategic Rationale and Future Milestones

• The combination of Halneuron and SP16 targets both pain and broader neuropathy symptoms, offering complementary and potentially synergistic mechanisms.

• The global CINP market is estimated at $1.5 billion, with potential expansion into broader cancer pain markets.

• Key upcoming milestones include Halneuron's interim analysis in Q4 or December 2025, final data in mid-2026, and SP16's IND filing and Phase 1b enrollment in 1H 2026.

• The SP16 deal strengthens the pipeline with no future royalty or milestone payments required, and reduces near-term capital requirements due to NCI funding.

• The company aims for deeper market penetration and bundled protocols with cancer centers, leveraging late-stage development experience.