Dogwood Therapeutics (DWTX) Study Update summary

Halneuron Phase II-B Study Update

• Halneuron, a Nav1.7 sodium channel inhibitor, is in an ongoing Phase II-B trial for chemotherapy-induced neuropathic pain (CINP), with FDA Fast Track designation, 82 patients enrolled, and a target of 200 patients.

• Interim analysis for Halneuron is expected in Q4 or December 2025, with final data anticipated by mid-2026.

• Previous Phase II studies showed pain reduction, no evidence of addiction or tolerance, and a strong safety profile in over 700 patients.

• The trial's primary endpoint is pain reduction at week 4, with secondary endpoints including global health, fatigue, sleep, anxiety, depression, and neuropathic symptom inventories.

• Halneuron's success could expand its use to broader cancer-related and post-surgical pain indications.

SP16 Licensing and Clinical Development

• An exclusive, global, royalty-free, all-stock license was secured for SP16, a first-in-class IV LRP1 agonist with anti-inflammatory and analgesic effects, to complement Halneuron.

• SP16's Phase I-B trial for chemotherapy-induced neuropathy is fully funded by the National Cancer Institute, with IND filing planned for Q4 2025 and patient enrollment projected for 1H 2026.

• The Phase I-B study will enroll up to 32 metastatic cancer patients, focusing on safety, prevention of CIPN, pharmacokinetics, and chemotherapy adherence, with secondary neuropathy endpoints.

• Serpin Pharma receives 7.31% equity in the company, with no future royalties or milestone payments, subject to shareholder approval.

• Webcast presentation scheduled for September 29, 2025, to discuss the transaction and development plans.

Mechanism and Synergy of Halneuron and SP16

• Halneuron inhibits peripheral pain signaling, while SP16 activates LRP1 to reduce inflammation and promote cell survival.

• SP16 is a 17-amino acid peptide derived from alpha-1 antitrypsin, targeting LRP1 to restore cellular homeostasis after chemotherapy-induced damage.

• Preclinical studies show SP16 reduces mechanical and temperature hypersensitivity, supports nerve recovery, and blocks development of tactile allodynia in animal models.

• SP16 does not diminish the anti-cancer effects of chemotherapy agents or promote tumor growth in preclinical studies.

• The two assets are expected to be complementary, addressing both pain and broader neuropathy symptoms, with potential for combination therapy.