Dogwood Announces Enrollment of First 100 Patients in Ongoing Halneuron(R) Phase 2b Trial, Interim Sample Size Analysis on Track for December 2025

- Continued low early termination rate among the first 80 study completers suggests Halneuron^® and placebotreatmenthave been well tolerated

ATLANTA, GEORGIA / ACCESS Newswire / November 11, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has successfully enrolled the first 100 patients in its ongoing HALT-CINP Phase 2b CINP trial. HALT-CINP remains on track to conduct a prespecified interim analysis during the fourth quarter of 2025 on patients who have completed or been terminated from the four-week study.

"High interest among cancer patients, significant unmet medical need and positive word of mouth among patients who have participated in the study have contributed to the brisk pace of recruitment in this landmark chemotherapy-induced neuropathic pain study," said R. Michael Gendreau, M.D., Ph.D., Dogwood Therapeutics Chief Medical Officer. "The primary goal of our fourth quarter interim analysis is to evaluate and adjust, if needed, the Phase 2b study sample size required to demonstrate statistically significant results. We are currently continuing with the original plan for a 200-patient sample size for this study, with final data available by the middle of 2026."

Halneuron CINP Phase 2b Trial ("HALT-CINP") Overview (NCT06848348)

HALT-CINPis a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron versus placebo in cancer patients with established neuropathy due to a previous platinum or taxane based chemotherapy regimen. Participants receive 8 sub-cutaneous doses of Halneuron or placebo over a 14-day period and will be followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores. The study is being conducted at approximately 25 sites in the US. Secondary measures will assess Halneuron's treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron and SP16 IV.

Our lead product candidate, Halneuron, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron has been granted fast track designation from the Food and Drug Administration ("FDA") for the treatment of CINP. Halneuron is a non-opioid, Na_V 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain ("CINP").