Dogwood Therapeutics, Inc. Chief Medical Officer, Dr. Michael Gendreau, to Present an Overview of the Halneuron® Pain Research Program at the 19th Annual Pain Therapeutics Summit

Rhea-AI Summary

Dogwood Therapeutics (Nasdaq:DWTX) announced that its Chief Medical Officer will present an overview of the Halneuron® (tetrodotoxin) pain research program at the 19th Annual Pain Therapeutics Summit on October 14, 2025.

Halneuron is a highly purified TTX formulation in development for chemotherapy‑induced neuropathic pain (CINP). A preclinical CINP study found Halneuron and VX‑548 each rapidly suppressed mechanical allodynia, with Halneuron showing comparable or greater pain reduction and the combination showing no additive benefit. Over 700 patients have received TTX in human studies. Halneuron showed pain reduction in prior Phase 2 studies and is being evaluated in a Phase 2b HALT‑CINP trial at 25 U.S. sites to assess low‑dose injectable safety and efficacy.

Insights

Clinical Development Expert

Halneuron® moves through Phase 2b with supportive preclinical and Phase 2 signals; key readouts remain the ongoing trial and upcoming presentation on October 14, 2025.

Dogwood advances Halneuron® (tetrodotoxin) as a targeted Nav 1.7 modulator for chemotherapy induced neuropathic pain (CINP). The release describes a preclinical head-to-head and combination study versus a Nav 1.8 agent (VX-548) showing rapid, significant suppression of mechanical allodynia in rats, with Halneuron® matching or exceeding VX-548 and no additive effect when combined.

The program rests on prior human exposure (>700 patients) and Phase 2 signals in cancer pain and CINP; the company now runs a multicenter Phase 2b (HALT-CINP) across 25 US sites to evaluate low-dose injectable safety and efficacy. The main dependencies are the randomized trial's blinded efficacy readouts and safety profile; without those results the preclinical and earlier Phase 2 data remain supportive but non‑conclusive. Watch the October 14, 2025 presentation for mechanistic details and the HALT-CINP timing and endpoints as the next concrete milestones within a typical clinical-readout horizon of months to a few quarters.

ATLANTA, GEORGIA / ACCESS Newswire / October 7, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development-stage biotechnology company developing new medicines to treat pain, today announced that its Chief Medical Officer will present an overview of the Halneuron^®(tetrodotoxin) pain management research program at the 19^th Annual Pain Therapeutics Summit on October 14, 2025.

Dogwood Therapeutics is developing Halneuron^®, a highly purified version of tetrodotoxin, to treat Chemotherapy Induced Neuropathic Pain ("CINP"), or peripheral neuropathic pain that occurs after chemotherapy with certain agents. Tetrodotoxin ("TTX") is a potent and specific modulator of the Na_v 1.7 sodium channel that is directly involved in pain transmission in the peripheral nervous system. Voltage Gated Sodium Channels (VSCGs) Na_v 1.7, Na_v 1.8 and Na_v 1.9 all play key roles in the perception and transmission of pain signals within the peripheral nervous system. Current research suggests that the Na_v 1.7 channel is a key regulator of the threshold for depolarization of sensory neurons, whereas changes in Na_v 1.8 regulate the rate of repolarization of sensory neurons. A recently conducted pre-clinical study compared the efficacy of Halneuron (Na_v 1.7 modulator) and VX-548 (Na_v 1.8 modulator) in rats with CINP and investigated the potential additive efficacy of combining the two agents. Halneuron^® and VX-548 rapidly and significantly suppressed mechanical allodynia in this preclinical CINP model, with Halneuron^® demonstrating pain reduction comparable to or greater than VX-548. Notably, the combination did not show additive synergy in reducing pain in the rat model.

To date, over 700 patients have been treated in human clinical studies with TTX for a variety of potential indications. Halneuron^® has demonstrated pain reduction in general cancer related pain in a large multicenter Phase 2 study, as well as in a subsequent Phase 2 CINP study. Halneuron^® is currently being evaluated in a Phase 2b clinical trial (HALT-CINP) being conducted at 25 sites in the United States. The goal of this study is to assess the safety and efficacy of low dose injectable Halneuron^® in reducing long standing CINP in cancer patients.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary, non-opioid, Na_V 1.7 analgesic program is centered on our lead development candidate, Halneuron^®, 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 a reduction in pain related to both general cancer and chronic CINP. Interim data from the ongoing Halneuron^® Phase 2 CINP study are expected in Q4 of 2025.

Dogwood is also developing SP16 IV, an LRP1 agonist with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial, which has been fully funded by the National Cancer Institute, is projected to commence enrolling patients in the first half of 2026.

For more information, please visit www.dwtx.com.

Forward-Looking Statements:

Statements in this press release 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 press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "suggest," "target," "aim," "should," "will," "would," 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 Dogwood's current expectations 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, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.

Investor Relations:

CORE IR
(516) 222-2560
IR@dwtx.com

SOURCE: Dogwood Therapeutics, Inc.

View the original press release on ACCESS Newswire

FAQ

When will Dogwood Therapeutics (DWTX) present at the Pain Therapeutics Summit?

The company's Chief Medical Officer will present on October 14, 2025.

What is Halneuron (DWTX) being developed to treat?

Halneuron (tetrodotoxin) is being developed to treat chemotherapy‑induced neuropathic pain (CINP).

What did the preclinical CINP study say about Halneuron versus VX‑548?

In the rat CINP model, both Halneuron and VX‑548 rapidly suppressed mechanical allodynia; Halneuron showed comparable or greater pain reduction and the combination showed no additive synergy.

How many patients have been treated with tetrodotoxin in human studies for DWTX programs?

More than 700 patients have been treated with TTX across various human clinical studies.

What clinical trials is Halneuron currently in for DWTX?

Halneuron is currently being evaluated in a Phase 2b HALT‑CINP trial conducted at 25 sites in the United States.

What is the goal of the HALT‑CINP Phase 2b trial (DWTX)?

The trial aims to assess the safety and efficacy of low‑dose injectable Halneuron in reducing long‑standing CINP in cancer patients.