Star Metro - 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

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:

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SOURCE: Dogwood Therapeutics, Inc.

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