Announcement • May 19
Dogwood Therapeutics, Inc. Announces Commencement of Halneuron Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study Dogwood Therapeutics, Inc. announced commencement of a new Halneuron chemotherapy induced neuropathic pain phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a Halneuron 12-week follow-on open-label extension study for patients completing the 4-week double-blinded treatment period. Several patients have already been enrolled in the new study that will assess the safety and efficacy of continued Halneuron treatment for an additional 3 months, using various dosing regimens. Data from the forthcoming extension trial will add to the data package the Company plans to submit to the FDA to support its planned Phase 3 development program, presently projected to start in the first half of 2027. Dogwood Therapeutics previously announced that a pre-planned interim analysis of the double-blinded Halneuron CINP Phase 2b study supported continuation of the study, with a sample size in the 210-240 range to achieve 80% power. This recommendation by an independent group of statisticians was based on the observed treatment difference between Halneuron-treated and placebo-treated patients amongst the 97 patients completing the trial. The double-blinded portion of the ongoing CINP study is expected to meet enrollment objectives to support release of top-line results in the fall of 2026. The current overall study dropout rate of under 5% is far below rates typically observed during other FDA-approved chronic pain clinical studies. Patients completing the ongoing CINP Phase 2b trial will be eligible to receive Halneuron for an additional 12 weeks to control their moderate-to-severe pain following chemotherapy treatment. A review of the demographics of the patients included in the interim analysis revealed that the mean duration of CINP for study enrollees exceeded five years, demonstrating the extraordinary medical need for novel new medicines to improve care for patients suffering from CINP. Currently, there are no FDA-approved treatments for CINP patients. 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 FDA for the treatment of CINP. Halneuron is a non-opioid, NaV 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. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) 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 chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute. Announcement • May 07
Dogwood Therapeutics, Inc. to Report Q1, 2026 Results on May 14, 2026 Dogwood Therapeutics, Inc. announced that they will report Q1, 2026 results Pre-Market on May 14, 2026 Announcement • Apr 25
Dogwood Therapeutics Announces Worldwide Development and Commercialization Partnership for Anti-Viral Assets Dogwood Therapeutics, Inc. had announced a global development and commercialization partnership with PRIDCor Therapeutics, LLC for Dogwood’s anti-viral candidates, IMC-1 and IMC-2. The agreement includes potential payments of up to $100 million to Dogwood and its current and former shareholders. Dogwood Therapeutics previously announced its intention to explore partnership opportunities to advance its combination antiviral drug candidates and shift its primary focus to advancing its NaV 1.7 inhibitor, Halneuron®, to treat both chronic and acute pain conditions. Dogwood subsequentially in-licensed SP16, administered via intravenous formulation, as a complement to its lead asset Halneuron®, further deepening the Company’s focus on developing new treatments for chemotherapy induced pain and neuropathy. Consistent with its prior announcement, Dogwood has entered into an agreement with PRIDCor pursuant to which PRIDCor will be fully responsible for financing and executing future development, commercialization and intellectual property maintenance for both IMC-1 and IMC-2. In exchange, Dogwood is entitled to a tiered royalty on net sales of up to 15% upon commercialization of IMC-1 or IMC-2. Further, Dogwood is entitled to 9% of all future capital raised by PRIDCor to advance IMC-1 or IMC-2, as well as future PRIDCor partnership-related development and regulatory payments associated with IMC-1 or IMC-2. Potential payments to Dogwood under the development partnership are capped at $100 million. To the extent that any payment to Dogwood resulting from the development partnership constitutes either an “Upfront Payment” or a “Milestone Payment” under the terms and conditions applicable to the contingent value rights (“CVRs”) issued by Dogwood on October 17, 2024, Dogwood will cause any required amounts to be delivered to the rights agent for further payment to holders of the CVRs. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. 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 FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) 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 chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute. 
