Core Insights - Dogwood Therapeutics has achieved over 50% enrollment in its HALT-CINP Phase 2b trial for chemotherapy-induced neuropathic pain, with top line results expected in Q3 2026 [1][4] - The low early termination rate of 4.3% among the first 116 patients indicates that the Halneuron treatment is well tolerated [1][2] - If successful, Halneuron could become the first approved therapy for chemotherapy-induced neuropathic pain, addressing a significant unmet medical need [2] Enrollment and Study Design - The HALT-CINP trial is designed to provide over 80% statistical power to detect treatment differences between Halneuron and placebo upon unblinding in Q3 2026 [3] - The trial involves 8 subcutaneous doses of Halneuron or placebo over 14 days, with a total follow-up of 28 days to assess safety and effectiveness [4] Interim Results - An interim analysis of 97 patients showed that those treated with Halneuron demonstrated significant pain improvement compared to placebo, with an average duration of chemotherapy-induced neuropathic pain of 5 years [2] - The overall dropout rate of approximately 4.0% is significantly lower than typical rates observed in studies of other FDA-approved chronic pain medications [2] Company Overview - Dogwood Therapeutics is focused on developing new medicines for pain and neuropathic disorders, with Halneuron as its lead product candidate currently in Phase 2b development [5] - Halneuron has received fast track designation from the FDA for treating chemotherapy-induced neuropathic pain and is a non-opioid analgesic targeting voltage-gated sodium channels [5] Future Developments - The company is also developing SP16 IV, which has potential applications in treating neuropathy and repairing nerve damage following chemotherapy, with funding from the National Cancer Institute for its upcoming Phase 1b trial [5]

Core Viewpoint - Dogwood Therapeutics, Inc. has entered into a securities purchase agreement for up to approximately $12.5 million in gross proceeds through a registered direct offering and a concurrent private placement, aimed at advancing the development of its non-opioid medicines for pain and neuropathy treatment [1][3] Group 1: Offerings Details - The offerings consist of the issuance of 4,386,037 shares of common stock and warrants to purchase an equal number of shares, priced at $2.85 per share [1][2] - The registered offering includes 2,338,948 shares of common stock, while the private offering includes pre-funded warrants for 2,047,089 shares and warrants for 4,386,037 shares [2] Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized to advance the clinical development of Halneuron® and for working capital and general corporate purposes [3][4] - The company aims to support the ongoing Phase 2b final data readout for Halneuron® and pursue strategic opportunities to enhance its research portfolio [3] Group 3: Company Overview - Dogwood Therapeutics is focused on developing new non-opioid medicines for pain and neuropathic disorders, with its lead product candidate Halneuron® currently in Phase 2b development for chemotherapy-induced neuropathic pain [8] - Halneuron® has received fast track designation from the FDA, and the company also has another candidate, SP16 IV, which is set to enter a Phase 1b trial funded by the National Cancer Institute [8]

Core Insights - Dogwood Therapeutics, Inc. announced positive interim results from its Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP), showing significant pain improvement compared to placebo [1][3] - The company expects to release top-line results in Q3 2026, with current enrollment trends indicating a statistical power of approximately 80% to 85% [2] - Halneuron is a non-opioid NaV 1.7 inhibitor, which has received fast track designation from the FDA for treating CINP, and aims to provide a new therapeutic option for cancer survivors [4][6] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating new medicines for pain and neuropathic disorders, with Halneuron as its lead product candidate [5] - The company also has another candidate, SP16 IV, which targets neuropathy and nerve damage repair following chemotherapy [7] Clinical Study Details - The Phase 2b study involved 97 patients, with a dropout rate of approximately 4.4%, significantly lower than typical rates for FDA-approved chronic pain medications [1][3] - The average duration of CINP among participants was 5 years, with 67% of patients concurrently using other chronic pain medications [3] Future Prospects - Positive outcomes from the ongoing Phase 2b trial could pave the way for a Phase 3 registration program for Halneuron, addressing a significant unmet need in treating moderate-to-severe neuropathic pain post-chemotherapy [4]

Core Viewpoint - Dogwood Therapeutics, Inc. is advancing its clinical trials and expanding its pipeline with a focus on pain management and neuropathy, reporting significant financial results for Q3 2025, including a notable increase in research and development expenses due to new initiatives and partnerships [2][3][5]. Financial Performance - Research and development expenses for Q3 2025 were $14.5 million, a substantial increase from $0.5 million in Q3 2024, primarily due to $12.0 million in acquired in-process research and development expenses related to the licensing of SP16 and increased clinical trial costs [3]. - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.8 million in Q3 2024, attributed to lower legal and accounting fees [4]. - The net loss attributable to common stockholders for Q3 2025 was $15.7 million, or $8.20 per share, compared to a net loss of $2.3 million, or $2.05 per share, in Q3 2024 [5]. Clinical Development - The company has enrolled 100 patients in the ongoing Halneuron Phase 2b trial, with 80 patients completing treatment, and plans to release an interim analysis in Q4 2025 [9]. - Halneuron is a non-opioid analgesic in Phase 2b development for chemotherapy-induced neuropathic pain, having received fast track designation from the FDA [7]. - SP16, a new pipeline asset, is a first-in-class candidate aimed at treating cancer-related pain and is fully funded for its Phase 1b study by the National Cancer Institute [2][10]. Pipeline Overview - The research pipeline includes two first-in-class candidates: Halneuron and SP16 IV, targeting pain and neuropathic disorders [6]. - SP16 IV acts as an LRP1 agonist, showing potential for anti-inflammatory effects and nerve damage repair in preclinical studies [8].

Core Insights - Dogwood Therapeutics has secured a royalty-free global license for Serpin Pharma's intravenous formulation of SP16 to manage cancer-related pain, particularly chemotherapy-induced neuropathy [2][3] - SP16 is a first-in-class LRP1 agonist that has shown both anti-inflammatory and neural repair activity, with a Phase 1b study fully funded by the National Cancer Institute set to begin patient enrollment in the first half of 2026 [1][3] - The licensing agreement includes the issuance of shares representing 7.31% of Dogwood's common stock on a fully diluted basis [10] Company Developments - The CEO of Dogwood Therapeutics emphasized that the SP16 in-license aligns with the company's strategic objective to expand its research pipeline in pain and neuropathy management [4] - Halneuron, Dogwood's lead product candidate, is currently in Phase 2b development for treating chemotherapy-induced neuropathic pain and has received fast-track designation from the FDA [7][13] - Interim data from the ongoing Halneuron Phase 2b study is expected in December 2025, with over eighty patients already recruited [7][14] Research and Clinical Insights - SP16 IV mimics the anti-inflammatory and immunomodulatory actions of alpha-1-antitrypsin, showing promise in addressing symptoms and damage associated with chemotherapy-induced peripheral neuropathy [4][8] - The combination of SP16 with Halneuron may provide adjunctive improvement for non-pain symptoms related to cancer treatment [6] - The unique approach of SP16 reflects the significant unmet medical need in managing cancer-related pain and neuropathy [3][4]