Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39811 DOGWOOD THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 85-4314201 (State of Other Jurisdiction of incorporation or Or ...

Financial Performance - Net loss attributable to common stockholders for Q4 2025 was $3.8 million, or $0.26 per share, compared to a net loss of $8.2 million, or $6.29 per share, in Q4 2024[6]. - The net loss for the full year 2025 was $35.5 million, or $7.13 per share, compared to a net loss of $12.9 million, or $12.52 per share, in 2024[9]. Expenses - Research and development expenses for Q4 2025 were $2.3 million, consistent with Q4 2024[4]. - Full year 2025 research and development expenses increased to $21.8 million from $3.5 million in 2024, driven by acquired in-process research and development expenses and clinical trial costs[7]. - General and administrative expenses for Q4 2025 decreased to $1.5 million from $5.2 million in Q4 2024, primarily due to a reduction in nonrecurring transaction costs[5]. - Full year 2025 general and administrative expenses were $6.1 million, down from $8.7 million in 2024, mainly due to lower transaction costs[8]. Cash Position - As of December 31, 2025, cash and cash equivalents totaled $6.5 million, expected to fund operations through the Phase 2b final data readout[10]. Clinical Trials - The Halneuron® Phase 2b trial has enrolled 143 patients, with top-line results expected in Q3 2026[2]. Financing - A financing of up to $26.9 million was completed in January 2026, with gross proceeds of $12.5 million received[5]. Regulatory Designation - Halneuron® has received fast track designation from the FDA for treating chemotherapy-induced neuropathic pain[13].

ATLANTA, March 18, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced financial results for the fourth quarter and full year ended December 31, 2025. “The Company continues to execute at a high level, including recruitment of 143 patients in our ongoing Halneuron® Phase 2b trial, commencement of a Phase 2b extension trial and the recent execution of a financing to ...

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 Viewpoint - Changjiang Life Sciences Technology (0775.HK) announced positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by its biopharmaceutical subsidiary Dogwood Therapeutics (DWTX.US) [1] Group 1 - The independent statistical review committee analyzed data from 97 patients who completed treatment and found a positive difference in pain improvement between patients receiving Halneuron and those receiving a placebo [1] - The current recruitment trend for the Phase 2b trial is expected to provide approximately 80% to 85% statistical power to detect differences in Halneuron treatment [1] - Dogwood anticipates obtaining preliminary results by the third quarter of 2026 based on the current recruitment pace and interim assessment results [1] Group 2 - The results of the independent interim analysis have strengthened the company's confidence that Halneuron could provide a treatment option for CINP patients, where standard therapies are currently lacking [1] - The analysis supports the strategic vision of the group to develop pain and related condition medications through Dogwood [1]

Group 1 - The core announcement is regarding the positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by Dogwood Therapeutics, Inc. [1] - The study involved 97 patients who completed treatment, showing a significant difference in pain improvement between those receiving Halneuron and those on placebo [1]. - The average duration of CINP among the study participants was 5 years, with 67% of patients concurrently on stable doses of other chronic pain medications [2]. Group 2 - The overall dropout rate for the study was approximately 4.4%, which is significantly lower than the dropout rates of other FDA-approved chronic pain medications [2]. - Dogwood anticipates obtaining preliminary results by Q3 2026, based on the current recruitment pace and interim analysis results, with an expected statistical power of 80% to 85% to detect treatment differences [2]. - Dogwood is a development-stage biopharmaceutical company focused on developing new drugs for pain relief and neuropathic symptoms, holding approximately 83% indirect equity interest in Dogwood [2].

Group 1 - The core announcement is regarding the positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by Dogwood Therapeutics, Inc. [1] - The study involved 97 patients who completed treatment, showing a significant difference in pain improvement between those receiving Halneuron and those on placebo [1] - Dogwood emphasizes that the preliminary evidence of Halneuron's effectiveness is noteworthy, especially considering that 67% of the patients were concurrently on stable doses of other chronic pain medications [2] Group 2 - The overall dropout rate for the study was approximately 4.4%, which is significantly lower than the dropout rates of other FDA-approved chronic pain medications [2] - Despite being in a blinded phase, Dogwood believes the findings reaffirm the encouraging safety and tolerability observed in previous clinical trials of Halneuron [2] - The company anticipates obtaining preliminary results by Q3 2026, with the current study expected to provide about 80% to 85% statistical power to detect treatment differences [2] Group 3 - Dogwood Therapeutics is a development-stage biopharmaceutical company registered in Delaware and listed on the NASDAQ under the ticker DWTX, focusing on developing new drugs for alleviating pain and neurological discomfort [2] - The company currently holds approximately 83% indirect equity interest in Dogwood [2]

Core Insights - Changjiang Life Sciences Technology (00775.HK) announced the latest developments regarding its investment in Dogwood Therapeutics, Inc. (DWTX), a biopharmaceutical company focused on developing new drugs for pain relief and neuropathic symptoms, holding approximately 83% indirect equity in Dogwood [1] Group 1: Clinical Trial Results - Dogwood reported positive mid-term analysis results from its ongoing Phase 2b study of Halneuron® for chemotherapy-induced neuropathic pain (CINP), with 97 patients completing treatment [1] - The independent statistical review committee found a significant difference in pain improvement between patients treated with Halneuron® and those receiving a placebo during the four-week study [1] Group 2: Patient Demographics and Treatment Context - The average duration of CINP among patients in the mid-term analysis was 5 years, with 67% of eligible patients concurrently receiving stable doses of other chronic pain medications, including pregabalin, gabapentin, duloxetine, and opioids [2] - The overall dropout rate for the study was approximately 4.4%, significantly lower than the dropout rates of other FDA-approved chronic pain medications [2] Group 3: Future Expectations - Dogwood anticipates obtaining preliminary results from the Phase 2b trial by the third quarter of 2026, based on current recruitment speed and mid-term evaluation results [2] - The ongoing study is expected to provide approximately 80% to 85% statistical power to detect treatment differences for Halneuron® [2]

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]