Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [2] - The company has two main research platforms: a non-opioid analgesic program and an antiviral program [2] Product Pipeline - The lead candidate in the non-opioid analgesic program is Halneuron, which targets voltage-gated sodium channels to reduce pain transmission [2] - Halneuron has shown pain reduction in clinical studies related to general cancer and chronic chemotherapy-induced neuropathic pain, with interim data from the ongoing Phase 2 CINP study expected in Q4 2025 [2] Antiviral Program - The antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib [3] - IMC-1 is advancing to Phase 3 development for fibromyalgia and is a focus for external partnerships [3] - IMC-2 has demonstrated successful fatigue reduction in Long-COVID patients and is set to progress into Phase 2b research following FDA agreement on using fatigue reduction as the primary endpoint [3] Upcoming Events - CEO Greg Duncan will present a corporate overview at the Sidoti Small-Cap Virtual Conference on June 11-12, 2025, and will be available for one-on-one meetings [1]

Core Viewpoint - Dogwood Therapeutics, Inc. is advancing its Halneuron® Chemotherapy Induced Neuropathic Pain Phase 2b study, with interim data expected in Q4 2025, while maintaining a strong financial position with $17.5 million in cash to support operations through Q1 2026 [1][6]. Company Developments - The company has commenced dosing patients in the Halneuron® Phase 2b study, which aims to be the first FDA-approved therapy for chemotherapy-induced neuropathic pain [6]. - Halneuron® has received fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain [6]. - An affiliate of the largest shareholder converted a $19.5 million loan into equity, enhancing the company's balance sheet [6]. - A recent capital raise of $4.8 million, combined with existing cash, provides operational runway through Q1 2026 [6]. Financial Performance - Research and development expenses for Q1 2025 were $2.4 million, a significant increase from $0.3 million in Q1 2024, primarily due to the business combination with Pharmagesic and increased clinical trial expenses [5]. - General and administrative expenses rose to $2.0 million in Q1 2025 from $1.0 million in Q1 2024, driven by higher legal and accounting fees [7]. - The net loss attributable to common stockholders for Q1 2025 was $12.2 million, compared to a net loss of $1.3 million in Q1 2024, reflecting a substantial increase in operational costs [8][14]. Research Pipeline - The proprietary pipeline includes Halneuron® as a non-opioid NaV 1.7 inhibitor for pain conditions, with interim data from the ongoing Phase 2b study expected in Q4 2025 [9]. - IMC-1 and IMC-2 are antiviral treatments in development, with IMC-1 ready for Phase 3 for fibromyalgia and IMC-2 in Phase 2a for Long-COVID [10].

Core Points - Dogwood Therapeutics has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million [1][2] - The company has a strong cash position of $17.5 million as of the end of Q1 2025 and is currently dosing patients in its Halneuron Phase 2b trial for chemotherapy-induced neuropathic pain [2][3] - Interim data from the ongoing Halneuron Phase 2 CINP study is expected in Q4 2025 [3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on new medicines for pain and fatigue-related disorders [3] - The company has two mechanistic platforms: a non-opioid analgesic program and an antiviral program [3][4] - The lead candidate, Halneuron, is a voltage-gated sodium channel modulator effective in reducing pain transmission, with demonstrated pain reduction in cancer-related and chemotherapy-induced neuropathic pain [3] Antiviral Program - The antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and celecoxib [4] - IMC-1 is advancing to Phase 3 development for fibromyalgia, while IMC-2 has shown successful fatigue reduction in Long-COVID trials [4] - The company has agreed with the FDA to use fatigue reduction as the primary endpoint for future Long-COVID research and plans to advance IMC-2 into Phase 2b research [4]

Core Viewpoint - Dogwood Therapeutics, Inc. has made significant advancements in its Halneuron CINP Phase 2b study and improved its financial position through a recent capital raise and debt-to-equity conversion, positioning the company as an attractive investment opportunity moving forward [2][6]. Financial Performance - Research and development expenses for Q4 2024 were $2.3 million, up from $0.3 million in Q4 2023, primarily due to increased clinical trial costs [5]. - General and administrative expenses for Q4 2024 were $5.2 million, compared to $0.8 million in Q4 2023, largely due to nonrecurring transaction costs related to the acquisition of Pharmagesic [8]. - The net loss attributable to common stockholders for Q4 2024 was $8.2 million, or $6.29 per share, compared to a net loss of $1.1 million, or $1.43 per share, in Q4 2023 [9]. Pipeline Development - Halneuron is in Phase 2b development as a non-opioid NaV 1.7 inhibitor for chemotherapy-induced neuropathic pain (CINP) and has received fast track designation from the FDA [4]. - IMC-1 is ready for Phase 3 development as a treatment for Fibromyalgia (FM) and has also received fast track designation from the FDA [4]. - IMC-2 is in Phase 2a development as a combination antiviral treatment for Long-COVID, with plans to seek external funding or partnerships for further development [4]. Capital and Liquidity - The company raised $4.8 million in common stock and converted $19.5 million in debt to equity, enhancing its balance sheet and providing operational runway through Q1 2026 [7][12]. - As of December 31, 2024, Dogwood Therapeutics had cash totaling $14.8 million, indicating sufficient resources to fund operations through early 2026 [12][19].

Core Insights - Dogwood Therapeutics is advancing Halneuron, a first-in-class, non-opioid treatment for chemotherapy-induced neuropathic pain (CINP), with the first patient dosed in its Phase 2b clinical trial [1][2] - The global market for CINP treatment is valued at $1.5 billion, indicating significant commercial potential for effective non-opioid therapies [1] - Halneuron specifically targets the NaV 1.7 sodium channel, which is crucial in pain transmission, and has shown a statistically significant reduction in cancer-related pain in previous trials [2][3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating non-opioid treatments for pain and fatigue-related disorders [3] - The company has a research pipeline that includes a non-opioid analgesic program centered on Halneuron and an antiviral program targeting conditions related to herpesvirus reactivation [4] - Halneuron has been evaluated in over 700 patients across Phase 1 and Phase 2 studies, demonstrating no signs of addiction potential [2] Clinical Development - The company aims to recruit 100 patients for the HALT-CINP trial by Q4 2025, with plans for an interim analysis to adapt the trial design if necessary [3] - Interim data from the Phase 2 CINP study is expected in the second half of 2025, which will provide insights into the efficacy of Halneuron [3] Antiviral Program - Dogwood's antiviral program includes IMC-1 and IMC-2, which are novel combinations of anti-herpes antivirals and celecoxib, targeting conditions like fibromyalgia and Long-COVID [4] - IMC-1 is set to progress to Phase 3 development for fibromyalgia, while IMC-2 has shown success in reducing fatigue associated with Long-COVID in clinical trials [4]

Core Points - Dogwood Therapeutics, Inc. has entered into a securities purchase agreement to sell 578,950 shares of common stock at $8.26 per share, expecting gross proceeds of approximately $4.8 million [1][2] - The net proceeds will be used to advance the clinical development of its lead candidate, Halneuron®, and for working capital and general corporate purposes [1] - The offering is expected to close on March 14, 2025, subject to customary closing conditions [1] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on non-opioid treatments for chronic and acute pain [5] - The company’s lead candidate, Halneuron, is a voltage-gated sodium channel modulator aimed at reducing pain transmission, with interim data from its Phase 2b trial expected in Q4 2025 [5] - Dogwood also has an antiviral program that includes IMC-1 and IMC-2, targeting conditions related to herpesvirus reactivation, with IMC-1 progressing to Phase 3 for fibromyalgia and IMC-2 advancing to Phase 2b for Long-COVID [6]

Largest shareholder, CK Life Sciences Int’l., (Holdings) Inc. agrees to conversion of debt into equity, removing all existing debt from Dogwood’s balance sheetATLANTA, March 12, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a development-stage biopharmaceutical company focused on advancing first-in-class, non-opioid, treatments for chronic and acute pain, announces that its largest shareholder, CK Life Sciences Int’l., (Holdings), Inc. (“CKLS”) has agreed, ...