Core Insights - Dogwood Therapeutics, Inc. has successfully enrolled the first 100 patients in its ongoing HALT-CINP Phase 2b CINP trial, indicating progress in its clinical development efforts [1] - The continued low early termination rate among the first 80 study completers suggests that both Halneuron® and placebo treatment have been well tolerated, reflecting positively on the safety profile of the treatments being tested [1] - An interim analysis is scheduled for the fourth quarter of 2025, focusing on patients who have completed or been terminated from the four-week study, which will provide insights into the trial's efficacy and safety [1]

Core Insights - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain management [1] - The Chief Medical Officer will present the Halneuron® pain management research program at the 19th Annual Pain Therapeutics Summit on October 14, 2025 [1] - Halneuron® is a highly purified version of tetrodotoxin aimed at treating Chemotherapy Induced Neuropathic Pain (CINP) [1] Company Overview - Dogwood Therapeutics is engaged in the development of innovative treatments for pain, specifically targeting conditions arising from chemotherapy [1] - The company is in the development stage, indicating ongoing research and potential future product offerings [1] Research Program Details - The Halneuron® program focuses on addressing peripheral neuropathic pain that occurs after chemotherapy with certain agents [1] - The presentation at the Pain Therapeutics Summit will provide insights into the research and development progress of Halneuron® [1]

Halneuron® Program - Halneuron® is undergoing a 4-week Phase 2b CINP study, with 80 patients currently randomized to treatment[7] - The Phase 2b study aims to assess the safety and efficacy of Halneuron® in treating moderate-to-severe CINP[9] - The target enrollment for the Phase 2b study is 200 patients, with a potential modification after an interim analysis in Q4 2025[11] - Halneuron® has shown pain relief of approximately 2 months in previous Phase 2 studies, with acceptable safety in over 700 patients[6] - The company plans to file new synthetic Halneuron® IP in Q4 2025 to support Phase 3 and commercialization[39] SP16 Program - The company acquired a royalty-free, global license for Serpin Pharma's SP16 IV formulation to treat neuropathy[13] - Serpin Pharma will receive approximately 382,000 common shares and approximately 179 preferred (A-2) shares, representing a projected 7.31% ownership of DWTX stock on a fully diluted basis, pending a shareholder vote[16] - CKLS ownership is projected to be approximately 83.00% on a fully diluted basis[16] - SP16 is poised to enter a Phase 1b study for CIPN, fully funded by the National Cancer Institute (NCI), with patient enrollment expected to begin in the first half of 2026[13,39] Strategic Rationale - The combined Halneuron® and SP16 programs aim to penetrate the global CINP treatment market, estimated at approximately $1.5 billion[38]

Group 1 - The company, Changjiang Life Sciences Technology, has announced a transaction involving the issuance of common and preferred shares to acquire 100% equity of Pharmagesic (Holdings) Inc, with specific rights related to cash settlement and buyback options for the preferred shares [1] - The transaction will lead to a business merger with WEX, allowing access to the buyer's extensive experience in biotech fundraising, R&D, and commercialization in the pharmaceutical sector, particularly for pain relief and related diseases [2] - The flagship candidate product, Halneuron®, is expected to advance its clinical trial data and market entry due to the integration of the buyer's expertise and resources [2] Group 2 - The buyer's listing on NASDAQ will facilitate access to the U.S. capital markets, enabling faster R&D for Halneuron® and increasing the company's stake in the buyer to approximately 90% after conversion of preferred shares [3] - Partial waivers of cash settlement and buyback rights for the preferred shares will help the buyer meet NASDAQ shareholder equity requirements while maintaining its listing status [3] - The buyback rights associated with the preferred shares allow the seller to repurchase all Halneuron assets in exchange for cash settlement amounts, ensuring that partial waivers do not affect the seller's rights to repurchase [3]

Summary of Dogwood Therapeutics (DWTX) FY Conference Call Company Overview - **Company Name**: Dogwood Therapeutics - **Industry**: Biotechnology - **Focus**: Development of novel non-opioid pain treatments targeting the NAV1.7 sodium channel for chronic pain management, particularly in cancer-related pain and chemotherapy-induced neuropathic pain [1][2][3] Core Product: Halneuron® - **Description**: Halneuron® is a NAV1.7 inhibitor, an injectable therapy aimed at reducing pain associated with cancer and chemotherapy-induced neuropathy [1][5] - **Clinical Stage**: Currently in phase 2b study [1] - **Target Patient Group**: Patients experiencing moderate to severe neuropathic pain post-chemotherapy, with about 70% of chemotherapy patients experiencing neuropathy [2][10] Clinical Data and Results - **Unmet Medical Need**: High demand for effective treatments for cancer-related pain, with millions of patients suffering globally [10] - **Study Results**: - 51% of patients treated with Halneuron® showed a 30% reduction in pain, and a 50% reduction in opioid use [11] - Placebo response rate was 35%, indicating Halneuron®'s effectiveness [11] - Durable effect observed, with patients experiencing pain relief for an average of 58 days post-treatment compared to one week for placebo [12] - **Current Phase 2b Study**: - 200 patients, assessing Halneuron® administered once daily over two weeks [14] - Primary endpoint assessed 30 days after the first dose [14] - Interim results expected by December 2025, with final results projected for mid-2026 [18][19] Regulatory Strategy - **FDA Interaction**: The company has established a good relationship with the FDA, aiming for a collaborative approach to drug approval [24] - **Fast-Track Designation**: Halneuron® has received fast-track review designation from the FDA due to its novel approach and high unmet medical need [15] Intellectual Property (IP) and Commercial Strategy - **Current IP**: Based on the unique process of collecting tetrodotoxin from pufferfish, with plans to file new IP for a synthetic formulation [29] - **Commercialization Strategy**: The company is open to partnerships but prioritizes data-driven decisions for maximizing shareholder value [30][31] Financial Position - **Cash Position**: Approximately $13.5 million on hand, sufficient to fund operations through Q1 of the following year [32] - **Burn Rate**: Low operational costs due to a small team of about 12-13 employees [32] Future Outlook - **Next Steps**: If phase 2b is successful, the company plans to initiate a phase 3 program in early 2027 and explore broader cancer-related pain studies [25][26] - **Potential Market**: With 20 million new cancer cases annually, the commercial opportunity for Halneuron® is significant [16] Additional Insights - **Team Experience**: The management team has a strong background in pain drug development, having successfully brought multiple pain medications to market [4][30] - **Synthetic Formulation**: Development of a synthetic version of tetrodotoxin is expected to improve yield, reduce costs, and enhance regulatory acceptance [21]

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 Viewpoint - Dogwood Therapeutics, Inc. has regained compliance with Nasdaq's minimum stockholders' equity requirement, positioning the company favorably for future growth and shareholder value enhancement [1][2]. Financial Position - As of the end of Q1 2025, Dogwood Therapeutics reported a strong cash position of $17.5 million with no debt, which supports its operational and strategic initiatives [2]. - The company had previously fallen below the $2.5 million minimum stockholders' equity requirement but has since taken steps to rectify this situation [2][3]. Compliance Actions - The company entered into a Debt Exchange and Cancellation Agreement with Conjoint, Inc., resulting in the cancellation of approximately $19.9 million in debt in exchange for shares of Series A-1 Non-Voting Convertible Preferred Stock [4]. - Additionally, Dogwood Therapeutics raised approximately $4.8 million through a stock purchase agreement with institutional investors [4]. Shareholder Information - As of March 31, 2025, there were 1,911,128 shares of the company's common stock issued and outstanding [5]. Research and Development - Dogwood Therapeutics is focused on developing new medicines for pain and fatigue-related disorders, with a research pipeline that includes a non-opioid analgesic program and an antiviral program [6]. - The lead candidate, Halneuron®, has shown promise in clinical studies for reducing pain related to cancer and chemotherapy-induced neuropathic pain, with interim data from ongoing studies expected in Q4 2025 [6]. - The antiviral program includes IMC-1 and IMC-2, targeting conditions related to dormant herpesvirus reactivation, with IMC-1 set to progress to Phase 3 development for fibromyalgia and IMC-2 advancing to Phase 2b research for Long-COVID [7].