长江生命科技执行董事兼副主席余英才表示，此次独立中期分析的结果令人鼓舞，不仅加强公司对 Halneuron有望成为目前缺乏标准疗法的CINP患者提供治疗选择的信心，也印证集团透过策略性布局， 以Dogwood研发疼痛及相关病症药物的前瞻视野。 独立统计审查委员会审阅97名完成治疗患者的非盲法治疗数据后，所得结论乃于为期四星期的研究中， 就改善疼痛方面而言，接受Halneuron治疗的患者与接受安慰剂治疗的患者之间存在正面差异。根据目 前第2b期试验的招募速度及中期评估结果，Dogwood仍预计将在2026年第三季内获得初步结果。目前的 研究患者招募趋势预计将可提供约80%至85%的统计功效，以检测Halneuron治疗差异。 格隆汇12月23日｜长江生命科技(0775.HK)宣布，旗下处于发展阶段的生物制药公司Dogwood Therapeutics(DWTX.US)公布正在进行的Halneuron第2b期因化疗引致的神经痛症(chemotherapy-induced neuropathic pain，CINP)研究的中期分析取得正面结果。 ...

长江生命科技(00775)发布公告，有关公司在Dogwood Therapeutics,Inc.(Dogwood)的投资的最新进展。于 2025年12月22日，Dogwood宣布正在进行的Halneuron第二b期因化疗引致的神经痛症(CINP)研究中，97 名完成接受治疗的患者的中期分析取得正面结果。独立统计审查委员会审阅第二b期试验中非盲法患者 的治疗数据后，所得结论乃于为期四星期的研究中，就改善疼痛方面而言，接受Halneuron治疗的患者 与接受安慰剂治疗的患者之间存在差异。 Dogwood表示Halneuron治疗效果的初步证据值得关注，基于中期分析群组中患者平均CINP患期为5年， 且67%符合入组标准的患者同时接受其他慢性疼痛药物的稳定剂量治疗，包括普瑞巴林(pregabalin)、加 巴喷丁(gabapentin)、度洛西汀(duloxetine)及类鸦片(opioids)药物。此外，该研究的整体退出率约4.4%， 远低于其他美国食品及药物管理局批准的慢性疼痛药物的退出率。尽管目前仍处于盲法阶段，但 Dogwood认为是项发现再次证明Halneuron在先前临床试验中观察所得令人鼓舞的安全性及 ...

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 is committed to improving the lives of cancer patients suffering from chemotherapy-induced peripheral neuropathy, a condition lacking FDA-approved treatments [2][3] Company Developments - The company has secured a global license to develop and commercialize SP16, a first-in-class LRP1 agonist, which will complement its lead compound, Halneuron [3][4] - SP16 is administered intravenously and has shown a dual mechanism of action in preclinical research, indicating potential benefits for patients with chemotherapy-induced neuropathy [3][4] Mechanism of Action - SP16 exhibits both anti-inflammatory and analgesic effects, along with enhanced protein signaling linked to cell survival, growth, and proliferation [4] - The potential use of SP16 alongside Halneuron aims to treat chemotherapy-induced peripheral neuropathy and may also help prevent or repair damage from chemotherapy's off-target effects [4]

Summary of Dogwood Therapeutics Investor Call - September 29, 2025 Company Overview - **Company**: Dogwood Therapeutics (NasdaqCM: DWTX) - **Focus**: Development of treatments for chemotherapy-induced peripheral neuropathy (CIPN) and cancer-related pain Key Points Industry and Market Context - **CIPN Prevalence**: Approximately 70% of cancer patients undergoing chemotherapy experience neuropathy, with 30% suffering long-term effects six months post-treatment [18] - **Market Opportunity**: The global market for CIPN treatments is estimated at $1.5 billion, with potential expansion into cancer-related pain markets [34] Core Developments - **SP16 License**: Dogwood has secured a global license to develop and commercialize SP16, a first-in-class LRP1 agonist, which is expected to complement the lead compound Halneuron [3][4] - **Halneuron**: A Nav1.7 sodium channel inhibitor currently in a Phase 2b study for CIPN, showing promise in reducing pain without addiction or tolerance [6][8][9] Clinical Trials and Research - **Halneuron Phase 2b Study**: - 82 patients enrolled, targeting a total of 200 [10][11] - Primary endpoint: Average pain score reduction at week four [10] - Safety profile confirmed with only two dropouts [12] - **SP16 Phase 1b Trial**: - Funded by the National Cancer Institute (NCI), with dosing planned to coincide with chemotherapy [14][41] - Focus on safety and tolerability as primary endpoints, with secondary endpoints assessing neuropathic symptoms [41][42] Scientific Insights - **Mechanism of Action**: SP16 exhibits anti-inflammatory and analgesic effects, potentially protecting against nerve damage caused by chemotherapy [4][13][24] - **Preclinical Evidence**: Studies indicate SP16 can reduce hypersensitivity and promote nerve recovery in models of chemotherapy-induced damage [26][28] Financial and Transactional Aspects - **Transaction Structure**: The SP16 deal is an all-stock transaction with no royalties or future development milestones required [40] - **Ownership Implications**: Serpent Pharma will hold approximately 7.31% of Dogwood's stock post-transaction [15][16] Future Outlook - **Milestones**: - Filing of new synthetic IP for Halneuron expected in Q4 2025 [36] - IND filing for SP16 planned for Q4 2025, with patient enrollment in the first half of 2026 [36][51] - **Strategic Positioning**: The combination of Halneuron and SP16 is anticipated to enhance market penetration and create unique revenue pathways [34][35] Additional Considerations - **Expertise**: The management team has a strong background in developing and commercializing pain and neuropathy treatments, having previously worked on drugs like Celebrex and Lyrica [16] - **Community Engagement**: High interest from the medical community in the ongoing trials, reflecting the urgent need for effective treatments for CIPN [12] Conclusion Dogwood Therapeutics is positioned to make significant advancements in the treatment of chemotherapy-induced peripheral neuropathy and cancer-related pain through its innovative pipeline, particularly with the addition of SP16 to its portfolio. The company is focused on leveraging its clinical trials and strategic partnerships to address a critical unmet need in oncology care.

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]

Core Viewpoint - The announcement details a transaction involving the sale of 100% equity in Pharmagesic (Holdings) Inc to Dogwood Therapeutics, Inc, which includes the issuance of common and preferred shares as part of the payment structure [1][2]. Group 1: Transaction Details - The transaction involves the issuance of buyer's common stock and preferred stock as payment for the sale of Pharmagesic (Holdings) Inc [1]. - A waiver agreement was established on September 26, 2025, allowing the buyer to forgo cash settlement and repurchase rights for certain preferred shares [1]. - The total number of waived shares is capped at 300 shares, with a valuation based on a sincere estimate of the difference between $2.5 million and the equity on the balance sheet at the end of the relevant quarter [1]. Group 2: Business Implications - The merger with WEX allows access to the buyer's extensive experience in biotech fundraising, R&D, and commercialization, particularly in pain relief medications [2]. - The flagship product Halneuron is expected to advance its clinical trial data release and market entry due to the buyer's resources and expertise [2]. - The buyer's NASDAQ listing will facilitate access to the U.S. capital markets, enabling accelerated funding for Halneuron's development [2]. Group 3: Rights and Repurchase - The preferred shares come with a repurchase right that allows the seller to buy back all Halneuron assets in exchange for cash settlement amounts [3]. - Partial waivers of cash settlement and repurchase rights will not affect the seller's right to repurchase all Halneuron assets in relevant events [3].

Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [3] - The company is publicly traded on Nasdaq under the ticker DWTX [3] Upcoming Events - Dogwood Therapeutics will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - CEO Greg Duncan will engage in a fireside chat with Sean Lee, VP of Equity Research at H.C. Wainwright on September 5, 2025, with the presentation available on-demand [2] Research and Development - The company has a research pipeline that includes a non-opioid analgesic program and an antiviral program [3] - The lead candidate in the analgesic program is Halneuron, which targets voltage-gated sodium channels to reduce pain transmission, showing efficacy in treating cancer-related pain and chronic chemotherapy-induced neuropathic pain [3] - Interim data from the ongoing Phase 2 study of Halneuron for chronic chemotherapy-induced neuropathic pain is expected in Q4 2025 [3] Antiviral Program - Dogwood's antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib [4] - IMC-1 is advancing towards Phase 3 development for fibromyalgia, while IMC-2 has shown success in reducing fatigue associated with Long-COVID in clinical trials [4] - The company has reached an agreement with the FDA to use fatigue reduction as the primary endpoint for future IMC-2 research related to Long-COVID [4]

Core Viewpoint - Dogwood Therapeutics is advancing its Halneuron Phase 2b trial for chemotherapy-induced neuropathic pain (CINP), with the potential to be the first FDA-approved treatment for this condition, while also expanding its research pipeline for other pain-related disorders [2][3]. Company Overview - Dogwood Therapeutics is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders, with a proprietary non-opioid NaV 1.7 analgesic program centered on Halneuron [10][11]. Clinical Development - The ongoing Halneuron Phase 2b trial has enrolled 52 patients to date, with interim data expected in Q4 2025 [3][6]. - Halneuron has received fast track designation from the FDA for the treatment of CINP, indicating its potential significance in the market [7]. Financial Performance - Research and development expenses for Q2 2025 were $2.5 million, a significant increase from $0.3 million in Q2 2024, primarily due to the business combination with Pharmagesic and increased clinical trial costs [5][9]. - General and administrative expenses rose to $1.3 million in Q2 2025 from $0.7 million in Q2 2024, driven by higher legal, accounting fees, and public company expenses [8]. - The net loss attributable to common stockholders for Q2 2025 was $3.8 million, compared to a net loss of $1.0 million in Q2 2024, reflecting the increased operational costs [9][15]. Cash Position - The company reported cash on hand of $13.4 million as of June 30, 2025, providing an operational runway through Q1 2026 [6][15]. Pipeline Overview - The proprietary pipeline includes Halneuron for CINP, IMC-1 for fibromyalgia, and IMC-2 for Long-COVID, with IMC-1 ready for Phase 3 development and IMC-2 in Phase 2a [7][11].