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 ...

智通财经APP讯，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于特拉华州注册成立，并于纳斯达克资本市场上市(股份代码：DWTX)，为一间处于发展阶段 的生物制药公司，专注开发舒缓痛楚及神经不适症状的新药。公司现持有Dogwood约83%间接股份权 益。 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(op ...

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，惟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 耐受性。 格隆汇12月23日丨长江生命科技(00775.HK)发布公告，有关公司在Dogwood Therapeutics, Inc. ("Dogwood")的投资的最新进展。Dogwood于特拉华州注册成立，并于纳斯达克资本市场上市(股份代 码：DWTX)，为一间处于发展阶段的生物制药公司，专注开发舒缓痛楚及神经不适症状的新药。公司 现持有Dogwood约83%间接股份权益。 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( ...

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]

Summary of Dogwood Therapeutics Special Meeting Company Overview - **Company**: Dogwood Therapeutics (NasdaqCM:DWTX) - **Event**: 2025 Extraordinary General Meeting - **Date**: November 21, 2025 Key Proposals Discussed 1. **Proposal One**: Approval for the issuance of common stock upon conversion of Series A non-voting convertible preferred stock, par value $0.0001 per share [8] 2. **Proposal Two**: Approval for the issuance of common stock upon conversion of Series A1 non-voting preferred stock, par value $0.0001 per share [9] 3. **Proposal Three**: Approval for the issuance of common stock upon conversion of Series A2 non-voting convertible preferred stock, par value $0.0001 per share [9] 4. **Proposal Four**: Approval of the Dogwood Therapeutics Second Amended and Restated 2020 Equity Incentive Plan [9] 5. **Proposal Five**: Approval for the adjournment of the special meeting to a later date if necessary [9] Voting Results - **Proposal One**: Approved under both Delaware law and NASDAQ Listing Rules [13] - **Proposal Two**: Approved under both Delaware law and NASDAQ Listing Rules [13] - **Proposal Three**: Approved under both Delaware law and NASDAQ Listing Rules [14] - **Proposal Four**: Approved [14] - **Proposal Five**: Approved [14] Additional Information - A quorum was established with more than one-third of the outstanding shares present [6] - The final voting results will be filed with the SEC on Form 8K within four business days after the meeting [16] - The meeting concluded with a focus on improving care for patients suffering from pain and neuropathy [16]

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]

Financial Performance - The company has incurred losses and generated negative cash flows from operations since inception, with cash totaling $10.1 million as of September 30, 2025 [161]. - For the nine months ended September 30, 2025, net cash used in operations was $12.0 million, consisting of a net loss of $30.5 million [168]. - The company experienced a decrease in cash of $4.7 million for the nine months ended September 30, 2025, compared to a decrease of $1.3 million in the same period of 2024 [167]. - The company has substantial doubt regarding its ability to continue as a going concern within 12 months from the issuance of the Quarterly Report [166]. Research and Development - Research and development expenses increased by $14.0 million and $18.3 million for the three and nine months ended September 30, 2025, respectively, compared to prior periods [158]. - The HALT-CINP-203 clinical trial is intended to assess the efficacy and safety of Halneuron® in approximately 200 patients with moderate to severe neuropathic pain [146]. - An interim analysis of data from approximately 40-50% of the patients enrolled in HALT-CINP-203 is expected in the fourth quarter of 2025 [148]. - The company licensed the rights to the IV formulation of SP16 for the treatment of chemotherapy-induced peripheral neuropathy, with initial Phase 1 evaluation expected to start in the first half of 2026 [149]. - Halneuron® has been granted FDA fast-track review designation as a treatment for chemotherapy-induced neuropathic pain (CINP) [147]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $15,809,125, compared to $2,301,172 for the same period in 2024 [157]. - General and administrative expenses decreased by $0.5 million for the three months ended September 30, 2025, compared to prior periods [160]. Financing Activities - The company entered into a Loan Agreement for a principal amount of $19,500,000, with $16,500,000 disbursed on October 7, 2024 [150]. - The company raised approximately $4.78 million through a registered direct offering of 578,950 shares of Common Stock on March 14, 2025 [163]. - The company received $3 million in loan proceeds on February 18, 2025, with no debt outstanding as of September 30, 2025 due to a Debt Exchange and Cancellation Transaction [164]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, attributed to loan proceeds and gross proceeds from the registered direct offering [170]. Cash Position - As of September 30, 2025, the company anticipates cash on hand of approximately $10.1 million to fund operations through the first quarter of 2026 [166]. - The company reclassified approximately $5.5 million from temporary equity to permanent equity due to waivers by holders of Series A Preferred Stock [174]. - The company will need to secure additional financing to fund ongoing clinical trials and operations beyond the first quarter of 2026 [166]. Off-Balance Sheet Arrangements - The company did not have any off-balance sheet arrangements as of September 30, 2025 [173].

Clinical Trials - Enrollment of 100 patients in the ongoing Halneuron® Phase 2b trial, with 80 patients completing treatment, and interim analysis expected in Q4 2025[1][2] - Halneuron® has received fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain (CINP)[7] - The forthcoming SP16 IV Phase 1b trial is fully funded by the National Cancer Institute and will commence after FDA consultation[8] Financial Performance - 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] - Research and development expenses for Q3 2025 were $14.5 million, a significant increase from $0.5 million in Q3 2024, primarily due to $12.0 million in acquired in-process R&D expenses related to SP16[3] - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.8 million in Q3 2024, mainly due to reduced legal and accounting fees[4] Assets and Liabilities - Cash on hand as of September 30, 2025, was $10.1 million, providing operational runway through Q1 2026[5] - Total assets as of September 30, 2025, were $91.99 million, down from $94.31 million at the end of 2024[16] - Total liabilities decreased to $14.61 million as of September 30, 2025, from $30.03 million at the end of 2024[16] Licensing and Partnerships - The company secured an exclusive worldwide, royalty-free license to develop and commercialize SP16 for cancer-related pain[1]

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].