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]

智通财经APP讯，长江生命科技(00775)发布公告，诚如首份公告所披露，根据售股协议，向卖方(本公 司全资附属公司)发行买方普通股付款股份及买方Dogwood Therapeutics, Inc(纳斯达克：DWTX)优先股 付款股份乃作为向买方出售目标公司(Pharmagesic (Holdings) Inc)100%股权的代价，及买方优先股付款 股份为卖方提供现金结算权及回购权。于2025年9月26日，卖方与买方订立弃权协议，双方同意就部分 买方优先股付款股份放弃现金结算权及回购权。 诚如首份公告所披露，该等交易导致由目标公司全资拥有的 WEX 与买方进行业务合并。此举让 WEX 可接触买方在医药(包括痛楚舒缓及疼痛相关疾病之药物)的生物科技集资、研发及商品化方面拥有丰富 经验的稳健管理团队。预期在纳入买方的技术、药物研发及产品商品化专长后， WEX 旗舰候选产品 Halneuron® 将能提前公布数据，并加快进入市场。买方作为一家在纳斯达克上市的实体，亦将获准进 入美国资本市场，从而获得更多资金以加快研发 Halneuron® 。本公司透过其于买方所持有的重大权 益，将能获得在买方许可範围内加快研发 H ...

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].

ATLANTA, April 03, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders today announced it believes it has regained compliance with the minimum stockholders’ equity requirement as set forth in Nasdaq Listing Rule 5550(b)(1). DWTX Chairman and CEO Greg Duncan stated, “We appreciate the consideration Nasdaq has shown Dogwood Therapeutics, Inc.” He continu ...