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Dogwood Therapeutics, Inc. - Special Call
Seeking Alpha· 2025-09-29 16:17
PresentationAt this time, I'd like to turn the call over to Greg Duncan, Chief Executive Officer for Dogwood Therapeutics. Please proceed, Mr. Duncan.Good morning, and welcome to today's Dogwood Therapeutics, Inc. Investor Call. [Operator Instructions] And please be advised that today's call is being recorded at the company's request.Greg DuncanChairman & CEO Thank you. Good morning all, and thank you for joining today's exciting investor call for Dogwood Therapeutics. I'm pleased to be joined by our Chief ...
Dogwood Therapeutics (NasdaqCM:DWTX) Update / Briefing Transcript
2025-09-29 13:32
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.
Dogwood Therapeutics Secures Exclusive Worldwide, Royalty Free License to Develop and Commercialize SP16 as a Treatment for Cancer Related Pain in an All-Stock Transaction Underscoring the Company's Dedication to Improving the Lives of Cancer Patients
Globenewswire· 2025-09-29 11:15
-A first-in-class LRP1 agonist, SP16 phase 1b Chemotherapy Induced Neuropathy (CIPN) Study fully funded by the National Cancer Institute, with projected patient enrollment beginning in the first half of 2026- -SP16 has demonstrated both anti-inflammatory and neural repair activity that has the potential to treat CIPN, synergistically complementing Halneuron®, the Company’s late stage NaV1.7 inhibitor, which has demonstrated significant pain reduction in previous Phase 2 studies- -Webcast today, September 29 ...
长江生命科技与DWTX订立弃权协议
Zhi Tong Cai Jing· 2025-09-26 14:28
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。 (a)买方将有权要求卖方就买方对买方优先股付款股份所确定的部分放弃现金结算权及回购权,而卖方 同意放弃上述权利,惟须受弃权协议的条款及条件所规限; (b)买方可不时行使其权利,惟不多于每个历季一次; (c)受弃权规限的买方优先股股份(弃权股份)的价值,应根据买方就250万美元与买方于发出弃权通知所 属历季结束时资产负债表上的持股人权益之间的差额进行的真诚估算;及 (d)所有弃权股份的总数不得超过300股(弃权门槛)。 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 ...
Dogwood Therapeutics to Participate in Fireside Chat at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-03 13:15
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]
Dogwood Therapeutics Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-13 13:00
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].
Dogwood Therapeutics Announces Enrollment of First Fifty Patients in Ongoing Halneuron® Phase 2b Trial
Globenewswire· 2025-08-07 17:08
Core Insights - Dogwood Therapeutics is progressing with its Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP), with interim data readout expected in Q4 2025 [1][5] - The trial has shown a low discontinuation rate of 6% due to adverse events among the first 35 patients, indicating good tolerability of both Halneuron and placebo treatments [1][4] - The company has enrolled the first 50 patients and aims to analyze data from approximately 100 patients by the end of 2025 [1][3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating new medicines for pain and fatigue-related disorders [5] - The lead product candidate, Halneuron, is a non-opioid NaV 1.7 inhibitor specifically targeting neuropathic pain associated with chemotherapy [4][5] - The company has received fast track designation from the FDA for Halneuron's treatment of CINP [4] Clinical Trial Details - The HALT-CINP trial is a randomized Phase 2b study evaluating Halneuron's safety and effectiveness against placebo in cancer patients with neuropathy from platinum or taxane-based chemotherapy [3] - Participants will receive 8 daily subcutaneous doses of Halneuron or placebo over 14 days, followed by a 28-day safety and effectiveness assessment [3] - Primary endpoints include overall safety and changes in pain intensity, while secondary measures will evaluate effects on sleep, fatigue, and overall health [3] Market Position and Future Plans - There is growing interest in sodium channel inhibition for pain treatment, with Halneuron's specificity and potency for Nav 1.7 setting it apart from other research programs [2] - Positive data from previous trials has increased interest from both patients and the research community, prompting the addition of more qualified research sites [2] - Full results from the Phase 2b trial are anticipated in mid-2026 [2]
Dogwood Therapeutics to Report Second Quarter 2025 Financial Results on Wednesday, August 13, 2025
Globenewswire· 2025-08-06 13:15
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, a voltage-gated sodium channel modulator that has shown effectiveness in reducing pain from cancer and chemotherapy-induced neuropathic pain [2] - Interim data from the ongoing Phase 2 study of Halneuron for chemotherapy-induced neuropathic pain is expected in Q4 2025 [2] 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 [3] - IMC-1 is advancing towards Phase 3 development for fibromyalgia and is a focus for external partnerships [3] - IMC-2 has shown successful fatigue reduction in clinical trials for Long-COVID and has received FDA agreement to use fatigue reduction as the primary endpoint for future research [3] Upcoming Financial Results - The company will report its second quarter 2025 financial results on August 13, 2025, before the market opens [1]
Dogwood Therapeutics to Present at Sidoti Small-Cap Virtual Conference
Globenewswire· 2025-06-03 13:15
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]
Dogwood Therapeutics, Inc. Receives Nasdaq Confirmation of Compliance
Globenewswire· 2025-04-11 13:15
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]