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
Dogwood Therapeutics (NASDAQ:DWTX) has secured a worldwide, royalty-free license for SP16, a first-in-class LRP1 agonist, through an all-stock transaction with Serpin Pharma. SP16 will be developed as a treatment for cancer-related pain, specifically focusing on chemotherapy-induced peripheral neuropathy (CIPN).
The National Cancer Institute has fully funded SP16's upcoming Phase 1b CIPN study, with patient enrollment expected to begin in H1 2026. SP16 has shown both anti-inflammatory and neural repair properties in preclinical research, potentially complementing Dogwood's existing drug Halneuron®, which is currently in Phase 2b trials for chemotherapy-induced neuropathic pain with interim data expected in December 2025.
Dogwood Therapeutics (NASDAQ:DWTX) ha ottenuto una licenza mondiale, royalty-free, per SP16, un agonista LRP1 di prima classe, tramite una transazione interamente azionaria con Serpin Pharma. SP16 sarà sviluppato come trattamento per il dolore associato al cancro, con particolare attenzione alla neuropatia periferica indotta dalla chemioterapia (CIPN).
L'Istituto Nazionale del Cancro ha finanziato interamente il prossimo studio di fase 1b CIPN di SP16, con l'arruolamento dei pazienti previsto per la H1 2026. SP16 ha mostrato proprietà anti-infiammatorie e di riparazione neurale in ricerche precliniche, potenzialmente complementari al farmaco esistente di Dogwood, Halneuron®, attualmente in Trial di fase 2b per il dolore neuropatico indotto da chemioterapia, con dati provvisori attesi nel dicembre 2025.
Dogwood Therapeutics (NASDAQ:DWTX) ha obtenido una licencia mundial, libre de regalías, para SP16, un agonista LRP1 de primera clase, mediante una transacción 100% en acciones con Serpin Pharma. SP16 se desarrollará como tratamiento para el dolor relacionado con el cáncer, centrándose específicamente en la neuropatía periférica inducida por quimioterapia (CIPN).
El Instituto Nacional del Cáncer ha financiado por completo el próximo estudio de Fase 1b CIPN de SP16, con el reclutamiento de pacientes previsto para comenzar en la H1 2026. SP16 ha mostrado propiedades antiinflamatorias y de reparación neural en investigaciones preclínicas, potencialmente complementando el fármaco existente de Dogwood, Halneuron®, que actualmente está en ensayos de Fase 2b para el dolor neuropático inducido por quimioterapia, con datos intermedios esperados en diciembre de 2025.
Dogwood Therapeutics (NASDAQ:DWTX)는 Serpin Pharma와의 전액 현금 없는 주식 거래를 통해 SP16에 대한 전 세계적 로열티 프리 라이선스를 확보했습니다. SP16은 LRP1 작용제의 일류로서 암 관련 통증 치료제로 개발될 예정이며, 특히 화학요법 유발 말초 신경병증(CIPN)에 초점을 맞춥니다.
국립암연구소(NCI)는 SP16의 향후 1b CIPN 연구를 전액 지원했으며, 환자 등록은 2026년 상반기에 시작될 것으로 예상됩니다. SP16은 전임상 연구에서 항염증 및 신경 재생 특성을 보여 왔으며, 현재 화학요법 유발 신경통을 다루는 Dogwood의 현존 약물 Halneuron®와 시너지를 낼 수 있습니다. 중간 데이터는 2025년 12월에 기대됩니다.
Dogwood Therapeutics (NASDAQ:DWTX) a obtenu une licence mondiale, sans redevance, pour SP16, un agoniste LRP1 de première classe, via une transaction entièrement en actions avec Serpin Pharma. SP16 sera développé comme traitement de la douleur liée au cancer, en se concentrant spécifiquement sur la neuropathie périphérique induite par la chimiothérapie (CIPN).
Le National Cancer Institute a entièrement financé la prochaine étude de phase 1b CIPN de SP16, avec le recrutement des patients prévu pour commencer au H1 2026. SP16 a démontré des propriétés anti-inflammatoires et de réparation neuronale dans des recherches précliniques, pouvant compléter le médicament existant de Dogwood, Halneuron®, actuellement en essais de phase 2b pour la douleur neuropathique induite par la chimiothérapie, avec des données intérimaires attendues en décembre 2025.
Dogwood Therapeutics (NASDAQ:DWTX) hat eine weltweite, lizenzgebührenfreie Lizenz für SP16 erworben, einen erstklassigen LRP1-Agonisten, durch eine rein aktienbasierte Transaktion mit Serpin Pharma. SP16 wird als Behandlung gegen krebssbedingte Schmerzen entwickelt, mit Fokus auf chemotherapieinduzierte periphere Neuropathie (CIPN).
Das National Cancer Institute hat SP16s kommende Phase-1b CIPN-Studie vollständig finanziert, mit der Patienteneinschreibung, die voraussichtlich im H1 2026 beginnen wird. SP16 hat in präklinischen Studien sowohl entzündungshemmende als auch neuronale Reparatur-Eigenschaften gezeigt, was potenziell Dogwoods bestehendem Medikament Halneuron® ergänzen könnte, das derzeit in Phase-2b-Studien gegen chemotherapieinduzierte neuropathische Schmerzen ist und Zwischen- daten voraussichtlich im Dezember 2025 erwartet.
دوغود ثيرابوتكس (NASDAQ:DWTX) حصلت على ترخيص عالمي خالٍ من الإتاوات لـ SP16، وهو مُنشِّط LRP1 من الفئة الأولى، من خلال صفقة كاملة بالأسهم مع Serpin Pharma. سيتم تطوير SP16 كعلاج لألم مرتبط بالسرطان، مع تركيز خاص على الاعتلال العصبي المحيطي الناتج عن العلاج الكيميائي (CIPN).
لقد موَّل المعهد الوطني للسرطان بالكامل الدراسة القادمة من المرحلة 1b CIPN لـ SP16، مع توقع بدء تسجيل المرضى في H1 2026. أظهر SP16 خصائص مضادة للالتهاب وإصلاح عصبي في أبحاث قبل السريرية، مما قد يكمل دواء Dogwood الحالي Halneuron®، الذي يقف حالياً في تجارب المرحلة 2b لعلاج الألم العصبي الناتج عن العلاج الكيميائي، مع توقع بيانات وسيطة في ديسمبر 2025.
Dogwood Therapeutics (NASDAQ:DWTX) 已通过与 Serpin Pharma 的全股票交易，获得 SP16 的全球、免版权使用许可，SP16 是一类领先的 LRP1 激动剂。SP16 将被开发为治疗癌症相关痛症的药物，特别关注化疗诱导的周围神经病变（CIPN）。
国家癌症研究所已为 SP16 即将开展的 CIPN 第1B期研究提供全额资助，预计患者招募将于 2026 年上半年 开始。SP16 在前临床研究中显示了抗炎和神经修复特性，可能补充 Dogwood 现有药物 Halneuron®，后者目前处于化疗诱导神经痛的 2B 期试验，预计 2025 年 12 月 的中期数据。
- National Cancer Institute fully funding Phase 1b CIPN study, preserving company capital
- Royalty-free worldwide license secured through all-stock transaction
- Potential synergistic effects between SP16 and existing drug Halneuron
- SP16 demonstrates dual benefits: anti-inflammatory and neural repair properties
- Phase 1b trials not starting until first half of 2026
- Early-stage asset with significant development timeline ahead
Insights
Dogwood secures worldwide royalty-free license for SP16, expanding cancer pain portfolio with NCI-funded trial starting 2026.
Dogwood Therapeutics has made a strategic move to expand its pain management pipeline by securing an exclusive, worldwide royalty-free license for SP16, a first-in-class LRP1 agonist with potential to treat chemotherapy-induced peripheral neuropathy (CIPN). The all-stock transaction with Serpin Pharma requires no immediate capital expenditure from Dogwood, as the upcoming Phase 1b CIPN study is fully funded by the National Cancer Institute with enrollment expected to begin in H1 2026.
The acquisition creates meaningful pipeline synergy potential. SP16 has demonstrated both anti-inflammatory and neural repair activity in preclinical studies, which could complement Dogwood's lead candidate Halneuron® (a NaV1.7 inhibitor) already in Phase 2b development for chemotherapy-induced neuropathic pain. This creates a two-pronged approach to addressing cancer-related pain: Halneuron® directly targeting pain signaling while SP16 potentially addressing underlying inflammation and nerve damage.
The deal structure is particularly favorable - the royalty-free aspect means Dogwood would retain all economics from potential commercialization. With the NCI funding the initial clinical development, this represents an efficient pipeline expansion without near-term cash burn. The external validation from NCI funding also underscores the scientific merit of SP16's approach to addressing the significant unmet need in CIPN.
For context, CIPN affects a substantial portion of cancer patients receiving chemotherapy and often limits treatment options. Current treatments are largely inadequate, leaving a significant market opportunity for effective therapies. With interim data from Halneuron's Phase 2b CIPN study expected in December 2025 and SP16's clinical program advancing with external funding, Dogwood is positioning itself as a specialist in the cancer pain/neuropathy space.
-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, 2025, at 8:30 a.m. Eastern Time-
ATLANTA, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a clinical-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced that in an all-stock transaction, it has secured a royalty free, global license to develop Serpin Pharma’s intravenous (IV) formulation of SP16 to manage cancer related pain (CRP) including a broad range of chemotherapy induced neuropathy symptoms.
Serpin Pharma has discovered the active portion of A1AT responsible for both the anti-inflammatory (analgesic) activity as well as tissue repair, and this active portion is represented by SP16. SP16 is a first-in-class LRP1 agonist which has demonstrated both anti-inflammatory and neural repair activity that has the potential to treat chemotherapy-induced peripheral neuropathy (CIPN). SP16 IV is the focus of a forthcoming Phase 1b CIPN study that is fully funded by the National Cancer Institute, reflecting the uniqueness of this approach, as well as the extraordinary unmet medical need associated with this debilitating cancer-related condition.
“The SP16 in-license aligns with our strategic objective of expanding our research pipeline in an area where Dogwood’s pain and neuropathy management research expertise can add value to both the asset increasing our equity value for shareholders,” said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. “The National Cancer Institute’s funding of the SP16 IV Phase 1b program obviates the need to use our existing capital in the near-term to advance SP16 into clinical development.”
SP16 IV mimics the activity of alpha-1-antitrypsin’s (A1AT) anti-inflammatory and immunomodulatory actions. In preclinical research, SP16 has demonstrated anti-inflammatory and analgesic benefits, as well as neural restorative and repair activity, both of which hold promise for addressing the multitude of symptoms and damage and functional complication of CIPN.
“After reviewing potential partners for this program, we believe Greg Duncan and the Dogwood team is best poised to take SP16 IV for cancer related pain through the clinic to address this major unmet need,” said Dr. Cohava Gelber, CEO of Serpin Pharma.
“SP16 IV may have intrinsic potential to deliver adjunctive improvement of non-pain symptoms if utilized with Halneuron®, the Company’s lead development candidate,” said Lawrence Steinman, MD, Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University and Scientific Advisory Board Member of Serpin Pharma.
Halneuron® is a NaV1.7 specific sodium channel inhibitor that has demonstrated statistically significant and clinically meaningful pain reductions in general cancer pain, as well as chemotherapy induced neuropathic pain (CINP), respectively. Halneuron® is currently in Phase 2b development to treat CINP, a condition for which the medicine has been granted fast-track review designation by the FDA. Over eighty patients have been recruited to date in this landmark Phase 2b CINP study, with interim data from 90-100 patients projected in December 2025.
“Expanding a biotech company’s quality shots on goal is always valued, but doing so with two development candidates that stand on their own merit, with additional potential to be mechanistically synergistic, adds additional value to this exciting worldwide SP16 license,” said Mike Gendreau, M.D., Ph.D., Dogwood Therapeutics Chief Medical Officer. “We intend to explore the potential of SP16, both as a treatment for a multitude of CIPN symptoms, as well as its potential to help with repair and/or restoration of nerve function damaged by chemotherapy.”
About the Licensing Transaction
Pursuant to an exclusive licensing agreement Serpin Pharma, Inc. and its designated affiliates will receive 382,034 shares of DWTX common stock and 179.1878 shares of a new series of non-voting convertible preferred stock (with a conversion ratio of preferred to common of 1:10,000) (the “Preferred Stock”) which collectively represents
The issuance of shares of common stock upon conversion of the Preferred Stock shall be subject to stockholder approval in compliance with the rules of the Nasdaq Stock Market.
Tungsten Advisors served as the exclusive financial advisor to the Company. Duane Morris LLP is serving as legal counsel to the Company. Rimon Law is serving as legal counsel to Serpin Pharma, Inc.
Webcast Presentation
The Company will host a webcast presentation to discuss the transaction today, September 29, 2025, at 8:30 a.m. Eastern Time.
Investors Dial-in:
Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 793917
Webcast URL: https://www.webcaster5.com/Webcast/Page/2639/53039
A replay of the webcast will also be available via the investor website after the call’s conclusion.
About Halneuron®
Dogwood’s lead product candidate, Halneuron®, is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® is the focus of an ongoing Phase 2b CINP trial with interim data readout projected for December of 2025. Halneuron® has been granted fast track designation from the Food and Drug Administration (“FDA”) for the treatment of CINP.
About Dogwood Therapeutics
Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary, non-opioid, NaV 1.7 analgesic program is centered on our lead development candidate, Halneuron®, which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to CINP. Interim data from the ongoing Halneuron® Phase 2 CINP study are expected in Q4 of 2025.
For more information, please visit www.dwtx.com.
Forward-Looking Statements:
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2024, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.
Investor Relations:
CORE IR
(516) 222-2560
IR@dwtx.com
FAQ
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