Dogwood Therapeutics Obtains Exclusive Global, Royalty-Free License for SP16 Development and Commercialization as a Cancer Pain Treatment in All-Stock Deal Highlighting Commitment to Enhancing Cancer Patient Care
SP16 Phase 1b Study Announcement: Dogwood Therapeutics has announced a fully funded Phase 1b study for SP16, a first-in-class LRP1 agonist aimed at treating chemotherapy-induced peripheral neuropathy (CIPN), with patient enrollment expected to start in the first half of 2026.
Licensing Agreement with Serpin Pharma: The company secured a royalty-free global license to develop Serpin Pharma's intravenous formulation of SP16 for managing cancer-related pain, complementing its lead candidate Halneuron®, which is currently in Phase 2b development for chemotherapy-induced neuropathic pain.
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- Significant Trial Progress: Dogwood Therapeutics has achieved over 50% enrollment in the HALT-CINP Phase 2b trial, with an early termination rate of only 4.3% among 116 patients, indicating good tolerability, and top-line results are expected in Q3 2026.
- Preliminary Clinical Efficacy: An interim analysis of 97 patients showed that Halneuron® treated patients demonstrated significant pain improvement compared to placebo, as confirmed by an independent statistical review committee, highlighting the drug's potential in treating chemotherapy-induced neuropathic pain.
- Statistical Power Assurance: The study is designed to provide over 80% statistical power to detect treatment differences between Halneuron® and placebo upon unblinding in Q3 2026, which could fill the current market gap for approved therapies if successful.
- Future Development Outlook: As a non-opioid NaV1.7 analgesic, Halneuron® has received FDA fast track designation, potentially offering new treatment options for millions of chemotherapy patients and addressing the urgent market need for effective therapies.
- Funding Amount: Dogwood Therapeutics successfully raised approximately $12.5 million through a registered direct offering and concurrent private placement, which is expected to be utilized for advancing the clinical development of Halneuron®, thereby enhancing the company's innovation in non-opioid medications.
- Equity Structure: The financing involves the issuance of 4,386,037 shares of common stock and corresponding warrants at a price of $2.85 per share, reflecting market recognition of the company's research potential and potentially boosting investor confidence.
- Strategic Use: The company plans to use the net proceeds from the offering to support the Phase 2b clinical trial of Halneuron® while also pursuing strategic opportunities to strengthen its research portfolio, aiming to improve care standards for patients suffering from chemotherapy-induced pain and neuropathy.
- Market Outlook: This financing not only provides Dogwood with additional capital support but also lays the groundwork for future Phase 3 clinical development, further solidifying its market position in the biopharmaceutical industry.

- Clinical Trial Progress: Dogwood Therapeutics' Phase 2b trial for chemotherapy-induced neuropathic pain shows that 97 patients experienced significant pain improvement over four weeks, with a dropout rate of only 4.4%, indicating the potential of Halneuron as a viable treatment option.
- Market Need: With no FDA-approved treatments for moderate-to-severe chemotherapy-induced neuropathic pain, Halneuron's success could address a significant unmet medical need for cancer survivors suffering from this debilitating condition.
- Financial Challenges: Despite the encouraging clinical data, Dogwood's stock plummeted nearly 24% due to concerns over its limited cash reserves of $10.1 million, which only provide operational runway through the first quarter of 2026, raising investor apprehensions.
- Future Outlook: The company expects to release top-line results in the third quarter of 2026, and if successful, this could represent the first statistically significant study under FDA chronic pain guidance, potentially paving the way for a Phase 3 registration program.

- Clinical Progress: Dogwood Therapeutics has conducted an interim analysis of its Phase 2b study for Halneuron, indicating the company's ongoing commitment to advancing its R&D pipeline, which may lay the groundwork for future market applications, although specific results have not been disclosed.
- Research Phase: The study aims to evaluate the efficacy and safety of Halneuron as a potential treatment for specific diseases, and successfully completing the interim analysis will provide critical data support for subsequent clinical trials, thereby enhancing investor confidence.
- Market Potential: The successful development of Halneuron could address the unmet demand for new therapies, particularly in treating specific neurological disorders, and positive results would help the company secure a foothold in the competitive biopharmaceutical sector.
- Investor Attention: With the release of the interim analysis, market interest in Dogwood Therapeutics may increase, as investors closely monitor subsequent research outcomes and company strategies to assess its future growth potential.

- Clinical Trial Progress: An interim analysis of 97 patients in the ongoing Phase 2b study for chemotherapy-induced neuropathic pain (CINP) shows that Halneuron®-treated patients are significantly improving in pain assessments compared to placebo, indicating the drug's potential in pain management.
- Low Dropout Rate Advantage: The overall dropout rate of approximately 4.4% is significantly lower than that of other FDA-approved chronic pain medications, demonstrating Halneuron®'s favorable tolerability and safety profile, which may enhance patient adherence to treatment.
- Expected Statistical Significance: Current enrollment trends are projected to provide approximately 80% to 85% statistical power to detect treatment differences with Halneuron®, laying the groundwork for a future Phase 3 registration program.
- Market Demand Opportunity: With no approved therapies available for moderate-to-severe neuropathic pain following chemotherapy, the success of Halneuron® could provide a much-needed treatment option for cancer survivors, addressing a critical market need for new therapies.

Study Enrollment: Dogwood Therapeutics (DWTX) has successfully enrolled the first 100 patients in its Phase 2b clinical study for Halneur.
Clinical Focus: The study aims to evaluate the efficacy and safety of Halneur in treating specific medical conditions.







