Dogwood Therapeutics Highlights Pipeline Expansion And Clinical Progress Toward Non-Opioid Cancer Pain And Neuropathy Treatments; Key Halneuron And SP16 Milestones Targeted For 2026

Dogwood Therapeutics, Inc. (NASDAQ:DWTX) ("DWTX" or "Company"), a company that focuses on developing new non-opioid medicines to treat pain and neuropathy, issues a corporate update in the following Letter to Shareholders from CEO, Greg Duncan.

Dear Shareholders,

Dogwood Therapeutics is a development-stage biotechnology company with the ultimate goal of advancing the standard of care for patients suffering from cancer-related pain and neuropathy, two conditions where both patients and providers are in clear need of alternative treatment options.  In 2025, the Company made extensive progress in expanding and advancing its pipeline of first-in-class new development candidates to treat cancer and chemotherapy induced pain and neuropathy.  

Highlights include:

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Recruitment of over 100 patients in the Halneuron® Phase 2b Chemotherapy Induced Pain (HALT-CINP) Study that enabled the execution of our interim analysis that determined the final study sample size and optimal analysis methodology.

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Expanded the DWTX pipeline by securing the license for SP16 IV, a potential treatment for neuropathy and inflammation caused by cancer chemotherapy.  The license is a royalty-free, global development and commercialization license to treat cancer-related pain and neuropathy.

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The forthcoming SP16 Phase 1b study is fully funded by a development grant from the National Cancer Institute.

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Advanced development of a chemically equivalent, synthesized version of Halneuron (as opposed to the biological extract currently used) to be used for Phase 3 development.

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This new formulation should reduce manufacturing costs and improve yields.

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Filed new intellectual property protection for the synthetically produced Halneuron, which, if granted, extends Halneuron's intellectual property protection to 2046.

As a team, we believe the year ahead holds great promise for DWTX shareholders and patients alike.  In 2026, we are focused on executing on the following target milestones:

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Progressing Halneuron through Phase 2b development with final Phase 2b data projected for release in Q3 2026 following a successful financing in January.

 

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Filing the SP16 Chemotherapy Induced Pain and Neuropathy Investigational New Drug application (IND) with FDA in collaboration with our partner Serpin Pharma in Q1.

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Commencing dosing patients in the forthcoming SP16 Phase 1b study by mid-2026.

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Executing a Halneuron bridging study to compare the biologically extracted material to the chemically synthesized material in support of using the synthetically produced Halneuron in our Phase 3 development program.

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Submitting our end of Phase 2 summary, manufacturing plans and Phase 3 clinical development plans to FDA towards the end of 2026, assuming favorable outcomes in our ongoing Halneuron Phase 2b program.

In closing, let me convey our appreciation for your support in our journey to advance the standard of care for patients suffering from pain and neuropathy.  As always, we plan to communicate our corporate progress in a timely manner.  We wish you a happy and healthy 2026.  

Sincerely,

Greg Duncan

Chairman & CEO of Dogwood Therapeutics, Inc.

January 2026