Dogwood Therapeutics, Inc. (NASDAQ: DWTX) Issues Q1 2026 Progress Report: Major Milestones and Pipeline Advancements

Key Points from the CEO Letter

• Significant Clinical Progress:
  Dogwood Therapeutics has recruited 145 patients for its pivotal Halneuron^® Phase 2b Chemotherapy Induced Pain (HALT-CINP) Study. Final study data is expected to be released in the fall of 2026, an important upcoming catalyst for the company and shareholders.
• Robust Financial Position:
  The company has successfully raised \$12.5 million in new capital during Q1 2026. When combined with year-end 2025 cash on hand, Dogwood has sufficient funds to operate through the release of key Halneuron data in the fall.
• Pipeline Expansion:
  The company filed an Investigational New Drug (IND) application for SP16 IV, a non-opioid, novel candidate targeting neuropathy and inflammation caused by cancer chemotherapy. The SP16 IV program is fully funded by a National Cancer Institute grant, mitigating financial risk to shareholders.
• Manufacturing Advancements:
  Dogwood is advancing a chemically synthesized version of Halneuron for Phase 3 development and commercialization. This new formulation is expected to reduce manufacturing costs and improve yields, potentially enhancing future profitability.

Shareholder-Relevant and Potentially Price-Sensitive Information

• Upcoming Catalysts in 2026:
  • Filing of the SP16 Chemotherapy Induced Pain and Neuropathy IND with the FDA in partnership with Serpin Pharma (targeted for Q1 2026).
  • Start of patient dosing in the SP16 Phase 1b study by mid-2026.
  • Full recruitment of the Halneuron Phase 2b HALT-CINP study expected this summer.
  • Submission of the end-of-Phase 2 summary, manufacturing plans, and Phase 3 clinical development plans for Halneuron to the FDA towards the end of 2026, contingent on favorable trial outcomes.
• Regulatory Advantages:
  Halneuron has received FDA Fast Track designation for the treatment of chemotherapy-induced neuropathic pain (CINP), which may accelerate its development and review timelines.
• Non-Opioid, First-in-Class Pipeline:
  Both lead candidates, Halneuron and SP16 IV, represent non-opioid, novel mechanisms of action addressing significant unmet needs in pain and neuropathy, potentially differentiating Dogwood from competitors.
• Strategic Partnerships and Financial Support:
  The SP16 IV study is fully backed by a National Cancer Institute grant, reducing dilution and risk for shareholders.
• Major Shareholder Support:
  Dogwood’s largest shareholder is a member of CK Life Sciences Int’l (Holdings) Inc., a publicly listed company on the Hong Kong Stock Exchange, suggesting institutional confidence and backing.

Product Pipeline Details

Halneuron^®: A highly specific voltage-gated sodium channel modulator (NaV 1.7 analgesic), Halneuron is being developed for cancer and chemotherapy-induced neuropathic pain. In clinical studies, it has demonstrated pain reduction in both general cancer pain and chronic CINP. The new synthetic formulation aims to improve cost efficiency and scalability ahead of Phase 3 testing.

SP16 IV: An LRP1 agonist, SP16 IV has shown preclinical efficacy in reducing inflammation and repairing nerve damage post-chemotherapy by modulating key inflammatory markers (IL-6, IL-8, IL-1B, TNF-alpha) and promoting tissue repair via pAKT and pERK pathways. The forthcoming Phase 1b trial is fully funded and represents a near-term milestone.

Forward-Looking Statements

Investors should note that the company’s statements regarding timelines, pipeline advancements, and expected outcomes are forward-looking and subject to significant risks, including clinical trial outcomes, regulatory approval, and market conditions. Dogwood’s latest risk factors are detailed in its 2025 Annual Report on Form 10-K.

Contact and Further Information

For more details, visit www.dwtx.com or contact [email protected].

Disclaimer: This article is for informational purposes only and does not constitute investment advice. All forward-looking statements are subject to risks and uncertainties. Investors should perform their own due diligence and consult professional advisors before making investment decisions.

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