Dogwood Therapeutics' largest shareholder, CK Life Sciences Int'l., (Holdings), Inc. (CKLS), has agreed to convert $19.5 million in outstanding debt plus accrued interest into preferred equity, significantly strengthening the company's balance sheet as it advances its lead candidate for chronic pain.
The strategic financial restructuring, announced on March 12, 2025, involves CKLS's wholly-owned subsidiary, Conjoint Inc., receiving 284.2638 shares of Series A-1 Non-Voting Convertible Preferred Stock in exchange for cancelling all of Dogwood's debt obligations. Each preferred share will be convertible into 10,000 shares of common stock, subject to stockholder and Nasdaq approval.
"We believe the decision by CKLS to exchange the outstanding loan amounts for equity in the Company is anchored to its conviction in Halneuron®, NaV 1.7 as a priority target for reducing pain," said Greg Duncan, Dogwood's Chairman and Chief Executive Officer. "This agreement enables us to remove all existing debt from our balance sheet, which, combined with the potential for Halneuron® to be the first FDA approved therapy to treat CINP, we believe makes us a more attractive investment opportunity moving forward."
Pipeline Progress and Financial Outlook
The debt-to-equity conversion comes at a pivotal time for Dogwood Therapeutics (Nasdaq: DWTX), which has recently commenced dosing patients in its Phase 2b clinical trial of Halneuron® for chemotherapy-induced neuropathic pain (CINP). The trial, known as HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain), is expected to reach an interim data readout in Q4 2025.
The financing initially provided by CKLS in October 2024 ensures the company has sufficient capital to recruit patients through the planned interim assessment without the burden of debt payments. This financial restructuring, combined with a recent $4.8 million common stock capital raise, provides Dogwood with an operational runway through Q1 2026.
In its recently announced financial results for the fourth quarter and full year 2024, Dogwood reported cash totaling $14.8 million as of December 31, 2024. Research and development expenses for Q4 2024 were $2.3 million, compared to $0.3 million for the same period in 2023, reflecting increased investment in clinical trials, drug development, and manufacturing.
Halneuron®: A Novel Approach to Pain Management
Halneuron® represents a potential breakthrough in pain management as a first-in-class, NaV 1.7 specific voltage-gated sodium channel inhibitor. The drug is being developed as a non-opioid alternative for chronic pain treatment, addressing a significant unmet need in pain management.
The FDA has granted Fast Track designation to Halneuron® for the treatment of CINP, recognizing the lack of approved therapies for this debilitating condition that affects many cancer patients undergoing chemotherapy.
In previous clinical studies, Halneuron® has demonstrated statistically significant reduction in cancer-related pain with an acceptable safety profile. The drug has been evaluated in over 700 patients across Phase 1 and Phase 2 studies and shows no signs of addiction potential—a critical advantage over opioid-based pain treatments.
Diversified Pipeline Beyond Pain Management
Beyond Halneuron®, Dogwood is advancing a diverse pipeline targeting both pain and fatigue-related disorders:
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IMC-1 (famciclovir + celecoxib): Ready for Phase 3 development as a treatment for fibromyalgia with FDA Fast Track designation. The company is exploring partnerships to execute the Phase 3 program with an update expected in Q2 2025.
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IMC-2 (valacyclovir + celecoxib): Currently in Phase 2a development for Long-COVID, with demonstrated success in reducing fatigue in both active control and double-blind, placebo-controlled trials. Dogwood is exploring external funding or partnerships to advance this program into Phase 2b development.
Both IMC-1 and IMC-2 represent novel, proprietary, fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib, targeting illnesses believed to be related to reactivation of dormant herpesviruses.
Market Opportunity and Strategic Position
The conversion of debt to equity significantly improves Dogwood's financial position at a critical juncture in its development timeline. With multiple clinical programs advancing and a strengthened balance sheet, the company is positioning itself as an attractive investment opportunity in the non-opioid pain management and antiviral therapy spaces.
"We have made considerable progress in advancing our flagship Halneuron® CINP Phase 2b study, with interim data expected by year end. We have also significantly improved our balance sheet and liquidity over the past few months," said Duncan. "We believe this substantial organizational progress, in the context of future milestones, positions Dogwood as a more attractive investment opportunity moving forward."
The potential for Halneuron® to become the first FDA-approved therapy for CINP represents a significant market opportunity, addressing a critical unmet need for cancer patients suffering from treatment-related neuropathic pain without the risks associated with opioid medications.
As Dogwood continues to advance its clinical programs throughout 2025, investors and industry observers will be closely watching for the interim data from the Halneuron® CINP trial expected in Q4, which could provide important validation for the company's approach to non-opioid pain management.
