Dogwood Therapeutics, Inc., a biopharmaceutical company focused on developing new medicines for pain and fatigue-related disorders, has released its Form 10-Q report for the quarter ended September 30, 2024, outlining financial results and providing updates on its clinical programs.
The company reported no revenue for the three and nine months ended September 30, 2024. Operating expenses were $2.3 million for the quarter and $4.7 million for the nine-month period, primarily due to increased legal and professional fees related to the acquisition of Pharmagesic. Net losses were $2.3 million for the quarter and $4.6 million for the nine months, attributed to research and development expenditures and general and administrative costs.
Halneuron® Phase 2b Study Planned for Q1 2025
Dogwood's lead development candidate, Halneuron®, a non-opioid NaV 1.7 analgesic, is set to begin a Phase 2b study in Q1 2025. Halneuron® has demonstrated pain reduction in both general cancer-related pain and chemotherapy-induced neuropathic pain (CINP). The FDA has granted Halneuron® fast track status for the treatment of CINP, highlighting the unmet need in this patient population.
Antiviral Program Advances with IMC-1 and IMC-2
The company's antiviral program includes IMC-1 and IMC-2, novel fixed-dose combinations of nucleoside analog, anti-herpes antivirals, and the anti-inflammatory agent celecoxib. These are being developed for the treatment of fibromyalgia (FM) and Long-COVID (LC).
Top-line data from an ongoing IMC-2 Phase 2 LC study conducted by the Bateman Horne Center (BHC) are expected in November 2024. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities.
Strategic Initiatives and Financial Outlook
Dogwood Therapeutics acquired Pharmagesic (Holdings) Inc. on October 7, 2024, to bolster its research and development capabilities. The company also entered into a Loan Agreement with Conjoint Inc. for $19.5 million to fund operations and clinical activities related to Halneuron®. Effective October 9, 2024, the company changed its name from Virios Therapeutics, Inc. to Dogwood Therapeutics, Inc., and effectuated a 25-for-1 reverse stock split.
As of September 30, 2024, the company had cash of $2,039,819 and an accumulated deficit of $66,091,074. Management anticipates requiring additional financing beyond 2025 to sustain its clinical trials and operations and is exploring various funding options.
Challenges and Risks
Dogwood Therapeutics faces integration challenges following the acquisition of Pharmagesic, as well as liquidity concerns and the need for additional financing. The company also acknowledges the potential impact of global economic volatility on its ability to secure funding and maintain operations.
