Virios Therapeutics, Inc. and Wex Pharmaceuticals, Inc. have announced a definitive share exchange agreement, resulting in a merger to form Dogwood Therapeutics, Inc. (NASDAQ: DWTX). The combined company will focus on advancing a pipeline of three assets, including Halneuron® for chemotherapy-induced neuropathic pain (CINP), IMC-1 for fibromyalgia (FM), and IMC-2 for Long-COVID (LC) sequelae.
Strategic Financing and Pipeline Development
Dogwood Therapeutics has secured $19.5 million in committed debt financing to support research and operations. A key milestone will be the release of interim results from the Phase 2b trial of Halneuron®, expected in the second half of 2025. This financing aims to drive the clinical development of their pipeline assets, addressing significant unmet needs in pain management and viral-associated conditions.
Halneuron®: A Novel Non-Opioid Pain Treatment
Halneuron® is a potential first-in-class non-opioid treatment for CINP, currently in Phase 2b development. Mike Gendreau, M.D., PhD, Chief Medical Officer, stated that both preclinical and clinical data support sodium channel inhibition as a non-opioid approach to treat CINP, a condition affecting approximately one in three patients following chemotherapy. Halneuron® modulates the transmission of pain signals via voltage-gated sodium channels, offering a potential alternative to opioids without the associated side effects.
IMC-1 and IMC-2: Addressing Fibromyalgia and Long-COVID
IMC-1, a combination of famciclovir and celecoxib, is Phase 3 development-ready for fibromyalgia. IMC-2, combining valacyclovir and celecoxib, is in Phase 2 development for Long-COVID. Top-line results from the IMC-2 Long-COVID Phase 2a study are expected in early 4Q24. These therapies target viral-triggered immune responses, which are implicated in the pathogenesis of FM and LC.
Leadership and Corporate Structure
Dogwood Therapeutics will be led by CEO Greg Duncan and CMO Mike Gendreau, along with other industry veterans. Existing Virios stockholders will receive a contingent value right (CVR) tied to potential milestone payments from future corporate partnering transactions for IMC-1 and IMC-2.
Reverse Stock Split and Nasdaq Listing
The company has announced a 25-for-1 reverse stock split, effective October 9, 2024, to facilitate the business combination and ensure compliance with Nasdaq listing requirements. The common stock will trade under the ticker symbol “DWTX” starting October 9, 2024.
About Dogwood Therapeutics' Pipeline
- Halneuron®: Phase 2b development for chemotherapy-induced neuropathic pain (CINP). Interim data expected in 2H25. Has FDA Fast Track designation.
- IMC-2 (valacyclovir + celecoxib): Phase 2 development for Long-COVID. Topline data from Phase 2a study expected in early 4Q24.
- IMC-1 (famciclovir + celecoxib): Phase 3 development ready for fibromyalgia. Dogwood is exploring partnerships for Phase 3 execution.
