Virios Therapeutics and Wex Pharmaceuticals announced that Virios has entered into a definitive share exchange agreement with Sealbond Limited, an indirect parent of Wex, pursuant to which the companies will combine in an all-stock transaction. The combined company’s new name will be Dogwood Therapeutics and it will be focused on the clinical development of three assets: Halneuron, currently in Phase 2b development for chemotherapy-induced neuropathic pain; IMC-1, poised for Phase 3 development as a treatment for fibromyalgia; and IMC-2, currently in Phase 2 development to treat Long-COVID sequelae. In connection with the Combination, the Company announced that it is raising $19.5 million in a committed debt financing by an affiliate of CKLS in two tranches with $16.5 million funding at closing and an additional $3 million funded in 1Q25, subject to certain customary conditions. This financing is expected to fund research and operations through several key milestones, including the release of results from the Halneuron Phase 2b interim analysis assessment expected in 2H25. Dogwood will be led by industry veterans, including Chief Executive Officer Greg Duncan; Chief Medical Officer Mike Gendreau, M.D., PhD; Senior Vice President Operations Ralph Grosswald; Chief Financial Officer Angela Walsh and Vice President Manufacturing Meng Zhou. The combined Board of Directors consists of Rick Keefer; John Thomas; Richard Whitely, MD; Abel De La Rosa, PhD; Alan Yu; Melvin Toh, MBBS; and Chairman Greg Duncan. Effective October 9, 2024, the Company will change its name from “Virios Therapeutics, Inc.” to “Dogwood Therapeutics, Inc.” The Company’s common stock will cease trading under the ticker symbol “VIRI” and will begin trading on the Nasdaq Capital Market under the ticker symbol “DWTX” as of the commencement of trading on October 9, 2024. Halneuron is in Phase 2b development as a non-opioid, Nav 1.7 inhibitor to treat the neuropathic pain associated with chemotherapy treatment. Halneuron has been granted Fast Track Designation from the FDA for the treatment of CINP. Next milestone: Interim data from the ongoing Phase 2 CINP study are expected in 2H25. IMC-2 is in Phase 2 development as a combination antiviral treatment for Long-COVID. Next milestone: Topline data from an investigator led, double blind controlled proof of concept study, assessing two doses of IMC-2 vs placebo, are expected in early 4Q24. IMC-1 is Phase 3 development ready as a combination antiviral treatment for FM. IMC-1 has been granted fast track designation by the FDA. Next milestone: Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program as agreed with the FDA. Pursuant to the definitive share exchange agreement, immediately following the reverse stock split, Sealbond, the sole stockholder of Wex and an indirect wholly-0wned subsidiary of CKLS, will receive an aggregate of 211,383 shares of common stock and 2,108.3854 shares of non-voting convertible preferred stock which represents, on a fully diluted basis, approximately 94% for Sealbond and approximately 6% for the pre-Combination stockholders of Virios Therapeutics and a combined fully diluted equity value of approximately $105 million. In connection with the Combination, the Company entered into a loan agreement with an affiliate of CKLS for a cash investment of $19.5 million, which will be funded in two tranches with $16.5 million funded at closing and an additional $3 million funded in 1Q25, subject to certain customary conditions. The issuance of shares of common stock upon conversion of the Preferred Stock issued in the Combination shall be subject to stockholder approval in compliance with the rules of the Nasdaq Stock Market. A non-transferrable CVR will be distributed to Dogwood stockholders of record as of October 17, 2024 to receive certain proceeds received by Dogwood, if any, related to future upfront, development or regulatory milestone payments resulting from corporate partnering transactions of IMC-1 and IMC-2.