Background and Organization |
12 Months Ended |
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Dec. 31, 2024 | |
Background and Organization | |
Background and Organization |
1. Background and Organization Dogwood Therapeutics, Inc. (“Dogwood”), formerly known as Virios Therapeutics, Inc. (the “Company”) was incorporated under the laws of the State of Delaware on December 16, 2020 through a corporate conversion (the “Corporate Conversion”) just prior to the Company’s initial public offering (“IPO”). The Company was originally formed on February 28, 2012 as a limited liability company (“LLC”) under the laws of the State of Alabama as Innovative Med Concepts, LLC. On July 23, 2020, the Company changed its name from Innovative Med Concepts, LLC to Virios Therapeutics, LLC. On October 7, 2024, the Company acquired Pharmagesic (Holdings) Inc., a Canadian corporation (“Pharmagesic”) and the parent company of Wex Pharmaceuticals, Inc. (“Wex”), and changed its name from Virios Therapeutics, Inc. to Dogwood Therapeutics, Inc. (the “Name Change”) on October 9, 2024. Dogwood operates in one segment and is a pre-revenue, development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline is focused on two separate mechanistic pillars; Nav 1.7 modulation to treat chronic and acute pain disorders and combination antiviral therapies targeting reactivated herpes virus mediated illnesses. The proprietary non-opioid Nav 1.7 analgesic program is centered on our lead development candidate Halneuron®. Halneuron® is a voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and chemotherapy-induced neuropathic pain (“CINP”). The Halneuron® Phase 2b study commenced in the first quarter of 2025. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib for the treatment of fibromyalgia (“FM”) and Long-COVID (“LC”). Going Concern Since its founding, the Company has been engaged in research and development activities, as well as organizational activities, including raising capital. The Company has not generated any revenues to date. As such, the Company is subject to all of the risks associated with any development-stage biotechnology company that has substantial expenditures for research and development. Since inception, the Company has incurred losses and negative cash flows from operating activities. The Company has funded its losses primarily through issuance of members’ interests, convertible debt instruments and issuances of equity securities. For the years ended December 31, 2024 and 2023, the Company incurred consolidated net losses of $12,349,724 and $5,296,015, respectively, and had consolidated net cash outflows used in operating activities for the years ended December 31, 2024 and 2023 of $8,790,805 and $4,870,489, respectively. As of December 31, 2024, the Company had a consolidated accumulated deficit of $73,818,946 and is expected to incur losses in the future as it continues its development activities. Concurrent with the Combination discussed below, on October 7, 2024, the Company entered into a Loan Agreement (the “Loan Agreement”) with Conjoint Inc., a Delaware corporation (“Lender”) and an affiliate of CKLS. Pursuant to the Loan Agreement, the Lender agreed to make a loan to the Company in the aggregate principal amount of $19,500,000, of which (i) $16,500,000 was disbursed on October 7, 2024 and (ii) $3,000,000 was disbursed on February 18, 2025. Pursuant to the terms of the Loan Agreement, the proceeds are to be used for the purpose of (1) funding operations and (2) performing clinical and research & development activities related to Halneuron®. During November 2024, the Company announced the results from an investigator-sponsored study conducted by the Bateman Horne Center (“BHC”) in a double-blinded, placebo-controlled investigator-sponsored study (“BHC-202”) assessing the combination of Val/Cel for the treatment of fatigue and related sequalae associated with Long-COVID (“LC”). The study demonstrated that the low dose combination antiviral therapy IMC-2 treated patient cohort (valacyclovir 750 mg + celecoxib dosed 200 mg twice daily) exhibited clinically meaningful reductions in LC associated fatigue and sleep disturbance, as compared with the placebo treated cohort. The high dose IMC-2 treated cohort (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) did not exhibit clinically meaningful differences versus placebo, believed to be related to higher levels of gastrointestinal (GI) adverse events associated with the higher dose regimen. The Company has initially applied for non-dilutive funding through the NIH’s initiative to address LC called RECOVER-Treating Long-COVID (“RECOVER-TLC”) which just allocated new funds for LC programs. The Company is also engaged with potential investors who are performing due diligence for funding a larger study. Management anticipates the cash on hand at December 31, 2024 of approximately $14.8 million plus the additional loan proceeds of $3 million received on February 18, 2025 and net offering proceeds of $4.25 million received on March 14, 2025, will fund operations through the first quarter of 2026. The Company will need to secure additional financing to fund its ongoing clinical trials and operations beyond the first quarter of 2026 to continue to execute its strategy. Management plans to explore various dilutive and non-dilutive sources of funding, including equity financings, debt financings, collaboration and licensing arrangements or other financing alternatives. There can be no assurance that management will be successful in raising additional funds or on terms acceptable to the Company. Accordingly, there is substantial doubt about the Company’s ability to operate as a going concern within one year after the issuance date of these consolidated financial statements. The consolidated financial statements have been prepared on a going concern basis and do not include any adjustments to reflect this uncertainty. |