Core Insights - Dogwood Therapeutics, Inc. is advancing its first-in-class, non-opioid Nav 1.7 inhibitor, Halneuron, for treating chemotherapy-induced neuropathic pain (CINP) and is set to begin dosing the first patient in its Phase 2b clinical trial in Q1 2025 [1][3]. Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating new medicines for pain and fatigue-related disorders, with a proprietary non-opioid analgesic program centered on Halneuron [4]. - The company has a history of developing and commercializing successful pain therapeutics, including Celebrex, Lyrica, and Savella [3]. Product Development - Halneuron has shown statistically significant pain reduction in cancer-related pain in previous clinical trials, with an acceptable safety profile and no addiction potential [2]. - The market for chronic neuropathy treatment, particularly in cancer patients, is valued at approximately $1.5 billion, indicating a high unmet medical need [3]. Clinical Trials and Future Plans - Halneuron has been evaluated in over 700 patients across Phase 1 and Phase 2 studies, demonstrating its potential effectiveness [2]. - Interim data from the upcoming Phase 2 CINP study is expected in the second half of 2025 [4]. - The company is also advancing an antiviral program targeting illnesses related to dormant herpesviruses, with IMC-1 progressing to Phase 3 for fibromyalgia and IMC-2 moving into Phase 2b research for Long-COVID [4].

Halneuron® Development and Studies - Halneuron® Phase 2b study for chemotherapy-induced neuropathic pain (CINP) is expected to commence in Q1 2025 with an interim efficacy readout in 2H 2025[90] - Halneuron® demonstrated statistically significant pain reduction in a Phase 2 study (n=165) for cancer-related pain (CRP), with some patients experiencing pain relief for over 30 days post-treatment[90] IMC-2 Development and Studies - IMC-2 Phase 2 study for Long-COVID (LC) is expected to report top-line data in November 2024[88] - IMC-2 showed statistically significant improvements in fatigue, pain, and autonomic dysfunction in a proof-of-concept study for Long-COVID (LC) with a mean illness duration of two years[95] - The company plans to explore dilutive and non-dilutive funding sources for a Phase 2b study of IMC-2 for Long-COVID (LC) pending positive results from the ongoing study[96] IMC-1 Development and Readiness - IMC-1 is Phase 3 ready for fibromyalgia (FM) treatment, with FDA agreement on Phase 3 program requirements, including a head-to-head study versus placebo and long-term extension study[94] Intellectual Property and Acquisitions - The company filed new intellectual property (IP) for IMC-2 with protection potential extending to 2044[96] - The company acquired Pharmagesic (Holdings) Inc. on October 7, 2024, issuing 211,383 shares of common stock and 2,108.3854 shares of Series A Preferred Stock to Sealbond Limited[97][98] - The company’s pipeline includes Halneuron® for pain disorders and IMC-1/IMC-2 for fibromyalgia and Long-COVID, with significant value creation potential post-Pharmagesic acquisition[88] Financial Agreements and Funding - The company entered into a Contingent Value Rights (CVR) agreement, entitling holders to 87.75% of any upfront or milestone payments received by the company[103] - The company entered into a Loan Agreement for an aggregate principal amount of $19.5 million, with $16.5 million disbursed on October 7, 2024, and $3 million to be disbursed on February 18, 2025, for funding operations and Halneuron® R&D activities[106] - The Loan Agreement bears interest at SOFR plus 2.00%, increasing by 1.00% in case of default, and is payable in full with principal and accrued interest on October 7, 2027[106] - The company plans to secure additional capital through equity offerings, debt financings, or other alternatives to fund ongoing clinical trials and operations[141] - The company closed a public offering on May 22, 2024, raising gross proceeds of $1.7 million and net proceeds of approximately $1.4 million[135] - The company terminated its ATM program in August 2023 after raising $1,355,090 in gross proceeds from the sale of 25,675 shares of Common Stock[136][137] Stock and Financial Transactions - The company filed a Certificate of Designation for Series A Non-Voting Convertible Preferred Stock, which entitles holders to receive dividends at a rate of 5.0% per annum payable in shares of Series A Preferred Stock[113] - The company completed a Reverse Stock Split, converting every 25 shares of Common Stock into one share, effective October 9, 2024, resulting in 1,110,317 outstanding shares prior to the Exchange Agreement[121] - The company issued 10,568 shares of Common Stock and 105.4190 shares of Series A Preferred Stock, along with $1.155 million in cash, to Tungsten Advisors as compensation for financial advisory services[124] - The company agreed to indemnify holders of Common Stock and Series A Preferred Stock, as well as their respective partners, directors, and other related parties, under the Registration Rights Agreement[110] Financial Performance and Expenses - Research and development expenses increased by $0.2 million for the three months ended September 30, 2024, primarily due to a $0.3 million increase in expenses for a proof-of-concept study, offset by a $0.1 million decrease in regulatory expenses[129] - General and administrative expenses increased by $0.9 million for the three months ended September 30, 2024, primarily due to higher legal and professional fees related to the Combination in October 2024[130][131] - The company incurred net losses of $2,280,684 and $4,621,852 for the three and nine months ended September 30, 2024, respectively[132] - As of September 30, 2024, the company had an accumulated deficit of $66,091,074 and cash of $2,039,819[132] - Cash is not sufficient to fund operating expenses and capital requirements for at least the next 12 months, requiring additional financing beyond 2025[133][139] - Net cash used in operations was $2.6 million for the nine months ended September 30, 2024, primarily due to a net loss of $4.6 million[142] - Net cash provided by financing activities was $1.4 million for the nine months ended September 30, 2024, from a public offering in May 2024[145] Corporate Changes and Compliance - The company changed its name from "Virios Therapeutics, Inc." to "Dogwood Therapeutics, Inc." effective October 9, 2024, and began trading under the ticker symbol "DWTX"[119] - The company regained compliance with Nasdaq's Minimum Bid Price Requirement on October 29, 2024, after maintaining a closing bid price of at least $1.00 per share for more than ten consecutive business days[128] - No changes in internal control over financial reporting were identified during the quarter[153] - The company is not currently involved in any material pending or ongoing litigation[155] Transaction Costs and Legal Fees - The company incurred transaction costs of approximately $1.033 million during the three and nine months ended September 30, 2024, related to the Combination[123]

Financial Performance - The net loss for Q3 2024 was $2.3 million, or $2.05 per share, compared to a net loss of $1.2 million, or $1.62 per share in Q3 2023[10]. - Cash as of September 30, 2024, was $2.0 million, which, along with $16.5 million in loan proceeds, is insufficient to fund operations for the next 12 months[11]. - Total assets as of September 30, 2024, were $2.3 million, down from $4.2 million at the end of 2023[17]. - Total liabilities increased to $1.3 million as of September 30, 2024, compared to $0.4 million at the end of 2023[17]. Expenses - Research and development expenses increased by $0.2 million in Q3 2024 compared to Q3 2023, primarily due to a $0.3 million increase related to a grant for a Long-COVID study[8]. - General and administrative expenses rose by $0.9 million in Q3 2024 compared to Q3 2023, mainly due to higher legal and professional fees of $1.0 million[9]. Funding and Financing - Dogwood Therapeutics raised $19.5 million in committed debt financing, with $16.5 million funded as of October 7, 2024, and an additional $3.0 million expected in Q1 2025[4]. Development Pipeline - The company has three late-stage assets: Halneuron® in Phase 2b for chemotherapy-induced neuropathic pain, IMC-1 ready for Phase 3 for fibromyalgia, and IMC-2 in Phase 2 for Long-COVID[3]. - Top-line results from the IMC-2 Phase 2a study are expected by mid-November 2024[5]. - Interim data from the Halneuron® Phase 2b study are anticipated in the second half of 2025[6].