ATLANTA, April 03, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders today announced it believes it has regained compliance with the minimum stockholders’ equity requirement as set forth in Nasdaq Listing Rule 5550(b)(1). DWTX Chairman and CEO Greg Duncan stated, “We appreciate the consideration Nasdaq has shown Dogwood Therapeutics, Inc.” He continu ...

Product Development - The company is focused on developing new medicines for pain and fatigue-related disorders, owning Pharmagesic and its subsidiaries[24]. - The lead product candidate, Halneuron®, is in late-stage clinical development for chemotherapy-induced neuropathic pain (CINP) and utilizes highly purified Tetrodotoxin as an active ingredient[26]. - The company commenced the HALT-CINP-203 Phase 2b clinical trial in Q1 2025, targeting 200 patients to assess the efficacy and safety of Halneuron®[43]. - The antiviral program includes IMC-1 and IMC-2, which are novel combinations of anti-herpes antivirals and celecoxib aimed at treating fibromyalgia and Long-COVID[50]. - The company plans to initiate a Phase 3 program that includes two pivotal trials to demonstrate the safety and efficacy of IMC-1 in treating FM[68]. - The Phase 2b study, known as FORTRESS, is designed to further assess the efficacy of IMC-1 in a larger patient population[63]. - The company plans to engage with the FDA in the second half of 2025 regarding the synthetic formulation of Halneuron® for Phase 3 development in 2026[115]. - The company is developing IMC-1 (famciclovir/celecoxib) and plans to explore additional therapeutic combinations in the future[109]. Clinical Trial Results - In a Phase 2 study, 51% of patients receiving Halneuron® experienced at least a 30% reduction in pain compared to 35% in the placebo group, with a pain response duration of 57.7 days for Halneuron® responders versus 10.5 days for placebo[37]. - Halneuron® has shown a favorable safety profile, with 84% of patients in a study experiencing at least one treatment-emergent adverse event, primarily mild or moderate[40]. - IMC-1 has been granted FDA fast-track review status for the treatment of fibromyalgia (FM) based on significant unmet needs and promising Phase 2a data[62]. - In the Phase 2a study, IMC-1 demonstrated statistically significant improvement in pain reduction compared to placebo, with a p-value of 0.001[56]. - The FORTRESS study showed that IMC-1-treated patients had a statistically significant improvement in pain reduction (p=0.03) and fatigue assessment (p=0.006) during the second half of the trial[65]. - Statistically significant improvements in various health metrics were observed, including a p-value of <0.001 for NRS Fatigue and 0.002 for Orthostatic Intolerance Symptoms Assessment Scale[83]. Market Potential - The global CINP treatment market is approximately $1.5 billion annually, with the larger cancer-related pain market reaching about $5 billion[36]. - Approximately 1.7 million CINP patients exist in the seven major markets, with opioids currently accounting for about 30% of the global CINP treatment market[36]. - Approximately 3.6 million patients in the U.S. are diagnosed with FM, with around 2 million currently receiving treatment[71]. - The market for FM treatments is significant, with peak sales of pregabalin and duloxetine reaching approximately $10 billion, highlighting the need for more effective therapies[91]. - Approximately 10 million Americans suffer from FM, with chronic pain conditions costing the U.S. economy between $560 billion and $635 billion annually[92]. Financial Overview - The Company incurred consolidated net losses of $12,349,724 and $5,296,015 for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $73,818,946 as of December 31, 2024[191]. - The Company raised approximately $4.78 million in gross proceeds from the March 2025 Offering, selling 578,950 shares of Common Stock at a price of $8.26 per share[184]. - The Loan Agreement with Conjoint Inc. provided a total principal amount of $19,500,000, with $16,500,000 disbursed on October 7, 2024, and $3,000,000 on February 18, 2025[181]. - The Company expects to incur significant additional operating losses for the next several years as it advances Halneuron®, IMC-1, and IMC-2 through clinical development[192]. - The Company has not commercialized any products and has never generated revenue from product commercialization[191]. - The Company will require additional capital to fund operations and may face challenges in obtaining necessary financing[194]. Regulatory Environment - The FDA review process for new drug applications (NDAs) typically takes about 10 to 12 months from submission, with a substantial application user fee required[125]. - The FDA may refer a novel drug application to an advisory committee for independent expert review and recommendations[130]. - The FDA typically inspects manufacturing facilities before approving a New Drug Application (NDA) to ensure compliance with current Good Manufacturing Practices (cGMP)[131]. - The FDA may issue a complete response letter if the NDA does not meet regulatory criteria, requiring additional testing for reconsideration[132]. - The FDA has expedited review programs, such as fast track designation and priority review, to accelerate the approval process for drugs addressing serious conditions[134][137]. - A drug may receive accelerated approval based on its effect on a surrogate endpoint that predicts clinical benefit, with post-marketing studies required to confirm its effectiveness[141][144]. - Orphan drug designation can provide exclusivity for seven years if the drug treats a rare disease affecting fewer than 200,000 individuals in the U.S.[145][146]. Challenges and Risks - The company has a limited operating history and no history of commercializing pharmaceutical products, which may complicate future viability assessments[203]. - The company is heavily dependent on the success of its product candidates Halneuron®, IMC-1, and IMC-2, which are still under clinical development and have not yet received regulatory approval[206]. - IMC-1 did not achieve statistically significant efficacy outcomes in the Phase 2b FORTRESS study, which raises concerns about future approval and commercialization[207]. - The regulatory approval processes for the FDA and comparable foreign authorities are lengthy, expensive, and unpredictable, potentially harming the company's business if approvals are not obtained[214]. - The company may face delays in clinical trials due to various factors, including disagreements with regulatory authorities and challenges in patient recruitment and retention[212][221]. - Clinical trials are expensive and time-consuming, with outcomes that are uncertain, leading to potential delays and increased costs[211]. - The company relies on third-party contract research organizations and clinical trial sites, which may impact the timely conduct of clinical trials[213]. Intellectual Property - The company holds 21 issued patents related to its antiviral portfolio, including three Composition of Matter patents for IMC-1, with exclusivity extending to 2033[102]. - The company has filed multiple U.S. patent applications related to the synthesis and use of Tetrodotoxin, including Application No. 63/652,113 and 63/672,146[106]. - The company holds U.S. patents for drug combinations involving famciclovir and celecoxib, with specific patents including US 8,809,351 and US 10,034,846[106]. - The company has a Know-How License Agreement with the University of Alabama, granting a non-exclusive, worldwide, royalty-free license for herpesvirus-related technical information, effective until June 1, 2037[112]. Corporate Structure and Operations - The Company changed its name from "Virios Therapeutics, Inc." to "Dogwood Therapeutics, Inc." on October 7, 2024, and its stock began trading under the ticker symbol "DWTX" on October 9, 2024[185]. - As of December 31, 2024, the company had twelve full-time employees, with four in the U.S. and eight in Canada, relying heavily on independent contractors for development projects[177]. - The company operates a virtual office in the U.S. and leases office space for its Canadian employees in Vancouver, B.C.[178]. - The company is subject to various federal and state laws targeting fraud and abuse in the healthcare industry, which may impact its sales and marketing programs[158]. - The company must comply with the federal Physician Payment Sunshine Act, requiring tracking and reporting of payments to U.S. physicians and teaching hospitals[159].

Financial Performance - Net loss attributable to common stockholders for Q4 2024 was $8.2 million, or $6.29 per share, compared to a net loss of $1.1 million, or $1.43 per share, in Q4 2023[10]. - For the full year 2024, net loss attributable to common stockholders was $12.9 million, or $12.52 per share, compared to a net loss of $5.3 million, or $7.05 per share, in 2023[14]. Expenses - Research and development expenses for Q4 2024 were $2.3 million, a 567% increase from $0.3 million in Q4 2023[8]. - General and administrative expenses for Q4 2024 were $5.2 million, up 575% from $0.8 million in Q4 2023, primarily due to nonrecurring transaction costs[9]. Capital and Funding - The company converted $19.5 million in debt to equity, significantly strengthening its balance sheet[5]. - A recent capital raise of $4.8 million, combined with existing cash, provides operational runway through Q1 2026[5]. - As of December 31, 2024, Dogwood Therapeutics had cash totaling $14.8 million, sufficient to fund operations through Q1 2026[14]. Assets and Liabilities - Total assets increased to $94.3 million as of December 31, 2024, compared to $4.2 million in 2023[23]. - Total liabilities were $30.0 million as of December 31, 2024, compared to $0.4 million in 2023[23]. Clinical Development - Dogwood Therapeutics commenced dosing in its Halneuron® Phase 2b CINP program, with interim data expected in Q4 2025[5].

Core Viewpoint - Dogwood Therapeutics, Inc. has made significant advancements in its Halneuron CINP Phase 2b study and improved its financial position through a recent capital raise and debt-to-equity conversion, positioning the company as an attractive investment opportunity moving forward [2][6]. Financial Performance - Research and development expenses for Q4 2024 were $2.3 million, up from $0.3 million in Q4 2023, primarily due to increased clinical trial costs [5]. - General and administrative expenses for Q4 2024 were $5.2 million, compared to $0.8 million in Q4 2023, largely due to nonrecurring transaction costs related to the acquisition of Pharmagesic [8]. - The net loss attributable to common stockholders for Q4 2024 was $8.2 million, or $6.29 per share, compared to a net loss of $1.1 million, or $1.43 per share, in Q4 2023 [9]. Pipeline Development - Halneuron is in Phase 2b development as a non-opioid NaV 1.7 inhibitor for chemotherapy-induced neuropathic pain (CINP) and has received fast track designation from the FDA [4]. - IMC-1 is ready for Phase 3 development as a treatment for Fibromyalgia (FM) and has also received fast track designation from the FDA [4]. - IMC-2 is in Phase 2a development as a combination antiviral treatment for Long-COVID, with plans to seek external funding or partnerships for further development [4]. Capital and Liquidity - The company raised $4.8 million in common stock and converted $19.5 million in debt to equity, enhancing its balance sheet and providing operational runway through Q1 2026 [7][12]. - As of December 31, 2024, Dogwood Therapeutics had cash totaling $14.8 million, indicating sufficient resources to fund operations through early 2026 [12][19].

Core Insights - Dogwood Therapeutics is advancing Halneuron, a first-in-class, non-opioid treatment for chemotherapy-induced neuropathic pain (CINP), with the first patient dosed in its Phase 2b clinical trial [1][2] - The global market for CINP treatment is valued at $1.5 billion, indicating significant commercial potential for effective non-opioid therapies [1] - Halneuron specifically targets the NaV 1.7 sodium channel, which is crucial in pain transmission, and has shown a statistically significant reduction in cancer-related pain in previous trials [2][3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating non-opioid treatments for pain and fatigue-related disorders [3] - The company has a research pipeline that includes a non-opioid analgesic program centered on Halneuron and an antiviral program targeting conditions related to herpesvirus reactivation [4] - Halneuron has been evaluated in over 700 patients across Phase 1 and Phase 2 studies, demonstrating no signs of addiction potential [2] Clinical Development - The company aims to recruit 100 patients for the HALT-CINP trial by Q4 2025, with plans for an interim analysis to adapt the trial design if necessary [3] - Interim data from the Phase 2 CINP study is expected in the second half of 2025, which will provide insights into the efficacy of Halneuron [3] Antiviral Program - Dogwood's antiviral program includes IMC-1 and IMC-2, which are novel combinations of anti-herpes antivirals and celecoxib, targeting conditions like fibromyalgia and Long-COVID [4] - IMC-1 is set to progress to Phase 3 development for fibromyalgia, while IMC-2 has shown success in reducing fatigue associated with Long-COVID in clinical trials [4]

Core Points - Dogwood Therapeutics, Inc. has entered into a securities purchase agreement to sell 578,950 shares of common stock at $8.26 per share, expecting gross proceeds of approximately $4.8 million [1][2] - The net proceeds will be used to advance the clinical development of its lead candidate, Halneuron®, and for working capital and general corporate purposes [1] - The offering is expected to close on March 14, 2025, subject to customary closing conditions [1] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on non-opioid treatments for chronic and acute pain [5] - The company’s lead candidate, Halneuron, is a voltage-gated sodium channel modulator aimed at reducing pain transmission, with interim data from its Phase 2b trial expected in Q4 2025 [5] - Dogwood also has an antiviral program that includes IMC-1 and IMC-2, targeting conditions related to herpesvirus reactivation, with IMC-1 progressing to Phase 3 for fibromyalgia and IMC-2 advancing to Phase 2b for Long-COVID [6]

Core Points - CK Life Sciences Int'l., (Holdings) Inc. has agreed to convert $19.5 million of debt into equity for Dogwood Therapeutics, removing all existing debt from the company's balance sheet [1][2][3] - The conversion reflects CKLS's confidence in Dogwood's management and the potential of Halneuron as a treatment for chemotherapy-induced neuropathic pain (CINP) [2][4] - The strategic financing ensures Dogwood has sufficient capital to continue its Phase 2b CINP trial without the burden of debt payments [2][5] Financial Details - The debt conversion involves the issuance of 284.2638 shares of Series A-1 Non-Voting Convertible Preferred Stock, which can be converted into 10,000 shares of common stock, pending stockholder approval [3] - The principal amount of the loans and accrued interest will be fully satisfied and cancelled as part of this agreement [3] Product Development - Halneuron is a first-in-class NaV 1.7 specific voltage-gated sodium channel inhibitor, showing significant pain reduction in previous clinical trials with an acceptable safety profile [4] - The upcoming Phase 2b trial, HALT-CINP, is expected to dose its first patient soon, with interim data anticipated in Q4 of 2025 [2][5] Research Pipeline - Dogwood's research pipeline includes a non-opioid analgesic program centered on Halneuron and an antiviral program targeting conditions related to herpesvirus reactivation [5][6] - The antiviral program includes IMC-1 and IMC-2, with IMC-1 progressing to Phase 3 for fibromyalgia and IMC-2 advancing to Phase 2b for Long-COVID [6][7]

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].