Core Insights - Dogwood Therapeutics is progressing with its Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP), with interim data readout expected in Q4 2025 [1][5] - The trial has shown a low discontinuation rate of 6% due to adverse events among the first 35 patients, indicating good tolerability of both Halneuron and placebo treatments [1][4] - The company has enrolled the first 50 patients and aims to analyze data from approximately 100 patients by the end of 2025 [1][3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating new medicines for pain and fatigue-related disorders [5] - The lead product candidate, Halneuron, is a non-opioid NaV 1.7 inhibitor specifically targeting neuropathic pain associated with chemotherapy [4][5] - The company has received fast track designation from the FDA for Halneuron's treatment of CINP [4] Clinical Trial Details - The HALT-CINP trial is a randomized Phase 2b study evaluating Halneuron's safety and effectiveness against placebo in cancer patients with neuropathy from platinum or taxane-based chemotherapy [3] - Participants will receive 8 daily subcutaneous doses of Halneuron or placebo over 14 days, followed by a 28-day safety and effectiveness assessment [3] - Primary endpoints include overall safety and changes in pain intensity, while secondary measures will evaluate effects on sleep, fatigue, and overall health [3] Market Position and Future Plans - There is growing interest in sodium channel inhibition for pain treatment, with Halneuron's specificity and potency for Nav 1.7 setting it apart from other research programs [2] - Positive data from previous trials has increased interest from both patients and the research community, prompting the addition of more qualified research sites [2] - Full results from the Phase 2b trial are anticipated in mid-2026 [2]

Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [2] - The company has two main research platforms: a non-opioid analgesic program and an antiviral program [2] Product Pipeline - The lead candidate in the non-opioid analgesic program is Halneuron, a voltage-gated sodium channel modulator that has shown effectiveness in reducing pain from cancer and chemotherapy-induced neuropathic pain [2] - Interim data from the ongoing Phase 2 study of Halneuron for chemotherapy-induced neuropathic pain is expected in Q4 2025 [2] Antiviral Program - Dogwood's antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib [3] - IMC-1 is advancing towards Phase 3 development for fibromyalgia and is a focus for external partnerships [3] - IMC-2 has shown successful fatigue reduction in clinical trials for Long-COVID and has received FDA agreement to use fatigue reduction as the primary endpoint for future research [3] Upcoming Financial Results - The company will report its second quarter 2025 financial results on August 13, 2025, before the market opens [1]

Summary of Dogwood Therapeutics (DWTX) Conference Call Company Overview - **Company Name**: Dogwood Therapeutics - **Ticker**: DWTX - **Industry**: Biotechnology, specifically focused on pain management - **Product**: Helmuron, a non-opioid Nav 1.7 specific channel inhibitor for treating chronic and acute pain [3][4] Core Points and Arguments Product Development - Helmuron is designed to treat chemotherapy-induced neuropathic pain (CINP) and has received fast track designation from the FDA, indicating a potential for breakthrough designation due to unmet medical needs [6][10] - The drug has shown statistically significant pain reduction in phase two studies for both CINP and general cancer pain, with a duration of response lasting upwards of two months [8][33] - Helmuron has demonstrated safety in over 700 patients, with no evidence of addiction or tolerance buildup, which are common issues with opioids [9][8] Market Opportunity - Approximately 70% of chemotherapy patients experience neuropathic pain, with 30% continuing to suffer from chronic pain six months post-treatment [19][20] - The number of patients suffering from CINP is expected to rise from 3 million to 4.5 million by 2040 due to increasing cancer diagnoses and longer patient lifespans [20] - There is a significant commercial opportunity as there are currently no approved treatments for CINP, leading many patients to rely on opioids [21][19] Intellectual Property and Competitive Advantage - Dogwood Therapeutics acquired Pharmagisix Holdings, which includes the Helmuron program, and plans to expand its intellectual property protection with a fully synthetic version of tetrodotoxin, the active ingredient in Helmuron [10][45] - The synthetic process will reset the patent clock by 20 years, providing a competitive edge in the market [45] Financial Position and Future Plans - The company has $17.5 million in capital and is burning approximately $5 million per year, allowing it to fund operations until the end of Q1 2026 [57][59] - An interim analysis of the ongoing phase 2b trial is expected in Q4 2025, with final data due in mid-2026 [42][60] - The company is exploring options for additional funding or partnerships to support the completion of clinical trials [61] Other Important Information - The team at Dogwood Therapeutics has extensive experience in drug development, having previously launched well-known drugs such as Zoloft, Viagra, and Lipitor [4] - The company is also developing two antiviral programs targeting fibromyalgia and long COVID, which are ready to progress into phase three trials [47][48] - The low float of shares and significant trading volume on positive news indicates a volatile but potentially rewarding investment opportunity [13][64] Conclusion Dogwood Therapeutics is positioned to address a significant unmet medical need in pain management with its innovative product Helmuron. The company has a strong team, promising clinical data, and a clear path forward for development and commercialization, making it an attractive opportunity for investors in the biotechnology sector [63][64]

Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [2] - The company has two main research platforms: a non-opioid analgesic program and an antiviral program [2] Product Pipeline - The lead candidate in the non-opioid analgesic program is Halneuron, which targets voltage-gated sodium channels to reduce pain transmission [2] - Halneuron has shown pain reduction in clinical studies related to general cancer and chronic chemotherapy-induced neuropathic pain, with interim data from the ongoing Phase 2 CINP study expected in Q4 2025 [2] Antiviral Program - The antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib [3] - IMC-1 is advancing to Phase 3 development for fibromyalgia and is a focus for external partnerships [3] - IMC-2 has demonstrated successful fatigue reduction in Long-COVID patients and is set to progress into Phase 2b research following FDA agreement on using fatigue reduction as the primary endpoint [3] Upcoming Events - CEO Greg Duncan will present a corporate overview at the Sidoti Small-Cap Virtual Conference on June 11-12, 2025, and will be available for one-on-one meetings [1]

Financial Performance - Total operating expenses for the three months ended March 31, 2025, were $4.4 million, significantly higher than $1.3 million for the same period in 2024[142] - For the three months ended March 31, 2025, the net cash used in operations was $4.7 million, consisting of a net loss of $10.9 million and non-cash items of $6.4 million[152] - In comparison, for the three months ended March 31, 2024, the net cash used in operations was $0.9 million, with a net loss of $1.3 million[153] - Net cash used in operating activities for the three months ended March 31, 2025, was $(4.7) million, compared to $(0.9) million for the same period in 2024[151] Expenses - Research and development expenses increased by $2.1 million to $2.4 million for the three months ended March 31, 2025, compared to $0.3 million for the same period in 2024[143] - General and administrative expenses rose by $1.0 million to $2.0 million for the three months ended March 31, 2025, from $1.0 million in the prior year[144] Cash and Financing - As of March 31, 2025, the company's cash totaled $17.5 million, expected to fund operations through the first quarter of 2026[145] - The company raised gross proceeds of approximately $4.8 million from a registered direct offering of 578,950 shares of Common Stock at $8.26 per share on March 14, 2025[147] - Net cash provided by financing activities during the three months ended March 31, 2025, was $7.4 million, attributed to cash proceeds from a Loan Agreement of $3.0 million and gross proceeds from a registered direct offering of $4.8 million[154] - There were no financing activities reported for the three months ended March 31, 2024[155] - The company entered into a Loan Agreement for a total principal amount of $19.5 million, with $16.5 million disbursed on October 7, 2024[136] Future Financing Needs - The company anticipates needing additional financing beyond the first quarter of 2026 to continue its clinical trials and operations[150] - The company has incurred losses and generated negative cash flows from operations since inception, with substantial doubt regarding its ability to continue as a going concern within the next 12 months[150] Clinical Trials - The HALT-CINP-203 clinical trial commenced in the first quarter of 2025, involving 200 patients with moderate to severe neuropathic pain[129] Accounting and Reporting - There were no significant changes to critical accounting policies during the three months ended March 31, 2025, compared to the previous year[159] - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced reporting requirements[160] - The company is not required to provide an auditor's attestation report on internal controls over financial reporting as per the JOBS Act provisions[161] - The company did not disclose any quantitative and qualitative disclosures about market risk, as it is not required for smaller reporting companies[162] Off-Balance Sheet Arrangements - As of March 31, 2025, the company did not have any off-balance sheet arrangements or relationships with unconsolidated entities[156]

Financial Performance - Net loss attributable to common stockholders for Q1 2025 was $12.2 million, or $8.45 per share, compared to a net loss of $1.3 million, or $1.68 per share, in Q1 2024[9] - Cash on hand as of March 31, 2025, was $17.5 million, providing operational runway through Q1 2026[1] - Total assets increased to $96.98 million as of March 31, 2025, compared to $94.31 million at the end of 2024[20] - Total liabilities decreased to $14.24 million as of March 31, 2025, down from $30.03 million at the end of 2024[20] - An affiliate of the company's largest shareholder converted a $19.5 million loan into equity, improving the company's balance sheet[3] Expenses - Research and development expenses for Q1 2025 were $2.4 million, a significant increase of 700% compared to $0.3 million in Q1 2024, primarily due to clinical trial expenses[7] - General and administrative expenses for Q1 2025 were $2.0 million, up 100% from $1.0 million in Q1 2024, driven by increased legal and accounting fees[8] Regulatory and Development Updates - Dogwood Therapeutics commenced dosing in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain program, aiming to be the first FDA approved therapy for this condition[3] - Halneuron® has been granted fast track designation by the FDA for the treatment of chemotherapy induced neuropathic pain, with interim data expected in Q4 2025[10] - The company received confirmation from Nasdaq that it has regained compliance with the minimum stockholders' equity requirement of $2.5 million[5]

Core Viewpoint - Dogwood Therapeutics, Inc. is advancing its Halneuron® Chemotherapy Induced Neuropathic Pain Phase 2b study, with interim data expected in Q4 2025, while maintaining a strong financial position with $17.5 million in cash to support operations through Q1 2026 [1][6]. Company Developments - The company has commenced dosing patients in the Halneuron® Phase 2b study, which aims to be the first FDA-approved therapy for chemotherapy-induced neuropathic pain [6]. - Halneuron® has received fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain [6]. - An affiliate of the largest shareholder converted a $19.5 million loan into equity, enhancing the company's balance sheet [6]. - A recent capital raise of $4.8 million, combined with existing cash, provides operational runway through Q1 2026 [6]. Financial Performance - Research and development expenses for Q1 2025 were $2.4 million, a significant increase from $0.3 million in Q1 2024, primarily due to the business combination with Pharmagesic and increased clinical trial expenses [5]. - General and administrative expenses rose to $2.0 million in Q1 2025 from $1.0 million in Q1 2024, driven by higher legal and accounting fees [7]. - The net loss attributable to common stockholders for Q1 2025 was $12.2 million, compared to a net loss of $1.3 million in Q1 2024, reflecting a substantial increase in operational costs [8][14]. Research Pipeline - The proprietary pipeline includes Halneuron® as a non-opioid NaV 1.7 inhibitor for pain conditions, with interim data from the ongoing Phase 2b study expected in Q4 2025 [9]. - IMC-1 and IMC-2 are antiviral treatments in development, with IMC-1 ready for Phase 3 for fibromyalgia and IMC-2 in Phase 2a for Long-COVID [10].

Core Points - Dogwood Therapeutics has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million [1][2] - The company has a strong cash position of $17.5 million as of the end of Q1 2025 and is currently dosing patients in its Halneuron Phase 2b trial for chemotherapy-induced neuropathic pain [2][3] - Interim data from the ongoing Halneuron Phase 2 CINP study is expected in Q4 2025 [3] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on new medicines for pain and fatigue-related disorders [3] - The company has two mechanistic platforms: a non-opioid analgesic program and an antiviral program [3][4] - The lead candidate, Halneuron, is a voltage-gated sodium channel modulator effective in reducing pain transmission, with demonstrated pain reduction in cancer-related and chemotherapy-induced neuropathic pain [3] Antiviral Program - The antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and celecoxib [4] - IMC-1 is advancing to Phase 3 development for fibromyalgia, while IMC-2 has shown successful fatigue reduction in Long-COVID trials [4] - The company has agreed with the FDA to use fatigue reduction as the primary endpoint for future Long-COVID research and plans to advance IMC-2 into Phase 2b research [4]

Core Viewpoint - Dogwood Therapeutics, Inc. has regained compliance with Nasdaq's minimum stockholders' equity requirement, positioning the company favorably for future growth and shareholder value enhancement [1][2]. Financial Position - As of the end of Q1 2025, Dogwood Therapeutics reported a strong cash position of $17.5 million with no debt, which supports its operational and strategic initiatives [2]. - The company had previously fallen below the $2.5 million minimum stockholders' equity requirement but has since taken steps to rectify this situation [2][3]. Compliance Actions - The company entered into a Debt Exchange and Cancellation Agreement with Conjoint, Inc., resulting in the cancellation of approximately $19.9 million in debt in exchange for shares of Series A-1 Non-Voting Convertible Preferred Stock [4]. - Additionally, Dogwood Therapeutics raised approximately $4.8 million through a stock purchase agreement with institutional investors [4]. Shareholder Information - As of March 31, 2025, there were 1,911,128 shares of the company's common stock issued and outstanding [5]. Research and Development - Dogwood Therapeutics is focused on developing new medicines for pain and fatigue-related disorders, with a research pipeline that includes a non-opioid analgesic program and an antiviral program [6]. - The lead candidate, Halneuron®, has shown promise in clinical studies for reducing pain related to cancer and chemotherapy-induced neuropathic pain, with interim data from ongoing studies expected in Q4 2025 [6]. - The antiviral program includes IMC-1 and IMC-2, targeting conditions related to dormant herpesvirus reactivation, with IMC-1 set to progress to Phase 3 development for fibromyalgia and IMC-2 advancing to Phase 2b research for Long-COVID [7].

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].