[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) Dogwood Therapeutics advanced its Halneuron® Phase 2b CINP trial with 52 patients enrolled, anticipating Q4 2025 interim data, and maintains a $13.4 million cash position - Enrollment in the ongoing Halneuron® Phase 2b CINP trial has reached **52 patients**[1](index=1&type=chunk)[3](index=3&type=chunk) - The interim data readout for the Halneuron® CINP Phase 2b study is expected in **Q4 2025**[1](index=1&type=chunk) - The trial has a low discontinuation rate of **5.8%** due to adverse events, indicating that Halneuron® and the placebo have been generally well tolerated[1](index=1&type=chunk) - Cash on hand is **$13.4 million**, which is expected to fund operations through the **first quarter of 2026**[1](index=1&type=chunk)[20](index=20&type=chunk) - Management believes Halneuron® has the potential to be the **first and only FDA-approved treatment** for CINP and sees opportunities to expand its NaV 1.7 research pipeline to other forms of pain[2](index=2&type=chunk) [Proprietary Pipeline Overview](index=3&type=section&id=Proprietary%20Pipeline%20Overview) The company's pipeline features Halneuron® in Phase 2b for CINP, IMC-1 ready for Phase 3 for Fibromyalgia, and IMC-2 for Long-COVID paused due to funding uncertainty - **Halneuron®**: A non-opioid, NaV 1.7 inhibitor in Phase 2b development for treating pain, specifically CINP. It has received FDA Fast Track designation, with interim data expected in **Q4 2025**[9](index=9&type=chunk) - **IMC-1 (famciclovir + celecoxib)**: A combination antiviral treatment for Fibromyalgia (FM) that is ready for Phase 3 development and has also been granted FDA Fast Track designation[9](index=9&type=chunk) - **IMC-2 (valacyclovir + celecoxib)**: A combination antiviral treatment for Long-COVID in Phase 2a development. Current external research funding and partnership discussions for this program are paused due to reductions in government health funding[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Dogwood Therapeutics reported a Q2 2025 net loss of $3.8 million, or $1.99 per share, driven by increased R&D and G&A expenses compared to Q2 2024 Expense Category | Expense Category | Q2 2025 | Q2 2024 | Change | Primary Driver | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2.5M | $0.3M | +$2.2M | $1.6M for Halneuron® CINP Phase 2b study | | General & Administrative | $1.3M | $0.7M | +$0.6M | Legal, accounting, and personnel costs | Metric | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss Attributable to Common Stockholders | $3.8 million | $1.0 million | | Net Loss Per Share (Basic and Diluted) | $1.99 | $1.15 | [Financial Statements](index=8&type=section&id=Financial%20Statements) Detailed financial statements for Q2 2025 and year-to-date show increased losses from R&D spending, alongside a strong cash position and improved stockholders' equity [Condensed Statements of Operations](index=8&type=section&id=Condensed%20Statements%20of%20Operations) Q2 2025 revenue remained at $0, with operating expenses rising to $3.9 million, resulting in a net loss of $3.8 million, and a six-month net loss of $14.7 million | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | R&D Expenses | $2,570 | $336 | | G&A Expenses | $1,353 | $734 | | **Loss from Operations** | **($3,923)** | **($1,070)** | | **Net Loss** | **($3,807)** | **($1,050)** | | **Net Loss Per Share** | **($1.99)** | **($1.15)** | | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | R&D Expenses | $5,007 | $680 | | G&A Expenses | $3,346 | $1,704 | | **Loss from Operations** | **($8,353)** | **($2,384)** | | **Net Loss** | **($14,732)** | **($2,341)** | | **Net Loss Per Share** | **($9.51)** | **($2.78)** | [Condensed Consolidated Balance Sheet](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2025, cash stood at $13.4 million, total liabilities decreased to $14.2 million, and stockholders' equity turned positive to $6.9 million | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $13,403 | $14,848 | | Total Assets | $96,693 | $94,308 | | Total Liabilities | $14,152 | $30,027 | | Total Stockholders' Equity (Deficit) | $6,879 | ($10,124) | [About Dogwood Therapeutics](index=5&type=section&id=About%20Dogwood%20Therapeutics) Dogwood Therapeutics is a biopharmaceutical company developing treatments for pain and fatigue, utilizing non-opioid analgesic and antiviral platforms - The company is a development-stage biopharmaceutical firm focused on pain and fatigue-related disorders[11](index=11&type=chunk) - The non-opioid analgesic program is centered on Halneuron®, a highly specific NaV 1.7 sodium channel modulator designed to reduce pain transmission[11](index=11&type=chunk) - The antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib, targeting fibromyalgia and Long-COVID respectively[12](index=12&type=chunk)

Core Viewpoint - Dogwood Therapeutics is advancing its Halneuron Phase 2b trial for chemotherapy-induced neuropathic pain (CINP), with the potential to be the first FDA-approved treatment for this condition, while also expanding its research pipeline for other pain-related disorders [2][3]. Company Overview - Dogwood Therapeutics is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders, with a proprietary non-opioid NaV 1.7 analgesic program centered on Halneuron [10][11]. Clinical Development - The ongoing Halneuron Phase 2b trial has enrolled 52 patients to date, with interim data expected in Q4 2025 [3][6]. - Halneuron has received fast track designation from the FDA for the treatment of CINP, indicating its potential significance in the market [7]. Financial Performance - Research and development expenses for Q2 2025 were $2.5 million, a significant increase from $0.3 million in Q2 2024, primarily due to the business combination with Pharmagesic and increased clinical trial costs [5][9]. - General and administrative expenses rose to $1.3 million in Q2 2025 from $0.7 million in Q2 2024, driven by higher legal, accounting fees, and public company expenses [8]. - The net loss attributable to common stockholders for Q2 2025 was $3.8 million, compared to a net loss of $1.0 million in Q2 2024, reflecting the increased operational costs [9][15]. Cash Position - The company reported cash on hand of $13.4 million as of June 30, 2025, providing an operational runway through Q1 2026 [6][15]. Pipeline Overview - The proprietary pipeline includes Halneuron for CINP, IMC-1 for fibromyalgia, and IMC-2 for Long-COVID, with IMC-1 ready for Phase 3 development and IMC-2 in Phase 2a [7][11].

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]