Part I: Financial Information [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents Dogwood Therapeutics' unaudited condensed consolidated financial statements for the periods ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$96.7 million**, liabilities decreased to **$14.2 million**, and stockholders' equity turned positive to **$6.9 million** as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (Unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$96,692,527** | **$94,308,246** | | Cash | $13,402,809 | $14,847,949 | | Goodwill | $12,458,383 | $11,812,476 | | Intangible assets | $69,303,582 | $65,710,527 | | **Total Liabilities** | **$14,151,904** | **$30,027,223** | | Debt with related party | $0 | $15,381,077 | | **Total stockholders' equity (deficit)** | **$6,878,599** | **($10,124,339)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported no revenue, with net loss increasing to **$14.7 million** for the six months ended June 30, 2025, driven by a **$6.1 million** debt conversion loss and higher R&D expenses Statement of Operations Highlights (Unaudited, Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and development expenses | $5,006,941 | $679,801 | | General and administrative expenses | $3,346,100 | $1,704,124 | | Loss from operations | ($8,353,041) | ($2,383,925) | | Loss on debt conversion with related party | ($6,134,120) | $0 | | **Net loss** | **($14,732,305)** | **($2,341,168)** | | Net loss per common share, basic and diluted | ($9.51) | ($2.78) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$8.7 million**, while financing activities provided **$7.3 million**, resulting in a **$1.5 million** net decrease in cash for the six months ended June 30, 2025 Cash Flow Summary (Unaudited, Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,708,672) | ($1,749,160) | | Net cash provided by financing activities | $7,252,245 | $1,452,397 | | **Net decrease in cash** | **($1,456,427)** | **($296,763)** | | Cash, beginning of period | $14,847,949 | $3,316,946 | | Cash, end of period | $13,402,809 | $3,020,183 | - Non-cash financing activities for the six months ended June 30, 2025, included the conversion of **$19.5 million** in related-party debt and **$0.4 million** in accrued interest into Series A-1 Non-Voting Convertible Preferred Stock[15](index=15&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business focus, going concern issues, the Pharmagesic acquisition, debt conversion, and recent equity financing activities - The company is a pre-revenue, development-stage biopharmaceutical firm focused on two main areas: Nav 1.7 modulation for pain (lead candidate Halneuron®) and antiviral therapies for fatigue-related illnesses (IMC-1, IMC-2)[18](index=18&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to operate as a going concern within one year, as current cash is insufficient to fund operations beyond the first quarter of 2026. Additional financing is required[23](index=23&type=chunk) - On October 7, 2024, the company acquired Pharmagesic (Holdings) Inc. in a business combination, which was accounted for using the acquisition method. This transaction brought in the Halneuron® program[17](index=17&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operations, and liquidity, highlighting increased expenses from clinical trials and the need for additional financing due to going concern issues [Overview](index=27&type=section&id=Overview) The company focuses on developing pain and fatigue medicines, with lead candidate Halneuron® in a Phase 2b trial and antiviral programs seeking partnerships - The lead product candidate, Halneuron®, is in a Phase 2b clinical trial (HALT-CINP-203) for chemotherapy-induced neuropathic pain (CINP)[125](index=125&type=chunk) - An interim analysis of the HALT-CINP-203 trial is expected in the fourth quarter of 2025, with top-line data anticipated in the second half of 2026[126](index=126&type=chunk) - The antiviral programs for IMC-1 (fibromyalgia) and IMC-2 (Long-COVID) are secondary priorities, and the company is seeking partnerships to advance them[127](index=127&type=chunk)[130](index=130&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operating expenses significantly increased for the six months ended June 30, 2025, driven by a **$4.3 million** rise in R&D and a **$1.6 million** increase in G&A expenses Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,006,941 | $679,801 | +$4,327,140 | | General and administrative | $3,346,100 | $1,704,124 | +$1,641,976 | | **Total operating expenses** | **$8,353,041** | **$2,383,925** | **+$5,969,116** | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) With **$13.4 million** cash as of June 30, 2025, the company's liquidity is limited to Q1 2026, necessitating additional financing due to going concern issues - The company's cash on hand of approximately **$13.4 million** as of June 30, 2025, is expected to fund operations only through the first quarter of 2026[138](index=138&type=chunk)[143](index=143&type=chunk) - A registered direct offering in March 2025 raised net proceeds of approximately **$4.25 million**[141](index=141&type=chunk) - Substantial doubt exists regarding the company's ability to continue as a going concern, and it will need to raise additional funds through equity, debt, or partnerships to continue its strategy[143](index=143&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Dogwood Therapeutics is not required to provide market risk disclosures - This item is not required for smaller reporting companies[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[156](index=156&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[157](index=157&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending or ongoing litigation - The company does not currently have any pending or ongoing material litigation[160](index=160&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) No material changes from previously disclosed risk factors in the 2024 Annual Report on Form 10-K are reported - No material changes from risk factors previously disclosed in the 2024 Annual Report on Form 10-K are reported[161](index=161&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[162](index=162&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 trading arrangements during the six months ended June 30, 2025 - No director or officer adopted or terminated any Rule 10b5-1 trading arrangement during the six months ended June 30, 2025[165](index=165&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section refers to the Exhibit Index, listing all exhibits filed with or incorporated by reference into this Quarterly Report on Form 10-Q

[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 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]