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Dogwood Therapeutics (NasdaqCM:DWTX) Update / Briefing Transcript
2025-09-29 13:32
Summary of Dogwood Therapeutics Investor Call - September 29, 2025 Company Overview - **Company**: Dogwood Therapeutics (NasdaqCM: DWTX) - **Focus**: Development of treatments for chemotherapy-induced peripheral neuropathy (CIPN) and cancer-related pain Key Points Industry and Market Context - **CIPN Prevalence**: Approximately 70% of cancer patients undergoing chemotherapy experience neuropathy, with 30% suffering long-term effects six months post-treatment [18] - **Market Opportunity**: The global market for CIPN treatments is estimated at $1.5 billion, with potential expansion into cancer-related pain markets [34] Core Developments - **SP16 License**: Dogwood has secured a global license to develop and commercialize SP16, a first-in-class LRP1 agonist, which is expected to complement the lead compound Halneuron [3][4] - **Halneuron**: A Nav1.7 sodium channel inhibitor currently in a Phase 2b study for CIPN, showing promise in reducing pain without addiction or tolerance [6][8][9] Clinical Trials and Research - **Halneuron Phase 2b Study**: - 82 patients enrolled, targeting a total of 200 [10][11] - Primary endpoint: Average pain score reduction at week four [10] - Safety profile confirmed with only two dropouts [12] - **SP16 Phase 1b Trial**: - Funded by the National Cancer Institute (NCI), with dosing planned to coincide with chemotherapy [14][41] - Focus on safety and tolerability as primary endpoints, with secondary endpoints assessing neuropathic symptoms [41][42] Scientific Insights - **Mechanism of Action**: SP16 exhibits anti-inflammatory and analgesic effects, potentially protecting against nerve damage caused by chemotherapy [4][13][24] - **Preclinical Evidence**: Studies indicate SP16 can reduce hypersensitivity and promote nerve recovery in models of chemotherapy-induced damage [26][28] Financial and Transactional Aspects - **Transaction Structure**: The SP16 deal is an all-stock transaction with no royalties or future development milestones required [40] - **Ownership Implications**: Serpent Pharma will hold approximately 7.31% of Dogwood's stock post-transaction [15][16] Future Outlook - **Milestones**: - Filing of new synthetic IP for Halneuron expected in Q4 2025 [36] - IND filing for SP16 planned for Q4 2025, with patient enrollment in the first half of 2026 [36][51] - **Strategic Positioning**: The combination of Halneuron and SP16 is anticipated to enhance market penetration and create unique revenue pathways [34][35] Additional Considerations - **Expertise**: The management team has a strong background in developing and commercializing pain and neuropathy treatments, having previously worked on drugs like Celebrex and Lyrica [16] - **Community Engagement**: High interest from the medical community in the ongoing trials, reflecting the urgent need for effective treatments for CIPN [12] Conclusion Dogwood Therapeutics is positioned to make significant advancements in the treatment of chemotherapy-induced peripheral neuropathy and cancer-related pain through its innovative pipeline, particularly with the addition of SP16 to its portfolio. The company is focused on leveraging its clinical trials and strategic partnerships to address a critical unmet need in oncology care.
Dogwood Therapeutics (NasdaqCM:DWTX) Earnings Call Presentation
2025-09-29 12:30
Halneuron® Program - Halneuron® is undergoing a 4-week Phase 2b CINP study, with 80 patients currently randomized to treatment[7] - The Phase 2b study aims to assess the safety and efficacy of Halneuron® in treating moderate-to-severe CINP[9] - The target enrollment for the Phase 2b study is 200 patients, with a potential modification after an interim analysis in Q4 2025[11] - Halneuron® has shown pain relief of approximately 2 months in previous Phase 2 studies, with acceptable safety in over 700 patients[6] - The company plans to file new synthetic Halneuron® IP in Q4 2025 to support Phase 3 and commercialization[39] SP16 Program - The company acquired a royalty-free, global license for Serpin Pharma's SP16 IV formulation to treat neuropathy[13] - Serpin Pharma will receive approximately 382,000 common shares and approximately 179 preferred (A-2) shares, representing a projected 7.31% ownership of DWTX stock on a fully diluted basis, pending a shareholder vote[16] - CKLS ownership is projected to be approximately 83.00% on a fully diluted basis[16] - SP16 is poised to enter a Phase 1b study for CIPN, fully funded by the National Cancer Institute (NCI), with patient enrollment expected to begin in the first half of 2026[13,39] Strategic Rationale - The combined Halneuron® and SP16 programs aim to penetrate the global CINP treatment market, estimated at approximately $1.5 billion[38]
Dogwood Therapeutics Secures Exclusive Worldwide, Royalty Free License to Develop and Commercialize SP16 as a Treatment for Cancer Related Pain in an All-Stock Transaction Underscoring the Company's Dedication to Improving the Lives of Cancer Patients
Globenewswire· 2025-09-29 11:15
Core Insights - Dogwood Therapeutics has secured a royalty-free global license for Serpin Pharma's intravenous formulation of SP16 to manage cancer-related pain, particularly chemotherapy-induced neuropathy [2][3] - SP16 is a first-in-class LRP1 agonist that has shown both anti-inflammatory and neural repair activity, with a Phase 1b study fully funded by the National Cancer Institute set to begin patient enrollment in the first half of 2026 [1][3] - The licensing agreement includes the issuance of shares representing 7.31% of Dogwood's common stock on a fully diluted basis [10] Company Developments - The CEO of Dogwood Therapeutics emphasized that the SP16 in-license aligns with the company's strategic objective to expand its research pipeline in pain and neuropathy management [4] - Halneuron, Dogwood's lead product candidate, is currently in Phase 2b development for treating chemotherapy-induced neuropathic pain and has received fast-track designation from the FDA [7][13] - Interim data from the ongoing Halneuron Phase 2b study is expected in December 2025, with over eighty patients already recruited [7][14] Research and Clinical Insights - SP16 IV mimics the anti-inflammatory and immunomodulatory actions of alpha-1-antitrypsin, showing promise in addressing symptoms and damage associated with chemotherapy-induced peripheral neuropathy [4][8] - The combination of SP16 with Halneuron may provide adjunctive improvement for non-pain symptoms related to cancer treatment [6] - The unique approach of SP16 reflects the significant unmet medical need in managing cancer-related pain and neuropathy [3][4]
长江生命科技(00775)与DWTX订立弃权协议
智通财经网· 2025-09-26 14:32
Group 1 - The company, Changjiang Life Sciences Technology, has announced a transaction involving the issuance of common and preferred shares to acquire 100% equity of Pharmagesic (Holdings) Inc, with specific rights related to cash settlement and buyback options for the preferred shares [1] - The transaction will lead to a business merger with WEX, allowing access to the buyer's extensive experience in biotech fundraising, R&D, and commercialization in the pharmaceutical sector, particularly for pain relief and related diseases [2] - The flagship candidate product, Halneuron®, is expected to advance its clinical trial data and market entry due to the integration of the buyer's expertise and resources [2] Group 2 - The buyer's listing on NASDAQ will facilitate access to the U.S. capital markets, enabling faster R&D for Halneuron® and increasing the company's stake in the buyer to approximately 90% after conversion of preferred shares [3] - Partial waivers of cash settlement and buyback rights for the preferred shares will help the buyer meet NASDAQ shareholder equity requirements while maintaining its listing status [3] - The buyback rights associated with the preferred shares allow the seller to repurchase all Halneuron assets in exchange for cash settlement amounts, ensuring that partial waivers do not affect the seller's rights to repurchase [3]
长江生命科技与DWTX订立弃权协议
Zhi Tong Cai Jing· 2025-09-26 14:28
Core Viewpoint - The announcement details a transaction involving the sale of 100% equity in Pharmagesic (Holdings) Inc to Dogwood Therapeutics, Inc, which includes the issuance of common and preferred shares as part of the payment structure [1][2]. Group 1: Transaction Details - The transaction involves the issuance of buyer's common stock and preferred stock as payment for the sale of Pharmagesic (Holdings) Inc [1]. - A waiver agreement was established on September 26, 2025, allowing the buyer to forgo cash settlement and repurchase rights for certain preferred shares [1]. - The total number of waived shares is capped at 300 shares, with a valuation based on a sincere estimate of the difference between $2.5 million and the equity on the balance sheet at the end of the relevant quarter [1]. Group 2: Business Implications - The merger with WEX allows access to the buyer's extensive experience in biotech fundraising, R&D, and commercialization, particularly in pain relief medications [2]. - The flagship product Halneuron is expected to advance its clinical trial data release and market entry due to the buyer's resources and expertise [2]. - The buyer's NASDAQ listing will facilitate access to the U.S. capital markets, enabling accelerated funding for Halneuron's development [2]. Group 3: Rights and Repurchase - The preferred shares come with a repurchase right that allows the seller to buy back all Halneuron assets in exchange for cash settlement amounts [3]. - Partial waivers of cash settlement and repurchase rights will not affect the seller's right to repurchase all Halneuron assets in relevant events [3].
Dogwood Therapeutics (DWTX) FY Conference Transcript
2025-09-05 12:00
Summary of Dogwood Therapeutics (DWTX) FY Conference Call Company Overview - **Company Name**: Dogwood Therapeutics - **Industry**: Biotechnology - **Focus**: Development of novel non-opioid pain treatments targeting the NAV1.7 sodium channel for chronic pain management, particularly in cancer-related pain and chemotherapy-induced neuropathic pain [1][2][3] Core Product: Halneuron® - **Description**: Halneuron® is a NAV1.7 inhibitor, an injectable therapy aimed at reducing pain associated with cancer and chemotherapy-induced neuropathy [1][5] - **Clinical Stage**: Currently in phase 2b study [1] - **Target Patient Group**: Patients experiencing moderate to severe neuropathic pain post-chemotherapy, with about 70% of chemotherapy patients experiencing neuropathy [2][10] Clinical Data and Results - **Unmet Medical Need**: High demand for effective treatments for cancer-related pain, with millions of patients suffering globally [10] - **Study Results**: - 51% of patients treated with Halneuron® showed a 30% reduction in pain, and a 50% reduction in opioid use [11] - Placebo response rate was 35%, indicating Halneuron®'s effectiveness [11] - Durable effect observed, with patients experiencing pain relief for an average of 58 days post-treatment compared to one week for placebo [12] - **Current Phase 2b Study**: - 200 patients, assessing Halneuron® administered once daily over two weeks [14] - Primary endpoint assessed 30 days after the first dose [14] - Interim results expected by December 2025, with final results projected for mid-2026 [18][19] Regulatory Strategy - **FDA Interaction**: The company has established a good relationship with the FDA, aiming for a collaborative approach to drug approval [24] - **Fast-Track Designation**: Halneuron® has received fast-track review designation from the FDA due to its novel approach and high unmet medical need [15] Intellectual Property (IP) and Commercial Strategy - **Current IP**: Based on the unique process of collecting tetrodotoxin from pufferfish, with plans to file new IP for a synthetic formulation [29] - **Commercialization Strategy**: The company is open to partnerships but prioritizes data-driven decisions for maximizing shareholder value [30][31] Financial Position - **Cash Position**: Approximately $13.5 million on hand, sufficient to fund operations through Q1 of the following year [32] - **Burn Rate**: Low operational costs due to a small team of about 12-13 employees [32] Future Outlook - **Next Steps**: If phase 2b is successful, the company plans to initiate a phase 3 program in early 2027 and explore broader cancer-related pain studies [25][26] - **Potential Market**: With 20 million new cancer cases annually, the commercial opportunity for Halneuron® is significant [16] Additional Insights - **Team Experience**: The management team has a strong background in pain drug development, having successfully brought multiple pain medications to market [4][30] - **Synthetic Formulation**: Development of a synthetic version of tetrodotoxin is expected to improve yield, reduce costs, and enhance regulatory acceptance [21]
Dogwood Therapeutics to Participate in Fireside Chat at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-03 13:15
Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [3] - The company is publicly traded on Nasdaq under the ticker DWTX [3] Upcoming Events - Dogwood Therapeutics will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - CEO Greg Duncan will engage in a fireside chat with Sean Lee, VP of Equity Research at H.C. Wainwright on September 5, 2025, with the presentation available on-demand [2] Research and Development - The company has a research pipeline that includes a non-opioid analgesic program and an antiviral program [3] - The lead candidate in the analgesic program is Halneuron, which targets voltage-gated sodium channels to reduce pain transmission, showing efficacy in treating cancer-related pain and chronic chemotherapy-induced neuropathic pain [3] - Interim data from the ongoing Phase 2 study of Halneuron for chronic chemotherapy-induced neuropathic pain is expected in Q4 2025 [3] 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 [4] - IMC-1 is advancing towards Phase 3 development for fibromyalgia, while IMC-2 has shown success in reducing fatigue associated with Long-COVID in clinical trials [4] - The company has reached an agreement with the FDA to use fatigue reduction as the primary endpoint for future IMC-2 research related to Long-COVID [4]
Dogwood Therapeutics, Inc(DWTX) - 2025 Q2 - Quarterly Report
2025-08-13 14:18
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
Dogwood Therapeutics, Inc(DWTX) - 2025 Q2 - Quarterly Results
2025-08-13 13:15
[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)
Dogwood Therapeutics Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-13 13:00
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].