Dogwood Therapeutics, Inc(DWTX) - 2025 Q2 - Quarterly Results

Business and Operational Highlights 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][3] - The interim data readout for the Halneuron® CINP Phase 2b study is expected in Q4 2025[1] - 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] - Cash on hand is $13.4 million, which is expected to fund operations through the first quarter of 2026[1][20] - 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] Proprietary Pipeline Overview 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] - 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] - 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] Second Quarter 2025 Financial Results 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 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 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 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 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] - The non-opioid analgesic program is centered on Halneuron®, a highly specific NaV 1.7 sodium channel modulator designed to reduce pain transmission[11] - 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]