Virios Therapeutics(VIRI) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Dogwood Therapeutics reported Q2 2025 progress in its Halneuron® trial and financial position, with CEO and CMO commentary highlighting pipeline potential and target mechanisms Q2 2025 Highlights Dogwood Therapeutics reported key progress in its Halneuron® Phase 2b trial, including patient enrollment and a low discontinuation rate, with interim data expected in Q4 2025. The company also highlighted its cash position, providing an operational runway through Q1 2026 - Enrollment to-date of 52 patients in the ongoing Halneuron® Phase 2b Trial for Chemotherapy-Induced Neuropathic Pain (CINP)[1][3] - Halneuron® CINP Phase 2b study interim data readout remains on track for Q4 2025[1] - Low discontinuation rate (5.8%) due to adverse events in the first 38 patients completing the trial, suggesting Halneuron® and placebo treatment have been generally well tolerated[1] - Cash on hand of $13.4 million provides operational runway through Q1 2026[1] CEO & CMO Commentary The CEO emphasized the potential for Halneuron® to be the first FDA-approved CINP treatment and the opportunity to expand the NaV 1.7 research pipeline to other pain forms. The CMO highlighted the fundamental role of the NaV 1.7 sodium channel in pain transmission as a critical treatment target - CEO Greg Duncan believes Halneuron® has the potential to be the first and only FDA-approved CINP treatment and highlights its significant potential to expand the NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia, and acute surgical pain[2] - CMO Michael Gendreau, MD, PhD, stated that the NaV 1.7 sodium channel plays a fundamental role in pain transmission, making its modulation applicable to both chronic and acute pain states, as evidenced by conditions like Congenital Insensitivity to Pain Syndrome[2] Proprietary Pipeline Overview Dogwood's pipeline includes Halneuron® for CINP in Phase 2b and an antiviral program with IMC-1 for Fibromyalgia (Phase 3 ready) and IMC-2 for Long-COVID (Phase 2a) Halneuron® Program Halneuron® is a non-opioid, NaV 1.7 inhibitor in Phase 2b development for chemotherapy-induced neuropathic pain (CINP), having received FDA Fast Track designation. Interim data from the ongoing study are anticipated in Q4 2025 - Halneuron® is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat pain conditions, including neuropathic pain associated with chemotherapy treatment[9] - Halneuron® has been granted Fast Track designation from the FDA for the treatment of CINP[9] - Interim data from the ongoing Phase 2b CINP study are expected in Q4 2025[9] Antiviral Program Dogwood's antiviral program includes IMC-1 for Fibromyalgia, which is Phase 3 ready with Fast Track designation, and IMC-2 for Long-COVID, currently in Phase 2a, with external funding paused due to government resource clarity issues IMC-1 (Fibromyalgia) IMC-1, a combination antiviral treatment for Fibromyalgia (FM), is ready for Phase 3 development and has received FDA Fast Track designation for FM - IMC-1 (famciclovir + celecoxib) is ready for Phase 3 development as a combination antiviral treatment for Fibromyalgia (FM)[9] - IMC-1 has been granted Fast Track designation by the FDA for the treatment of FM[9] IMC-2 (Long-COVID) IMC-2, a combination antiviral treatment for Long-COVID, is in Phase 2a development. External research funding and partnership discussions are currently paused due to uncertainties regarding U.S. Government commitment to COVID illness funding. The FDA has agreed to use reduction in fatigue as the primary endpoint for future IMC-2 research - IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for Long-COVID[9] - Current external research funding and partnership discussions for IMC-2 have been paused due to pervasive reductions in government health funding and a lack of clarity on U.S. Government resources for COVID illness[9] - The company has reached an agreement with FDA on using reduction in fatigue as the primary endpoint for future IMC-2 Long-COVID research[12] Second Quarter 2025 Financial Results Dogwood Therapeutics reported a significant increase in operating expenses and net loss for Q2 2025, primarily driven by higher R&D and G&A costs Operating Expenses Operating expenses significantly increased in Q2 2025 compared to Q2 2024, primarily driven by higher research and development costs related to clinical trials and general and administrative expenses due to legal, accounting, and public company costs Research and Development Expenses Research and development expenses for Q2 2025 increased by $2.2 million year-over-year, primarily due to the business combination with Pharmagesic, leading to higher clinical trial, drug development, and personnel costs Research and Development Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :-------- | :----- | | R&D Expenses | $2.5 million | $0.3 million | +$2.2 million | - The $2.2 million increase was primarily due to the business combination with Pharmagesic, including increases in expenses for clinical trials ($1.6 million related to Halneuron® CINP Phase 2b study), drug development and manufacturing costs ($0.5 million), and salaries and related personnel costs ($0.2 million), offset by a decrease in regulatory costs ($0.1 million)[6] General and Administrative Expenses General and administrative expenses for Q2 2025 rose by $0.6 million compared to Q2 2024, mainly driven by increased legal and accounting fees, personnel costs, and expenses associated with being a public company General and Administrative Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :-------- | :----- | | G&A Expenses | $1.3 million | $0.7 million | +$0.6 million | - The $0.6 million increase was primarily due to increases in legal and accounting fees ($0.2 million), salaries and related personnel costs ($0.2 million), expenses associated with being a public company ($0.1 million), and other general and administrative costs ($0.1 million)[7] Net Loss and EPS Dogwood Therapeutics reported a significantly higher net loss attributable to common stockholders in Q2 2025, reaching $3.8 million, compared to $1.0 million in Q2 2024, resulting in a basic and diluted net loss per share of $1.99 Net Loss and EPS (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--------------------------------------- | :-------- | :-------- | | Net Loss Attributable to Common Stockholders | $(3.8) million | $(1.0) million | | Basic and Diluted Net Loss Per Share | $(1.99) | $(1.15) | Financial Statements The financial statements reveal increased operating expenses and net losses for Q2 2025, alongside a stronger balance sheet with improved stockholders' equity Condensed Statements of Operations The condensed statements of operations show a significant increase in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to the prior year, primarily driven by increased R&D and G&A costs, and a substantial loss on debt conversion for the six-month period Condensed Statements of Operations Data (Three Months Ended June 30) | Statements of Operations Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | Revenue | $ — | $ — | | Research and development | $2,569,943 | $336,084 | | General and administrative | $1,353,172 | $733,740 | | Total operating expenses | $3,923,115 | $1,069,824 | | Loss from operations | $(3,923,115) | $(1,069,824) | | Total other income (expense), net | $115,911 | $19,991 | | Loss before income taxes | $(3,807,204) | $(1,049,833) | | Deferred income tax provision | $(149) | $— | | Net Loss | $(3,807,353) | $(1,049,833) | | Net loss attributable to common stockholders | $(3,807,353) | $(1,049,833) | | Net loss per share of common stock — basic and diluted | $(1.99) | $(1.15) | | Weighted average shares outstanding — basic and diluted | 1,911,128 | 916,031 | Condensed Statements of Operations Data (Six Months Ended June 30) | Statements of Operations Data | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | Revenue | $ — | $ — | | Research and development | $5,006,941 | $679,801 | | General and administrative | $3,346,100 | $1,704,124 | | Total operating expenses | $8,353,041 | $2,383,925 | | Loss from operations | $(8,353,041) | $(2,383,925) | | Loss on debt conversion with related party | $(6,134,120) | $— | | Interest income (expense), net | $(35,711) | $42,757 | | Exchange gain (loss), net | $(18,742) | $— | | Total other income (expense), net | $(6,188,573) | $42,757 | | Loss before income taxes | $(14,541,614) | $(2,341,168) | | Deferred income tax provision | $(190,691) | $— | | Net Loss | $(14,732,305) | $(2,341,168) | | Accrual of paid-in kind dividends on Series A non-voting convertible preferred stock | $(1,256,662) | $— | | Net loss attributable to common stockholders | $(15,988,967) | $(2,341,168) | | Net loss per share of common stock — basic and diluted | $(9.51) | $(2.78) | | Weighted average shares outstanding — basic and diluted | 1,680,827 | 843,174 | Condensed Consolidated Balance Sheet As of June 30, 2025, Dogwood Therapeutics reported $13.4 million in cash, total assets of $96.7 million, and a significant improvement in stockholders' equity, moving from a deficit of $10.1 million at December 31, 2024, to a positive $6.9 million Condensed Consolidated Balance Sheet Data | Data | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Cash | $13,402,809 | $14,847,949 | | Total assets | $96,692,527 | $94,308,246 | | Total liabilities | $14,151,904 | $30,027,223 | | Total stockholders' equity (deficit) | $6,878,599 | $(10,124,339) | About Dogwood Therapeutics Dogwood Therapeutics is a development-stage biopharmaceutical company focused on developing new medicines for pain and fatigue-related disorders. Its research pipeline includes a non-opioid analgesic program, with Halneuron® as its lead candidate, and an antiviral program featuring IMC-1 and IMC-2 for conditions like fibromyalgia and Long-COVID - Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders[11] - The Dogwood research pipeline includes two separate mechanistic platforms: a non-opioid analgesic program and an antiviral program[11] - The non-opioid, NaV 1.7 analgesic program is centered on Halneuron®, a highly specific voltage-gated sodium channel modulator, which has demonstrated pain reduction in general cancer pain and chronic chemotherapy-induced neuropathic pain (CINP)[11] - The antiviral program includes IMC-1 and IMC-2, novel, proprietary, fixed-dose combinations of anti-herpes antivirals and celecoxib, applied to illnesses believed to be related to reactivation of previously dormant herpesviruses, such as fibromyalgia (FM) and Long-COVID (LC)[12] Forward-Looking Statements This section contains standard forward-looking statements, subject to substantial risks and uncertainties, as defined by the U.S. Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions, with risks detailed in the company's Form 10-K, and Dogwood undertakes no obligation to update them except as required by law - Statements in this press release are "forward-looking statements" under the U.S. Private Securities Litigation Reform Act of 1995, subject to substantial risks and uncertainties[14] - Forward-looking statements are based on Dogwood's current expectations and are subject to inherent uncertainties, risks, and assumptions, including those related to the completion, timing, and results of current and future clinical studies[14] - These risks and uncertainties are described more fully in the "Risk Factors" section of the Annual Report on Form 10-K for the year ended December 31, 2024[16] - Dogwood undertakes no duty to update such information except as required under applicable law[16] Investor Relations This section provides contact information for investor relations inquiries - Investor Relations contact: CORE IR, (516) 222-2560, IR@dwtx.com[17]