Grace Therapeutics, lnc.(GRCE) - 2025 Q4 - Annual Results

Business Update and Highlights CEO's Statement & Strategic Focus The company highlights positive Phase 3 data for GTx-104 and plans an NDA submission by June 2025, supported by recent financing - The New Drug Application (NDA) for GTx-104 is on track for submission to the FDA in the first half of calendar year 2025, with an expected completion by the end of June 2025[2][3] - Secured a private placement financing of $15 million in upfront gross proceeds, with the potential for an additional $15 million from warrant exercises to support pre-commercial activities for GTx-104[2][3] - Data from the Phase 3 STRIVE-ON trial provided evidence of improved clinical outcomes and potential pharmacoeconomic benefits for GTx-104 compared to oral nimodipine[3] 2025 Corporate Highlights & Financing The company confirmed its NDA data package with the FDA, completed the STRIVE-ON trial, and secured financing to extend its cash runway into Q3 2026 - Held a Type C meeting with the FDA, which confirmed the existing data and regulatory packages are sufficient for an NDA submission for GTx-104[10] - Completed a private placement financing for up to approximately $30.0 million in potential total gross proceeds, consisting of $15.0 million upfront[10] - The company's current cash and cash equivalents provide a runway into Q3 2026, which could extend into Q2 2027 if all common warrants are exercised[12] - Received FDA guidance on the design of a single pivotal efficacy and safety trial for GTx-102, which could support a future NDA[10][17] Financial Performance Fiscal Year 2025 Financial Results Summary The company's net loss decreased to $9.6 million in FY2025 from $12.9 million in FY2024, driven by a favorable change in warrant liabilities Fiscal Year 2025 vs 2024 Key Metrics | Metric | FY 2025 | FY 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $9.6M | $12.9M | -$3.3M | | Loss Per Share | $0.79 | $1.35 | -$0.56 | | R&D Expenses | $9.5M | $4.7M | +$4.8M | | G&A Expenses | $7.2M | $6.7M | +$0.5M | | Cash & Equivalents (End of Period) | $22.1M | $23.0M | -$0.9M | Consolidated Balance Sheets Total assets slightly decreased to $72.0 million, while a significant reduction in liabilities boosted total stockholders' equity to $66.6 million Balance Sheet Summary | Account (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,133 | $23,005 | | Total Assets | $71,993 | $73,300 | | Derivative warrant liabilities | $1,141 | $4,359 | | Total Liabilities | $5,383 | $11,557 | | Total Stockholders' Equity | $66,610 | $61,743 | Consolidated Statements of Loss and Comprehensive Loss The FY2025 net loss improved to $9.6 million, as a positive change in derivative warrant liabilities offset a higher operating loss Statement of Loss Summary | Account (in thousands) | Year Ended March 31, 2025 | Year Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $(9,511) | $(4,683) | | Loss from operating activities | $(16,679) | $(12,852) | | Change in fair value of derivative warrant liabilities | $3,218 | $(2,728) | | Net loss | $(9,568) | $(12,853) | | Basic and diluted loss per share | $(0.79) | $(1.35) | Clinical Pipeline and Market Lead Asset: GTx-104 for aSAH GTx-104, an injectable nimodipine for aSAH, met its primary endpoint in a Phase 3 trial, showing safety and potential clinical benefits STRIVE-ON Phase 3 Trial Results The trial met its primary endpoint, showing GTx-104 reduced hypotension and improved dosing intensity and patient outcomes versus oral nimodipine - The trial met its primary endpoint, with GTx-104 patients showing a 19% reduction in clinically significant hypotension compared to oral nimodipine (28% versus 35%)[13] - Dosing and outcome measures favored GTx-104, with 54% of patients achieving a relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine[13] - Patients receiving GTx-104 had fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days compared to the oral nimodipine arm[13] About GTx-104 and aSAH GTx-104 is an IV nimodipine formulation targeting the 42,500 annual U.S. aSAH patients, addressing oral administration challenges - aSAH is a type of stroke that affects an estimated 42,500 U.S. hospital treated patients annually[14] - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion, potentially eliminating nasogastric tube administration and reducing dosing errors[15][16] Other Pipeline Assets The pipeline includes GTx-102 for A-T with a clear regulatory path, while GTx-101 for PHN has been deprioritized for potential licensing GTx-102 for Ataxia-Telangiectasia (A-T) GTx-102 is an oral spray for A-T, a condition with no approved therapies, and has a defined pivotal trial design following FDA guidance - GTx-102 is a concentrated oral spray of betamethasone for A-T, for which there are no FDA-approved therapies[17] - The FDA has provided guidance on a path toward an NDA, including the design of a single pivotal efficacy and safety trial[17] GTx-101 for Postherpetic Neuralgia (PHN) GTx-101, a topical spray for PHN, has been deprioritized to focus resources on GTx-104 and is available for licensing or sale - GTx-101 is a non-narcotic, topical bupivacaine spray designed to treat pain from postherpetic neuralgia (PHN)[18] - The development of GTx-101 has been deprioritized to focus on GTx-104, and the company may license or sell this asset[18] Company Information and Disclosures About Grace Therapeutics Grace Therapeutics is a late-stage biopharma using novel drug delivery for rare diseases, with lead assets granted Orphan Drug Designation - The company is a late-stage biopharma focused on drug candidates for rare and orphan diseases[19] - Lead clinical assets, including GTx-104, have been granted Orphan Drug Designation by the FDA, providing seven years of U.S. marketing exclusivity post-launch[19] Forward-Looking Statements Forward-looking statements cover cash runway, NDA timing, and commercial prospects, which are subject to significant risks and uncertainties - Statements regarding the company's cash runway, timing of the GTx-104 NDA submission, and future prospects of its drug candidates are forward-looking and involve risks[21] - Key risks that could affect outcomes include the success and timing of regulatory submissions, changes to regulatory pathways, and broader economic developments[21]