Grace Therapeutics, lnc.(GRCE) - 2026 Q1 - Quarterly Results

Business Highlights Grace Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. FDA for its lead candidate, GTx-104, for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH), a key milestone supported by positive Phase 3 STRIVE-ON trial data - Submitted a New Drug Application (NDA) to the FDA for GTx-104 in treating aSAH, based on positive Phase 3 STRIVE-ON trial results[2][3][6] - The NDA submission has the potential to trigger the exercise of warrants from a September 2023 private placement, which could provide up to $7.6 million in proceeds[6][11] - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity in the U.S. upon approval[6][19] - The FDA has a 60-day period to determine if the NDA is complete and acceptable for filing and formal review[6] Financial Performance For the quarter ended June 30, 2025, Grace Therapeutics reported a net loss of $3.4 million, an increase from $2.6 million in the prior year, primarily due to changes in derivative warrant liabilities, partially offset by a $1.8 million decrease in R&D expenses Key Financial Metrics Net loss increased to $3.4 million, primarily due to derivative warrant liabilities, partially offset by reduced R&D expenses Q1 2026 vs Q1 2025 Financial Results | Metric | Q1 2026 (ended June 30, 2025) | Q1 2025 (ended June 30, 2024) | | :--- | :--- | :--- | | Net Loss | $3.4 million | $2.6 million | | Loss Per Share | $0.21 | $0.24 | - The increase in net loss was mainly driven by a $1.9 million difference in the change in fair value of derivative warrant liabilities and a $0.7 million decrease in income tax benefit[5] - The higher net loss was partially offset by a $1.8 million decrease in R&D expenses and a $0.1 million decrease in G&A expenses[5] Operating Expenses Operating expenses decreased, with R&D down $1.8 million following GTx-104 trial completion, and G&A slightly reduced Operating Expenses Comparison (in millions) | Expense Category | Q1 2026 (ended June 30, 2025) | Q1 2025 (ended June 30, 2024) | Change | | :--- | :--- | :--- | :--- | | Research & Development | $0.9 | $2.7 | -$1.8 | | General & Administrative | $2.1 | $2.2 | -$0.1 | - R&D expenses decreased by $1.8 million, primarily due to a $1.9 million reduction in research activities following the completion of the GTx-104 pivotal Phase 3 STRIVE-ON trial[7] - G&A expenses decreased slightly by $0.1 million, resulting from lower professional fees related to the company's 2024 continuance and domestication[8] Financial Position and Cash Runway The company maintains a cash position of $20.0 million, projecting a runway through at least the next twelve months, with potential extension from warrant exercises - As of June 30, 2025, the company held $20.0 million in cash and cash equivalents[9] - Management believes current cash provides a runway through at least the next twelve months, potentially extending into Q2 2027 if all common warrants from the February 2025 and September 2023 private placements are exercised[12] - The company has potential gross proceeds of $22.6 million from the exercise of outstanding warrants ($15.0 million from the Feb 2025 placement and $7.6 million from the Sep 2023 placement)[10][11] Clinical Pipeline and Trials The company's lead asset, GTx-104, demonstrated positive results in the Phase 3 STRIVE-ON trial, meeting its primary endpoint by reducing drug-induced hypotension compared to oral nimodipine, while other pipeline assets have been deprioritized GTx-104 and the STRIVE-ON Trial GTx-104, an injectable nimodipine formulation, met its primary endpoint in the STRIVE-ON trial, significantly reducing hypotension and improving patient outcomes - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion in patients with aSAH, designed to overcome limitations of oral administration[15][16] - The Phase 3 STRIVE-ON trial met its primary endpoint, with GTx-104 showing a 19% reduction in clinically significant hypotension compared to oral nimodipine (28% vs. 35%)[13] Key Secondary Outcomes from STRIVE-ON Trial (GTx-104 vs. Oral Nimodipine) | Metric | GTx-104 | Oral Nimodipine | | :--- | :--- | :--- | | Relative Dose Intensity (RDI) ≥ 95% | 54% of patients | 8% of patients | | Favorable Functional Outcomes at 90 days | 29% more patients | Baseline | | Other Benefits | Fewer ICU readmissions, ICU days, and ventilator days | Baseline | Other Pipeline Assets Development of GTx-102 and GTx-101 has been deprioritized to focus on GTx-104, with potential licensing or sale opportunities being explored - The development of GTx-102 (for Ataxia-Telangiectasia) and GTx-101 (for postherpetic neuralgia) has been deprioritized to focus resources on the lead asset, GTx-104[17][18] - The company may pursue licensing or sale opportunities for both GTx-102 and GTx-101[17][18] Financial Statements This section provides the unaudited condensed consolidated financial statements for Grace Therapeutics, Inc. as of June 30, 2025, and for the three-month period then ended, including the Balance Sheets and Statements of Loss and Comprehensive Loss Condensed Consolidated Balance Sheets The balance sheet presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and March 31, 2025 Condensed Consolidated Balance Sheets (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $20,005 | $22,133 | | Total current assets | $20,525 | $22,712 | | Total assets | $69,805 | $71,993 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $2,315 | $1,930 | | Total liabilities | $6,255 | $5,383 | | Total stockholders' equity | $63,550 | $66,610 | | Total liabilities and stockholders' equity | $69,805 | $71,993 | Condensed Consolidated Statements of Loss and Comprehensive Loss The statement of loss details the company's revenues and expenses, resulting in a net loss for the three months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Loss (in thousands) | Account | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development expenses | $(955) | $(2,708) | | General and administrative expenses | $(2,135) | $(2,255) | | Loss from operating activities | $(3,090) | $(4,963) | | Net loss and total comprehensive loss | $(3,362) | $(2,617) | | Basic and diluted loss per share | $(0.21) | $(0.24) |