Core Viewpoint - Grace Therapeutics has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine aimed at treating patients with aneurysmal Subarachnoid Hemorrhage (aSAH), supported by positive results from the Phase 3 STRIVE-ON trial [1][2][6]. Company Highlights - The NDA submission for GTx-104 represents a significant milestone for Grace Therapeutics, building on over a decade of research and innovation [2]. - The STRIVE-ON trial demonstrated improved clinical outcomes for aSAH patients treated with GTx-104 compared to oral nimodipine, indicating potential medical and pharmacoeconomic benefits [2][12]. - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity upon approval [6][18]. Financial Results - For the quarter ended June 30, 2025, the company reported a net loss of $3.4 million, or $0.21 per share, an increase from a net loss of $2.6 million, or $0.24 per share, for the same period in 2024 [4][24]. - Research and development expenses decreased to approximately $0.9 million from $2.7 million year-over-year, primarily due to the completion of the STRIVE-ON trial [5]. - General and administrative expenses were approximately $2.1 million, a slight decrease from $2.2 million in the previous year [7]. Cash Position - As of June 30, 2025, the company had cash and cash equivalents of $20.0 million, down from $22.1 million at the end of March 2025 [8]. - The company believes its current cash runway extends through at least the next twelve months, potentially into the second quarter of 2027 if all common warrants from recent private placements are exercised [11]. STRIVE-ON Trial Details - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with the primary endpoint showing a 19% reduction in clinically significant hypotension for GTx-104 [12]. - Secondary endpoints indicated that 54% of patients on GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% on oral nimodipine [12]. - The trial also reported fewer ICU readmissions and days for patients treated with GTx-104, with no new safety issues identified [12]. Market Context - aSAH is a rare but serious condition accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [13][18]. - The standard of care for aSAH has not seen significant innovation in nearly 40 years, highlighting the potential impact of GTx-104 as a breakthrough treatment [2].
Grace Therapeutics Announces First Quarter 2026 Financial Results, Provides Business Update