Core Insights - Grace Therapeutics is advancing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) with a New Drug Application (NDA) submission planned for the first half of 2025 [1][2][3] - The company secured $15 million in upfront financing, with the potential for an additional $15 million through warrant exercises, totaling up to approximately $30 million to support pre-commercial planning and product launch [1][2][3] - The Phase 3 STRIVE-ON safety trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine, indicating potential clinical benefits for GTx-104 [2][11] Corporate Highlights - The company held a Type C meeting with the FDA to discuss the STRIVE-ON trial results and NDA submission requirements, believing the current data will suffice for the NDA [3] - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with additional measures favoring GTx-104 [11] - The NDA submission for GTx-104 is on track for completion by the end of June 2025 [2][3] Financial Results - For the fiscal year ended March 31, 2025, the company reported a net loss of $9.6 million, a decrease from a net loss of $12.9 million in the previous fiscal year [4] - Research and development expenses increased to $9.5 million from $4.7 million, primarily due to the pivotal Phase 3 safety trial for GTx-104 [5] - General and administrative expenses rose to $7.2 million, reflecting increased professional fees and salaries [6] Cash Position - As of March 31, 2025, the company had cash and cash equivalents of $22.1 million, a slight decrease from $23.0 million a year earlier [7] - The private placement completed in February 2025 included common warrants with an exercise price of $3.395 per share, potentially generating $15 million upon exercise [8] - The company believes its current cash runway extends into the third quarter of 2026, potentially extending to the second quarter of 2027 if all common warrants are exercised [10] Product Overview - GTx-104 is designed to provide IV delivery of nimodipine, potentially improving management of hypotension in aSAH patients and eliminating the need for nasogastric tube administration [14][15] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and lower pharmacokinetic variability compared to oral nimodipine [15]
Grace Therapeutics Announces 2025 Fiscal Year-End Results, Provides Business Update