Business
Grace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update
Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application
About this update from Grace Therapeutics, Inc.
[{"type":"text","content":"Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application (NDA) Submission Anticipated First Half of Calendar 2025 Secured Private Placement Financing of $15 Million in Upfront Gross Proceeds with the Potential to Receive up to an Additional $15 Million in Potential Warrant Exercise Proceeds for an Aggregate of Up to Approximately $30 Million in Potential Total Gross Proceeds PRINCETON, N.J., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced financial results and business highlights for the quarter ended December 31, 2024. “During our third quarter and in subsequent weeks we continued to make significant progress in both clinical and corporate goals, announcing positive topline data from our Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405), and securing up to $30 million in gross proceeds from a private placement financing with leading healthcare investors,” said Prashant Kohli, CEO of Grace Therapeutics. “Data from our STRIVE-ON trial exceeded our expectations, demonstrating that GTx-104 was associated with improved clinical outcomes for patients when compared to patients treated with orally administered nimodipine. Importantly, the data also provides both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in aSAH patients, which could help drive adoption of GTx-104 by neurocritical care physicians and hospital pharmacies.” “We secured up to $30 million in a private placement led by Nantahala Capital and ADAR1 Partners, along with other leading healthcare-focused investors. This investment will support pre-commercial planning, commercial team build out and product launch if GTx-104 is approved. Our focus now is to finalize NDA submission for GTx-104 by the end of June 2025. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe the STRIVE-ON trial results point to a very promising role for GTx-104 as a pote...