Grace Therapeutics reports FY25 EPS (79c), consensus ($1.66)

At March 31, 2025, the Company had cash and cash equivalents of $22.1 million, a net decrease of $0.9 million compared to cash and cash equivalents of $23.0 million at March 31, 2024. “During our 2025 fiscal year we made significant progress in both clinical and corporate goals, led by our announcement of positive topline data from our Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial-NCT05995405) and alignment with the U.S. Food and Drug Administration (FDA) on our planned submission of an NDA for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO. “We also secured financing of $15 million up front with the potential to receive up to an additional $15 million upon cash exercise of accompanying warrants issued in a private placement led by Nantahala Capital and ADAR1 Partners, LP 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 our NDA submission for GTx-104, which we expect to complete by the end of June 2025. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years. Data from our STRIVE-ON trial exceeded our expectations, and although STRIVE-ON was not designed or powered to demonstrate efficacy, the data provide support for improved clinical outcomes for patients treated with GTx-104 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 believe the STRIVE-ON trial results point to a very promising role for GTx-104 as a potential breakthrough for the care of aSAH patients should it be approved by the FDA.”