Core Insights - Grace Therapeutics announced that its Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint, showing improved clinical outcomes compared to orally administered nimodipine [1][15] - The company secured a private placement financing of up to $30 million, which will support pre-commercial planning and the potential launch of GTx-104 if approved [2][5] - The New Drug Application (NDA) submission for GTx-104 is anticipated in the first half of 2025, marking a significant step towards addressing unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients [1][2] Financial Highlights - For the quarter ended December 31, 2024, the company reported a net loss of $4.2 million, or $0.36 per share, an increase from a net loss of $2.4 million, or $0.21 per share, for the same period in 2023 [4][19] - Research and development expenses increased to $2.2 million for the quarter, up from $1.4 million in the prior year, primarily due to activities related to the GTx-104 pivotal Phase 3 trial [6][19] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease from $23.0 million at the end of March 2024 [8][19] Product Development - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion in aSAH patients, addressing significant unmet medical needs [10][15] - The drug's unique nanoparticle technology allows for a standard peripheral IV infusion, potentially improving delivery and reducing complications associated with oral administration [11][15] - The company is also developing GTx-102, a novel oral-mucosal spray of betamethasone for Ataxia-Telangiectasia, with an NDA submission path outlined by the FDA [12][15] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually, indicating a significant market opportunity for GTx-104 [9][15] - The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, positioning GTx-104 as a potential breakthrough treatment if approved by the FDA [2][5]
Grace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update