Acasti Announces Year-End 2024 Financial Results, Provides Business Update

Core Insights - Acasti Pharma Inc. is advancing GTX-104, a novel injectable formulation of nimodipine, targeting aneurysmal subarachnoid hemorrhage (aSAH) with a potential NDA submission to the FDA anticipated in the first half of calendar 2025 [1][2][3] Financial Performance - For the fiscal year ended March 31, 2024, Acasti reported a net loss of $12.9 million, or$1.35 loss per share, a significant decrease from a net loss of $42.4 million, or$5.71 per share, for the previous year [4][24] - Research and development expenses were $4.7 million, down from$10.0 million in the prior year, primarily due to strategic realignment efforts [5] - General and administrative expenses decreased to $6.4 million from$7.6 million, attributed to reduced headcount and restructuring costs [5] Cash Position - As of March 31, 2024, the company had cash and cash equivalents of $23.0 million, down from$27.9 million a year earlier, with a projected cash runway extending into the second calendar quarter of 2026 [6][2] Clinical Development - The STRIVE-ON trial, a pivotal Phase 3 safety trial for GTX-104, is progressing well, with steady patient enrollment since its initiation in October 2023 [2][3] - Acasti hosted a Key Opinion Leader event in October 2023 to discuss GTX-104 as a potential new treatment standard for aSAH [3] Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research [9] - Aneurysmal subarachnoid hemorrhage affects around 50,000 patients annually in the U.S., with significant mortality and dependency rates [7]