Acasti Announces First Fiscal Quarter 2025 Financial Results, Provides Business Update

Core Insights - Acasti Pharma Inc. has surpassed the 50% enrollment milestone in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] - The company anticipates completing patient enrollment by late 2024 to early 2025, with a New Drug Application (NDA) submission to the FDA expected in the first half of 2025 [2][3] - Acasti has projected a cash runway extending into the second quarter of 2026 [1][5] Company Developments - The STRIVE-ON trial is designed to provide an effective intravenous alternative to the current oral nimodipine treatment, which is challenging for aSAH patients due to complications [2][8] - Acasti reported a net loss of $2.6 million for the quarter ended June 30, 2024, a decrease from a net loss of $4.0 million in the same quarter of the previous year [4][18] - Research and development expenses increased to $2.7 million for the quarter ended June 30, 2024, compared to $1.1 million for the same period in 2023, primarily due to the ongoing STRIVE-ON trial [4][5] Financial Performance - General and administrative expenses rose to $2.3 million for the quarter ended June 30, 2024, up from $1.9 million in the same quarter of 2023, attributed to increased professional fees related to a proposed change in incorporation jurisdiction [5] - As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, down from $23.0 million as of March 31, 2024 [5][15] - The total assets of the company were reported at $69.7 million as of June 30, 2024, compared to $73.3 million as of March 31, 2024 [16]