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 the unmet medical needs of patients with aneurysmal subarachnoid hemorrhage (aSAH) and is on track for a potential NDA submission to the FDA in the first half of calendar 2025 [1][2]. 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]. - The decrease in net loss was primarily due to the absence of asset impairments totaling $25.3 million from the previous year, along with the impact of a strategic realignment plan initiated in May 2023 [4][5]. - Research and development expenses were $4.7 million for the year ended March 31, 2024, down from $10.0 million in the prior year, reflecting reduced clinical development costs [5][24]. - General and administrative expenses decreased to $6.4 million from $7.6 million, mainly due to a reduction in headcount following restructuring [5][24]. Cash Position - As of March 31, 2024, Acasti had cash and cash equivalents of $23.0 million, down from $27.9 million a year earlier, with sufficient cash projected to support operations into the second calendar quarter of 2026 [6][8]. 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]. - The company presented a pharmacokinetic comparison of GTX-104 with oral nimodipine at the 2023 Neurocritical Care Society annual meeting [3]. Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research, with aSAH affecting about 50,000 patients annually in the U.S. [9][7].