Acasti Pharma(ACST) - 2024 Q4 - Annual Results

Financial Performance - Acasti reported a net loss of $12.9 million, or $1.35 loss per share, for the year ended March 31, 2024, a decrease of $29.5 million from the net loss of $42.4 million, or $5.71 per share, for the year ended March 31, 2023[5]. - For the year ended March 31, 2024, Acasti reported a net loss of $12.9 million, or $1.35 loss per share, a decrease of $29.5 million from the net loss of $42.4 million, or $5.71 per share, for the year ended March 31, 2023[23]. - The net loss for the year ended March 31, 2024, was $12,853,000, compared to a net loss of $42,429,000 for the previous year, indicating an improvement of approximately 69.7%[36]. - Basic and diluted loss per share improved to $(1.35) from $(5.71), representing a reduction of approximately 76.4%[36]. Expenses - Research and development expenses decreased to $4.7 million for the year ended March 31, 2024, compared to $10.0 million for the year ended March 31, 2023[5]. - Research and development expenses decreased to $4.7 million for the year ended March 31, 2024, compared to $10.0 million for the previous year, primarily due to a strategic realignment[23]. - General and administrative expenses were $6.4 million for the year ended March 31, 2024, down from $7.6 million for the year ended March 31, 2023[5]. - General and administrative expenses decreased from $7,614,000 to $6,432,000, a reduction of about 15.5%[36]. - Operating expenses reduced significantly, with research and development expenses decreasing from $9,972,000 to $4,683,000, a reduction of about 53%[36]. - The company incurred restructuring costs of $1,485,000 during the year, which were not present in the previous year[36]. Cash Position - As of March 31, 2024, Acasti had cash and cash equivalents of $23.0 million, compared to $27.9 million as of March 31, 2023, with a projected cash runway extending into the second calendar quarter of 2026[5]. - Acasti's cash and cash equivalents as of March 31, 2024, were $23.0 million, compared to $27.9 million as of March 31, 2023, with sufficient cash to support operations into the second calendar quarter of 2026[23]. Strategic Focus - Patient enrollment in the pivotal STRIVE-ON Phase 3 safety trial for GTX-104 is on track for a potential NDA submission to the FDA in the first half of calendar 2025[2]. - Acasti's strategic realignment in May 2023 has prioritized resources towards GTX-104, resulting in reduced clinical development and administrative costs[5]. - Acasti's strategic realignment in May 2023 prioritized resources towards GTX-104, contributing to the decrease in net loss[23]. - The company has deprioritized further development of GTX-102 and GTX-101 in favor of focusing on GTX-104[27][28]. Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be about $300 million[8]. - GTX-104 is targeting a market estimated at approximately $300 million in the United States, addressing significant unmet medical needs for aSAH[26]. - Approximately 50,000 patients in the United States are affected by aSAH annually, with an estimated 70% experiencing death or dependence[6]. Financing Activities - Acasti completed a $7.5 million private placement equity financing in September 2023, enhancing its balance sheet[3]. - Acasti completed a $7.5 million private placement equity financing in September 2023, enhancing its balance sheet[20]. Other Financial Metrics - Total shareholders' equity decreased to $61,743,000 from $67,955,000 year-over-year, reflecting a decline of approximately 9.5%[35]. - Total liabilities and shareholders' equity amounted to $73,300,000, compared to $79,123,000 in the previous year, indicating a decrease of approximately 7.3%[35]. - Interest income increased to $911,000 from $246,000, reflecting a growth of approximately 269.5%[36]. - The company reported a foreign exchange loss of $16,000, down from $72,000, showing a decrease of approximately 77.8%[36]. - The company conducted a meeting of STRIVE-ON trial investigators in April 2024 to ensure quality data collection[21].