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].

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]

Patient Enrollment in Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 On-Track for Potential NDA Submission in 1H Calendar 2025Projected Cash Runway into Second Calendar Quarter 2026 PRINCETON, N.J., June 21, 2024 (GLOBE NEWSWIRE) --  Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ACASTI PHARMA INC. (Exact name of registrant as specified in its charter) Québec, Canada 98-1359336 (State or other jurisdiction ...

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ A ...

PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (NASDAQ:ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has been accepted for presentation at the 2024 International Stroke Conference, to be held F ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ Acast ...