Acasti Pharma(ACST) - 2025 Q2 - Quarterly Report

Financial Performance - As of September 30, 2024, total assets decreased to $65,349,000 from $73,300,000 as of March 31, 2024, representing a decline of approximately 10.8%[18] - Cash and cash equivalents decreased to $15,155,000 from $23,005,000, a reduction of about 34.3%[18] - The net loss for the quarter was $3,432,000, compared to a net loss of $3,273,000 for the same quarter in 2023, indicating a year-over-year increase of about 4.9%[20] - Basic and diluted loss per share for the quarter was $0.30, compared to $0.43 for the same quarter in 2023, reflecting a decrease of approximately 30.2%[20] - The net loss for the six months ended September 30, 2024, was $6,049,000, compared to a net loss of $7,296,000 for the same period in 2023, representing a 17.1% improvement[8] - For the three months ended September 30, 2024, the net loss was $3.4 million, or $0.30 per share, an increase of $159 from the net loss of $3.3 million, or $0.43 per share, for the same period in 2023[150] Research and Development - Research and development expenses for the quarter ended September 30, 2024, were $2,976,000, significantly higher than $460,000 for the same period in 2023, marking an increase of approximately 548.7%[20] - Total research and development expenses for the six months ended September 30, 2024, were $5.684 million, compared to $1.5 million for the same period in 2023, reflecting a $4.184 million increase[154] - The company incurred a $4.2 million increase in research and development activities for the GTx-104 pivotal Phase 3 STRIVE-ON trial protocol during the second quarter of 2025[170] Cash Flow and Liquidity - The company incurred a net cash used in operating activities of $7,835,000 for the six months ended September 30, 2024, compared to $8,353,000 for the same period in 2023, a decrease of 6.2%[8] - The company expects its existing cash and cash equivalents to fund operations into the second calendar quarter of 2026[31] - The company believes its cash runway will be sufficient to fund operations into the second calendar quarter of 2026[149] - The company plans to raise additional capital to maintain adequate liquidity beyond the second quarter of 2026[32] Shareholder Equity and Liabilities - Shareholders' equity decreased to $56,134,000 from $61,743,000, a decline of about 9.1%[19] - Total current liabilities increased to $2,674,000 from $1,684,000, an increase of approximately 58.8%[19] - Total liabilities as of September 30, 2024, were $4,359 million, entirely attributed to derivative warrant liabilities measured at fair value[45] Corporate Developments - The company changed its corporate name to Grace Therapeutics, Inc. effective October 28, 2024, with common stock trading under the symbol "GRCE" on Nasdaq[147] - The company has implemented a strategic realignment plan to enhance shareholder value, resulting in a streamlined workforce and focused development on its lead product candidate GTx-104[30] Product Development and Market Potential - GTx-104 is a clinical-stage injectable formulation of nimodipine for IV infusion in aSAH patients, addressing significant unmet medical needs[91] - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 50,000 patients affected annually[105] - GTx-104 has demonstrated 100% bioavailability compared to approximately 8% for oral nimodipine capsules, significantly reducing dosing variability[109] - The pivotal Phase 3 STRIVE-ON trial for GTx-104 is expected to enroll approximately 100 patients across 25 hospitals in the U.S.[112] - The first patient in the STRIVE-ON trial was enrolled on October 23, 2023, with data readout anticipated in the first quarter of 2025[115] Clinical Trials and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025, pending trial results[115] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to prioritize GTx-104[94] Restructuring and Cost Management - The company incurred restructuring costs of $1.5 million in the six months ended September 30, 2023, with no restructuring costs reported for the same period in 2024[161] - The company has $398 million of commitments to contract manufacturing organizations (CMOs) and $3.9 million of commitments to contract research organizations (CROs) for the next twelve months[72] Patents and Intellectual Property - The company has a portfolio of more than 40 granted and pending patents in various jurisdictions worldwide supporting its therapeutic pipeline[86] - The company has three unique clinical-stage drug candidates that have received orphan drug designation (ODD) status, which provides seven years of marketing exclusivity in the U.S. post-launch[87]