Acasti Pharma(ACST) - 2026 Q2 - Quarterly Report

Financial Performance - Net loss for the three months ended September 30, 2025, was $938 thousand, a reduction of 78.1% compared to a net loss of $4,284 thousand for the same period in 2024[25] - The company reported a basic and diluted loss per share of $0.06 for the three months ended September 30, 2025, compared to $0.30 for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $938, a decrease of $2,494 from the net loss of $3,432 for the same period in 2024[169] - Research and development expenses for the three months ended September 30, 2025, were $568, down from $2,976 in the same period in 2024, a decrease of $2,408[173] - General and administrative expenses for the three months ended September 30, 2025, were $1,961, an increase of $106 from $1,855 for the same period in 2024[180] Assets and Liabilities - Total assets decreased from $71,993 thousand as of March 31, 2025, to $66,576 thousand as of September 30, 2025, representing a decline of approximately 7.4%[23] - Cash and cash equivalents decreased from $22,133 thousand at the beginning of the period to $16,862 thousand at the end of the period, a decrease of 24.0%[29] - Total stockholders' equity decreased from $66,610 thousand as of March 31, 2025, to $62,818 thousand as of September 30, 2025, a decline of approximately 5.6%[23] - Total liabilities measured at fair value were $201, primarily from derivative warrant liabilities[51] - Trade and other payables decreased from $1,930 as of March 31, 2025, to $1,245 as of September 30, 2025, reflecting a reduction in trade payables and accrued expenses[53] Funding and Capital Raising - The company completed a private placement in February 2025, raising net proceeds of $13,705 thousand[34] - The company raised $13,705 in net proceeds from the 2025 Private Placement, which closed on February 11, 2025[60] - The 2023 Private Placement generated net proceeds of $7,338 after deducting fees and expenses[62] - The company received $4,000 thousand in gross proceeds from the exercise of common warrants in October 2025[35] - The company plans to raise additional capital to maintain adequate liquidity, as it does not expect to generate revenue from product sales until regulatory approval is obtained[187] Research and Development - Research and development expenses for the six months ended September 30, 2025, were $1,523 thousand, down 73.3% from $5,684 thousand in the same period of 2024[25] - Clinical development program expenses for the six months ended September 30, 2025, were $527, a decrease from $5,067 in the same period of 2024[86] - The company is focused on the development of its lead product candidate GTx-104 while streamlining its research and development activities[33] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating well-tolerated results with significantly lower pharmacokinetic variability compared to oral nimodipine[117] - The company has streamlined its operations and reduced workforce to focus on the development of GTx-104 following a strategic realignment plan[115] Product Development and Market Potential - The company has submitted a New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine, with the FDA establishing April 23, 2026, as the target date for review completion[104] - The market opportunity for GTx-104 targets approximately 42,500 aSAH patients annually in the U.S., with potential estimates suggesting up to 70,000 cases per year[120] - GTx-104's unique nanoparticle technology allows for IV infusion, potentially eliminating the need for nasogastric tube administration in unconscious patients[110] - The FDA orphan drug designation for GTx-104 could provide seven years of exclusivity and tax credits of up to 25% of clinical development costs, translating to estimated savings of approximately $4.3 million[100] - A market research survey indicated an 80% likelihood of adoption for an IV formulation of nimodipine among hospital administrators and critical care physicians, assuming improved bioavailability and safety[121] Executive Compensation and Governance - Mr. DelAversano has an annual base salary of $306,360 and a discretionary bonus of up to 30% of his base salary[216] - Mr. Kumar has an annual base salary of $310,000 and a discretionary bonus of up to 30% of his base salary[216] - Ms. D'Andrea has an annual base salary of $310,000 and a discretionary bonus of up to 30% of her base salary[216] - Mr. Macdonald has an annual base salary of $200,000 and a discretionary bonus of up to 30% of his base salary[216] - If terminated without Cause, executive officers are entitled to six months of base salary continuation and COBRA premium reimbursement[217]