Acasti Pharma(ACST) - 2026 Q2 - Quarterly Results

Financial Performance - The company reported a net loss of $0.9 million, or $0.06 per share, for Q2 2026, a decrease of $2.5 million from a net loss of $3.4 million, or $0.30 per share, in Q2 2025[6]. - As of September 30, 2025, Grace Therapeutics reported cash and cash equivalents of $16.862 million, a decrease from $22.133 million as of March 31, 2025, representing a decline of approximately 24%[21]. - The net loss for the three months ended September 30, 2025, was $938,000, compared to a net loss of $3.432 million for the same period in 2024, indicating a significant improvement[22]. - 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[22]. - Total liabilities decreased to $3.758 million from $5.383 million, a reduction of approximately 30%[21]. - The company’s accumulated deficit increased to $224.987 million as of September 30, 2025, from $220.687 million as of March 31, 2025[21]. Research and Development - Research and development expenses decreased to $0.6 million in Q2 2026 from $3.0 million in Q2 2025, a reduction of $2.4 million[7]. - Research and development expenses for the three months ended September 30, 2025, were $568,000, down from $2.976 million in the same period of 2024, showing a reduction of approximately 81%[22]. - Grace Therapeutics is focused on the development of its drug candidates GTx-104, GTx-102, and GTX-101, with ongoing regulatory submissions and trials expected to impact future performance[20]. Cash Management - Cash and cash equivalents were approximately $20.0 million as of October 31, 2025, following a $4.0 million funding secured through warrant exercises[5]. - The company estimates a cash runway through at least the next twelve months, potentially extending into Q2 2027 if all common warrants are exercised[11]. - Grace Therapeutics is actively managing its cash runway and evaluating future funding strategies to support ongoing operations and development efforts[20]. Product Development and Regulatory Status - FDA accepted the NDA for GTx-104 for aSAH treatment, with a PDUFA target date of April 23, 2026[4]. - The STRIVE-ON trial showed a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine[12]. - GTx-104 has been administered to over 200 patients and was well tolerated, showing lower pharmacokinetic variability compared to oral nimodipine[14]. - Grace Therapeutics has received Orphan Drug Designation for GTx-104, granting seven years of marketing exclusivity in the U.S. upon FDA approval[4]. - The company holds five patents on the composition of GTx-104, providing protection until 2037, with a new patent extending protection for the IV dosing regimen to 2043[4]. General and Administrative Expenses - General and administrative expenses increased to $2.0 million in Q2 2026 from $1.9 million in Q2 2025, an increase of $0.1 million[8]. Asset Management - Total assets decreased to $66.576 million from $71.993 million, reflecting a reduction of about 7.4%[21].