Acasti Pharma(ACST) - 2025 Q1 - Quarterly Report

Financial Performance - As of June 30, 2024, total current assets decreased to $20,429,000 from$ 24,010,000 as of March 31, 2024, representing a decline of approximately 15.5%[19] - The net loss for the quarter was $2,617,000, compared to a net loss of$ 4,023,000 for the same quarter in 2023, reflecting an improvement of approximately 34.8%[27] - The company reported a basic and diluted loss per share of $0.24 for the quarter ended June 30, 2024, compared to$ 0.54 for the same quarter in 2023[27] - The total stockholders' equity decreased to $59,364,000 as of June 30, 2024, down from$ 64,010,000 as of June 30, 2023, reflecting a decline of approximately 7%[192] - Acasti Pharma's accumulated deficit increased to $213,736,000 as of June 30, 2024, compared to$ 202,289,000 as of June 30, 2023, marking an increase of approximately 6%[191] Operating Expenses - Operating expenses for the quarter ended June 30, 2024, included research and development expenses of $2,708,000, up from$ 1,095,000 in the same period last year, indicating a year-over-year increase of approximately 147%[25] - General and administrative expenses for the three months ended June 30, 2024, were $2.3 million, an increase of$ 0.4 million from $1.9 million for the same period in 2023[138][139] - Operating expenses for the three months ended June 30, 2024, were$ 4.963 million, compared to $4.454 million for the same period in 2023, reflecting an increase in research and development expenses[187] Cash Flow and Liquidity - Net cash used in operating activities was$ 3,596,000 for the three months ended June 30, 2024, compared to $6,240,000 for the same period in 2023, indicating a 42.4% reduction[33] - Cash and cash equivalents at the end of the period were$ 19,394,000, down from $21,633,000 at the end of June 30, 2023, reflecting a decrease of 10.4%[34] - The company plans to raise additional capital to maintain liquidity and fund operations beyond the second calendar quarter of 2026[39] - The company plans to use the net proceeds from the private placement for clinical trial expenses related to the Phase 3 trial for GTX-104, pre-commercial planning, and working capital[200] Drug Development and Pipeline - The company plans to prioritize the development of its GTX-104 drug candidate, which aims to improve management of hypotension in patients with aneurysmal subarachnoid hemorrhage[10] - The company aims to maximize the value of its de-prioritized drug candidates, GTX-102 and GTX-101, through potential development, licensing, or sale[11] - GTX-104 has been administered to over 150 healthy volunteers and demonstrated significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[84] - The pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has exceeded the 50% patient enrollment milestone as of June 27, 2024, with potential NDA submission anticipated in the first half of 2025[84] - The company has three clinical-stage drug candidates, with GTX-104 being prioritized for commercialization, while the development of GTX-102 and GTX-101 has been deferred for at least three years[86] Strategic Plans and Management - A strategic realignment plan was implemented in May 2023, resulting in a streamlined workforce and a focus on the development of GTX-104[37] - The company implemented a strategic realignment plan in May 2023, which included engaging a new management team and streamlining research and development activities[199] - The management team has significant experience in drug formulation, clinical development, and regulatory affairs, enhancing the company's capabilities in advancing its drug candidates[88] Market Potential - Approximately 50,000 individuals experience aSAH each year in the U.S., with a total addressable market of approximately$ 300 million[96] - The incidence of aSAH is approximately six per 100,000 person years, with a mortality rate of about 29% at five years post-hemorrhage[95] - GTX-102 targets a total addressable market of $150 million in the U.S., affecting approximately 4,300 patients per year[106] - The total addressable market for GTX-101 is estimated to be as large as$ 2.5 billion, with approximately $200 million for PHN pain and$ 2.3 billion for non-PHN pain indications[119] Financing Activities - The company raised approximately $7,500,000 from a private placement on September 24, 2023, to fund clinical trial expenses for GTX-104 and other corporate purposes[38] - A private placement on September 24, 2023, raised approximately$ 7.3 million after fees, selling 1,951,371 Class A common shares at $1.848 each[149] - The company anticipates the need for additional financing to support its operations and development programs[172] Legal and Compliance - The company has no reserves or liabilities accrued for legal proceedings as of June 30, 2024, but believes it has established appropriate legal reserves[74] - A settlement agreement with Aker BioMarine resulted in the transfer of all rights and assets related to the CaPre product, with no liability recorded[152]