Acasti Pharma(ACST) - 2025 Q3 - Quarterly Results

Clinical Trials and Drug Development - The Phase 3 STRIVE-ON safety trial met its primary endpoint, demonstrating improved clinical outcomes for patients compared to orally administered nimodipine[2] - The company anticipates submitting a New Drug Application (NDA) for GTx-104 in the first half of calendar year 2025[4] - The company is focusing on pre-commercial planning and building a commercial team in anticipation of GTx-104's potential approval[3] Financial Performance - For the third fiscal quarter ended December 31, 2024, the company reported a net loss of $4.2 million, or $0.36 per share, an increase from a net loss of $2.4 million, or $0.21 per share, for the same period in 2023[5] - The net loss for the nine months ended December 31, 2024, was $10,204,000, compared to a net loss of $9,687,000 for the same period in 2023, reflecting an increase of 5.3%[18] - The total loss before income tax benefit for the nine months ended December 31, 2024, was $12,385,000, up from $10,630,000 in the same period of 2023[18] - Basic and diluted loss per share for Q3 2024 was $0.36, compared to $0.21 in Q3 2023, indicating a deterioration in earnings per share[18] Expenses and Cash Flow - Research and development expenses for the quarter were $2.2 million, up from $1.4 million in the same quarter of 2023, primarily due to increased activities for the GTx-104 trial[6] - General and administrative expenses were $1.5 million for the quarter, a slight decrease from $1.6 million in the same quarter of 2023[7] - Research and development expenses for Q3 2024 were $2,194,000, an increase of 52% compared to $1,443,000 in Q3 2023[18] - General and administrative expenses decreased slightly to $1,510,000 in Q3 2024 from $1,600,000 in Q3 2023[18] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease of $11.9 million from $23.0 million at March 31, 2024[8] Assets and Deficits - Total assets decreased to $61.2 million as of December 31, 2024, down from $73.3 million at March 31, 2024[17] - The company’s accumulated deficit increased to $221.3 million as of December 31, 2024, compared to $211.1 million at March 31, 2024[17] Financing Activities - The company secured a private placement financing of up to approximately $30 million, with $15 million received upfront and the potential for an additional $15 million upon warrant exercise[4] Other Financial Metrics - The company reported a foreign exchange loss of $16,000 in Q3 2024, compared to a gain of $3,000 in Q3 2023[18] - Interest and other income, net, decreased to $138,000 in Q3 2024 from $316,000 in Q3 2023[18] - The weighted-average number of shares outstanding increased to 11,506,234 in Q3 2024 from 8,874,872 in the same quarter of the previous year[18] - The income tax benefit for the nine months ended December 31, 2024, was $2,181,000, compared to $943,000 for the same period in 2023[18] - The company did not incur any restructuring costs in Q3 2024, while it had restructuring costs of $1,485,000 in the same period of 2023[18]