Acasti Pharma(ACST) - 2026 Q3 - Quarterly Results

Financial Performance - The company reported a net loss of approximately $2.3 million, or $0.14 per share, for Q3 2026, a decrease of $1.8 million from the net loss of $4.2 million, or $0.36 per share, for Q3 2025[5]. - The net loss for the three months ended December 31, 2025, was $2,315,000, compared to a net loss of $4,155,000 for the same period in 2024, indicating an improvement of approximately 44.5%[20]. - The company reported a basic and diluted loss per share of $0.14 for the three months ended December 31, 2025, compared to $0.36 for the same period in 2024, showing a reduction of approximately 61.1%[20]. Research and Development - Total research and development expenses for Q3 2026 were $0.5 million, down from $2.2 million in Q3 2025, primarily due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial[6]. - Research and development expenses for the three months ended December 31, 2025, were $462,000, significantly lower than $2,194,000 for the same period in 2024, a decrease of about 78.9%[20]. - The company is focused on the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-102, which is expected to provide clinical benefits for patients with A-T[18]. Cash and Assets - As of December 31, 2025, cash and cash equivalents were $18.7 million, a decrease of $3.4 million compared to $22.1 million at March 31, 2025[8]. - As of December 31, 2025, the company's cash and cash equivalents decreased to $18,672,000 from $22,133,000 as of March 31, 2025, representing a decline of approximately 15.5%[19]. - Total assets decreased to $68,488,000 as of December 31, 2025, down from $71,993,000 as of March 31, 2025, reflecting a reduction of about 4.5%[19]. Liabilities and Deficit - Total liabilities decreased to $3,596,000 as of December 31, 2025, from $5,383,000 as of March 31, 2025, a decline of about 33.2%[19]. - The company's accumulated deficit increased to $227,302,000 as of December 31, 2025, from $220,687,000 as of March 31, 2025, reflecting an increase of approximately 3%[19]. Funding and Future Prospects - The company secured approximately $4.0 million in additional funding through the exercise of common warrants at an exercise price of $3.003 per share[4]. - The company anticipates the FDA's PDUFA target date for GTx-104 approval on April 23, 2026, supported by a robust data package from the STRIVE-ON trial[3]. - The company anticipates the potential of its GTx-104 drug candidate to enhance treatment options for patients suffering from aSAH, with ongoing regulatory submissions expected to impact future prospects[18]. Intellectual Property - The company has over 40 granted and pending patents, enhancing its intellectual property protection for GTx-104[16]. - Grace Therapeutics is actively pursuing the protection of its intellectual property for new developments, which may influence its market position and future growth strategies[18]. Clinical Trial Results - The STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine (28% vs. 35%)[11]. - GTx-104 has been administered to over 200 patients and healthy volunteers, showing well-tolerated results with lower pharmacokinetic variability compared to oral nimodipine[13]. - The company plans to utilize its cash reserves for regulatory review, pre-commercial planning, and potential product launch of GTx-104 if approved[10].