Acasti Pharma(US:ACST)2024-08-09 12:00Financial Performance - Acasti reported a net loss of $2.6 million, or $0.24 loss per share, for the quarter ended June 30, 2024, a decrease of $1.4 million from the net loss of $4.0 million, or $0.54 per share, for the same quarter in 2023[4]. - The net loss for Q2 2024 was $2,617,000, an improvement from a net loss of $4,023,000 in Q2 2023[42]. - Basic and diluted loss per share improved to $0.24 in Q2 2024 from $0.54 in Q2 2023[42]. - Loss before income tax recovery decreased to $3,341,000 in Q2 2024 from $4,312,000 in Q2 2023, indicating a positive trend[42]. Research and Development - Total research and development expenses for the quarter were $2.7 million, compared to $1.1 million for the quarter ended June 30, 2023, reflecting an increase of $1.6 million due to heightened research activities for GTX-104[4]. - Research and development expenses increased to $2,708,000 in Q2 2024 from $1,095,000 in Q2 2023, representing a significant rise[41]. General and Administrative Expenses - General and administrative expenses increased to $2.3 million for the quarter ended June 30, 2024, up from $1.9 million for the same period in 2023, primarily due to increased professional fees[5]. - General and administrative expenses rose to $2,255,000 in Q2 2024 compared to $1,874,000 in Q2 2023, indicating an increase[41]. Cash and Assets - As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, down from $23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[5]. - Cash and cash equivalents at June 30, 2024, were $19.4 million, down from $23.0 million as of March 31, 2024, with sufficient cash projected to support operations into the second calendar quarter of 2026[26]. - The total assets decreased to $69.7 million as of June 30, 2024, from $73.3 million as of March 31, 2024[37]. - Total liabilities decreased to $10.4 million as of June 30, 2024, from $11.6 million as of March 31, 2024[38]. Clinical Trials and Drug Development - Acasti surpassed the 50% enrollment milestone in the pivotal Phase 3 STRIVE-ON safety trial of GTX-104, with full enrollment of 100 patients projected for late 2024 to early 2025[3]. - The company anticipates submitting a New Drug Application (NDA) for GTX-104 to the FDA in the first half of calendar 2025[3]. - The company has deprioritized further development of GTX-102 and GTX-101 in favor of focusing on GTX-104[8][9]. - Acasti's GTX-104 is designed to provide an intravenous alternative to oral nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH), a condition affecting approximately 50,000 patients annually in the U.S.[6]. - Acasti's lead clinical asset, GTX-104, has been granted Orphan Drug Designation by the FDA, providing seven years of marketing exclusivity post-launch in the U.S.[11]. Market Potential - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[7]. - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[28]. Share Information - The company had 9,399,404 shares issued and outstanding as of June 30, 2024[39]. - The weighted-average number of shares outstanding increased to 10,928,543 in Q2 2024 from 7,435,533 in Q2 2023[42]. Other Income and Tax - Total other income, net, increased to $1,622,000 in Q2 2024 from $142,000 in Q2 2023, showing substantial growth[42]. - Income tax benefit increased to $724,000 in Q2 2024 from $289,000 in Q2 2023, reflecting improved tax recovery[42]. - The company reported a foreign exchange loss of $8,000 in Q2 2024, compared to a gain of $8,000 in Q2 2023[42]. - Change in fair value of derivative warrant liabilities contributed $1,395,000 in Q2 2024, with no contribution in Q2 2023[42].