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Acasti Pharma(ACST) - 2025 Q2 - Quarterly Results
ACSTAcasti Pharma(ACST)2024-11-13 13:00

Financial Performance - The company reported a net loss of 3.4million,or3.4 million, or 0.30 per share, for the quarter ended September 30, 2024, compared to a net loss of 3.3million,or3.3 million, or 0.43 per share, for the same period in 2023[6]. - The net loss for the three months ended September 30, 2023, was 3,432,000,comparedtoanetlossof3,432,000, compared to a net loss of 3,273,000 for the same period in 2022, indicating an increase in loss of approximately 4.9%[23]. - The company reported a basic and diluted loss per share of 0.30forthethreemonthsendedSeptember30,2023,comparedto0.30 for the three months ended September 30, 2023, compared to 0.43 for the same period in 2022[23]. Research and Development - Research and development expenses increased to 3.0millionforthequarter,upfrom3.0 million for the quarter, up from 0.5 million in the same quarter of 2023, primarily due to activities related to the GTx-104 pivotal Phase 3 STRIVE-ON safety trial[7]. - Research and development expenses for the three months ended September 30, 2023, were 2,976,000,whilegeneralandadministrativeexpenseswere2,976,000, while general and administrative expenses were 1,855,000[23]. - Patient enrollment in the Phase 3 STRIVE-ON safety trial was completed ahead of schedule, with a data readout expected in the first calendar quarter of 2025[4]. Financial Position - The company had cash and cash equivalents of 15.1millionasofSeptember30,2024,adecreaseof15.1 million as of September 30, 2024, a decrease of 7.9 million from 23.0millionasofMarch31,2024,withaprojectedcashrunwayintothesecondcalendarquarterof2026[9].AsofSeptember30,2024,totalassetsdecreasedto23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[9]. - As of September 30, 2024, total assets decreased to 65,349,000 from 73,300,000asofMarch31,2024,representingadeclineofapproximately10.273,300,000 as of March 31, 2024, representing a decline of approximately 10.2%[19]. - Current assets fell to 16,062,000 from 24,010,000,adecreaseofabout33.124,010,000, a decrease of about 33.1%[19]. - Total liabilities decreased to 9,215,000 from 11,557,000,areductionofapproximately20.211,557,000, a reduction of approximately 20.2%[19]. - Shareholders' equity decreased to 56,134,000 from 61,743,000,reflectingadeclineofabout9.161,743,000, reflecting a decline of about 9.1%[19]. Corporate Developments - The company completed its redomicile to Delaware and rebranded to Grace Therapeutics, with trading under the symbol "GRCE" on Nasdaq effective October 28, 2024[5]. - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of calendar 2025[4]. - A virtual Key Opinion Leader event is scheduled for November 20, 2024, to discuss the treatment landscape for aneurysmal Subarachnoid Hemorrhage (aSAH) patients[10]. Product Information - The addressable market for GTx-104 in the United States is estimated to be approximately 300 million[14]. - GTx-104 is a novel injectable formulation of nimodipine being developed for intravenous infusion in aSAH patients, addressing significant unmet medical needs[13]. Other Financial Metrics - The company experienced a foreign exchange gain of 13,000forthethreemonthsendedSeptember30,2023,comparedtoalossof13,000 for the three months ended September 30, 2023, compared to a loss of 13,000 in the previous year[23]. - The change in fair value of derivative warrant liabilities resulted in a gain of 362,000forthethreemonthsendedSeptember30,2023[23].Generalandadministrativeexpenseswere362,000 for the three months ended September 30, 2023[23]. - General and administrative expenses were 1.9 million for the quarter, an increase of 0.3millionfrom0.3 million from 1.6 million in the same quarter of 2023[8]. - The weighted average number of shares outstanding increased to 11,506,234 for the three months ended September 30, 2023, compared to 7,552,677 for the same period in 2022[23].