Acasti Pharma(ACST) - 2025 Q3 - Quarterly Report

Financial Performance - Net loss for the three months ended December 31, 2024, was $4,155,000, compared to a net loss of $2,391,000 for the same period in 2023, representing an increase of 74%[20] - The company reported a basic and diluted loss per share of $0.36 for the three months ended December 31, 2024, compared to $0.21 for the same period in 2023, an increase of 71%[20] - The net loss for the three months ended December 31, 2024, was $4.2 million, or $0.36 per share, compared to a net loss of $2.4 million, or $0.21 per share, for the same period in 2023[170] Assets and Liabilities - Total current assets decreased from $24,010,000 on March 31, 2024, to $11,939,000 on December 31, 2024, a decline of approximately 50%[18] - Cash and cash equivalents decreased from $23,005,000 at the beginning of the period to $11,055,000 at the end of the period, a decrease of 52%[24] - The accumulated deficit increased from $211,119,000 on March 31, 2024, to $221,323,000 on December 31, 2024, an increase of approximately 5%[18] - Total liabilities decreased from $11,557,000 on March 31, 2024, to $9,085,000 on December 31, 2024, a reduction of approximately 21%[18] Research and Development - Research and development expenses for the nine months ended December 31, 2024, were $7,877,000, up from $2,998,000 in the same period of 2023, an increase of 163%[20] - Research and development expenses for the three months ended December 31, 2024, were $2.2 million, an increase of $751,000 from $1.4 million in the same period in 2023[170] - Research and development expenses for the nine months ended December 31, 2024, totaled $7.9 million, up from $3.0 million in the same period in 2023, reflecting increased activities for the GTx-104 pivotal Phase 3 trial[175] Capital and Funding - The Company raised approximately $7,500 from the 2023 Private Placement, issuing 1,951,371 Common Shares at a price of $1.848 per share[33] - The net proceeds from the 2025 Private Placement were approximately $13,800, intended for clinical trial expenses and product launch preparations for GTx-104[34][35] - The Company plans to raise additional capital to maintain adequate liquidity and fund operations beyond the next 12 months[36] - The company completed a private placement in February 2025, raising approximately $13.8 million in net proceeds[168] Clinical Development - The company has three clinical-stage drug candidates aimed at treating rare and orphan diseases, supported by over 40 granted and pending patents worldwide[91] - GTx-104, an injectable formulation of nimodipine, aims to address significant unmet medical needs in aSAH patients and has shown improved bioavailability with 100% compared to oral forms[110] - The STRIVE-ON trial for GTx-104 met its primary endpoint, demonstrating clinical benefit over orally administered nimodipine, with an NDA submission planned for the first half of 2025[100] - GTx-102, an oral-mucosal betamethasone spray for A-T, is in development with FDA guidance received for a pivotal efficacy and safety trial[101] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to focus resources on GTx-104[96] Market Potential - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 150,000 annual cases in China and 60,000 in the European Union[117] - GTx-102 has a potential total addressable market of $150 million in the U.S., affecting approximately 4,300 patients annually[133] - GTx-101 has a total addressable market estimated at $2.5 billion, with approximately $200 million for postherpetic neuralgia (PHN) pain and $2.3 billion for non-PHN pain indications[152] Operational Changes - The company implemented a strategic realignment plan in May 2023, resulting in a streamlined workforce and a focus on the development of its lead product candidate GTx-104[31] - The company incurred $1,485 million in restructuring costs during the nine months ended December 31, 2023, primarily due to employee severance costs and legal fees[82] - The company incurred $1.5 million in restructuring costs related to workforce termination announced on May 8, 2023[182] Financial Controls and Compliance - Management concluded that existing disclosure controls and procedures were effective as of December 31, 2024, providing reasonable assurance but not absolute assurance against errors and fraud[209] - No changes were made to internal controls over financial reporting during the quarter ended December 31, 2024, that materially affected internal controls[210] - The company is not currently a party to any legal proceedings likely to have a material adverse effect on its business[212] - There have been no material changes from the risk factors disclosed in the Annual Report[214]