Acasti Pharma(US:ACST)2026-02-12 12:31Financial Performance - 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, representing a 44% improvement [23]. - The company reported a net loss of $6,615,000 for the nine months ended December 31, 2025, compared to a net loss of $10,204,000 for the same period in 2024 [76]. - The net loss for the three months ended December 31, 2025, was $2,315, or $0.14 per share, a decrease of $1,840 from the net loss of $4,155, or $0.36 per share, for the same period in 2024 [162]. - The effective income tax rate for the nine months ended December 31, 2025, was 0.0%, compared to 17.6% for the same period in 2024, primarily due to a partial valuation allowance against net domestic deferred tax assets [78][79]. Cash and Assets - Total current assets decreased from $22,712,000 on March 31, 2025, to $19,211,000 on December 31, 2025, a decline of approximately 15% [21]. - Cash and cash equivalents decreased from $22,133,000 at the beginning of the period to $18,672,000 at the end of the period, a decrease of about 16.6% [26]. - As of December 31, 2025, the company reported cash and cash equivalents of $18,672, a decrease of $3,461 from $22,133 at March 31, 2025 [178]. - The accumulated deficit increased to $227,302,000 as of December 31, 2025, from $220,687,000 on March 31, 2025 [21]. Research and Development - Research and development expenses for the nine months ended December 31, 2025, were $1,985,000, down from $7,877,000 in the same period of 2024, a reduction of approximately 75% [23]. - Clinical development program expenses for the nine months ended December 31, 2025, were $651,000, significantly reduced from $6,977,000 in the same period of 2024 [76]. - Research and development expenses for the three months ended December 31, 2025, were $462, down from $2,194 in the same period in 2024, reflecting a decrease of $1,732 [166]. - Total research and development expenses for the nine months ended December 31, 2025, were $1,985, down from $7,877 in the same period in 2024, a decrease of $5,892 [167]. Funding and Capital - The company raised $4,040,000 in gross proceeds from the exercise of common warrants in October 2025 [33]. - The company completed a private placement in February 2025, generating net proceeds of $13,705,000 to support its operations [32]. - The company raised $13,705 in net proceeds from the 2025 Private Placement, which closed on February 11, 2025, after deducting fees and expenses [56]. - The 2023 Private Placement, which closed on September 25, 2023, generated net proceeds of $7,338 from the sale of 1,951,371 shares at $1.848 per share [58]. Product Development - The company plans to use existing cash for regulatory review, pre-commercial planning, and product launch for GTx-104, indicating a focus on advancing this lead product candidate [34]. - The company is focused on its lead product candidate GTx-104 while planning further development of GTx-102 and GTx-101 contingent on securing additional funding [31]. - GTx-104 has shown a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine in the Phase 3 STRIVE-ON trial, with rates of 28% for GTx-104 versus 35% for oral nimodipine [114]. - The company aims to address significant unmet medical needs in rare diseases, leveraging existing approved drugs with established safety profiles [91]. Market and Commercialization - A third-party market analysis indicated that GTx-104 has a potential total addressable market of $150 million in the U.S. for treating aSAH patients [136]. - GTx-101 has a potential total addressable market of $2.5 billion, with approximately $200 million for PHN pain and $2.3 billion for non-PHN pain indications [151]. - The commercialization strategy for GTx-104 includes a targeted hospital-based sales force and potential commercial partnerships [126]. - The company plans to prioritize the development of GTx-104 over GTx-102, contingent on additional funding or strategic partnerships [144]. Legal and Regulatory - The company has not accrued any reserves for legal contingencies as of December 31, 2025, but acknowledges the potential for material impact from ongoing legal proceedings [197]. - The company is currently evaluating the impact of adopting ASU 2024-03 on its consolidated financial statements and disclosures, which will be effective for annual reporting periods beginning after December 15, 2026 [45]. - The company continues to evaluate contingencies and establish loss provisions for probable losses that can be reasonably estimated [188]. Operational Efficiency - The company has streamlined its operations and focused on GTx-104's development following a strategic realignment plan implemented in May 2023 [103]. - The company expects general and administrative expenses to continue increasing as it advances research and development programs and prepares for potential commercial launch of GTx-104 [171]. - The company has $185,000 of commitments to contract manufacturing organizations (CMOs) for the next twelve months as of December 31, 2025 [82].