Financial Performance - Net loss for the three months ended September 30, 2025, was $938 thousand, compared to a net loss of $3,432 thousand for the same period in 2024, representing a reduction of approximately 72.6%[25] - The company reported a basic and diluted loss per share of $0.06 for the three months ended September 30, 2025, compared to $0.30 for the same period in 2024, reflecting an improvement of 80.0%[25] - The company reported a net loss of $4,301 for the six months ended September 30, 2025, compared to a net loss of $6,049 for the same period in 2024[86] - For the three months ended September 30, 2025, the net loss was $938, a decrease of $2,494 from the net loss of $3,432 for the same period in 2024[169] Expenses - Research and development expenses for the six months ended September 30, 2025, were $1,523 thousand, down from $5,684 thousand in the same period of 2024, a decrease of approximately 73.3%[25] - The company incurred total operating expenses of $2,529 thousand for the three months ended September 30, 2025, down from $4,831 thousand in the same period of 2024, a decrease of approximately 47.7%[25] - Research and development expenses for the three months ended September 30, 2025, were $568, down from $2,976 for the same period in 2024, a decrease of $2,408[173] - General and administrative expenses for the three months ended September 30, 2025, were $1,961, an increase of $106 from $1,855 for the same period in 2024[180] Assets and Liabilities - Total assets decreased from $71,993 thousand as of March 31, 2025, to $66,576 thousand as of September 30, 2025, a decline of approximately 7.4%[23] - The company’s accumulated deficit increased to $224,987 thousand as of September 30, 2025, from $220,687 thousand as of March 31, 2025, an increase of approximately 1.4%[23] - As of September 30, 2025, total assets measured at fair value were $14,969, with treasury bills classified as cash equivalents contributing $14,969[51] - Total liabilities measured at fair value were $201, primarily from derivative warrant liabilities[51] Cash Flow - Cash and cash equivalents decreased from $22,133 thousand at the beginning of the period to $16,862 thousand at the end of the period, a decrease of approximately 24.0%[29] - Net cash used in operating activities for the six months ended September 30, 2025, was $4,944, a decrease of $2,891 compared to $7,835 for the same period in 2024, primarily due to a $4,248 decrease in research and development activities[188] - Net cash used in financing activities for the six months ended September 30, 2025, was $327 related to stock issuance costs from the 2025 Private Placement, with no financing activities reported for the same period in 2024[190] Funding and Capital Raising - The company completed a private placement in February 2025, raising net proceeds of $13,705 thousand to support its operations[34] - The company raised $13,705 in net proceeds from the 2025 Private Placement, which closed on February 11, 2025[60] - The 2023 Private Placement generated net proceeds of $7,338 after deducting fees and expenses[62] - The company plans to raise additional capital to maintain adequate liquidity, as it does not expect to generate revenue from product sales until regulatory approval is obtained[187] Product Development - The company has submitted a New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine, with the FDA establishing April 23, 2026, as the target date for review completion[104] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating well-tolerated results with significantly lower pharmacokinetic variability compared to oral nimodipine[110] - GTx-104 aims to address significant unmet medical needs in aSAH patients, potentially improving patient outcomes through better management of hypotension and reduced dosing errors[118] - GTx-102, another drug candidate, has completed a Phase-1 pharmacokinetic study with no serious adverse events reported, targeting treatment for ataxia-telangiectasia in pediatric patients[110] Market Opportunity - The market opportunity for GTx-104 includes approximately 42,500 aSAH patients in the U.S. annually, with potential estimates suggesting up to 70,000 cases per year[120] - A market research survey indicated an 80% likelihood of adoption for an IV formulation of nimodipine among hospital administrators and critical care physicians, assuming improved bioavailability and safety[121] - GTx-102 has a potential total addressable market of $150 million in the U.S., affecting approximately 4,300 patients per year[145] - GTx-101 has a total addressable market estimated at $2.5 billion, with $200 million for PHN pain and $2.3 billion for non-PHN pain indications[158] Executive Compensation - Mr. DelAversano has an annual base salary of $306,360 and a discretionary bonus of up to 30% of his base salary[216] - Mr. Kumar has an annual base salary of $310,000 and a discretionary bonus of up to 30% of his base salary[216] - Ms. D'Andrea has an annual base salary of $310,000 and a discretionary bonus of up to 30% of her base salary[216] - Mr. Macdonald has an annual base salary of $200,000 and a discretionary bonus of up to 30% of his base salary[216]
Grace Therapeutics, lnc.(GRCE) - 2026 Q2 - Quarterly Report