Financial Performance - The net loss for the three months ended December 31, 2025, was $2,315,000, a reduction of 45% compared to a net loss of $4,155,000 for the same period in 2024[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 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]. - 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 a net loss of $4,155, or $0.36 per share, for the same period in 2024[162]. Assets and Liabilities - As of December 31, 2025, total assets decreased to $68,488,000 from $71,993,000 as of March 31, 2025, representing a decline of approximately 4%[21]. - Cash and cash equivalents at the end of the period were $18,672,000, a decrease of 16.6% from $22,133,000 at the beginning of the period[26]. - The accumulated deficit increased to $227,302,000 as of December 31, 2025, from $220,687,000 as of March 31, 2025[21]. - Total trade and other payables decreased from $1,930 as of March 31, 2025 to $1,284 as of December 31, 2025, indicating a reduction of approximately 33.5%[49]. Research and Development - Research and development expenses for the nine months ended December 31, 2025, were $1,985,000, down 75% from $7,877,000 in the same period of 2024[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]. - Total research and development expenses for the nine months ended December 31, 2025, were $1,985, down from $7,877 for the same period in 2024, a decrease of $5,892[167]. - The company reported a $5,892 decrease in research and development expenses due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON trial[181]. Capital and Financing - 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, raising net proceeds of $13,705 from the sale of 3,252,132 shares of Common Stock at $3.395 per share[56]. - In the 2023 Private Placement, the Company raised $7,338 from the sale of 1,951,371 Common Shares at $1.848 per share[58]. - The company plans to raise additional capital to maintain liquidity and fund operations beyond the next 12 months[180]. Strategic Plans and Operations - A strategic realignment plan was implemented in May 2023, resulting in a streamlined organization focused on the development of GTx-104[31]. - The company plans to use existing cash for regulatory review, pre-commercial planning, and product launch for GTx-104, expecting sufficient funds for at least 12 months[34]. - The company has incurred operating losses and negative cash flows since inception, indicating a need for additional capital to fund operations[29]. - 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]. Product Development and Market Potential - The company has submitted a New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine, to the FDA, with a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for review completion[94][115]. - 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]. - Approximately 42,500 patients in the U.S. are affected by aneurysmal subarachnoid hemorrhage (aSAH) annually, with potential market research suggesting incidence could be as high as 70,000[110]. - The total addressable market for GTx-101, targeting postherpetic neuralgia (PHN), could reach $2.5 billion, with approximately $200 million specifically for PHN pain[151]. Intellectual Property - The company holds over 40 granted and pending patents globally, with the new patent for GTx-104 extending protection to 2043, enhancing its intellectual property position[89][96]. - The 2024 Equity Incentive Plan was approved on September 30, 2024, replacing prior plans, with 1,350,000 shares authorized for issuance and 964,470 shares available for future issuance as of December 31, 2025[64][67]. Financial Reporting and Compliance - The unaudited condensed consolidated financial statements reflect all necessary adjustments for fair presentation as of December 31, 2025, including results for the three and nine months ended December 31, 2025 and 2024[38]. - The Company has not made any changes to its significant accounting policies since the last audited financial statements for the year ended March 31, 2025[40]. - There were no changes to internal controls over financial reporting during the quarter ended December 31, 2025, that materially affected the company's financial reporting[195]. - The company’s disclosure controls and procedures were evaluated as effective as of December 31, 2025, providing reasonable assurance against errors and fraud[194].
Grace Therapeutics, lnc.(GRCE) - 2026 Q3 - Quarterly Report