Applied Therapeutics(US:APLT)2025-11-13 12:15Financial Performance - Total revenue for the three months ended September 30, 2025, was $1,000,000, compared to $122,000 for the same period in 2024, representing a significant increase[20]. - The net loss for the three months ended September 30, 2025, was $18,990,000, compared to a net loss of $68,591,000 for the same period in 2024, reflecting an improvement of approximately 72%[20]. - For the nine months ended September 30, 2025, the company reported a net loss of $62.1 million, compared to a net loss of $149.6 million for the same period in 2024, indicating a 58.5% improvement year-over-year[27]. - The company reported a net cash used in operating activities of $67.4 million for the nine months ended September 30, 2025, compared to $64.8 million for the same period in 2024[27]. - The company reported a net loss of $62.1 million for the nine months ended September 30, 2025, with an accumulated deficit of $636.4 million[153]. Cash and Liquidity - Cash and cash equivalents decreased to $11,945,000 as of September 30, 2025, from $79,398,000 as of December 31, 2024, a decline of approximately 85%[18]. - The company had cash and cash equivalents of $11.9 million as of September 30, 2025, down from $98.9 million at the beginning of the period, reflecting a net decrease of $67.5 million in cash[27]. - As of September 30, 2025, cash and cash equivalents were $11.9 million, indicating a need for substantial additional funding for ongoing operations[188]. - The company has not generated any product revenue since inception and is dependent on debt and equity financing[188]. Expenses - Research and development expenses for the nine months ended September 30, 2025, were $27,361,000, down from $37,049,000 in the same period in 2024, indicating a reduction of approximately 26%[20]. - Total research and development expenses for the three months ended September 30, 2025 were $9.6 million, a decrease of $5.2 million (35%) from $14.8 million in 2024[174]. - General and administrative expenses for the three months ended September 30, 2025 were $8.2 million, down $6.9 million (46%) from $15.0 million in 2024[174]. - General and administrative expenses increased to $39.0 million for the nine months ended September 30, 2025, from $34.7 million in 2024, representing a $4.3 million increase[184]. - Legal and professional fees rose by $15.7 million, primarily due to securities class action and shareholder derivative litigation[184]. Assets and Liabilities - The total assets decreased to $34,374,000 as of September 30, 2025, from $86,691,000 as of December 31, 2024, a decline of approximately 60%[18]. - Total current liabilities increased to $32,902,000 as of September 30, 2025, from $27,296,000 as of December 31, 2024, representing an increase of about 21%[18]. - The total stockholders' equity showed a deficit of $(561,000) as of September 30, 2025, compared to a positive equity of $57,006,000 as of December 31, 2024[18]. - The accumulated deficit increased to $(636,355,000) as of September 30, 2025, from $(574,210,000) as of December 31, 2024, indicating a worsening of approximately 11%[18]. Financing and Capital Raising - The company is actively pursuing long-term financing options, including equity capital and debt, to support its operations and has engaged in discussions with potential partners for business development opportunities[33]. - The Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald, allowing for the sale of up to $75.0 million in common stock[97]. - The March 2024 Private Placement raised approximately $92.3 million from the sale of 12,285,714 shares at $7.00 each and 2,000,000 Pre-Funded Warrants[99]. - The Company sold an aggregate of 20,615,976 shares of common stock under the Leerink ATM Agreement, resulting in net proceeds of $49.3 million[96]. Research and Development - The company operates in a single segment focused on research and development activities related to rare diseases[37]. - The FDA accepted the New Drug Application (NDA) for AT-007 for Classic Galactosemia in February 2024, but issued a Complete Response Letter on November 27, 2024, citing deficiencies in the clinical application[146]. - The company initiated a clinical development program for AT-007 in PMM2-CDG, a rare pediatric disease affecting an estimated 14,000 patients in North America and Europe[149]. - AT-007 reduced blood sorbitol levels by approximately 66% from baseline in a pilot study involving eight CMT-SORD patients[148]. Legal and Regulatory Matters - A settlement loss of $15.4 million was recognized within General and Administrative Expense due to a securities class action lawsuit, which includes a $15.0 million cash settlement and $0.4 million for warrant liability[137]. - The Company expects to recover $16.7 million from insurance related to the settlement loss, which includes $15.0 million for the cash settlement and $1.7 million for legal expenses[137]. - The Company is involved in multiple derivative actions seeking corporate governance reforms and recovery for alleged misconduct by current and former officers and directors[138]. - As of September 30, 2025, the Company assessed the probability of loss from the derivative lawsuits as reasonably possible, but does not believe any potential exposure will be material to its operations[142]. Internal Controls and Compliance - Management has identified a material weakness in internal control over financial reporting related to communication deficiencies, which has been addressed through enhanced controls and resources[215][216]. - The company has implemented a rigorous disclosure review process involving the executive team and legal counsel to improve communication and compliance[216]. - Management believes that enhanced resources and control activities will support the functioning of information and communication processes[216]. - The company has evaluated its disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of September 30, 2025[214].