Applied Therapeutics(US:APLT)2025-11-13 12:11Financial Performance - Cash and cash equivalents totaled $11.9 million as of September 30, 2025, down from $79.4 million at December 31, 2024, representing a decrease of approximately 85%[12] - Net loss for Q3 2025 was $19.0 million, or $0.13 per share, compared to a net loss of $68.6 million, or $0.48 per share, for Q3 2024, indicating a significant reduction in losses[13] - Total revenue for the three months ended September 30, 2025, was $1,000, compared to $122 for the same period in 2024, representing a significant increase[23] - The net loss for the three months ended September 30, 2025, was $18,990, compared to a net loss of $68,591 for the same period in 2024[23] - Net loss per share attributable to common stockholders for the three months ended September 30, 2025, was $(0.13), compared to $(0.48) for the same period in 2024[23] - Total costs and expenses for the three months ended September 30, 2025, were $17,758, a decrease from $29,865 in the same period in 2024[23] - Interest income for the three months ended September 30, 2025, was $144, compared to $1,357 for the same period in 2024[23] - The change in fair value of warrant liabilities resulted in a loss of $(2,369) for the three months ended September 30, 2025, compared to a loss of $(40,184) for the same period in 2024[23] - The total other income (expense), net for the three months ended September 30, 2025, was $(2,232), compared to $(38,848) for the same period in 2024[23] Expenses - Research and development expenses for Q3 2025 were $9.6 million, a decrease of approximately 35% compared to $14.8 million in Q3 2024[12] - General and administrative expenses were $8.2 million for Q3 2025, down approximately 46% from $15.0 million in Q3 2024[12] - Research and development expenses for the three months ended September 30, 2025, were $9,601, a decrease from $14,828 in the same period in 2024[23] - General and administrative expenses for the three months ended September 30, 2025, were $8,157, down from $15,037 in the same period in 2024[23] Regulatory and Development Updates - The company received constructive feedback from the FDA regarding the regulatory strategy for govorestat for CMT-SORD, with plans to submit another meeting request to discuss a potential Phase 3 trial design[7] - A meeting is scheduled with the FDA in Q4 2025 to review govorestat for the treatment of Classic Galactosemia, following a Complete Response Letter received in November 2024[9] - Results from a single-patient trial of govorestat for PMM2-CDG showed a 46% improvement in the Nijmegen Pediatric CDG Rating Scale, with no adverse effects reported[10] - The company has received Orphan Drug Designation and Rare Pediatric Disease designation from the FDA for govorestat for PMM2-CDG[10] Liabilities and Deficits - Total current liabilities increased to $32.9 million as of September 30, 2025, compared to $27.3 million at December 31, 2024[21] - The company’s accumulated deficit increased to $636.4 million as of September 30, 2025, compared to $574.2 million at December 31, 2024[21]