GlobeNewswire·Nov 13, 2025, 7:00 AM ET

Applied Therapeutics Reports Third Quarter 2025 Financial Results

APLT

Applied Therapeutics received Type C meeting minutes from the FDA regarding govorestat for CMT-SORD to refine regulatory strategy for a potential NDA submission.
The company plans to request an additional Type C meeting with the FDA in 2025 to discuss the design of a potential Phase 3 trial for CMT-SORD.
A meeting with the FDA is scheduled for the fourth quarter of 2025 to review govorestat for the treatment of Classic Galactosemia following a previous Complete Response Letter.
New data from a single-patient trial of govorestat for PMM2-CDG was published in JIMD and presented at the 2025 ASHG Annual Meeting, showing a 46% improvement on the Nijmegen Pediatric CDG Rating Scale.
Govorestat demonstrated a well-tolerated safety profile with a dose-dependent decrease in whole blood sorbitol levels in the PMM2-CDG trial.
John Johnson stepped down as Executive Chairman and director for personal reasons effective November 2025.
Cash and cash equivalents decreased to $11.9 million as of September 30, 2025, from $79.4 million at December 31, 2024.
Research and development expenses for the third quarter of 2025 were $9.6 million, a decrease of approximately $5.2 million from the prior year period.
General and administrative expenses for the third quarter of 2025 were $8.2 million, a decrease of approximately $6.9 million from the prior year period.
The company reported a net loss of $19.0 million, or $0.13 per share, for the third quarter of 2025, compared to a net loss of $68.6 million, or $0.48 per share, in the same period last year.