Applied Therapeutics Reports Second Quarter 2025 Financial Results

Core Insights - The company is advancing its CMT-SORD program and has scheduled a meeting with the FDA in Q3 2025 to discuss the New Drug Application (NDA) submission for govorestat [1][4] - Full 12-month clinical results from the INSPIRE Phase 2/3 trial of govorestat for CMT-SORD were presented, showing slowed disease progression observed via MRI at 24 months [1][4] - A new sponsored Sorbitol Assay has been launched to assist in identifying patients suspected of having CMT-SORD [1][4] - The company has entered into an out-licensing agreement with Biossil, Inc. for AT-001, an investigational therapy for Diabetic Cardiomyopathy [1][9] CMT-SORD Program - A meeting with the FDA is planned to align on the NDA submission strategy for govorestat, focusing on comprehensive data for Sorbitol Dehydrogenase Deficiency [4] - The newly launched Urine Sorbitol Assay aims to support healthcare providers in identifying suspected CMT-SORD cases at no cost to patients [4] - Clinical results from the INSPIRE trial indicated that govorestat was generally safe and well-tolerated, with significant improvements in key secondary endpoints at 12 months [4] Other Development Programs - New data on govorestat for PMM2-CDG will be presented at the 2025 ASHG Annual Meeting [2][6] - The review of the govorestat development program for Classic Galactosemia is progressing as planned, including responses to the Complete Response Letter from the FDA [5] Financial Performance - As of June 30, 2025, cash and cash equivalents totaled $30.4 million, down from $79.4 million at the end of 2024 [8] - Research and development expenses for Q2 2025 were $9.9 million, slightly down from $10.0 million in Q2 2024 [8] - General and administrative expenses increased to $13.2 million in Q2 2025 from $10.6 million in Q2 2024 [8] - The net loss for Q2 2025 was $21.3 million, compared to a net income of $2.9 million in Q2 2024 [8][15]