Aclaris Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

Core Insights - Aclaris Therapeutics reported positive interim results from its Phase 1a trials for the bispecific antibody ATI-052, indicating strong safety and tolerability, with complete results expected in Q2 2026 [1][3] - The company has initiated Phase 1b proof-of-concept trials for ATI-052 in atopic dermatitis and asthma, with top line results anticipated in the second half of 2026 [1][2] - Aclaris plans to file an Investigational New Drug (IND) application for its lead ITK inhibitor candidate, ATI-9494, in the second half of 2026 [1][12] Pipeline Developments - Positive interim results from the Phase 1a SAD/MAD trial of ATI-052 showed a favorable safety profile and robust target engagement, supporting potential extended dosing every three months [3][2] - Two Phase 1b POC trials for ATI-052 have been initiated, with results expected in the latter half of 2026 [3][2] - Planning for a Phase 2b program for ATI-052 is underway, targeting asthma and atopic dermatitis as initial indications [3] Financial Performance - Aclaris reported a net loss of $19.8 million for Q4 2025, a significant decrease from a net loss of $96.6 million in Q4 2024 [7] - Total revenue for Q4 2025 was $1.3 million, down from $9.2 million in Q4 2024, primarily due to a prior commercial milestone [8] - Research and development expenses increased to $16.6 million in Q4 2025 from $9.0 million in the prior year, driven by higher costs associated with product candidate development [9] Liquidity and Capital Resources - As of December 31, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $151.4 million, down from $203.9 million in 2024 [6][20] - The company believes its current financial resources will be sufficient to fund operations into the second half of 2028 [6]