ACRS News & Events

Reports Q4 revenue $1.3M, consensus $2.07M. Believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2H28, without giving effect to any potential business development transactions or financing activities, or trial execution costs associated with its planned Phase 2b program for ATI-052. "2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program," stated CEO Neal Walker. "2026 started with derisking events for two of our key programs, ITK and ATI-052..Since then, we have initiated two Phase 1b POC trials with ATI-052, with top line results expected from both trials in the second half of this year. With a strong cash position and several meaningful catalysts across our biologics and ITK pipeline expected this year, including top line results from the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in AD, we are looking forward to an exciting and productive year."

Aclaris Therapeutics has initiated a placebo-controlled Phase 1b proof-of-concept trial of ATI-052, the Company's potential best-in-class investigational bispecific anti-TSLP/IL-4Ralpha antibody, in asthma. This announcement follows the recent initiation of the Company's Phase 1b POC trial of ATI-052 in atopic dermatitis. Planning is ongoing for a Phase 2b program encompassing asthma and atopic dermatitis as potential first indications. The Company expects to initiate this program in the second half of 2026. The randomized, double-blind, placebo-controlled Phase 1b POC trial will evaluate the safety, tolerability, and efficacy of ATI-052 compared to placebo in approximately 16 patients with asthma on GINA steps 2-4 treatment prior to screening. Endpoints that will be assessed include safety and tolerability parameters; pharmacokinetic parameters; respiratory pharmacodynamic biomarker assessments including FeNO; blood PD biomarker assessments including blood eosinophil count and endogenous cytokines/chemokines and inflammation markers in plasma/serum; and efficacy measures including FEV1. Top line results from this trial and the ongoing Phase 1b POC trial in AD are expected in the second half of 2026.