Aclaris Therapeutics (ACRS) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Pipeline overview and clinical progress

• Three clinical-stage programs are advancing, with a lead anti-TSLP mAb (bosakitug) completing phase II in 2026 and a bispecific (ATI-052) nearing phase I completion, with top-line results expected later this year.

• ATI-052, combining TSLP and IL-4R blockade, has shown a 26-day half-life and 4x potency over current combinations in preclinical assays, with phase 1b studies in atopic dermatitis and asthma ongoing.

• Small molecule ATI-2138 (ITK/JAK3 inhibitor) is advancing, with preclinical data supporting efficacy in alopecia and a next-gen ITK-selective candidate (ATI-9494) aiming for IND submission by year-end.

• 2026 is positioned as a pivotal year with multiple readouts and potential catalysts across the pipeline.

Bosakitug (anti-TSLP mAb) program

• Demonstrated over 90% EASI-75 response in open-label POC and over 80% in IJ01, prompting a larger phase II study in atopic dermatitis.

• Unique 400-hour retention time and 23-day half-life may enable dosing every two to three months, a significant improvement over current standards.

• Phase II study designed to minimize placebo effect and optimize patient selection, with top-line data expected in the second half of the year.

• Additional indications are being explored by partners in respiratory diseases, while dermatology remains the primary focus.

ATI-052 (bispecific TSLP/IL-4R) program

• Phase I in healthy volunteers showed a 26-day half-life and strong safety, with no significant adverse events.

• Demonstrated 4x greater potency than Tezspire plus Dupi in PBMC assays and sustained target inhibition for up to six weeks.

• Phase 1b studies in atopic dermatitis (12 patients, severe population) and asthma (16 patients, TH2-high) are ongoing, with data expected in the second half of the year.

• Dosing strategy in early studies is designed to inform future phase II/III dosing intervals, targeting two to three months between doses.

• Program aims to address both T2-high and T2-low populations, with broader potential than current therapies.