Aclaris Therapeutics (ACRS) investor relations material

Pipeline and near-term priorities

• Upcoming data releases include bispecific datasets in asthma and atopic dermatitis, followed by TSLP mAb data in atopic dermatitis, spaced about six weeks apart.

• Regulatory milestones include starting a study of ATI-2138 (oral ITK/JAK3) in lichen planus in Q4, with potential for interim data review and possible registrational study discussion in early 2027.

• IND submission for next-generation ITK inhibitor ATI-9494 is planned, with SAD/MAD and POC data expected throughout 2027.

• Phase II-B trials in asthma and atopic dermatitis are set to begin in Q4, with asthma trial fully funded and top-line data expected in 2028.

• Cash on hand is sufficient to fund all planned studies through 2028, including EoE proof-of-concept and lichen planus cohorts.

Lichen planus program (ATI-2138)

• Chosen for its unmet need, mechanistic fit, and market potential exceeding $1 billion for oral LP alone.

• Basket study design covers mucosal, cutaneous, and scalp phenotypes, starting with 40 patients in the oral mucosa cohort.

• Primary endpoint is Oral Disease Severity Score (ODSS) over 16 weeks, with IGA as a secondary endpoint; study is placebo-controlled.

• Interim analysis planned at 60% enrollment in mucosal cohort to inform dose selection and potential registrational pathway.

• Current treatments have high failure rates; ATI-2138 targets both ITK and JAK3, addressing disease mechanism more directly.

Bispecific and TSLP programs

• Bispecific targets IL-4Rα/TSLP, aiming for broader efficacy than IL-13-only approaches; quarterly dosing possible.

• Phase I-B readouts in asthma and atopic dermatitis will present FeNO, FEV1, and EASI/itch endpoints, focusing on severe AD patients.

• Phase II-B in asthma will use a six-month FEV1 primary endpoint with COMPACT as secondary, aiming for efficient dose selection.

• TSLP mAb monotherapy data expected six weeks after bispecific; if statistically significant, could be out-licensed.

• Competitor data (Sanofi, Pfizer) inform strategy; trispecifics and bispecifics compared for efficacy and breadth.