Aclaris Therapeutics (ACRS) investor relations material

Pipeline and near-term priorities

• Upcoming data releases include bispecific 1b results in asthma and atopic dermatitis, followed by TSLP mAb data in atopic dermatitis, spaced about six weeks apart.

• Regulatory milestones include starting the ATI-2138 oral ITK/JAK3 study in lichen planus in Q4 and IND submission for next-gen ITK-9494.

• Interim data from the lichen planus study may enable early regulatory discussions for a registrational study, leveraging Fast Track designation.

• SAD/MAD and proof-of-concept data for ITK-9494 are expected throughout 2027.

• Cash on hand is sufficient to fund all major studies through 2028, including phase II-B in asthma and EoE proof-of-concept.

Lichen planus program

• ATI-2138 targets lichen planus due to its strong mechanistic fit and lack of approved therapies, addressing a market opportunity exceeding $1 billion.

• The basket study covers mucosal, cutaneous, and scalp phenotypes, with initial focus on oral mucosal LP and 40 patients per dose group.

• Primary endpoint is Oral Disease Severity Score (ODSS), with IGA and other secondary endpoints; study is placebo-controlled.

• Interim analysis at 60% enrollment may inform dose selection and accelerate registration pathway.

• Current treatments have high failure rates; ATI-2138’s dual ITK/JAK3 mechanism is supported by case reports and preclinical data.

Bispecific and TSLP programs

• Bispecific asset targets IL-4Rα and TSLP, aiming for broader efficacy than IL-13-only approaches and quarterly dosing potential.

• Phase I-B readouts in asthma and atopic dermatitis are imminent; asthma study uses a single-dose design with FeNO and FEV1 as key endpoints.

• Phase II-B in asthma will use a six-month FEV1 primary endpoint and COMPACT as a sensitive secondary, with top-line data expected in 2028.

• Atopic dermatitis phase I-B focuses on severe, biologic-naive patients, with endpoints including mean EASI change, EASI 50, and itch scores.

• TSLP mAb monotherapy data will follow bispecific readouts; strong efficacy could prompt strategic reevaluation.