Aclaris Therapeutics (ACRS) investor relations material

Pipeline and near-term priorities

• Upcoming data releases include bispecific phase 1B results in asthma and atopic dermatitis, with both data sets released simultaneously, followed by TSLP mAb data in atopic dermatitis about six weeks later.

• Regulatory milestones include starting a lichen planus study with ATI-2138 in Q4 and advancing next-gen ITK (ATI-9494) to IND.

• Interim data from the lichen planus study could enable early regulatory discussions, potentially accelerating the registrational pathway.

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

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

Lichen planus program

• ATI-2138 targets lichen planus due to its strong mechanistic fit, addressing T cell receptor and JAK3 pathways.

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

• Current treatments have high failure rates; ATI-2138 aims to address unmet needs with a placebo-controlled, 16-week trial using ODSS and IGA as primary endpoints.

• Interim analysis at 60% enrollment may inform dose selection and accelerate regulatory engagement.

• The LP market opportunity is estimated at over $1 billion for oral LP alone.

Bispecific and TSLP programs

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

• Phase 1B asthma study uses a single-dose design, tracking FeNO and FEV1, with home run targets of FeNO reduction (4–5 handle) and FEV1 increase (>150 mL).

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

• Atopic dermatitis phase 1B focuses on severe, biologic-naive patients, with endpoints including mean change in EASI, EASI 50, and itch scores at 12 weeks.

• TSLP mAb monotherapy readout is expected six weeks after the bispecific; if efficacy is strong, out-licensing may be considered.