Aclaris Therapeutics (ACRS) investor relations material

Pipeline overview and clinical progress

• Three clinical assets are advancing, with a fourth approaching IND submission in the second half of the year.

• Two phase I-B studies for ATI-052 bispecific (TSLP/IL-4R) are ongoing, with data expected in early second half of the year.

• A phase II study for TSLP mAb in moderate to severe atopic dermatitis will read out by year-end.

• ATI-2138 (oral ITK/JAK3) will begin a lichen planus study in the second half of the year.

• Next-gen ITK, engineered to remove JAK3, is moving toward IND in the second half.

Competitive landscape and bispecific strategy

• Recent competitor data (Pfizer, Sanofi, J&J) inform confidence in the bispecific approach targeting IL-4R and TSLP.

• Pfizer’s tri-specific data is most relevant, as it targets the same three inflammatory mediators.

• Preclinical evidence supports additive and synergistic effects of dual pathway targeting.

Clinical data and expectations for ATI-052

• SAD/MAD studies in healthy volunteers showed strong PK, with potential for dosing every three months.

• Pharmacodynamics demonstrated complete inhibition of TSLP and IL-4R pathways for extended periods.

• Low immunogenicity observed, with half-life over three times longer than Dupixent.

• Phase I-B studies in atopic dermatitis and asthma will focus on additive/synergistic efficacy and biomarker improvements.