Aclaris Therapeutics (ACRS) investor relations material

Company overview and recent progress

• Focus on large and small molecule therapeutics in immunology and inflammation, with three clinical-stage assets and a fourth nearing IND submission later this year.

• Large molecule pipeline includes TSLP mAb (ATI-045) in phase II for atopic dermatitis (AD) and a bispecific construct (ATI-052) targeting TSLP and IL-4R, both with data readouts expected by year-end.

• Oral small molecule ATI-2138 is being positioned for a lead indication, supported by a full phase II-ready package and long-term toxicology data.

• Next-generation ITK inhibitor, engineered to remove JAK activity, is advancing toward IND in the second half of the year.

TSLP antibody program (ATI-045)

• Demonstrates 20x longer TSLP binding retention and superior potency compared to tezepelumab and other clinical candidates.

• Phase II-A open-label study showed 94% EASI response and 88% IGA 0/1, prompting advancement to a 96-subject, double-blind, placebo-controlled phase II trial with data expected by year-end.

• Dosing interval could extend to every 3 months due to a 23-day half-life and durable efficacy observed post-dosing.

• Stringent patient screening and image review processes are used to minimize placebo response and ensure accurate diagnosis.

• Success bar is set at achieving statistical significance and responder rates comparable to or exceeding Dupixent, with safety as a key differentiator.

Bispecific antibody program (ATI-052)

• Early phase I data show 100% target inhibition and a 26-day half-life, with potential for 2-3 month dosing intervals.

• Ongoing phase I-B studies in asthma and AD will inform phase II design, with expectations of a 10% improvement in responder rates over current standards.

• Immunogenicity data so far show no enhanced clearance or neutralization, with further analysis pending.

• Asthma is prioritized for phase II-B, leveraging mechanistic differentiation between TSLP and IL-4R for broad patient applicability.