Aclaris Therapeutics (ACRS) Goldman Sachs 45th Annual Global Healthcare Conference summary

Company overview and recent restructuring

• Focuses on immunoinflammatory disorders with a pipeline including ATI-1777 (topical JAK), ATI-2138 (oral ITK/JAK3 inhibitor), and preclinical assets.

• Recent restructuring prioritized cost control, reduced headcount, and capital reallocation to key assets, especially the ITK/JAK3 program.

• Core strengths are a multidisciplinary team and a productive drug discovery platform, having advanced three assets to clinic in 2-3 years.

ATI-2138 program and differentiation

• ATI-2138 is a dual covalent ITK/JAK3 inhibitor, offering high selectivity and potency, with potential for broad T cell-driven disease impact.

• Demonstrates 2,000-fold selectivity over other JAK isoforms and strong efficacy in preclinical arthritis and colitis models.

• Phase I data showed dose-dependent, linear PK, good safety, and 50-90% inhibition of key cytokine readouts at 5-40 mg doses.

• More potent than ritlecitinib against both JAK3 (5x) and ITK (30-80x), enabling dual target engagement at clinical doses.

Clinical development strategy and market positioning

• Shifted lead indication from IBD to atopic dermatitis (AD) for faster, cost-efficient proof of concept; 12-week, open-label study in 15 patients planned.

• Targeting unmet need in AD by addressing both TH2 and TH1 pathways, aiming for efficacy and safety competitive with JAK inhibitors and biologics.

• Initial dose is 10 mg BID, with plans to study up to three doses over time.

• Broader franchise includes selective ITK and ITK-TXK inhibitors for additional indications like alopecia areata and vitiligo.