Company Overview and Strategy - Aclaris is developing therapeutic franchises to address gaps in important Immune and Inflammatory (I&I) diseases, focusing on patient-driven innovation [1, 8] - The company anticipates having three clinical programs in 2025 and four in 2026, with 2026 being an important year for potential inflection points [11] - Aclaris expects its cash runway to extend into the second half of 2028, supporting its preclinical and clinical development plans [11, 14] Pipeline and Programs - Aclaris's pipeline includes Bosakitug (ATI-045), a monoclonal antibody targeting TSLP, ATI-052, a bispecific antibody targeting both TSLP and IL-4Rα, and ATI-2138, an oral inhibitor of ITK/JAK3 [14] - ATI-2138's Phase 2a open-label trial in Atopic Dermatitis (AD) achieved primary and key secondary endpoints, validating ITK as a therapeutic target; at week 12, 63% of patients experienced a ≥4-point improvement in worst itch [14, 103] - Bosakitug is currently in a two-arm placebo-controlled Phase 2 trial, while ATI-052 is in a Phase 1a/1b SAD MAD program with ongoing dosing [14] - The company is developing next-generation ITK selective inhibitors and bispecific antibodies, with potential for IND submissions starting in 2026 [14, 61] Market Opportunity and Technology - The total addressable market for select Th1, Th2, and Th17-mediated diseases is projected to be in the range of $0 to $70 billion globally from 2028-2034 [16] - Aclaris is leveraging its KINect® Technology Platform to target approximately 60% of the Kinome, with the annual sales of kinase drugs in 2024 at $62.8 billion and a market opportunity of $88.6 billion in 2029 [28, 30] - The global healthcare spending in autoimmune diseases in 2024 was $215 billion, with a global AI disease therapeutics market opportunity of $396 billion by 2030 [38] - Multi-specific antibodies had annual sales of $12.6 billion in 2024, highlighting an opportunity for best-in-class multi-specific antibodies for autoimmune and inflammatory diseases [38]
Aclaris Therapeutics (NasdaqGS:ACRS) 2025 Earnings Call Presentation