Aclaris Therapeutics (ACRS) Status Update summary

Strategic Review, Transactions, and Corporate Transformation

• Completed a comprehensive strategic review, resulting in exclusive global license agreements with Biogen and Biosion for two biologics, BSI-045B and BSI-502, and the addition of key executives with extensive biologics and regulatory experience.

• Raised $80 million in financing led by Vivo Capital, with pro forma cash and equivalents of $213 million as of September 30, 2024, extending the cash runway into 2028.

• Management team enhanced with leaders experienced in biologics, drug development, and financial management.

• Financial advisors Leerink Partners and Cantor supported the transaction, with legal counsel from Cooley LLP, DLA Piper, and Morgan, Lewis & Bockius.

• Management to host a conference call to discuss the transaction and provide a corporate update.

Pipeline Expansion and Clinical Assets

• Pipeline now includes four programs: BSI-045B (anti-TSLP mAb, phase II), BSI-502 (bispecific TSLP/IL-4R mAb, IND-enabling), ATI-2138 (oral ITK/JAK3 inhibitor, phase IIa), and a next-generation ITK inhibitor advancing toward IND filing in 1H 2026.

• BSI-045B demonstrated high potency, long residence time, and strong efficacy in phase IIa atopic dermatitis trial, with 94% EASI-75, 65% EASI-90, and 88% IGA 0/1 at week 26.

• BSI-502, a bispecific antibody targeting TSLP and IL4R, shows superior potency in ex vivo studies and is positioned for respiratory and dermatologic indications, with IND submission planned for Q1 2025.

• ATI-2138 is a potent oral ITK/JAK3 inhibitor, showing 44x and 5x greater potency than ritlecitinib for ITK and JAK3, respectively, with phase IIa trial in atopic dermatitis underway and data expected in 1H 2025.

• Additional catalysts anticipated from BSI-045B development in China by a partner.

Clinical Data and Differentiation

• BSI-045B outperformed approved biologics in AD in phase IIa, with higher EASI-75 and EASI-90 rates compared to dupilumab, tralokinumab, and lebrikizumab.

• The molecule's long residence time and high affinity are believed to drive its durable efficacy, with effects persisting post-treatment.

• Safety profile for BSI-045B was favorable with low immunogenicity and no serious adverse events.

• The phase IIa study was open-label and not placebo-controlled, but the robust signal supports advancement to a larger, controlled phase IIb trial.

• BSI-502 exhibits greater cellular bioactivity on CCL17 release than the combination of tezepelumab and dupilumab.