Celldex Therapeutics (CLDX) investor relations material

Recent clinical data and competitive landscape

• 76-week phase II data in CSU showed a 41% complete response rate seven months post-treatment, indicating unprecedented durability compared to competitors like Xolair and Dupixent.

• Mast cells return to normal levels post-treatment, but disease modification is suggested by sustained response.

• Ongoing phase III studies (EMBARK-CSU1 and CSU2) are enrolling, with primary endpoint data expected as early as the first half of next year.

• Study design allows for statistical analysis in Xolair-refractory populations and robust safety data.

Future study directions and dosing strategies

• Open-label extension (OLE) studies will explore retreatment and alternative dosing schedules, potentially including maintenance or less frequent dosing.

• Phase IV studies may investigate real-world dosing regimens post-approval.

• No special baseline monitoring for hypersensitivity beyond standard urticaria inclusion.

Pipeline updates: PN, AD, and CDX-622

• Phase II studies in prurigo nodularis (PN) and atopic dermatitis (AD) are ongoing, with data expected in the second half of next year.

• PN trial is placebo-controlled, testing two regimens, with endpoints focused on itch reduction and lesion healing.

• AD phase II tests two regimens with a 16-week primary endpoint, focusing on non-histaminergic itch and inflammation.

• CDX-622, a bispecific targeting stem cell factor and TSLP, showed promising phase I data with no immunogenicity and effective mast cell targeting.

• Multiple ascending dose and subcutaneous formulation studies are ongoing, with future directions including asthma, COPD, chronic cough, and food allergy.