Celldex Therapeutics (CLDX) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Key data highlights and clinical progress

• Presented positive phase 2 data for CSU and CIndU, both showing statistically significant efficacy and excellent safety, meeting all endpoints.

• Initiated global phase 3 studies in CSU and planning phase 3 for CIndU in 2025, with phase 2 meeting with FDA scheduled for 2025.

• 52-week CSU data showed up to 70% complete response, with deepening efficacy over time and favorable safety profile.

• Consistent efficacy observed across Xolair-naive, exposed, and refractory patients in CSU studies.

• CIndU phase 2 demonstrated significant results for both cold urticaria and symptomatic dermographism, with a large, underserved market opportunity estimated at up to 1.2 million patients.

Study design, timelines, and future catalysts

• CSU phase 3 studies are larger, include a loading dose, and are designed to provide statistical power for Xolair-refractory patients; enrollment expected to complete in two years.

• CIndU phase 3 program will be smaller, leveraging CSU safety data, with study design details to be finalized.

• EOE study uses 300mg monthly dosing, targeting mast cell depletion, with data expected in the second half of next year at a medical conference.

• PN and AD studies are ongoing, with AD positioned as a second-line therapy after Dupixent, enrolling patients with prior biologic exposure.

• CDX-622 healthy volunteer studies start next month, with therapeutic studies planned for the second half of 2025.

Competitive landscape and commercial strategy

• KIT inhibition seen as best-in-class approach for mast cell-driven diseases, with differentiated safety and efficacy compared to other modalities.

• No black box warning anticipated for KIT mechanism; only one confirmed anaphylaxis in over 500 patients.

• Commercial positioning aims to follow Xolair, targeting both allergists and dermatologists, with pricing expected in the $50,000 range.

• CIndU market is significantly larger than previously thought, with no approved therapies, representing a major growth opportunity.

• Additional indications under consideration, especially those involving itch, based on ongoing data review.