Celldex Therapeutics (CLDX) investor relations material

Company overview and lead program

• Focuses on antibody therapies, with barzolvolimab as the lead asset targeting c-KIT, in phase III for CSU, symptomatic dermographism, and cold urticaria.

• Phase III CSU studies are among the largest ever, with nearly 2,000 patients; data expected later this year.

• Additional pipeline includes early-stage antibody and bispecific programs, notably CDX-622 targeting stem cell factor and TSLP.

Clinical trial design and differentiation

• Phase III CSU trials closely mirror phase II, with the addition of a loading dose to enhance KIT receptor saturation and rapid symptom reduction.

• Trials are powered for 90% to detect a 10-point UAS7 difference, with a focus on omalizumab-refractory patients and multiple secondary endpoints including itch, hive, and angioedema scores.

• Loading dose demonstrated rapid mast cell inhibition and maintained a strong safety profile in related PN studies.

Commercial strategy and market opportunity

• Barzolvolimab is positioned for both first-line advanced therapy in severe cases and as a preferred second-line option for patients unresponsive to other biologics.

• Efficacy is consistent regardless of prior biologic use or IgE levels, addressing significant unmet needs.

• Dermatologists are increasingly prescribing advanced therapies, presenting an opportunity for market expansion.