Celldex Therapeutics (CLDX) Evercore ISI 8th Annual HealthCONx Conference summary

Pipeline and clinical development updates

• Phase III development ongoing for CSU, with accrual expected to complete by July 2026; phase III in CIndU to start by end of month.

• Phase II studies in prurigo nodularis and atopic dermatitis expected to read out in 2026.

• CDX-622, a bispecific targeting SCF and TSLP, is in healthy volunteer studies; multiple ascending dose (MAD) data expected Q3 2026.

• Subcutaneous dosing and proof-of-mechanism study in severe asthma planned for 2026.

• Additional allergic disease indications, including food allergy and allergic rhinitis, are under consideration.

Scientific rationale and biomarker strategy

• CDX-622 targets soluble SCF-248, aiming to inhibit mast cells while minimizing KIT-related side effects.

• Maximum 50% tryptase reduction observed in SAD; further reduction possible with MAD.

• Skin punch biopsies and preclinical models will help identify mast cell populations most affected.

• TSLP biomarker data to be gathered in an upcoming asthma study.

• Each indication may require tailored biomarker benchmarks for optimal clinical activity.

Commercial and market access considerations

• Barzol expected to launch behind omalizumab but could be used across antihistamine-refractory and biologic-experienced populations.

• Pricing anticipated to exceed $59,000 annually, with payer discussions to determine final premium.

• U.S. patient pool estimated to be 40% higher than 80,000 omalizumab users.

• Market access and commercial teams being built to support launch and expansion.

• Partnership opportunities considered, especially for ex-U.S. markets.