Celldex Therapeutics (CLDX) Corporate presentation summary

Leadership and strategic focus

• Experienced team with a track record in antibody development and drug approvals, especially in immunology and inflammation.

• Focus on pioneering therapies for mast cell-driven diseases, targeting significant unmet needs.

Clinical pipeline and programs

• Barzolvolimab is a first-in-class KIT antagonist mAb with broad potential, advancing through multiple late-stage trials for CSU, ColdU, SD, and AD.

• Phase 3 CSU program completed enrollment ahead of schedule; topline data expected Sept/Oct 2026, with BLA filing planned for 2027.

• Phase 3 ColdU/SD study initiated Dec 2025; Phase 2 AD study fully enrolled with data expected late 2026.

• CDX-622, a novel bispecific antibody targeting TSLP and mast cells, showed positive Phase 1 data and is in a proof-of-mechanism asthma study.

Market opportunity and unmet need

• Over 10.4 million people are affected by mast cell-driven diseases with high unmet need.

• CSU market is underpenetrated, with only about one-third of 1.8M US patients currently diagnosed and treated.

• Advanced therapy adoption is expected to accelerate, with barzolvolimab positioned for both first- and second-line advanced therapy markets.