Celldex Therapeutics (CLDX) investor relations material

Leadership and strategic vision

• Experienced team with a track record of drug approvals and market success in immunology and inflammation.

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

Clinical pipeline and development milestones

• Barzolvolimab is advancing through multiple late-stage trials, including Phase 3 for chronic spontaneous urticaria (CSU), ColdU, and symptomatic dermographism (SD), with topline data expected Q4 2026.

• Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD) are fully enrolled, with data expected in summer and late 2026, respectively.

• CDX-622, a bispecific antibody targeting TSLP and SCF, is in Phase 1 with data expected Q3 2026 and a proof-of-mechanism asthma study initiated in January 2026.

Barzolvolimab clinical results and market opportunity

• Phase 2 data in CSU show rapid, profound, and durable efficacy, with up to 71% complete response at 52 weeks and sustained benefits 7 months post-treatment.

• Statistically significant improvements in ColdU and SD, with up to 53% and 58% complete response rates at Week 12, respectively.

• Barzolvolimab addresses a >10.5M patient population across mast cell-driven diseases, with significant headroom for advanced therapy growth in CSU.