Celldex Therapeutics (CLDX) investor relations material

Key clinical and operational highlights

• Phase III CSU study completed enrollment six months ahead of schedule, enrolling 1,939 patients across 43 countries and 500 sites, with strong participation from both dermatologists and allergists.

• Phase II and III studies in CSU and CIndU showed unprecedented efficacy, with up to 71% complete response at 52 weeks and 41% maintaining response at 76 weeks off drug.

• Loading dose added in phase III CSU to enhance early efficacy, with safety profile expected to remain consistent with prior studies.

• Retreatment in CIndU phase II demonstrated consistent efficacy and safety, supporting durability and repeatability of response.

• Phase III studies in cold urticaria and SD leverage learnings from prior trials, using similar endpoints and operational strategies.

Market positioning and commercial outlook

• Barzolvolimab targets severe angioedema and CSU patients as a potential frontline or advanced second-line therapy, especially for those not controlled on existing agents.

• Recent launches of Rhapsido and remibrutinib are seen as positive for the market, with barzolvolimab positioned to fill gaps in efficacy and durability.

• PN and CIndU are considered smaller but underserved markets, with potential for growth as diagnosis and awareness improve.

• Atopic dermatitis phase II study is enrolling all-comers, aiming for efficacy at least comparable to current standards, with a potential niche after DUPIXENT and before JAK inhibitors.

Forward-looking data and development milestones

• PN phase II data expected in summer, CSU phase III data in Q4, and atopic dermatitis phase II data by year-end.

• CDX-622 in phase I for asthma and healthy volunteers, with Q3 data readout planned for healthy volunteer study.

• Ongoing studies are powered to detect significant improvements over placebo, with high expectations for efficacy and safety replication from earlier phases.