Celldex Therapeutics (CLDX) TD Cowen 46th Annual Health Care Conference summary

Key program updates and clinical trial progress

• Enrollment completed ahead of schedule for CSU EMBARQ program and phase III CIndU study, reflecting strong global interest and enthusiasm among investigators and patients.

• Phase III CSU studies are 90% powered to detect a 10-point difference in UAS7, including both overall and omalizumab-refractory subgroups, with primary endpoint at 12 weeks and a 52-week study duration.

• Phase II prurigo nodularis (PN) and atopic dermatitis (AD) studies have completed enrollment, with PN data expected in summer and AD data later in the year.

• CIndU phase III study uses a single dose regimen to optimize accrual, with a higher loading dose for faster onset; CIndU remains underdiagnosed but is gaining attention.

• Stem cell factor/TSLP bispecific phase I progressing, with multiple ascending dose and subcutaneous data expected in Q3; asthma proof-of-mechanism study underway.

Clinical insights and differentiation

• Phase II CSU data showed high and deepening response rates, with 51% complete response at 12 weeks and 71% at 52 weeks, outperforming competitors.

• Durable activity attributed to profound mast cell suppression, with slow disease recurrence after therapy cessation.

• PN and AD studies focus on both itch reduction and skin clearance, aiming for rapid and comprehensive patient benefit.

• Barzolvolimab positioned for frontline use in severe CSU/angioedema and as a second-line advanced therapy after other biologics.

• Subcutaneous administration planned for commercial launch, with pre-filled syringes in-office and self-injectable auto-injector targeted within the first year.

Safety, monitoring, and commercial strategy

• Neutropenia events in trials have been mild and reversible, with no infection association; routine monitoring not deemed necessary.

• Sperm study in healthy men is ongoing, with results expected in time for BLA filing; prior data indicate reversible effects on sperm maturation.

• Pricing strategy under evaluation, aiming for a premium above current market leaders like Dupixent and Rinvoq.

• Phase IV studies may explore longer dosing intervals and alternative regimens post-approval.

• Market expected to expand as new therapies drive increased diagnosis and treatment, similar to trends in psoriasis and rheumatoid arthritis.