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

Key program updates and clinical progress

• Enrollment completed for CSU EMBARQ program and phase III CIndU study, with rapid global accrual driven by strong investigator and patient enthusiasm.

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

• Phase II PN trial completed enrollment (140 patients), with data expected later this year; phase II AD trial also fully enrolled, with data readout anticipated late this year.

• Phase Ia bispecific (stem cell factor/TSLP) program showed positive SAD data; multiple ascending dose and subcutaneous data expected this summer.

• Proof-of-mechanism asthma study for the bispecific has started, focusing on lung inflammation and mast cell activity.

Clinical trial design and differentiation

• CSU and CIndU studies use subcutaneous dosing with in-office administration; commercial plans include pre-filled syringes and auto-injectors within the first year.

• PN and AD studies use higher doses and loading doses to address disease severity and optimize efficacy.

• PN trial endpoints include both itch reduction and skin clearance, reflecting patient priorities.

• AD trial uses percent decrease in peak pruritus at 16 weeks as primary endpoint, with skin clearance as secondary.

• Sperm study in healthy men is ongoing, with results expected by BLA filing; reversibility of sperm effects is anticipated.

Market positioning and commercial strategy

• Barzolvolimab expected to enter as frontline advanced therapy for severe CSU/angioedema and as second-line after other advanced therapies.

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

• Pricing strategy under evaluation, with intent to position at a premium to current advanced therapies.

• Real-world use expected to evolve, with phase IV studies and physician-driven dosing adjustments anticipated.

• Differentiation in PN and AD based on dual efficacy in itch and skin clearance, and potential for use before JAK inhibitors in AD.