Celldex Therapeutics (NasdaqCM:CLDX) FY Conference Transcript

Summary of Celldex Therapeutics FY Conference Call Company Overview - Company: Celldex Therapeutics (NasdaqCM:CLDX) - Current Status: Late-stage company in phase three development for CSU program and planning to initiate phase three for CIndU program by the end of December 2025 [5][6] Key Programs and Developments - CSU Program: Expected to complete accrual by July 2026, with significant data anticipated [5] - CIndU Program: Phase three initiation planned by the end of December 2025 [5] - Prurigo Nodularis and Atopic Dermatitis: Phase two studies expected to read out in 2026 [5] - CDX-622: First bispecific program targeting stem cell factor (SCF) and TSLP, currently in healthy volunteer studies with multiple ascending dose (MAD) study ongoing [6][18] Scientific Insights - SCF-248 vs. SCF-220: CDX-622 targets the soluble form SCF-248, which is believed to be more relevant in inflammation contexts, potentially avoiding adverse effects associated with other KIT functions [8][10] - Tryptase Reduction: Current maximum inhibition achieved is 50%, with ongoing studies to determine if further reductions can be achieved [10][12] - Biomarkers: Skin punch biopsies are being performed to assess mast cell populations and their responses [11][13] Market and Commercial Strategy - Pricing Strategy: Anticipated pricing for Barzal is expected to be higher than $40,000 per year, potentially aligning with other immunology treatments priced around $59,000 [21][24] - Patient Population: Initial use of Barzal is expected to be among patients who are refractory to existing treatments, with a focus on both antihistamine refractory and biologically experienced populations [19][23] Future Considerations - Additional Indications: Potential exploration of food allergies, chronic urticaria, and allergic rhinitis as future indications for Barzal [32] - Partnership Opportunities: Considering partnerships outside the U.S. while focusing on self-commercialization in the U.S. [33] - Next Steps for CDX-622: Plans to conduct randomized phase 2 trials following the MAD data expected in Q3 2026 [34] Conclusion - Outlook: The company is optimistic about the upcoming data from CSU and other programs, indicating a bright future with multiple indications being explored [37]