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]