Summary of Celldex Therapeutics Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 13, 2025 - **Key Speakers**: Anthony Marucci (CEO), Tibor Keler (CSO), Diane Young (CMO) Key Points Industry and Product Focus - The discussion primarily revolves around Celldex's ongoing clinical trials and data related to their drug Barzolvolimab, particularly in the context of Chronic Spontaneous Urticaria (CSU), Prurigo Nodularis (PN), and Atopic Dermatitis (AD) [3][4][34] Clinical Data Highlights - **CSU Phase Two Data**: - A 76-week phase two study showed a **41% complete response rate** seven months after stopping Barzolvolimab, indicating a durable remission [3][4] - This response rate is comparable to Xolair and higher than Dupixent, suggesting significant efficacy [3][4] - **Competitor Comparison**: - Xolair's effects diminish within weeks after cessation, while Ruxolitinib's long-term effects remain unclear. Dupixent shows modest efficacy [4][5] - **Mast Cell Dynamics**: - Data indicates that mast cells return to normal levels after treatment, but the long-term effects on disease modification are still being evaluated [6] Future Studies and Trials - **OLE (Open Label Extension)**: - The OLE is designed to gather additional follow-up data and explore retreatment options post-approval [7][8] - **Upcoming Trials**: - Ongoing phase two studies for PN and AD are expected to yield results in the second half of 2026. The PN trial involves 120 patients and focuses on itch reduction and lesion healing [17][21][34] - **CDX-622 Development**: - CDX-622, a bispecific targeting mast cells and TSLP, is in phase one trials with promising pharmacokinetics and no immunogenicity observed [28][29] Market Position and Strategy - **Competitive Landscape**: - Celldex aims to position Barzolvolimab as a competitive option against existing treatments like Dupixent, focusing on improving itch reduction and lesion healing [19][20] - **Pipeline Expansion**: - The company is considering various indications for CDX-622, including severe asthma and food allergies, based on ongoing data [31][32] Upcoming Catalysts - Key upcoming milestones include: - Phase three study initiation for cold urticaria and symptomatic dermographism by the end of 2025 - Phase two readouts for cold urticaria and symptomatic dermographism in Q1 2026 - Completion of CSU phase three accrual by summer 2026 - Data releases for AD and PN in the second half of 2026 [34][36] Enrollment and Study Progress - Enrollment for the ongoing EMBARK studies is proceeding well, with expectations to complete by summer 2026 [36][37] Additional Insights - The discussion emphasizes the importance of understanding mast cell roles in various conditions, which could lead to innovative treatment strategies and improved patient outcomes [20][22]