Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 11, 2025 - **Key Executives Present**: Tibor Keler (Chief Scientific Officer), Diane Young (Chief Medical Officer), Sarah Cavanaugh (SVP Corporate Affairs) Key Industry Insights - **Urticaria Programs**: 2025 has been a significant year for Celldex, particularly with advancements in their urticaria programs, including chronic spontaneous urticaria (CSU) and inducible urticaria [2][3] - **Data Presentation**: The company presented 76-week data from the CSU program, showcasing high efficacy and off-treatment durability, with a 41% complete response rate seven months post-treatment [5][6] - **Phase Three Studies**: Ongoing phase three studies in CSU and a new phase three study for inducible urticaria set to begin in December [2][10] Core Product Insights - **Barzolimab**: The drug has shown unprecedented off-treatment durability compared to existing treatments like Xolair and Dupixent, which typically see symptom recurrence shortly after discontinuation [6][8] - **Safety Profile**: The safety data from the 76-week study indicates that barzolimab is well tolerated, with mild and reversible side effects [8][9] Pipeline Developments - **CDX-622 Program**: Recent data from the CDX-622 program indicates a promising future for 2026, with a focus on targeting both TSLP and stem cell factor [3][36] - **Inducible Urticaria Study**: The phase two study for inducible urticaria reported that about two-thirds of cold urticaria patients achieved a complete response at 20 weeks [15][16] - **Future Studies**: Plans for phase two studies in prurigo nodularis (PN) and atopic dermatitis (AD) are underway, with expectations for data in the second half of next year [25][26][31] Financial Position - **Cash Position**: The company reported a cash position of $583.2 million, which is expected to fund operations through 2027 [48][49] Competitive Landscape - **Market Dynamics**: The entry of competitors like Novartis with Remibrutinib is expected to expand the market for CSU treatments, which Celldex believes positions barzolimab favorably within this growing market [47] Additional Considerations - **Future Indications**: Celldex is exploring additional indications related to itch and other allergic conditions, leveraging the unique properties of their bispecific antibody portfolio [32][34][45] - **Biomarker Strategy**: The company plans to utilize biomarkers to assess the efficacy of their treatments, particularly in asthma studies [46] This summary encapsulates the key points discussed during the conference call, highlighting the advancements, pipeline developments, and strategic positioning of Celldex Therapeutics in the biopharmaceutical industry.