Core Insights - Celldex Therapeutics reported strong efficacy data for barzolvolimab in chronic urticarias, with ongoing Phase 3 studies in chronic spontaneous urticaria (CSU) and plans to initiate a Phase 3 program in chronic inducible urticaria (CIndU) in 2025 [2][7][12] - The company has initiated two new programs, including advancing barzolvolimab into atopic dermatitis and introducing a bispecific candidate, CDX-622, targeting inflammatory pathways [2][10] - Financial results showed a net loss of $47.1 million for Q4 2024, with total revenues of $1.2 million for the quarter and $7.0 million for the year, reflecting a decrease in revenue primarily due to reduced services under agreements [11][12][17] Pipeline Developments - Barzolvolimab is a humanized monoclonal antibody targeting the KIT receptor, crucial for mast cell activity, with significant results in Phase 2 studies for CSU and CIndU [3][6] - The Phase 3 program for CSU includes two trials enrolling approximately 915 patients each across 40 countries, aiming to establish the drug's efficacy and safety [7] - CDX-622, a bispecific antibody, is designed to neutralize TSLP and deplete mast cells, with a Phase 1 study in healthy volunteers initiated in November 2024 [10][13] Financial Performance - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $725.3 million, down from $756.0 million at the end of Q3 2024 [11][25] - Research and development expenses increased to $46.9 million for Q4 2024 and $163.6 million for the year, driven by clinical trial costs for barzolvolimab [14] - General and administrative expenses rose to $10.3 million for Q4 2024, attributed to higher stock-based compensation and commercial planning expenses [15]
Celldex Reports Fourth Quarter and Year End 2024 Financial Results and Provides Corporate Update