Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Core Insights - Celldex Therapeutics has made significant advancements in the development of barzolvolimab, particularly in treating mast cell-mediated diseases, with positive data reported from various clinical studies [2][4]. Clinical Development - Phase 3 studies for chronic spontaneous urticaria (CSU) are expected to begin in summer 2024, following positive Phase 2 data [1][4]. - The Phase 2 CSU study reported a statistically significant mean change in the weekly urticaria activity score (UAS7) at 12 weeks, demonstrating the drug's efficacy [4][5]. - Enrollment is nearing completion for the Phase 2 chronic inducible urticaria (CIndU) study, with data anticipated in the second half of 2024 [1][5]. - A Phase 2 study for prurigo nodularis (PN) is set to start in early 2024, building on positive Phase 1 data [1][6]. Financial Performance - As of December 31, 2023, the company reported cash, cash equivalents, and marketable securities totaling $423.6 million, a significant increase from $235.3 million at the end of Q3 2023 [8]. - Total revenue for Q4 2023 was $4.1 million, up from $1.6 million in Q4 2022, driven by increased services under manufacturing and research agreements [9]. - Research and development expenses rose to $30.4 million in Q4 2023, compared to $22.9 million in Q4 2022, primarily due to barzolvolimab clinical trials [9][10]. - The net loss for Q4 2023 was $43.3 million, or ($0.83) per share, compared to a net loss of $26.5 million, or ($0.56) per share, in Q4 2022 [12]. Pipeline and Future Plans - Celldex is expanding its barzolvolimab program into additional mast cell-mediated diseases and plans to introduce a bispecific antibody for inflammatory diseases [2][3]. - The company is also conducting a Phase 2 study in eosinophilic esophagitis (EoE), with protocol amendments to optimize dosing [6].