Celldex Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Core Insights - Celldex Therapeutics reported significant progress in its clinical trials for barzolvolimab, demonstrating its potential as a transformative treatment for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [2][4][6] Clinical Development - Enrollment is ongoing in Phase 3 trials for CSU, with two trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to evaluate the efficacy and safety of barzolvolimab in patients who remain symptomatic despite antihistamine treatment [4] - A global Phase 3 program for CIndU is planned to initiate in 2025 [5] - Barzolvolimab met all primary and secondary endpoints in Phase 2 studies for both CSU and CIndU, with results showing high statistical significance [6] - Long-term data from the Phase 2 CSU study indicated a complete response rate of 71% at Week 52 for patients receiving 150 mg Q4W [7] - In the Phase 2 CIndU study, barzolvolimab was the first drug to show clinical benefit in cold urticaria, with complete response rates of 53.1% and 57.6% for cold urticaria and symptomatic dermographism, respectively [8] Pipeline Expansion - A Phase 2 study for eosinophilic esophagitis (EoE) is ongoing, with data expected in the second half of 2025 [9] - A Phase 2 study for prurigo nodularis (PN) is also in progress, targeting approximately 120 patients [10] - Atopic dermatitis (AD) has been selected as a new indication for barzolvolimab, with a Phase 2 study set to begin by the end of 2024 [11] - Celldex's first bispecific antibody, CDX-622, is expected to enter clinical trials by the end of 2024, targeting chronic inflammation pathways [12][13] Financial Performance - As of September 30, 2024, Celldex reported cash, cash equivalents, and marketable securities of $756 million, down from $802 million as of June 30, 2024, primarily due to operating cash usage of $55.3 million [15] - Total revenue for Q3 2024 was $3.2 million, an increase from $1.5 million in Q3 2023, attributed to enhanced services under manufacturing and research agreements [16] - Research and development expenses rose to $45.3 million in Q3 2024 from $34.5 million in Q3 2023, driven by increased clinical trial costs [17] - General and administrative expenses increased to $10.1 million in Q3 2024 from $8.2 million in Q3 2023, mainly due to higher stock-based compensation [18] - The net loss for Q3 2024 was $42.1 million, compared to a net loss of $38.3 million in Q3 2023 [19]