Financial Performance - Total revenue for the third quarter of 2025 was $0.0 million, and $1.4 million for the nine months ended September 30, 2025, compared to $3.2 million and $5.8 million for the same periods in 2024, reflecting a decrease primarily due to reduced services under manufacturing and research agreements[13] - Net loss for the third quarter of 2025 was $67.0 million, or ($1.01) per share, compared to a net loss of $42.1 million, or ($0.64) per share, for the third quarter of 2024[16] - The net loss for the three months ended September 30, 2025, was $67.044 million, compared to a net loss of $42.121 million for the same period in 2024, indicating a 59% increase in losses[23] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $1.01, compared to $0.64 for the same period in 2024[24] Cash and Assets - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $583.2 million, down from $630.3 million as of June 30, 2025, primarily due to $48.6 million used in operating activities during the third quarter[12] - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $583.223 million, down from $725.281 million as of December 31, 2024[25] - Total assets decreased to $648.439 million as of September 30, 2025, from $792.340 million as of December 31, 2024[25] - Current liabilities increased to $46.465 million as of September 30, 2025, compared to $39.501 million as of December 31, 2024[25] - Stockholders' equity decreased to $598.363 million as of September 30, 2025, from $747.005 million as of December 31, 2024[25] Expenses - Research and development (R&D) expenses were $62.9 million in the third quarter of 2025, up from $45.3 million in the same quarter of 2024, driven by increased costs associated with barzolvolimab clinical trials[14] - General and administrative (G&A) expenses were $10.7 million in the third quarter of 2025, compared to $10.1 million in the same quarter of 2024, attributed to higher stock-based compensation and increased employee headcount[15] - Operating expenses for the three months ended September 30, 2025, were $73.617 million, up from $55.317 million in the same period in 2024, reflecting a 33% increase[23] - Research and development expenses for the three months ended September 30, 2025, were $62.931 million, compared to $45.263 million for the same period in 2024, marking a 39% increase[23] - Investment and other income for the three months ended September 30, 2025, was $6.573 million, down from $10.005 million in the same period in 2024, representing a 34% decrease[23] Clinical Trials and Future Plans - Barzolvolimab demonstrated a complete response in 71% of patients at 52 weeks in the Phase 2 study for Chronic Spontaneous Urticaria (CSU), with over 40% of patients maintaining a complete response at 76 weeks post-treatment[10] - In the Phase 2 study for Cold Urticaria (ColdU) and Symptomatic Dermographism (SD), 66% of patients achieved a complete response at 20 weeks, compared to 16% in the placebo group[10] - Celldex plans to initiate a global Phase 3 study in ColdU and SD in December 2025, following the positive results from earlier studies[7] - The company expects multiple data readouts throughout 2026, indicating ongoing progress across its pipeline[3] Cash Position - Celldex believes its cash position is sufficient to meet working capital requirements and fund planned operations through 2027[17]
Celldex Therapeutics(CLDX) - 2025 Q3 - Quarterly Results