Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $27.5 million, compared to a net loss of $34.7 million for the same period in 2024[104]. - The accumulated deficit as of September 30, 2025, was $570.0 million, indicating ongoing financial challenges[104]. - The net loss for the nine months ended September 30, 2025, was $121.6 million, compared to a net loss of $113.6 million in the same period of 2024[128]. - Total operating expenses for the nine months ended September 30, 2025, were $127.1 million, down from $135.7 million in 2024, a decrease of $8.5 million[128]. - Total other income decreased by $15.9 million for the nine months ended September 30, 2025, compared to the same period in 2024[134]. - Cash used in operating activities was $90.2 million for the nine months ended September 30, 2025, compared to $102.7 million for the same period in 2024, reflecting a decrease of $12.6 million[152]. - Net cash provided by investing activities was $84.3 million for the nine months ended September 30, 2025, compared to $70.7 million for the same period in 2024, an increase of $13.6 million[153]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $159.2 million[138]. - The company raised an aggregate net proceeds of $841.3 million since inception through various financing activities[137]. - The company expects existing cash and marketable securities to be sufficient to fund operations for at least the next 12 months[144]. Clinical Development - The company has advanced two clinical-stage allogeneic CAR-T cell therapies: vispa-cel for relapsed or refractory large B cell lymphoma and CB-011 for relapsed or refractory multiple myeloma[95]. - In the ANTLER phase 1 clinical trial, vispa-cel demonstrated an 82% overall response rate and a 64% complete response rate in a confirmatory cohort of 22 patients[97]. - The optimized profile cohort of vispa-cel, which included 35 patients, achieved an 86% overall response rate and a 63% complete response rate[97]. - CB-011 achieved a 92% overall response rate and a 75% complete response rate in a cohort of 12 BCMA-naïve patients[99]. - The company anticipates initiating a pivotal phase 3 clinical trial for vispa-cel involving approximately 250 patients who are ineligible for transplant[98]. - The successful development of CAR-T product candidates remains highly uncertain, impacting the timeline and costs associated with their commercialization[115]. Expenses and Cost Management - Total research and development expenses decreased to $22.4 million in Q3 2025 from $30.4 million in Q3 2024, a reduction of $8.0 million[123]. - General and administrative expenses decreased to $9.2 million in Q3 2025 from $9.8 million in Q3 2024, a decrease of $0.6 million[124]. - Research and development expenses for the nine months ended September 30, 2025, were $85.6 million, down from $99.7 million in 2024, a reduction of $14.1 million[128]. - General and administrative expenses decreased by $6.6 million to $29.3 million for the nine months ended September 30, 2025, from $36.0 million for the same period in 2024[132]. - Impairment charges totaling $10.0 million were recognized for leasehold improvements and lab equipment in the second quarter of 2025[101]. - Impairment charges of $12.2 million were recorded for the nine months ended September 30, 2025, related to strategic pipeline prioritization[128]. - The company recorded cash severance costs of $1.8 million due to a workforce reduction of 32%[100]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[106]. - Licensing and collaboration revenue for Q3 2025 was $2.2 million, an increase of $0.2 million from $2.0 million in Q3 2024[121]. - For the nine months ended September 30, 2025, licensing and collaboration revenue decreased to $7.2 million from $7.9 million in the same period of 2024, a decline of $0.7 million[129]. - Total licensing and collaboration revenue decreased by $699,000 to $7.2 million for the nine months ended September 30, 2025, compared to $7.9 million for the same period in 2024[130]. Market Risk - There have been no material changes to market risk during the nine months ended September 30, 2025[158]. - For a detailed discussion of market risk exposure, refer to the Form 10-K section titled "Quantitative and Qualitative Disclosures About Market Risk"[158].
Caribou Biosciences(CRBU) - 2025 Q3 - Quarterly Report