On August 12, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter 2025 and provided a business update for its oncology clinical programs CB-010 and CB-011 with data disclosures on track for H2 2025 (Press release, Caribou Biosciences, AUG 12, 2025, View Source [SID1234655130]).

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"Caribou is advancing allogeneic CAR-T cell programs to deliver off-the-shelf therapies designed for rapid treatment and broad patient access," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "Our clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to generate encouraging Phase 1 results, reinforcing our conviction in the potential of these therapies. We remain on track to report robust datasets from both programs this year, which we expect to provide meaningful insights into the potential of our approach and the future of allogeneic CAR-T cell therapies."
Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou completed enrollment of the 20-patient confirmatory cohort using the Company’s partial HLA matching strategy in the ANTLER Phase 1 clinical trial for patients with second-line large B cell lymphoma (2L LBCL).
•To date, data continue to demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•Caribou completed planned enrollment for the dose escalation portion of the CaMMouflage Phase 1 clinical trial for patients with relapsed or refractory multiple myeloma (r/r MM).
•Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple active dose levels.

2025 anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
▪Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
▪Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data from its ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:

▪Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
▪Recommended dose(s) for expansion and plans for dose expansion.
Second quarter 2025 financial results
Cash, cash equivalents, and marketable securities: Caribou had $183.9 million in cash, cash equivalents, and marketable securities as of June 30, 2025, compared to $249.4 million as of December 31, 2024. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into H2 2027.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.7 million for the three months ended June 30, 2025, compared to $3.5 million for the same period in 2024.

R&D expenses: Research and development expenses were $27.7 million for the three months ended June 30, 2025, compared to $35.5 million for the same period in 2024. The decrease was primarily related to the previously announced strategic pipeline prioritization and related workforce reduction and lower costs associated with the ongoing CB-010 ANTLER and CB-011 CaMMouflage Phase 1 clinical trials.

G&A expenses: General and administrative expenses were $10.4 million for the three months ended June 30, 2025, compared to $11.5 million for the same period in 2024. The decrease was primarily due to reduced personnel-related expenses, including stock-based compensation, related to the previously announced strategic pipeline prioritization and related workforce reduction, lower patent prosecution and maintenance costs, and lower legal and other service related expenses. The decrease was partially offset by an increase in other facilities and allocated expenses.

Non-recurring, non-cash impairment charges: Non-recurring, non-cash impairment charges were $21.3 million for the three months ended June 30, 2025, and include charges related to the previously announced strategic pipeline prioritization and an impairment of the Company’s stock investment in a private company.

GAAP and non-GAAP net loss and net loss per share, basic and diluted: Caribou reported a net loss of $54.1 million, or $0.58 per share, basic and diluted, for the three months ended June 30, 2025, compared to $37.7 million, or $0.42 per share, basic and diluted, for the same period in 2024. Non-GAAP net loss for the three months ended June 30, 2025, excluding $21.3 million of non-cash impairment charges, was $32.8M, or $0.35 per share, basic and diluted.

About CB-010
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.