On May 7, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the first quarter of 2026 and provided a business update.
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"We are pleased to have aligned with the FDA on the pivotal ANTLER-3 trial design for vispa-cel," said Rachel Haurwitz, PhD, president and CEO of Caribou. "Vispa-cel continues to demonstrate a differentiated profile as an off-the-shelf CAR-T cell therapy with a well-tolerated safety profile and robust response rates resulting in long-term durable outcomes in high-risk patients. Our pivotal trial will compare vispa-cel to standard-of-care regimens that lack curative intent yet are often the only options available to the 75% of second-line large B cell lymphoma patients who do not receive autologous CAR-T cell therapy. We look forward to reporting longer follow up on the phase 1 data for vispa-cel at an upcoming medical conference this year as well as sharing longer follow up on dose escalation and initial dose expansion data for CB-011 in patients with relapsed or refractory multiple myeloma in 2026."
Clinical highlights
Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•Caribou reached alignment with the U.S. Food and Drug Administration (FDA) regarding the vispa-cel pivotal trial design following interactions to date with the agency enabled by the Regenerative Medicine Advanced Therapy (RMAT) designation for vispa-cel.
•ANTLER-3 is expected to be a randomized, controlled pivotal phase 3 clinical trial enrolling approximately 250 CD19-naïve second-line (2L) large B cell lymphoma (LBCL) patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy.
◦Patients in the investigational arm will receive a single dose of 80×106 vispa-cel CAR-T cells following lymphodepletion.
◦Patients in the comparator arm will be treated with an investigator’s choice of standard-of-care regimen, such as: polatuzumab vedotin (Pola), bendamustine, rituximab (R) (Pola-BR); R, gemcitabine, and oxaliplatin (R-GemOx); Pola-R-GemOx (Pola-RGO); or tafasitamab and lenalidomide. Crossover to the vispa-cel arm is permitted after progressive disease.
◦The primary endpoint is progression-free survival (PFS).
◦Clinical trial sites will include both academic and sophisticated community centers in the United States and globally.
•Clinical data disclosed in November 2025 and in a poster presented at the 2026 Tandem Meetings highlight vispa-cel’s potential — as an immediately available, off-the-shelf CAR-T cell therapy manufactured at scale — to help meet the needs of the 75% of 2L LBCL patients who do not receive autologous CAR-T cell therapy.
•Longer follow up ANTLER phase 1 clinical trial data will be presented at a medical conference in 2026.
CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•On March 31, 2026, Caribou announced the FDA granted RMAT designation to CB-011 for r/r MM.
•RMAT was granted based on promising initial clinical data, including previously disclosed data on the 12-patient, BCMA-naïve r/r MM patient cohort treated at the recommended dose for expansion: 92% overall response rate, 75% complete response (CR) or stringent CR rate, and 91% minimal residual disease negativity. These data highlight CB-011’s potential as the best-in-class allogeneic CAR-T cell therapy for patients with r/r MM.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial and expects to report longer follow up on dose escalation data and initial dose expansion data in 2026.
Upcoming events
•BofA Securities 2026 Health Care Conference, Las Vegas, NV
May 13, 2026, fireside chat at 8:40 am PT
Webcast
First quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $2.4 million for the three months ended March 31, 2026, unchanged from the same period in 2025.
R&D expenses: Research and development expenses were $20.6 million for the three months ended March 31, 2026, compared to $35.5 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities, expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025, facilities and allocated expenses, and expenses related to licenses, sublicensing revenue, and milestones.
G&A expenses: General and administrative expenses were $8.1 million for the three months ended March 31, 2026, compared to $9.7 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025 and lower legal expenses.
Cash, cash equivalents, and marketable securities: Caribou had $118.6 million in cash, cash equivalents, and marketable securities as of March 31, 2026, compared to $142.8 million as of December 31, 2025. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. The Company is exploring multiple options to fully fund its planned vispa-cel pivotal trial.
About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel 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 vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.
About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a September 2, 2025, data cutoff date, 84 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40×106, 80×106, and 120×106 CAR-T cell CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million (80×106) CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.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). 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. The FDA granted CB-011 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for r/r MM.
About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial is evaluating safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.
(Press release, Caribou Biosciences, MAY 7, 2026, View Source [SID1234665313])