CRBU

-- Achieved alignment with FDA on pivotal ANTLER-3 trial design for vispa-cel in 2L LBCL -- -- Longer follow up on vispa-cel phase 1 clinical data expected at medical conference in 2026 -- -- CaMMouflage phase 1 trial evaluating CB-011 continues to enroll r/r MM patients, dose escalation and expansion clinical data updates expected in 2026 -- BERKELEY, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the first quarter of 2026 and provided a business update. “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 s...

BERKELEY, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for fourth quarter and full year 2025 and provided an overview of recent corporate highlights. “2025 was a year of strong execution for Caribou as we advance two potentially best-in-class allogeneic CAR-T cell therapy programs,” said Rachel Haurwitz, PhD, Caribou’s president and CEO. “The vispa-cel ANTLER phase 1 data in second-line LBCL patients demonstrated efficacy and durability on par with autologous CAR-T therapy and solidified our confidence that this program is delivering on the promise of an off-the-shelf CAR-T cell therapy with speed, scalability, and access. We continue to engage with the FDA on the pivotal trial design and look forward to reporting longer follow up on the phase 1 data later this year. In addition, we initiated dose expansion of the CB-011 CaMMouflage phase 1 clinical trial for patients with multiple myeloma and look forward to sharing initial dose expansion data and longer follow-up on dose escalation data later this year.” 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 On February 5, 2026, Caribou presented a poster at the 2026 Tandem Meetings that included the clinical data disclosed in November 2025 as well as new supportive translational data that demonstrate vispa-cel drives outcomes that are on par with autologous CAR-T cell therapies. These data highlight vispa-cel’s potential as the best-in-class allogeneic CAR-T cell therapy for second-line (2L) large B cell lymphoma (LBCL). Caribou is in ongoing engagement with the FDA regarding the design of the pivotal trial for vispa-cel in 2L LBCL. Longer follow up from the ANTLER phase 1 clinical trial data is expected 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 February 7, 2026, Caribou delivered an oral presentation at the 2026 Tandem Meetings that included the clinical data disclosed in November 2025 as well as new supportive translational data that correlate CAR-T cell expansion with deep, durable responses and support the regim...

Vispa-cel (CB-010) ANTLER phase 1 data demonstrate efficacy and durability on par with autologous CAR-T cell therapy and safety allows for outpatient use, highlighting its potential as a best-in-class allogeneic CAR-T cell therapy for LBCL CB-011 CaMMouflage phase 1 data demonstrate deep, durable responses and manageable safety, highlighting its potential as a best-in-class allogeneic CAR-T cell therapy for r/r multiple myeloma $159.2 million in cash, cash equivalents, and marketable securities as of September 30, 2025 BERKELEY, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the third quarter 2025 and provided an overview of recent corporate highlights. “We were thrilled to recently share positive clinical data from both our off-the-shelf CAR-T cell therapy programs, vispa-cel for second-line large B cell lymphoma and CB-011 for relapsed or refractory multiple myeloma. These results represent a defining moment for our company and the field of allogeneic CAR-T cell therapy,” said Rachel Haurwitz, PhD, Caribou’s president and CEO. “As we advance both programs, we are committed to delivering on the promise of off-the-shelf cell therapies – offering rapid treatment, scalable manufacturing, and the possibility of broad patient access.” 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 On November 3, 2025, Caribou announced positive data from the ANTLER phase 1 trial demonstrating efficacy and durability on par with autologous CAR-T cell therapies in the confirmatory cohort (N=22) as well as in patients who received vispa-cel with an optimized profile (N=35). These data highlight vispa-cel’s potential as the best-in-class allogeneic CAR-T cell therapy for second-line (2L) large B cell lymphoma (LBCL). As of the September 29, 2025, efficacy data cutoff date, the efficacy data for the confirmatory cohort with partial HLA matching (≥4 HLA matches; N=22) included: 82% overall response rate (ORR), 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months. The median follow up for the confirmatory cohort was 6.0 months. The Company leveraged its l...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An “off-the-shelf” cancer cell therapy developed by Caribou Biosciences induced responses in more than 80% of enrollees in an early-stage trial in lymphoma, similar to the response rates seen with personalized treatments manufactured from patients’ own immune cells, the company said Monday. The trial data will support plans by Caribou to run a Phase 3 trial that will evaluate its treatment’s impact on survival and report results in 2026. The results offer the chance at a turnaround for Caribou, which initially reported disappointing findings but has since refined its strategy by using donor cells more compatible with patients’ immune systems. Caribou has twice cut staff over the last two years to extend its cash reserves, and decided against pursuing autoimmune cell therapy as many of its peers have done. Company shares rose by as much as 40% in Monday morning trading before settling into a smaller double-digit gains. If successful, donor-derived or “allogeneic” cell therapies could prove attractive to patients and physicians by reducing the complexity and waiting times involved in making treatments out of a person’s immune cells. But many companies have tried to prove the technology could yield a more convenient alternative to these “autologous” treatments, only to see their products underwhelm in clinical testing. Caribou believes it may have found an answer, though. By “matching” proteins called human leukocyte antigens, or HLAs, on donor cells to the patients in its trials, Caribou hopes that its treatments won’t be shut down by the immune system. The data disclosed Monday are the first evidence in support of that theory. The data came from two groups of enrollees in a trial called Antler, which tested the treatment, called vispacabtagene regedleucel or vispa-cel, in people whose diffuse large B-cell lymphoma resisted first-line treatment or returned afterward. As of a Sept. 2 data cutoff, 82% of people with four or more “matched” HLAs responded, 64% went into total remission, and 51% of them lived 12 months without their disease progressing. A second cohort that got “optimized” CAR-T cells had similar results. In that study cohort, 86% responded, 63% had a complete remission, and 53% lived 12 months without di...

-- Two robust clinical datasets from CB-010 and CB-011 expected to be disclosed in H2 2025 -- -- $184 million in cash, cash equivalents, and marketable securities expected to fund the Company’s current operating plan into H2 2027 -- BERKELEY, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today 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. “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...

-- Two robust clinical datasets from CB-010 and CB-011 expected to be disclosed in H2 2025 -- -- $212.5 million in cash, cash equivalents, and marketable securities expected to fund the Company’s current operating plan into H2 2027 -- BERKELEY, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the first quarter 2025 and provided a business update for its lead oncology clinical programs CB-010 and CB-011 with data disclosure for each planned for H2 2025. “Caribou’s two lead Phase 1 clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to demonstrate encouraging efficacy and have the potential to benefit individuals living with hematologic malignancies,” said Rachel Haurwitz, PhD, Caribou’s president and CEO. “We look forward to disclosing two robust clinical datasets from these programs in the second half of this year as we focus on our goal to deliver these off-the-shelf allogeneic CAR-T cell therapies that offer the potential for broad access and rapid availability to both patients and healthcare systems.” Clinical highlightsCB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma Caribou is enrolling a 20-patient confirmatory cohort using the Company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL) patients. In H2 2025, Caribou expects to present data from this cohort with at least six months of follow up for the majority of patients. To date, data 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. Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy. CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma In 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 dose levels following a lymphodepletion regimen that includes...

Wall Street expects a year-over-year increase in earnings on higher revenues when Clearside Biomedical, Inc. (CLSD) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.12 per share in its upcoming report, which represents a year-over-year change of +29.4%. Revenues are expected to be $0.26 million, up 13% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat...

The market expects Caribou Biosciences, Inc. (CRBU) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.43 per share in its upcoming report, which represents a year-over-year change of +6.5%. Revenues are expected to be $2.5 million, up 2.9% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.35% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a stron...