RankAlpha logo
Back to Rankings

CRBU

Caribou BiosciencesF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
10
Stored
Transcripts
0
Recent loaded
Latest report
2026-08-13
Investor release

Document history

Earnings documents stored for CRBU.

10 shown
Investor releaseQuarter not tagged2026-08-13

Caribou Biosciences Reports Second Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
-- ANTLER phase 1 data presented at EHA 2026 reinforce vispa-cel safety, efficacy, and durability are on par with approved autologous CAR-T cell therapies and that vispa-cel has the potential to overcome access barriers for patients with 2L LBCL -- -- CaMMouflage dose escalation phase 1 data presented at EHA 2026 demonstrate single dose of CB-011 produced deep, durable responses in high-risk, late-line BCMA-naïve r/r MM patients; initial dose expansion data in BCMA-naïve and BCMA-exposed patients expected in H2 2026 -- BERKELEY, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the second quarter of 2026 and provided a business update. "At Caribou, we are redefining what patients and physicians should expect from allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, president and CEO of Caribou. "The data presented at EHA 2026 continue to demonstrate that a single dose of vispa-cel can produce durable responses on par with autologous CAR-T cell therapies in patients with second-line large B cell lymphoma, and a single dose of CB-011 results in deep, durable responses in high-risk patients with relapsed or refractory multiple myeloma. With our off-the-shelf approach, these programs have the potential to dramatically expand CAR-T cell therapy access for patients." 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 In June, long-term follow-up clinical data from the ANTLER phase 1 clinical trial were presented at the 2026 European Hematology Association (EHA) Annual Meeting. Data presented reinforced vispa-cel is the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line (2L) large B cell lymphoma (LBCL). Efficacy and safety data in 2L LBCL patients who had received a single dose of 80 million optimized vispa-cel CAR-T cells (N=27) included: Optimized vispa-cel is defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen (HLA) alleles between patient and donor. The 27-patient subgroup best represents the treatment regimen and patient…Read full document

-- ANTLER phase 1 data presented at EHA 2026 reinforce vispa-cel safety, efficacy, and durability are on par with approved autologous CAR-T cell therapies and that vispa-cel has the potential to overcome access barriers for patients with 2L LBCL -- -- CaMMouflage dose escalation phase 1 data presented at EHA 2026 demonstrate single dose of CB-011 produced deep, durable responses in high-risk, late-line BCMA-naïve r/r MM patients; initial dose expansion data in BCMA-naïve and BCMA-exposed patients expected in H2 2026 -- BERKELEY, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the second quarter of 2026 and provided a business update. "At Caribou, we are redefining what patients and physicians should expect from allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, president and CEO of Caribou. "The data presented at EHA 2026 continue to demonstrate that a single dose of vispa-cel can produce durable responses on par with autologous CAR-T cell therapies in patients with second-line large B cell lymphoma, and a single dose of CB-011 results in deep, durable responses in high-risk patients with relapsed or refractory multiple myeloma. With our off-the-shelf approach, these programs have the potential to dramatically expand CAR-T cell therapy access for patients." 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 In June, long-term follow-up clinical data from the ANTLER phase 1 clinical trial were presented at the 2026 European Hematology Association (EHA) Annual Meeting. Data presented reinforced vispa-cel is the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line (2L) large B cell lymphoma (LBCL). Efficacy and safety data in 2L LBCL patients who had received a single dose of 80 million optimized vispa-cel CAR-T cells (N=27) included: Optimized vispa-cel is defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen (HLA) alleles between patient and donor. The 27-patient subgroup best represents the treatment regimen and patient population for Caribou's planned ANTLER-3 pivotal phase 3 clinical trial. Caribou previously reached alignment with the U.S. Food and Drug Administration (FDA) regarding its planned ANTLER-3 pivotal phase 3 clinical trial design, which is expected to be a randomized, controlled clinical trial enrolling approximately 250 CD19-naïve 2L 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 urgent need for therapy. CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM) In June, longer follow-up dose escalation clinical data from the CaMMouflage phase 1 clinical trial were presented at the 2026 EHA Annual Meeting. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Twelve BCMA-naïve patients were treated with the recommended dose for expansion (RDE) of 450 million CB-011 CAR-T cells after lymphodepletion. Efficacy and safety data for this cohort included: Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a CR following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date. Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial. In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation. Second quarter 2026 financial resultsLicensing and other third-party revenue: Revenue from licensing and other third-party agreements was $1.5 million for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025. R&D expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2026, compared to $27.7 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 $7.9 million for the three months ended June 30, 2026, compared to $10.4 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; lower legal expenses; other service-related expenses; and other facilities and allocated expenses. GAAP net loss and net loss per share, basic and diluted: Caribou reported a GAAP net loss of $24.3 million, or $0.24 per share, basic and diluted, for the three months ended June 30, 2026, compared to $54.1 million, or $0.58 per share, basic and diluted, for the same period in 2025, which included $21.3 million in non-cash impairment charges. Cash, cash equivalents, and marketable securities: Caribou had $113.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026, compared to $142.8 million as of December 31, 2025. Caribou now expects that 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 ANTLER-3 pivotal phase 3 clinical trial for vispa-cel, to the end of 2027. Caribou is exploring multiple options to fully fund its planned ANTLER-3 clinical 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. Eighty-five 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, 80, or 120 million 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. Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Six 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-011CB-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-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM. About the CaMMouflage phase 1 clinical trialThe 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. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 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. About Caribou Biosciences, Inc.Caribou is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Caribou’s chRDNA genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on vispacabtagene regedleucel (vispa-cel) and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the Company @CaribouBio and visit www.cariboubio.com. Forward-looking statements and important information This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, any statements regarding the initiation, timing, progress, strategy, plans, objectives, expectations (including as to the results) with respect to the Company’s CAR-T cell therapy product candidate clinical trials, including the expected design, protocol, and timing of initiation of the pivotal phase 3 clinical trial for vispa-cel in 2L LBCL CD19-naïve patients and its expectations regarding reporting initial dose expansion data and longer follow-up dose escalation data in the second half of 2026 from its ongoing CaMMouflage phase 1 clinical trial for CB-011 in patients with r/r MM; its ability to successfully develop its CAR-T cell therapy product candidates and to obtain and maintain regulatory approval for these product candidates; the likelihood of its clinical trials demonstrating safety and efficacy of its CAR-T cell therapy product candidates; the beneficial characteristics, safety, efficacy, therapeutic effects, and potential advantages of its CAR-T cell therapy product candidates; the expected timing or likelihood of regulatory filings and approval for its CAR-T cell therapy product candidates; and the sufficiency of its cash, cash equivalents, and marketable securities to fund its current operating plan to the end of 2027. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of its CAR-T cell therapy product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and CAR-T cell therapy product candidate development, including the ability to fully fund its pivotal phase 3 clinical trial for vispa-cel; as well as other risk factors described from time to time in the Company’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Caution should be exercised when interpreting results from separate trials involving commercially approved autologous CAR-T cell therapies. The results of autologous CAR-T cell therapies referenced in this press release have been derived from publicly available reports of clinical trials not conducted by the Company, and the Company has not performed any head-to-head trials comparing any of these autologous CAR-T cell therapies with vispa-cel. As such, the results of these autologous CAR-T cell therapy clinical trials may not be comparable to clinical results for vispa-cel. The autologous CAR-T cell therapy clinical trials vary in material ways from the ANTLER clinical trial for vispa-cel including with respect to trial design and duration, patient population, patient characteristics, clinical trial phase, treatment protocols, investigators, and other important factors. As a result, cross-trial comparisons may have no interpretive value on the Company’s existing or future clinical results. For further information and to understand these material differences, you should read the reports for the autologous CAR-T cell therapy clinical trials and the sources included in the Company’s corporate presentations on its website. Caribou Biosciences, Inc. contact:Peggy Vorwald, [email protected]@cariboubio.com

Investor releaseQuarter not tagged2026-08-06

Vir Biotechnology, Inc. (VIR) Q2 Earnings and Revenues Miss Estimates

Zacks
Vir Biotechnology, Inc. (VIR) came out with quarterly earnings of $0.47 per share, missing the Zacks Consensus Estimate of $0.83 per share. This compares to a loss of $0.8 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -43.37%. A quarter ago, it was expected that this company would post a loss of $0.01 per share when it actually produced a loss of $0.85, delivering a surprise of -8400%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Vir Biotechnology, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $238.95 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 7.51%. This compares to year-ago revenues of $1.21 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vir Biotechnology shares have added about 52.1% since the beginning of the year versus the S&P 500's gain of 13%. While Vir Biotechnology has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vir Biotechnology was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of tod…Read full document

Vir Biotechnology, Inc. (VIR) came out with quarterly earnings of $0.47 per share, missing the Zacks Consensus Estimate of $0.83 per share. This compares to a loss of $0.8 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -43.37%. A quarter ago, it was expected that this company would post a loss of $0.01 per share when it actually produced a loss of $0.85, delivering a surprise of -8400%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Vir Biotechnology, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $238.95 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 7.51%. This compares to year-ago revenues of $1.21 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vir Biotechnology shares have added about 52.1% since the beginning of the year versus the S&P 500's gain of 13%. While Vir Biotechnology has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vir Biotechnology was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.76 on $0.85 million in revenues for the coming quarter and -$1.81 on $267.04 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Caribou Biosciences, Inc. (CRBU), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.33 per share in its upcoming report, which represents a year-over-year change of +5.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Caribou Biosciences, Inc.'s revenues are expected to be $2.5 million, down 6.4% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vir Biotechnology, Inc. (VIR) : Free Stock Analysis Report Caribou Biosciences, Inc. (CRBU) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-08

Caribou Biosciences Reports First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
-- 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…Read full document

-- 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 single dose of 80x106 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 reported $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. Caribou 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 40x106, 80x106, or 120x106 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 (80x106) 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 (50x106 [N=3], 150x106 [N=7], and 450x106 [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 (150x106 [N=6], 300x106 [N=13], 450x106 [N=13], and 800x106 [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 450x106 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. About Caribou Biosciences, Inc. Caribou is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Caribou’s chRDNA genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on vispacabtagene regedleucel (vispa-cel) and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the company @CaribouBio and visit www.cariboubio.com. Forward-looking statements and important information This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “likely,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, any statements regarding the initiation, timing, progress, strategy, plans, objectives, and expectations (including as to the results) with respect to the company’s CAR-T cell therapy product candidate clinical trials, including the expected trial design of the pivotal phase 3 clinical trial for vispa-cel in 2L LBCL CD19-naïve patients and efforts to secure funding this pivotal trial; the expected release of longer follow up data on ANTLER phase 1 clinical trial data at an upcoming medical conference this year; reporting longer follow-up on dose escalation and initial dose expansion data in 2026 from the company’s ongoing CaMMouflage phase 1 clinical trial for CB-011 in patients with r/r MM; the company’s ability to successfully develop the company’s CAR-T cell therapy product candidates and to obtain and maintain regulatory approval for these product candidates; the likelihood of the company’s clinical trials demonstrating safety and efficacy of the company’s CAR-T cell therapy product candidates; the beneficial characteristics, safety, efficacy, therapeutic effects, and potential advantages of the company’s CAR-T cell therapy product candidates; the expected timing or likelihood of regulatory filings and approval for the company’s CAR-T cell therapy product candidates; and the expected runway of cash, cash equivalents, and marketable securities. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of the company’s current and future clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of the company’s CAR-T cell therapy product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to the company’s limited operating history, history of net operating losses, financial position, and the company’s ability to raise additional capital as needed to fund the company’s operations and CAR-T cell therapy product candidate development, including the ability to fully fund the company’s pivotal phase 3 clinical trial for vispa-cel; as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission (SEC), including the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason. Caribou Biosciences, Inc. contact: Peggy Vorwald, PhD [email protected] [email protected]

Investor releaseQuarter not tagged2026-03-06

Caribou Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 regimen selected for dose expansion (450x106 CAR-T cells following a lymphodepletion regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days). 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 exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial and expects to report initial dose expansion data as well as longer follow up on dose escalation data in 2026. Upcoming events Leerink 2026 Global Healthcare Conference, Miami, FL March 10, 2026, fireside chat at 8:00 am ET Webcast Fourth quarter and full year 2025 financial results Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $3.9 million for the three months ended December 31, 2025 and $11.2 million for full year 2025, compared to $2.1 million and $10.0 million, respectively, for the same periods in 2024. The increase for full year 2025 was primarily driven by a net increase in revenues related to prior licenses of certain of Caribou's intellectual property to third parties. R&D expenses: Research and development expenses were $23.8 million for the three months ended December 31, 2025 and $109.4 million for full year 2025, compared to $30.5 million and $130.2 million, respectively, for the same periods in 2024. The decrease for full year 2025 was primarily due to lower R&D and personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, external contract manufacturing and contract research organization activities and timing of activities for clinical trials, expenses related to licenses, sublicensing revenue, and milestones, and other facilities and allocated expenses. G&A expenses: General and administrative expenses were $8.6 million for the three months ended December 31, 2025 and $37.9 million for full year 2025, compared to $10.5 million and $46.5 million, respectively, for the same periods in 2024. The decrease for full year 2025 was primarily due to lower legal expenses and personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization. Non-recurring, non-cash impairment charges: Non-recurring, non-cash impairment charges were $21.3 million for the year ended December 31, 2025, and include charges related to the previously announced strategic pipeline prioritization and an impairment of Caribou's stock investment in a private company. There were no non-recurring, non-cash impairment charges for full year 2024. GAAP net loss and net loss per share (basic and diluted): Caribou reported GAAP net loss of $26.5 million, or $0.28 per share, for the three months ended December 31, 2025 and $148.1 million, or $1.59 per share, for full year 2025, compared to a net loss of $35.5 million, or $0.39 per share, and $149.1 million, or $1.65 per share, respectively, for the same periods in 2024. Non-GAAP net loss and net loss per share (basic and diluted): Caribou reported non-GAAP net loss of $126.8 million, or $1.36 per share, for full year 2025, compared to non-GAAP net loss of $149.1 million, or $1.65 per share, for full year 2024. Non-GAAP net loss for full year 2025 excludes $21.3 million of non-cash impairment charges incurred for second quarter 2025. Cash, cash equivalents, and marketable securities: Caribou reported $142.8 million in cash, cash equivalents, and marketable securities as of December 31, 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, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. Caribou is exploring multiple options to fully fund its planned vispa-cel pivotal trial. Note regarding use of non-GAAP financial measures In this press release, Caribou has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures are non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash impairment charges. Caribou believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Caribou’s operational performance from period-to-period by excluding items that are not indicative of Caribou's core business operations. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Caribou’s operating results and underlying business trends. In addition, these non-GAAP financial measures are among the indicators Caribou’s management uses for planning purposes and to measure Caribou’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Caribou may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. 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 clinical trial is a multicenter, open-label phase 1 trial that evaluated vispa-cel in adult patients with r/r B-NHL. Eighty-four patients were treated in the ANTLER clinical trial as of September 2, 2025. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation evaluating 40x106, 80x106, and 120x106 CAR-T cell dose levels with 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. Forty-one second-line large B cell lymphoma (2L LBCL) patients were enrolled in the dose expansion portion, and 80x106 CAR-T cells was selected as the recommended phase 2 dose (RP2D). An additional 22 2L LBCL patients were enrolled in the confirmatory cohort, which prospectively evaluated Caribou’s partial HLA matching strategy. 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. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. 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 (50x106 [N=3], 150x106 [N=7], and 450x106 [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 (150x106 [N=6], 300x106 [N=13], 450x106 [N=13], and 800x106 [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 will evaluate safety and efficacy of CB-011 at 450x106 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. About Caribou Biosciences, Inc. Caribou is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Caribou’s genome-editing platform based on its chRDNA genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on vispacabtagene regedleucel (vispa-cel) and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the Company @CaribouBio and visit www.cariboubio.com. Forward-looking statements and important information This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, any statements regarding the initiation, timing, progress, strategy, plans, objectives, expectations (including as to the results) with respect to the Company’s CAR-T cell therapy product candidate clinical trials, including the expected outcome of ongoing engagement with the FDA regarding the trial design, and timing of initiation, of the pivotal phase 3 clinical trial for vispa-cel in 2L LBCL CD19-naïve patients; the expected release of longer follow up data on ANTLER phase 1 clinical trial data; reporting dose expansion data, along with longer follow-up data on dose escalation, in 2026 from its ongoing CaMMouflage phase 1 clinical trial for CB-011 in patients with r/r MM; its ability to successfully develop its CAR-T cell therapy product candidates and to obtain and maintain regulatory approval for these product candidates; the likelihood of its clinical trials demonstrating safety and efficacy of its CAR-T cell therapy product candidates; the beneficial characteristics, safety, efficacy, therapeutic effects, and potential advantages of its CAR-T cell therapy product candidates; and the expected timing or likelihood of regulatory filings and approval for its CAR-T cell therapy product candidates. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of its CAR-T cell therapy product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and CAR-T cell therapy product candidate development, including the ability to fully fund its pivotal phase 3 clinical trial for vispa-cel; as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason. Caution should be exercised when interpreting results from separate trials involving commercially approved autologous CAR-T cell therapies. The results of autologous CAR-T cell therapies referenced in this press release have been derived from publicly available reports of clinical trials not conducted by Caribou, and Caribou has not performed any head-to-head trials comparing any of these autologous CAR-T cell therapies with vispa-cel. As such, the results of these autologous CAR-T cell therapy clinical trials may not be comparable to clinical results for vispa-cel. The autologous CAR-T cell therapy clinical trials vary in material ways from the ANTLER clinical trial for vispa-cel including with respect to trial design and duration, patient population, patient characteristics, clinical trial phase, treatment protocols, investigators, and other important factors. As a result, cross-trial comparisons may have no interpretive value on Caribou’s existing or future clinical results. For further information and to understand these material differences, you should read the reports for the autologous CAR-T cell therapy clinical trials and the sources included in Caribou’s corporate presentations on its website. *Non-GAAP net loss per share, basic and diluted may not total due to rounding Caribou Biosciences, Inc. contact: Peggy Vorwald, PhD [email protected] [email protected]

Investor releaseQuarter not tagged2025-11-13

Caribou Biosciences Reports Third Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 large allogeneic CAR-T cell clinical data set (>140 patients dosed across multiple clinical trials) to identify key factors linked to successful patient outcomes. Two of those factors are donor age (young donors drive enhanced outcomes relative to older donors) and partial HLA matching (matching 2 or more [2+] alleles correlates with outcomes on par with autologous CAR-T cell therapies). Of the 84 patients dosed with vispa-cel, there are 35 CD19-naïve LBCL patients who received vispa-cel with an optimized profile (32 of these patients were 2L and 3 of these patients were 3L+). The optimized profile vispa-cel was manufactured from young donor-derived T cells, and the 35 patients matched a minimum of 2 HLA alleles with the T cell donor. As of the September 29, 2025, efficacy data cutoff date, the efficacy data for the cohort that received vispa-cel with an optimized profile (≥2 HLA matched, young donor; N=35) included: 86% ORR, 63% CR rate, and 53% PFS at 12 months. The median follow up for the optimized profile cohort was 11.8 months, and the longest responding patient, who completed the 2-year ANTLER trial and enrolled in the long-term follow-up study, is in complete response 3 years post infusion. In all patients treated in ANTLER (N=84) as of the September 2, 2025, safety data cutoff date, vispa-cel demonstrated a generally well-tolerated safety profile, which will allow for administration in the outpatient setting and at community hospitals. In recent interactions, the FDA has recommended the Company conduct a randomized, controlled trial in 2L LBCL CD19-naive patients who are ineligible for transplant and autologous CAR-T cell therapy. The Company intends to follow this approach with its planned pivotal phase 3 clinical trial design, which it expects to further refine through continued engagement with the FDA in the coming months. CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM) On November 3, 2025, Caribou announced positive first clinical data from the dose escalation portion of the CaMMouflage phase 1 trial, highlighting CB-011’s potential as a best-in-class allogeneic CAR-T cell therapy for patients with r/r MM. 48 patients have been treated in the dose escalation portion of the CaMMouflage phase 1 trial. The Company disclosed on November 3, 2025, that the recommended dose for expansion (RDE) is a single dose of 450 million CAR-T cells following a lymphodepletion regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. In the 12-patient, BCMA-naïve cohort treated at the RDE with the selected lymphodepletion regimen, as of the September 24, 2025, data cutoff date, the efficacy data included: 92% ORR, 75% ≥CR, and 91% (10/11 evaluable patients) minimal residual disease (MRD)-negativity. Caribou is advancing CB-011 into dose expansion by the end of this year and expects to report dose expansion data as well as longer follow up on dose escalation data in 2026. Upcoming events 8th Annual Evercore Healthcare Conference, Coral Gables, FL December 2, 2025, fireside chat at 8:45 am ET Webcast Caribou to host a breakfast reception and KOL panel at the 67th ASH Annual Meeting December 6, 2025, 7:30 am ET Panel of clinicians from sophisticated community hospitals and academic centers to discuss how vispa-cel could change the treatment paradigm for lymphoma by bringing CAR-T cell therapies into the community setting, closer to where patients live. Webcast details to be posted on Caribou’s Events page Third quarter 2025 financial results Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.2 million for the three months ended September 30, 2025, compared to $2.0 million for the same period in 2024. R&D expenses: Research and development expenses were $22.4 million for the three months ended September 30, 2025, compared to $30.4 million for the same period in 2024. The decrease was primarily related to decreases in clinical trial-related activities, including manufacturing for the Company’s clinical CAR-T cell therapy product candidates, personnel-related expenses related to its reduction in workforce and strategic pipeline prioritization, and other facilities and allocated expenses. G&A expenses: General and administrative expenses were $9.2 million for the three months ended September 30, 2025, compared to $9.8 million for the same period in 2024. This decrease was primarily related to a decrease in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization and was partially offset by an increase in legal and other service-related expenses. Cash, cash equivalents, and marketable securities: Caribou had $159.2 million in cash, cash equivalents, and marketable securities as of September 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, 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 being 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), Orphan Drug, and Fast Track designations for B-NHL. About the ANTLER phase 1 clinical trial The ANTLER clinical trial is a multicenter, open-label phase 1 trial evaluating vispa-cel in adult patients with r/r B-NHL. Eighty-four patients have been treated in the ANTLER clinical trial as of September 2, 2025. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation evaluating 40x106, 80x106, and 120x106 CAR-T cell dose levels with 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. Forty-one second-line large B cell lymphoma (2L LBCL) patients were enrolled in the dose expansion portion, and 80x106 CAR-T cells was selected as the recommended phase 2 dose (RP2D). An additional 22 2L LBCL patients were enrolled in the confirmatory cohort, which prospectively evaluated the Company’s partial HLA matching strategy. 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 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 clinical 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. 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 (50x106 [N=3], 150x106 [N=7], and 450x106 [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 (150x106 [N=6], 300x106 [N=13], 450x106 [N=13], and 800x106 [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 will evaluate safety and efficacy of CB-011 at 450x106 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 clinicaltrials.gov. About Caribou Biosciences, Inc. Caribou is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Company’s genome-editing platform, including its Cas12a chRDNA technology, enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on vispacabtagene regedleucel (vispa-cel) and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the Company @CaribouBio and visit www.cariboubio.com. Forward-looking statements and important information This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, any statements regarding the initiation, timing, progress, strategy, plans, objectives, expectations (including as to the results) with respect to the Company’s CAR-T cell therapy product candidate clinical trials, including the expected design, protocol, and timing of initiation of the pivotal phase 3 clinical trial for vispa-cel in 2L LBCL CD19-naïve patients; for initiating dose expansion by the end of 2025 and reporting dose expansion data, along with longer follow-up data on dose escalation, in 2026 from its ongoing CaMMouflage phase 1 clinical trial for CB-011 in patients with r/r MM; its ability to successfully develop its CAR-T cell therapy product candidates and to obtain and maintain regulatory approval for these product candidates; the likelihood of its clinical trials demonstrating safety and efficacy of its CAR-T cell therapy product candidates; the beneficial characteristics, safety, efficacy, therapeutic effects, and potential advantages of its CAR-T cell therapy product candidates; and the expected timing or likelihood of regulatory filings and approval for its CAR-T cell therapy product candidates. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of its CAR-T cell therapy product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and CAR-T cell therapy product candidate development, including the ability to fully fund its pivotal phase 3 clinical trial for vispa-cel; as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason. Caution should be exercised when interpreting results from separate trials involving commercially approved autologous CAR-T cell therapies. The results of autologous CAR-T cell therapies referenced in this press release have been derived from publicly available reports of clinical trials not conducted by Caribou, and Caribou has not performed any head-to-head trials comparing any of these autologous CAR-T cell therapies with vispa-cel. As such, the results of these autologous CAR-T cell therapy clinical trials may not be comparable to clinical results for vispa-cel. The autologous CAR-T cell therapy clinical trials vary in material ways from the ANTLER clinical trial for vispa-cel including with respect to trial design and duration, patient population, patient characteristics, clinical trial phase, treatment protocols, investigators, and other important factors. As a result, cross-trial comparisons may have no interpretive value on Caribou’s existing or future clinical results. For further information and to understand these material differences, you should read the reports for the autologous CAR-T cell therapy clinical trials and the sources included in Caribou’s corporate presentations on its website. MSKCC: Memorial Sloan Kettering Cancer Center Caribou Biosciences, Inc. contacts: Peggy Vorwald, PhD [email protected] [email protected]

Investor releaseQuarter not tagged2025-11-03

Caribou results suggest renewed promise for ‘off-the-shelf’ cancer cell therapy

BioPharma Dive
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…Read full document

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 disease progression. In both groups, more than half were still responding to treatment as of the data cutoff date. While cross-trial comparisons can be misleading, Gilead’s marketed lymphoma therapy Yescarta had an 83% response rate and a complete remission rate of 65% in a similar group of patients. Caribou said vispa-cel recipients had low rates of immunological and neurological side effects in the study, indicating the treatment could be administered in outpatient settings. People receiving autologous cell therapy often have to stay in a hospital for close monitoring because of such side effects. “This clinical dataset demonstrates vispa-cel’s efficacy and durability are comparable to autologous CAR-T therapies, yet its off-the-shelf availability and favorable tolerability profile make it well suited for outpatient administration at both large academic centers and sophisticated community hospitals,” said Mehdi Hamadani, a trial investigator and professor at the Medical College of Wisconsin, in a statement. The results “validate” Caribou’s HLA-matching approach, wrote Leerink Partners analyst Mani Foroohar in a Monday note to clients. The findings also represent “the upside case for vispa-cel,” which would be a profile “on par” with personalized treatments while offering logistical advantages and lower production costs, he added. Recommended Reading Janux shares triple on early cancer immunotherapy data

Investor releaseQuarter not tagged2025-08-13

Caribou Biosciences Reports Second Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
-- 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…Read full document

-- 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 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. Note regarding use of non-GAAP financial measures In this press release, Caribou has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures are non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash impairment charges. Caribou believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Caribou’s operational performance from period-to-period by excluding items that are not indicative of Caribou's core business operations. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Caribou’s operating results and underlying business trends. In addition, these non-GAAP financial measures are among the indicators Caribou’s management uses for planning purposes and to measure Caribou’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Caribou may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. 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. About Caribou Biosciences, Inc. Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Company’s genome-editing platform, including its Cas12a chRDNA technology, enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on CB-010 and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the Company @CaribouBio and visit www.cariboubio.com. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, without limitation, statements related to Caribou’s strategy, plans, and objectives, and expectations regarding its clinical programs, including its expectations relating to (i) the timing of reporting ANTLER Phase 1 clinical trial data in H2 2025 from both the additional 2L and prior CD19 relapsed LBCL patient cohorts and the timing of an ANTLER pivotal clinical trial, including reaching alignment with the FDA on a pivotal trial design; (ii) the timing of reporting dose escalation data in H2 2025 from the ongoing CaMMouflage Phase 1 clinical trial for CB-011 in r/r MM; and (iii) its expected funding runway of cash, cash equivalents, and marketable securities. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future research and development programs and clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of Caribou’s product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that preclinical study results observed will not be borne out in human patients or different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and product candidate development, as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason. Caribou Biosciences, Inc. contact: Peggy Vorwald, PhD [email protected] [email protected]

Investor releaseQuarter not tagged2025-05-09

Caribou Biosciences Reports First Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
-- 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 in…Read full document

-- 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 a deeper dose of cyclophosphamide. Caribou is rapidly enrolling additional patients with the deeper lymphodepletion regimen to make a data-driven decision on the recommended doses for expansion. The Company plans to present data in H2 2025 with at least three months of follow up on a minimum of 25 patients at multiple dose levels. Corporate updatesRecently announced pipeline prioritization with workforce and cost reduction initiatives As previously reported on April 24, 2025, Caribou implemented a strategic pipeline prioritization to focus resources on its lead oncology programs, CB-010 and CB-011. The Company discontinued its Phase 1 clinical trial of CB-010 for lupus, Phase 1 clinical trial of CB-012 for relapsed or refractory acute myeloid leukemia (r/r AML), and preclinical research. Patients treated in the CB-012 phase 1 clinical trial will continue to be followed as part of the Company’s long-term follow up study. Caribou also reduced its workforce by approximately 32%. Cash payments resulting from the reduction in force and strategic pipeline prioritization are estimated to be $2.5 to $3.5 million. These changes are expected to extend Caribou’s cash runway by one year, funding the Company’s current operating plan into H2 2027, compared to into H2 2026 as previously reported. 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 and share the recommended doses for expansion 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 doses for expansion and plans for dose expansion. First quarter 2025 financial results Cash, cash equivalents, and marketable securities: Caribou had $212.5 million in cash, cash equivalents, and marketable securities as of March 31, 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 $2.4 million for the three months ended March 31, 2025, compared to $2.4 million for the same period in 2024. R&D expenses: Research and development expenses were $35.5 million for the three months ended March 31, 2025, compared to $33.8 million for the same period in 2024. The increase was primarily due to costs associated with the ongoing CB-010 ANTLER and CB-011 CaMMouflage Phase 1 clinical trials and the recently discontinued CB-012 AMpLify and CB-010 GALLOP Phase 1 clinical trials; facility and other allocated expenses; and personnel-related expenses, including stock-based compensation; partially offset by a reduction in expenses relating to licenses, other R&D expenses, and consulting services. G&A expenses: General and administrative expenses were $9.7 million for the three months ended March 31, 2025, compared to $14.6 million for the same period in 2024. The decrease was primarily due to lower legal expenses, including the accrual of a litigation settlement expense in 2024, other service-related expenses, and personnel-related expenses, including stock-based compensation and salary and benefit expenses. Net loss: Caribou reported a net loss of $40.0 million for the three months ended March 31, 2025, compared to $41.2 million for the same period in 2024. About CB-010CB-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-011CB-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. About Caribou Biosciences, Inc.Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Company’s genome-editing platform, including its Cas12a chRDNA technology, enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on CB-010 and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the Company @CaribouBio and visit www.cariboubio.com. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, without limitation, statements related to Caribou’s strategy, plans, and objectives, and expectations regarding its clinical programs, including its expectations relating to (i) the timing of reporting ANTLER Phase 1 clinical trial data in H2 2025 from both the additional 2L and prior CD19 relapsed LBCL patient cohorts and the timing of an ANTLER pivotal clinical trial; (ii) the timing of reporting dose escalation data in H2 2025 from the ongoing CaMMouflage Phase 1 clinical trial for CB-011 in r/r MM; (iii) expected one-time costs associated with its cost-reduction initiatives; and (iv) its expected funding runway of cash, cash equivalents, and marketable securities. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future research and development programs and clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of Caribou’s product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that preclinical study results observed will not be borne out in human patients or different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and product candidate development, as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason. Caribou Biosciences, Inc. contacts:Investors:Amy Figueroa, [email protected] Media:Peggy Vorwald, [email protected]

Investor releaseQuarter not tagged2025-05-01

Will Clearside Biomedical, Inc. (CLSD) Report Negative Q1 Earnings? What You Should Know

Zacks
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…Read full document

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, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Clearside Biomedical, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -2.85%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Clearside Biomedical will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Clearside Biomedical would post a loss of $0.13 per share when it actually produced a loss of $0.10, delivering a surprise of +23.08%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Clearside Biomedical doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Caribou Biosciences, Inc. (CRBU), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.43 for the quarter ended March 2025. This estimate points to a year-over-year change of +6.5%. Revenues for the quarter are expected to be $2.5 million, up 2.9% from the year-ago quarter. The consensus EPS estimate for Caribou Biosciences has been revised 15.1% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -6.98%. This Earnings ESP, combined with its Zacks Rank #3 (Hold), makes it difficult to conclusively predict that Caribou Biosciences will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Clearside Biomedical, Inc. (CLSD) : Free Stock Analysis Report Caribou Biosciences, Inc. (CRBU) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2025-04-29

Will Caribou Biosciences, Inc. (CRBU) Report Negative Q1 Earnings? What You Should Know

Zacks
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…Read full document

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 strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Caribou Biosciences, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -6.98%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Caribou Biosciences will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Caribou Biosciences would post a loss of $0.40 per share when it actually produced a loss of $0.39, delivering a surprise of +2.50%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Caribou Biosciences doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Amgen (AMGN) is soon expected to post earnings of $4.16 per share for the quarter ended March 2025. This estimate indicates a year-over-year change of +5.1%. This quarter's revenue is expected to be $7.96 billion, up 6.8% from the year-ago quarter. The consensus EPS estimate for Amgen has been revised 1.6% lower over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -0.05%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Amgen will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Caribou Biosciences, Inc. (CRBU) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook