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Caribou Biosciences (CRBU)’s CB-011 May Reach $734 Million in Peak 2040 Sales, According to Clear Street
Yahoo Finance· 2026-02-20 17:00
Caribou Biosciences, Inc. (NASDAQ:CRBU) is included in our list of the 7 most volatile stocks under $5 for day trading. Caribou Biosciences (CRBU)’s CB-011 May Reach $734 Million in Peak 2040 Sales, According to Clear Street A dose bottle of the medication is in the medical tech's hand On February 2, 2026, Clear Street began covering Caribou Biosciences, Inc. (NASDAQ:CRBU) with a ‘Buy’ rating and a $13 price target. The firm’s bullish stance was attributed to the company’s off-the-shelf allogeneic CAR-T ...
Genomics Stocks That Deserve a Place in Your Portfolio in 2026
ZACKS· 2026-02-20 16:51
An updated edition of the Jan. 6, 2026, article.Genomics is the comprehensive study of genomes—the complete set of deoxyribonucleic acid (DNA) within an organism. Rapid scientific progress in this field has intensified interest among pharmaceutical and biotechnology companies seeking deeper insight into disease biology and more effective therapeutic strategies.It is important to distinguish between genetics and genomics. Genetics focuses on individual genes and their functions, whereas genomics primarily ai ...
Caribou Biosciences Announces Late-Breaking Presentations at the 2026 Tandem Meetings of ASTCT® and CIBMTR®
Globenewswire· 2026-02-04 13:00
Core Insights - Caribou Biosciences, Inc. is presenting clinical data on its allogeneic CAR-T cell therapies, vispa-cel and CB-011, at the 2026 Tandem Meetings, highlighting their potential in treating relapsed or refractory hematologic malignancies [1][2][3] Group 1: Clinical Trials and Data - The ANTLER phase 1 clinical trial for vispa-cel shows outcomes comparable to autologous CAR-T therapies in patients with relapsed/refractory B cell non-Hodgkin lymphoma [5][6] - The CaMMouflage phase 1 clinical trial for CB-011 demonstrates a correlation between CAR-T cell expansion and durable responses in patients with relapsed/refractory multiple myeloma [5][8] - A total of 84 patients have been treated in the ANTLER trial, with a recommended phase 2 dose of 80x10^6 CAR-T cells selected [6] Group 2: Product Information - Vispa-cel is the first allogeneic CAR-T cell therapy with a PD-1 knockout, aimed at enhancing CAR-T cell activity by reducing exhaustion [4][9] - CB-011 employs an immune cloaking strategy with a B2M knockout and a B2M–HLA-E fusion protein to mitigate immune rejection [7][9] - Both therapies have received Fast Track and Orphan Drug designations from the FDA, indicating their potential to address unmet medical needs [4][7] Group 3: Company Overview - Caribou Biosciences focuses on developing transformative therapies using its CRISPR genome-editing platform, aiming to improve access to cellular therapies for patients with severe diseases [9] - The company emphasizes the potential of its off-the-shelf CAR-T cell therapies to provide rapid treatment options for patients with hematologic malignancies [9]
Caribou Biosciences (CRBU) Upgraded to Buy: Here's Why
ZACKS· 2026-01-13 18:01
Core Viewpoint - Caribou Biosciences, Inc. (CRBU) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Company Performance and Investor Sentiment - The upgrade reflects an improvement in Caribou Biosciences' underlying business, suggesting that investors may respond positively by driving the stock price higher [5][10]. - Over the past three months, the Zacks Consensus Estimate for Caribou Biosciences has increased by 2.2%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - Caribou Biosciences' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].
Caribou Biosciences (NasdaqGS:CRBU) FY Conference Transcript
2025-12-02 14:47
Summary of Caribou Biosciences FY Conference Call Company Overview - **Company**: Caribou Biosciences (NasdaqGS:CRBU) - **Focus**: Development of CAR-T therapies, specifically the Vispacel product for treating large cell B-cell lymphoma and the CB-011 program for myeloma Key Points on Vispacel Program - **Clinical Updates**: - Vispacel has been evaluated in the clinic for approximately four and a half years, showing promising results that resemble autologous CAR-T therapies [4][5] - After treating 84 patients, response rates and duration of response for Vispacel are nearly identical to autologous CAR-T, with a notable safety profile [5][6] - 75% of large cell B-cell lymphoma patients do not receive autologous CAR-T, indicating a significant market opportunity [5] - **Safety Profile**: - Vispacel demonstrated low rates of cytokine release syndrome, high-grade neurotoxicity, and severe infections, making it comparable to Lysosel, a better-tolerated product [6][7] - **Target Patient Population**: - Focus on patients ineligible for autologous CAR-T and auto transplants, including those facing geographical, insurance, and manufacturing challenges [7][19] - Plans for a pivotal trial involving approximately 250 patients randomized against immunochemotherapy, which lacks curative intent [7][9] - **Durability of Outcomes**: - Data indicates a plateau in durability of responses similar to autologous CAR-T, with low relapse rates compared to immunochemotherapy [8][9] - **Regulatory Strategy**: - Anticipated label for Vispacel will include auto CAR-T ineligible and auto transplant ineligible populations, with no significant barriers expected [19][20] - **Community Center Access**: - There is a strong desire from community centers to treat patients with Vispacel, as many patients refuse to travel to academic centers [25][27] Key Points on CB-011 Program - **Market Positioning**: - CB-011 is positioned against bispecific antibodies, with a focus on the myeloma patient population, where only about 10% currently receive autologous CAR-T [30] - Physicians express interest in an allogeneic CAR-T that matches or exceeds the efficacy of bispecifics, highlighting the treatment burden associated with bispecific therapies [30][31] - **Clinical Development**: - Expansion of the 450 million cell cohort to approximately 30 patients to better estimate overall response rates and MRD negativity [33][41] - The goal is to achieve median progression-free survival (PFS) rates comparable to bispecifics, targeting around 15 months [33] - **Competitive Landscape**: - Other allogeneic CAR-T products and in vivo CAR-T therapies are seen as less competitive due to their current stage of development and regulatory challenges [42][44] Additional Insights - **Manufacturing and Cost Efficiency**: - Vispacel can be manufactured and stockpiled, allowing for immediate availability upon patient eligibility confirmation, with significantly lower costs of goods sold (COGS) compared to autologous CAR-T [45][46] - **Patient Access Challenges**: - A significant portion of patients in the second-line setting are dual ineligible for both transplant and autologous CAR-T, indicating a meaningful market for Vispacel [27][29] This summary encapsulates the critical insights from the conference call, highlighting Caribou Biosciences' strategic focus on expanding access to CAR-T therapies through innovative product development and addressing patient needs in underserved populations.
Caribou Biosciences to Host In-Person and Virtual KOL Event at ASH 2025
Globenewswire· 2025-12-01 21:05
Core Insights - Caribou Biosciences, Inc. is hosting a panel discussion on vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy, aimed at expanding patient access for second-line large B cell lymphoma treatment [1][2] Company Overview - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for patients with severe diseases [6] - The company is advancing vispacabtagene regedleucel (vispa-cel), which is the first allogeneic CAR-T cell therapy in clinical trials with a PD-1 knockout designed to enhance CAR-T cell activity [4] Clinical Trial Information - The ANTLER phase 1 clinical trial is evaluating vispa-cel in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma, with 84 patients treated as of September 2, 2025 [5] - The trial has shown positive data indicating that vispa-cel's efficacy and durability are comparable to autologous CAR-T cell therapies [5] Event Details - The expert panel discussion will take place in-person at the Hyatt Regency Orlando on December 6, 2025, and will also be available virtually [2][3] - The event will be moderated by Caribou's Chief Medical Officer, Dr. Tina Albertson, and will feature insights from leading physicians regarding access challenges and patient needs [2]
Caribou Biosciences, Inc. (CRBU) Reports Q3 Loss, Misses Revenue Estimates
ZACKS· 2025-11-12 23:30
Core Insights - Caribou Biosciences, Inc. reported a quarterly loss of $0.3 per share, which was better than the Zacks Consensus Estimate of a loss of $0.36, marking an earnings surprise of +16.67% [1] - The company generated revenues of $2.2 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 14.34% [2] - Caribou's shares have increased by approximately 40.9% year-to-date, outperforming the S&P 500's gain of 16.4% [3] Financial Performance - The company has surpassed consensus EPS estimates three times over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.40, with expected revenues of $2.59 million, and for the current fiscal year, it is -$1.73 on revenues of $8.88 million [7] Market Outlook - The sustainability of the stock's price movement will depend on management's commentary during the earnings call [3] - The estimate revisions trend for Caribou Biosciences was unfavorable prior to the earnings release, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] - The Medical - Biomedical and Genetics industry is currently in the top 34% of Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]
Caribou Biosciences(CRBU) - 2025 Q3 - Quarterly Report
2025-11-12 21:09
Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $27.5 million, compared to a net loss of $34.7 million for the same period in 2024[104]. - The accumulated deficit as of September 30, 2025, was $570.0 million, indicating ongoing financial challenges[104]. - The net loss for the nine months ended September 30, 2025, was $121.6 million, compared to a net loss of $113.6 million in the same period of 2024[128]. - Total operating expenses for the nine months ended September 30, 2025, were $127.1 million, down from $135.7 million in 2024, a decrease of $8.5 million[128]. - Total other income decreased by $15.9 million for the nine months ended September 30, 2025, compared to the same period in 2024[134]. - Cash used in operating activities was $90.2 million for the nine months ended September 30, 2025, compared to $102.7 million for the same period in 2024, reflecting a decrease of $12.6 million[152]. - Net cash provided by investing activities was $84.3 million for the nine months ended September 30, 2025, compared to $70.7 million for the same period in 2024, an increase of $13.6 million[153]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $159.2 million[138]. - The company raised an aggregate net proceeds of $841.3 million since inception through various financing activities[137]. - The company expects existing cash and marketable securities to be sufficient to fund operations for at least the next 12 months[144]. Clinical Development - The company has advanced two clinical-stage allogeneic CAR-T cell therapies: vispa-cel for relapsed or refractory large B cell lymphoma and CB-011 for relapsed or refractory multiple myeloma[95]. - In the ANTLER phase 1 clinical trial, vispa-cel demonstrated an 82% overall response rate and a 64% complete response rate in a confirmatory cohort of 22 patients[97]. - The optimized profile cohort of vispa-cel, which included 35 patients, achieved an 86% overall response rate and a 63% complete response rate[97]. - CB-011 achieved a 92% overall response rate and a 75% complete response rate in a cohort of 12 BCMA-naïve patients[99]. - The company anticipates initiating a pivotal phase 3 clinical trial for vispa-cel involving approximately 250 patients who are ineligible for transplant[98]. - The successful development of CAR-T product candidates remains highly uncertain, impacting the timeline and costs associated with their commercialization[115]. Expenses and Cost Management - Total research and development expenses decreased to $22.4 million in Q3 2025 from $30.4 million in Q3 2024, a reduction of $8.0 million[123]. - General and administrative expenses decreased to $9.2 million in Q3 2025 from $9.8 million in Q3 2024, a decrease of $0.6 million[124]. - Research and development expenses for the nine months ended September 30, 2025, were $85.6 million, down from $99.7 million in 2024, a reduction of $14.1 million[128]. - General and administrative expenses decreased by $6.6 million to $29.3 million for the nine months ended September 30, 2025, from $36.0 million for the same period in 2024[132]. - Impairment charges totaling $10.0 million were recognized for leasehold improvements and lab equipment in the second quarter of 2025[101]. - Impairment charges of $12.2 million were recorded for the nine months ended September 30, 2025, related to strategic pipeline prioritization[128]. - The company recorded cash severance costs of $1.8 million due to a workforce reduction of 32%[100]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[106]. - Licensing and collaboration revenue for Q3 2025 was $2.2 million, an increase of $0.2 million from $2.0 million in Q3 2024[121]. - For the nine months ended September 30, 2025, licensing and collaboration revenue decreased to $7.2 million from $7.9 million in the same period of 2024, a decline of $0.7 million[129]. - Total licensing and collaboration revenue decreased by $699,000 to $7.2 million for the nine months ended September 30, 2025, compared to $7.9 million for the same period in 2024[130]. Market Risk - There have been no material changes to market risk during the nine months ended September 30, 2025[158]. - For a detailed discussion of market risk exposure, refer to the Form 10-K section titled "Quantitative and Qualitative Disclosures About Market Risk"[158].
Caribou Biosciences(CRBU) - 2025 Q3 - Quarterly Results
2025-11-12 21:08
Financial Position - As of September 30, 2025, Caribou Biosciences expects cash, cash equivalents, and marketable securities to be approximately $159.2 million[7]. - As of September 30, 2025, the Company reported preliminary unaudited cash, cash equivalents, and marketable securities[38]. Clinical Trials and Results - The ANTLER phase 1 trial for vispacabtagene regedleucel ("vispa-cel") reported an overall response rate (ORR) of 82% and a complete response (CR) rate of 64% among 22 patients[17]. - The 12-month progression-free survival (PFS) rate for the confirmatory cohort of vispa-cel was 51%[17]. - In the optimized product cohort of 35 patients, the ORR was 86% and the CR rate was 63%[22]. - The 12-month PFS for the optimized cohort was 53%[22]. - The ANTLER trial has enrolled a total of 84 patients, including a confirmatory cohort of 22 patients[15]. - In the ongoing CaMMouflage phase 1 trial for CB-011, 48 patients were enrolled, with a recommended dose for expansion of 450x10 viable CAR-T cells following a selected lymphodepletion regimen[29][31]. - The 12-patient BCMA-naïve cohort treated with the recommended dose showed a 92% overall response rate (ORR) and a 75% stringent complete response (sCR) rate[35]. - Notable adverse events in the CaMMouflage trial included infections (49% any grade) and cytokine release syndrome (31% any grade) across all treated patients[37]. - The longest responding patient in the BCMA-naïve cohort is in stringent complete response at 15 months post-infusion[31]. Regulatory Designations and Plans - Vispa-cel has received regenerative medicine advanced therapy (RMAT) designation and fast track designation from the FDA for relapsed or refractory large B cell lymphoma (r/r LBCL)[13]. - The FDA has recommended a randomized, controlled trial design for vispa-cel, which the Company believes provides a straightforward regulatory path to full approval[28]. - The Company plans to initiate a pivotal phase 3 trial for vispa-cel in second-line large B cell lymphoma patients who are ineligible for transplant[8]. - The Company plans to conduct a pivotal phase 3 trial for vispa-cel in 2L LBCL CD19-naïve patients, evaluating approximately 250 patients, with a primary endpoint of progression-free survival (PFS) and an interim analysis planned[28]. - The Company anticipates initiating dose expansion of the CaMMouflage trial before the end of 2025 and reporting data in 2026[37]. - The Company plans to further refine its pivotal phase 3 clinical trial design through continued engagement with the FDA prior to trial initiation[28]. Safety Profile - The safety profile of vispa-cel showed treatment emergent adverse events (TEAEs) in 25% or more of patients, including thrombocytopenia (62%) and cytokine release syndrome (55%)[25]. - The Company has not completed any head-to-head trials comparing vispa-cel or CB-011 with autologous CAR-T therapies, making cross-trial comparisons challenging[42].
Caribou Biosciences Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-12 21:05
Core Insights - Caribou Biosciences, Inc. reported positive clinical data for its off-the-shelf CAR-T cell therapies, vispa-cel and CB-011, marking a significant advancement in allogeneic CAR-T cell therapy [2][6] - The company has demonstrated promising efficacy and safety profiles for both therapies, with plans for further clinical trials and dose expansions [5][13] Clinical Highlights - Vispa-cel showed an overall response rate (ORR) of 82% and a complete response (CR) rate of 64% in a confirmatory cohort of patients with relapsed or refractory large B cell lymphoma [6] - CB-011 demonstrated a 92% ORR and a 75% CR rate in a cohort of patients with relapsed or refractory multiple myeloma [13] Financial Results - Licensing and collaboration revenue for Q3 2025 was $2.2 million, up from $2.0 million in Q3 2024 [8] - Research and development expenses decreased to $22.4 million in Q3 2025 from $30.4 million in Q3 2024, primarily due to reduced clinical trial activities [9] - General and administrative expenses also decreased to $9.2 million in Q3 2025 from $9.8 million in Q3 2024 [10] - As of September 30, 2025, the company had $159.2 million in cash and marketable securities, down from $249.4 million at the end of 2024 [11] Upcoming Events - Caribou will participate in the 8th Annual Evercore Healthcare Conference on December 2, 2025, and host a panel at the 67th ASH Annual Meeting on December 6, 2025 [13]