Caribou Biosciences(CRBU)
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Caribou Biosciences(CRBU) - 2025 Q2 - Quarterly Results
2025-08-12 20:07
[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) [Q2 2025 Business and Financial Highlights](index=1&type=section&id=Q2%202025%20Business%20and%20Financial%20Highlights) Caribou Biosciences reported Q2 2025 financial results and business updates, anticipating clinical data disclosures for CB-010 and CB-011 in H2 2025, supported by sufficient cash reserves until H2 2027 - Two robust clinical datasets for CB-010 and CB-011 are anticipated to be disclosed in **H2 2025**[1](index=1&type=chunk) - The company holds **$184 million** in cash, cash equivalents, and marketable securities, projected to fund current operations until **H2 2027**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) Caribou's CEO highlighted the advancement of allogeneic CAR-T cell programs to deliver off-the-shelf therapies for rapid treatment and broad patient access, with encouraging Phase 1 results for CB-010 and CB-011 expected in H2 2025 - Caribou is advancing allogeneic CAR-T cell programs to provide **off-the-shelf therapies** for rapid treatment and broad patient accessibility[2](index=2&type=chunk) - Clinical programs CB-010 and CB-011 continue to yield encouraging Phase 1 results, with robust datasets anticipated in **H2 2025**[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) [CB-010 (ANTLER Phase 1 Clinical Trial)](index=1&type=section&id=CB-010%20%28ANTLER%20Phase%201%20Clinical%20Trial%29) Caribou completed enrollment for the confirmatory cohort of 20 second-line large B cell lymphoma (2L LBCL) patients in the ANTLER Phase 1 trial, with data suggesting single-dose CB-010 may rival approved autologous CAR-T therapies in safety, efficacy, and durability - Enrollment for the confirmatory cohort of **20 second-line large B cell lymphoma (2L LBCL) patients** in the ANTLER Phase 1 clinical trial has been completed[4](index=4&type=chunk) - Data indicates that a single dose of CB-010 shows promise in safety, efficacy, and durability comparable to approved autologous CAR-T cell therapies[4](index=4&type=chunk) [CB-011 (CaMMouflage Phase 1 Clinical Trial)](index=1&type=section&id=CB-011%20%28CaMMouflage%20Phase%201%20Clinical%20Trial%29) The company completed planned enrollment for the dose-escalation portion of the CaMMouflage Phase 1 clinical trial in relapsed or refractory multiple myeloma (r/r MM) patients, with CB-011 consistently demonstrating encouraging efficacy across multiple active dose levels - Planned enrollment for the dose-escalation portion of the CaMMouflage Phase 1 clinical trial in **relapsed or refractory multiple myeloma (r/r MM) patients** has been completed[4](index=4&type=chunk) - CB-011 continues to demonstrate encouraging efficacy across multiple active dose levels[4](index=4&type=chunk) [2025 Anticipated Milestones](index=1&type=section&id=2025%20Anticipated%20Milestones) Caribou plans to release data from the CB-010 ANTLER and CB-011 CaMMouflage trials in H2 2025, including preliminary safety and efficacy data for CB-010's confirmatory cohort and dose-escalation data for CB-011 - CB-010 ANTLER data is expected in **H2 2025**, including preliminary safety and efficacy data for the confirmatory cohort (**20 patients** with at least six months follow-up for most), and updates on pivotal trial design and timeline[4](index=4&type=chunk) - CB-011 CaMMouflage dose-escalation data is anticipated in **H2 2025**, including preliminary safety and efficacy data for at least **25 patients** across multiple dose levels (with at least three months follow-up), along with recommended expansion dose and plan[4](index=4&type=chunk)[12](index=12&type=chunk) [Second Quarter 2025 Financial Performance](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Performance) [Cash, Cash Equivalents, and Marketable Securities](index=3&type=section&id=Cash%2C%20Cash%20Equivalents%2C%20and%20Marketable%20Securities) As of June 30, 2025, Caribou's cash, cash equivalents, and marketable securities decreased to **$183.9 million** from **$249.4 million** at December 31, 2024, projected to fund operations until **H2 2027** Cash, Cash Equivalents, and Marketable Securities | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $183.9 million | $249.4 million | - Cash, cash equivalents, and marketable securities are expected to fund the company's current operating plans until **H2 2027**[5](index=5&type=chunk) [Licensing and Collaboration Revenue](index=3&type=section&id=Licensing%20and%20Collaboration%20Revenue) Licensing and collaboration revenue for the three months ended June 30, 2025, was **$2.7 million**, a **22.9% decrease** from **$3.5 million** in the prior year period Licensing and Collaboration Revenue | Metric | Q2 2025 | Q2 2024 | Y-o-Y Change | | :-------------------------------- | :-------- | :-------- | :--------- | | Licensing and Collaboration Revenue | $2.7 million | $3.5 million | -22.9% | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses increased to **$50.2 million** in Q2 2025 from **$47.0 million** in Q2 2024, primarily due to non-recurring impairment charges despite reductions in R&D and G&A expenses Total Operating Expenses | Metric | Q2 2025 | Q2 2024 | Y-o-Y Change | | :-------------------- | :-------- | :-------- | :--------- | | Total Operating Expenses | $50.2 million | $47.0 million | +6.8% | [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20%28R%26D%29%20Expenses) R&D expenses for Q2 2025 were **$27.7 million**, a **22.0% decrease** from **$35.5 million** in Q2 2024, driven by strategic pipeline prioritization, personnel reductions, and lower clinical trial costs Research and Development Expenses | Metric | Q2 2025 | Q2 2024 | Y-o-Y Change | | :---------------------- | :-------- | :-------- | :--------- | | Research and Development Expenses | $27.7 million | $35.5 million | -22.0% | - The decrease in expenses is primarily linked to strategic pipeline prioritization, associated personnel reductions, and lower costs for the CB-010 ANTLER and CB-011 CaMMouflage Phase 1 clinical trials[7](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20%28G%26A%29%20Expenses) G&A expenses for Q2 2025 were **$10.4 million**, a **9.4% decrease** from **$11.5 million** in Q2 2024, mainly due to reduced personnel-related costs, patent expenses, and legal fees General and Administrative Expenses | Metric | Q2 2025 | Q2 2024 | Y-o-Y Change | | :-------------------------- | :-------- | :-------- | :--------- | | General and Administrative Expenses | $10.4 million | $11.5 million | -9.4% | - The decrease in expenses is primarily attributed to reduced personnel-related costs (including stock-based compensation), lower patent application and maintenance costs, and decreased legal and other service-related fees, partially offset by increased other facility and allocated costs[8](index=8&type=chunk) [Non-recurring, Non-cash Impairment Charges](index=3&type=section&id=Non-recurring%2C%20Non-cash%20Impairment%20Charges) Caribou recorded **$21.3 million** in non-recurring, non-cash impairment charges in Q2 2025, related to strategic pipeline prioritization and an equity investment in a private company Non-recurring, Non-cash Impairment Charges | Metric | Q2 2025 | Q2 2024 | | :------------------------------------ | :-------- | :-------- | | Non-recurring, Non-cash Impairment Charges | $21.3 million | $0 | - Charges include those related to strategic pipeline prioritization and the impairment of an equity investment in a private company[9](index=9&type=chunk) [Net Loss and Net Loss Per Share (GAAP & Non-GAAP)](index=3&type=section&id=Net%20Loss%20and%20Net%20Loss%20Per%20Share%20%28GAAP%20%26%20Non-GAAP%29) Caribou reported a GAAP net loss of **$54.1 million** (or **$0.58 per share**) in Q2 2025, up from **$37.7 million** in Q2 2024, primarily due to non-cash impairment charges, while non-GAAP net loss was **$32.8 million** (or **$0.35 per share**) Net Loss and Net Loss Per Share | Metric | Q2 2025 | Q2 2024 | Y-o-Y Change | | :-------------------------- | :-------- | :-------- | :--------- | | GAAP Net Loss | $(54.1) million | $(37.7) million | +43.5% | | GAAP Net Loss Per Share | $(0.58) | $(0.42) | +38.1% | | Non-GAAP Net Loss | $(32.8) million | $(37.7) million | -13.0% | | Non-GAAP Net Loss Per Share | $(0.35) | $(0.42) | -16.7% | [Note Regarding Use of Non-GAAP Financial Measures](index=4&type=section&id=Note%20Regarding%20Use%20of%20Non-GAAP%20Financial%20Measures) Caribou utilizes non-GAAP net loss and non-GAAP net loss per share, excluding non-cash impairment charges, to provide a clearer understanding of operational performance by focusing on core business activities, which management uses for planning and performance measurement - Non-GAAP financial measures (net loss and net loss per share) exclude non-cash impairment charges, aiming to enhance the overall understanding of operational performance[11](index=11&type=chunk) - These non-GAAP financial measures are used by management for planning and assessing company performance, serving as a supplement to, not a substitute for, GAAP financial measures[11](index=11&type=chunk)[13](index=13&type=chunk) [Product Candidate and Company Information](index=4&type=section&id=Product%20Candidate%20and%20Company%20Information) [About CB-010](index=4&type=section&id=About%20CB-010) CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), currently in the ANTLER Phase 1 trial, and is the first clinical allogeneic CAR-T with PD-1 knockout to enhance activity, having received RMAT, Orphan Drug, and Fast Track designations from the FDA - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for **relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL)**[14](index=14&type=chunk) - It is the first allogeneic CAR-T cell therapy in the clinic to incorporate **PD-1 knockout**, designed to enhance CAR-T cell activity[14](index=14&type=chunk) - The FDA has granted CB-010 **Regenerative Medicine Advanced Therapy (RMAT)**, **Orphan Drug**, and **Fast Track** designations[14](index=14&type=chunk) [About CB-011](index=4&type=section&id=About%20CB-011) CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM), evaluated in the CaMMouflage Phase 1 trial, engineered with B2M knockout and a B2M–HLA-E fusion protein for immune cloaking to mitigate immune-mediated rejection, and has received FDA Fast Track and Orphan Drug designations - CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for **relapsed or refractory multiple myeloma (r/r MM)**[15](index=15&type=chunk) - It is engineered with a B2M knockout and a B2M–HLA-E fusion protein for **immune cloaking**, designed to mitigate immune-mediated rejection[15](index=15&type=chunk) - CB-011 has received **FDA Fast Track** and **Orphan Drug** designations[15](index=15&type=chunk) [About Caribou Biosciences, Inc.](index=4&type=section&id=About%20Caribou%20Biosciences%2C%20Inc.) Caribou Biosciences is a clinical-stage CRISPR gene-editing biopharmaceutical company focused on developing transformative therapies for devastating diseases, leveraging its Cas12a chRDNA technology to create 'armored' cell therapies with enhanced activity, specifically focusing on CB-010 and CB-011 as off-the-shelf CAR-T cell therapies for hematologic malignancies - Caribou Biosciences is a clinical-stage **CRISPR gene-editing biopharmaceutical company** dedicated to developing transformative therapies[16](index=16&type=chunk) - The company's gene-editing platform, including its **Cas12a chRDNA technology**, enables exceptional precision to develop 'armored' cell therapies[16](index=16&type=chunk) - Caribou focuses on CB-010 and CB-011 as **off-the-shelf CAR-T cell therapies** for hematologic malignancies[16](index=16&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines Caribou's future strategies, plans, and objectives, including expectations for clinical program data disclosures and cash runway, subject to inherent risks and uncertainties in allogeneic CAR-T cell therapy development - Forward-looking statements include expectations regarding the timing of ANTLER Phase 1 clinical trial data and pivotal clinical trial initiation, CaMMouflage Phase 1 clinical trial dose-escalation data, and the projected cash runway from cash, cash equivalents, and marketable securities[17](index=17&type=chunk)[18](index=18&type=chunk) - These statements are subject to inherent risks and uncertainties in developing allogeneic CAR-T cell therapy products, including the initiation, cost, timing, progress, and results of clinical trials, and the ability to obtain key regulatory approvals[18](index=18&type=chunk) [Condensed Consolidated Financial Data](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Data) [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Caribou's condensed consolidated balance sheet shows decreases in cash, cash equivalents, marketable securities, total assets, total liabilities, and total stockholders' equity compared to December 31, 2024 Condensed Consolidated Balance Sheet Data (in thousands of dollars) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $183,948 | $249,386 | | Total Assets | $220,903 | $313,313 | | Total Liabilities | $54,771 | $60,362 | | Total Stockholders' Equity | $166,132 | $252,951 | [Condensed Consolidated Statement of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) For the three months ended June 30, 2025, Caribou's licensing and collaboration revenue and R&D expenses decreased, but total operating expenses increased due to impairment charges, leading to an expanded net loss compared to the prior year period Condensed Consolidated Statement of Operations (in thousands of dollars, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Licensing and Collaboration Revenue | $2,667 | $3,464 | $5,020 | $5,893 | | Research and Development Expenses | $27,692 | $35,480 | $63,223 | $69,268 | | General and Administrative Expenses | $10,403 | $11,485 | $20,138 | $26,128 | | Impairment Charges | $12,150 | — | $12,150 | — | | Total Operating Expenses | $50,245 | $46,965 | $95,511 | $95,396 | | Operating Loss | $(47,578) | $(43,501) | $(90,491) | $(89,503) | | Net Loss | $(54,098) | $(37,697) | $(94,089) | $(78,931) | | Net Loss Per Share, Basic and Diluted | $(0.58) | $(0.42) | $(1.01) | $(0.88) | [Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss per Share](index=8&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Net%20Loss%20and%20Net%20Loss%20per%20Share) This reconciliation details the adjustment from GAAP to non-GAAP net loss by excluding non-cash impairment charges, showing a significantly lower non-GAAP net loss in Q2 2025 due to **$21.3 million** in impairment charges Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss per Share (in thousands of dollars, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss (GAAP) | $(54,098) | $(37,697) | $(94,089) | $(78,931) | | Adjustment: Non-cash Impairment Charges | $21,308 | — | $21,308 | — | | Non-GAAP Net Loss | $(32,790) | $(37,697) | $(72,781) | $(78,931) | | Net Loss Per Share, Basic and Diluted (GAAP) | $(0.58) | $(0.42) | $(1.01) | $(0.88) | | Adjustment: Non-cash Impairment Charges (Per Share) | $0.23 | — | $0.23 | — | | Non-GAAP Net Loss Per Share, Basic and Diluted | $(0.35) | $(0.42) | $(0.78) | $(0.88) | [Company Contact Information](index=9&type=section&id=Company%20Contact%20Information) This section provides contact information for Caribou Biosciences' investor relations and media inquiries - Email contact information is provided for investor relations and media inquiries[25](index=25&type=chunk)
Caribou Biosciences Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 20:05
Core Insights - Caribou Biosciences, Inc. is advancing its allogeneic CAR-T cell programs, CB-010 and CB-011, with robust clinical datasets expected to be disclosed in the second half of 2025 [1][2] - The company reported $184 million in cash, cash equivalents, and marketable securities, which is projected to fund operations into the second half of 2027 [1][4] Clinical Programs - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy targeting B cell non-Hodgkin lymphoma, while CB-011 is an anti-BCMA CAR-T cell therapy for multiple myeloma [3][11][12] - Both programs are generating encouraging Phase 1 results, reinforcing the potential of these therapies [2] Financial Performance - As of June 30, 2025, Caribou had $183.9 million in cash, down from $249.4 million at the end of 2024 [4][17] - Licensing and collaboration revenue for Q2 2025 was $2.7 million, a decrease from $3.5 million in Q2 2024 [5][18] - Research and development expenses were $27.7 million for Q2 2025, down from $35.5 million in the same period last year [5][18] Losses and Expenses - The company reported a net loss of $54.1 million, or $0.58 per share, for Q2 2025, compared to a net loss of $37.7 million, or $0.42 per share, for Q2 2024 [9][18] - Non-GAAP net loss for Q2 2025, excluding non-cash impairment charges, was $32.8 million, or $0.35 per share [9][19] Strategic Updates - Caribou is interacting with the FDA regarding a potential pivotal trial for CB-010, contingent on positive data and alignment [5][6] - The company plans to present data from both clinical trials in H2 2025, which will include initial safety and efficacy data [5][6]
Caribou Biosciences (CRBU) 2025 Conference Transcript
2025-06-04 14:22
Summary of Caribou Biosciences Conference Call Company Overview - **Company**: Caribou Biosciences - **Technology**: Proprietary next-generation CRISPR technology, referred to as Chardonnay technology - **Programs**: Two off-the-shelf CAR T cell therapies in clinical stages for lymphoma (CB10) and multiple myeloma (CB11) [3][4] Core Insights CAR T Cell Therapy Landscape - **Current State**: Autologous CAR T therapies have transformative outcomes for patients, but only a small percentage can access them (20% for lymphoma, 10% for myeloma) [5][6] - **Opportunity**: Significant unmet medical need exists for allogeneic CAR T therapies, which can be readily available off the shelf [5][6] Program Updates - **CB10 (Lymphoma)**: - Ongoing study shows potential outcomes on par with autologous CAR Ts [3][4] - First patient remains in complete response after four years [8] - Focus on patients with at least four shared HLA alleles, which correlates with better outcomes [9][21] - Data disclosure expected in the second half of the year, with a majority of patients at least six months post-dosing [10][11] - **CB11 (Multiple Myeloma)**: - Initial dose escalation study showed low efficacy; lymphodepletion increased from 300 mg/m² to 500 mg/m², resulting in improved outcomes [32][34] - Data from at least 25 patients expected in the second half of the year [35][36] Regulatory and Development Path - **Pivotal Trial Design**: Discussions with the FDA ongoing; RMAT designation allows proactive engagement [15][16] - **Safety Database**: Sufficient data from phase one studies to inform future pivotal trials [22] Competitive Landscape - **Positioning**: Caribou is the only group in advanced development for second-line large B cell lymphoma, providing a unique competitive advantage [27] - **In Vivo CAR Ts**: Early-stage discussions on the potential of in vivo approaches and their implications for CAR T therapy [28][29] Financial Guidance - **Cash Runway**: Approximately $212 million available, expected to last into the second half of 2027 [42][43] - **Capital Allocation**: Focused on advancing the two primary programs, with discontinuation of other phase one studies and preclinical research [42][43] Additional Insights - **Patient Access**: Only about 10% of patients currently have access to commercial autologous CAR Ts, highlighting the opportunity for allogeneic therapies [41] - **MRD Negativity**: Important metric for assessing depth of response in myeloma therapy, with data to be provided in upcoming updates [36] This summary encapsulates the key points discussed during the conference call, focusing on the company's strategic direction, program updates, regulatory considerations, competitive positioning, and financial outlook.
Caribou Biosciences to Participate in the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 20:00
Company Overview - Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for patients with severe diseases [3] - The company's genome-editing platform utilizes Cas12a chRDNA technology, which offers superior precision for developing cell therapies [3] - Caribou is concentrating on CB-010 and CB-011 as off-the-shelf CAR-T cell therapies aimed at providing broad access and rapid treatment for patients with hematologic malignancies [3] Upcoming Events - Rachel Haurwitz, PhD, the president and CEO of Caribou, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4 at 9:20 AM EDT [1] - A link to the webcast of the event will be available on Caribou's website, and the webcasts will remain accessible for at least 30 days post-event [2]
Caribou Biosciences (CRBU) 2025 Conference Transcript
2025-05-13 22:35
Summary of Caribou Biosciences (CRBU) Conference Call Company Overview - **Company**: Caribou Biosciences (CRBU) - **Industry**: Biotechnology, specifically focused on cell therapies for cancer treatment Key Points Pipeline Strategy - Caribou has prioritized the development of two key programs: **CB10** for lymphoma and **CB11** for myeloma, while discontinuing two phase one programs in AML and lupus [3][4] - The company has extended its cash runway guidance from the second half of 2026 to the second half of 2027, allowing for more strategic advancements in its pipeline [4][28] - The focus on CB10 and CB11 is driven by encouraging efficacy data, particularly CB10 showing potential comparable to autologous CAR T therapies [4][5] Clinical Trials and Efficacy Metrics - For CB10, success will be measured by overall response rate, complete response rate, and duration of response, with a focus on a cohort of 20 patients with partial HLA matching [6][7] - The trial has shifted to include second-line patients, as the initial cohort was primarily third-line and later patients [9][10] - The company aims to demonstrate that modest HLA matching can yield outcomes similar to autologous CAR T therapies [7][8] Market Need and Competitive Landscape - The unmet need for cell therapies is significant, with only **20%** of lymphoma patients and **10%** of myeloma patients currently receiving autologous CAR T therapies [16][17] - Physicians expect AlloCAR therapies to have efficacy on par with bispecific therapies, targeting an overall response rate of **60-70%** [17][21] - The convenience of an off-the-shelf AlloCAR therapy is seen as a critical factor for adoption, addressing both rapid access and scalability [20][21] Manufacturing and Supply Chain - Caribou's manufacturing process allows for **200-300 doses** from a single run, significantly enhancing scalability compared to autologous CAR T strategies [26][27] - The company outsources manufacturing to contract manufacturing organizations (CMOs), allowing flexibility without heavy capital investment in infrastructure [27] Financial Guidance and Future Steps - The current guidance allows for critical data updates but does not include pivotal trials for CB10 or dose expansion for CB11 [28][29] - There is potential for preparatory work for pivotal studies ahead of raising necessary capital [29] Investor Insights - A common investor question revolves around the durability of outcomes for AlloCAR therapies, with evidence from long-term patients showing sustained complete responses [31][32] - The company emphasizes that AlloCAR therapies can indeed drive durable responses, which is a key differentiator in the market [32] Additional Important Insights - The evolving patient characteristics in trials indicate a shift towards a population more representative of those receiving autologous CAR T therapies, enhancing the relevance of the data [10][11] - The company is actively discussing trial designs with the FDA, indicating a proactive approach to regulatory engagement [13] This summary encapsulates the critical insights from the Caribou Biosciences conference call, highlighting the company's strategic focus, clinical developments, market positioning, and financial outlook.
Caribou Biosciences (CRBU) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-05-13 17:00
Core Viewpoint - Caribou Biosciences, Inc. (CRBU) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Caribou Biosciences indicates an expected loss of -$1.37 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 17% [9]. - Over the past three months, the Zacks Consensus Estimate for Caribou Biosciences has increased by 23.2%, suggesting a positive outlook for the company's earnings [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is tracked through EPS estimates from sell-side analysts [2]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has shown an impressive track record, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. - The upgrade of Caribou Biosciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].
Caribou Biosciences(CRBU) - 2025 Q1 - Quarterly Report
2025-05-08 20:19
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Outlines the unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and related notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | ASSETS | March 31, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $29,417 | $16,293 | | Marketable securities, short-term | $179,048 | $193,244 | | Total current assets | $217,323 | $219,377 | | Total assets | $273,656 | $313,313 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $28,491 | $30,651 | | Total liabilities | $56,434 | $60,362 | | Total stockholders' equity | $217,222 | $252,951 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $273,656 | $313,313 | - Total assets decreased by **$39.66 million** from **$313.313 million** as of December 31, 2024, to **$273.656 million** as of March 31, 2025, primarily driven by a decrease in marketable securities (short-term and long-term)[11](index=11&type=chunk) - Total stockholders' equity decreased by **$35.729 million** from **$252.951 million** as of December 31, 2024, to **$217.222 million** as of March 31, 2025, mainly due to the accumulated deficit increasing to **$488.381 million**[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Licensing and collaboration revenue | $2,353 | $2,429 | | Research and development | $35,531 | $33,788 | | General and administrative | $9,735 | $14,643 | | Total operating expenses | $45,266 | $48,431 | | Loss from operations | $(42,913) | $(46,002) | | Net loss | $(39,991) | $(41,234) | | Net loss per share, basic and diluted | $(0.43) | $(0.46) | - Net loss decreased by **$1.243 million**, from **$41.234 million** in Q1 2024 to **$39.991 million** in Q1 2025, primarily due to a significant decrease in general and administrative expenses[13](index=13&type=chunk) - Operating expenses decreased by **$3.165 million**, from **$48.431 million** in Q1 2024 to **$45.266 million** in Q1 2025, mainly driven by a **$4.908 million** reduction in general and administrative expenses[13](index=13&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Changes in Stockholders' Equity (in thousands) | Item | December 31, 2024 | March 31, 2025 | | :-------------------------------- | :---------------- | :------------- | | Total Stockholders' Equity | $252,951 | $217,222 | | Additional Paid-In Capital | $701,077 | $705,427 | | Accumulated Deficit | $(448,390) | $(488,381) | | Common Stock Shares Outstanding | 92,378,577 | 93,004,602 | - Total stockholders' equity decreased by **$35.729 million** from December 31, 2024, to March 31, 2025, primarily due to a net loss of **$39.991 million**, partially offset by **$3.882 million** in stock-based compensation expense and **$0.468 million** from ESPP issuances[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(36,725) | $(37,203) | | Net cash provided by investing activities | $49,381 | $22,956 | | Net cash provided by financing activities | $468 | $12,485 | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $13,124 | $(1,762) | | Cash, cash equivalents, and restricted cash — End of Period | $29,463 | $49,446 | - Net cash used in operating activities slightly decreased by **$0.478 million** to **$36.725 million** in Q1 2025 compared to **$37.203 million** in Q1 2024[19](index=19&type=chunk) - Net cash provided by investing activities significantly increased by **$26.425 million** to **$49.381 million** in Q1 2025, primarily due to lower purchases of marketable securities[19](index=19&type=chunk) - Net cash provided by financing activities substantially decreased by **$12.017 million** to **$0.468 million** in Q1 2025, mainly due to the absence of common stock issuances under the ATM Sales Agreement, which provided **$11.329 million** in Q1 2024[19](index=19&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Description of the Business, Organization, and Liquidity](index=7&type=section&id=1.%20Description%20of%20the%20Business%2C%20Organization%2C%20and%20Liquidity) - Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing allogeneic CAR-T cell therapies for devastating diseases[22](index=22&type=chunk) - The company has incurred operating losses and negative cash flows since inception, with an accumulated deficit of **$488.4 million** as of March 31, 2025[24](index=24&type=chunk) - Management expects existing cash, cash equivalents, and marketable securities of **$212.5 million** as of March 31, 2025, to fund operations for at least the next 12 months[24](index=24&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - No changes to significant accounting policies disclosed in the annual consolidated financial statements for the year ended December 31, 2024[25](index=25&type=chunk) - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include accounts of wholly-owned subsidiaries, with intercompany transactions eliminated[26](index=26&type=chunk) Licensee Revenue and Accounts Receivable/Contract Assets Concentration | Licensee | Revenue (3 Months Ended March 31, 2025) | Revenue (3 Months Ended March 31, 2024) | Accounts Receivable and Contract Assets (As of March 31, 2025) | Accounts Receivable and Contract Assets (As of December 31, 2024) | | :--------- | :-------------------------------------- | :-------------------------------------- | :------------------------------------------------------------- | :------------------------------------------------------------- | | Licensee A | 26.2 % | 25.3 % | * | * | | Licensee B | 16.8 % | 23.1 % | 60.7 % | 49.3 % | | Licensee C | 26.4 % | 25.6 % | * | * | | Licensee D | * | * | 10.9 % | * | | Total | 69.4 % | 74.0 % | 71.6 % | 49.3 % | - The company is evaluating the impact of new accounting pronouncements ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation), not expecting a material impact from ASU 2023-09[31](index=31&type=chunk)[32](index=32&type=chunk) [3. Fair Value Measurements and Fair Value of Financial Instruments](index=9&type=section&id=3.%20Fair%20Value%20Measurements%20and%20Fair%20Value%20of%20Financial%20Instruments) - Financial instruments are classified into Level 1 (money market funds, U.S. Treasury bills), Level 2 (commercial paper, corporate debt securities, U.S. government agency bonds), and Level 3 (MSKCC success payments liability) based on observability of inputs[33](index=33&type=chunk) Fair Value Measurements of Assets and Liabilities (in thousands) | Category | Total (March 31, 2025) | Level 1 (March 31, 2025) | Level 2 (March 31, 2025) | Level 3 (March 31, 2025) | | :-------------------------------- | :--------------------- | :----------------------- | :----------------------- | :----------------------- | | Total fair value of assets | $212,452 | $149,944 | $62,508 | $0 | | Total fair value of liabilities | $451 | $0 | $0 | $451 | | Total (December 31, 2024) | $249,386 | $181,123 | $68,263 | $0 | | Total (December 31, 2024) | $785 | $0 | $0 | $785 | - The MSKCC success payments liability, a Level 3 financial instrument, decreased from **$785 thousand** as of December 31, 2024, to **$451 thousand** as of March 31, 2025, reflecting a **$334 thousand** gain recognized in other income[34](index=34&type=chunk)[37](index=37&type=chunk) - Key assumptions for MSKCC success payments liability valuation include a common stock fair value of **$0.91 per share** as of March 31, 2025 (down from **$1.59** as of December 31, 2024), a risk-free interest rate of **4.58%**, and expected volatility of **105%**[38](index=38&type=chunk) [4. Significant Agreements](index=12&type=section&id=4.%20Significant%20Agreements) - No material changes to significant agreements since December 31, 2024[39](index=39&type=chunk) - Agreements include nonrefundable upfront payments, annual license maintenance fees, sublicensing fees, patent prosecution reimbursements, success payments, regulatory/clinical/commercial milestones, and royalty payments, contingent on milestones and agreement effectiveness[40](index=40&type=chunk) - As of March 31, 2025, potential future payments for development, regulatory, and sales milestones under license and assignment agreements totaled approximately **$159.9 million**[42](index=42&type=chunk) [5. Revenue](index=12&type=section&id=5.%20Revenue) Revenue by Geographic Location (in thousands) | Geographic Location | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------ | :-------------------------------- | :-------------------------------- | | United States | $2,224 | $2,269 | | Rest of world | $129 | $160 | | Total | $2,353 | $2,429 | - The company recognized **$1.8 million** of revenue from performance obligations satisfied at a point in time and **$0.6 million** from performance obligations satisfied over time for both Q1 2025 and Q1 2024[43](index=43&type=chunk) - Transaction prices allocated to remaining unsatisfied performance obligations were approximately **$5.4 million** as of March 31, 2025, down from **$8.3 million** as of March 31, 2024. Approximately **$2.8 million** is expected to be recognized in the next 12 months[48](index=48&type=chunk) [6. Balance Sheet Items](index=14&type=section&id=6.%20Balance%20Sheet%20Items) Prepaid Expenses and Other Current Assets (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Prepaid contract manufacturing and clinical costs | $3,315 | $3,919 | | Prepaid insurance | $540 | $889 | | Other | $2,263 | $1,781 | | Total | $6,118 | $6,589 | Property and Equipment, Net (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Total property and equipment, gross | $32,569 | $32,166 | | Less: accumulated depreciation and amortization | $(14,050) | $(12,885) | | Property and equipment, net | $18,519 | $19,281 | Accrued Expenses and Other Current Liabilities (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Accrued research and development expenses | $12,530 | $12,020 | | Accrued employee compensation and related expenses | $4,518 | $8,560 | | Accrued patent expenses | $731 | $769 | | Accrued expenses related to sublicensing revenues | $565 | $592 | | Other | $1,544 | $1,679 | | Total | $19,888 | $23,620 | [7. Related Party Transactions](index=14&type=section&id=7.%20Related%20Party%20Transactions) - No new related party transactions since December 31, 2024, except as noted[52](index=52&type=chunk) - Recognized **$0.6 million** in revenue from the Information Rights Agreement with Pfizer for both Q1 2025 and Q1 2024[53](index=53&type=chunk) - Related party deferred revenue from Pfizer was approximately **$3.1 million** as of March 31, 2025 (**$2.5 million** current, **$0.6 million** long-term), down from **$3.7 million** as of December 31, 2024[53](index=53&type=chunk) [8. Commitments and Contingencies](index=15&type=section&id=8.%20Commitments%20and%20Contingencies) - The company enters into various cancellable agreements (CMOs, CROs, licensors) in the ordinary course of business, with contingent payments for milestones that are uncertain to estimate[54](index=54&type=chunk) - No material indemnification claims were probable or reasonably possible as of March 31, 2025, or December 31, 2024[55](index=55&type=chunk) - The Bergman class action lawsuit was settled for **$3.9 million**, with final approval granted on February 18, 2025. The Saylor class action lawsuit was voluntarily dismissed without prejudice on April 27, 2025. Two shareholder derivative complaints were consolidated into a single action, which is at a preliminary stage[57](index=57&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk) [9. Common Stock](index=16&type=section&id=9.%20Common%20Stock) Common Stock Reserved for Future Issuances | Item | As of March 31, 2025 | As of December 31, 2024 | | :-------------------------------- | :------------------- | :---------------------- | | Stock options, issued and outstanding | 14,022,265 | 10,782,103 | | Stock options, authorized for future issuances | 7,902,961 | 7,618,931 | | Stock available under ESPP | 2,655,169 | 2,139,666 | | Unvested RSUs | 2,217,789 | 1,297,327 | | Total common stock reserved for future issuances | 26,798,184 | 21,838,027 | - The company has a shelf registration statement on Form S-3, effective until August 16, 2025, allowing for the sale of up to **$400.0 million** of various securities, with **$239.4 million** remaining available as of March 31, 2025[62](index=62&type=chunk)[113](index=113&type=chunk) - Under its at-the-market (ATM) equity offering program, the company did not issue any shares during Q1 2025, but issued **1,594,171 shares** for **$11.3 million** net proceeds in Q1 2024[63](index=63&type=chunk)[64](index=64&type=chunk) [10. Stock-Based Compensation](index=16&type=section&id=10.%20Stock-Based%20Compensation) Stock Option Activity (Three Months Ended March 31, 2025) | Item | Stock Options | Weighted Average Exercise Price | | :-------------------------------- | :------------ | :------------------------------ | | Outstanding at December 31, 2024 | 10,782,103 | $7.47 | | Options granted | 3,335,888 | $1.43 | | Options cancelled or forfeited | (95,726) | $7.53 | | Outstanding at March 31, 2025 | 14,022,265 | $6.04 | | Exercisable at March 31, 2025 | 6,515,145 | $8.14 | - The weighted average grant date fair value for stock options granted in Q1 2025 was **$1.07** (**3,335,888 options**), significantly lower than **$4.59** in Q1 2024 (**2,913,727 options**)[67](index=67&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Research and development | $1,743 | $1,617 | | General and administrative | $2,139 | $2,371 | | Total | $3,882 | $3,988 | | Stock options | $3,175 | $3,489 | | RSUs | $585 | $427 | | ESPP | $122 | $72 | - Total unrecognized stock-based compensation expense was **$21.1 million** for employee stock options (expected over **2.8 years**) and **$6.1 million** for unvested RSUs (expected over **3.2 years**) as of March 31, 2025[67](index=67&type=chunk)[69](index=69&type=chunk) [11. Income Taxes](index=18&type=section&id=11.%20Income%20Taxes) - No income tax expense was recorded for the three months ended March 31, 2025, and March 31, 2024, due to operating losses[72](index=72&type=chunk) [12. Net Loss Per Share](index=19&type=section&id=12.%20Net%20Loss%20Per%20Share) Net Loss Per Share (in thousands, except share and per share amounts) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss | $(39,991) | $(41,234) | | Weighted-average common shares outstanding, basic and diluted | 92,679,493 | 89,302,937 | | Net loss per share, basic and diluted | $(0.43) | $(0.46) | - Basic and diluted net loss per share are the same due to the company being in a net loss position, making all common stock equivalents anti-dilutive[73](index=73&type=chunk) Potentially Dilutive Securities (Anti-Dilutive) | Item | As of March 31, 2025 | As of March 31, 2024 | | :------------------------ | :------------------- | :------------------- | | Stock options outstanding | 14,022,265 | 12,094,332 | | RSUs issued and outstanding | 2,217,789 | 1,128,191 | | Shares committed under ESPP | 509,727 | 108,788 | | Total | 16,749,781 | 13,331,311 | [13. Segment Information](index=19&type=section&id=13.%20Segment%20Information) - The company operates as a single reportable segment focused on developing allogeneic CAR-T cell therapies[74](index=74&type=chunk) - The Chief Operating Decision Maker (CODM) assesses performance and allocates resources based on consolidated net loss[74](index=74&type=chunk) Reportable Segment Profit and Loss (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Licensing and collaboration revenue | $2,353 | $2,429 | | Research and development | $32,736 | $31,574 | | General and administrative | $7,484 | $12,158 | | Other segment items | $4,712 | $4,396 | | Other income, net | $(2,588) | $(4,465) | | Segment and consolidated net loss | $(39,991) | $(41,234) | [14. Subsequent Events](index=20&type=section&id=14.%20Subsequent%20Events) - On April 24, 2025, the company announced a strategic pipeline prioritization, discontinuing the GALLOP phase 1 trial (CB-010 for lupus), AMpLify phase 1 clinical trial (CB-012 for AML), and preclinical research to focus on CB-010 and CB-011 oncology programs[76](index=76&type=chunk) - The strategic prioritization included a workforce reduction of **47 employees** (approximately **32%** of the company), with estimated expenses of **$2.5 million** to **$3.5 million** for severance and clinical trial wind-down costs[76](index=76&type=chunk) - On May 7, 2025, the company received a Nasdaq deficiency letter for its common stock closing below **$1.00** for **30 consecutive business days**, initiating a **180-calendar day** period to regain compliance[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's analysis of financial condition and operations, detailing business overview, strategic shifts, and financial performance [Overview](index=21&type=section&id=Overview) - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company developing allogeneic CAR-T cell therapies, utilizing its chRDNA technology for precise genome editing[81](index=81&type=chunk) - The company is advancing two clinical-stage allogeneic CAR-T cell therapies for hematologic malignancies: CB-010 (anti-CD19 for r/r B-NHL) and CB-011 (anti-BCMA for r/r MM). CB-010 has RMAT and fast track designations, while CB-011 has fast track designation[82](index=82&type=chunk)[83](index=83&type=chunk) - A strategic pipeline prioritization on April 24, 2025, led to the discontinuation of the GALLOP (CB-010 for lupus) and AMpLify (CB-012 for AML) clinical trials and preclinical research, along with a **32%** workforce reduction, to focus resources on CB-010 and CB-011 oncology programs[85](index=85&type=chunk)[76](index=76&type=chunk) - The company has incurred operating losses since inception, with a net loss of **$40.0 million** in Q1 2025 and an accumulated deficit of **$488.4 million** as of March 31, 2025[88](index=88&type=chunk) [Components of Results of Operations](index=23&type=section&id=Components%20of%20Results%20of%20Operations) - All revenue to date is from licensing and collaboration agreements, including upfront fees, annual maintenance fees, milestone payments, R&D payments, and royalties[91](index=91&type=chunk) - Research and development expenses include external costs (CMO/CRO services, licenses) and internal costs (personnel, facilities). These costs are expensed as incurred, with prepaid amounts deferred[94](index=94&type=chunk)[97](index=97&type=chunk) - General and administrative expenses primarily cover personnel, intellectual property, consulting, and allocated overhead. These are expected to increase with clinical trial success and potential commercialization[101](index=101&type=chunk)[102](index=102&type=chunk) - Other income mainly consists of interest income from cash and marketable securities and changes in the fair value of the MSKCC success payments liability[103](index=103&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Summary of Results of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | :----- | | Licensing and collaboration revenue | $2,353 | $2,429 | $(76) | | Research and development | $35,531 | $33,788 | $1,743 | | General and administrative | $9,735 | $14,643 | $(4,908) | | Total operating expenses | $45,266 | $48,431 | $(3,165) | | Loss from operations | $(42,913) | $(46,002) | $3,089 | | Net loss | $(39,991) | $(41,234) | $1,243 | - Licensing and collaboration revenue slightly decreased by **$0.076 million** to **$2.353 million** in Q1 2025, with Pfizer contributing **$0.622 million** in both periods[105](index=105&type=chunk)[106](index=106&type=chunk) - Research and development expenses increased by **$1.7 million** to **$35.5 million** in Q1 2025, driven by a **$3.9 million** increase in external CMO and CRO activities, partially offset by a **$2.5 million** decrease in license-related expenses[107](index=107&type=chunk) - General and administrative expenses decreased significantly by **$4.9 million** to **$9.7 million** in Q1 2025, primarily due to a **$4.5 million** reduction in legal expenses, including a **$3.9 million** securities class action litigation settlement expense in Q1 2024[108](index=108&type=chunk) - Total other income decreased by **$1.8 million** in Q1 2025, mainly due to a **$1.9 million** decrease in interest income from marketable securities[109](index=109&type=chunk)[110](index=110&type=chunk) [Liquidity, Capital Resources, and Capital Requirements](index=27&type=section&id=Liquidity%2C%20Capital%20Resources%2C%20and%20Capital%20Requirements) - As of March 31, 2025, the company had **$212.5 million** in cash, cash equivalents, and marketable securities[112](index=112&type=chunk) - Management expects existing capital to fund operations for at least the next 12 months[115](index=115&type=chunk) - The company has a shelf registration statement with **$239.4 million** available as of March 31, 2025, and an ATM equity offering program with **$83.1 million** remaining[113](index=113&type=chunk) - Future funding requirements are dependent on clinical trial progress, regulatory approvals, manufacturing, personnel, intellectual property, and potential commercialization, with continued reliance on equity/debt financing or collaborations[117](index=117&type=chunk)[119](index=119&type=chunk) [Strategic Investment](index=30&type=section&id=Strategic%20Investment) - On June 29, 2023, Pfizer invested approximately **$25.0 million** in Caribou Biosciences by purchasing **4,690,431 shares** of common stock at **$5.33 per share**[121](index=121&type=chunk) - Proceeds from the Pfizer Investment are to be used for the development program of the allogeneic anti-BCMA CAR-T cell therapy product candidate (CB-011) for **36 months**[121](index=121&type=chunk) - An Information Rights Agreement grants Pfizer a **30-day** right of first negotiation for potential grants of rights to develop/commercialize a BCMA Product Candidate and provides Pfizer with quarterly updates and access to clinical data[122](index=122&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Cash used in operating activities | $(36,725) | $(37,203) | $478 | | Cash provided by investing activities | $49,381 | $22,956 | $26,425 | | Cash provided by financing activities | $468 | $12,485 | $(12,017) | | Net increase (decrease) in cash, and cash equivalents, and restricted cash | $13,124 | $(1,762) | $14,886 | - Net cash provided by investing activities increased significantly by **$26.4 million** in Q1 2025, primarily due to lower purchases of marketable securities[125](index=125&type=chunk) - Net cash provided by financing activities decreased by **$12.0 million** in Q1 2025, mainly due to the absence of proceeds from ATM common stock issuances, which occurred in Q1 2024[126](index=126&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - No material changes to critical accounting policies or estimates since the audited consolidated financial statements for the year ended December 31, 2024[127](index=127&type=chunk) [Recently Issued Accounting Pronouncements](index=31&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - Refer to Note 2 for information regarding recently issued accounting pronouncements, including ASU 2023-09 and ASU 2024-03[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) States no material changes to market risk exposure during the quarter, referring to the previous Form 10-K for detailed discussion - No material changes to market risk during the three months ended March 31, 2025[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[131](index=131&type=chunk) - No changes in internal control over financial reporting materially affected or are reasonably likely to materially affect internal control during the three months ended March 31, 2025[132](index=132&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) Details the company's legal proceedings, including class action lawsuits and shareholder derivative complaints, with updates on settlements and dismissals - The Bergman class action lawsuit, challenging disclosures related to CB-010, was settled for **$3.9 million**, with final court approval granted on February 18, 2025[135](index=135&type=chunk) - The Saylor class action lawsuit, alleging violations of the Exchange Act regarding CB-010's safety, efficacy, and financial statements, was voluntarily dismissed without prejudice on April 27, 2025[136](index=136&type=chunk) - Two shareholder derivative complaints, alleging breach of fiduciary duties by directors and officers, were consolidated into a single action (In re Caribou Biosciences, Inc. Derivative Litigation) and are currently in the preliminary stage[137](index=137&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, primarily concerning Nasdaq minimum bid price non-compliance, potential delisting, and impacts of a reverse stock split - The company is not in compliance with Nasdaq's Minimum Bid Price Rule, having received a deficiency letter on May 7, 2025, due to its common stock closing below **$1.00** for **30 consecutive business days**[139](index=139&type=chunk) - The company has **180 calendar days** (until November 3, 2025) to regain compliance by having its stock close at or above **$1.00** for at least **10 consecutive business days**[140](index=140&type=chunk) - A reverse stock split may be implemented to regain compliance, but there is no assurance it will sustain the stock price or prevent delisting, and it could lead to dilution from future issuances[141](index=141&type=chunk)[144](index=144&type=chunk) - Delisting from Nasdaq could negatively impact liquidity, market price, investor interest, ability to raise equity financing, and the company's reputation[142](index=142&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Confirms no unregistered sales of equity securities by the company during the three months ended March 31, 2025 - No unregistered sales of equity securities occurred during the three months ended March 31, 2025[145](index=145&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) Provides details on the Nasdaq deficiency notice, plans to address it, Rule 10b5-1 trading arrangements, and an advisory consulting agreement - The company received a Nasdaq Notice on May 7, 2025, for non-compliance with the **$1.00** minimum bid price rule, with a compliance deadline of November 3, 2025[146](index=146&type=chunk)[147](index=147&type=chunk) - The company is monitoring its stock price and evaluating options, including a potential reverse stock split, which requires stockholder approval at the upcoming June 12, 2025, Annual Meeting[149](index=149&type=chunk) - CFO Sriram Ryali entered into a Rule 10b5-1 'sell-to-cover' trading arrangement for RSUs on January 2, 2025. CEO Rachel Haurwitz's similar arrangement was modified on February 5, 2025, to allow cash payment of withholding taxes for a specific RSU vesting[151](index=151&type=chunk)[152](index=152&type=chunk) - Steven B. Kanner, Ph.D., the Chief Scientific Officer, will retire on June 30, 2025, and has entered into a one-year advisory consulting agreement, effective July 1, 2025, for **$6,400 per month**[154](index=154&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including corporate governance documents, employment agreements, certifications, and XBRL documents - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Description of Common Stock, Officer Employment Agreement for Sri Ryali, Advisory Consulting Agreement for Steven B. Kanner, and various certifications (302 and 906)[155](index=155&type=chunk) - XBRL instance and taxonomy documents are also filed as exhibits[155](index=155&type=chunk) [Signatures](index=37&type=section&id=Signatures) Contains the required signatures of the principal executive and financial officers, certifying the report's filing - The report is signed by Rachel E. Haurwitz, President and Chief Executive Officer, and Sriram Ryali, Chief Financial Officer, on May 8, 2025[160](index=160&type=chunk)
Caribou Biosciences(CRBU) - 2025 Q1 - Quarterly Results
2025-05-08 20:06
[Form 8-K: Caribou Biosciences, Inc. Current Report](index=1&type=section&id=Form%208-K%3A%20Caribou%20Biosciences%2C%20Inc.%20Current%20Report) This Form 8-K details Caribou Biosciences' strategic pipeline prioritization, cost reductions, and clinical trial timeline updates [Results of Operations and Financial Condition](index=2&type=section&id=Item%202%2E02%20Results%20of%20Operations%20and%20Financial%20Condition) Caribou Biosciences reported a preliminary unaudited cash balance of **$212.5 million** as of March 31, 2025, and announced strategic pipeline prioritization Preliminary Cash, Cash Equivalents, and Marketable Securities | Metric | Value (Preliminary, Unaudited) | | :--- | :--- | | Cash, cash equivalents, and marketable securities | $212.5 million | - The announced financial estimate is **preliminary** and may be **materially different** from the final reported figures for the quarter ended March 31, 2025, as the company finalizes its financial statements[7](index=7&type=chunk) [Costs Associated with Exit or Disposal Activities](index=2&type=section&id=Item%202%2E05%20Costs%20Associated%20with%20Exit%20or%20Disposal%20Activities) Caribou is undergoing strategic restructuring, including a **32%** workforce reduction and **$2.5M-$3.5M** in charges, to extend its cash runway into H2 2027 - The company is prioritizing its lead oncology programs: **CB-010** (ANTLER trial for B cell non-Hodgkin lymphoma) and **CB-011** (CaMMouflage trial for multiple myeloma)[9](index=9&type=chunk) - The company has discontinued: the **GALLOP** phase 1 trial (CB-010 for lupus), the **AMpLify** phase 1 trial (CB-012 for acute myeloid leukemia), and **all preclinical research**[9](index=9&type=chunk) Workforce Reduction Details | Metric | Value | | :--- | :--- | | Workforce Reduction | 47 employees (~32%) | | Expected Completion | End of Q2 2025 | Estimated Restructuring Costs | Cost Category | Estimated Amount | Expected Timing | | :--- | :--- | :--- | | **Total Restructuring Costs** | **$2.5M - $3.5M** | - | | Workforce Reduction Costs | $1.8M - $2.0M | Q2 2025 | | Clinical Trial Wind-down Costs | $0.7M - $1.5M | Through Q3 2025 | - As a result of the restructuring, the company's cash runway is now expected to fund operations into the **second half of 2027**[11](index=11&type=chunk) [Other Events](index=3&type=section&id=Item%208%2E01%20Other%20Events) Caribou announced updated timelines for presenting ANTLER and CaMMouflage clinical trial data in H2 2025 - Initial data from the ANTLER phase 1 trial's confirmatory cohort (CB-010 in 2L LBCL) is now planned for presentation in **H2 2025**, with at least six months of follow-up for most patients[13](index=13&type=chunk) - Dose escalation data from the CaMMouflage phase 1 trial (CB-011 in r/r MM) is also planned for presentation in **H2 2025**, including data from at least 25 patients[13](index=13&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209%2E01%20Financial%20Statements%20and%20Exhibits) This section lists the Form 8-K exhibits, primarily the press release detailing strategic changes and financial updates Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release Issued by Caribou Biosciences, Inc. on April 24, 2025 |
Caribou Biosciences Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 20:05
Core Insights - Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focusing on developing allogeneic CAR-T cell therapies for hematologic malignancies, with two lead programs, CB-010 and CB-011, expected to disclose clinical data in H2 2025 [1][2][17] Financial Overview - As of March 31, 2025, Caribou had $212.5 million in cash, cash equivalents, and marketable securities, down from $249.4 million as of December 31, 2024, which is expected to fund operations into H2 2027 [10][21] - Licensing and collaboration revenue for Q1 2025 was $2.4 million, consistent with the same period in 2024 [11] - Research and development expenses increased to $35.5 million in Q1 2025 from $33.8 million in Q1 2024, primarily due to ongoing clinical trials [12] - General and administrative expenses decreased to $9.7 million in Q1 2025 from $14.6 million in Q1 2024, attributed to lower legal and personnel-related expenses [13] - The net loss for Q1 2025 was $40.0 million, slightly improved from a net loss of $41.2 million in Q1 2024 [14] Clinical Program Updates - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for large B cell lymphoma, while CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma [3][4] - Caribou is currently enrolling a 20-patient confirmatory cohort in the ANTLER Phase 1 clinical trial for CB-010, with data expected in H2 2025 [7][8] - Encouraging efficacy has been observed in the ongoing CaMMouflage Phase 1 clinical trial for CB-011, with plans to present data in H2 2025 [7][18] Strategic Initiatives - The company has implemented a strategic pipeline prioritization, focusing resources on lead oncology programs and reducing workforce by approximately 32%, which is expected to extend the cash runway by one year [5][10] - Discontinued clinical trials include CB-010 for lupus and CB-012 for relapsed or refractory acute myeloid leukemia, with ongoing follow-up for patients previously treated [5]
Caribou Biosciences to Participate in the BofA Securities 2025 Health Care Conference
GlobeNewswire News Room· 2025-05-06 20:00
Company Overview - Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for patients with severe diseases [3] - The company's genome-editing platform utilizes Cas12a chRDNA technology, which offers superior precision for developing cell therapies aimed at improving activity against diseases [3] Product Focus - Caribou is concentrating on two off-the-shelf CAR-T cell therapies, CB-010 and CB-011, which have the potential to provide broad access and rapid treatment for patients suffering from hematologic malignancies [3] Upcoming Events - Rachel Haurwitz, PhD, the president and CEO of Caribou, will participate in a fireside chat at the BofA Securities 2025 Health Care Conference on May 13th at 2:35 PM PDT [1] - Webcasts of the event will be available on Caribou's website for at least 30 days following the event [2]