[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 |

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]

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]

Core Insights - Caribou Biosciences is strategically prioritizing its lead oncology programs, CB-010 and CB-011, while implementing workforce and cost reduction initiatives to extend its cash runway into H2 2027 [1][13] - The company plans to disclose robust clinical datasets for CB-010 and CB-011 in H2 2025, which are expected to demonstrate efficacy in treating hematologic malignancies [2][14] Pipeline Prioritization - Caribou is focusing resources on CB-010 and CB-011, discontinuing the GALLOP Phase 1 trial for lupus and the AMpLify Phase 1 trial for acute myeloid leukemia [5][7] - The workforce reduction is approximately 32%, with expected cash savings of $2.5 to $3.5 million from these strategic decisions [13] Clinical Programs - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma, with data expected to show outcomes comparable to approved autologous CAR-T therapies [6][10] - CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma, with ongoing dose escalation trials showing encouraging efficacy [4][11] Financial Position - As of March 31, 2025, Caribou expects to report $212.5 million in cash, cash equivalents, and marketable securities [8] - The strategic changes are anticipated to extend the company's cash runway by one year, allowing operations to continue into H2 2027 [13] Upcoming Milestones - In H2 2025, Caribou plans to present data from the ANTLER Phase 1 trial for CB-010, including safety and efficacy data from a 20-patient cohort [14] - For CB-011, the company will present dose escalation data and recommended doses for expansion from the ongoing CaMMouflage Phase 1 trial [14]

Group 1: Earnings Performance - Caribou Biosciences reported a quarterly loss of $0.39 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.40, and consistent with the loss of $0.39 per share from the previous year, indicating an earnings surprise of 2.50% [1] - The company posted revenues of $2.08 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 18.23%, and down from $3.56 million in the same quarter last year [2] - Over the last four quarters, Caribou has surpassed consensus EPS estimates three times, but has only topped revenue estimates once [2] Group 2: Stock Performance and Outlook - Caribou Biosciences shares have declined approximately 27% since the beginning of the year, contrasting with the S&P 500's decline of 1.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.44 on revenues of $3.5 million, and for the current fiscal year, it is -$1.78 on revenues of $11.4 million [7] - The estimate revisions trend for Caribou is currently unfavorable, resulting in a Zacks Rank 4 (Sell), indicating expected underperformance in the near future [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Caribou belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Clinical Development - The company is advancing four clinical-stage allogeneic CAR-T cell therapy programs targeting hematologic malignancies and autoimmune diseases, with CB-010 receiving RMAT designation for relapsed or refractory large B cell lymphoma (r/r LBCL) and fast track designations for r/r B-NHL and refractory systemic lupus erythematosus (SLE) from the FDA[32]. - CB-010 is being evaluated in the ANTLER phase 1 clinical trial with 16 patients enrolled at three dose levels: 40x10, 80x10, and 120x10 viable CAR-T cells, with dose level 2 (80x10) selected as the recommended phase 2 dose (RP2D)[40]. - In the ANTLER trial, patients receiving CB-010 from donors with at least four matching HLA alleles showed improved progression-free survival (PFS) compared to those with fewer matches[41]. - CB-011, an anti-BCMA CAR-T cell therapy, is being evaluated in the CaMMouflage phase 1 clinical trial, with dose levels ranging from 50x10 to 800x10 viable CAR-T cells cleared without any observed dose-limiting toxicities (DLTs)[43]. - CB-012, an anti-CLL-1 CAR-T cell therapy, is being evaluated in the AMpLify phase 1 clinical trial, with dose levels from 25x10 to 300x10 viable CAR-T cells cleared without DLTs[43]. - The ongoing clinical trials for CB-010 are being conducted in multiple countries, including the United States, Australia, and Israel, indicating a broad geographical focus for its clinical development[58]. - A total of 46 patients were evaluated in the ANTLER trial, showing a safety profile consistent with anti-CD19 CAR-T therapies, with no grade 3+ cytokine release syndrome (CRS) observed[72]. - The GALLOP phase 1 trial is evaluating CB-010 for LN and ERL, focusing on safety and initial clinical activity with a single dose of 80x10 viable CAR-T cells[76]. - CB-011 has received fast track and orphan drug designations for r/r MM from the FDA, indicating significant regulatory support[81]. - CB-012 is being evaluated in the AMpLify phase 1 trial for r/r AML, utilizing a fully human scFv targeting CLL-1 licensed from MSKCC[88]. - The AMpLify trial is designed to assess the maximum tolerated dose (MTD) and overall response rate (ORR) at active dose levels of CB-012[95]. Technology and Innovation - The company is developing in vivo genome-editing capabilities using Cas12a chRDNA guides, aiming to demonstrate functional gene disruptions in animal models[44]. - The company’s chRDNA genome-editing technologies enable enhanced activity of allogeneic cell therapies through strategies like checkpoint disruption and immune cloaking, improving genomic integrity and reducing off-target edits[36]. - The chRDNA technology demonstrates a gene insertion efficiency of approximately 76-80% for site-specific gene insertions, with over 60% of manufacturing-scale CAR-T cells achieving all four intended edits[52]. - The chRDNA platform is designed to reduce off-target editing events significantly compared to first-generation CRISPR systems, enhancing the specificity of genome editing[51]. - The company employs immune cloaking strategies to enhance the persistence of CAR-T cells in circulation, aiming to reduce rapid immune-mediated rejection[56]. - The company aims to enhance CAR-T cell activity by employing a PD-1 knockout strategy, which is expected to maintain CAR-T cells in a higher activity state for a longer duration, potentially improving therapeutic outcomes[54][59]. - The company is focused on developing allogeneic CAR-T cell therapies targeting hematologic malignancies and autoimmune diseases, utilizing its chRDNA genome-editing technologies[48]. - The company is exploring strategic collaborations to maximize the value of its genome-editing technologies across multiple indications[102]. Market Opportunity - The estimated number of individuals diagnosed with NHL in the U.S. in 2024 is 80,620, representing 4% of all cancers, highlighting the significant market opportunity for the company's therapies[62]. - Allogeneic CAR-T cell therapies offer broad patient access, with only approximately 20% of patients currently receiving commercially available autologous CAR-T therapies due to long wait times and manufacturing limitations[34]. - The company is developing additional allogeneic CAR-T cell therapies against targets with limited treatment options, such as CB-012 for r/r AML[48]. Financial Overview - For the years ended December 31, 2024, and 2023, the company incurred net losses of $149.1 million and $102.1 million, respectively, with an accumulated deficit of $448.4 million as of December 31, 2024[218]. - The company has not commercialized any products and has never generated revenue from product sales, focusing almost all financial resources on research and development[218]. - The company anticipates continued significant operating losses as it seeks to advance product candidates through preclinical development and clinical trials[219]. - The company anticipates substantial additional financing will be needed for the development and commercialization of its product candidates, particularly for CAR-T cell therapy[222]. - Future capital requirements may increase significantly due to factors such as establishing a sales and marketing infrastructure and potential royalty payments[224]. - The company expects to finance cash needs through equity offerings, debt financings, and strategic collaborations until substantial product revenues are generated[229]. - Significant commercialization expenses are anticipated if marketing approval is obtained for product candidates, especially if no partners are found to share costs[222]. Regulatory Environment - The regulatory framework for biologics requires substantial time and financial resources for compliance with various authorities, including the FDA and EMA[133]. - The IND application must be submitted and cleared by the FDA before initiating human clinical trials, with a 30-day automatic effectiveness period unless a clinical hold is placed[137]. - The FDA requires a clinical trial sponsor to submit a diversity action plan for clinical trials, which must include enrollment goals by sex, ethnicity, and age, unless a waiver is granted[142]. - The FDA has established a timeline for reviewing resubmissions, with two months for class 1 and six months for class 2 resubmissions[158]. - The FDA's approval of a BLA is contingent upon the product candidate being safe, pure, and potent, and the manufacturing facility meeting required standards[153]. - The FDA may impose post-approval studies, including phase 4 clinical trials, and may require testing and surveillance programs to monitor products after commercialization[159]. - Current product candidates have been designated as fast track products, allowing for greater interactions with the FDA and potential rolling reviews of applications[161]. - Breakthrough therapy designations may be granted if preliminary clinical evidence indicates substantial improvement over available therapies[162]. - Orphan drug designation is available for drugs intended for rare diseases, providing exclusivity for seven years if the drug is the first approved for that indication[174]. Competition and Market Landscape - The company faces substantial competition from larger pharmaceutical companies and academic institutions, which have greater financial and technical resources[125]. - Autologous T cell therapies directed at CD19, such as Kymriah®, Yescarta®, and Breyanzi®, are experiencing increased market adoption[127]. - 2seventy bio's Abecma® and Legend Biotech's Carvykti® have shown success in pivotal trials for earlier lines of r/r MM and are expected to gain label extensions[127]. Employee and Community Engagement - The company has 147 total employees, all of whom are full-time, with 39 holding advanced degrees[203]. - The company has implemented a comprehensive talent strategy, including competitive salaries and performance-based incentives, to attract and retain talent[204]. - The company is committed to environmental sustainability, offering pre-tax commuter benefits and promoting bicycle use among employees[213][214]. - The company has established a culture advisory group to enhance workplace culture based on employee feedback[210]. - The company actively participates in community outreach efforts, including STEM programs and volunteer opportunities for employees[212].

Financial Performance - Caribou reported a net loss of $149.1 million for the full year 2024, compared to a net loss of $102.1 million in 2023[15]. - The net loss for the year ended December 31, 2024, was $149,105,000, compared to a net loss of $102,070,000 in 2023, reflecting a year-over-year increase of 46.1%[27]. - The net loss per share, basic and diluted, for the year ended December 31, 2024, was $1.65, compared to $1.38 in 2023[27]. Revenue and Expenses - Licensing and collaboration revenue decreased to $10.0 million for the full year 2024, compared to $34.5 million in 2023, primarily due to the termination of the AbbVie Collaboration and License Agreement[13]. - For the three months ended December 31, 2024, licensing and collaboration revenue was $2,077,000, a decrease of 41.7% from $3,558,000 in the same period of 2023[27]. - Total operating expenses for the year ended December 31, 2024, were $176,610,000, an increase of 17.3% compared to $150,536,000 in 2023[27]. - Research and development expenses increased to $130.2 million for the full year 2024, up from $112.1 million in 2023, driven by costs to advance clinical pipeline programs[13]. - Research and development expenses for the year ended December 31, 2024, were $130,153,000, an increase of 16.1% from $112,075,000 in 2023[27]. - General and administrative expenses rose to $46.5 million for the full year 2024, compared to $38.5 million in 2023, mainly due to legal and personnel-related expenses[14]. - General and administrative expenses increased to $46,457,000 for the year ended December 31, 2024, up 20.9% from $38,461,000 in 2023[27]. Cash and Assets - Caribou reported $249.4 million in cash, cash equivalents, and marketable securities as of December 31, 2024, down from $372.4 million as of December 31, 2023, with expectations to fund operations into H2 2026[12]. - Cash, cash equivalents, and marketable securities decreased to $249,386,000 as of December 31, 2024, down 33.1% from $372,404,000 in 2023[25]. - Total assets decreased to $313,313,000 as of December 31, 2024, down 27.5% from $432,209,000 in 2023[25]. - Total stockholders' equity decreased to $252,951,000 as of December 31, 2024, down 31.2% from $368,401,000 in 2023[25]. Clinical Trials and Developments - The company plans to present clinical data from the ANTLER Phase 1 trial of CB-010 and the CaMMouflage Phase 1 trial of CB-011 in H1 2025[2]. - Caribou is enrolling approximately 20 additional patients in the ongoing ANTLER Phase 1 clinical trial to confirm the HLA matching strategy[4]. - The company expects to initiate a pivotal Phase 3 clinical trial for CB-010 in H2 2025, pending data confirmation and FDA agreement[11]. - CB-011 has shown encouraging signs of efficacy in patients treated at active dose levels following a deeper lymphodepletion regimen[10]. Management Changes - Caribou appointed Sri Ryali as chief financial officer in January 2025, enhancing its finance and investor relations functions[7]. Shareholder Information - The weighted-average common shares outstanding for the year ended December 31, 2024, were 90,317,925, compared to 73,807,597 in 2023, reflecting a 22.4% increase[27].

Core Insights - Caribou Biosciences is advancing its clinical programs for hematologic malignancies and autoimmune diseases, with two key clinical data disclosures expected in the first half of 2025 [2][11] - The company reported a cash position of $249.4 million as of December 31, 2024, which is projected to fund operations into the second half of 2026 [12][20] Clinical Programs - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in the ANTLER Phase 1 trial for second-line large B cell lymphoma and in the GALLOP Phase 1 trial for lupus nephritis [3][4][17] - CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma, currently in the CaMMouflage Phase 1 trial [5][18] - CB-012 is an allogeneic anti-CLL-1 CAR-T cell therapy for relapsed or refractory acute myeloid leukemia, undergoing the AMpLify Phase 1 trial [6][19] Financial Performance - Licensing and collaboration revenue for Q4 2024 was $2.1 million, down from $3.6 million in Q4 2023, with full-year revenue of $10.0 million compared to $34.5 million in 2023 [13] - Research and development expenses increased to $30.5 million for Q4 2024 and $130.2 million for the full year, compared to $31.3 million and $112.1 million in the previous year [14] - General and administrative expenses rose to $10.5 million for Q4 2024 and $46.5 million for the full year, compared to $9.7 million and $38.5 million in 2023 [15] Corporate Updates - Sri Ryali was appointed as the new Chief Financial Officer in January 2025, overseeing finance, investor relations, and corporate communications [9] - Chief Scientific Officer Steve Kanner will retire in June 2025 after nearly eight years, transitioning to an advisory role [10] Anticipated Milestones - Caribou plans to present data from the ANTLER and CaMMouflage trials in H1 2025, with a pivotal Phase 3 trial for CB-010 expected to start in H2 2025 if initial data supports it [11][15][22]

Core Viewpoint - A class action securities lawsuit has been filed against Caribou Biosciences, Inc. alleging securities fraud that affected investors between July 14, 2023, and July 16, 2024 [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Caribou Biosciences overstated the safety, efficacy, and durability of its product CB-010 compared to approved CAR-T cell therapies for treating patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) and large B-cell lymphoma (LBCL) [2]. - It is alleged that Caribou was at significant risk of having insufficient cash and liquidity to fund its business operations, including preclinical research for its allogeneic CAR-NK platform [2]. - The lawsuit suggests that these issues were likely to have a significant negative impact on Caribou's business and operations, rendering the defendants' public statements materially false and misleading [2]. Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until February 24, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating no financial obligation to participate in the lawsuit [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Core Viewpoint - The Gross Law Firm is notifying shareholders of Caribou Biosciences, Inc. regarding a class action lawsuit due to alleged misleading statements and financial risks associated with the company's product CB-010 [1][2]. Group 1: Allegations and Class Period - The class period for the allegations is from July 14, 2023, to July 16, 2024 [2]. - Allegations include that Caribou overstated the safety, efficacy, and durability of CB-010 compared to approved therapies, and failed to disclose significant risks regarding cash and liquidity [2]. Group 2: Shareholder Actions - Shareholders are encouraged to register for the class action by February 24, 2025, to potentially become lead plaintiffs [3]. - Registration allows shareholders to receive updates on the case through portfolio monitoring software [3]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights and seeks recovery for losses incurred due to misleading statements that inflated the company's stock [4].