UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K ________________________________________ Delaware 001-40631 45-3728228 (Commission File Number) (IRS Employer Identification No.) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 24, 2025 ________________________________________ Caribou Biosciences, Inc. (Exact name of Registrant as Specified in Its Charter) ____________________________ ...

-- Strategic pipeline prioritization with workforce and cost reductions expected to extend the company’s cash runway by one year into H2 2027 -- -- Two robust clinical datasets from CB-010 and CB-011 now expected to be disclosed in H2 2025 -- -- CB-010 ANTLER 2L LBCL Phase 1 dataset expected to include at least six months of follow up on the majority of patients; ongoing interactions with FDA on potential pivotal trial design -- -- CB-011 CaMMouflage r/r MM Phase 1 dose escalation dataset expected to includ ...

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]

NEW YORK, Feb. 21, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Caribou Biosciences, Inc. ("Caribou Biosciences, Inc." or the "Company") (NASDAQ: CRBU) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Caribou Biosciences, Inc. investors who were adversely affected by alleged securities fraud between July 14, 2023 and July 16, 2024. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/ ...

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].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Caribou Biosciences, Inc. due to allegations of violations of federal securities laws, particularly concerning misleading statements about the company's product safety and financial stability [2][4]. Group 1: Allegations Against Caribou - The complaint alleges that Caribou overstated the safety, efficacy, and durability of its product CB-010 compared to approved therapies [4]. - It is claimed that Caribou was at significant risk of insufficient cash and liquidity to fund its operations, including preclinical research [4]. - The allegations suggest that these issues could have a significant negative impact on Caribou's business and operations [4]. Group 2: Stock Performance and Analyst Reactions - Following the announcement of updated clinical data on June 2, 2024, Caribou's stock was downgraded by Evercore ISI, with a price target reduction from $13.00 to $3.00 [5]. - On June 3, 2024, Caribou's stock price fell by $0.735, or 25.52%, closing at $2.145 per share [6]. - After disclosing workforce reductions and the discontinuation of preclinical research on July 16, 2024, the stock price fell by $0.09, or 3.3%, to close at $2.64 per share on July 17, 2024 [7]. Group 3: Legal Proceedings and Class Action - Investors who suffered losses exceeding $75,000 between July 14, 2023, and July 16, 2024, are encouraged to contact Faruqi & Faruqi to discuss their legal rights [1]. - There is a deadline of February 24, 2025, for investors to seek the role of lead plaintiff in the federal securities class action against Caribou [2]. - The lead plaintiff is defined as the investor with the largest financial interest who directs and oversees the litigation on behalf of the class [8].

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 faced significant risks regarding 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 substantial 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 appointment 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].