Caribou Biosciences(CRBU) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Q2 2025 Business and Financial Highlights 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] - The company holds $184 million in cash, cash equivalents, and marketable securities, projected to fund current operations until H2 2027[1] CEO Commentary 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] - Clinical programs CB-010 and CB-011 continue to yield encouraging Phase 1 results, with robust datasets anticipated in H2 2025[2] Clinical Program Updates CB-010 (ANTLER Phase 1 Clinical Trial) 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] - 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] CB-011 (CaMMouflage Phase 1 Clinical Trial) 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] - CB-011 continues to demonstrate encouraging efficacy across multiple active dose levels[4] 2025 Anticipated Milestones 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] - 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][12] Second Quarter 2025 Financial Performance Cash, Cash Equivalents, and Marketable Securities 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] Licensing and Collaboration Revenue 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 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 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] General and Administrative (G&A) Expenses 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] Non-recurring, Non-cash Impairment Charges 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] Net Loss and Net Loss Per Share (GAAP & Non-GAAP) 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 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] - 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][13] Product Candidate and Company Information About CB-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] - 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] - The FDA has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations[14] About CB-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] - It is engineered with a B2M knockout and a B2M–HLA-E fusion protein for immune cloaking, designed to mitigate immune-mediated rejection[15] - CB-011 has received FDA Fast Track and Orphan Drug designations[15] About Caribou Biosciences, Inc. 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] - The company's gene-editing platform, including its Cas12a chRDNA technology, enables exceptional precision to develop 'armored' cell therapies[16] - Caribou focuses on CB-010 and CB-011 as off-the-shelf CAR-T cell therapies for hematologic malignancies[16] Forward-Looking Statements 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][18] - 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] Condensed Consolidated Financial Data Condensed Consolidated Balance Sheet Data 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 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 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 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]