Caribou Biosciences(CRBU)
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Caribou Biosciences Announces Positive Data from ANTLER Phase 1 Trial Demonstrating Efficacy and Durability of Vispa-cel (CB-010), an Allogeneic CAR-T Cell Therapy, on Par with Autologous CAR-T Cell Therapies
Globenewswire· 2025-11-03 12:00
Core Insights - Caribou Biosciences, Inc. announced positive results from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma [1][4][8] Clinical Trial Results - The ANTLER trial enrolled 84 patients, with a confirmatory cohort of 22 CD19-naïve second-line large B cell lymphoma patients, demonstrating an 82% overall response rate (ORR), 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months [2][4][5] - In a cohort of 35 patients receiving an optimized profile of vispa-cel, the results showed an 86% ORR, 63% CR rate, and 53% PFS at 12 months, with a median follow-up of 11.8 months [6][4] Safety Profile - Vispa-cel exhibited a generally well-tolerated safety profile, with treatment-emergent adverse events occurring in ≥25% of patients, including thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), and anemia (52%) [7][9] - No cases of graft-versus-host disease (GvHD) or grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in the confirmatory and optimized profile cohorts [7][9] Regulatory Path and Future Plans - The FDA has recommended a randomized, controlled phase 3 trial for vispa-cel in second-line large B cell lymphoma, which will evaluate approximately 250 patients [12][8] - The primary endpoint of the upcoming trial will be progression-free survival, with secondary endpoints including overall response rate, complete response rate, and overall survival [12] Company Overview - Caribou Biosciences is focused on developing transformative therapies using its CRISPR genome-editing platform, with vispacabtagene regedleucel being a key candidate for hematologic malignancies [18]
Caribou Biosciences to Host Webcast to Report New Data Updates from Two Allogeneic CAR-T Cell Therapy Programs in Lymphoma and Multiple Myeloma
Globenewswire· 2025-11-02 21:00
Core Insights - Caribou Biosciences, Inc. will present new data from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel) and the CaMMouflage Phase 1 trial for CB-011 on November 3, 2025 [1] - The company is focused on developing allogeneic CAR-T cell therapies for hematologic malignancies, specifically targeting relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma [1][5] Summary of vispacabtagene regedleucel (vispa-cel) - Vispacabtagene regedleucel is an allogeneic anti-CD19 CAR-T cell therapy designed for patients with relapsed or refractory B cell non-Hodgkin lymphoma [3] - It is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, aimed at enhancing CAR-T cell activity by reducing premature exhaustion [3] - The therapy has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track for B-NHL [3] Summary of CB-011 - CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated for relapsed or refractory multiple myeloma in the CaMMouflage Phase 1 trial [4] - It is the first allogeneic CAR-T cell therapy engineered with an immune cloaking strategy, featuring a B2M knockout and a B2M–HLA-E fusion protein to mitigate immune rejection [4] - CB-011 has also been granted Fast Track and Orphan Drug designations by the FDA [4] Company Overview - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on transformative therapies for severe diseases [5] - The company's genome-editing platform utilizes Cas12a chRDNA technology for precise development of cell therapies [5] - Caribou aims to provide broad access and rapid treatment options through its off-the-shelf CAR-T cell therapies, vispacabtagene regedleucel and CB-011 [5]
Caribou Biosciences to Host Webcast to Report New Data Updates from Two Allogeneic CAR-T Cell Therapy Programs in Lymphoma and Multiple Myeloma
Globenewswire· 2025-11-02 21:00
Core Insights - Caribou Biosciences, Inc. will present new data from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel) and the CaMMouflage Phase 1 trial for CB-011 on November 3, 2025 [1] - The company is focused on developing allogeneic CAR-T cell therapies for hematologic malignancies, specifically targeting relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma [5] Group 1: Clinical Trials - The ANTLER trial evaluates vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma [3] - The CaMMouflage trial assesses CB-011, an allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma [4] - Both therapies have received Fast Track and Orphan Drug designations from the FDA, indicating their potential significance in treating these conditions [3][4] Group 2: Technology and Innovation - Vispacabtagene regedleucel (vispa-cel) is noted for being the first allogeneic CAR-T cell therapy with a PD-1 knockout, aimed at enhancing CAR-T cell activity [3] - CB-011 is distinguished as the first allogeneic CAR-T cell therapy utilizing an immune cloaking strategy with a B2M knockout and B2M–HLA-E fusion protein [4] - Caribou's genome-editing platform employs Cas12a chRDNA technology, which allows for superior precision in developing cell therapies [5]
Caribou Biosciences (CRBU) Conference Transcript
2025-09-03 19:30
Summary of Cariboo's Biopharma Back to School Summit Company Overview - **Company**: Cariboo - **Technology**: CRISPR genome editing, specifically the Chardonnay technology, which allows for more precise genome editing compared to first-generation CRISPR Cas9 [4][4] Key Studies and Developments CB10 (Lymphoma) - **Type**: Off-the-shelf CAR T cell therapy targeting CD19 - **Mechanism**: Utilizes Chardonnay technology to knock out PD-1 to prevent CAR T cell exhaustion [6][6] - **Clinical Trials**: Ongoing phase one studies with significant data readouts expected by the end of the year [4][5] - **Patient Outcomes**: First patient remains in complete response after treatment; data suggests that modest partial HLA matching improves outcomes [7][9] - **Data Sharing**: Plans to share data from a new cohort of 20 patients with at least four matched HLA alleles, aiming for outcomes comparable to autologous CAR Ts [10][12] - **FDA Discussions**: Actively engaging with the FDA regarding pivotal study pathways for CB10 [12][32] CB11 (Multiple Myeloma) - **Type**: Off-the-shelf CAR T cell therapy targeting BCMA - **Mechanism**: Focuses on immune cloaking by knocking out endogenous HLA class one expression and overexpressing HLAE to prevent NK cell rejection [63][65] - **Clinical Trials**: First data update expected this half, with a focus on being on par with bispecific therapies in terms of efficacy [66][70] - **Patient Population**: Only about 10% of myeloma patients currently access autologous CAR Ts, indicating a significant market opportunity [66][67] Market Dynamics and Opportunities - **Access to Therapy**: Approximately 80% of lymphoma patients do not currently benefit from CAR T therapies due to logistical and geographical barriers [35][37] - **Manufacturing Capabilities**: Current processes can produce enough cells for 200 to 300 doses per manufacturing run, indicating readiness for market supply [49][49] - **Community Integration**: Plans to leverage community sites for distribution, making therapies more accessible [100][100] Financial Considerations - **Current Funding**: Approximately $184 million available, sufficient to fund current plans into 2027 but not for pivotal trials [94][94] - **Strategic Investment**: Pfizer made a $25 million investment focused on the myeloma program, with a right of first negotiation for future funding [95][95] Future Directions - **Expansion of Indications**: Potential to explore earlier lines of therapy for both lymphoma and myeloma based on learnings from ongoing studies [89][89] - **Global Reach**: The Antler study has been expanded to include patients in Israel and Australia, providing access to diverse patient populations [102][102] Conclusion Cariboo is positioned to make significant advancements in the CAR T therapy landscape with its innovative CRISPR technology and strategic focus on accessibility and patient outcomes. Upcoming data readouts and FDA discussions will be critical in shaping the future of its therapies.
Caribou Biosciences to Participate in the Citi 2025 Biopharma Back to School Conference
Globenewswire· 2025-08-25 20:05
Core Insights - Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for patients with severe diseases [3] - The company will have its president and CEO, Rachel Haurwitz, participate in a fireside chat at the Citi 2025 Biopharma Back to School Conference on September 3, 2025 [1] Company Overview - Caribou's genome-editing platform utilizes Cas12a chRDNA technology, which allows for superior precision in developing cell therapies [3] - The company 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] Event Information - A webcast of the fireside chat will be available on Caribou's website for at least 30 days following the event [2]
Caribou Biosciences(CRBU) - 2025 Q2 - Quarterly Report
2025-08-12 20:09
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining significant accounting policies, fair value measurements, significant agreements, revenue recognition, balance sheet items, related party transactions, commitments, common stock, stock-based compensation, net loss per share, segment information, restructuring charges, and subsequent events [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates ASSETS (in thousands) | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | **CURRENT ASSETS** | | | | Cash and cash equivalents | $25,201 | $16,293 | | Marketable securities, short-term | $158,747 | $193,244 | | Total current assets | $192,506 | $219,377 | | **NON-CURRENT ASSETS**| | | | Investments in equity securities | $132 | $9,276 | | Marketable securities, long-term | — | $39,849 | | Property and equipment, net | $8,179 | $19,281 | | TOTAL ASSETS | $220,903 | $313,313 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | **CURRENT LIABILITIES** | | | | Total current liabilities | $28,887 | $30,651 | | **LONG-TERM LIABILITIES** | | | | Total liabilities | $54,771 | $60,362 | | **STOCKHOLDERS' EQUITY** | | | | Total stockholders' equity | $166,132 | $252,951 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $220,903 | $313,313 | - Total assets decreased from **$313.3 million** as of December 31, 2024, to **$220.9 million** as of June 30, 2025, primarily due to a reduction in marketable securities and property and equipment[11](index=11&type=chunk) - Total stockholders' equity decreased from **$252.9 million** as of December 31, 2024, to **$166.1 million** as of June 30, 2025, largely due to accumulated deficit[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) This statement reports the company's revenues, expenses, and net loss over specific periods, including comprehensive loss (in thousands, except share and per share amounts) | (in thousands, except share and per share amounts) | 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 | $27,692 | $35,480 | $63,223 | $69,268 | | General and administrative | $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 | | Loss from operations | $(47,578) | $(43,501) | $(90,491) | $(89,503) | | Impairment of equity investment | $(9,158) | — | $(9,158) | — | | Change in fair value of MSKCC success payments liability | $451 | $1,795 | $785 | $2,098 | | Other income, net | $2,187 | $4,009 | $4,775 | $8,474 | | 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) | - Net loss increased significantly for both the three and six months ended June 30, 2025, primarily due to impairment charges and impairment of equity investment, despite decreases in R&D and G&A expenses[14](index=14&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This statement details changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, over specific periods (in thousands, except share amounts) | (in thousands, except share amounts) | Common Stock Shares | Common Stock Amount | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Total Stockholders' Equity | | :----------------------------------- | :------------------ | :------------------ | :------------------------- | :-------------------------------------------- | :------------------ | :------------------------- | | BALANCE—December 31, 2024 | 92,378,577 | $9 | $701,077 | $255 | $(448,390) | $252,951 | | Issuances of common stock under ESPP | 408,282 | — | $468 | — | — | $468 | | Stock-based compensation expense | — | — | $3,882 | — | — | $3,882 | | Net loss | — | — | — | — | $(39,991) | $(39,991) | | Other comprehensive loss | — | — | — | $(88) | — | $(88) | | BALANCE—March 31, 2025 | 93,004,602 | $9 | $705,427 | $167 | $(488,381) | $217,222 | | Stock-based compensation expense | — | — | $3,129 | — | — | $3,129 | | Net loss | — | — | — | — | $(54,098) | $(54,098) | | Other comprehensive loss | — | — | — | $(127) | — | $(127) | | BALANCE—June 30, 2025 | 93,123,239 | $9 | $708,562 | $40 | $(542,479) | $166,132 | - The accumulated deficit increased significantly from **$(448.4) million** at December 31, 2024, to **$(542.5) million** at June 30, 2025, primarily due to net losses incurred during the period[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :----------------------------- | :----------------------------- | | **CASH FLOWS FROM OPERATING ACTIVITIES:** | | | | Net loss | $(94,089) | $(78,931) | | Net cash used in operating activities | $(64,983) | $(70,069) | | **CASH FLOWS FROM INVESTING ACTIVITIES:** | | | | Proceeds from maturities of marketable securities | $122,628 | $204,889 | | Purchases of marketable securities | $(47,751) | $(155,419) | | Net cash provided by investing activities | $73,417 | $44,156 | | **CASH FLOWS FROM FINANCING ACTIVITIES:** | | | | Proceeds from exercise of stock options | $6 | $619 | | Proceeds from issuances of common stock under ESPP | $468 | $669 | | Proceeds from issuances of common stock related to ATM, net of offering expenses | — | $11,329 | | Net cash provided by financing activities | $474 | $12,617 | | NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | $8,908 | $(13,296) | | CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — END OF PERIOD | $25,247 | $37,912 | - Net cash used in operating activities decreased by **$5.1 million** to **$65.0 million** for the six months ended June 30, 2025, compared to **$70.1 million** for the same period in 2024[20](index=20&type=chunk) - Net cash provided by investing activities increased significantly to **$73.4 million** in H1 2025 from **$44.2 million** in H1 2024, primarily due to lower purchases of marketable securities[20](index=20&type=chunk) - Net cash provided by financing activities decreased substantially to **$0.5 million** in H1 2025 from **$12.6 million** in H1 2024, mainly due to no ATM stock sales in 2025[20](index=20&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the company's significant accounting policies, fair value measurements, and other financial statement items [1. Description of the Business, Organization, and Liquidity](index=7&type=section&id=1.%20Description%20of%20the%20Business,%20Organization,%20and%20Liquidity) Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing allogeneic CAR-T cell therapies. The company has incurred significant operating losses and negative cash flows since inception, with an accumulated deficit of $542.5 million as of June 30, 2025. Management expects existing cash, cash equivalents, and marketable securities of $183.9 million to fund operations for at least the next 12 months - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company developing allogeneic CAR-T cell therapies[23](index=23&type=chunk) - The company had an accumulated deficit of **$542.5 million** as of June 30, 2025[25](index=25&type=chunk) - Net loss for the six months ended June 30, 2025, was **$94.1 million**, with **$65.0 million** cash used in operating activities[25](index=25&type=chunk) - Existing cash, cash equivalents, and marketable securities (**$183.9 million** as of June 30, 2025) are expected to fund operations for at least the next **12 months**[25](index=25&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note confirms no material changes to significant accounting policies since December 31, 2024, and outlines the basis of presentation, principles of consolidation, use of estimates, and concentrations of credit risk. It also details recent accounting pronouncements not yet adopted, including ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation), which the company is currently evaluating - No changes to significant accounting policies since December 31, 2024[26](index=26&type=chunk) - The company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation), effective for fiscal years beginning after December 15, 2024, and December 15, 2026, respectively[31](index=31&type=chunk)[32](index=32&type=chunk) Licensees Representing 10% or More of Revenue and Accounts Receivable/Contract Assets | Licensee | Revenue (3 Months Ended June 30, 2025) | Revenue (6 Months Ended June 30, 2025) | Accounts Receivable and Contract Assets (As of June 30, 2025) | | :--------- | :------------------------------------- | :------------------------------------- | :------------------------------------------------------------ | | Licensee B | 21.8 % | 19.4 % | 60.6 % | | Licensee C | 23.3 % | 24.8 % | * | | Licensee F | 37.5 % | 19.9 % | * | | Total | 82.6 % | 76.4 % | 82.3 % | [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) This note details the company's fair value measurements, classifying financial instruments into a three-level hierarchy. It provides tables for recurring fair value measurements of assets (U.S. Treasury bills, government agency bonds, money market funds, commercial paper) and liabilities (MSKCC success payments liability). The MSKCC success payments liability was re-measured to zero as of June 30, 2025, due to the termination of the MSKCC Agreement. An impairment expense of $9.2 million was recorded for the equity investment in Edge Animal Health Fair Value Measurements of Assets (in thousands) | Assets (in thousands) | Total (June 30, 2025) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | Level 3 (June 30, 2025) | | :-------------------- | :-------------------- | :---------------------- | :---------------------- | :---------------------- | | U.S. Treasury bills | $122,717 | $122,717 | — | — | | U.S. government agency bonds | $30,483 | — | $30,483 | — | | Money market fund investments | $15,843 | $15,843 | — | — | | Commercial paper | $14,905 | — | $14,905 | — | | Total fair value of assets | $183,948 | $138,560 | $45,388 | — | - The MSKCC success payments liability was re-measured to zero as of June 30, 2025, due to the termination of the MSKCC Agreement, resulting in a gain of **$0.5 million** for the three months and **$0.8 million** for the six months ended June 30, 2025[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - An impairment expense of **$9.2 million** was recorded for the equity investment in Edge Animal Health for the three and six months ended June 30, 2025, reducing its fair value to zero[40](index=40&type=chunk) [4. Significant Agreements](index=12&type=section&id=4.%20Significant%20Agreements) This note states there have been no material changes to ongoing significant agreements since December 31, 2024. It outlines various payment obligations under these agreements, such as upfront payments, license fees, milestones, and royalties. The company recorded $0.4 million and $0.7 million in R&D expenses related to license agreements for the three and six months ended June 30, 2025, respectively. Potential future payments for development, regulatory, and sales milestones total approximately $48.9 million as of June 30, 2025 - No material changes to ongoing significant agreements since December 31, 2024[41](index=41&type=chunk) - Research and development expenses related to license agreements were **$0.4 million** for Q2 2025 (down from **$0.3 million** in Q2 2024) and **$0.7 million** for H1 2025 (down from **$1.6 million** in H1 2024)[43](index=43&type=chunk) - Potential future payments for development, regulatory, and sales milestones total approximately **$48.9 million** as of June 30, 2025[44](index=44&type=chunk) [5. Revenue](index=13&type=section&id=5.%20Revenue) Revenue is disaggregated by geographical market and by performance obligations satisfied at a point in time versus over time. Total revenue decreased for both the three and six months ended June 30, 2025, compared to the prior year. Contract balances, including accounts receivable, contract assets, and deferred revenue, are also detailed, with $1.8 million of revenue recognized from opening contract liabilities in H1 2025 Revenue by Geographic Location (in thousands) | Geographic Location | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | United States | $1,662 | $3,444 | $3,886 | $5,713 | | Rest of world | $1,005 | $20 | $1,134 | $180 | | Total | $2,667 | $3,464 | $5,020 | $5,893 | - For the six months ended June 30, 2025, **$3.8 million** of revenue was recognized from performance obligations satisfied at a point in time, and **$1.2 million** from obligations satisfied over time[46](index=46&type=chunk) - The value of transaction prices allocated to remaining unsatisfied performance obligations was approximately **$4.6 million** as of June 30, 2025, with **$2.8 million** expected to be recognized in the next **12 months**[52](index=52&type=chunk) [6. Balance Sheet Items](index=14&type=section&id=6.%20Balance%20Sheet%20Items) This note provides a breakdown of prepaid expenses and other current assets, property and equipment (net), and accrued expenses and other current liabilities. Property and equipment, net, significantly decreased from $19.3 million to $8.2 million, primarily due to impairment charges on leasehold improvements and lab equipment Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Prepaid contract manufacturing and clinical costs | $3,060 | $3,919 | | Other | $2,718 | $2,670 | | Total | $5,778 | $6,589 | Property and Equipment, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Lab equipment | $15,833 | $19,054 | | Leasehold improvements | $3,016 | $11,518 | | Total property and equipment, gross | $20,443 | $32,166 | | Less: accumulated depreciation and amortization | $(12,264) | $(12,885) | | Property and equipment, net | $8,179 | $19,281 | Accrued Expenses and Other Current Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accrued research and development expenses | $11,680 | $12,020 | | Accrued employee compensation and related expenses | $5,240 | $8,560 | | Total | $20,528 | $23,620 | [7. Related Party Transactions](index=15&type=section&id=7.%20Related%20Party%20Transactions) This note details related party transactions, specifically with Pfizer and Edge Animal Health. The company recognized $0.6 million in revenue from Pfizer for both the three-month periods ended June 30, 2025 and 2024, and $1.2 million for the six-month periods. Deferred revenue from Pfizer was $2.5 million as of June 30, 2025. No revenue was recognized from Edge Animal Health in 2025, compared to $1.6 million in 2024, and the investment in Edge was deemed impaired - Recognized **$0.6 million** in revenue from Pfizer for the three months ended June 30, 2025, and **$1.2 million** for the six months ended June 30, 2025[58](index=58&type=chunk) - Deferred revenue from Pfizer was approximately **$2.5 million** as of June 30, 2025[58](index=58&type=chunk) - No revenue was recognized from Edge Animal Health in 2025, compared to **$1.6 million** in 2024, and the investment in Edge was deemed impaired[59](index=59&type=chunk) [8. Commitments and Contingencies](index=15&type=section&id=8.%20Commitments%20and%20Contingencies) The company enters into various agreements with CMOs, CROs, and licensors, which are generally cancellable with less than one-year notice. Contingent payments for development, regulatory, clinical, and commercial milestones are uncertain and cannot be reasonably estimated. The company is involved in a consolidated shareholder derivative action filed in March 2025, alleging breach of fiduciary duties related to disclosures challenged in a previously dismissed class action lawsuit - Agreements with CMOs, CROs, and licensors are generally cancellable with less than one-year notice[60](index=60&type=chunk) - A putative class action lawsuit (Saylor v. Caribou Biosciences, Inc., et al.) filed in December 2024 was voluntarily dismissed without prejudice on April 27, 2025[63](index=63&type=chunk) - Two shareholder derivative complaints were consolidated into a single action (In re Caribou Biosciences, Inc. Derivative Litigation) in April 2025, alleging breach of fiduciary duties by directors and officers[64](index=64&type=chunk) [9. Common Stock](index=16&type=section&id=9.%20Common%20Stock) This note details common stock reserved for future issuances, including stock options, authorized shares for future issuances, ESPP, and unvested RSUs. It also describes the filing of a new $300.0 million universal shelf registration statement (2025 Shelf Registration Statement) and the refreshing of the at-the-market (ATM) equity offering program for up to $100.0 million. No shares were sold under the ATM program during the three or six months ended June 30, 2025 Common Stock Reserved for Future Issuances | Item | As of June 30, 2025 | As of December 31, 2024 | | :------------------------------------ | :------------------ | :---------------------- | | Stock options, issued and outstanding | 12,909,834 | 10,782,103 | | Stock options, authorized for future issuances | 9,430,205 | 7,618,931 | | Stock available under ESPP | 2,655,169 | 2,139,666 | | Unvested RSUs | 1,684,339 | 1,297,327 | | Total common stock reserved for future issuances | 26,679,547 | 21,838,027 | - A new **$300.0 million** universal shelf registration statement (2025 Shelf Registration Statement) was filed and became effective on May 14, 2025[67](index=67&type=chunk) - The at-the-market (ATM) equity offering program was refreshed for up to **$100.0 million** under the 2025 Shelf Registration Statement[68](index=68&type=chunk) - No shares were sold under the ATM Sales Agreement during the three or six months ended June 30, 2025[69](index=69&type=chunk) [10. Stock-Based Compensation](index=17&type=section&id=10.%20Stock-Based%20Compensation) This note provides details on equity incentive plans, including stock option activity, grant date fair values, and restricted stock units (RSUs). It also summarizes stock-based compensation expense recognized across research and development and general and administrative categories. Total stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to the prior year Stock Option Activity (Six Months Ended June 30, 2025) | Item | Stock Options | Weighted Average Exercise Price | | :------------------------------------ | :------------ | :------------------------------ | | Outstanding as of December 31, 2024 | 10,782,103 | $7.47 | | Options granted | 3,365,288 | $1.43 | | Options exercised | (15,000) | $0.40 | | Options cancelled or forfeited | (1,222,557) | $4.92 | | Outstanding as of June 30, 2025 | 12,909,834 | $6.15 | Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,298 | $1,994 | $3,041 | $3,610 | | General and administrative | $1,831 | $2,744 | $3,970 | $5,116 | | Total | $3,129 | $4,738 | $7,011 | $8,726 | - Unrecognized stock-based compensation expense related to employee stock options was **$14.9 million** as of June 30, 2025, expected to be recognized over **2.7 years**[74](index=74&type=chunk) [11. Net Loss Per Share](index=20&type=section&id=11.%20Net%20Loss%20Per%20Share) This note presents the computation of basic and diluted net loss per share. Due to the net loss position, basic and diluted net loss per share are the same for all periods presented, as the inclusion of common stock equivalents would be anti-dilutive Net Loss Per Share (in thousands, except share and per share amounts) | Item | 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 | $(54,098) | $(37,697) | $(94,089) | $(78,931) | | Weighted-average common shares outstanding | 93,028,698 | 90,340,932 | 92,855,060 | 89,821,935 | | Net loss per share, basic and diluted | $(0.58) | $(0.42) | $(1.01) | $(0.88) | - Basic and diluted net loss per share are identical due to the company being in a net loss position, making all common stock equivalents anti-dilutive[78](index=78&type=chunk) [12. Segment Information](index=20&type=section&id=12.%20Segment%20Information) The company operates and manages its business as one reportable segment, focused on developing allogeneic CAR-T cell therapies. The Chief Operating Decision Maker (CODM) assesses performance based on consolidated net loss and total consolidated assets - The company operates as a single reportable segment, focused on developing allogeneic CAR-T cell therapies[79](index=79&type=chunk) - Performance is assessed by the CODM based on consolidated net loss and total consolidated assets[79](index=79&type=chunk) Reportable Segment Profit and Loss (in thousands) | Item | 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 | | Total research and development | $25,359 | $32,727 | $58,095 | $64,301 | | General and administrative | $8,463 | $8,644 | $15,947 | $20,802 | | Other segment items | $25,130 | $3,799 | $29,842 | $8,195 | | Segment and consolidated net loss | $(54,098) | $(37,697) | $(94,089) | $(78,931) | [13. Restructuring Charges](index=22&type=section&id=13.%20Restructuring%20Charges) In April 2025, the company announced a strategic pipeline prioritization, discontinuing preclinical research and two clinical programs (CB-010 for lupus and CB-012). This led to a workforce reduction of 47 employees (32%) and resulted in $1.8 million in severance costs and $0.3 million in wind-down costs. Additionally, impairment charges totaling $12.2 million were recognized for leased office/lab space and lab equipment due to reduced usage - Strategic pipeline prioritization in April 2025 led to the discontinuation of preclinical research and two clinical programs (CB-010 for lupus and CB-012)[81](index=81&type=chunk) - Workforce reduced by **47 employees** (approximately **32%**), resulting in **$1.8 million** in severance costs for the three and six months ended June 30, 2025[81](index=81&type=chunk) - Wind-down costs of **$0.3 million** were recorded for the discontinuation of clinical trials[81](index=81&type=chunk) - Impairment charges totaled **$12.2 million** for the three and six months ended June 30, 2025, including **$7.4 million** for tenant improvements, **$2.6 million** for right-of-use assets, and **$2.2 million** for lab equipment[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) [14. Subsequent Events](index=23&type=section&id=14.%20Subsequent%20Events) This note mentions the enactment of the OneBig Beautiful BillAct on July 4, 2025, which includes significant changes to federal tax law and other regulatory provisions. The company is currently evaluating the potential impact of this new legislation on deferred taxes and related disclosures - The OneBig Beautiful BillAct was enacted on July 4, 2025, introducing significant changes to federal tax law[86](index=86&type=chunk) - The company is evaluating the potential impact of the new legislation on deferred taxes and disclosures[86](index=86&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including an overview of its business, pipeline, and recent strategic prioritization. It analyzes the components of revenue and expenses, compares financial results for the three and six months ended June 30, 2025, and discusses liquidity, capital resources, funding requirements, and cash flow changes. It also touches upon critical accounting policies and recently issued accounting pronouncements [Overview](index=24&type=section&id=Overview) Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on allogeneic CAR-T cell therapies. Key clinical programs include CB-010 for r/r B-NHL and CB-011 for r/r MM. The company recently underwent a strategic pipeline prioritization, discontinuing two clinical programs and preclinical research, and reducing its workforce by 32%. This prioritization resulted in significant impairment charges and severance costs. The company has incurred operating losses since inception and relies on capital stock sales and licensing revenue for funding - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company developing allogeneic CAR-T cell therapies[90](index=90&type=chunk) - Key clinical programs are CB-010 (anti-CD19 CAR-T for r/r B-NHL) and CB-011 (anti-BCMA CAR-T for r/r MM)[91](index=91&type=chunk)[92](index=92&type=chunk) - A strategic pipeline prioritization in April 2025 discontinued the GALLOP phase 1 trial (CB-010 for lupus), AMpLify phase 1 clinical trial (CB-012), and preclinical research[94](index=94&type=chunk) - Workforce was reduced by **47 employees** (approximately **32%**), leading to **$1.8 million** in severance costs and **$0.3 million** in wind-down costs[94](index=94&type=chunk) - Impairment charges of **$10.0 million** for leased space and **$2.2 million** for lab equipment were recognized due to reduced usage[95](index=95&type=chunk) - Net losses for the three and six months ended June 30, 2025, were **$54.1 million** and **$94.1 million**, respectively, with an accumulated deficit of **$542.5 million**[98](index=98&type=chunk) [Components of Results of Operations](index=27&type=section&id=Components%20of%20Results%20of%20Operations) This section outlines the primary components of the company's results of operations: licensing and collaboration revenue, operating expenses (research and development, general and administrative, impairment charges), and other income (expense). It details the types of costs included in R&D and G&A, and explains the nature of impairment charges and other income/expense items - Revenue is primarily from licensing and collaboration agreements, including upfront fees, annual maintenance fees, milestone payments, and royalties[103](index=103&type=chunk) - Research and development expenses include both external costs (e.g., CMOs, CROs, licenses) and internal costs (e.g., personnel, facilities)[105](index=105&type=chunk) - General and administrative expenses cover personnel, intellectual property, consulting, and allocated overhead costs[110](index=110&type=chunk) - Impairment charges relate to the strategic pipeline prioritization, specifically for leasehold improvements, right-of-use assets, and lab equipment[112](index=112&type=chunk) - Other income (expense) includes impairment of equity investment, interest income, and changes in the fair value of the MSKCC success payments liability[113](index=113&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's financial performance for the three and six months ended June 30, 2025, versus the same periods in 2024. It highlights significant changes in licensing and collaboration revenue, operating expenses (R&D, G&A, impairment charges), and other income/expense, which collectively led to increased net losses Comparison of Three Months Ended June 30, 2025 vs. 2024 (in thousands) | Item | 2025 | 2024 | Change | | :------------------------------------ | :---------- | :---------- | :---------- | | Licensing and collaboration revenue | $2,667 | $3,464 | $(797) | | Research and development | $27,692 | $35,480 | $(7,788) | | General and administrative | $10,403 | $11,485 | $(1,082) | | Impairment charges | $12,150 | — | $12,150 | | Total operating expenses | $50,245 | $46,965 | $3,280 | | Loss from operations | $(47,578) | $(43,501) | $(4,077) | | Impairment of equity investment | $(9,158) | — | $(9,158) | | Change in fair value of MSKCC success payments liability | $451 | $1,795 | $(1,344) | | Other income, net | $2,187 | $4,009 | $(1,822) | | Net loss | $(54,098) | $(37,697) | $(16,401) | - Licensing and collaboration revenue decreased by **$0.8 million** for the three months ended June 30, 2025, primarily due to a **$1.6 million** decrease from Edge Animal Health, partially offset by an increase from other licensees[116](index=116&type=chunk)[117](index=117&type=chunk) - Research and development expenses decreased by **$7.8 million** for the three months ended June 30, 2025, driven by reductions in other R&D expenses, external CMO/CRO activities, and personnel costs due to workforce reduction[118](index=118&type=chunk) - Impairment charges of **$12.2 million** were recorded in Q2 2025, related to tenant improvements, right-of-use assets, and lab equipment[120](index=120&type=chunk) Comparison of Six Months Ended June 30, 2025 vs. 2024 (in thousands) | Item | 2025 | 2024 | Change | | :------------------------------------ | :---------- | :---------- | :---------- | | Licensing and collaboration revenue | $5,020 | $5,893 | $(873) | | Research and development | $63,223 | $69,268 | $(6,045) | | General and administrative | $20,138 | $26,128 | $(5,990) | | Impairment charges | $12,150 | — | $12,150 | | Total operating expenses | $95,511 | $95,396 | $(12,035) | | Loss from operations | $(90,491) | $(89,503) | $11,162 | | Impairment of equity investment | $(9,158) | — | $(9,158) | | Change in fair value of MSKCC success payments liability | $785 | $2,098 | $(1,313) | | Other income, net | $4,775 | $8,474 | $(3,699) | | Net loss | $(94,089) | $(78,931) | $6,150 | - General and administrative expenses decreased by **$6.0 million** for the six months ended June 30, 2025, primarily due to a **$4.7 million** decrease in legal expenses (including a 2024 litigation settlement accrual) and a **$1.3 million** decrease in personnel-related expenses[128](index=128&type=chunk) - Total other income (expense) decreased by **$12.3 million** for the three months and **$5.0 million** for the six months ended June 30, 2025, mainly due to the **$9.2 million** impairment of equity investment in Edge and a decrease in interest income[121](index=121&type=chunk)[123](index=123&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk) [Liquidity, Capital Resources, and Capital Requirements](index=33&type=section&id=Liquidity,%20Capital%20Resources,%20and%20Capital%20Requirements) The company has raised $840.0 million since inception and held $183.9 million in cash, cash equivalents, and marketable securities as of June 30, 2025. It has a $300.0 million universal shelf registration statement and a $100.0 million at-the-market equity offering program, though no shares were sold in H1 2025. Management expects current liquidity to fund operations for at least the next 12 months but anticipates needing additional capital for future development and commercialization, facing risks from market volatility and funding availability - Since inception through June 30, 2025, the company has raised **$840.0 million** in net proceeds[133](index=133&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$183.9 million**[134](index=134&type=chunk) - A new **$300.0 million** universal shelf registration statement (2025 Shelf Registration Statement) was declared effective on May 14, 2025[136](index=136&type=chunk) - The at-the-market (ATM) equity offering program was refreshed for up to **$100.0 million**, but no shares were sold in H1 2025[137](index=137&type=chunk)[138](index=138&type=chunk) - Existing cash, cash equivalents, and marketable securities are expected to fund operations for at least the next **12 months**[139](index=139&type=chunk) - Future funding requirements depend on clinical trial progress, regulatory approvals, manufacturing, and potential commercialization, with reliance on equity/debt financing or collaborations[141](index=141&type=chunk)[143](index=143&type=chunk) Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | Change | | :---------------------------------- | :---------- | :---------- | :---------- | | Cash used in operating activities | $(64,983) | $(70,069) | $5,086 | | Cash provided by investing activities | $73,417 | $44,156 | $29,261 | | Cash provided by financing activities | $474 | $12,617 | $(12,143) | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $8,908 | $(13,296) | $22,204 | [Critical Accounting Policies and Significant Judgments and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section states that there have been no material changes to the company's critical accounting policies since December 31, 2024, except for estimates related to impairment of long-lived assets. The policy for impairment review involves grouping assets, testing for recoverability based on undiscounted cash flows, and measuring impairment loss using fair value (market or income approach) - No material changes to critical accounting policies since December 31, 2024, except for estimates related to impairment of long-lived assets[148](index=148&type=chunk) - Impairment of long-lived assets is recognized when projected undiscounted cash flows are less than the carrying value, with the loss measured by the difference between fair value and carrying value[149](index=149&type=chunk) [Recently Issued Accounting Pronouncements](index=36&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to Note 2 for information on recently issued accounting pronouncements not yet adopted - Refer to Note 2 for details on recently issued accounting pronouncements not yet adopted[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there have been no material changes to the company's market risk during the six months ended June 30, 2025, and refers to the Form 10-K for a detailed discussion of market risk exposure - No material changes to market risk during the six months ended June 30, 2025[151](index=151&type=chunk) - Refer to the Form 10-K for a discussion of market risk exposure[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the principal executive and financial officers, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective. There were no changes in internal control over financial reporting during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[153](index=153&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[154](index=154&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information on legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's involvement in legal proceedings. A putative class action lawsuit filed in December 2024 was voluntarily dismissed in April 2025. However, two shareholder derivative complaints were consolidated into a single action in April 2025, alleging breach of fiduciary duties by directors and officers, with an amended complaint filed in July 2025. The defendants intend to file a motion to dismiss this litigation - A putative class action lawsuit (Saylor v. Caribou Biosciences, Inc., et al.) filed in December 2024 was voluntarily dismissed without prejudice on April 27, 2025[158](index=158&type=chunk) - Two shareholder derivative complaints were consolidated into a single action (In re Caribou Biosciences, Inc. Derivative Litigation) in April 2025, alleging breach of fiduciary duties[159](index=159&type=chunk) - An amended complaint was filed in the Consolidated Derivative Action on July 7, 2025, and defendants intend to file a motion to dismiss[159](index=159&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section updates the risk factors, primarily focusing on the company's compliance with Nasdaq's continued listing requirements. The company regained compliance with the Minimum Bid Price Rule in June 2025 but faces ongoing risks of delisting if it fails to maintain compliance. Stockholders approved a reverse stock split, which could increase the stock price but does not guarantee sustained compliance or prevent dilution from future issuances - The company regained compliance with Nasdaq's Minimum Bid Price Rule (**$1.00** per share) in June 2025 after its stock price closed below **$1.00** for **30 consecutive business days**[161](index=161&type=chunk) - There is no assurance of continued compliance with Nasdaq listing requirements, and future delisting could negatively impact liquidity, market price, and ability to raise equity financing[162](index=162&type=chunk)[163](index=163&type=chunk) - Stockholders approved a reverse stock split (ratio **1-for-5** to **1-for-50**) at the board's discretion, which aims to increase stock price but does not guarantee sustained compliance or prevent future price declines[165](index=165&type=chunk) - A reverse stock split could effectively increase authorized shares available for future issuance, potentially leading to dilution for existing stockholders[167](index=167&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section states that there were no unregistered sales of equity securities during the three months ended June 30, 2025 - No unregistered sales of equity securities occurred during the three months ended June 30, 2025[168](index=168&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including organizational documents, descriptions of common stock, an advisory consulting agreement, certifications from executive officers (Sections 302 and 906 of Sarbanes-Oxley Act), and Inline XBRL documents - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Description of Common Stock, an Advisory Consulting Agreement, and certifications (31.1, 31.2, 32.1, 32.2)[169](index=169&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents, and Cover Page Interactive Data File) are also filed[169](index=169&type=chunk) [SIGNATURES](index=42&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, affirming that the report has been duly caused to be signed on behalf of Caribou Biosciences, Inc. by its President and Chief Executive Officer (Principal Executive Officer) and its Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) - The report is signed by Rachel E. Haurwitz, Ph.D., President and Chief Executive Officer (Principal Executive Officer), and Sriram Ryali, M.B.A., Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)[174](index=174&type=chunk) - Signatures are dated August 12, 2025[174](index=174&type=chunk)
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]