Caribou Biosciences, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024; balance-sheet amounts are as of March 31, 2024. Amounts are in U.S. dollars unless stated otherwise. Caribou is a clinical-stage genome-editing company developing allogeneic CAR-T and CAR-NK therapies; it has no approved products and has not generated product-sales revenue.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 / comparison |
|---|---|---|
| Licensing and collaboration revenue | $2.4 million | $3.5 million; down $1.1 million |
| Research and development expense | $33.8 million | $25.7 million; up $8.1 million |
| General and administrative expense | $14.6 million | $8.9 million; up $5.7 million |
| Operating loss | $46.0 million | $31.1 million |
| Net loss | $41.2 million | $28.0 million |
| Basic and diluted loss per share | $0.46 | $0.46 |
| Cash used in operating activities | $37.2 million | $27.9 million |
Revenue declined primarily because no revenue was recognized under the AbbVie agreement, terminated in October 2023, compared with $1.6 million in Q1 2023. This was partly offset by $0.6 million recognized under the Pfizer information-rights agreement. Other income was $4.8 million, including $4.5 million of other income, primarily interest income.
At March 31, cash, cash equivalents, and marketable securities totaled $345.9 million, down from $372.4 million at December 31, 2023. Current assets were $304.5 million and current liabilities $29.0 million. Total liabilities were $63.5 million; the filing reports no debt balance. Accumulated deficit was $340.5 million. Management expects existing cash, cash equivalents, and marketable securities to fund its current operating plan for at least 12 months from the financial-statement issuance date.
Cash from investing activities was $23.0 million, largely reflecting net maturities and purchases of marketable securities; financing activities provided $12.5 million, including $11.3 million net ATM proceeds. Cash and cash equivalents decreased by $1.8 million during the quarter. No product gross margin is reported because the company has no product sales.
Material changes and notable items
- Operating expenses rose $13.8 million year over year. R&D increases included license and milestone costs, higher personnel expense, and clinical CRO activity; G&A included a $3.9 million accrued litigation settlement.
- On April 22, 2024, after quarter-end, Caribou agreed in principle to settle the federal Bergman securities class action for $3.9 million. The settlement is subject to court approval. A separate California Lowry case was dismissed, with the dismissal order entered April 15, 2024.
- Caribou issued 1.59 million shares through its ATM program during Q1, receiving $11.3 million net. Shares outstanding increased from 88.45 million at December 31, 2023, to 90.31 million at March 31, 2024.
- Potential future development, regulatory, and sales milestone payments under certain license and assignment agreements totaled approximately $160.2 million; payment timing and achievement are contingent and uncertain.
- Revenue was concentrated: four licensees together represented 74.0% of Q1 revenue. The Pfizer-related deferred revenue balance was approximately $5.6 million at quarter-end.
Business outlook, commentary, and risks
Management expects substantial future losses and increasing expenses as clinical trials and product development advance. The company says it may need additional capital and may never achieve profitability; financing could dilute shareholders or require giving up rights on unfavorable terms. It has a $100 million ATM authorization within its shelf registration, and funding availability is not assured.
- CB-010: The ANTLER Phase 1 trial is evaluating the lead anti-CD19 CAR-T candidate. Caribou planned to present initial dose-expansion data, the recommended Phase 2 dose in second-line LBCL, and translational data at ASCO on June 3, 2024. The FDA cleared the IND for a Phase 1 lupus nephritis and extrarenal lupus trial, which the company expects to initiate by year-end 2024.
- CB-011: The anti-BCMA CAR-T candidate is in dose escalation in the CaMMouflage Phase 1 trial for relapsed or refractory multiple myeloma.
- CB-012: The CLL-1 CAR-T candidate is in dose escalation in the AMpLify Phase 1 trial for relapsed or refractory AML.
Key risks include clinical efficacy and safety uncertainty, trial timing and enrollment, regulatory approval, reliance on contract manufacturers and other third parties, intellectual-property disputes, and the need for additional financing. Management reported no material changes to previously disclosed risk factors, no material changes in market-risk exposure, and effective disclosure controls as of March 31, 2024.
Important facts for investors to verify
- Whether CB-010 dose-expansion results and the recommended Phase 2 dose support further development, and the timing of the planned lupus trial.
- Actual cash burn and runway as trial activity and expenses change; the stated runway is based on the current operating plan.
- Final court approval and payment terms for the $3.9 million Bergman settlement.
- Future share issuance under the ATM and resulting dilution, alongside potential financing needs.
- Progress and potential financial exposure from the approximately $160.2 million in contingent milestone obligations and the company’s concentrated licensing revenue.