Business Context and Reporting Period
Company: Caribou Biosciences, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: June 11, 2026
Context: The filing discloses the release of clinical trial data for two allogeneic CAR-T cell therapy candidates: vispa-cel (CB-010) for relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) and CB-011 for relapsed/refractory multiple myeloma (r/r MM). Data will be presented at the European Hematology Association (EHA) 2026 Annual Meeting.
Key Financial Metrics
This Form 8-K is a disclosure of clinical trial results and does not contain financial statements. The filing text does not provide values for revenue, profit, cash flow, margins, debt, or liquidity. Investors should refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2025, for financial data.
Material Changes and Clinical Results
ANTLER Phase 1 Trial (vispa-cel for r/r B-NHL)
- Population: 85 patients treated total; pivotal subgroup of 27 second-line (2L) large B cell lymphoma (LBCL) patients received optimized vispa-cel.
- Efficacy (Pivotal Subgroup):
- Overall Response Rate (ORR): 82%
- Complete Response Rate: 67%
- Median Progression-Free Survival (PFS): 17.1 months
- Safety (Pivotal Subgroup): No graft-versus-host disease (GvHD) or grade 3+ immune effector cell-associated neurotoxicity syndrome (ICANS). One (4%) grade 3+ cytokine release syndrome (CRS). Two deaths reported (one vispa-cel-related due to IEC-HS, one possibly related due to progressive multifocal leukoencephalopathy).
- Regulatory Status: FDA alignment reached on ANTLER-3 Phase 3 trial design (approx. 250 patients, randomized, controlled).
CaMMouflage Phase 1 Trial (CB-011 for r/r MM)
- Population: 48 patients treated in dose escalation; 12 BCMA-naïve patients treated at Recommended Dose for Expansion (RDE).
- Efficacy (BCMA-naïve RDE Cohort):
- ORR: 92%
- Complete Response or Stringent Complete Response (≥CR): 83%
- Minimal Residual Disease (MRD) Negativity: 91% (10 of 11 evaluable)
- Durability: 50% of patients in ≥CR at 15 months
- Safety (RDE Cohort): No GvHD. One (8%) grade 3+ CRS. No grade 3+ ICANS. One CB-011-related death due to hematotoxicity in the broader selected LD regimen cohort (N=35).
- Case Study: A 71-year-old patient with 8 prior lines of therapy achieved a complete response maintained at month 3.
Guidance, Outlook, and Risks
- Upcoming Presentations: vispa-cel data on June 12, 2026; CB-011 data on June 14, 2026, at EHA 2026 in Stockholm.
- Future Data: Initial dose expansion data for CaMMouflage (BCMA-naïve and exposed) expected in the second half of 2026.
- Phase 3 Plans: ANTLER-3 Phase 3 trial for vispa-cel is planned to enroll CD19-naïve 2L LBCL patients ineligible for transplant or autologous CAR-T.
- Risks: Forward-looking statements are subject to risks including clinical trial uncertainties, regulatory approval timelines, and the Company's history of net operating losses. The filing explicitly notes the risk regarding the ability to raise additional capital to fund operations and the pivotal Phase 3 trial.
Investor Verification Checklist
- Verify the full text of the press releases attached as Exhibit 99.1 and 99.2 for detailed statistical tables.
- Review the Company's most recent Form 10-K (Year ended Dec 31, 2025) to assess cash runway and capital requirements for the planned ANTLER-3 Phase 3 trial.
- Monitor the EHA 2026 Annual Meeting presentations on June 12 and 14, 2026, for oral updates and Q&A sessions.
- Confirm the timeline for the initiation of the ANTLER-3 Phase 3 trial and any potential changes to the FDA alignment.
- Assess the safety profile details regarding the two deaths in the vispa-cel trial and the one death in the CB-011 trial to understand potential regulatory hurdles.