At a Citi investor summit, Caribou executives detailed the design of a pivotal Phase II/III trial for Vispa-cel, an allogeneic CAR-T therapy targeting relapsed/refractory B-cell malignancies. The study will enroll 150 patients across multiple centers starting in Q3 2026, with a primary endpoint of complete response rate at six months.

Management indicated that existing cash resources will sustain operations only through Q3 2025, after which additional funding will be necessary to advance Vispa-cel into pivotal studies and pre-commercial preparations. They projected a minimum new financing requirement of $100 million and are exploring equity raises or strategic partnerships to secure capital.

Caribou plans to complete trial enrollment by early 2028 and file a Biologics License Application by year-end 2028, targeting FDA approval in 2029. The company will pursue accelerated review pathways, including orphan drug designation, to expedite regulatory assessment and market entry.