Allogene Therapeutics (ALLO) Citigroup’s Biopharma Back to School Summit 2026 summary

Business and pipeline overview

• Significant progress in 2026, with key data from an interim futility analysis and brisk enrollment in a novel CAR T-cell phase I program for autoimmune diseases.

• CEO transition in July 2026, with a focus on executing pivotal cema-cel, ALPHA3, and RESOLUTION (ALLO-329) studies, plus advancing a preclinical pipeline.

• Lead programs are prioritized for the coming years, with additional preclinical data expected at upcoming conferences.

Cema-cel and ALPHA3 program updates

• Cema-cel is being studied in a randomized trial for MRD-positive B-cell non-Hodgkin's lymphoma, comparing it to observation.

• Interim futility analysis in April showed a 42% MRD clearance differential favoring cema-cel.

• Interim event-free survival (EFS) analysis planned for 2027, with primary EFS in 2028; majority of statistical alpha reserved for the primary analysis.

• Disclosure of interim EFS will be limited to study continuation or stopping, as determined by the IDMC.

Commercial strategy and MRD testing landscape

• Commercial launch planning underway, with initial hires focused on market access and reimbursement.

• MRD testing adoption is rapidly increasing, with 25-30% of patients currently tested and up to 80% projected if cema-cel is approved.

• Community oncologists are enthusiastic, with about 50% of trial sites in community centers, many new to CAR T therapy.

• Cema-cel's outpatient regimen and ease of administration could expand access and address the 80% gap in CAR T utilization.

• Commercial opportunity estimated at $2.5–$3.5 billion annually.