Allogene Therapeutics (ALLO) investor relations material

Strategic vision and value proposition

• Allogeneic cell therapy aims to provide one-time, potentially curative treatment with durable responses, improving patient accessibility by enabling administration in community-based cancer centers and reducing logistical barriers compared to autologous therapies.

• Manufacturing advances allow production of 20,000–60,000 patient doses per year at $10,000–$20,000 per dose, supporting biologic-like scale and cost efficiency.

• Multiplex gene editing and controlled manufacturing offer unique advantages over other modalities, enhancing product consistency and scalability.

Clinical program highlights

• The cema-cel CD19 program targets MRD-positive patients after frontline R-CHOP for large B-cell lymphoma, with an initial futility analysis expected in April and primary event-free survival (EFS) data in 2027.

• ALLO-329, a dual CD19/CD70 CAR-T, is being studied in autoimmune diseases, with proof-of-concept data anticipated in June 2026.

• ALLO-316, a CD70-directed program, has shown proof-of-concept in renal cell cancer but is not the current focus.

Study design and endpoints

• The ALPHA3 study randomizes MRD-positive patients post-R-CHOP to cema-cel or observation, with a primary endpoint of event-free survival and secondary endpoints including PFS, overall survival, and MRD clearance.

• Interim futility analysis will assess MRD clearance in 24 patients, targeting a 25–30% absolute improvement, referencing regulatory benchmarks and prior CAR-T studies.

• Enrollment is ongoing at over 59 sites in North America, with plans to expand to Asia Pacific; enrollment completion is targeted by end of next year.