Allogene Therapeutics (ALLO) TD Cowen 46th Annual Health Care Conference summary

Strategic program updates

• Advancing allogeneic CAR-T therapies with a focus on cema-cel for frontline large B-cell lymphoma and ALLO-329 for autoimmune diseases, emphasizing outpatient, community-based administration.

• Manufacturing capabilities enable production of 20,000–60,000 doses annually at $10,000–$20,000 per dose, supporting broad patient access and biologic-like economics.

• Multiplex gene editing and controlled manufacturing offer unique advantages over other modalities, supporting consistent product quality and scalability.

• Allogeneic CAR-T aims to provide a one-time, potentially curative treatment, with growing confidence in its clinical utility and cost-effectiveness.

• Expansion into autoimmune and solid tumor indications is planned, leveraging MRD-guided approaches and transient immune system reset.

Clinical trial design and milestones

• The ALPHA3 study randomizes MRD-positive patients post-R-CHOP to cema-cel or observation, targeting event-free survival as the primary endpoint.

• Interim futility analysis in April will assess MRD clearance in 24 patients, with a 25–30% improvement set as the meaningful bar.

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

• MRD testing turnaround is under two weeks, facilitating timely treatment decisions and supporting integration into standard care.

• Preliminary safety data and outpatient feasibility will be disclosed at the interim readout, aiming to demonstrate safe administration in community settings.

Market opportunity and future directions

• Estimated 34,000 eligible patients in the US and Europe for MRD-positive post-R-CHOP, representing a $5 billion total addressable market and potential peak sales over $2 billion.

• ALLO-329 targets rheumatologic autoimmune diseases, with proof-of-concept data expected by June, focusing on cell kinetics, biomarkers, and Dagger technology validation.

• The Dagger platform may reduce or eliminate the need for lymphodepletion, with early trials testing Cytoxan alone or no lymphodepletion.

• Future pivotal programs may expand into nephrology, neurology, and other autoimmune indications, with prioritization post-proof-of-concept.

• The transformative potential of ALPHA3 and renewed momentum in allogeneic cell therapy are seen as underappreciated by investors.