Allogene Therapeutics (ALLO) H.C. Wainwright 4th Annual Cell Therapy Virtual Conference summary

Strategic vision and pipeline overview

• Focus remains on executing the pivotal cema-cel program for first-line consolidation in diffuse large B-cell lymphoma, with continuity in strategic direction and subtle optimizations expected under new leadership.

• Pipeline includes ALLO-329 for autoimmune diseases and a phase I program in metastatic renal cell carcinoma, with a forthcoming publication.

• The Dagger platform underpins pipeline innovation, including dual-targeting CARs and intrinsic lymphodepletion technology.

Cema-cel pivotal trial and market opportunity

• ALPHA3 trial uses MRD testing to identify high-risk patients post-first-line therapy, randomizing them to cema-cel or observation, aiming to prevent relapse.

• The study is powered to detect a 50% reduction in event-free survival events, with interim EFS analysis expected mid-2027.

• MRD testing adoption is rapidly increasing, with significant quarter-over-quarter growth and updated NCCN guidelines supporting its use.

• Market opportunity for cema-cel estimated at $2.5–$3.5 billion across the US and EU5, driven by access in community oncology settings.

Interim ALPHA3 data and clinical impact

• Interim futility analysis showed 58.3% MRD clearance in cema-cel arm versus 16.7% in observation, with most responses by day 45.

• Safety profile was highly favorable: no CRS, ICANS, high-grade infections, or hospitalizations observed.

• About one-third of cema-cel infusions occurred in community practices, validating outpatient and decentralized delivery.