Autolus Therapeutics (AUTL) Leerink’s Global Healthcare Conference 2025 summary

Commercial launch and product adoption

• Obe-cel received approval in November without REMS, reflecting a strong safety profile.

• Over 30 centers activated by early 2024, aiming for 60 by year-end to reach over 90% patient access in the US.

• Inclusion in NCCN guidelines and publication of the FELIX study accelerated adoption and payer support.

• Centers show repeat use, indicating positive experience and growing demand.

• Acute lymphoblastic leukemia patients are managed in academic transplant centers due to disease complexity.

Clinical outcomes and product differentiation

• Obe-cel demonstrates a markedly lower rate of high-grade CRS (2%) and neurological toxicity (7%) compared to other CAR-Ts.

• Product design enables rapid disengagement after cell kill, reducing toxicity and improving efficacy.

• CAR-T cells show persistence up to 3-4 years, supporting sustained disease control.

• High activity and deep responses observed, with most responders achieving undetectable MRD.

Pipeline expansion and future plans

• Plans to expand Obe-cel into non-Hodgkin's lymphoma and autoimmune diseases, targeting settings with low disease burden for optimal outcomes.

• Early data in autoimmune disease to be presented in April, with a six-patient cohort using a fixed dose.

• Product is uniquely positioned in autoimmune disease due to existing approval, commercial manufacturing, and safety data.

• Further follow-up data expected in the second half of the year.