Autolus Therapeutics plc

We are an early commercial-stage biopharmaceutical company focused on developing, manufacturing, and delivering T cell therapies for cancer and autoimmune diseases. We use proprietary T cell programming technologies to engineer targeted T cell therapies designed to recognize and eliminate target cells. Our key product is AUCATZYL (obecabtagene autoleucel, also known as obe-cel), a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy. AUCATZYL is designed with a fast target binding off-rate to minimize excessive activation of programmed T cells. In November 2024, the United States Food and Drug Administration (FDA) approved AUCATZYL for adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The commercial launch and first sale in the United States occurred in January 2025. The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted AUCATZYL conditional marketing authorization in April 2025. In November 2025, the National Institute for Health and Care Excellence (NICE) recommended AUCATZYL for use in the National Health Service (NHS) in England and Wales for adult patients (age 26 and older) with r/r B-ALL. We launched AUCATZYL in the United Kingdom in January 2026, where it is available through routine NHS commissioning. In July 2025, the European Commission (EC) granted marketing authorization for AUCATZYL for adult patients (age 26 and older) with r/r B-ALL. Evaluation of pricing and market entry in certain European Union (EU) countries is ongoing, but launch in the EU is currently on hold, and we do not anticipate any EU sales of AUCATZYL in 2026.