Autolus Therapeutics (AUTL) Goldman Sachs 45th Annual Global Healthcare Conference summary

Program and regulatory progress

• Lead CAR T program, obe-cel, is under FDA review with a PDUFA date set for November 16 and filings also underway with European and UK agencies.

• Obe-cel pivotal FELIX study shows 22-month median follow-up with event-free and overall survival stabilizing at 40%, indicating potential for long-term remission in relapsed ALL patients.

• FDA review is in the second half, focusing on product specification, labeling, and REMS, with no advisory committee expected.

• European review is ongoing, with a formal question cycle and country-by-country reimbursement expected post-approval.

• Anticipates rapid inclusion in NCCN guidelines upon approval.

Manufacturing and launch readiness

• Commercial manufacturing facility supports up to 3,000 patients annually, covering at least two-thirds of adult ALL patients in the US and Europe.

• Facility built and validated in under 24 months, with a 5% out-of-spec rate and 84% patient dosing during the pandemic.

• Achieved MHRA license for export; FDA review ongoing for US launch.

• Launch systems ensure robust chain of custody, center accreditation, and streamlined logistics, with 30–36 centers ready at launch, expanding to 60 for broad US coverage.

Product differentiation and competitive landscape

• Obe-cel uniquely delivers long-term outcomes without the need for stem cell transplant, with superior safety profile compared to competitors.

• High-grade CRS and neurotoxicity rates are significantly lower than other CAR T therapies, enabling more outpatient treatments and higher reimbursement potential.

• Predictability of adverse events and resource use is improved, with a new technology access payment application planned.