Autolus Therapeutics (AUTL) Status Update summary

Strategic Positioning and Commercial Progress

• Strong cash position (£588 million/$588M) supports ongoing and future clinical programs and launches.

• Commercial launch of AUCATZYL (obe-cel) in the US is progressing, with 38 centers activated and plans to expand to 60 by year-end, covering over 85% of eligible patients.

• UK approval decision for AUCATZYL is expected in Q2 2025, with EU decision anticipated in H2 2025; launches in these regions are planned within 12 months.

• Manufacturing infrastructure and collaborations with UCL support current and future indications and cost-efficient early data generation.

Clinical Development and Data Highlights

• Obe-cel demonstrates deep, durable remissions in B cell malignancies, with long-term follow-up beyond five years in some cases.

• In r/r ALL, obe-cel shows high MRD-negative remission rates (94%) and strong efficacy in non-Hodgkin lymphoma.

• Early Phase 1 data in refractory lupus nephritis show 50% of patients achieving complete renal response within three months, with normalization of complement and resolution of musculoskeletal and dermal symptoms.

• Safety profile in autoimmune indications remains favorable, with no high-grade CRS or ICANS in lupus nephritis patients; in oncology, CRS occurred in 75% and ICANS in 24% of patients, mostly manageable.

• Dose escalation studies in MS are planned, focusing on progressive disease and leveraging biomarkers and imaging to assess CNS penetration and efficacy.

Regulatory and Clinical Trial Strategy

• Phase II pivotal study in lupus nephritis will enroll 30 patients who have failed both B cell targeting agents and calcineurin inhibitors, with complete renal response as the primary endpoint; FDA has cleared the IND and aligned on single-arm design.

• First patient enrollment in pivotal lupus nephritis and MS trials is expected by year-end 2025.

• Global trial footprint includes US, Europe, and select additional countries.

• Biomarker-driven approach in MS trials aims to demonstrate reduction in CNS inflammation and oligoclonal bands, differentiating CAR T from existing therapies.