Autolus Therapeutics (AUTL) Corporate presentation summary

Product performance and market expansion

• AUCATZYL achieved FY 2025 net product revenue of $74.3 million and is projected to reach $120–$135 million in FY 2026, with deepening US market penetration and early UK launch success.

• Conditional marketing authorization was received in the UK (April 2025) and EU (July 2025), with ongoing country-by-country EU market access evaluations.

• Over 80 US treatment centers are now authorized, and the company shifted to a positive gross margin in 2026 due to increased volumes and manufacturing improvements.

Clinical data and efficacy

• FELIX trial showed a 77% overall remission rate and excellent tolerability, with durable responses and low rates of high-grade immunotoxicities.

• At 24 months, overall survival probability was 46%, and median duration of response was 42.5 months.

• Real-world data from the ROCCA registry confirmed favorable safety and efficacy, with no high-grade CRS and only 3% high-grade ICANS.

Pipeline and development strategy

• Obe-cel is being developed for pediatric ALL, lupus nephritis, and progressive multiple sclerosis, with ongoing pivotal and early-stage trials.

• Pediatric ALL Phase 1 data showed a 95% ORR and 91% CRR, with low rates of high-grade CRS and ICANS; Phase 2 is enrolling.

• Lupus nephritis Phase 1 (CARLYSLE) showed 83% DORIS and 50% complete renal remission, with no ICANS or high-grade CRS; Phase 2 (LUMINA) is enrolling.

• Progressive MS Phase 1 (BOBCAT) is underway, targeting high unmet need and using biomarker and clinical endpoints.