Autolus Therapeutics (AUTL) Corporate presentation summary

Product portfolio and approvals

• AUCATZYL, a CD19 CAR T cell therapy, is approved in the US, UK, and EU for adult relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), with commercial launches and established infrastructure in over 70 US centers.

• Achieved FY 2025 net product revenue of $74.3 million, with expectations to reach $120–$135 million in FY 2026.

• AUCATZYL is the first and only approved CAR T therapy with customized, tumor-burden guided dosing and no FDA REMS obligation.

• NICE determined AUCATZYL to be cost effective, with UK launch in January 2026 and ongoing EU pricing and reimbursement evaluations.

Clinical data and efficacy

• FELIX trial demonstrated high overall response rates, deep molecular responses, and favorable tolerability in adult r/r B-ALL, with 77% remission and low rates of high-grade immunotoxicities.

• At 24 months, overall survival probability was 46%, and median duration of response was 42.5 months, with more than half of patients in remission at 24 months.

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

• Obe-cel in lupus nephritis (CARLYSLE trial) achieved DORIS in 83% and complete renal remission in 50% of patients, with favorable safety and deep B-cell depletion.

Manufacturing and operational strengths

• Manufacturing success rate exceeds 90%, with fast, reliable, and consistent product delivery and no capacity limitations.

• Ongoing optimization of manufacturing processes, automation, and next-generation platforms to improve margins and capacity.

• Shift to positive gross margin in 2026 expected due to increased volumes and improved plant operations.