Autolus Therapeutics Plc Q3 FY2024 earnings call

• AUCATZYL received FDA approval, the first CAR-T program without a REMS requirement.
• 60 centers in onboarding process for AUCATZYL, with 30 ready to activate, reaching ~60% of US relapsed/refractory ALL patients, aiming for 90% with additional 30 centers.
• Nucleus manufacturing facility in the UK with capacity for ~2,000 ALL products/year and a 16-day turnaround time.
• Q3 focus on launch readiness; engaged with EU/UK regulators for Obe-cel; published/presented FELIX study data.
• New Chief Development Officer joined; 4 abstracts planned for ASH presentation.
• Pipeline includes AUTO1/22, AUTO8, and updates on SLE and pediatric ALL trials.

Cash and cash equivalents at September 30, 2024, totaled $657.1 million, up from $239.6 million at the end of December 2023. Total net operating expenses for the three months ending September 30, 2024 were $67.9 million, compared to $42.9 million in the same period in 2023. Research and development expenses increased from $32.3 million to $40.3 million due to higher salaries, Obe-cel clinical trial, and manufacturing costs. General and administrative expenses rose from $10.6 million to $27.3 million due to increased headcount for pre-commercialization activities. Net loss for the three months ending September 30, 2024 was $82.1 million, compared to $45.8 million in the same period in 2023.

• Will present 4 abstracts at the ASH meeting.
• Expect initial data from Phase 1 SLE trial by end of Q1 2025, additional data from pediatric ALL and longer-term studies in H2 2025.
• Triggered a $30 million milestone payment from Blackstone and a £10 million regulatory milestone payment in Q4.

Q: Is obe-cel's EU approval still on track for mid-25 or could this be slightly pulled forward?

A: On track for mid-2025, with a similar timeline expected for UK approval. The safety profile of obe-cel allows for potential outpatient administration.

Q: How many of the 30 onboarded centers were involved in the FELIX study?

A: The 30 centers are in the final administrative steps to activate; specific details on FELIX study center involvement were not provided.

Q: Insights on SLE data patient numbers and enrollment?

A: SLE trial enrolled the first patient in Q2, with additional patients enrolled in H2, and enrollment expected to complete early Q1 2025; initial data will be available in Q1, with longer-term data in H2.