Autolus Q2 2024 Earnings Report
Key Takeaways
Autolus Therapeutics reported a net loss of $58.3 million for the second quarter of 2024, compared to a net loss of $45.6 million for the same period in 2023. Cash and cash equivalents totaled $705.9 million as of June 30, 2024. The company is focused on commercial readiness activities for obecabtagene autoleucel (obe-cel).
On track for potential US commercial launch of obe-cel with a PDUFA date of November 16, 2024.
Longer follow up and subset analyses from pivotal FELIX Phase 2 data presented at ASCO and EHA showed durable responses.
A Market Authorization Application (MAA) for obe-cel was submitted to the MHRA in the UK at the end of July 2024.
The MAA review process continues with the European Medicines Agency (EMA).
Autolus
Autolus
Forward Guidance
Autolus anticipates several key milestones in the near term, including the PDUFA target action date for obe-cel, presentation of obe-cel FELIX data at ASH, and initial data from the SLE Phase 1 study.
Positive Outlook
- Obe-cel U.S. FDA PDUFA target action date November 16, 2024
- Obe-cel FELIX data at American Society of Hematology (ASH) meeting December 2024
- Obe-cel in autoimmune disease – initial data from SLE Phase 1 study Late 2024