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 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.