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Dec 31, 2023
Autolus Q4 2023 Earnings Report
Autolus reported its financial results for the full year ended December 31, 2023, and provided business updates.
Key Takeaways
Autolus Therapeutics reported a net loss of $208.4 million for the year ended December 31, 2023, with cash and cash equivalents totaling $239.6 million. The company highlighted its strategic alliance with BioNTech and the submission of the BLA for obecabtagene autoleucel (obe-cel) to the FDA.
Strategic collaboration and equity investment from BioNTech for aggregate proceeds of $250 million upfront, plus underwritten offering of ADSs for $350 million, for gross proceeds of $600 million received in February 2024.
Submitted a Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel) to the US FDA with a PDUFA target action date of November 16, 2024.
Successfully completed first facility inspection and obtained a Manufacturer’s Importation Authorization (MIA) from the Medicines and Healthcare products Regulatory Agency (MHRA).
Submitted a Market Authorization Application (MAA) for obe-cel in r/r adult ALL with the European Medicines Agency (EMA).
Autolus
Autolus
Forward Guidance
Autolus anticipates several milestones in 2024, including obe-cel data updates, regulatory submissions, and initial data from the SLE Phase 1 study.
Positive Outlook
- Obe-cel FELIX data update at ASCO, EHA & ASH in June & December 2024
- Obe-cel Marketing Authorization Application to MHRA in the second half of 2024
- Obe-cel U.S. FDA PDUFA target action date November 16, 2024
- Obe-cel in autoimmune disease – initial data from SLE Phase 1 study in late 2024
- Well capitalized to drive the full launch and commercialization of obe-cel in r/r adult ALL
Challenges Ahead
- Risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all
- The results of early clinical trials are not always being predictive of future results
- The cost, timing and results of clinical trials
- That many product candidates do not become approved drugs on a timely or cost effective basis or at all
- The ability to enroll patients in clinical trials and possible safety and efficacy concerns