NEW YORK – Autolus Therapeutics on Thursday provided a pipeline update in reporting its 2024 financials, including how the US launch of its lead autologous CAR T-cell therapy Aucatzyl (obecabtagene autoleucel) is progressing and the timing of potential European approvals of the product.
The US Food and Drug Administration approved Aucatzyl as a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) in November. Autolus on Thursday said it expects approval decisions from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency for the same indication in the second half of 2025.
In the US, the firm said it has 33 authorized centers that can provide Aucatzyl to patients as of this week. The currently authorized centers cover approximately 60 percent of the target B-ALL patient population in the US, according to the company. By the end of the year, the firm expects to have 60 authorized treatment centers operating. Moreover, Autolus' CAR T-cell manufacturing facility, the Nucleus, is poised to handle 2,000-plus batches per year and has been licensed by the MHRA and FDA to produce commercial supplies of Aucatzyl, the firm said.
Under the terms of a prior collaboration agreement, the FDA approval of Aucatzyl triggered a $30 million dollar milestone payment from Blackstone to Autolus. Under a separate license agreement, Autolus said it made a £10 million (around $13 million) regulatory milestone payment to UCL business, the technology-transfer company of University College London, also related to the CAR T-cell therapy.
London-based Autolus also said on Thursday that BioNTech, its development partner for several of its pipeline candidates, has decided as part of a strategic pipeline prioritization that it will not exercise its option to further advance the CD19- and CD22-directed CAR T-cell therapy candidate AUTO1/22. The cell therapy is currently undergoing a Phase I trial involving children with high-risk, relapsed CD19- or CD22-positive acute lymphoblastic leukemia.
With the approval of Aucatzyl late last year, Autolus' total revenue in 2024 shot up nearly sixfold to $10.1 million from $1.70 million in 2023. The firm reported a net loss of $220.7 million, or $.86 per share, in 2024, compared to a net loss of $208.4 million, or $1.20 per share, in 2023. As of Dec. 31, 2024, Autolus had $588 million in cash, cash equivalents, and marketable securities.