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Autolus Therapeutics plc (AUTL-0.66%) has filed its annual report on Form 10-K for the fiscal year ended December 31, 2024 filing.
The company reported a focus on developing next-generation programmed T cell therapies for cancer and autoimmune diseases. Its first commercial product, AUCATZYL/obe-cel, received FDA approval for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) and was launched in the U.S. in January 2025.
The filing details Autolus' plans to expand AUCATZYL/obe-cel into the European Union and the United Kingdom, pending regulatory approval expected in the second half of 2025.
Autolus is advancing multiple clinical-stage programs, including obe-cel for pediatric B-ALL and B-NHL, and AUTO1/22 and AUTO4 for other hematological cancers. The company is also exploring obe-cel for treating autoimmune diseases such as systemic lupus erythematosus.
The company reported a net loss of $220.7 million for 2024, compared to $208.4 million in 2023, with an accumulated deficit of $1,099.2 million as of December 31, 2024.
Autolus highlighted its strategic priorities, including the commercialization of AUCATZYL/obe-cel, developing additional indications for obe-cel, and expanding its research and development pipeline.
The company noted risks related to its financial position, including the need for additional funding to support commercialization and development efforts, potential competition, and regulatory challenges.
Autolus also discussed its manufacturing capabilities, emphasizing its facility in Stevenage, U.K., which supports commercial and clinical supply needs, and its reliance on third-party suppliers for certain materials and processes.
The filing outlines various risk factors, including potential adverse side effects of its therapies, intellectual property challenges, and the impact of regulatory changes on its operations.
Autolus is subject to extensive regulation in the U.S., EU, and other jurisdictions, with ongoing compliance requirements related to manufacturing, marketing, and post-approval monitoring of its products.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Autolus Therapeutics plc annual 10-K report dated March 20, 2025. To report an error, please email earnings@qz.com.