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LONDON - Autolus Therapeutics plc (NASDAQ:AUTL), a biopharmaceutical company specializing in T cell therapies, has reported a net product revenue of $9.0 million for the first quarter of 2025 for its therapy AUCATZYL®. This announcement comes alongside the news that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL® for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
The company also shared preliminary data from its Phase 1 CARLYSLE trial for systemic lupus erythematosus (SLE), indicating plans to initiate a Phase 2 pivotal clinical trial in lupus nephritis (LN) and a Phase 1 trial in progressive forms of multiple sclerosis (MS) before the end of 2025.
Autolus is an early commercial-stage company focusing on programmed T cell therapies for cancer and autoimmune diseases. It recently celebrated the inclusion of AUCATZYL® in the Centers for Medicare and Medicaid Services (CMS) coding determinations, which formalizes reimbursement for patients under government programs.
For the first quarter ended March 31, 2025, Autolus reported a net loss of $70.2 million, with research and development expenses decreasing to $26.7 million, compared to $30.7 million in the same period in 2024. Selling, general, and administrative expenses rose to $29.5 million, reflecting increased headcount supporting U.S. commercialization activities.
The company’s cash reserves, including cash equivalents and marketable securities, stood at $516.6 million as of March 31, 2025, a decrease from $588.0 million at the end of 2024. The decrease reflects net cash used in operating and investing activities, along with a delayed R&D tax credit receipt expected from the UK HMRC.
The company has stated it is well capitalized to support the launch and commercialization of AUCATZYL® in r/r B-ALL and to obtain data in the LN pivotal trial and MS Phase 1 trial.
This report is based on a press release statement from Autolus Therapeutics plc.
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