Autolus Therapeutics plc (AUTL), a leader in T-cell therapies, announced its Q2 2024 financial results and business updates.
The company is preparing for a potential U.S. launch of its lead therapy, obecabtagene autoleucel (obe-cel), for adult B-cell Acute Lymphoblastic Leukemia (B-ALL).
The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is set for November 16, 2024, with marketing applications also under review by the EMA and the UK’s MHRA.
FELIX Trial Shows Long-Term Remission Potential
In June 2024, Autolus presented extended data from the pivotal FELIX Phase 2 trial at ASCO and EHA meetings, showing strong results for obe-cel.
With a median follow-up of 21 months, 40% of treated patients maintained remission without needing further stem cell transplants.
This data suggests obe-cel could serve as a stand-alone therapy for relapsed or refractory (r/r) B-ALL patients, reducing the need for additional interventions.
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Increased R&D Investment Reflects Growth Commitment
For the quarter ending June 30, 2024, Autolus reported a net loss of $58.3 million, up from $45.6 million in Q2 2023, due to increased R&D and commercialization efforts.
Research and development expenses rose to $36.6 million, while general and administrative expenses reached $21.9 million as Autolus scaled operations in preparation for obe-cel’s launch.
As of June 30, 2024, Autolus held $705.9 million in cash and equivalents, up significantly from $239.6 million at year-end 2023. This cash position supports the commercial launch of obe-cel and ongoing pipeline development.
Additionally, Autolus is advancing additional programs, including a Phase 1 trial for obe-cel in autoimmune conditions like systemic lupus erythematosus (SLE), with initial data expected in late 2024.
Partnerships with University College London support other promising programs, including AUTO8, AUTO6NG, and AUTO1/22, with data updates anticipated in 2025.
Positioned for Growth in T-cell Therapy Market
Autolus’s Q2 2024 results highlight its strategic focus on pioneering T-cell therapies, with obe-cel poised for a potentially transformative role in r/r B-ALL.
With a growing pipeline and strong financial position, Autolus is well-positioned to advance cutting-edge therapies across oncology and autoimmune disease markets.
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