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Autolus Therapeutics plc (NASDAQ: AUTL) is a pioneering biopharmaceutical company dedicated to the development and commercialization of engineered T-cell immunotherapy products. These innovative therapies are designed to treat life-threatening cancers with remarkable efficacy. Autolus is at the forefront of biotechnology, focusing on both haematological and solid tumors using patient-specific T-cell therapies.
At the heart of Autolus' clinical-stage pipeline is obecabtagene autoleucel (obe-cel). Additional promising candidates include AUTO1/22, AUTO3, AUTO5, AUTO6, AUTO7, and AUTO8. These products represent the next generation of programmed T-cell therapies, offering new hope for cancer patients worldwide.
Autolus' strategic initiatives are equally impressive. The company has formed a strategic alliance with BioNTech SE, a key player in the biotech industry. This partnership is poised to enhance the development and reach of Autolus' therapies. Additionally, Autolus has successfully completed an underwritten offering, strengthening its financial foundation.
Recent financial results highlight the company's strong performance. For the full year ended December 31, 2023, Autolus reported unaudited financial results, including significant UK SME R&D Tax Credits. These credits amounted to $19.5 million and $24.6 million for the years ended December 31, 2023, and 2022, respectively, providing a substantial boost to their research and development efforts.
Looking ahead, Autolus has outlined key updates and anticipated milestones for obe-cel, along with financial results for the quarter ended March 31, 2024. These updates are critical for investors and stakeholders who are keen to track the company's progress and achievements.
In summary, Autolus Therapeutics plc is leading a transformative revolution in medicine, treating life-threatening diseases through cutting-edge T-cell therapies. The company's strategic partnerships, robust pipeline, and solid financials position it as a leader in the biopharmaceutical industry.
Autolus Therapeutics announced longer-term follow-up and additional data from the pivotal Phase 1b/2 FELIX study of obe-cel for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). Presented at ASCO 2024, the data revealed that 40% of patients remain in remission without further therapy, showing potential long-term survival benefits. Median overall survival (OS) was 23.8 months, and median event-free survival (EFS) was 11.9 months. The FDA BLA submission has a target action date of November 16, 2024. The results support obe-cel as a standalone therapy with CAR T persistence linked to improved outcomes.
Autolus Therapeutics (NASDAQ: AUTL) reported its Q1 2024 financial results, highlighting key developments and financial metrics. The company is progressing with its regulatory review processes for obe-cel in relapsed/refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) with the FDA and European Medicines Agency (EMA). Key milestones include longer follow-up data from the FELIX Phase 2 trial, initial data from the CARLYSLE Phase 1 trial for Systemic Lupus Erythematosus (SLE) expected by late 2024, and the strategic CAR T cell therapy collaboration with BioNTech. Financially, the company reported cash and cash equivalents totaling $758.5 million as of March 31, 2024. Operating expenses were $38.8 million, with a net loss of $52.7 million for the quarter.
Autolus Therapeutics (Nasdaq: AUTL) announced the publication of three abstracts for the upcoming 2024 European Hematology Association (EHA) Congress, set for June 13-16, 2024. The studies focus on obecabtagene autoleucel (obe-cel) for treating relapsed/refractory B-Cell acute lymphoblastic leukemia. Key presentations include:
- An oral presentation by Dr. Claire Roddie on survival rates and CAR-T cell persistence in the FELIX study.
- A poster by Dr. Jae H. Park discussing the effects of inotuzumab-containing bridging therapy.
- Another poster by Dr. Claire Roddie on the sensitivity of droplet digital PCR and flow cytometry in measuring CAR-T cell kinetics.
Autolus Therapeutics plc, a biopharmaceutical company, has delayed its first quarter 2024 earnings release and conference call. The company will file a Form 12b-25 for an extension to file its Quarterly Report on Form 10-Q. The earnings release and call scheduled for May 14, 2024, are canceled, with the Q1 2024 10-Q expected to be filed by May 20, 2024. The conference call is rescheduled to May 17, 2024, for discussing financial results.
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