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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 (AUTL) announced the appointment of Dr. Edgar Braendle as Chief Development Officer, effective immediately. His expertise in oncology development is expected to propel the company's lead program, obe-cel, through its pivotal study aimed at treating relapsed/refractory adult Acute Lymphoblastic Leukemia (ALL). Dr. Braendle previously held leadership roles at Sumitomo Dainippon Pharma Oncology and Boston Biomedical. His experience includes managing global oncology programs and a strong background in clinical affairs. Autolus aims to advance its proprietary CAR T cell therapies.
Autolus Therapeutics plc (Nasdaq: AUTL) will release its second quarter 2021 financial results and operational highlights on August 5, 2021, before U.S. market open. A conference call will follow at 8:30 AM EDT to discuss these results. CEO Christian Itin will also participate in a panel discussion on July 14, 2021, at the William Blair Biotech Focus Conference 2021. Autolus specializes in developing advanced programmed T cell therapies for cancer treatment, leveraging proprietary programming technologies for improved efficacy against malignancies.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, AUTO1 (obe-cel), has received innovative licensing and access pathway (ILAP) designation from the UK MHRA. This designation is part of the regulatory body’s initiative to expedite the development of promising medicines.
CEO Dr. Christian Itin highlighted that this is a crucial step in accelerating the review process for obe-cel, which is currently under investigation for relapsed/refractory adult B-cell Acute Lymphocytic Leukemia (ALL) in a Phase 1b/2 study.
Autolus Therapeutics (AUTL) reported a 100% complete remission rate in patients with indolent B Cell Non-Hodgkin lymphoma, alongside robust CAR T engraftment. No severe Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred. In adult Acute Lymphoblastic Leukemia (ALL), 85% achieved minimal residual disease-negative complete remission. The event-free survival rate at 12 months is 50.2%, indicating potential for obe-cel as a transformative therapy. A conference call on findings will be held on June 11.
Autolus Therapeutics (NASDAQ: AUTL) announced insights from a Nature Cancer publication on the durability of acute lymphoblastic leukemia (ALL) treatments using AUTO1. The findings reveal that long-term response in pediatric ALL patients correlates with an enrichment of Stem Cell Memory T cells (TSCM). These TSCM cells are believed to support sustained immune response. AUTO1's design encourages efficient targeting and minimized T cell exhaustion, enhancing its therapeutic potential. The investigational therapy is being evaluated in ongoing clinical trials.
Autolus Therapeutics (Nasdaq: AUTL) announced its Annual General Meeting (AGM) scheduled for June 18, 2021, at its headquarters in White City, London. Due to COVID-19 restrictions, in-person attendance is prohibited, and a minimum quorum of two shareholders is required. Shareholders are encouraged to submit proxy votes ahead of the meeting as voting during the AGM will not be possible. No webcast will be provided this year, and results will be announced via press release afterwards.
Autolus Therapeutics plc (Nasdaq: AUTL) announced a 100% complete remission rate in a cohort of patients with relapsed/refractory indolent B cell lymphomas (IBCL) treated with its investigational therapy, AUTO1. The early results were presented at the European Hematology Association Virtual Congress on June 9-17, 2021. Of the 10 patients treated, 9 were evaluable, and 8 remain in ongoing remission at a median of 3.1 months. Importantly, no high-grade cytokine release syndrome or neurotoxicity was observed, indicating a favorable safety profile for AUTO1.
Autolus Therapeutics (Nasdaq: AUTL) reported Q1 2021 results, showing a net loss of $33.3 million or $(0.53) per share. Cash reserves amounted to $239 million, up from $153.3 million at year-end 2020. The company is focusing on its AUTO1 program, with upcoming data expected in 2022 from pivotal studies. The firm also received PRIME designation for AUTO1 in the EU, and innovative licensing for AUTO4 in PTCL. Operational changes aim to save $15 million annually. A follow-on public offering generated $106.9 million in February 2021. Management expects cash runway to last into H1 2023.
Autolus Therapeutics plc (Nasdaq: AUTL) announced it will release its Q1 2021 financial results and operational highlights on May 6, 2021, before U.S. market open. Management will host a conference call at 8:30 am ET to discuss these results and provide a business update. Interested parties can access the webcast on Autolus' website or dial in via provided numbers. A replay of the call will be available post-event.
Autolus Therapeutics plc (Nasdaq: AUTL) has received the Innovative Licensing and Access Pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO4, a product in Phase 1 trials for TRBC1 positive Peripheral T Cell Lymphoma (PTCL). This designation follows the PRIME designation received for AUTO1, aimed at accelerating the review of therapies addressing unmet medical needs. The ILAP facilitates enhanced dialogue with regulators and access to development tools, potentially leading to faster patient access in the UK.
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