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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 (Nasdaq: AUTL) presented promising updates on its clinical trials at the ASH Annual Meeting. In the ALLCAR19 trial, 35% of adult relapsed/refractory B-ALL patients achieved sustained complete remission after three years without additional therapy. The AUTO1/22 trial showed an 83% MRD negative complete response rate in challenging pediatric B-ALL cases, with no antigen-negative relapses. Additionally, AUTO4 demonstrated sustained metabolic complete remissions in peripheral T-cell lymphoma patients. Full data from the pivotal FELIX trial is expected in mid-2023.
Autolus Therapeutics plc (Nasdaq: AUTL) announced the pricing of a public offering of 75 million American Depositary Shares (ADSs) at $2.00 each, totaling $150 million in gross proceeds. The offering, set to close on December 13, 2022, includes a 30-day option for underwriters to purchase an additional 11.25 million ADSs. The proceeds will support the development of its next-generation T cell therapies targeting cancer treatment. Jefferies LLC, William Blair, and Wells Fargo Securities are the joint bookrunners for this offering.
Autolus Therapeutics plc (Nasdaq: AUTL) has initiated an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing one ordinary share. The company plans to grant underwriters a 30-day option to purchase up to 15% of the ADSs sold at the public offering price. The offering is subject to market conditions and no assurance can be given regarding its completion or terms. Jefferies LLC, William Blair & Company, and Wells Fargo Securities are the joint bookrunners. The securities are offered under an effective shelf registration statement with the SEC.
Autolus Therapeutics (AUTL) has secured two milestone payments of $35 million each from Blackstone Life Sciences, totaling $70 million, due to positive interim results from the pivotal FELIX Phase 2 trial of their CAR T cell therapy, obecabtagene autoleucel (obe-cel). The first payment was received earlier than expected due to the trial meeting its primary endpoint. The second payment follows the successful demonstration of the manufacturing process for obe-cel. Autolus aims to submit a Biologics License Application to the FDA by the end of 2023.
Autolus Therapeutics plc (AUTL) announced positive interim results from its Phase 2 FELIX trial for obe-cel in relapsed/refractory adult Acute Lymphoblastic Leukemia (ALL). The study showed a promising Overall Remission Rate (ORR) of 70% among 50 evaluated patients. Safety data indicated low rates of serious adverse events, with 3% experiencing Grade 3 Cytokine Release Syndrome (CRS) and 8% experiencing Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Additionally, a $35 million milestone payment from Blackstone Life Sciences was triggered.
Autolus Therapeutics (Nasdaq: AUTL) announced the completion of the first clean room at its new commercial manufacturing facility named ‘The Nucleus’ in Stevenage, UK. This milestone is part of a broader £120 million redevelopment project aimed at creating a life sciences district, housing a cluster of cell and gene therapy companies. The facility is expected to enhance Autolus' capacity for next-generation T cell therapies. Collaboration among Autolus, Reef Group, and Merit facilitated timely project delivery despite challenges posed by the pandemic and supply chain issues.
Autolus Therapeutics (NASDAQ: AUTL) announced the online publication of three abstracts for the upcoming American Society of Hematology Annual Meeting in December 2022. These abstracts will highlight the clinical data of three therapies: obe-cel in B-ALL and B-NHL, AUTO1/22 in pediatric ALL, and AUTO4 in T-Cell Lymphoma. CEO Dr. Christian Itin emphasized obe-cel's promising safety and efficacy profile, showing potential in long-term remission for B-ALL patients. The presentations are set for December 11 and 12, providing updated data for clinical trials.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its Q3 2022 operational and financial results, highlighting several strategic progress points. The pivotal FELIX Phase 2 trial for obe-cel in relapsed/refractory adult ALL is on track for a Q4 2022 update. The commercial manufacturing facility in the UK is scheduled for completion in Q4 2022. Financially, cash decreased to $163.1 million, while the net loss expanded to $42.8 million compared to $34.0 million in Q3 2021. The company expects future pipeline updates at the upcoming ASH Annual Meeting in December 2022.
Autolus Therapeutics (Nasdaq: AUTL) will announce its Q3 2022 financial results and operational highlights on November 3, 2022, prior to the U.S. market opening. Management will hold a conference call at 8:30 am ET to discuss these results and provide updates on the company’s business. Participants are encouraged to pre-register for access details. Autolus is focused on developing next-generation programmed T cell therapies for cancer treatment, utilizing proprietary technologies for targeting and eliminating cancer cells in hematological malignancies and solid tumors.
Autolus Therapeutics plc (Nasdaq: AUTL) announces that Moderna has exercised its option to license proprietary binders for an undisclosed immuno-oncology target. This exercise follows a previous agreement granting Moderna options on four targets. Autolus has received an option exercise fee and stands to gain from development and commercial milestone payments, as well as royalties on net sales of products derived from this collaboration. This partnership underscores Autolus' capabilities in innovative cell programming technologies aimed at treating cancer.
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