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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 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.
Autolus Therapeutics plc (Nasdaq: AUTL) appointed Dr. Martin Murphy as non-executive chairman of its Board of Directors, effective April 15, 2021. This change follows Dr. Christian Itin's long tenure as chairman and CEO since the company's inception in 2014. The separation of these roles aims to enhance leadership focus as the lead program, AUTO1, progresses through clinical trials and gears up for potential commercialization. Dr. Murphy brings over 25 years of life sciences experience, previously serving as a non-executive director since 2014.
Autolus Therapeutics plc (Nasdaq: AUTL) announced participation in several investor conferences throughout April 2021. Key events include the Wells Fargo Annual Biotech Corporate Access on April 6 and 8, and the 20th Annual Needham Virtual Healthcare Conference on April 14, where the CEO and CFO will engage in a Fireside Chat. Additionally, Autolus will partake in the Raymond James Oncology Summit on April 22 and Kempen & Co. European Life Sciences: Gene, Cell, and RNA Day on April 28. This participation highlights Autolus's commitment to advancing its next-generation T cell therapies for cancer treatment.
Autolus Therapeutics (Nasdaq: AUTL) has received PRIME designation from the European Medicines Agency for its CAR T cell therapy AUTO1, aimed at treating relapsed/refractory adult B-acute lymphocytic leukemia. This designation enhances support for development and review, potentially expediting access to patients with unmet medical needs. AUTO1 showcases promising activity and safety data, with ongoing studies evaluating its effectiveness. The FELIX study will enroll 100 patients to assess overall response rate and safety, positioning AUTO1 as a potential game-changer in treating this condition.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced a strategic shift in its manufacturing operations for AUTO1, moving to a more cost-effective commercial supply strategy based in the UK. This change will utilize existing facilities and a new site to enhance its operational capacity. Additionally, the company has mutually terminated its lease in Rockville, MD, resulting in a cash payment and the cessation of lease obligations, which aims to further reduce costs.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its operational and financial results for Q4 and FY 2020, showcasing a robust financial position after raising $131 million, enabling a cash runway into H1 2023. The company's AUTO1 program for adult B-ALL has shown promising results, with an 84% MRD-negative response in treated patients. However, net loss rose to $142.1 million in 2020, compared to $123.8 million in 2019. Management expects multiple clinical readouts in 2021 and 2022, including updates on AUTO1 and other CAR T therapies.
Autolus Therapeutics plc (Nasdaq: AUTL) announced that CEO Dr. Christian Itin will present at the virtual H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The event will feature one-on-one meetings with participants. A live audio webcast of the presentation will be available on Autolus’ investor relations page starting March 9 at 7:00 a.m. EST, with an archived replay accessible for 90 days. Autolus is focused on developing next-generation programmed T cell therapies aimed at treating various cancers.
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