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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) reported operational and financial results for Q3 2021, highlighting continued progress in clinical evaluations, particularly for obe-cel in the FELIX study. The expected delivery of primary endpoint data is slated for mid-2022. Cash at the end of Q3 totaled $173.1 million, down from $216.4 million in Q2 2021. The net loss attributable to ordinary shareholders was $34.0 million, an improvement from $37.3 million in 2020. The company anticipates key data presentations at the 63rd ASH Meeting in December 2021.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its plan to release third quarter 2021 financial results on November 3, 2021, before U.S. markets open. The company’s management will host a conference call at 8:30 am ET to discuss the financial results and provide a business update. Interested parties can access the webcast through the company’s events section on its website. The call can also be dialed in using provided numbers for U.S. and international callers with a reference conference ID of 6984737.
Autolus Therapeutics has received planning approval to construct a new manufacturing facility in Stevenage, UK, aimed at enhancing global commercial launch capacity for obe-cel (AUTO1). The 70,000 square foot facility will allow for GMP production of approximately 2,000 batches annually, with potential for expansion. The company anticipates pivotal data from the FELIX study in 2022 for treating adult patients with acute lymphoblastic leukemia (ALL). This new facility positions Autolus to secure its place in Europe's growing biotechnology sector.
Autolus Therapeutics (Nasdaq: AUTL) announced the appointment of John H. Johnson as non-executive chairman of its Board of Directors, effective September 15, 2021. Johnson, with over 30 years in the life sciences sector, previously held executive roles at Strongbridge Biopharma and major firms like Eli Lilly and Pfizer. The company is preparing for pivotal data on obe-cel, a CD19 CAR T cell therapy aimed at treating adult acute lymphoblastic leukemia, expected in 2022. This leadership change is seen as pivotal for advancing Autolus' clinical programs.
Novaremed AG has acquired Metys Pharmaceuticals AG in an all-share transaction, expanding its pipeline of non-opioid treatments for chronic pain. The acquisition includes two new development projects, allowing Novaremed to target neuropathic pain, including chemotherapy-induced peripheral neuropathy (CIPN). This move aligns with Novaremed's strategy to lead in non-opioid pain management. Additionally, Andrew J. Oakley has been appointed to the Board of Directors, enhancing the leadership team. Key objectives include advancing clinical studies and seeking further capital for development.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced its participation in three upcoming virtual investor conferences. These events include the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, the Wells Fargo Healthcare Conference on September 10 at 7:30 am ET, and the H.C. Wainwright & Co 23rd Annual Global Investment Conference on September 13 at 7:00 am ET. Audiences can access live audio webcasts of the presentations through the company's website, with archived versions available for a limited time.
Autolus is focused on developing innovative T cell therapies to treat various cancers.
Autolus Therapeutics has reported promising results from the Phase 1 ALLCAR19 clinical trial of its CD19 CAR-T therapy, obe-cel, published in the Journal of Clinical Oncology. The therapy is designed to minimize toxicity while enhancing patient response rates in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Notably, 85% of participants achieved minimal residual disease negative complete responses at one month, and no patients experienced severe cytokine release syndrome. The company plans to advance obe-cel into the pivotal FELIX study to further evaluate its efficacy.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, obe-cel, has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This designation acknowledges obe-cel's potential to significantly benefit adult patients with relapsed/refractory B-cell Acute Lymphocytic Leukemia (ALL). The ongoing FELIX Phase 1b/2 study is exploring its efficacy and safety, with promising implications for early access to treatment for patients with high unmet medical needs.
Autolus Therapeutics (Nasdaq: AUTL) reported its Q2 2021 financial results, revealing a net loss of $33.2 million, or $(0.47) per share, an improvement from $(0.62) per share in the prior year. Cash reserves totaled $216.4 million, projected to fund operations into H1 2023. Promising updates on the obe-cel therapy highlighted a 50% event-free survival rate in adult acute lymphoblastic leukemia patients after 24 months and successful outcomes in B-cell non-Hodgkin lymphoma trials. The company anticipates pivotal data from ongoing trials in 2022.
Autolus Therapeutics has entered an exclusive licensing agreement with Moderna for up to four immuno-oncology targets, permitting Moderna to develop and commercialize mRNA therapeutics utilizing Autolus' proprietary binders.
Autolus will receive upfront payments for each licensed target, along with milestone payments for successful commercialization, plus royalties on net sales. This partnership underscores Autolus' innovative positioning in the biopharmaceutical field, particularly in cancer treatment technologies.
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