Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHATwo patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE) trial; study on track for initial data end of 2024Market Authorization Application (MAA) for obe-cel in r/r adult ALL accepted by European Medicines Agency (EMA)Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press re ...

Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHATwo patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE) trial; study on track for initial data end of 2024Market Authorization Application (MAA) for obe-cel in r/r adult ALL accepted by European Medicines Agency (EMA)Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press re ...

LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology (A ...

LONDON, April 23, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will release its first quarter 2024 financial results and operational highlights before open of US markets on Tuesday, May 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company's financial results and provide a general business update. Conference ca ...

Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from to Commission file number: 001-38547 Autolus Therapeutics plc (Exact name of Registrant as specified in its charter) England and Wales Not applicable (State ...

Autolus Therapeutics plc (NASDAQ:AUTL) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET Company Participants Olivia Manser - Investor Relations Christian Itin - Chief Executive Officer Rob Dolski - Chief Financial Officer Conference Call Participants James Shin - Deutsche Bank Gil Blum - Needham & Company Eric Yeung - William Blair Yanan Zhu - Wells Fargo Jacob Mekhael - KBC Securities Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics' Call to discuss the Full Year 2023 ...

Full Year 2023 Financial Results and Business Updates ...

Announced strategic collaboration and equity investment from BioNTech for aggregate proceeds of $250 million upfront, plus underwritten offering of ADSs for $350 million, for gross proceeds of $600 million received in February 2024Submitted a Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel), a potentially transformational treatment for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), to the US Food & Drug Administration (FDA); Prescription Drug User Fee Act ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2024 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane Lon ...

Core Insights - Autolus Therapeutics plc has received Manufacturer's Importation Authorisation (MIA) and a GMP certificate for its Nucleus manufacturing facility, enabling global commercial and clinical product supply starting March 18, 2024 [1][2] - The MHRA inspection found no major or critical observations, indicating a successful certification process for both clinical and commercial manufacturing [1][2] Company Overview - Autolus is a clinical-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [3] - The company has a pipeline targeting hematological malignancies, solid tumors, and autoimmune diseases [3] Product Development - Obe-cel, an investigational CD19 CAR T cell therapy, has received multiple designations including Orphan Drug Designation from the FDA and EMA, and RMAT designation from the FDA for adult relapsed/refractory B-ALL [2][4] - Clinical trials for obe-cel have shown a "fast off-rate" profile that reduces toxicity and T cell exhaustion, leading to improved persistence and durable remissions in patients [4] Clinical Trials - The Phase Ib/II clinical trial of obe-cel enrolled over 100 patients across 30 leading centers in the US, UK, and Europe, focusing on overall response rate and safety [5]