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Autolus(AUTL) - 2023 Q4 - Annual Report
2024-03-21 20:55
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(AUTL) - 2023 Q4 - Earnings Call Transcript
2024-03-15 09:23
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 ...
Autolus(AUTL) - 2023 Q4 - Earnings Call Presentation
2024-03-14 16:20
Full Year 2023 Financial Results and Business Updates ...
Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates
Newsfilter· 2024-03-14 11:00
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 ...
Autolus(AUTL) - 2023 Q4 - Annual Results
2024-03-13 16:00
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 ...
Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site
Newsfilter· 2024-03-12 11:00
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]
Autolus Therapeutics announces publication in Blood Cancer Journal
Newsfilter· 2024-03-11 11:00
LONDON, March 11, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a publication in Blood Cancer Journal entitled ‘Dual T-cell constant β chain (TRBC)1 and TRBC2 staining for the identification of T-cell neoplasms by flow cytometry.' 1 Diagnosing leukemic T-cell malignancies poses challenges due to their resemblance to reactive T-cells. In the paper published by Pedro Horna of M ...
Strength Seen in Autolus Therapeutics PLC Sponsored ADR (AUTL): Can Its 6.3% Jump Turn into More Strength?
Zacks Investment Research· 2024-02-12 08:31
Autolus Therapeutics PLC Sponsored ADR (AUTL) shares soared 6.3% in the last trading session to close at $6.38. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 17.7% loss over the past four weeks.The sudden surge in the stock price can be attributed to the positive investor mindset regarding Autolus’ CAR T cell pipeline. The company is also currently looking to advance and expand the same through strategic initiatives. Last week, ...
Autolus Announces Pricing of Underwritten Offering
Newsfilter· 2024-02-08 12:00
LONDON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the pricing of an underwritten offering in the United States of 58,333,336 American Depositary Shares ("ADSs") representing 58,333,336 ordinary shares at a public offering price of $6.00 per ADS, for total gross proceeds of $350 million. All ADSs sold in the offering were offered by Autolus. Autolus intends to use ...
BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs
Newsfilter· 2024-02-08 10:45
Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both companies' autologous CAR-T programs towards market, pending market authorization BioNTech secures the right to utilize Autolus' manufacturing capacity in a cost-efficient set-up to accelerate the development of BNT211 into pivotal trials in CLDN6+ tumors BioNTech to support launch and expansion of development program of Autolus' lead cell therapy candidate obe-cel and will receive a r ...