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Autolus Therapeutics (AUTL) FY Conference Transcript
2025-06-11 18:20
Autolus Therapeutics (AUTL) FY Conference June 11, 2025 01:20 PM ET Speaker0 Good afternoon, everyone, and thank you for joining. My name is Rajan Sharma, European pharma and biotech analyst here at Goldman Sachs. I'm very pleased that we have Rob Dolsky, Chief Financial Officer at Autolus. Rob, you so much for joining us. Speaker1 Great to be here. Speaker0 Maybe kind of just to start for people who may be less familiar with the Autolus story, could you just kind of give us an overview of the company, key ...
Autolus: A Buy Before Key Data Readout, Potential Expansion Into Autoimmune Market
Seeking Alpha· 2025-06-06 15:09
Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - Autolus Therapeutics plc (NASDAQ: AUTL) was previously covered with a bullish outlook due to an upcoming PDUFA date, indicating potential positive developments for the company [1] - The investing group Haggerston BioHealth offers resources for both novice and experienced biotech investors, including sales forecasts and financial analyses for major pharmaceutical companies [1] Group 2 - The article emphasizes the expertise of Edmund Ingham, a biotech consultant with over five years of experience in the sector, who has produced detailed reports on more than 1,000 companies [1]
Autolus Therapeutics (AUTL) 2025 Conference Transcript
2025-06-05 20:10
Autolus Therapeutics (AUTL) 2025 Conference June 05, 2025 03:10 PM ET Speaker0 For attending JeffA's Global Healthcare Conference. My name is Kelly Xu, a senior analyst on biotech team here. For this fireside chat session, we are very pleased to have doctor Kristen Iting, Chief Executive Officer from Autolus Therapeutics. Welcome, Kristin. Speaker1 Well, thanks for having us. Speaker0 And maybe to start off, could you please give us an overview of autologous therapeutics as of today? And compared to one yea ...
Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
Globenewswire· 2025-05-23 12:30
Core Viewpoint - Autolus Therapeutics plc has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of its therapy, obecabtagene autoleucel (obe-cel), for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][6]. Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [9]. - The company has a pipeline of product candidates and has received FDA approval and MHRA authorization for obe-cel [9]. Product Details - Obe-cel is an autologous CD19 CAR T cell therapy designed to target B-cell precursor acute lymphoblastic leukemia [4]. - The therapy has shown a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of the FELIX study [2]. - The median response duration for patients treated with obe-cel was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. Clinical Study Insights - The CHMP recommendation was based on the results of the FELIX study, which was an open-label, multi-center, single-arm study involving adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia [2][10]. - The study enrolled over 100 patients across 30 leading academic and non-academic centers in the U.S., U.K., and Europe [10]. Safety Profile - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3]. - Cytokine release syndrome occurred in 68.5% of patients, with severe cases in 2.4% [3]. Market Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [5]. - Conventional treatments for adult B-ALL have a median overall survival of only eight months, highlighting the need for effective therapies like obe-cel [5]. Regulatory Status - The positive CHMP opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a final decision within approximately two months [6][8]. - Obe-cel has already received FDA approval in November 2024 and MHRA conditional marketing authorization in April 2025 [4][6].
Autolus Therapeutics Presents Clinical Data Updates at the 2025 European Hematology Association (EHA) Congress
Globenewswire· 2025-05-14 13:30
LONDON, May 14, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 12-15, 2025, Milan, Italy. Autolus will have two oral and one poster presentation, which includes updated follow up from the FELIX study of obecabtagene autole ...
Autolus(AUTL) - 2025 Q1 - Quarterly Report
2025-05-08 20:12
Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ 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) En ...
Autolus(AUTL) - 2025 Q1 - Earnings Call Transcript
2025-05-08 13:32
Autolus Therapeutics (AUTL) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Company Participants Amanda Cray - Executive Director - IR & External CommunicationsChristian Itin - CEORob Dolski - CFOJames Shin - Director of Biopharma Equity ResearchMatt Phipps - Group Head - BiotechnologyKarina Rabayeva - VP - Biotech Equity ResearchYifan Xu - Senior Associate - Biotechnology Equity Research Conference Call Participants Gil Blum - Senior AnalystYanan Zhu - Analyst Operator Good day, and thank you for standing b ...
Autolus(AUTL) - 2025 Q1 - Earnings Call Transcript
2025-05-08 13:30
Autolus Therapeutics (AUTL) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the Autolus First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. Please ...
Autolus(AUTL) - 2025 Q1 - Earnings Call Presentation
2025-05-08 12:38
Q1 2025 Financial Results and Business Updates May 8, 2025 For Investor communication only. Not for use in product promotion. Not for further distribution. Autolus.com Developing and Delivering a New Generation of T Cell Therapies Disclaimer These slides contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by te ...
Autolus(AUTL) - 2025 Q1 - Quarterly Results
2025-05-08 12:04
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): May 8, 2025 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of (Commission File Number) (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane London W12 7FP United Kingdom (Addres ...