Autolus Therapeutics

Autolus Therapeutics Plc is a biopharmaceutical company, which engages in the development and commercialization of gene therapies. It uses proprietary and modular T cell programming technologies that are designed to recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The company was founded by Martin Pule in September 2014 and is headquartered in London, the United Kingdom.

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Autolus reports robust Q4 performance, poised for CAR T therapy success

Autolus Therapeutics demonstrated strong operational and financial performance in Q4 2022, supported by key partnerships and successful clinical data for obe-cel.
While facing challenges in competitive positioning and pricing strategy, the company has opportunities to capitalize on upcoming milestones and data releases to drive growth.
By focusing on long-term data integrity and strategic market positioning, Autolus aims to establish obe-cel as a leading therapy in the CAR T landscape.

Autolus Therapeutics reports Q1 loss, highlights CAR T progress

Autolus Therapeutics showcased progress with CAR T programs and a strong financial position
The company's focus on Obe-cel and collaborations with key partners present growth opportunities
Challenges include data disclosure queries, program potential, and partnership considerations
Opportunities lie in extending runway, expanding collaborations, and exploring new indications

Autolus Therapeutics reports strong Q2 results and eyes market expansion

Autolus Therapeutics is on track with its lead program, Obe-cel, and is making strategic moves to enhance its product portfolio and operational capabilities.
The company's financial performance remains stable, with a focus on cost management and extending its cash runway into 2025 through milestone payments.
Despite facing challenges in expense management and regulatory processes, Autolus is well-positioned to capitalize on opportunities in new indications and product development.

Autolus Therapeutics reports strong Q3 earnings and pipeline advancements

Autolus Therapeutics is making significant progress with its pipeline programs, focusing on advancing obe-cel for autoimmune diseases and presenting data at ASH.
The company's strong financial position and anticipated milestones, such as BLA filing and AUTO8 program updates, provide a solid foundation for future growth.
While facing challenges in a competitive market and logistical hurdles for pivotal trials, Autolus has opportunities to differentiate its offerings and strengthen its position in new indications.

Autolus Therapeutics reports strong financials and strategic growth opportunities

Autolus Therapeutics had a successful year financially and operationally, well positioned with a cash reserve for upcoming milestones and program expansions.
While facing regulatory challenges and cost management considerations, the company is strategically focused on expanding its therapeutic opportunities and enhancing operational efficiency.
Opportunities lie in exploring new indications, streamlining patient enrollment processes, and leveraging partnerships for broader market access and growth.

Autolus reports robust Q1 earnings, poised for strategic growth

Autolus Therapeutics demonstrated strong financial performance with increased revenue and cash reserves, positioning the company well for upcoming milestones and commercialization efforts.
While facing challenges related to accounting matters and escalating operating expenses, Autolus remains well-prepared for the launch of obe-cel and future pipeline developments.
Opportunities lie in upcoming regulatory reviews, milestone conferences, and potential treatment regimen evolution in the autoimmune space, signaling a promising outlook for Autolus.

Autolus reports robust Q3 earnings, poised for growth and innovation

Autolus Therapeutics demonstrated strong financial performance and progress in its CAR T therapy programs in Q3 2024, supported by milestone payments and a robust manufacturing facility.
While well-capitalized and positively received by physicians, the company faces challenges in cost guidance, market access strategies, and pediatric trial outcomes.
Opportunities lie in upcoming milestones, pediatric market positioning, and operational efficiency improvements, positioning Autolus for continued growth and success.

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PDUFA Goal date is November 16, 2024 Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 16, 2024, a standard review timeline consistent with recently approved CAR T therapies.

Autolus Therapeutics announces acceptance of Biologics License Application for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory Adult B-cell Acute Lymphoblastic Leukemia (ALL)

Autolus Therapeutics is developing cell-based immunotherapy for cancer, focusing on CD19 in ALL. Their flagship product, obe-cel, has shown promising results in treating relapsed/refractory B-cell ALL with reduced toxicities compared to other CAR T-cell therapies. Autolus Therapeutics also has a dual-targeted BCMA/CD19 CAR T-cell therapy called AUTO8, which has shown positive responses in patients with relapsed/refractory multiple myeloma.

Autolus Therapeutics: Pivotal Trial Using Familiar Approach, Possible Approval Coming Fast

Pooled analysis of the FELIX Phase Ib/II study demonstrated prolonged event free survival and low overall immunotoxicity across all cohorts in r/r B-ALL, and particularly in patients with low leukemic burden at lymphodepletion Longer-term data from a pooled analysis from the ALLCAR19 study and FELIX Phase Ib in r/r B-ALL showed durable remissions with obe-cel as a stand-alone therapy in a subset of patients after a median follow up of >3 years Additionally, ALLCAR19 extension cohorts demonstrated long-term responses with low immunotoxicity and prolonged persistence in patients with aggressive and indolent r/r NHL and r/r CLL Initial data from the MCARTY Phase I study in multiple myeloma showed AUTO8 was well tolerated, with responses observed in all patients Autolus will host an in-person and webcast Analyst/Investor event to discuss the data on Sunday, December 10, 2023 at 8:00 AM PT / 4.00 PM GMT LONDON, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces two oral presentations and two poster presentations at the American Society of Hematology (ASH) Annual Meeting, December 9-12, 2023, including an oral presentation highlighting data from a pooled analysis of the FELIX Phase Ib/II study of obe-cel, an autologous fast off-rate CD19 CAR T therapy, in relapsed/refractory adult B-ALL; and as a poster presentation a long-term update on the pooled ALLCAR19 and FELIX phase 1b studies, evaluating obe-cel in adult patients with r/r B-ALL as well from the ALLCAR19 study patients with B-NHL and B-CLL. Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.

Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023

BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for obecabtagene autoleucel (obe-cel). Obe-cel is Autolus' lead investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL).

Autolus Therapeutics Submits Biologics License Application to U.S. Food and Drug Administration for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL)

In-person and webcast event on Sunday, 10 December, 2023 at 8:00 AM PT / 4:00 PM GMT Review of pooled analysis of the ongoing FELIX Phase Ib/II study, pooled analysis from ALLCAR19 and FELIX Phase Ib studies and ALLCAR19 extension with obe-cel, as well as initial data from the AUTO8 MCARTY Phase I Study LONDON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, will host an in-person Analyst/Investor event during the 65th ASH Annual Meeting in San Diego. Date: Sunday, December 10, 2023 Time: The presentation will be from 8:00 AM PT / 4:00 PM GMT to 9:00 AM PT / 5:00 PM GMT.

Autolus Therapeutics to Host Analyst / Investor event at the American Society of Hematology (ASH) Annual Meeting 2023

LONDON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces its participation in three upcoming conferences in November. Truist Securities BioPharma Symposium Panel : Considerations for an Oncology Company's Autoimmune Side Hustle Date and time: 9 November 2023, 11:40am ET / 16:40pm GMTLocation: New York, USAPresenter: Dr Christian Itin, Chief Executive Officer, Autolus Therapeutics Jefferies London Healthcare Conference   Fireside Chat Date and time: 16 November 2023, 4:00am ET / 9:00am GMTLocation: London, UKPresenter: Dr Christian Itin, Chief Executive Officer, Autolus Therapeutics Piper Sandler 35th Annual Healthcare Conference Fireside Chat Date and time: 28 November 2023, 11:30am ET/ 16:30pm GMTLocation: New York, USAPresenter: Dr Christian Itin, Chief Executive Officer, Autolus Therapeutics Find out more information about upcoming events and any webcast and replay details at: https://www.autolus.com/investor-relations/events/ About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease.

Autolus Therapeutics announces participation in upcoming conferences

Autolus Therapeutics plc (NASDAQ:AUTL ) Q3 2023 Earnings Conference Call November 2, 2023 9:00 AM ET Company Participants Julia Wilson – Investor Relations Christian Itin – Chief Executive Officer Rob Dolski – Chief Financial Officer Conference Call Participants Matthew Phipps – William Blair Dev Prasad – Jefferies Gil Blum – Needham and Company Yanan Zhu – Wells Fargo Karina Rabayeva – Truist Simon Baker – Redburn Atlantic Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Third Quarter 2023 Financial Results Conference Call and Business Update. At this time, all participants are in listen-only mode.

Autolus Therapeutics plc (AUTL) Q3 2023 Earnings Call Transcript

Obe-cel, a potentially transformational treatment for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), on track for a Biologics License Application (BLA) submission to the US Food & Drug Administration (FDA) by end of 2023 Updated clinical data at the American Society of Hematology (ASH) meeting in December 2023: Long-term follow-up and sub-group analysis from the FELIX trial of obe-cel and initial data from a study of AUTO8 in multiple myeloma Continued progress with commercial manufacturing facility, The Nucleus, with process performance qualification production phase complete and data package on track to support BLA submission Obe-cel Phase 1 study in refractory systemic lupus erythematosus (SLE) expected to initiate in early 2024 Conference call to be held today at 09:00 am EDT/1:00 pm GMT: Conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended September 30, 2023. “The coming months will be an exciting and instrumental time for Autolus as we plan for our first BLA submission for obe-cel with the US FDA by year end and we continue with our preparatory activities for a planned commercial launch in 2024, pending the necessary regulatory approvals,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

LONDON, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will hold a virtual event on Tuesday, October 24, 2023 at 8:30 am ET, 1:30 pm BST, to discuss the company's CAR T strategy in autoimmune diseases and recent decision to advance obecabtagene autoleucel (obe-cel) into a Phase 1 study in systemic lupus erythematosus (SLE) in early 2024. The event will include an introduction from Autolus's Chief Executive Officer, Dr Christian Itin, and presentations from key thought leader, Dr Maria Leandro, consultant rheumatologist at UCL Hospitals and senior lecturer at University College London, and company management.

Autolus Therapeutics to host virtual event to discuss the company's obe-cel program in systemic lupus erythematosus

LONDON, Oct. 11, 2023 (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 third quarter 2023 financial results and operational highlights before open of US markets on Thursday, November 2, 2023. Management will host a conference call and webcast at 9:00 am ET/1:00 pm GMT to discuss the company's financial results and provide a general business update.

Correction - Autolus Therapeutics to report third quarter 2023 financial results and host conference call on November 2, 2023

Autolus Therapeutics to report third quarter 2023 financial results and host conference call on November 2, 2023

Autolus is a UK-based CAR-T therapy developer with a lead program, obecabtagene autoleucel, that has met the endpoint in a pivotal trial for adult acute lymphoblastic leukemia. Obecabtagene autoleucel has a faster off-rate than other CAR-T therapies, potentially leading to increased efficacy and safety. The trial results showed a 70% complete remission rate and a manageable safety profile, with 61% of responders still in remission at 9.5 months of follow-up.

Autolus: CAR-T Therapy Looks Promising

Autolus Therapeutics plc (NASDAQ:AUTL ) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Dr. Christian Itin - CEO Dr. Lucinda Crabtree - CFO Rob Dolski - incoming CFO Julia Wilson - IR Conference Call Participants Matt Phipps - William Blair Asthika Goonewardene - Truist Financial Kelly Shi - Jefferies Noah Burhance - J.P. Morgan Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Second Quarter 2023 Financial Results Conference.

Autolus Therapeutics plc (AUTL) Q2 2023 Earnings Call Transcript

LONDON, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended June 30, 2023.

Autolus Therapeutics Reports Second Quarter 2023 Financial Results and Operational Progress

- Veronica Hersberger appointed as Senior Vice President, Medical Affairs- Miranda Neville promoted to Senior Vice President, Project Management and will continue to lead the obe-cel program

Autolus Therapeutics announces appointment of Robert F. Dolski as Chief Financial Officer

LONDON, July 18, 2023 (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 second quarter 2023 financial results and operational highlights before open of US markets on Thursday, August 3, 2023.

Autolus Therapeutics to report second quarter 2023 financial results and host conference call on August 3, 2023

Obe-cel and pipeline offer many catalysts in 2023. The CAR T-cell candidate offer a safer alternative to commercial rivals. Strong cash position should see the company through to obe-cel launch.

Autolus Therapeutics Could Hold A Winning CAR T-Cell Ticket

LONDON, June 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a publication in Cancer Immunology Research 1 entitled: ‘Enhancing CAR T cell therapy using Fab-Based Constitutively Heterodimeric Cytokine Receptors.'

Autolus Therapeutics announces publication in Cancer Immunology Research

LONDON, June 16, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces clinical data of AUTO4 (Phase 1/2 LibrA T1 study), a TRBC1-targeting CAR T cell therapy in relapsed/refractory TRBC1-Positive Peripheral T-Cell Lymphoma (PTCL) at the International Conference on Malignant Lymphoma (ICML) being held June 13 to 17, 2023 in Lugano, Switzerland. PTCL is a rare and heterogeneous form of non-Hodgkin lymphoma.

Autolus Therapeutics Presents Positive Results from AUTO4 in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

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LONDON, June 02, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the presentation of top-line data from the Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Autolus Therapeutics Presents Positive Results from Pivotal Phase 2 FELIX study in adult r/r B-ALL at ASCO

LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will hold an analyst call to highlight data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from the Pivotal Phase 2 FELIX study of obe-cel data in adult r/r B-ALL. The event will be held on June 2 at 4.00 pm ET/9.00 pm BST. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

Autolus Therapeutics to hold Analyst call to highlight data at ASCO from the Pivotal Phase 2 FELIX study of obe-cel data in adult r/r B-ALL

LONDON, May 04, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended March 31, 2023.

Autolus Therapeutics Reports First Quarter 2023 Financial Results and Operational Progress

Autolus (AUTL) partners with Cardinal Health to bring next-generation CAR-T cell therapies to the market and revolutionize cancer treatment.

Autolus (AUTL) Selects Cardinal Health for Cell Therapy Supply

LONDON, April 27, 2023 (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 the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) has been selected for an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2 - 6, 2023, in Chicago.

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