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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Autolus Therapeutics' AUCATZYL, approved by the FDA for relapsed/refractory B-cell ALL, shows strong potential despite safety concerns. The Company's Obe-cel family and oncology pipeline include multiple catalysts for 2025, expanding potential indications in autoimmune diseases and hematologic malignancies. AUTL's cash runway of 1.9 years and no financial debt provide a solid financial foundation to support AUCATZYL's commercialization and future growth.

AUCATZYL's Approval Positions Autolus Therapeutics Favorably In The CAR-T Market

Autolus Therapeutics plc (NASDAQ:AUTL ) Q3 2024 Earnings Conference Call November 12, 2024 8:30 AM ET Company Participants Olivia Manser - Director-Investor Relations Christian Itin - Chief Executive Officer Rob Dolski - Chief Financial Officer Conference Call Participants James Shin - Deutsche Bank Matthew Phipps - William Blair Sebastiaan van der Schoot - VLK Hanze Zu - Jefferies Gil Blum - Needham & Company Jacob Mekhael - KBC Securities Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Call to discuss its Third Quarter 2024 Financial Results and Business Updates. At this time, all participants are in a listen-only mode.

Autolus Therapeutics plc (AUTL) Q3 2024 Earnings Call Transcript

AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy) Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the U.S. Food and Drug Administration (FDA) has granted marketing approval for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). “Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes,” said Elias Jabbour, MD, U.S. lead investigator of the FELIX study and professor of Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center, Houston, Texas.

Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

LONDON, Oct. 28, 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 third quarter 2024 financial results and operational highlights before open of US markets on Tuesday, November 12, 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.

Autolus Therapeutics to Report Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024

Autolus Therapeutics plc has a PDUFA date upcoming for its cell therapy obe-cel, indicated for B-ALL. The FDA will decide whether to approve the drug for commercial use. There is already a cell therapy approved in this indication, as well as Amgen's blincyto, but obe-cel's safety and efficacy profile appears strong. Autolus has taken its time gathering the data required to push for approval, but now it has US and EU approval in its sights.

Autolus: Start Thinking About Obe-Cel PDUFA -- And The (Baby) Bull Case

Autolus Therapeutics plc (NASDAQ:AUTL ) Q2 2024 Earnings Conference Call August 8, 2024 8:30 AM ET Company Participants Olivia Manser – Director-Investor Relations Christian Itin – Chief Executive Officer Rob Dolski – Chief Financial Officer Conference Call Participants Gil Blum – Needham & Company Asthika Goonewardene – Truist Kelly Shi – Jefferies James Shin – Deutsche Bank Matthew Phipps – William Blair Yanan Zhu – Wells Fargo Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Call to discuss its Second Quarter 2024 Financial Results and Business Updates. As a reminder, this conference call is being recorded.

Autolus Therapeutics plc (AUTL) Q2 2024 Earnings Call Transcript

LONDON, July 26, 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 second quarter 2024 financial results and operational highlights before open of US markets on Thursday, August 8, 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.

Autolus Therapeutics to Report Second Quarter 2024 Financial Results and Host Conference Call on August 8, 2024

LONDON, June 14, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces three abstracts to be presented at the European Hematology Association (EHA) Congress, June 13-16, 2024. “We are looking forward to presenting longer-term data from adult patients with r/r ALL treated with obe-cel in the FELIX study,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

Autolus Therapeutics to Present Three Clinical Data Updates on obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) B-Cell acute lymphoblastic leukemia (ALL) patients at the 2024 European Hematology Association (EHA) Congress

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The majority of patients that responded to obe-cel showed durable responses with the potential for a long-term plateau of survival outcomes 40% patients are in ongoing remission without subsequent stem cell transplant (SCT) or other intervention Ongoing CAR T persistence was associated with improved event-free survival Autolus will host a conference call and webcast to discuss the presented data on Saturday June 1, 2024 at 9:30 am EDT/8:30 am CDT/2:30 pm BST (details below) LONDON, May 31, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces longer-term follow-up and additional data analysis from the pivotal Phase 1b/2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), being presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago). “At 21 months of median follow up, we're really pleased to be observing the potential for a long-term plateau of survival outcomes with obe-cel in the FELIX trial,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

Autolus Therapeutics presents longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL in an oral presentation at ASCO

Autolus Therapeutics plc (NASDAQ:AUTL ) Q1 2024 Earnings Conference Call May 17, 2024 8:30 AM ET Company Participants Olivia Manser – Investor Relations Christian Itin – Chief Executive Officer Rob Dolski – Chief Financial Officer Conference Call Participants Kelly Shi – Jefferies James Shin – Deutsche Bank Asthika Goonewardene – Truist Matthew Phipps – Blair Gil Blum – Needham & Company Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics' Call to discuss its First Quarter 2024 Financial Results and Business Updates. As a reminder, this conference call is being recorded.

Autolus Therapeutics plc (AUTL) Q1 2024 Earnings Call Transcript

Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHA Two patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE) trial; study on track for initial data end of 2024 Market 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 release LONDON, May 17, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces its operational and financial results for the first quarter ended March 31, 2024. “We continue to engage with the FDA in the regulatory review process for obecabtagene autoleucel (obe-cel) in adult ALL as we head towards the PDUFA target action date of November 16, 2024, and are driving commercial readiness activities across the Company," said Dr. Christian Itin, Chief Executive Officer of Autolus.

Autolus Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

Autolus Therapeutics now has years of operational runway after recent financing. Operating expenses are manageable, with numerous pipeline projects in the hopper. Autolus likely has an approved therapy on their hands, just waiting for the November action date to realize it.

Autolus Therapeutics: Trading Like Their Products Are Not Valuable, Which Is An Opportunity

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 (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago). ASCO Oral Presentation, abstract #6504: Title: Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX Phase Ib/II study Session Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Session date and time: Friday, May 31, 2024, 14:45 – 17:45 EDT, 19:45 – 22:45 BST Presenting Author: Dr Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX A conference call and webcast to discuss the presented data will be held at 9:30 am EDT/2:30 pm BST on Saturday June 1, 2024.

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO

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.

Autolus Therapeutics to Report First Quarter 2024 Financial Results and Host Conference Call on May 14, 2024

LONDON, April 01, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director.

Autolus Therapeutics Announces Changes to its Board of Directors

Autolus Therapeutics plc (AUTL) Q4 2023 Earnings Call Transcript

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 2024 Submitted 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 (PDUFA) target action date November 16, 2024 Successfully completed first facility inspection and obtained a Manufacturer's Importation Authorization (MIA) from the Medicines and Healthcare products Regulatory Agency (MHRA), enabling the commercial product supply for obe-cel at The Nucleus manufacturing facility Submitted a Market Authorization Application (MAA) for obe-cel in r/r adult ALL with the European Medicines Agency (EMA) Conference call to be held today at 08:30 am EDT/12:30 pm GMT: Conference call participants should pre-register using the link at the bottom of this press release LONDON, March 14, 2024 (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 full year ended December 31, 2023. “We're delighted to be starting 2024 in such a strong financial position; our recently announced strategic alliance with BioNTech, coupled with two equity financing transactions, raised gross proceeds of $600 million.

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus' Nucleus manufacturing facility in Stevenage has obtained a Manufacturer's Importation Authorisation (MIA) together with the accompanying GMP certificate. This authorisation enables Autolus to manufacture for global commercial and clinical product supply from the Nucleus effective as of March 18, 2024.

Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site

LONDON, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it will release its fourth quarter and full year 2023 results and operational highlights on Thursday March 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT to discuss the company's financial results and provide a general business update.

Autolus Therapeutics to Report Full Year 2023 Financial Results and Business Updates on March 14, 2024

Autolus Therapeutics PLC Sponsored ADR (AUTL) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Strength Seen in Autolus Therapeutics PLC Sponsored ADR (AUTL): Can Its 6.3% Jump Turn into More Strength?

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 Announces Pricing of Underwritten Offering

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 royalty on net sales BioNTech has co-commercialization options for Autolus' AUTO1/22 and AUTO6NG programs BioNTech has the option to access a suite of Autolus target binders and cell programming technologies to support BioNTech's development of in vivo cell therapy and antibody-drug conjugate candidates BioNTech agrees to invest $200 million in Autolus MAINZ, Germany and LONDON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, “Autolus”), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a strategic collaboration aimed at advancing both companies' autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs

Obe-cel continues to demonstrate comparative efficacy with fewer side effects to approved therapies. Thus, the company will likely gain its first market authorization in November. Autolus made several strong leadership hires with direct experience in M&A, oncology, and lupus, a new research area.

Autolus Upgrades Leadership And Faces CAR-T Approval

LONDON, Jan. 23, 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 ACS Chemical Biology 1 entitled: ‘Designer small molecule control system based on Minocycline induced disruption of protein-protein interaction.' 1 Cell-based therapies have become increasingly complex and are being used to treat a wide range of diseases such as cancer and autoimmunity.

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