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Autolus Therapeutics plc (AUTL)

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Previous Close8.86
Open8.87
Bid8.40 x 1400
Ask0.00 x 1100
Day's Range8.21 - 8.90
52 Week Range3.00 - 17.19
Volume220,859
Avg. Volume175,354
Market Cap439.311M
Beta (5Y Monthly)1.74
PE Ratio (TTM)N/A
EPS (TTM)-1.40
Earnings DateMay 07, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est20.78
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  • Autolus Therapeutics provides business outlook for 2021 & 2022
    GlobeNewswire

    Autolus Therapeutics provides business outlook for 2021 & 2022

    • Company prioritizes AUTO1, a potentially transformational treatment for Adult Acute Lymphoblastic Leukemia (ALL), with full data from the AUTO1-AL1 study expected in 2022 • Company intends to partner AUTO3, ahead of progressing into the next phase of development • Company adjusting its workforce and infrastructure footprint to align with AUTO1 prioritization• Company continues to develop its pipeline of next generation programs, specifically tailored for oncology indications with high unmet need LONDON, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, updated its business outlook, strengthening its focus on its potentially transformational CAR T cell therapy candidate, AUTO1, which is being investigated in relapsed / refractory adult B-Acute Lymphoblastic Leukemia (ALL).“We are very excited about the unique characteristics of AUTO1 that we reported at ASH in December 2020, with some patients continuing in molecular complete remission at 24 months without a subsequent transplant, an event-free survival of 52% at 12 months and a well-tolerated safety profile. Taking into consideration the high unmet need in adult ALL and the commercial opportunity this represents, we are prioritizing this program with potential pivotal data expected in 2022,” said Dr. Christian Itin, chairman and chief executive officer of Autolus. “We also plan to capitalize on the differentiated profile of AUTO1 by exploring activity in additional B-cell malignancies, including Primary CNS Lymphoma (PCNSL) where no adequate standard of care currently exists. We expect to see first data from these additional indications in 2021.”Additional clinical data points in 2021 are expected from AUTO1/22, a novel dual targeting CAR T cell based therapy candidate based on AUTO1, with the first pediatric ALL patient dosed in December 2020, and AUTO4 in Peripheral T Cell Lymphoma (PTCL), which will continue in 2021 through a dose escalation phase. Furthermore, the company continues to progress its pipeline of next generation programs, including for solid tumor indications, in collaboration with its academic partners.With the prioritization of the AUTO1 program, the company plans to seek a partner for the AUTO3 program, its CD19 and CD22 dual targeting CAR T product candidate being investigated in relapsed/refractory diffuse large B cell lymphoma (DLBCL), before progressing the program into the next phase of development. In addition, through Q1 2021, the company will adjust its workforce and infrastructure footprint, which will involve an overall reduction in headcount of approximately 20%. The company expects to realize cash savings, on an annualized basis, of approximately $15 million per annum once the operational changes are fully implemented. Additionally, the company announced a reorganization of its management team. David Brochu was promoted to Chief Technical Officer (CTO) with expanded responsibilities from Senior Vice President, Product Delivery. Senior Vice Presidents Dr. Adam Hacker and Dr. Nushmia Khokhar will be leaving the company in Q1 2021. A search for a new Chief Medical Officer is ongoing.“Building on its differentiated clinical profile, we believe AUTO1 is well positioned to deliver fundamental value for patients and shareholders. Our organizational focus will position us well to realize the potential of AUTO1 and lay the foundation for the next opportunities in our pipeline with several clinical proof of concepts targeted during 2021 and 2022,” said Dr. Christian Itin, chairman and chief executive officer of Autolus.About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit www.autolus.com.About AUTO1  AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. AUTO1 is currently being evaluated in two Phase 1 trials, one in pediatric ALL and one in adult ALL. The company has also now progressed the program to a potential pivotal trial, AUTO1-AL1.About AUTO1-AL1 pivotal trial The AUTO1-AL1 trial will enroll patients with relapsed / refractory ALL. The trial will have a short Phase1b component prior to proceeding to a single arm Phase 2 trial. The primary endpoint is overall response rate and the key secondary endpoints include duration of response, MRD negative CR rate and safety. The trial will enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe.About AUTO3 AUTO3 is a programmed T cell investigational therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in diffuse large B cell lymphoma in the ALEXANDER clinical trial, including a 20-patient cohort to assess feasibility of treatment in an outpatient setting.Forward-Looking Statements This press release contains 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 terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus’ refocus in business strategy; the efficacy, safety and therapeutic potential of AUTO1 and the future clinical development of AUTO1, including progress, expectations as to the reporting of data, conduct and timing and potential future activity in additional B-cell malignancies; expectations regarding the initiation, design and reporting of data from the AUTO1-AL1 trial and other clinical trials; the development of Autolus’ pipeline of next generation programs, including for solid tumor indications, in collaboration with its academic partners, including expectations as to the reporting of data, conduct and timing; the efficacy, safety and therapeutic potential of AUTO3 and ability for Autolus to obtain a partner for next stages of clinical development; needs for additional funding and ability to raise additional capital; Autolus’ ability to attract and retain qualified employees and key personnel; the restructuring program and Autolus’ expected cash savings as a result of the restructuring program and operational changes. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 3, 2020, as amended, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.Contact: Lucinda Crabtree, PhD Vice President, Investor Relations and Corporate Communications +44 (0) 7587 372 619  l.crabtree@autolus.comJulia Wilson +44 (0) 7818 430877 j.wilson@autolus.com Susan A. Noonan S.A. Noonan Communications +1-212-966-3650 susan@sanoonan.com

  • Autolus Therapeutics to participate in Investor Conferences through January
    GlobeNewswire

    Autolus Therapeutics to participate in Investor Conferences through January

    LONDON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that management will participate in investor conferences through January 2021. * 11 January 2021 – The company will present at the H.C. Wainwright BioConnect 2021 Conference which will be available on demand as of 6:00 am ET, 11 am GMT on Monday, January 11, 2021. The webcast will be available on the investor relations section of the Company’s website at Autolus. * 13 January 2021 – The company will present at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 9:10 am ET, 2.10 pm GMT. The Company will host virtual one-on-one meetings at the J.P. Morgan event and a live audio webcast will be available on the investor relations section of the Company’s website at Autolus. Archived replays will be available for a period of 30 days after the conferences.About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit www.autolus.com.Contact: Lucinda Crabtree, PhD Vice President, Investor Relations and Corporate Communications +44 (0) 7587 372 619  l.crabtree@autolus.comJulia Wilson +44 (0) 7818 430877 j.wilson@autolus.comSusan A. Noonan S.A. Noonan Communications +1-212-966-3650 susan@sanoonan.com

  • Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the 62nd ASH Annual Meeting
    GlobeNewswire

    Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the 62nd ASH Annual Meeting

    AUTO3 continues to show a differentiated product profile supporting outpatient administration Conference call and webcast to be held Monday, December 7, 2020  at 4:00 pm ET / 9:00 pm GMTLONDON, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on AUTO3, the company’s CD19 and CD22 dual targeting CAR T product candidate being investigated in the ALEXANDER study, a Phase 1/2 clinical study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the American Society of Hematology (ASH) All-Virtual Annual Meeting, held between December 5-8, 2020.As of the October 30, 2020 data cut-off date, 49 patients in the ALEXANDER study have been treated and were evaluable for safety. AUTO3 was observed to be well tolerated, with low rates of cytokine release syndrome (CRS) and neurotoxicity (NT). Across all 49 patients, there was only one case of Grade 3 CRS with primary infusion, and only three cases of NT were reported, with two being ≥ Grade 3. None of the patients achieving a complete response (CR) experienced any NT and all cases of NT were seen in a setting of disease progression and with confounding factors. No prophylactic measures of any kind have been used to manage patients in this study.The majority of patients receiving AUTO3 in the outpatient setting did not require hospital admission. Those patients admitted were easily managed, with no patients requiring ICU care. Combined with the overall favorable safety data across the Phase 1 study, the profile of AUTO3 supports administration in an outpatient setting.Across all dose levels, 43 patients were evaluable for efficacy, with an objective response rate (ORR) of 65% and a CR rate of 51%. Of the 29 evaluable patients receiving the recommended Phase 2 dose (a dose of ≥ 150 x 106 cells) and pre-conditioning with pembrolizumab at Day -1, the ORR was 66% and the CR rate was 55%. A subsequent analysis of these data suggested a superior response rate at higher dose levels, with 15 evaluable patients treated at 450 x 106 cells achieving an ORR of 87% and a CRR of 73%.Across all cohorts in the study, 73% (16/22) of patients achieving a CR were without disease progression at a median follow up of 4 months (1 – 24 months). Of note, none of the five patients who achieved a CR in the cohort receiving three doses of pembrolizumab had disease progression.  “AUTO3 continues to have a tolerable and favorable safety profile when compared with approved CD19 CAR T therapies,” said Dr. Aravind Ramakrishnan, Medical Director, Adult Blood and Marrow Transplant, Texas Transplant Institute at the Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center. “The complete response rate is high and the longest patient on the study is now over 2 years post treatment and remains in remission.”Dr. Christian Itin, chairman and chief executive officer of Autolus, added, “AUTO3 continues to show a high level of clinical activity across all dose levels and conditions evaluated in this expanded Phase 1 study. The favorable tolerability profile was confirmed in the outpatient cohort which supports the use of AUTO3 in an outpatient setting. This differentiated profile may widen the potential use of CAR T therapy in DLBCL. Based on these data, we are assessing a strategy that potentially optimizes the development path in r/r DLBCL and expect to update on next steps for AUTO3 in Q1 2021.”Investor call on Monday December 7, 2020 Management will host a conference call and webcast today at 4:00 pm ET/9:00 pm GMT to discuss the ASH data. To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-and-events/events.The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9188389. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9188389.About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit www.autolus.com.About AUTO3 AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in diffuse large B cell lymphoma in the ALEXANDER clinical study, including a 20-patient cohort to assess feasibility of treatment in an outpatient setting.Forward-Looking Statements This press release contains 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 terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of AUTO3 and the future clinical development of AUTO3 including progress, expectations as to the reporting of data, conduct and timing. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 3, 2020, as amended, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.Contact: Lucinda Crabtree, PhD Vice President, Investor Relations and Corporate Communications +44 (0) 7587 372 619  l.crabtree@autolus.comJulia Wilson +44 (0) 7818 430877 j.wilson@autolus.comSusan A. Noonan S.A. Noonan Communications +1-212-966-3650 susan@sanoonan.com