ALLO Allogene Therapeutics Inc.

25.86
+0.54  (+2%)
Previous Close 25.32
Open 25.56
52 Week Low 20.58
52 Week High 44.92
Market Cap $3,676,863,189
Shares 142,183,418
Float 87,198,887
Enterprise Value $3,001,025,439
Volume 557,107
Av. Daily Volume 663,961
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Upcoming Catalysts

Drug Stage Catalyst Date
ALLO-501 - ALPHA
Non-Hodgkin lymphoma (NHL)
Phase 1
Phase 1
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ALLO-715 - UNIVERSAL
Multiple myeloma
Phase 1/2
Phase 1/2
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ALLO-316 - TRAVERSE
Clear cell renal cell carcinoma (ccRCC)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
ALLO-501A (ALPHA2)
Large B-cell lymphoma
Phase 1
Phase 1
Phase 1 data at ASCO June 4, 2021 noted overall response rate 56% (5/9). Pivotal trial to be initiated late-2021.
ALLO-605 (IGNITE)
Multiple Myeloma
Phase 1
Phase 1
Phase 1 trial to commence mid-2021.
AUTO8
Multiple Myeloma
Phase 1
Phase 1
Phase 1 trial to commence mid-2021.
UCART19 (PALL)
Acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1
Phase 1 trial ongoing.
UCART19 - CALM
Refractory B-cell Acute Lymphoblastic Leukaemia
Phase 1
Phase 1
Phase 1 trial ongoing.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced the appointment of Jae Park, M.D., acting Chief of Cellular Therapeutics at Memorial Sloan Kettering Cancer Center in New York, to its Scientific Advisory Board (SAB). Dr. Park, widely recognized as one of the world experts in cell therapies, is the leading principal investigator of several clinical trials in patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

    "We are honored to welcome Dr. Park to our Scientific Advisory Board," said Rafael Amado, M.D…

    SOUTH SAN FRANCISCO, Calif., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced the appointment of Jae Park, M.D., acting Chief of Cellular Therapeutics at Memorial Sloan Kettering Cancer Center in New York, to its Scientific Advisory Board (SAB). Dr. Park, widely recognized as one of the world experts in cell therapies, is the leading principal investigator of several clinical trials in patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

    "We are honored to welcome Dr. Park to our Scientific Advisory Board," said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "Dr. Park's groundbreaking research and experience treating patients with CAR T and other novel immunotherapies will help us maintain our leadership postion as we advance our platform for patients with blood cancers and solid tumors."

    Dr. Park is Associate Attending Physician in the Division of Hematologic Oncology, Leukemia Service, a Director of Adult Acute Lymphoblastic Leukemia Program and the Acting Chief of Cellular Therapeutics Service at Memorial Sloan Kettering Cancer Center in New York, New York. Dr. Park received his medical degree from the Johns Hopkins School of Medicine, and completed an internal medicine residency at Massachusetts General Hospital and a hematology/oncology fellowship at Memorial Sloan Kettering Cancer Center. Dr. Park has written numerous peer-reviewed articles appearing in New England Journal of Medicine, Science Translational Medicine, Blood, Cancer Discovery and Journal of Clinical Oncology. His research – which focuses on translating and establishing novel targeted and immunotherapies for patients with hematologic malignancies – has been recognized and funded by the The American Society of Hematology, The American Association for Cancer Research, The American Society of Clinical Oncology, The Leukemia and Lymphoma Society, The Geoffrey Beene Research Foundation, and The National Comprehensive Cancer Network.

    The Allogene SAB comprises experts across oncology, immunology, cell therapy, and drug discovery and development. Dr. Park joins existing SAB members, Chair Ton Schumacher, Ph.D., Donald B. Kohn, M.D., Malcom K. Brenner, M.D., Ph.D., Matthew Porteus, M.D., Ph.D., Owen Witte, M.D., Stephan Grupp, M.D., Ph.D., Stephen J. Forman, M.D., Thomas F. Gajewski, M.D., Ph.D., and Wendell Lim, Ph.D.

    About Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

    Cautionary Note on Forward-Looking Statements for Allogene

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to develop allogeneic CAR T therapies for cancer and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the SEC, including without limitation in its Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    AlloCAR T is a trademark of Allogene Therapeutics, Inc.

    Allogene Media/Investor Contact:

    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    Christine.Cassiano@allogene.com



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  2. SOUTH SAN FRANCISCO, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that management plans to participate in two upcoming virtual investor conferences.

    H.C. Wainwright 23rd Annual Global Investment Conference
    Monday, September 13, 2021
    4:00AM PT/7:00AM ET

    BofA Global Research Global Healthcare Conference 2021
    Thursday, September 16, 2021
    10:25AM PT/1:25PM ET

    Webcasts will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website…

    SOUTH SAN FRANCISCO, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that management plans to participate in two upcoming virtual investor conferences.

    H.C. Wainwright 23rd Annual Global Investment Conference

    Monday, September 13, 2021

    4:00AM PT/7:00AM ET

    BofA Global Research Global Healthcare Conference 2021

    Thursday, September 16, 2021

    10:25AM PT/1:25PM ET

    Webcasts will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

    About Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

    Cautionary Note on Forward-Looking Statements for Allogene

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to develop allogeneic CAR T therapies for cancer and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the SEC, including without limitation in its Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

    Allogene Media/Investor Contact:

    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    Christine.Cassiano@allogene.com



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    • ODD Follows RMAT Designation Granted to ALLO-715 by the U.S. Food and Drug Administration in Multiple Myeloma Patients
    • Phase 1 Data from the ALLO-715 UNIVERSAL Trial Demonstrated for the First Time that an Allogeneic CAR T Therapy Directed at BCMA Can Achieve Clinical Responses While Eliminating the Need for Bridging Therapy or Delays in Treatment Associated with Manufacturing
    • Next Clinical Update from the ALLO-715 UNIVERSAL Trial Planned for Late 2021

    SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has…

    • ODD Follows RMAT Designation Granted to ALLO-715 by the U.S. Food and Drug Administration in Multiple Myeloma Patients
    • Phase 1 Data from the ALLO-715 UNIVERSAL Trial Demonstrated for the First Time that an Allogeneic CAR T Therapy Directed at BCMA Can Achieve Clinical Responses While Eliminating the Need for Bridging Therapy or Delays in Treatment Associated with Manufacturing
    • Next Clinical Update from the ALLO-715 UNIVERSAL Trial Planned for Late 2021

    SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.

    Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology annual meeting in December 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). The UNIVERSAL trial continues to enroll patients to ALLO-715 including in combination with nirogacestat, a gamma secretase inhibitor from SpringWorks Therapeutics and in consolidation therapy.

    "We are pleased to have received ODD for ALLO-715 just months after the FDA granted RMAT designation. These designations from the FDA underscore the importance of bringing this important therapeutic option to patients with multiple myeloma," said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "We look forward to presenting the next update from our UNIVERSAL trial by the end of 2021 and providing additional insight into the potential of our allogeneic cell therapy platform."

    Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for clinical testing, prescription drug user fee exemptions, and seven year marketing exclusivity in the event of regulatory approval. ODD does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

    About ALLO-715

    ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow, and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites. Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available. Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented in December 2020 at an oral session of the American Society of Hematology (ASH) annual meeting. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).

    About Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the UNIVERSAL trial and present any data from the trial; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the SEC, including without limitation in its Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

    ALLO-715 utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for this investigational candidate.

    Allogene Media/Investor Contact:

    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    Christine.Cassiano@allogene.com



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  3. CD19 Program Highlights

    • Phase 1 ALPHA Data at ASCO 2021 Showed a Single Dose of ALLO-501 was Associated with Overall Response, Complete Response and Durable Response Rates on Par with Autologous CD19 CAR T Therapies in CAR T Naïve Patients with Relapsed/Refractory Non-Hodgkin Lymphoma
    • Next CD19 Program Clinical Update Planned for Q4 2021
    • ALLO-501A Pivotal Trial on Track for Initiation in Late 2021

    BCMA Program Highlights

    • Updated Phase 1 UNIVERSAL Data on ALLO-715 Planned for Q4 2021
    • Began Dosing Patients in Phase 1 IGNITE Trial of ALLO-605, the First TurboCAR™ T Cell Therapy, for Relapsed/Refractory Multiple Myeloma
    • ALLO-605 Granted Fast Track Designation by the FDA

    Solid Tumor Program Highlights

    • Phase 1 TRAVERSE Trial Ongoing for ALLO-316 (anti-CD70…

    CD19 Program Highlights

    • Phase 1 ALPHA Data at ASCO 2021 Showed a Single Dose of ALLO-501 was Associated with Overall Response, Complete Response and Durable Response Rates on Par with Autologous CD19 CAR T Therapies in CAR T Naïve Patients with Relapsed/Refractory Non-Hodgkin Lymphoma
    • Next CD19 Program Clinical Update Planned for Q4 2021
    • ALLO-501A Pivotal Trial on Track for Initiation in Late 2021

    BCMA Program Highlights

    • Updated Phase 1 UNIVERSAL Data on ALLO-715 Planned for Q4 2021
    • Began Dosing Patients in Phase 1 IGNITE Trial of ALLO-605, the First TurboCAR™ T Cell Therapy, for Relapsed/Refractory Multiple Myeloma
    • ALLO-605 Granted Fast Track Designation by the FDA

    Solid Tumor Program Highlights

    • Phase 1 TRAVERSE Trial Ongoing for ALLO-316 (anti-CD70) in Advanced or Metastatic Renal Cell Carcinoma. Initial Clinical Readout Expected in 2022

    Corporate Highlights

    • Appointed Liz Barrett and Vicki Sato, Ph.D., Executives with Significant Strategic and Commercial Expertise, to the Board of Directors
    • State-of-the-Art cGMP Manufacturing Facility in Newark, California to Support Industry's First Allogeneic Pivotal Trial and Future Commercial Launch
    • Ended Second Quarter with $913 Million in Cash, Cash Equivalents and Investments
    • Quarterly Conference Call and Webcast Scheduled for 2:00 PM PT/5:00 PM ET

    SOUTH SAN FRANCISCO, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today provided a corporate update and reported second quarter 2021 financial results for the quarter ended June 30, 2021.

    "We have made exceptional progress across our broad pipeline of AlloCAR T candidates, bringing our goal of revolutionizing cell therapy for patients with blood cancers and solid tumors closer to reality," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our foundational and ongoing work has the potential to drive us toward an industry first - our planned pivotal trial for ALLO-501A in relapsed/refractory non-Hodgkin lymphoma which we expect to initiate at the end of this year. This month, we are also marking an exciting milestone with the planned inauguration of our state-of-the-art manufacturing facility, Cell Forge 1. This facility is intended to allow us to control manufacturing of ALLO-501A and future therapies and prepare us for potential commercialization."

    Pipeline Highlights

    Anti-CD19 Program: ALPHA and ALPHA2 Trials

    • Updated data from the ongoing Phase 1 ALPHA (ALLO-501) and ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin lymphoma (NHL) presented at the Company's CD19 Forum in May and Annual Meeting of the American Society of Clinical Oncology (ASCO) in June.
    • Data from the ALPHA trial supports the ability of a single administration of ALLO-501 to generate deep and durable responses at a rate that is similar to approved autologous CAR T therapies. In the trial, 98% of patients received ALLO-501 with an average time from enrollment to the start of therapy of five days.
      • Durable complete responses (CR) were observed with the longest ongoing CR at 15 months in both large B cell lymphoma (LBCL) and follicular lymphoma.
      • Overall response rate (ORR) of 75% and CR rate of 50% across histologies in CAR T naïve patients, and on par with data from pivotal trials of autologous CAR T therapies.
      • Six-month CR rate of 36% in CAR T naïve patients with LBCL.
    • Interim Phase 1 ALPHA2 data demonstrated a comparable efficacy and safety profile for ALLO-501A relative to ALLO-501.
      • Consolidation dosing was well tolerated and showed early promise with four patients converting from partial response (PR) to CR following second dose of ALLO-501 or ALLO-501A.
      • 75% ORR and 63% CR among patients (n=8) treated in the consolidation cohorts across ALPHA studies.
    • ALLO-501 and ALLO-501A demonstrated a manageable safety profile with no dose limiting toxicities or graft-vs-host disease, limited immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) observed.
    • Next readout from this program is expected in late 2021.
    • The Company plans to collect additional data from the consolidation arms of the ALPHA and ALPHA2 studies, finalize a dose and schedule of ALLO-501A and lymphodepletion for a pivotal Phase 2 trial, and discuss the Phase 2 trial design with regulatory authorities.
    • Pending regulatory feedback, the Company plans to move to the Phase 2 Pivotal ALPHA2 trial at the end of 2021.

    Anti-BCMA AlloCAR T Program

    The Company continues to advance its portfolio of allogeneic therapies targeting the B cell maturation antigen (BCMA) for patients with multiple myeloma (MM).

    • ALLO-715 UNIVERSAL Trial
      • The UNIVERSAL trial, investigating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics' investigational gamma secretase inhibitor, continues to enroll patients with relapsed/refractory MM.
      • Updated data from the monotherapy arm of the study are anticipated in Q4 2021.
      • In April, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).
    • ALLO-605 TurboCAR™ IGNITE Trial
      • The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605, the first anti-BCMA TurboCAR T cell therapy, began dosing patients.
      • In June, the FDA granted ALLO-605 Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard MM therapies.

    Solid Tumor AlloCAR T Program

    • ALLO-316 (anti-CD70) TRAVERSE Trial

      The Phase 1 TRAVERSE trial of ALLO-316, Allogene's first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) continues to progress with initial data anticipated in 2022. The trial is examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316.

    Corporate Highlights

    • Manufacturing Updates
      • The Company plans to unveil its state-of-the-art cGMP cell manufacturing facility, Cell Forge 1, in Newark, California in preparation for a pivotal trial of ALLO-501A and future commercialization. Company is on track to begin cGMP production in this facility in the second half of 2021.
    • Allogene Overland Biopharm
      • Allogene Overland Biopharm, a joint venture created with Overland Pharmaceuticals, appointed Shuyuan Yao, Ph.D., as Chief Executive Officer. Dr. Yao brings 15 years of scientific and management experience in advanced cell and gene therapy development, manufacturing and commercialization, and will lead Allogene Overland in its mission to bring certain AlloCAR T therapies to patients in China and other Asian Pacific markets.

    Second Quarter Financial Results

    • Research and development expenses were $52.3 million for the second quarter of 2021, which includes $10.5 million of non-cash stock-based compensation expense.
    • General and administrative expenses were $18.8 million for the second quarter of 2021, which includes $10.6 million of non-cash stock-based compensation expense.
    • Net loss for the second quarter of 2021 was $70.9 million, or $0.53 per share, including non-cash stock-based compensation expense of $21.1 million.
    • The Company had $913.2 million in cash, cash equivalents, and investments as of June 30, 2021.

    Allogene continues to expect full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.

    Conference Call and Webcast Details

    Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 8080137. The webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

    About Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com and follow @AllogeneTx on Twitter and LinkedIn.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALPHA, ALPHA2, UNIVERSAL, IGNITE and TRAVERSE trials, including progressing to the Phase 2 portion of the ALPHA2 trial, and present any data from the trials; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; the ability to manufacture AlloCAR T™ therapies, including for use in clinical trials and at the Company's manufacturing facility; the potential benefits of AlloCAR T™ therapy; and the 2021 financial guidance. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    Comparative statements regarding autologous CAR T data are based on review of Kymriah United States product insert (USPI), Schuster S et al NEJM 2019; Yescarta USPI, Locke, AACR 2017; and Breyanzi USPI. Caution should be exercised when interpreting results from separate trials involving separate product candidates. There are differences in the clinical trial design, patient populations, published data, and the product candidates themselves, and the results from the clinical trials of autologous products may have no interpretative value on our existing or future results.

    AlloCAR T™ and TurboCAR™ are trademarks of Allogene Therapeutics, Inc.

    Allogene's CD19 AlloCAR T program utilizes Cellectis technologies. ALLO-501 and ALLO-501A are being jointly developed under a collaboration agreement between Servier1 and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. The anti-BCMA and anti-CD70 AlloCAR T programs, which utilize the Cellectis TALEN® technology, are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.

    _____________________________________

    1 Servier is an independent international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).



    ALLOGENE THERAPEUTICS, INC.

    SELECTED FINANCIAL DATA

    (unaudited; in thousands, except share and per share data)

    STATEMENTS OF OPERATIONS

     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Collaboration revenue - related party$44   $   $38,389   $  
    Operating expenses:       
    Research and development$52,290   $47,296   $107,473   $89,337  
    General and administrative18,783   15,862   35,146   31,502  
    Total operating expenses71,073   63,158   142,619   120,839  
    Loss from operations(71,029)  (63,158)  (104,230)  (120,839) 
    Other income (expense), net:       
    Interest and other income, net624   2,340   1,135   5,600  
    Other expenses(531)  (156)  (856)  (215) 
    Total other income (expense), net93   2,184   279   5,385  
    Net loss(70,936)  (60,974)  (103,951)  (115,454) 
    Net loss per share, basic and diluted$(0.53)  $(0.53)  $(0.78)  $(1.03) 
    Weighted-average number of shares used in computing net loss per share, basic and diluted134,826,805   115,377,210   133,503,262   112,163,123  



    SELECTED BALANCE SHEET DATA

     As of June 30, 2021 As of December 31, 2020
    Cash, cash equivalents and investments$913,230  $1,032,118 
    Total assets1,126,724  1,227,829 
    Total liabilities102,912  148,212 
    Total stockholders' equity1,023,812  1,079,617 



    Allogene Media/Investor Contact:


    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    Christine.Cassiano@allogene.com



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  4. SOUTH SAN FRANCISCO, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced the appointment of Elizabeth (Liz) Barrett and Vicki Sato, Ph.D. to the company's Board of Directors. Ms. Barrett, an executive with deep experience in the commercialization of novel oncology therapies, is currently the President and Chief Executive Officer (CEO) of UroGen Pharma (NASDAQ:URGN). Dr. Sato, former faculty member at Harvard University and Harvard Business School, has an exceptional track record of execution as an executive at several leading biotechnology companies.

    "We are very fortunate…

    SOUTH SAN FRANCISCO, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced the appointment of Elizabeth (Liz) Barrett and Vicki Sato, Ph.D. to the company's Board of Directors. Ms. Barrett, an executive with deep experience in the commercialization of novel oncology therapies, is currently the President and Chief Executive Officer (CEO) of UroGen Pharma (NASDAQ:URGN). Dr. Sato, former faculty member at Harvard University and Harvard Business School, has an exceptional track record of execution as an executive at several leading biotechnology companies.

    "We are very fortunate to welcome Liz and Vicki to our Board of Directors," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics. "These talented executives will provide critical guidance as we plan to initiate our first pivotal study later this year and position Allogene to potentially become the first company to commercialize an allogeneic CAR T therapy. Liz is a CAR T veteran whose deep knowledge of the oncology marketplace will be invaluable as Allogene seeks to commercialize off-the-shelf therapies for cancer patients. Vicki is a skillful and strategic thinker whose scientific and business acumen will help steer us as we enter the next phase of growth in the field of allogeneic cell therapy."

    Ms. Barrett is currently the President and CEO of UroGen Pharma, a biotechnology company that develops and commercializes treatments for urologic and uro-oncological conditions. At UroGen, Liz spearheaded the 2020 approval of Jelmyto® for the treatment of low-grade upper tract urothelial carcinoma. She previously served as CEO of Novartis Oncology, where she managed the development and launch of the autologous CAR T therapy Kymriah® (tisagenlecleucel). Prior to her tenure at Novartis, she held several leadership positions at Pfizer, including Global President and General Manager of Oncology, and led the rollout of Ibrance®. She has also held leadership roles at Cephalon and Johnson & Johnson. Ms. Barrett currently serves on the Board of Directors of Sage Therapeutics.

    "I am excited to join Allogene's Board of Directors and resume participation in one of the most promising therapeutic modalities within oncology," said Ms. Barrett. "I believe allogeneic cell therapy is the future of CAR T, and I am eager to play a role in bringing this potentially revolutionary therapy to many more patients with hematologic and solid tumor malignancies."

    Dr. Sato served as President of Vertex Pharmaceuticals where she was responsible for research and development, business and corporate management, and commercial, legal and financial operations. Before joining Vertex, Dr. Sato was Vice President of Research at Biogen, Inc., where she led programs in inflammation, thrombosis, and HIV and contributed to the executive management of the company. She also served as a member of the Biogen Scientific Advisory Board. Dr. Sato began her career as a Professor in the Department of Cell and Developmental Biology at Harvard University and then returned to academia from 2006-2017 to serve as a Professor of the Practice in Molecular and Cell Biology at Harvard University and a Professor of Management Practice at Harvard Business School. Dr. Sato is currently on the Board of Directors at Denali Therapeutics, Vir Biotechnology and Akouos.

    "I am honored to join Allogene's Board of Directors," said Dr. Sato. "Allogene has produced exciting clinical data showcasing the potential for allogeneic CAR T therapy to offer distinct advantages over autologous cell therapy. I believe it is still early days in terms of our ability to unlock the full potential of cell therapy and look forward to supporting Allogene's leadership position in this field."

    About Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: timing and ability to advance to a pivotal trial of an AlloCAR T™ therapy; ability to generate positive data, obtain regulatory approval and commercialize any AlloCAR T™ therapy; and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

    Allogene Media/Investor Contact:

    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    Christine.Cassiano@allogene.com



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