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Allogene Therapeutics, Inc. (ALLO)

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Previous Close29.39
Open29.87
Bid27.00 x 900
Ask29.19 x 900
Day's Range28.35 - 29.95
52 Week Range20.15 - 55.00
Volume438,052
Avg. Volume878,806
Market Cap4.062B
Beta (5Y Monthly)1.15
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
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  • Allogene Therapeutics Reports First Quarter 2021 Financial Results
    GlobeNewswire

    Allogene Therapeutics Reports First Quarter 2021 Financial Results

    CD19 Program Highlights Data from the ALLO-501 ALPHA Study and ALLO-501A ALPHA2 Study to be Presented at the American Society of Clinical Oncology (ASCO) Annual MeetingLonger Term Follow-Up from the ALPHA Study and Consolidation Dosing in Both ALPHA and ALPHA2 Study to be IncludedAllogene to Host Virtual CD19 Forum to Review ASCO Datasets on May 19, 2021 at 2:30 p.m. PT/5:30 p.m. ET BCMA Program Highlights FDA Granted RMAT Designation to ALLO-715, the First for an AlloCAR T™ Candidate for Relapsed/Refractory Multiple MyelomaInitiated Combination Arm of the UNIVERSAL Trial with ALLO-715 and NirogacestatFDA Cleared IND Application for ALLO-605, the First TurboCAR™ T Cell Candidate Targeting BCMA for Patients with Relapsed/Refractory Multiple Myeloma Solid Tumor Program Highlights TRAVERSE Trial Initiated for ALLO-316 (anti-CD70) in Patients with Advanced or Metastatic Renal Cell CarcinomaEnded First Quarter with $964 Million in Cash, Cash Equivalents and InvestmentsQuarterly Conference Call and Webcast Scheduled for 2:00 PM PT/5:00 PM ET SOUTH SAN FRANCISCO, Calif., May 05, 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 financial results for the quarter ended March 31, 2021. "We’ve had a strong start to the year as evidenced by the significant clinical and regulatory progress made across our growing AlloCAR T portfolio, including the start of our first solid tumors study,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “We believe our progress demonstrates our ability to advance the field of allogeneic CAR T cell therapy and we look forward to sharing data from our CD19 program on May 19th during our virtual forum event.” Pipeline Highlights Anti-CD19 Program Updated data from the dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 study of ALLO-501A at the American Society of Clinical Oncology (ASCO) annual meeting. The presentation will include longer-term follow-up from the initial cohort of patients reported at ASCO 2020, additional data on patients treated subsequent to ASCO 2020, dose escalation data from ALPHA2, and initial results from patients treated with consolidation dosing of ALLO-501 and ALLO-501A. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory NHL and multiple myeloma.Subject to further study progress and data, the Company plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021.On May 19, 2021, the Company will host a virtual CD19 Forum focused on clinical data being presented at ASCO, along with the Company’s vision for the future of CAR T therapy. In addition to presentations from Company management, the Forum will include a discussion with clinical investigators. Anti-BCMA ProgramThe Company continues to execute on its portfolio of anti-B cell maturation antigen (BCMA) therapies in patients with multiple myeloma (MM). ALLO-715 UNIVERSAL Trial The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715, Allogene’s most advanced AlloCAR T candidate for relapsed/refractory MM. The designation follows proof-of-concept data from the Phase 1 UNIVERSAL trial in heavily pretreated, relapsed/refractory MM patients, which 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. Patient dosing has begun in the portion of the UNIVERSAL trial investigating ALLO-715 in combination with nirogacestat in patients with relapsed/refractory MM. Nirogacestat is an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics. ALLO-605 TurboCAR™ IGNITE Trial The FDA cleared the Investigational New Drug (IND) application to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in relapsed/refractory MM. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells to potentially improve efficacy, overcome exhaustion, and reduce cell dose requirements. The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021. Solid Tumor Program ALLO-316 TRAVERSE Trial Patient dosing has begun in the Phase 1 TRAVERSE trial examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316, Allogene’s first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma. Expanded TurboCAR Platform In April 2021, at the American Association for Cancer Research (AACR) Annual Meeting, the Company reported on pre-clinical data that expands the TurboCAR technology platform to address the biology of solid tumor oncology. TurboCARs were engineered to confer cytokine signaling that is inducible upon binding to PDL1 in the tumor microenvironment or when stimulated with an anti-PD1 antibody while acting as a dominant negative for PDL1 and PDL2 immunosuppressive signaling. These TurboCARs are designed to overcome the challenges in solid tumors associated with an immuno-suppressive tumor microenvironment (TME) by turning negative signals into positive signals. First Quarter Financial Results Research and development expenses were $55.2 million for the first quarter of 2021, which includes $7.9 million of non-cash stock-based compensation expense. General and administrative expenses were $16.4 million for the first quarter of 2021, which includes $8.9 million of non-cash stock-based compensation expense. Net loss for the first quarter of 2021 was $33.0 million, or $0.25 per share, including non-cash stock-based compensation expense of $16.8 million. The Company had $964.2 million in cash, cash equivalents, and investments as of March 31, 2021. 2021 Financial GuidanceAllogene 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 DetailsAllogene 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 9435559. 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. Virtual CD19 ForumAdditional information on the Company’s May 19 Virtual CD19 Forum will be made available in a separate press release and on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event. About Allogene TherapeuticsAllogene 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 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 timing and ability to initiate a clinical trial of ALLO-605; the ability of ALLO-605 to improve efficacy, overcome exhaustion, and reduce cell dose requirements; the ability to expand the TurboCAR platform; the ability to manufacture AlloCAR T™ therapies, including for use in clinical trials, 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 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™ 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 March 31, 2021 2020Collaboration revenue - related party$38,345 $— Operating expenses: Research and development$55,183 $42,042 General and administrative16,363 15,641 Total operating expenses71,546 57,683 Loss from operations(33,201) (57,683) Other income (expense), net: Interest and other income, net511 3,261 Other expenses(325) (58) Total other income (expense), net186 3,203 Net loss(33,015) (54,480) Net loss per share, basic and diluted$(0.25) $(0.50) Weighted-average number of shares used in computing net loss per share, basic and diluted132,165,014 108,963,522 SELECTED BALANCE SHEET DATA As of March 31, 2021 As of December 31, 2020Cash, cash equivalents and investments$964,154 $1,032,118 Total assets1,179,044 1,227,829 Total liabilities109,265 148,212 Total stockholders’ equity1,069,779 1,079,617 Allogene Media/Investor Contact: Christine Cassiano Chief Communications Officer (714) 552-0326 Christine.Cassiano@allogene.com

  • ACCESSWIRE

    Allogene Therapeutics, Inc. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / May 5, 2021 / Allogene Therapeutics, Inc. (NASDAQ:ALLO) will be discussing their earnings results in their 2021 First Quarter Earnings call to be held on May 5, 2021 at 5:00 PM Eastern Time.

  • Allogene Therapeutics to Present Data from its Anti-CD19 AlloCAR T™ Therapy Program in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology
    GlobeNewswire

    Allogene Therapeutics to Present Data from its Anti-CD19 AlloCAR T™ Therapy Program in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology

    Longer Term Data from the ALLO-501 Phase 1 ALPHA Study to be Presented Alongside Initial Data from the Phase 1 ALLO-501A ALPHA2 StudySeparate Presentation to Include Safety and PK/PD Data on ALLO-647 Used in, Allogene’s Proprietary Lymphodepletion RegimenALLO-501A, Intended for a Potentially Pivotal Phase 2 Trial, Previously Granted FDA Fast Track Designation for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)Allogene to Host Virtual CD19 Forum to Review ASCO Datasets on May 19, 2021 at 2:30 p.m. PT/5:30 p.m. ET SOUTH SAN FRANCISCO, Calif. and PARIS, April 28, 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, in collaboration with its development partner Servier, an independent international pharmaceutical company, today announced that longer-term follow-up data from Allogene’s dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 trial of ALLO-501A at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4 - 9, 2021. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory non-Hodgkin lymphoma and multiple myeloma. These Phase 1 trials are designed to assess the safety and tolerability at increasing dose levels of ALLO-501, ALLO-501A and ALLO-647 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma or follicular lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for Phase 2 development in diffuse large B cell lymphoma (DLBCL), eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. “We are excited to present the first clinical data on ALLO-501A, our anti-CD19 AlloCAR T candidate intended for registrational trials in DLBCL, along with longer-term follow up from ALPHA, our first Phase 1 study of ALLO-501,” said Rafael Amado, MD, Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “Over the past year, we have moved quickly and diligently to advance multiple AlloCAR T programs into the clinic using innovative technologies and across a variety of malignancies. We’re looking forward to discussing our progress in these two foundational studies during our virtual CD19 Forum.” Allogene will host a virtual CD19 Forum for investors and other interested parties on May 19, 2021 at 2:30 p.m. Pacific Time/5:30 p.m. Eastern Time. The Forum will include data being presented at the virtual 2021 ASCO Annual Meeting along with discussion from clinical investigators and Allogene’s vision for the future of its AlloCAR T platform. Allogene presentations at the virtual 2021 ASCO Annual Meeting: First-in-human data of ALLO-501A, an allogeneic chimeric antigen receptor (CAR) T-cell therapy and ALLO-647 in relapsed/refractory large B-cell lymphoma (R/R LBCL): ALPHA2 study.Presenter: Frederick Locke, MD, H. Lee Moffitt Cancer Center and Research Institute, Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy Poster Session Title: Developmental Therapeutics—ImmunotherapyAbstract #2529Session Release Date: June 4, 2021 Safety and PK/PD of ALLO-647, an anti-CD52 antibody, with fludarabine (Flu)/cyclophosphamide (Cy) for lymphodepletion in the setting of allogeneic CAR-T cell therapy.Presenter: Michael Tees, MD, Colorado Blood Cancer Institute/Sarah Cannon, Associate Member Physician Poster Session Title: Developmental Therapeutics—ImmunotherapyAbstract # 2527Session Release Date: June 4, 2021 Virtual CD19 ForumAdditional information on the Virtual CD19 Forum will be made available in a separate press release and on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event. About ALLO-501 (Allogene Sponsored)ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier and utilizing Cellectis technologies. Servier grants to Allogene exclusive rights to ALLO-501 in the U.S. while Servier retains exclusive rights for all other countries. About ALLO-501A (Allogene Sponsored)ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for Phase 2 development, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. Like ALLO-501, ALLO-501A is being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier and utilizing Cellectis technologies. ALLO-501A uses the Cellectis TALEN technology. Servier grants to Allogene exclusive rights to ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. About Allogene TherapeuticsAllogene 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 world-class 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. About ServierServier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2020, Servier employs 22,500 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities, from research to support beyond the pill. A leader in cardiology, the ambition of the Servier Group is to become a recognized and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, and immuno-inflammatory and neurodegenerative diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. More information: www.servier.com Servier Group press contacts:Sonia Marques: presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13Jean-Clément Vergeau: presse@servier.com – Tel. +33 (0)1 55 46 16 / +33 6 79 56 75 96 Cautionary Note on Forward-Looking Statements for AllogeneThis 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 and ALPHA2 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, 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 Securities and Exchange Commission (SEC), including without limitation in its Form 10-K for the year ended December 31, 2020. 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 CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com