SOUTH SAN FRANCISCO, Calif., Nov. 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 financial results for the quarter ended September 30, 2021.
“While our clinical studies are on hold, our work to bring AlloCAR T products to patients continues with a strong sense of urgency. We remain confident in our platform and the potential of our AlloCAR T candidates to meaningfully improve the lives of patients living with cancer,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Our teams are busy progressing our preclinical programs, advancing production at our Cell Forge 1 manufacturing facility, and preparing for data presentations at the American Society of Hematology (ASH) Annual Meeting in December. In the meantime, we continue to work closely with the U.S. Food and Drug Administration (FDA) on the review of the end of Phase 1 materials in support of a pivotal trial for ALLO-501A as well as to resolve the clinical hold and we look forward to providing an update after further interaction with the agency.”
Pipeline Updates
The FDA placed a hold on the Company’s AlloCAR T clinical trials (ALPHA, ALPHA2, IGNITE, TRAVERSE, UNIVERSAL) following a report of a chromosomal abnormality in a single patient treated in the ALPHA2 study. Allogene is working with the FDA to address next steps to resolve the hold.
Anti-CD19 Program: ALPHA and ALPHA2 Trials
Anti-BCMA AlloCAR T Program: UNIVERSAL Trial
Third Quarter Financial Results
2021 Financial Guidance
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 1924859. 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 ability to progress the Company’s clinical trials and present any data from the trials; clinical outcomes, which may materially change as more patient data become available; the ability to resolve the current clinical hold on the Company’s trials; the ability to manufacture AlloCAR T™ therapies; the potential benefits of AlloCAR T therapies; 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 SEC, including without limitation in its Form 10-Q for the quarter ended September 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’s AlloCAR T™ programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier 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. ALLO-715 targets BCMA. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for these investigational candidates.
ALLOGENE THERAPEUTICS, INC.
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Collaboration revenue - related party | $ | 49 | $ | — | $ | 38,438 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 58,720 | $ | 51,421 | $ | 166,193 | $ | 140,759 | |||||||
General and administrative | 18,999 | 16,619 | 54,144 | 48,122 | |||||||||||
Total operating expenses | 77,719 | 68,040 | 220,337 | 188,881 | |||||||||||
Loss from operations | (77,670 | ) | (68,040 | ) | (181,899 | ) | (188,881 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest and other income, net | 393 | 2,005 | 1,528 | 7,606 | |||||||||||
Other expenses | (909 | ) | (162 | ) | (1,766 | ) | (376 | ) | |||||||
Total other income (expense), net | (516 | ) | 1,843 | (238 | ) | 7,230 | |||||||||
Net loss | (78,186 | ) | (66,197 | ) | (182,137 | ) | (181,651 | ) | |||||||
Net loss per share, basic and diluted | $ | (0.57 | ) | $ | (0.52 | ) | $ | (1.35 | ) | $ | (1.55 | ) | |||
Weighted-average number of shares used in computing net loss per share, basic and diluted | 137,025,698 | 127,140,755 | 134,690,310 | 117,227,079 |
SELECTED BALANCE SHEET DATA
As of September 30, 2021 | As of December 31, 2020 | ||||||
Cash, cash equivalents and investments | $ | 861,707 | $ | 1,032,118 | |||
Total assets | 1,079,246 | 1,227,829 | |||||
Total liabilities | 109,304 | 148,212 | |||||
Total stockholders’ equity | 969,942 | 1,079,617 |
Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
[email protected]
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