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SOUTH SAN FRANCISCO, Calif., March 08, 2019 (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 fourth quarter and full-year 2018 financial results for the periods ended December 31, 2018.
"We are very proud of what Allogene has accomplished in just ten months. Every move we have made has been toward achieving one goal, making allogeneic CAR T therapy available to patients,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We are excited to soon embark upon our first company sponsored trial for ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and progress the buildout of our planned state-of-the-art manufacturing facility in Newark, California. With our focus and drive to progress our pipeline of cell therapy candidates, which includes the planned IND submission of ALLO-715 in multiple myeloma (MM) later this year, we feel confident in Allogene’s ability to be a leader in the development of AlloCAR T™ therapies.”
2018 and Recent Highlights
ALLO-501 (Allogene-Sponsored Program in Collaboration with Servier)
UCART19 (Servier-Sponsored Program in Collaboration with Allogene)
Fourth Quarter and Full Year 2018 Financial Results
2019 Financial Guidance
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM 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 3589112. 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 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 faster, more reliably and at greater scale to more patients.
AlloCAR T™ cell therapies are engineered from cells of healthy donors, which is intended to allow for creation of inventory for on demand use in patients. This approach is designed to eliminate the need to create personalized therapy from a patient’s own cells, simplify manufacturing, and reduce the time patients must wait for CAR T cell treatment. The Allogene portfolio includes rights to 16 pre-clinical CAR T cell therapy assets and AlloCAR T™ therapy candidates ALLO-501 and UCART19. Allogene is the sponsor of the ALLO-501 program which is expected to begin Phase 1 in the first half of 2019 for the treatment of relapsed/refractory non-Hodgkin lymphoma (NHL). Servier is the sponsor of the UCART19 program which is currently in Phase 1 for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL). 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 initiate and progress ALLO-501 clinical trials and obtain regulatory approval for ALLO-501, the timing and ability to file an IND for ALLO-715 and progress a clinical trial of ALLO-715, the ability of an anti-CD52 mAb to contribute to AlloCAR T™ cell expansion, the timing and ability to complete the build-out of the manufacturing facility, the ability to manufacture AlloCAR T™ therapies, the ability to initiate and progress additional clinical trials of AlloCAR T™ therapies, the potential benefits of AlloCAR T™ therapy and the 2019 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 September 30, 2018. 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.
ALLOGENE THERAPEUTICS, INC.
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENT OF OPERATIONS
to December 31,
|Research and development||$||18,503||$||151,860||$||—|
|General and administrative||14,543||40,982||2|
|Total operating expenses||33,046||192,842||2|
|Loss from operations||(33,046||)||(192,842||)||(2||)|
|Other income (expense), net:|
|Change in fair value of convertible note payable||(1,796||)||(21,211||)||—|
|Interest and other income, net||4,216||5,789||—|
|Total other income (expense), net||2,420||(18,780||)||—|
|Loss before income taxes||(30,626||)||(211,622||)||(2||)|
|Benefit from income taxes||117||117||—|
|Net loss per share, basic and diluted||$||(0.37||)||$||(7.31||)||$||(0.00||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||82,064,497||28,948,386||26,249,993|
SELECTED BALANCE SHEET DATA
As of December 31,
|Cash, cash equivalents and investments||$||721,350|
|Total stockholders' equity||703,164|
Allogene Media/Investor Contact:
Chief Communications Officer