CD19 Program Highlights

BCMA Program Highlights

Solid Tumor Program Highlights

Corporate Highlights

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

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).

Solid Tumor AlloCAR T Program

Corporate Highlights

Second Quarter Financial Results

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.

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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