Allogene Therapeutics Reports First Quarter 2019 Financial Results
- Initiated ALLO-501 Phase 1 ALPHA Trial in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (
- Investigational New Drug (IND) Application Submitted to the
U.S. Food & Drug Administration( FDA) for ALLO-715 Targeting BCMA for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
- Ended First Quarter 2019 with
$681 Millionin Cash, Cash Equivalents and Investments
- Conference Call and Webcast Scheduled for
5:30 AM PT/ 8:30 AM ET
“We are very pleased with our ability to accelerate the research and development activities for both ALLO-501 and ALLO-715,” said
ALLO-501 (anti-CD19 AlloCAR T)
- The ALLO-501 Phase 1 ALPHA trial for patients with relapsed/refractory non-Hodgkin lymphoma (
NHL) has been initiated. The trial is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 in the most common NHLsubtypes of relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Multiple sites with expertise in CAR T are fully activated and the Company continues to expect to report initial data from the trial in the first half of 2020.
- The Company is rapidly progressing the planned second generation of ALLO-501 through preclinical development. The second generation ALLO-501 is devoid of the rituximab off-switch and is expected to be introduced prior to the start of the Phase 2 portion of the ALPHA study.
ALLO-715 (anti-BCMA AlloCAR T)
- An Investigational New Drug (IND) application has been submitted to the
U.S. Food & Drug Administration( FDA) for ALLO-715, a wholly-owned CAR T product candidate targeting B cell maturation antigen (BCMA) for relapsed/refractory multiple myeloma. The Company remains on track to initiate a Phase 1 trial in 2019.
- In April, the Company published in the journal Molecular Therapy preclinical study results validating the potential for an AlloCAR T to treat multiple myeloma. These results demonstrated the ability for ALLO-715 to sustain potent anti-tumor responses in pre-clinical models.
Additional Pipeline Updates
- UCART19 (Servier-Sponsored Program in Collaboration with Allogene) - Servier is in the process of advancing its supply and re-initiating recruitment for the CALM and PALL trials in relapsed/refractory acute lymphoblastic leukemia. UCART19 is expected to be advanced to potential registrational trials in 2020.
- CD70 - At the 2019 American Association for Cancer Research (AACR) Annual Meeting, the Company presented pre-clinical data on its AlloCAR T program targeting CD70, a cancer target that is expressed on both hematologic and solid tumor cells. The data demonstrated the therapeutic potential of an AlloCAR T therapy directed at CD70 in renal cell carcinoma (RCC). The Company plans to select an anti-CD70 AlloCAR T candidate for IND-enabling studies.
In May, the Company announced the expansion of its
First Quarter Financial Results
- Research and development expenses were
$23.4 millionfor the first quarter of 2019, which includes $2.7 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$13.1 millionfor the first quarter of 2019, which includes $5.1 millionof non-cash stock-based compensation expense.
- Net loss for the first quarter of 2019 was
$31.6 million, or $0.32per share, including non-cash stock-based compensation expense of $7.9 million.
- As of
March 31, 2019, Allogene had $680.7 millionin cash, cash equivalents, and investments.
- The Company continues to expect full-year 2019 net losses to be between
$200 million and $210 million dollars, including estimated non-cash stock-based compensation expense of $45 million to $50 millionand excluding any impact from potential business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALLO-501 ALPHA trial, the timing and ability to report initial clinical results from the ALPHA trial, the ability to introduce the second generation of ALLO-501 prior to the start of the Phase 2 portion of the ALPHA trial, the timing and ability to initiate and progress a clinical trial of ALLO-715, Servier’s ability to re-initiate enrollment in the CALM and PALL trials, the timing and ability to progress the CALM and PALL trials to potential registrational trials, the ability to manufacture AlloCAR T™ therapies, the ability to initiate and progress additional clinical trials of AlloCAR T™ therapies, the potential benefits of AlloCAR T™ therapy and the 2019 financial guidance. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
|Three Months Ended March 31,|
|Research and development||$||23,403||$||—|
|General and administrative||13,058||2,597|
|Total operating expenses||36,461||2,597|
|Loss from operations||(36,461||)||(2,597||)|
|Interest and other income, net||4,825||—|
|Total other income (expense), net||(31,636||)||(2,597||)|
|Loss before income taxes||(31,636||)||(2,597||)|
|Benefit from income taxes||50||—|
|Net loss per share, basic and diluted||$||(0.32||)||$||(0.10||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||97,315,890||26,249,993|
SELECTED BALANCE SHEET DATA
|As of March 31,
|Cash, cash equivalents and investments||$||680,728|
|Total stockholders' equity||681,228|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.