Allogene Therapeutics Reports Third Quarter 2019 Financial Results
- Initiated ALLO-715 Phase 1 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma (MM)
- Patient Accrual Ongoing for ALLO-501 Phase 1 ALPHA Trial in Relapsed/Refractory Non-Hodgkin Lymphoma (
NHL) with Data Expected in First Half of 2020
- Entered into Exclusive Collaboration with Notch Therapeutics to Develop Next Generation iPSC-Based Cell Therapies
- Ended Third Quarter 2019 with
$601.9 Millionin Cash, Cash Equivalents and Investments
- Conference Call and Webcast Scheduled for
5:30 AM PT/ 8:30 AM ET
“I am very pleased with the progress we have made in a short period of time. While we leveraged the research from Pfizer to launch Allogene, we have built the company from the ground up. In parallel, we have initiated the build-out of in-house manufacturing capabilities, successfully progressed AlloCAR T programs into Phase 1 clinical development while creating next generation therapies and entering into agreements that will keep us at the forefront of cell therapy,” said
ALLO-501 (anti-CD19 AlloCAR T)
- ALLO-501 Phase 1 ALPHA trial in patients with relapsed/refractory non-Hodgkin lymphoma (
NHL) continues to accrue as planned with data expected in the first half of 2020.
ALLO-715 (anti-BCMA AlloCAR T)
- The Company initiated the ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory multiple myeloma (MM).
- The Phase 1 ALLO-715 UNIVERSAL trial is designed to assess the safety and tolerability at increasing dose levels of ALLO-715 to identify an optimal dose of ALLO-715 for the potential Phase 2 study. This trial utilizes ALLO-647, the Company’s proprietary anti-CD52 monoclonal antibody, as a part of the lymphodepletion regimen. The UNIVERSAL trial also includes the potential to evaluate alternative lymphodepletion regimens that do not include fludarabine and cyclophosphamide.
- ALLO-715 utilizes TALEN® gene-editing technology pioneered and owned by
Cellectis. Allogene has an exclusive license to the Cellectistechnology for allogeneic products directed at the BCMA target. Allogene holds global development and commercial rights for this investigational candidate.
Additional Pipeline Updates
- UCART19 (Servier-Sponsored Program in Collaboration with Allogene) – Servier continues to expect that UCART19, an anti-CD19 AlloCAR T being developed for pediatric and adult relapsed/refractory acute lymphoblastic leukemia (ALL), will advance into potential Phase 2 registrational trials in 2020.
- Earlier today, the Company announced a worldwide collaboration with Notch Therapeutics to develop induced Pluripotent Stem Cell (iPSC)-derived allogeneic therapies for hematologic cancer indications.
- The Company will receive exclusive rights and targets for initial applications in non-Hodgkin lymphoma, leukemia and multiple myeloma and has made an equity investment in Notch. Notch will receive an upfront payment, research funding, development and commercial milestones, and royalties on net sales.
- Notch was established in 2018 by Juan Carlos Zúñiga-Pflücker, Ph.D. and
Peter Zandstra, Ph.D., recognized pioneers in iPSC and T cell differentiation technology.
Third Quarter Financial Results
- As of
September 30, 2019, Allogene had $601.9 millionin cash, cash equivalents, and investments.
- Research and development expenses were
$40.0 millionfor the third quarter of 2019, which includes $5.5 millionof non-cash stock-based compensation expense, compared to $10.9 millionfor the third quarter of 2018. Research and development expenses also included a $5.0 millionmilestone to Cellectisthat is associated with the initiation of the ALLO-715 UNIVERSAL trial.
- General and administrative expenses were
$15.0 millionfor the third quarter of 2019, which includes $7.3 millionof non-cash stock-based compensation expense, compared to $11.3 millionfor the third quarter of 2018.
- Net loss for the third quarter of 2019 was
$50.7 million, or $0.50per share, including non-cash stock-based compensation expense of $12.8 million, compared to a net loss of $43.5 million, or $10.71per share for the third quarter of 2018.
- Including expenses associated with the Notch transaction, the Company reiterates full-year 2019 Net Loss guidance of between
$200 million and $210 million dollars, which includes an estimated non-cash stock-based compensation expense of $45 to $50 million dollars, and excludes any impact from future business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALLO-501 ALPHA trial and ALLO-715 UNIVERSAL trial, the timing and Servier’s ability to progress the CALM and PALL trials to potential registrational trials, the ability to manufacture AlloCAR T™ therapies, the ability to initiate and progress additional clinical trials of AlloCAR T™ therapies, the potential benefits of AlloCAR T™ therapy and the 2019 financial guidance. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS
|Three Months Ended
|Nine Months Ended
|Research and development||$||39,995||$||10,870||$||95,172||$||133,356|
|General and administrative||15,016||11,317||42,261||26,440|
|Total operating expenses||55,011||22,187||137,433||159,796|
|Loss from operations||(55,011||)||(22,187||)||(137,433||)||(159,796||)|
|Other income (expense), net:|
|Change in fair value of convertible note payable||—||(19,415||)||—||(19,415||)|
|Interest and other income, net||4,309||1,463||13,693||1,573|
|Loss before income taxes||(50,702||)||(43,497||)||(123,740||)||(180,996||)|
|Benefit (expense) from income taxes||(33||)||—||176||—|
|Net loss per share, basic and diluted||$||(0.50||)||$||(10.71||)||$||(1.24||)||$||(16.38||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||102,186,644||4,060,419||99,801,001||11,048,451|
SELECTED BALANCE SHEET DATA
|As of September 30,
|As of December 31,
|Cash, cash equivalents and investments||$||601,946||$||721,350|
|Total stockholders’ equity||619,716||703,164|
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.