Allogene Therapeutics Reports Second Quarter 2019 Financial Results
August 07 2019 - 7:30AM
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 June
30, 2019.
“The second quarter was an important one on many fronts, from
advancing our pipeline with the clearance of our second
investigational new drug application, to designing our
state-of-the-art manufacturing facility and the continued
onboarding of highly-skilled employees who are passionate about
bringing allogeneic cell therapy to patients,” said David Chang,
M.D., Ph.D., President, Chief Executive Officer and Co-Founder of
Allogene. "Our teams are focused on advancing our allogeneic
platform, which includes our first company-sponsored clinical trial
with ALLO-501 for patients with relapsed/refractory non-Hodgkin
lymphoma. We are pleased with how this dose escalation study is
progressing, which includes the use of our selective
lymphodepletion strategy anchored around our proprietary anti-CD52
antibody, ALLO-647.”
Recent
Highlights ALLO-501
(anti-CD19 AlloCAR T)
- The ALLO-501 Phase 1 portion of the ALPHA trial for patients
with relapsed/refractory non-Hodgkin lymphoma (NHL) was initiated
in Q2 2019. The trial is designed to assess the safety and
tolerability at increasing dose levels of ALLO-501 in the most
common NHL subtypes of relapsed/refractory large B-cell lymphoma,
including diffuse large B-cell lymphoma (DLBCL) and follicular
lymphoma (FL). Five sites with expertise in CAR T are open for
enrollment. The company remains on track to release topline
data from the ongoing Phase 1 ALPHA trial in the first half of
2020.
- The Company continues to progress the planned second generation
of ALLO-501, which is devoid of the rituximab off-switch, through
preclinical development and plans to introduce this next generation
prior to the start of the Phase 2 registrational study.
ALLO-715 (anti-BCMA AlloCAR T)
- An Investigational New Drug (IND) application for ALLO-715, a
wholly-owned CAR T product candidate targeting B cell maturation
antigen (BCMA) for relapsed/refractory multiple myeloma, was
cleared by the U.S. Food & Drug Administration (FDA) in May
2019. The Company remains on track to initiate a Phase 1 trial in
the second half of 2019.
- 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 will utilize ALLO-647, the Company’s proprietary
anti-CD52 monoclonal antibody, as a part of the lymphodepletion
regimen. The trial also includes the potential for exploratory
cohorts that will allow study of additional lymphodepletion
regimens, including one that only uses ALLO-647 without fludarabine
and cyclophosphamide.
Additional Pipeline Updates
- UCART19 (Servier-Sponsored Program in Collaboration
with Allogene) - Servier has re-initiated 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.
Corporate Highlights
- The Company recently announced the appointment of Rafael G.
Amado, M.D. as Executive Vice President of Research and Development
and Chief Medical Officer. In this new position, Dr. Amado will
lead the Company’s clinical and research functions with the goal of
rapidly advancing our pipeline of allogeneic CAR T therapies for
hematologic and solid tumors. This appointment reunites Dr.
Amado with many former colleagues, including David Chang, M.D.,
Ph.D., President, Chief Executive Officer and Co-Founder.
Second Quarter Financial Results
- As of June 30, 2019, Allogene had $650.2 million in cash, cash
equivalents, and investments, compared to $721.4 million as of
December 31, 2018.
- Research and development expenses were $31.8 million for the
second quarter of 2019, which includes $4.7 million of non-cash
stock-based compensation expense, compared to $122.5 million for
the second quarter of 2018. The second quarter of 2018 included a
non-cash charge of $109.4 million related to in-process research
and development acquired as a result of the Pfizer asset
acquisition.
- General and administrative expenses were $14.2 million for the
second quarter of 2019, which includes $6.7 million of non-cash
stock-based compensation expense, compared to $12.5 million for the
second quarter of 2018.
- Net loss for the second quarter of 2019 was $41.2 million, or
$0.41 per share, including non-cash stock-based compensation
expense of $11.5 million, compared to a net loss of $134.9 million,
or $43.82 per share for the second quarter of 2018.
- 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
million and excluding any impact from potential business
development activities.
Conference Call and Webcast DetailsAllogene
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 4851687. 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 TherapeuticsAllogene
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 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 ALLO-501 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 complete site initiation activities, produce
additional ALLO-715 clinical supply and initiate the UNIVERSAL
study in the second half of 2019, 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
Securities and Exchange Commission (SEC), including without
limitation in its Form 10-Q for the quarter ended March 31,
2019. 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)
STATEMENTS OF OPERATIONS
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
31,774 |
|
|
$ |
122,486 |
|
|
$ |
55,177 |
|
|
$ |
122,486 |
|
General and administrative |
14,187 |
|
|
12,526 |
|
|
27,245 |
|
|
15,123 |
|
Total operating expenses |
45,961 |
|
|
135,012 |
|
|
82,422 |
|
|
137,609 |
|
Loss from operations |
(45,961 |
) |
|
(135,012 |
) |
|
(82,422 |
) |
|
(137,609 |
) |
Interest and other income,
net |
4,559 |
|
|
110 |
|
|
9,384 |
|
|
110 |
|
Loss before income taxes |
(41,402 |
) |
|
(134,902 |
) |
|
(73,038 |
) |
|
(137,499 |
) |
Benefit from income taxes |
159 |
|
|
— |
|
|
209 |
|
|
— |
|
Net loss |
(41,243 |
) |
|
(134,902 |
) |
|
(72,829 |
) |
|
(137,499 |
) |
Net loss per share, basic and
diluted |
$ |
(0.41 |
) |
|
$ |
(43.82 |
) |
|
$ |
(0.74 |
) |
|
$ |
(9.42 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
99,846,946 |
|
|
3,078,783 |
|
|
98,588,410 |
|
|
14,600,379 |
|
SELECTED BALANCE SHEET DATA
|
As of June 30,2019 |
|
As of December 31, 2018 |
Cash, cash equivalents and investments |
$ |
650,193 |
|
|
$ |
721,350 |
|
Total assets |
733,997 |
|
|
773,855 |
|
Total liabilities |
78,362 |
|
|
70,691 |
|
Total stockholders’
equity |
655,635 |
|
|
703,164 |
|
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
Allogene Therapeutics (NASDAQ:ALLO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Allogene Therapeutics (NASDAQ:ALLO)
Historical Stock Chart
From Apr 2023 to Apr 2024