Allogene Therapeutics Reports First Quarter 2021 Financial Results
May 05 2021 - 4:02PM
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 March
31, 2021.
"We’ve had a strong start to the year as evidenced by the
significant clinical and regulatory progress made across our
growing AlloCAR T portfolio, including the start of our first solid
tumors study,” said David Chang, M.D., Ph.D., President, Chief
Executive Officer and Co-Founder of Allogene. “We believe our
progress demonstrates our ability to advance the field of
allogeneic CAR T cell therapy and we look forward to sharing data
from our CD19 program on May 19th during our virtual forum
event.”
Pipeline Highlights
Anti-CD19 Program
- Updated data from the dose escalation Phase 1 ALPHA study of
ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be
jointly presented with initial data from the ALPHA2 study of
ALLO-501A at the American Society of Clinical Oncology (ASCO)
annual meeting. The presentation will include longer-term follow-up
from the initial cohort of patients reported at ASCO 2020,
additional data on patients treated subsequent to ASCO 2020, dose
escalation data from ALPHA2, and initial results from patients
treated with consolidation dosing of ALLO-501 and ALLO-501A. A
separate poster presentation will detail safety and biomarker
findings from ALLO-647, Allogene’s wholly owned antibody used for
lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in
patients with relapsed/refractory NHL and multiple myeloma.
- Subject to further study progress and data, the Company plans
to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the
end of 2021.
- On May 19, 2021, the Company will host a virtual CD19 Forum
focused on clinical data being presented at ASCO, along with the
Company’s vision for the future of CAR T therapy. In addition to
presentations from Company management, the Forum will include a
discussion with clinical investigators.
Anti-BCMA ProgramThe Company continues to
execute on its portfolio of anti-B cell maturation antigen (BCMA)
therapies in patients with multiple myeloma (MM).
- ALLO-715 UNIVERSAL Trial
- The U.S. Food and Drug Administration (FDA) granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
ALLO-715, Allogene’s most advanced AlloCAR T candidate for
relapsed/refractory MM. The designation follows proof-of-concept
data from the Phase 1 UNIVERSAL trial in heavily pretreated,
relapsed/refractory MM patients, which demonstrated for the first
time that an allogeneic CAR T therapy directed at BCMA can achieve
clinical responses while eliminating the need for bridging therapy
or delays in treatment associated with manufacturing.
- Patient dosing has begun in the portion of the UNIVERSAL trial
investigating ALLO-715 in combination with nirogacestat in patients
with relapsed/refractory MM. Nirogacestat is an investigational
gamma secretase inhibitor being developed by SpringWorks
Therapeutics.
- ALLO-605 TurboCAR™ IGNITE Trial
- The FDA cleared the Investigational New Drug (IND) application
to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in
relapsed/refractory MM. TurboCAR technology allows cytokine
activation signaling to be engineered selectively into CAR T cells
to potentially improve efficacy, overcome exhaustion, and reduce
cell dose requirements. The Phase 1 IGNITE trial will evaluate
escalating doses of ALLO-605 beginning in mid-2021.
Solid Tumor Program
- ALLO-316 TRAVERSE Trial
- Patient dosing has begun in the Phase 1 TRAVERSE trial
examining safety, tolerability, anti-tumor efficacy,
pharmacokinetics and pharmacodynamics of ALLO-316, Allogene’s first
CAR T candidate for solid tumors, in patients with advanced or
metastatic clear cell renal cell carcinoma.
- Expanded TurboCAR Platform
- In April 2021, at the American Association for Cancer Research
(AACR) Annual Meeting, the Company reported on pre-clinical data
that expands the TurboCAR technology platform to address the
biology of solid tumor oncology. TurboCARs were engineered to
confer cytokine signaling that is inducible upon binding to PDL1 in
the tumor microenvironment or when stimulated with an anti-PD1
antibody while acting as a dominant negative for PDL1 and PDL2
immunosuppressive signaling. These TurboCARs are designed to
overcome the challenges in solid tumors associated with an
immuno-suppressive tumor microenvironment (TME) by turning negative
signals into positive signals.
First Quarter Financial Results
- Research and
development expenses were $55.2 million for the first
quarter of 2021, which includes $7.9 million of non-cash
stock-based compensation expense.
- General and
administrative expenses were $16.4 million for the first
quarter of 2021, which includes $8.9 million of non-cash
stock-based compensation expense.
- Net loss for the
first quarter of 2021 was $33.0 million,
or $0.25 per share, including non-cash stock-based
compensation expense of $16.8 million.
- The Company had $964.2 million in cash, cash equivalents, and
investments as of March 31, 2021.
2021 Financial GuidanceAllogene 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 DetailsAllogene 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
9435559. 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.
Virtual CD19 ForumAdditional information on the
Company’s May 19 Virtual CD19 Forum will be made available in a
separate press release and on the Company's website at
www.allogene.com under the Investors tab in the News and Events
section. Materials presented will be available on the Allogene
website prior to the start of the event.
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 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 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
timing and ability to initiate a clinical trial of ALLO-605; the
ability of ALLO-605 to improve efficacy, overcome exhaustion, and
reduce cell dose requirements; the ability to expand the TurboCAR
platform; the ability to manufacture AlloCAR T™ therapies,
including for use in clinical trials, 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 March 31, 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.
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.
_____________________________________
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 March 31, |
|
2021 |
|
2020 |
Collaboration revenue - related party |
$ |
38,345 |
|
|
|
$ |
— |
|
|
Operating expenses: |
|
|
|
Research and development |
$ |
55,183 |
|
|
|
$ |
42,042 |
|
|
General and administrative |
16,363 |
|
|
|
15,641 |
|
|
Total operating expenses |
71,546 |
|
|
|
57,683 |
|
|
Loss from operations |
(33,201 |
) |
|
|
(57,683 |
) |
|
Other income (expense),
net: |
|
|
|
Interest and other income, net |
511 |
|
|
|
3,261 |
|
|
Other expenses |
(325 |
) |
|
|
(58 |
) |
|
Total other income (expense),
net |
186 |
|
|
|
3,203 |
|
|
Net loss |
(33,015 |
) |
|
|
(54,480 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.25 |
) |
|
|
$ |
(0.50 |
) |
|
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
132,165,014 |
|
|
|
108,963,522 |
|
|
SELECTED BALANCE SHEET DATA
|
As of March 31, 2021 |
|
As of December 31, 2020 |
Cash, cash equivalents and investments |
$ |
964,154 |
|
|
$ |
1,032,118 |
|
Total assets |
1,179,044 |
|
|
1,227,829 |
|
Total liabilities |
109,265 |
|
|
148,212 |
|
Total stockholders’
equity |
1,069,779 |
|
|
1,079,617 |
|
Allogene Media/Investor Contact: Christine
Cassiano Chief Communications Officer (714) 552-0326
Christine.Cassiano@allogene.com
Allogene Therapeutics (NASDAQ:ALLO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Allogene Therapeutics (NASDAQ:ALLO)
Historical Stock Chart
From Sep 2023 to Sep 2024