Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today provided a corporate
update and reported financial results for the quarter ended March
31, 2023.
“Our first quarter progress continues to establish Allogene as
the leader in the development of allogeneic CAR T product
candidates,” said David Chang, M.D., Ph.D., President, Chief
Executive Officer and Co-Founder of Allogene. “Our success across
multiple clinical programs, ability to attract top tier talent, and
financial stewardship to weather the challenging external market
environment paves the way toward to bringing a new generation of
CAR T products to patients.”
Pipeline Updates
ALLO-501A: Anti-CD19 AlloCAR T Program The
Company continues to enroll patients in the industry’s first
potentially pivotal Phase 2 allogeneic CAR T clinical trial with
ALLO-501A. The single-arm ALPHA2 trial is enrolling patients with
relapsed/refractory (R/R) large B cell lymphoma (LBCL) and utilizes
a single dose of ALLO-501A (120 million CAR+ cells) following
lymphodepletion with FCA90 (fludarabine, 30 mg/m2; cyclophosphamide
300 mg/m2; and ALLO-647 30 mg, daily for 3 days). This trial will
enroll approximately 100 patients who have received at least two
prior lines of therapy and have not received prior anti-CD19
therapy. The primary endpoint is overall response rate (ORR), and
the key secondary endpoint is duration of response (DoR). Patients
may receive treatment as an outpatient at the investigator’s
discretion. The Company expects to complete enrollment in 1H
2024.
During the first quarter, the Company initiated the EXPAND trial
to support licensure of ALLO-647. The Company is developing
ALLO-647, an anti-CD52 monoclonal antibody, to permit the use of
standard low-dose FC (fludarabine, 30 mg/m2 and cyclophosphamide
300 mg/m2, daily for 3 days) lymphodepletion regimens across our
portfolio. This proprietary regimen is intended to prevent
premature rejection, thereby enabling expansion and persistence of
AlloCAR T cells and supporting improved clinical performance of
product candidates. In the EXPAND trial, approximately 70 patients
with R/R LBCL will be randomized to be lymphodepleted with FCA90
(which includes 90 mg of ALLO-647) versus FC alone before receiving
a single 120 million cell dose of ALLO-501A. The study is designed
to demonstrate the superiority of FCA90 over FC as measured by
progression free survival (PFS).
After the close of the quarter, the Company announced that
pooled data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A,
in R/R LBCL would be presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago,
Illinois.
ALLO-316: Anti-CD70 AlloCAR T ProgramThe
Company presented interim data from its Phase 1 TRAVERSE trial of
ALLO-316, the Company’s first AlloCAR T investigational product
candidate for solid tumors, during an oral presentation at the
American Association for Cancer Research (AACR) Annual Meeting in
April.
The ongoing dose escalation study is enrolling patients with
advanced or metastatic renal cell carcinoma (RCC) who have
progressed on standard therapies that included an immune checkpoint
inhibitor and a VEGF-targeting therapy. Emerging data from this
trial have demonstrated the potential of an allogeneic CAR T
product to treat CD70 expressing RCC. In this trial, ALLO-316
showed early anti-tumor activity with deepening responses over
time. The data reported to date is primarily from the DL1 and DL2
cohorts.
Anti-tumor activity was primarily observed in patients with
tumors confirmed to express CD70 (N=10). Among 18 patients
evaluable for efficacy, the disease control rate (DCR) was 89%. In
the 10 patients whose tumors were known to express CD70, the
disease control rate was 100%, which included three patients who
achieved partial remission (two confirmed, one unconfirmed). The
longest response lasted until month eight. There was a trend toward
greater tumor shrinkage in patients with higher levels of CD70
expression.
In patients evaluable for safety (N=19), ALLO-316 demonstrated
an adverse event profile generally consistent with autologous CAR T
therapies. One dose-limiting toxicity of Grade 3 autoimmune
hepatitis occurred in the second dose level. Cytokine release
syndrome (CRS) was all low-grade with the exception of one Grade 3.
Neurotoxicity, which is now defined more broadly, was generally low
grade and reversible with most events being fatigue or headache.
There were no cases of immune effector cell-associated
neurotoxicity syndrome (ICANS). Infections occurred in eight
patients of which four were Grade 3+ including one Grade 5
respiratory failure due to Covid-19 infection deemed unrelated to
study treatment. Grade 3+ prolonged cytopenia was observed in three
patients (16%). There were no cases of graft-versus-host disease
(GvHD).
The Dagger™ technology, which is a feature of ALLO-316, is
designed to resist rejection of AlloCAR T cells by the host immune
cells, thereby supporting expansion and enabling a prolonged window
of persistence during which AlloCAR T cells can target and destroy
cancer cells. Initial translational data from the TRAVERSE trial
demonstrates the suppression of CD70 positive, alloreactive host T
cells and marked peak expansion of ALLO-316 despite the relatively
low cell doses tested. The Company plans to deploy Dagger
technology to potentially enhance the persistence and activity of
next generation AlloCAR T products, including those that target
other hematological and solid tumors.
The Company has deployed a new investigational in vitro
companion diagnostic (IVD) assay designed to prospectively assess
CD70 expression levels to enhance patient selection. Dose
escalation in the TRAVERSE trial is expected to be completed in
2023.
ALLO-715: Anti-BCMA AlloCAR T Program During
the quarter, data from the Phase 1 UNIVERSAL trial with ALLO-715
for the treatment of r/r multiple myeloma (MM) was published
in Nature Medicine. UNIVERSAL is the first allogeneic
anti-BCMA CAR T to demonstrate proof-of-concept in MM with response
rates that are similar to an approved autologous CAR T therapy. The
Company is evaluating manufacturing processes improvements across
its BCMA candidates to achieve optimal performance.
Corporate UpdatesIn April, it was announced
that Timothy Moore had been appointed as Executive Vice President,
Chief Technical Officer. The appointment of Mr. Moore, an industry
pioneer responsible for the global development of two of the most
commercially successful autologous CAR T manufacturing processes,
reinforces the Company’s focus on being the first to bring an
AlloCAR T product to market.
First Quarter Financial Results
- Research and development expenses were $80.2 million for the
first quarter of 2023, which includes $9.2 million of non-cash
stock-based compensation expense.
- General and administrative expenses were $18.9 million for the
first quarter of 2023, which includes $9.6 million of non-cash
stock-based compensation expense.
- Net loss for the first quarter of 2023 was $98.7 million, or
$0.68 per share, including non-cash stock-based compensation
expense of $18.8 million.
- The Company had $514 million in cash, cash equivalents, and
investments as of March 31, 2023.
2023 Financial Guidance
- The Company now expects a decrease in cash, cash equivalents,
and investments of approximately $230 million in 2023. Based
on current expectation, the Company expects its cash runway to be
sufficient to fund operations into Q2 2025. GAAP Operating Expenses
are expected to be approximately $340 million, including estimated
non-cash stock-based compensation expense of approximately $80
million. These estimates exclude any impact from potential 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. If you would like the option to ask
a question on the conference call, please use this
link to register. Upon registering for the conference
call, you will receive a personal PIN to access the call, which
will identify you as the participant and allow you the option to
ask a question. The listen-only 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™) products
for cancer. Led by a management team with significant experience in
cell therapy, Allogene is developing a pipeline of “off-the-shelf”
CAR T product 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
StatementsThis 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," “projects,”
"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: ALPHA2 being a
potentially pivotal trial; expected enrollment and related
timelines; the expected timing to complete dose escalation; the
potential of an allogeneic CAR T product to treat CD70 express RCC
based on emerging data; study design; the timing and ability to
progress the ALPHA2 and TRAVERSE trials; clinical outcomes, which
may materially change as more patient data become available; ; the
ability to achieve optimal clinical performance through
manufacturing processes improvements; the design and potential
benefits of our Dagger technology, including its ability to resist
rejection of AlloCAR T cells by the host immune cells and the
expected benefits therefrom, and our plans to deploy Dagger
technology; the potential for our product candidates to be
approved; the potential benefits of AlloCAR T products and 2023
financial guidance. Various factors may cause material differences
between Allogene’s expectations and actual results, including,
risks and uncertainties related to: our product candidates are
based on novel technologies, which makes it difficult to predict
the time and cost of product candidate development and obtaining
regulatory approval; Servier’s discontinuation of its involvement
in the development of all CD19 products pursuant to our Exclusive
License and Collaboration Agreement and our disputes with Servier
may have adverse consequences; the limited nature of our Phase 1
data from our clinical trials and the extent to which such data may
or may not be validated in any future clinical trial; our ability
to maintain intellectual property rights necessary for the
continued development of our product candidates, including pursuant
to our license agreements; our product candidates may cause
undesirable side effects or have other properties that could halt
their clinical development, prevent their regulatory approval or
limit their commercial potential; the extent to which COVID-19
adversely impacts our business, including our preclinical studies
and clinical trials; the extent to which the Food and Drug
Administration disagrees with our clinical or regulatory plans or
the import of our clinical results, which could cause future delays
to our clinical trials or require additional clinical trials; we
may encounter difficulties enrolling patients in our clinical
trials; we may not be able to demonstrate the safety and efficacy
of our product candidates in our clinical trials, which could
prevent or delay regulatory approval and commercialization;
challenges with manufacturing or optimizing manufacturing of our
product candidates; and our ability to obtain additional financing
to develop our products and implement our operating plans. These
and other risks are discussed in greater detail in Allogene’s
filings with the SEC, including without limitation under the
“Risk Factors” heading in its Annual Report on Form 10-K for the
year ended December 31, 2022, and in its Quarterly Report on Form
10-Q for the quarter ended March 31, 2023, being filed with
the SEC today. 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.
Caution should be exercised regarding statements comparing
autologous CAR T data. There are differences in the clinical trial
design, patient populations, published data, follow-up times 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 Dagger™ are trademarks of Allogene
Therapeutics, Inc.
Allogene’s AlloCAR T™ programs utilize Cellectis technologies.
ALLO-501 and ALLO-501A are anti-CD19 products being jointly
developed under a collaboration agreement between Servier 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. The anti-BCMA and anti-CD70 AlloCAR T
programs are licensed exclusively from Cellectis by Allogene and
Allogene holds global development and commercial rights to these
AlloCAR T programs.
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
2022 |
Collaboration revenue -
related party |
$ |
52 |
|
$ |
61 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
80,238 |
|
$ |
60,156 |
General and administrative |
|
18,884 |
|
|
19,897 |
Total operating expenses |
|
99,122 |
|
|
80,053 |
Loss from operations |
|
(99,070) |
|
|
(79,992) |
Other income (expense),
net: |
|
|
|
|
|
Interest and other income, net |
|
2,059 |
|
|
492 |
Other expenses |
|
(1,693) |
|
|
(350) |
Total other income (expense),
net |
|
366 |
|
|
142 |
Net loss |
|
(98,704) |
|
|
(79,850) |
Net loss per share, basic and
diluted |
$ |
(0.68) |
|
$ |
(0.56) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
144,563,829 |
|
|
141,356,306 |
SELECTED BALANCE SHEET DATA |
|
|
As of March 31, 2023 |
|
As of December 31, 2022 |
Cash, cash equivalents and
investments |
$ |
514,012 |
|
$ |
576,471 |
Total assets |
|
746,871 |
|
|
817,079 |
Total liabilities |
|
154,609 |
|
|
151,209 |
Total stockholders’
equity |
|
592,262 |
|
|
665,870 |
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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