Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer and autoimmune disease, today
provided a corporate update and reported financial results for the
quarter and year ended December 31, 2023.
“We are more enthusiastic than ever about the potential for
allogeneic CAR T to transform the field,” said David Chang, M.D.,
Ph.D., President, Chief Executive Officer and Co-Founder of
Allogene. “From our innovative ALPHA3 trial which is designed to
embed cema-cel as part of a curative first-line regimen for
patients with large B cell lymphoma, to specifically creating a CAR
T that can meet the unique needs of patients with autoimmune
disease and reduce reliance on lymphodepletion, our development
approach focuses on the distinctive attributes of an off-the-shelf
alternative and creates an advantage for our AlloCAR T™
programs.”
Core Program Updates
Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in Large
B Cell Lymphoma (LBCL)The Company continues to focus on
the development of its investigational product cemacabtagene
ansegedleucel, or cema-cel (previously known as ALLO-501A) as part
of the first line (1L) treatment plan for LBCL patients who are
likely to relapse following 1L chemoimmunotherapy.
This innovative trial takes advantage of the unique attributes
of cema-cel, the only allogeneic cell therapy product with Phase 1
data comparable to that of an autologous therapy. With
off-the-shelf availability and convenience, cema-cel will be
administered as a one-time infusion immediately upon detection of
minimal residual disease (MRD) at the completion of six cycles of
R-CHOP or equivalent 1L chemoimmunotherapy. The potential outcome
of this consolidation treatment could improve the cure rate and
uniquely position cema-cel to become the standard “7th cycle” of
frontline treatment available to all eligible patients with
MRD.
The design of the ALPHA3 1L consolidation trial builds upon the
results demonstrated in the cema-cel Phase 1 ALPHA2 trial and will
leverage an investigational, cutting-edge diagnostic test for MRD
developed by Foresight Diagnostics. ALPHA3 will randomize
approximately 230 patients who are in clinical remission but remain
MRD positive at the end of standard 1L chemoimmunotherapy to either
consolidation with cema-cel or the current standard of care,
observation, which means to “watch and wait” for the disease to
relapse. The primary endpoint of the ALPHA3 trial is event free
survival (EFS). The trial will initially test two lymphodepletion
regimens (one with standard fludarabine and cyclophosphamide plus
ALLO-647 and one without ALLO-647). One lymphodepletion arm will be
discontinued following a planned interim analysis in mid-2025
designed to select the most appropriate regimen for this patient
population.
Start-up activities for the ALPHA3 trial are underway and the
trial is expected to begin in mid-2024. The ALPHA3 trial will be
conducted in a wide array of cancer treatment centers, including
community cancer centers where most earlier line patients seek
care.
Cema-Cel: Phase 1 ALPHA2 Trial in Chronic Lymphocytic
Leukemia (CLL)In the first quarter, the Company began
enrollment in the ALPHA2 trial of the investigational product
cema-cel in patients with relapsed/refractory (r/r) CLL. While
recent autologous CD19 CAR T data has been a positive step for
patients with relapsed/refractory (r/r) CLL, T cell dysfunction and
high circulating leukemia burden often found in patients with CLL,
make the isolation of functional T cells for autologous CAR T
manufacturing difficult. As a result, this trial has been driven by
investigator enthusiasm for an allogeneic CAR T to potentially
boost the curative power of CAR T.
Initial data readout from Phase 1 ALPHA2 CLL cohort (n=12) is
projected by year-end 2024.
ALLO-329: CD19 Dagger®
in Autoimmune Disease (AID)The Company has applied
its deep understanding of CAR T research and development to design
next-generation allogeneic CAR T investigational products that the
Company believes can sustain the scale of the AID market while also
meeting the unique requirements for these patients where they seek
care.
ALLO-329, the Company’s first AlloCAR T investigational product
for AID, incorporates the Dagger® technology which is intended to
reduce or eliminate the need for lymphodepletion while targeting
CD19+ B-cells and CD70+ activated T-cells, both of which play a
role in AID.
As part of its overarching AID 2.0 platform, the Company also
announced a non-exclusive, global gene editing licensing agreement
with Arbor Biotechnologies, Inc. for use of their proprietary
CRISPR-based gene-editing technology.
ALLO-329 is expected to enter Phase 1 clinical trials in early
2025.
ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma
(RCC)Building upon the field’s understanding of how
certain drugs can act as a “safety key” to mitigate
treatment-associated adverse events without compromising CAR T
function or efficacy, the Company has developed and implemented a
diagnostic and treatment algorithm in its solid tumor trial that
may mitigate the treatment-associated hyperinflammatory response
without compromising the CAR T function needed to eradicate solid
tumors with ALLO-316 in renal cell carcinoma (RCC).
Details on this potentially cornerstone discovery in the Phase 1
TRAVERSE trial is planned for a publication in Q2 2024. A more
comprehensive data update from the ongoing trial with the updated
protocol is planned for later in 2024.
Financial UpdatesAs noted in the February 16,
2024 press release, the Company has now issued restated financials
for the years ended December 31, 2020, 2021 and 2022 and interim
quarters during 2022 and 2023 due to non-cash accounting
adjustments associated with the December 2020 formation of the
Allogene Overland Biopharm joint venture in Asia. These restated
financial statements have no impact on the Company’s cash, cash
equivalents and marketable investments, cash runway or business
operations.
2023 Fourth Quarter and Year-End Financial
Results
- Research and development expenses were $54.7
million for the fourth quarter of 2023, which
includes $7.0 million of non-cash stock-based
compensation expense. For the full year of 2023, research and
development expenses were $242.9 million, which includes $31.9
million of non-cash stock-based compensation expense.
- General and administrative expenses were $17.2
million for the fourth quarter of 2023, which
includes $8.2 million of non-cash stock-based
compensation expense. For the full year of 2023, general and
administrative expenses were $71.7 million, which includes $34.0
million of non-cash stock-based compensation expense.
- Net loss for the fourth quarter of 2023 was $85.8 million,
or $0.51 per share, including non-cash stock-based
compensation expense of $15.2 million and $13.2 million in
non-cash impairment of long-lived asset expense. For the full year
of 2023, net loss was $327.3 million, or $2.09 per share, including
non-cash stock-based compensation expense of $66.0 million and
$13.2 million in non-cash impairment of long-lived asset
expense.
- The Company had $448.7 million in cash, cash equivalents, and
investments as of December 31, 2023.
2024 Financial GuidanceThe Company expects a
decrease in cash, cash equivalents, and investments of
approximately $190 million in 2024. Based on current
assumptions, the Company continues to expect its cash runway to
fund operations into 2026. GAAP Operating Expenses are expected to
be approximately $280 million, including estimated non-cash
stock-based compensation expense of approximately $60 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 and autoimmune disease. Led by a management team with
significant experience in cell therapy, Allogene is developing a
pipeline of “off-the-shelf” CAR T cell 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.
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," "designed to, " "can,
", "become," "build, " "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: ALPHA3 being a pivotal trial; the design of
ALPHA3; the potential of ALPHA3 to be administered as a one-time
infusion; the potential for cema-cel to become the standard of
frontline treatment available to eligible patients with MRD; the
potential for ALPHA3 to improve cure rates; plans to administer
cema-cel in community cancer centers in the ALPHA3 trial; use of a
Foresight Diagnostics test in ALPHA3 and its anticipated
sensitivity; the potential for cema-cel’s safety profile to further
improve in patients with no radiological evidence of disease; the
potential outcomes of ALPHA3; the pace, timing and extent to which
we may initiate or enroll patients in our clinical trials or
release data from such trials including ALPHA2, ALPHA3,
ALLO-329, and TRAVERSE trials; statements related to ALPHA2,
including expected enrollment timing, expected timing for data, the
potential to isolate functional T cells in manufacturing allogeneic
CAR T less difficult, and the potential to boost the curative
potential of CAR T; clinical outcomes, which may materially change
as more patient data become available; the design and potential
benefits of our Dagger® technology including the ability to
reduce or eliminate the need for lymphodepletion, and the expected
benefits therefrom, to treat autoimmune disease, and our plans
to deploy the Dagger® technology; the potential for our
product candidates to be approved; the potential benefits
of AlloCAR T™ products; the ability of our product
candidates to treat various stages and types of cancers including
hematological and solid tumors or to treat autoimmune disease; the
potential ability of our diagnostic and treatment algorithm to
address emerging safety findings or mitigate treatment-associated
hyperinflammatory response without compromising CAR T function; our
expectation that our cash runway extends into 2026; financial
guidance for 2024; the modes of action or the biologic impacts
of our product candidates; the potential for off-the-shelf CAR T
products, including its potential to transform the field; and other
statements related to future events or conditions. Various factors
may cause material differences
between Allogene’s expectations and actual results,
including, risks and uncertainties related to: changes in the
macroeconomic environment or industry that impact our business;
competition; risks related to third-party performance; 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; the limited nature
of the 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; preliminary results may not be indicative of results that
may be observed in the future; 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 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,
including ALPHA2, ALPHA3, ALLO-329 and TRAVERSE trials; there is no
guarantee that Foresight will successfully develop an MRD assay for
use as a companion diagnostic with cema-cel, and without a
companion diagnostic the prospects for cema-cel could be materially
and negatively impacted; 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 or any companion diagnostic
for use with our product candidates; and our ability to obtain
additional financing to develop our product candidates 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, 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 investigational AlloCAR T™ oncology products utilize
Cellectis technologies. ALLO-501 and cemacabtagene ansegedleucel
(previously known as ALLO-501A) are anti-CD19 AlloCAR T™
investigational 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-CD70 AlloCAR T program is licensed exclusively from
Cellectis by Allogene and Allogene holds global development and
commercial rights to this AlloCAR TTM program.
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS |
|
|
Three Months Ended December 31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue -
related party |
$ |
21 |
|
|
$ |
26 |
|
|
$ |
95 |
|
|
$ |
156 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
54,661 |
|
|
|
75,419 |
|
|
|
242,914 |
|
|
|
256,387 |
|
General and administrative |
|
17,224 |
|
|
|
21,002 |
|
|
|
71,673 |
|
|
|
79,305 |
|
Impairment of long-lived asset |
|
13,245 |
|
|
|
- |
|
|
|
13,245 |
|
|
|
- |
|
Total operating expenses |
|
85,130 |
|
|
|
96,421 |
|
|
|
327,832 |
|
|
|
335,692 |
|
Loss from operations |
|
(85,109 |
) |
|
|
(96,395 |
) |
|
|
(327,737 |
) |
|
|
(335,536 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest and other income, net |
|
6,265 |
|
|
|
2,757 |
|
|
|
18,307 |
|
|
|
4,566 |
|
Other expenses |
|
(6,934 |
) |
|
|
(3,637 |
) |
|
|
(17,835 |
) |
|
|
(9,444 |
) |
Total other income (expense), net |
|
(669 |
) |
|
|
(880 |
) |
|
|
472 |
|
|
|
(4,878 |
) |
Net loss |
|
(85,778 |
) |
|
|
(97,275 |
) |
|
|
(327,265 |
) |
|
|
(340,414 |
) |
Net loss per share, basic and
diluted |
$ |
(0.51 |
) |
|
$ |
(0.67 |
) |
|
$ |
(2.09 |
) |
|
$ |
(2.38 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
168,335,828 |
|
|
|
144,149,240 |
|
|
|
156,931,778 |
|
|
|
143,147,165 |
|
SELECTED BALANCE SHEET DATA |
|
|
As of December 31, 2023 |
|
As of December 31, 2022 |
Cash, cash equivalents and investments |
$ |
448,697 |
|
$ |
576,471 |
Total assets |
|
642,837 |
|
|
821,579 |
Total liabilities |
|
130,604 |
|
|
154,697 |
Total stockholders’
equity |
|
512,233 |
|
|
666,882 |
|
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
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