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 corporate updates and reported financial results for the
quarter ended March 31, 2024.
“We are very proud of the progress we’ve made across our
portfolio, in particular the transformative potential of our
pivotal ALPHA3 trial with cema-cel which is expected to readout in
2026. Securing the EU and UK rights reinforces our conviction in
the cema-cel program,” said David Chang, M.D., Ph.D., President,
Chief Executive Officer and Co-Founder of Allogene. “We will
continue to focus all of our resources on advancing these core
programs and believe we are well-positioned to change the CAR T
treatment landscape for the benefit of patients.”
Key Corporate Updates
Expansion of CD19 Oncology Program RightsThe
Company has obtained development and commercialization
oncology rights to all EU Member States and the United Kingdom
(Extended Territory) for its CD19-directed allogeneic cell therapy
products from Servier.
These new expanded rights, combined with the U.S. rights already
owned by the Company, substantially increase the potential total
market opportunity from more than $6 billion in the U.S. alone to
more than $9.5 billion in the combined U.S. and Extended Territory.
It is expected that the future multibillion-dollar revenue
potential for cema-cel now could increase by 50% with these
expanded rights. The Company also has the ability
to obtain the development and commercialization rights for
cema-cel in Japan and China in the future at no additional cost,
subject to Allogene demonstrating the resources to pursue those
markets.
Program Updates
Cema-Cel: Pivotal Phase 2 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 at risk of relapse following 1L
chemoimmunotherapy. 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.
This innovative trial will identify patients at high risk for
relapse after 1L treatment by utilizing a novel and highly accurate
test for minimal residual disease, or MRD. This investigational
test is being developed by our partners Foresight Diagnostics and
aims to offers improved prediction over existing methods for future
relapse after completion of 1L treatment. ALPHA3 takes advantage of
the allogeneic attributes of cema-cel. With off-the-shelf
availability and convenience, cema-cel will be administered as a
one-time infusion immediately upon detection of MRD at the
completion of six cycles of R-CHOP or other standard 1L
chemoimmunotherapy regimen. The outcome of this consolidation
treatment could potentially 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.
Start-up activities for the ALPHA3 trial are ongoing with a
planned study initiation in mid-2024. This randomized study will
enroll approximately 240 patients and is designed to demonstrate a
meaningful improvement in event free survival (EFS) in patients
treated with cema-cel relative to patients who receive the current
standard of care (observation). Efficacy analyses are expected
to occur in 2026 and will include the Independent Data Safety
Monitoring Board (IDSMB) interim EFS analysis in 1H 2026 and
the data readout of the primary EFS analysis in 2H 2026 with a
Biologics License Application (BLA) submission targeted for
2027.
Cema-Cel: Phase 1 Trial in Chronic Lymphocytic Leukemia
(CLL)Enrollment is ongoing in the relapsed/refractory
(r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel. While
recent approval of an autologous CD19 CAR T therapy has been a
positive step for patients with 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. 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 the Phase 1 ALPHA2 CLL cohort (n=12)
is projected by year-end 2024 with a Phase 2 pivotal study expected
in 2025.
ALLO-329: CD19/CD70 Dual CAR with
Dagger® Technology 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
could sustain the scale of the AID market while also meeting the
unique requirements for these patients.
ALLO-329, the Company’s CRISPR-based AlloCAR T™
investigational product for AID, incorporates the Dagger®
technology which is intended to eliminate the need for
lymphodepletion while targeting CD19+ B-cells and CD70+ activated
T-cells, both of which are likely to play a role in AID.
The Company plans to file an Investigational New Drug (IND)
application in Q1 2025 and expects to have proof-of-concept by YE
2025.
ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma
(RCC)
In April 2024, the Company announced a $15 million grant from
the California Institute for Regenerative Medicine (CIRM) to
support the ongoing TRAVERSE trial with ALLO-316 in RCC.
The Company has developed and implemented a diagnostic and
treatment algorithm in the TRAVERSE trial that may mitigate the
treatment-associated hyperinflammatory response without
compromising the CAR T function needed to eradicate solid tumors.
This builds upon the field’s understanding of how certain drugs can
act as a “safety key” to mitigate hyperinflammatory response
without compromising CAR T function or efficacy.
Details on this potentially cornerstone discovery in the Phase 1
TRAVERSE trial are planned for release Q2 2024. A Phase 1
data update from approximately 20 patients with CD70 positive RCC
is planned by YE 2024.
2024 First Quarter Financial Results
- Research and development expenses were $52.3
million for the first quarter of 2024, which
includes $3.8 million of non-cash stock-based
compensation expense.
- General and administrative expenses were $17.3
million for the first quarter of 2024, which
includes $8.1 million of non-cash stock-based
compensation expense.
- Net loss for the first quarter of 2024 was $65.0 million,
or $0.38 per share, including non-cash stock-based
compensation expense of $11.9 million.
- The Company had $397.3 million in cash, cash equivalents, and
investments as of March 31, 2024.
Based on the cash runway as of March 31, 2024, the Company
expects its cash runway to fund operations into 2026. The Company
expects a decrease in cash, cash equivalents, and investments of
approximately $200 million in 2024. GAAP Operating Expenses are
expected to be approximately $300 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 Cemacabtagene Ansegedleucel (Previously Known as
ALLO-501A)Cemacabtagene ansegedleucel, or cema-cel is a
next generation anti-CD19 AlloCAR T™ investigational product for
the treatment of large B cell lymphoma (LBCL). The ALPHA3 pivotal
Phase 2 trial in first line (1L) consolidation for the treatment of
LBCL is expected to begin mid-2024. In June 2022,
the U.S. Food and Drug Administration granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
cema-cel in third line (3L) r/r LBCL.
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
on X (formerly Twitter) and @AllogeneTherapeutics on 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," “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: Allogene's belief that it is well-positioned to change the
CAR T treatment landscape; the potential market opportunity for
Allogene’s product candidates; the potential to boost the curative
potential of CAR T; 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; 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; 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 TTM 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; 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 Securities and
Exchange Commission (SEC), including without limitation under the
“Risk Factors” heading in its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2024 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. These products are developed based on an
exclusive license granted by Cellectis to Servier. Servier, which
has an exclusive license to the anti-CD19 AlloCAR T™
investigational products from Cellectis, has granted Allogene
exclusive rights to these products in the U.S., all EU Member
States and the United Kingdom. The anti-CD70 AlloCAR T™ program is
licensed exclusively from Cellectis by Allogene and Allogene holds
global development and commercial rights to this AlloCAR
T™ program.
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS |
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue -
related party |
$ |
22 |
|
|
$ |
30 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
52,259 |
|
|
$ |
80,238 |
|
General and administrative |
|
17,267 |
|
|
|
18,884 |
|
Total operating expenses |
|
69,526 |
|
|
|
99,122 |
|
Loss from operations |
|
(69,504 |
) |
|
|
(99,092 |
) |
Other income (expense),
net: |
|
|
|
Interest and other income, net |
|
5,433 |
|
|
|
2,059 |
|
Other expenses |
|
(929 |
) |
|
|
(2,935 |
) |
Total other income (expense),
net |
|
4,504 |
|
|
|
(876 |
) |
Net loss |
|
(65,000 |
) |
|
|
(99,968 |
) |
Net loss per share, basic and
diluted |
$ |
(0.38 |
) |
|
$ |
(0.69 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
169,128,362 |
|
|
|
144,563,829 |
|
SELECTED BALANCE SHEET DATA |
|
As of March 31, 2024 |
|
As of December 31, 2023 |
Cash, cash equivalents and investments |
$ |
397,265 |
|
$ |
448,697 |
Total assets |
|
586,350 |
|
|
642,837 |
Total liabilities |
|
124,983 |
|
|
130,604 |
Total stockholders’
equity |
|
461,367 |
|
|
512,233 |
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Allogene Therapeutics (NASDAQ:ALLO)
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