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 June 30, 2024.
“The second quarter has been an excellent example of the power
of momentum, particularly as we bring into the fold community
cancer centers who are eager to be a part of our pivotal Phase 2
ALPHA3 trial and we are now manufacturing all of our CAR T
investigational products in-house,” said David Chang, M.D., Ph.D.,
President, Chief Executive Officer and Co-Founder of Allogene.
“Beyond the progress we’ve seen across our four core programs with
cema-cel in blood cancers, ALLO-329 in autoimmune disease, and
ALLO-316 in relapsed and refractory renal cell carcinoma, there is
renewed energy from investigators, clinical trial sites, and
top-tier investors as it becomes increasingly apparent that we have
the potential to reshape the future of CAR T therapies.”
Program Updates
Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in Large
B Cell Lymphoma (LBCL)The pivotal Phase 2 ALPHA3 trial was
initiated in June 2024 and site activation is ahead of schedule
with ten community cancer and academic centers opened in less than
two months. Patient screening for minimal residual disease (MRD)
and enrollment are proceeding as planned.
This groundbreaking study is evaluating the use of cemacabtagene
ansegedleucel (cema-cel) as part of the first line (1L) treatment
regimen for patients with LBCL who are likely to relapse after
standard 1L treatment. ALPHA3 is the first pivotal trial to offer
CAR T as part of 1L treatment consolidation.
This innovative ALPHA3 trial will identify patients at high risk
for relapse after 1L treatment by utilizing the Foresight
CLARITY™ Investigational Use Only (IUO) MRD test, powered
by PhasED-Seq™. This randomized trial 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). ALPHA3 is expected to complete enrollment in 1H
2026. Efficacy analyses are expected to occur in 2026 and will
include an interim EFS analysis monitored by the independent Data
Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of
the primary EFS analysis YE 2026. A potential biologics license
application (BLA) submission is 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. Initial
data readout from the CLL cohort is projected by early 2025.
ALLO-329: CD19/CD70 Dual CAR with
Dagger® Technology in Autoimmune
Disease (AID)ALLO-329, the Company’s first CRISPR-based
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 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)A Phase 1 data update from approximately 20 patients
with CD70 positive RCC, which will include details on the
diagnostic and treatment algorithm used to mitigate
treatment-associated hyperinflammatory response seen in some
patients, is planned by YE 2024. In April 2024, the Company
announced a $15 million award from the California Institute for
Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial
with ALLO-316 in RCC.
2024 Second Quarter Financial Results
- Research and development expenses were $50.4
million for the second quarter of 2024, which
includes $5.3 million of non-cash stock-based
compensation expense.
- General and administrative expenses were $16.1
million for the second quarter of 2024, which
includes $8.2 million of non-cash stock-based
compensation expense.
- Net loss for the second quarter of 2024 was $66.4 million,
or $0.35 per share, including non-cash stock-based
compensation expense of $13.6 million and $5.0 million in
non-cash impairment of long-lived asset expense.
- The Company had $444.6 million in cash, cash equivalents, and
investments as of June 30, 2024.
Based on the cash runway as of June 30, 2024, the Company
continues to expect its cash runway to fund operations into the
second half of 2026. Guidance remains unchanged from the most
recent update with an expectation of 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 PM
PT/5:00 PM ET 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 Allogene
Therapeutics on X (formerly 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 “proceeding as planned,” “on
track,” “ahead,” “targeted,” “ongoing,” “likely to,” “believes,”
“potential,” “continue,” “estimates,” “expects,” “plans,”
“intends,” “designed to, “ “can, “, “become,” “may,” “could,”
“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 has the
potential to reshape the future of CAR T therapies; the potential
market opportunity for Allogene’s product candidates; ALPHA3 being
a pivotal trial; the design of ALPHA3; the potential of ALPHA3 to
be administered as part of 1L treatment consolidation; the
potential for cema-cel to become the part of the first line
treatment regimen available to patients with LBCL who are likely to
relapse after standard 1L treatment; 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 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; 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, including
manufacturing our CAR T product candidates in-house, 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 June 30, 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.CLARITY™ and PhasED-Seq™ are trademarks of
Foresight Diagnostics.
Allogene’s investigational AlloCAR T™ oncology products utilize
Cellectis technologies. The anti-CD19 oncology 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. ALLO-329 (CD19/CD70) in autoimmune disease uses
CRISPR gene-editing technology.
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
STATEMENTS OF OPERATIONS |
|
|
Three Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue -
related party |
$ |
— |
|
|
$ |
22 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
50,355 |
|
|
$ |
62,038 |
|
General and administrative |
|
16,087 |
|
|
|
18,524 |
|
|
|
|
|
|
|
|
|
Impairment of long-lived assets |
|
4,989 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
71,431 |
|
|
|
80,562 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(71,431 |
) |
|
|
(80,540 |
) |
Other income (expense),
net: |
|
|
|
Interest and other income, net |
|
4,988 |
|
|
|
3,778 |
|
Other income and expense, net |
|
85 |
|
|
|
(2,470 |
) |
Total
other income (expense), net |
|
5,073 |
|
|
|
1,308 |
|
|
|
|
|
|
|
|
|
Net loss |
|
(66,358 |
) |
|
|
(79,232 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.35 |
) |
|
$ |
(0.54 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
190,026,638 |
|
|
|
146,795,826 |
|
SELECTED BALANCE SHEET DATA |
|
|
As of June 30, 2024 |
|
As of December 31, 2023 |
Cash, cash equivalents and investments |
$ |
444,628 |
|
|
$ |
448,697 |
|
|
|
|
|
|
|
|
|
Total assets |
|
646,883 |
|
|
|
642,837 |
|
Total liabilities |
|
131,845 |
|
|
|
130,604 |
|
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
515,038 |
|
|
|
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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