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
September 30, 2023.
“Our experience continues to deepen as we successfully execute
across our platform, creating a code for allogeneic cell therapy
that can be applied not just in the industry’s first potentially
pivotal trial of an allogeneic CAR T product candidate, but in
other harder modes such as earlier line trials, solid tumors, and
next-generation products and indications,” said David Chang, M.D.,
Ph.D., President, Chief Executive Officer and Co-Founder of
Allogene. “We look forward to the months ahead and sharing these
insights, potentially unlocking new opportunities and broadening
patient access to CAR T therapy.”
Pipeline Updates
Anti-CD19 AlloCAR T Program ALPHA2 is the
industry’s first potentially pivotal Phase 2 allogeneic CAR T
clinical trial. This global trial for the ALLO-501A product
candidate will enroll approximately 100 patients who have received
at least two prior lines of therapy and have not received prior
anti-CD19 therapy.
The single-arm ALPHA2 trial in relapsed/refractory (R/R) large B
cell lymphoma (LBCL) utilizes a single dose of ALLO-501A (120
million CAR+ cells) following lymphodepletion with FCA90
(fludarabine, 30 mg/m2; cyclophosphamide 300 mg/m2; and
investigational ALLO-647 30 mg, daily for 3 days). 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.
Enrollment is expected to be completed by the 1H 2024 with the
first data readout by the end of 2024.
The Company announced it will have two poster presentations from
the ALPHA/ALPHA2 trials focused on lymphodepletion in allogeneic
cell therapy at the 65th Annual Meeting of the American Society of
Hematology (ASH) December 2023.
The first poster is a comprehensive safety review of all 85
patients treated in the Phase 1 ALPHA/ALPHA2 studies in
relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and
follicular lymphoma (FL) to characterize the overall safety profile
when ALLO-647 is added to standard lymphodepletion.
The second poster showcases translational results from ALPHA2
generated through a collaboration with The University of Texas MD
Anderson Cancer Center. This study compared expansion kinetics
among 11 allogeneic CAR T recipients treated with the ALLO-501A
product candidate in the ALPHA2 trial. The study revealed the
impact of recipient alloreactive CD8+ T cells in allogeneic CAR T
rejection. Results of this study could help define strategies to
improve allogeneic CAR T expansion, persistence and efficacy.
Long-term follow up data was previously presented from the Phase
1 ALPHA/ALPHA2 trials in LBCL and has been extensively
characterized in presentations earlier this year at the American
Society of Clinical Oncology (ASCO) Annual Meeting, European
Hematology Association Congress, and International Conference on
Malignant Lymphoma (ICML) in Lugano.
The Phase 1 trials enrolled heavily pre-treated patients with a
median of three prior lines of therapy. Data from 33 CAR T-naïve
LBCL patients receiving Alloy™ cell product, including 12 patients
treated with the Phase 2 regimen, are the first to demonstrate the
potential for an investigational allogeneic CAR T product to induce
complete responses at rates and durability similar to approved
autologous therapies. Treatment with the ALLO-501/501A product
candidates was generally well tolerated with no incidence of Grade
3 or greater cytokine release syndrome, and no cases of immune
effector cell-associated neurotoxicity syndrome or graft versus
host disease. Cytopenia and infections were manageable and
comparable to the experience with autologous CAR T cell therapies
in patients with r/r LBCL.
The EXPAND trial, enrolling in the United States and Europe, is
expected to support licensure of ALLO-647, the Company’s
investigational anti-CD52 monoclonal antibody used in conjunction
with standard low-dose FC (fludarabine, 30 mg/m2 and
cyclophosphamide 300 mg/m2, daily for 3 days) lymphodepletion
regimens. The trial will enroll approximately 70 patients with r/r
LBCL who will be randomized to lymphodepletion with FCA90 (which
includes 90 mg of ALLO-647) versus FC alone before receiving a
single 120 million cell dose of ALLO-501A. The primary endpoint of
the study is progression free survival (PFS).
Anti-CD70 AlloCAR T ProgramThe Phase 1 dose
escalation TRAVERSE trial in patients with advanced or metastatic
renal cell carcinoma (RCC) who have progressed on standard
therapies including an immune checkpoint inhibitor and a
VEGF-targeting therapy is ongoing. Dose escalation in the
TRAVERSE trial is expected to be completed by early 2024. The
Company intends to target an academic forum in early 2024 to
provide an update from this trial.
Next Generation Technologies and Targets
Cloak™ and Dagger™ Platform Technologies
The Company recently announced three poster presentations from
its next generation AlloCAR T Platform at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting. The meeting will
spotlight its novel, targeted Cloak and Dagger platform
technologies designed to enhance engraftment, expansion and
persistence of AlloCAR T cells.
These innovative approaches are intended to simplify
lymphodepletion for allogeneic CAR T products and may provide a
path to further expand the potential of off-the-shelf CAR T
products beyond current targets and indications.
The Cloak platform technology is designed to prevent AlloCAR T
cells from being recognized by host T cells without triggering
substantial natural killer (NK) cell rejection while preserving CAR
T cell function.
The Dagger™ platform technology, a feature of our ALLO-316
candidate, is designed to engineer AlloCAR T cells to selectively
eliminate CD70 positive, alloreactive host immune cells, thereby
mitigating potential premature rejection of AlloCAR T cells by the
patient’s immune system. Translational results shared at AACR
suggest this unique immunomodulatory effect of ALLO-316 contributed
to robust AlloCAR T cell expansion and persistence, and clinical
remissions.
Based on preclinical results demonstrating the ability to
combine anti-CD19 and other AlloCARs™ with the Dagger technology,
the Company intends to explore this approach to potentially enhance
the activity of next generation AlloCAR T products candidates,
including those that target other hematological and solid
tumors.
ALLO-182
SITC will also include a review of research which provided early
validation of ALLO-182, an AlloCAR T candidate currently in the
IND-enabling phase of development targeting Claudin18.2 for the
treatment of patients with gastric and pancreatic cancers.
Corporate UpdatesThe Company has recently
announced two new appointments to the leadership team. In August,
the Company announced Earl Douglas as General Counsel, overseeing
all aspects of the Company’s legal function. Following the close of
the third quarter, the Company announced Geoffrey Parker as
Executive Vice President, Chief Financial Officer, overseeing the
Company’s financial operations and business development
activities.
Third Quarter Financial Results
- The Company had $497.7 million in cash, cash equivalents, and
investments as of September 30, 2023.
- Research and development expenses were $46.0 million for the
third quarter of 2023, which includes $6.7 million of non-cash
stock-based compensation expense.
- General and administrative expenses were $17.0 million for the
third quarter of 2023, which includes $8.6 million of non-cash
stock-based compensation expense.
- Net loss for the third quarter of 2023 was $61.3 million, or
$0.37 per share, including non-cash stock-based compensation
expense of $15.4 million.
2023 Financial Guidance
- As previously provided, the Company expects a decrease in cash,
cash equivalents, and investments of approximately $230
million in 2023. Based on current assumptions, the Company
continues to expect its cash runway to fund operations into 2H
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 X (formerly 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," “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; the
pace, timing and extent to which we may enroll patients in our
clinical trials or release data from such trials; the timing and
ability to progress the ALPHA2 and TRAVERSE trials; clinical
outcomes, which may materially change as more patient data become
available; the design and potential benefits of our Cloak ™ and
Dagger™ technologies including the ability to enhance engraftment,
expansion and persistence of AlloCAR T cells or the ability to
resist rejection of AlloCAR T cells by the host immune cells and
the expected benefits therefrom, and our plans to deploy Cloak ™
and Dagger™ technologies; 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 gastric and
pancreatic cancers; our level of operating expenses and the extent
of our cash runway; our ability to expand indications for our
allogeneic CAR T product candidates; our ability to broaden patient
access to CAR T therapy; the modes of action or the biologic
impacts of our product candidates including the engraftment,
expansion, persistence and efficacy of allogeneic CAR T cells, the
ability of AlloCAR T cells from being recognized by host T cells
without triggering an immune response, and the ability to
selectively eliminate CD70 positive alloreactive host immune cells;
the incidence, severity and manageability of side effects of
allogeneic CAR T therapies; the extent to which our clinical trials
will support regulatory approval of our product candidates; the
extent to which and type of lymphodepletion strategies that may be
required in conjunction with our product candidates; the potential
for off-the-shelf CAR T products; our ability to deliver cell
therapy on-demand, more reliably, and at greater scale to more
patients. 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 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 September 30, 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™, AlloCAR™, Cloak™ 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-CD70 and anti-Claudin18.2
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 September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue -
related party |
$ |
43 |
|
|
$ |
49 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
45,977 |
|
|
$ |
63,641 |
|
General and administrative |
|
17,041 |
|
|
|
18,897 |
|
Total operating expenses |
|
63,018 |
|
|
|
82,538 |
|
Loss from operations |
|
(62,975 |
) |
|
|
(82,489 |
) |
Other income (expense),
net: |
|
|
|
Interest and other income, net |
|
6,205 |
|
|
|
1,002 |
|
Other expenses |
|
(4,545 |
) |
|
|
(1,661 |
) |
Total other income (expense),
net |
|
1,660 |
|
|
|
(659 |
) |
Net loss |
|
(61,315 |
) |
|
|
(83,148 |
) |
Net loss per share, basic and
diluted |
$ |
(0.37 |
) |
|
$ |
(0.58 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
167,649,010 |
|
|
|
143,661,721 |
|
SELECTED BALANCE SHEET DATA
|
As of September 30, 2023 |
|
As of December 31, 2022 |
Cash, cash equivalents and
investments |
$ |
497,675 |
$ |
576,471 |
Total assets |
|
712,326 |
|
817,079 |
Total liabilities |
|
129,224 |
|
151,209 |
Total stockholders’
equity |
|
583,102 |
|
665,870 |
|
|
|
|
|
|
|
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Allogene Therapeutics (NASDAQ:ALLO)
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