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 June
30, 2023.
“The last few months have been exciting for cell therapy as the
transformative potential of an allogeneic CAR T product becomes
more evident. Within this framework, we are thrilled that our
off-the-shelf CD19 AlloCAR T data continues to demonstrate what I
believe to be both first-in-class and best-in class promise in
hematological cancers,” said David Chang, M.D., Ph.D., President,
Chief Executive Officer and Co-Founder of Allogene. “We remain
focused on advancing the industry’s first potentially pivotal
allogeneic CAR T trials in order to enable more patients to receive
cell therapy.”
Pipeline Updates
ALLO-501A: Anti-CD19 AlloCAR T Program The
Company is enrolling patients in the industry’s first potentially
pivotal Phase 2 allogeneic CAR T clinical trial with ALLO-501A
across sites in the United States and Canada. The European
Medicines Agency (EMA) recently approved the ALPHA2 Clinical Trial
Application (CTA) and patient enrollment in Europe is expected to
begin in Q3 2023 and in Australia by year-end.
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 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 with the first data readout by the
end of 2024.
Long-term follow up data from the Phase 1 ALPHA/ALPHA2 trials in
LBCL was presented at both the American Society of Clinical
Oncology (ASCO) Annual Meeting with an encore presentation at the
European Hematology Association Congress, and the International
Conference on Malignant Lymphoma (ICML) Lugano in June 2023. 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 allogeneic CAR T product to induce complete
responses at rates and durability similar to approved autologous
therapies. Treatment with ALLO-501/501A 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 is also underway to support licensure of
ALLO-647, the Company’s 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 to control premature rejection of AlloCAR T cells by the
patient’s immune system. At the ASCO and Lugano data presentations,
the Company’s proprietary lymphodepletion strategy was shown to
promote robust AlloCAR T cell expansion and best-in-class longest
persistence without incurring significant changes in infectious or
immunosuppressive complications as compared to autologous CAR T
therapies.
The EXPAND trial, which is designed to demonstrate the
contribution of ALLO-647 to the standard low dose FC
lymphodepletion, 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).
ALLO-316: Anti-CD70 AlloCAR T ProgramThe
ongoing Phase 1 dose escalation TRAVERSE study is enrolling
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. Initial data
from TRAVERSE were presented at the American Association of Cancer
Research (AACR) conference in April and 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 and a trend toward greater tumor
shrinkage in patients with higher levels of CD70 expression.
The Dagger™ effect, which is a feature of ALLO-316, enables
ALLO-316 CAR T cells to target and eliminate 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.
The TRAVERSE trial is now deploying an investigational in vitro
companion diagnostic (IVD) assay designed to prospectively assess
CD70 expression levels in patients. Dose escalation in the TRAVERSE
trial is expected to be completed in 2023.
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-715: Anti-BCMA AlloCAR T Program The
Company previously presented ALLO-715 Phase 1 data from the
UNIVERSAL trial which was the first study to demonstrate that an
allogeneic anti-BCMA CAR T could produce response rates in multiple
myeloma similar to an approved autologous CAR T therapy. As
treatments in multiple myeloma advance, the Company is evaluating
manufacturing process improvement across its BCMA candidates to
achieve an improved competitive profile.
Second Quarter Financial Results
- The Company had $544.5 million in cash, cash equivalents, and
investments as of June 30, 2023, which includes net proceeds of
approximately $87.9 million raised in the second quarter from an
at-the market (ATM) equity financing facility. Based on current
expectations, the Company expects its cash runway to fund
operations into 2H 2025.
- Research and development expenses were $62.0 million for the
second quarter of 2023, which includes $6.9 million of non-cash
stock-based compensation expense.
- General and administrative expenses were $18.5 million for the
second quarter of 2023, which includes $9.7 million of non-cash
stock-based compensation expense.
- Net loss for the second quarter of 2023 was $78.0 million, or
$0.53 per share, including non-cash stock-based compensation
expense of $16.6 million.
2023 Financial Guidance
- As previously reported, the Company expects a decrease in cash,
cash equivalents, and investments of approximately $230
million in 2023. 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, including expected cash runway. 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 June 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™ 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 June 30, |
|
2023 |
|
2022 |
Collaboration revenue - related party |
$ |
44 |
|
$ |
86 |
Operating expenses: |
|
|
|
Research and development |
$ |
62,038 |
|
$ |
57,171 |
General and administrative |
|
18,524 |
|
|
19,509 |
Total operating expenses |
|
80,562 |
|
|
76,680 |
Loss from operations |
|
(80,518) |
|
|
(76,594) |
Other income (expense),
net: |
|
|
|
Interest and other income, net |
|
3,778 |
|
|
315 |
Other income (expenses) |
|
(1,249) |
|
|
1,492 |
Total other income, net |
|
2,529 |
|
|
1,807 |
Net loss |
|
(77,989) |
|
|
(74,787) |
Net loss per share, basic and
diluted |
$ |
(0.53) |
|
$ |
(0.52) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
|
146,795,826 |
|
|
143,385,045 |
|
SELECTED BALANCE SHEET DATA |
|
|
As of June 30, 2023 |
|
As of December 31, 2022 |
Cash, cash equivalents and investments |
$ |
544,548 |
|
$ |
576,471 |
Total assets |
|
770,971 |
|
|
817,079 |
Total liabilities |
|
148,065 |
|
|
151,209 |
Total stockholders’
equity |
|
622,906 |
|
|
665,870 |
|
|
|
|
|
|
Allogene Media/Investor
Contact:Christine CassianoChief Communications
OfficerChristine.Cassiano@allogene.com
Allogene Therapeutics (NASDAQ:ALLO)
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