Allogene Therapeutics Reports Third Quarter 2021 Financial Results and Business Update
November 04 2021 - 4:02PM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer, today provided a corporate
update and reported financial results for the quarter ended
September 30, 2021.
“While our clinical studies are on hold, our work to bring
AlloCAR T products to patients continues with a strong sense of
urgency. We remain confident in our platform and the potential of
our AlloCAR T candidates to meaningfully improve the lives of
patients living with cancer,” said David Chang, M.D., Ph.D.,
President, Chief Executive Officer and Co-Founder of Allogene. “Our
teams are busy progressing our preclinical programs, advancing
production at our Cell Forge 1 manufacturing facility, and
preparing for data presentations at the American Society of
Hematology (ASH) Annual Meeting in December. In the meantime, we
continue to work closely with the U.S. Food and Drug Administration
(FDA) on the review of the end of Phase 1 materials in support of a
pivotal trial for ALLO-501A as well as to resolve the clinical hold
and we look forward to providing an update after further
interaction with the agency.”
Pipeline Updates The FDA placed a hold on the
Company’s AlloCAR T clinical trials (ALPHA, ALPHA2, IGNITE,
TRAVERSE, UNIVERSAL) following a report of a chromosomal
abnormality in a single patient treated in the ALPHA2 study.
Allogene is working with the FDA to address next steps to resolve
the hold.
- In parallel with the clinical hold investigation, the FDA is
actively reviewing the end of Phase 1 materials the Company
submitted in support of the pivotal trial for ALLO-501A.
Anti-CD19 Program: ALPHA and ALPHA2 Trials
- Abstracts from the ALPHA (poster session) and ALPHA2 (oral
session) trials were selected for presentation at the ASH meeting
in early December. The data contained in the abstracts continue to
show the utility of AlloCAR T therapy in patients with
relapsed/refractory non-Hodgkin lymphoma. Updated results will be
presented at the meeting.
- In the ALPHA2 trial, consolidation dosing appeared to be well
tolerated with the potential for enhanced efficacy compared to a
single dose of ALLO-501A. In the consolidation cohort, both the
overall response rate (ORR) and complete response (CR) rate were
67% with all three partial responses (PRs) converting to CR
following consolidation. All four consolidation patients who
achieved a CR remained in CR as of the July 2021 data cut-off. The
safety profile of ALLO-501A was manageable in both single dose and
consolidation cohorts. Events of interest in the single dose cohort
were previously reported at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting. In the consolidation cohort, there
was no cytokine release syndrome (CRS), no graft-versus-host
disease (GvHD), no immune effector cell-associated neurotoxicity
syndrome (ICANS), no dose-limiting toxicities (DLTs), no dose
reductions, no Grade 3+ infections and infusion-related reactions
were Grade 2. Among all treated patients, cytopenias were the most
common adverse event and occurred in 72% of patients.
- In the ALPHA trial as of the July data cutoff for the ASH
abstract, five additional patients were treated relative to the
data previously reported at the 2021 ASCO Annual Meeting. ORR and
CR rates remain at 75% and 50%, respectively. In patients with LBCL
(n=13), the ORR was 62% and the CR rate was 46%. In patients with
FL (n=23), the ORR was 83% and the CR rate was 52%. Four of the
seven patients (all FL) enrolled in the consolidation cohort were
evaluable for assessment after consolidation dosing at the time of
the data cutoff with an ORR and CR rate of 100% and 75%,
respectively. The percent of patients remaining in CR at six months
following a single infusion was 36% in LBCL, which is similar to
6-month CR rates reported in the pivotal trials of autologous CAR T
therapies, with the longest ongoing CR at 15+ months, as of the
data cut-off. The 6-month CR rate in FL was 28%. No cases of GvHD
or DLTs were observed. As noted previously, one case of Grade 3
ICANS was reported. Grade 1/2 CRS occurred in 22% of patients with
one case of Grade 3 CRS. All were managed with standard protocols.
Cytopenias were the most common adverse event and occurred in 83%
of patients. Infection rates remained similar to those observed in
autologous CAR T trials.
Anti-BCMA AlloCAR T Program: UNIVERSAL
Trial
- In August, ALLO-715 received Orphan Drug Designation (ODD) from
the FDA for the treatment of multiple myeloma (MM).
- Updated results from the UNIVERSAL trial investigating ALLO-715
as a monotherapy in patients with relapsed/refractory MM will be
presented at an oral session at ASH. Findings from the UNIVERSAL
trial indicate an allogeneic CAR T therapy can be delivered rapidly
without the need for bridging therapy to patients with
relapsed/refractory multiple myeloma, with single dose of therapy
capable of inducing deep responses. The ORR was 62% with a very
good partial response or better (VGPR+) rate of 39% in the 26
patients treated at the highest two dose levels (320 and 480 x 106
CAR+ cells). Median follow-up for these patients was 7.4 months
with a median duration of response of 8.3 months. Of the 10
patients with a best response of VGPR+, eight were found to be
minimal residual disease (MRD) negative. No GvHD was observed. The
most common Grade 3+ adverse events included anemia, neutropenia,
lymphopenia, and thrombocytopenia. CRS was reported in 52% of
patients, in all cases Grade 1/2 except for one patient with Grade
3. One patient with Grade 2 CRS experienced Grade 1 neurotoxicity
that resolved. Grade 3+ infections occurred in 13% of patients,
including two previously reported Grade 5 events (fungal pneumonia
and adenovirus hepatitis).
Third Quarter Financial Results
- Research and development expenses were $58.7
million for the third quarter of 2021, which
includes $10.1 million of non-cash stock-based
compensation expense.
- General and administrative expenses were $19.0
million for the third quarter of 2021, which
includes $10.8 million of non-cash stock-based
compensation expense.
- Net loss for the third quarter of 2021 was $78.2 million,
or $0.57 per share, including non-cash stock-based
compensation expense of $20.9 million.
- The Company had $861.7 million in cash, cash equivalents, and
investments as of September 30, 2021.
2021 Financial Guidance
- Allogene continues to expect full year GAAP Operating Expenses
to be between $300 and $330 million including estimated non-cash
stock-based compensation expense of $80 to $90 million and
excluding 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. To access the live conference call
by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409)
216-0618 (International). The conference ID number for the live
call is 1924859. The 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™) therapies
for cancer. Led by a management team with significant experience in
cell therapy, Allogene is developing a pipeline of “off-the-shelf”
CAR T cell therapy 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," "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: the ability to progress the
Company’s clinical trials and present any data from the trials;
clinical outcomes, which may materially change as more patient data
become available; the ability to resolve the current clinical hold
on the Company’s trials; the ability to manufacture AlloCAR T™
therapies; the potential benefits of AlloCAR T therapies; and the
2021 financial guidance. Various factors may cause differences
between Allogene’s expectations and actual results as discussed in
greater detail in Allogene’s filings with the SEC, including
without limitation in its Form 10-Q for the quarter
ended September 30, 2021. 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.
AlloCAR T™ is a trademark 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. while Servier retains exclusive rights
for all other countries. ALLO-715 targets BCMA. Allogene has an
exclusive license to the Cellectis technology for allogeneic
products directed at BCMA and holds all global development and
commercial rights for these investigational candidates.
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA(unaudited; in thousands, except share and
per share data)
STATEMENTS OF OPERATIONS
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue - related party |
$ |
49 |
|
|
$ |
— |
|
|
$ |
38,438 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
58,720 |
|
|
$ |
51,421 |
|
|
$ |
166,193 |
|
|
$ |
140,759 |
|
General and administrative |
18,999 |
|
|
16,619 |
|
|
54,144 |
|
|
48,122 |
|
Total operating expenses |
77,719 |
|
|
68,040 |
|
|
220,337 |
|
|
188,881 |
|
Loss from operations |
(77,670 |
) |
|
(68,040 |
) |
|
(181,899 |
) |
|
(188,881 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest and other income, net |
393 |
|
|
2,005 |
|
|
1,528 |
|
|
7,606 |
|
Other expenses |
(909 |
) |
|
(162 |
) |
|
(1,766 |
) |
|
(376 |
) |
Total other income (expense),
net |
(516 |
) |
|
1,843 |
|
|
(238 |
) |
|
7,230 |
|
Net loss |
(78,186 |
) |
|
(66,197 |
) |
|
(182,137 |
) |
|
(181,651 |
) |
Net loss per share, basic and
diluted |
$ |
(0.57 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.35 |
) |
|
$ |
(1.55 |
) |
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
137,025,698 |
|
|
127,140,755 |
|
|
134,690,310 |
|
|
117,227,079 |
|
SELECTED BALANCE SHEET DATA
|
As of September 30, 2021 |
|
As of December 31, 2020 |
Cash, cash equivalents and investments |
$ |
861,707 |
|
|
$ |
1,032,118 |
|
Total assets |
1,079,246 |
|
|
1,227,829 |
|
Total liabilities |
109,304 |
|
|
148,212 |
|
Total stockholders’
equity |
969,942 |
|
|
1,079,617 |
|
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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