Adicet Reports Second Quarter 2022 Financial Results and Provides Business Updates
August 10 2022 - 7:00AM
Business Wire
ADI-001 demonstrated 75% CR and ORR rate across
all dose levels with favorable safety and tolerability profile in
patients with relapsed/refractory high grade aggressive NHL, as of
May 31, 2022 data-cut date
ADI-001 received FDA Fast Track Designation
Strong balance sheet with $304.3 million in
cash and cash equivalents, as adjusted for anticipated proceeds
from at-the-market transaction
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing first-in-class allogeneic gamma
delta CAR T cell therapies for cancer, today reported financial
results and operational highlights for the second quarter ended
June 30, 2022.
“During the second quarter of 2022, we made significant
progress, achieving a number of clinical and regulatory
milestones,” said Chen Schor, President and Chief Executive Officer
at Adicet Bio. “We are particularly pleased with the positive
clinical data from our lead product candidate ADI-001 presented at
ASCO in June, and the Fast Track Designation by the FDA. We are
excited to report that we are currently enrolling patients to dose
level 4 (DL4) and are on track to potentially initiate at least one
pivotal study during the first half of 2023. Our pipeline of
preclinical programs is advancing, and we look forward to providing
a more comprehensive update on several preclinical programs during
the second half of 2022. With $304 million in cash and cash
equivalents, as adjusted for the at-the-market transaction, we are
capitalized into the first half of 2025 and expect to meet several
meaningful milestones along the way, including during the second
half of this year.”
Second Quarter 2022 and Recent Operational
Highlights:
- Received FDA Fast Track Designation for lead candidate
ADI-001. In April, Adicet announced the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation to ADI-001, an
investigational therapy targeting CD20 for the potential treatment
of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
- Presented positive preclinical data at the ISCT Annual
Meeting. In May, Adicet announced data from a preclinical
evaluation of ADI-001 at the International Society for Cell and
Gene Therapy (ISCT) Annual Meeting. The preclinical data showed
that ADI-001 exhibited robust in vitro and in vivo tumor growth
inhibition in multiple human lymphoma cell lines, with adaptive and
innate activation pathways contributing to its anti-tumor activity.
These cells demonstrated superior resilience to host versus graft
targeting when compared to common gene-edited approaches.
- Presented positive interim data from the Phase 1 study of
ADI-001 at the 2022 ASCO Annual Meeting. During the second
quarter, Adicet presented positive data from the Phase 1 study of
ADI-001 at the 2022 American Society of Clinical Oncology (ASCO)
Annual Meeting. As of the May 31, 2022 data-cut date, ADI-001
demonstrated 75% complete response (CR) and objective response rate
(ORR) across all dose levels with favorable safety and tolerability
profile in patients with relapsed/refractory high grade aggressive
NHL.
- Future development plans for ADI-001. In June, Adicet
announced that given the safety profile to date, the Phase 1 study
protocol was amended to include a new dose level – dose level 4
(DL4) (1E9 CAR+ cells) and a potential ADI-001 consolidation dosing
at dose level 3 to finalize the recommended Phase 2 dose in the
second half of 2022. The Company plans to provide at least one
additional clinical update for the ADI-001 Phase 1 study in the
second half of 2022. The Company also announced that it expects to
discuss with the U.S. FDA and the European Medicines Agency (EMA)
the design of two pivotal intent studies and a potential path to
support a Biologics License Application (BLA) and Marketing
Authorization Application (MAA) for ADI-001 and initiate at least
one potentially pivotal study in the first half of 2023.
- Moved Research & Development (R&D) operations to
Redwood City, California; Establishing in-house manufacturing
capacity. Adicet completed the move of its California
operations to Redwood City, California for the purpose of
establishing in-house manufacturing capabilities in the Redwood
City facility to enable manufacturing for early clinical
development of its potential clinical candidates. The manufacturing
areas of the facility are expected to be operational in the fourth
quarter of 2022.
Financial Results for Second Quarter 2022:
- R&D Expenses: R&D expenses were $16.2 million
for the three months ended June 30, 2022, compared to $10.6 million
during the same period in 2021. The $5.6 million increase is
primarily driven by a $2.5 million increase in payroll and
personnel expenses resulting from an increase in headcount, a $1.4
million increase in contract manufacturing organization and other
externally conducted R&D expense and a $0.7 million increase in
contract research organization expense related to the Company’s
Phase 1 trial. Payroll and personnel expenses for the three months
ended June 30, 2022, includes $1.9 million of non-cash stock-based
compensation expense compared to $0.8 million during the same
period in 2021.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.5 million for the three months ended June 30,
2022, compared to $5.0 million during the same period in 2021. The
$1.5 million increase is primarily driven by an increase of $1.1
million of payroll and personnel expenses, which was partially
offset by a $0.2 million decrease in professional service fees and
a $0.2 million decrease in lab fees. Payroll and personnel expenses
for the three months ended June 30, 2022, includes $2.4 million of
non-cash stock-based compensation expense compared to $1.8 million
during the same period in 2021.
- Net Loss: Net loss attributable to common shareholders
for the three months ended June 30, 2022 was $22.5 million, or a
net loss of $0.56 per basic and diluted share, including non-cash
stock-based compensation expense of $4.3 million, as compared to a
net loss of $10.9 million during the same period in 2021, or a net
loss of $0.34 per basic and diluted share, including non-cash
stock-based compensation expense of $2.7 million.
- Cash Position: Cash and cash equivalents were $260.6
million as of June 30, 2022, compared to $277.5 million as of
December 31, 2021. On August 9, 2022, the Company sold an aggregate
of 2,611,723 shares of the Company’s common stock at a purchase
price of $17.23 per share under its existing at-the-market
agreement. This resulted in aggregate gross proceeds to the Company
of approximately $45.0 million, before deducting sales agent fees
and expenses payable by the Company. The Company expects that
current cash and cash equivalents of $304.3 million, adjusted for
sales agent fees from the at-the-market transaction, will be
sufficient to fund its operating expenses into the first half of
2025.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma
delta T cells, engineered with chimeric antigen receptors and T
cell receptor-like targeting moieties to enhance selective tumor
targeting, facilitate innate and adaptive anti-tumor immune
response, and improve persistence for durable activity in patients.
For more information, please visit our website at
http://www.adicetbio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" of
Adicet within the meaning of the Private Securities Litigation
Reform Act of 1995 relating to business and operations of Adicet
including, but not limited to, preclinical and clinical development
of Adicet’s product candidates, including future plans or
expectations for ADI-001, potential safety, tolerability and
therapeutic effects of ADI-001 and the planned release of interim
clinical data from the Phase 1 trial in NHL patients; the
advancement of Adicet’s preclinical pipeline programs; the launch
of in-house manufacturing capabilities in Adicet’s Redwood City
facility; and Adicet’s growth as a company and expectations
regarding its uses of capital, expenses, future accumulated deficit
and financial results, including the expected cash runway. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs of future events, and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements, including
without limitation, the effect of COVID-19 on Adicet’s business and
financial results, including with respect to disruptions to our
clinical trials, business operations, employee hiring and
retention, and ability to raise additional capital; Adicet’s
ability to execute on its strategy, including obtaining the
requisite regulatory approvals on the expected timing, if at all;
that positive results from a clinical study may not necessarily be
predictive of the results of future or ongoing clinical studies;
regulatory approval processes of the FDA and comparable foreign
regulatory authorities are lengthy, time-consuming, and inherently
unpredictable; as well as those risks and uncertainties set forth
in the company’s most recent annual report on Form 10-K and
subsequent filings with the Securities and Exchange Commission. For
a discussion of these and other risks and uncertainties, and other
important factors, any of which could cause Adicet’s actual results
to differ from those contained in the forward-looking statements,
see the section entitled “Risk Factors” in Adicet’s most recent
annual report on Form 10-K and our periodic reports on Form 10-Q
and Form 8-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in
Adicet’s other filings with the SEC. All information in this press
release is as of the date of the release, and Adicet undertakes no
duty to update this information unless required by law.
ADICET BIO, INC.
Consolidated Statements of
Operations and Comprehensive Loss
(in thousands, except share
and per share amounts)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenue—related party
$
—
$
4,814
$
24,990
$
833
Operating expenses:
Research and development
16,178
10,616
29,661
22,359
General and administrative
6,529
5,025
13,330
10,655
Total operating expenses
22,707
15,641
42,991
33,014
Loss from operations
(22,707
)
(10,827
)
(18,001
)
(32,181
)
Interest income
325
9
357
50
Interest expense
(18
)
(51
)
(36
)
(101
)
Other expense, net
(138
)
(62
)
(240
)
(66
)
Loss before income tax provision
(benefit)
(22,538
)
(10,931
)
(17,920
)
(32,298
)
Income tax provision (benefit)
—
(77
)
—
(125
)
Net loss
$
(22,538
)
$
(10,854
)
$
(17,920
)
$
(32,173
)
Net loss, basic and diluted
$
(0.56
)
$
(0.34
)
$
(0.45
)
$
(1.11
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
40,075,060
31,824,405
39,975,503
28,977,993
Other comprehensive loss:
Unrealized loss on marketable debt
securities, net of tax
—
(2
)
—
(24
)
Total other comprehensive loss
—
(2
)
—
(24
)
Comprehensive loss
$
(22,538
)
$
(10,856
)
$
(17,920
)
$
(32,197
)
ADICET BIO, INC.
Balance Sheet Data
(In thousands)
(unaudited)
June 30, 2022
December 31, 2021
Cash and cash equivalents
$
260,642
$
277,544
Working capital
247,690
266,121
Total assets
329,904
338,938
Contract liabilities – related party
—
4,805
Accumulated deficit
(186,244
)
(168,324
)
Total stockholders’ equity
293,267
303,129
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version on businesswire.com: https://www.businesswire.com/news/home/20220810005305/en/
Adicet Bio, Inc. Investor and Media Contacts Anne
Bowdidge abowdidge@adicetbio.com Janhavi Mohite Stern Investor
Relations, Inc. 212-362-1200 janhavi.mohite@sternir.com
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