On track to report additional efficacy,
durability and safety data and provide a regulatory update and plan
for ADI-001 pivotal program in 2Q 2023
Strong balance sheet with $231.6 million in
cash, cash equivalents and investments as of March 31, 2023
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for cancer, today reported financial results and
operational highlights for the first quarter ended March 31,
2023.
“We are excited about the continued clinical progress of our
lead asset ADI-001,” said Chen Schor, President and Chief Executive
Officer of Adicet. “In the second quarter, we plan to discuss with
the FDA the path forward for a potential pivotal study for ADI-001
in post-CAR T large B-cell lymphoma patients and expect to initiate
this study in the fourth quarter of 2023. We plan to report updated
efficacy, durability and safety data from ADI-001’s ongoing Phase 1
trial, as well as provide an update on our meeting with the FDA in
the second quarter of 2023. Additionally, Adicet is making steady
advances in developing our early-stage pipeline candidates,
including presenting promising data demonstrating preclinical
proof-of-concept for our armored allogeneic gamma delta T cell
therapy ADI-270 at ASGCT later this month. Further, we are on track
to submit an IND for our novel CAd gamma delta T cell product
candidate ADI-925 in the second half of this year.”
First Quarter 2023 and Recent Operational Highlights:
- Company remains on track to report additional efficacy,
durability and safety data and provide a regulatory update and plan
for ADI-001 pivotal program in the second quarter of 2023. In
December 2022, Adicet reported interim safety and efficacy data
from its ongoing Phase 1 study of ADI-001, the Company’s
investigational therapy targeting CD20 for the potential treatment
of relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). The
Company is preparing to initiate its first potential pivotal study
with ADI-001 in the fourth quarter of 2023.
- ADI-270 preclinical data at ASGCT. Adicet will present a
preclinical data poster for ADI-270, an armored CD70-targeted
allogeneic gamma delta chimeric antigen receptor (CAR) T cell
development candidate, at the American Society of Gene and Cell
Therapy (ASGCT) Annual Meeting on May 18, 2023. This encouraging
data demonstrates preclinical proof-of-concept for Adicet’s
first-in-class development candidate specifically designed to
address the needs of solid tumor indications with the addition of
TGFb dominant negative receptor armoring and additional protection
against host elimination.
- Continuing to advance new pipeline programs. In November
2022, Adicet presented preclinical data for four new CAR and CAd
(chimeric antigen adaptor) gamma delta T cell programs targeting
several hematologic and solid malignancies. The Company continues
to advance these new pipeline programs and expects to submit an
Investigational New Drug Application (IND) for ADI-925 in the
second half of 2023.
Financial Results for First Quarter 2023:
- Research and Development (R&D) Expenses: R&D
expenses were $26.8 million for the three months ended March 31,
2023, compared to $13.5 million during the same period in 2022. The
$13.3 million increase is primarily driven by a $5.0 million
increase in contract development manufacturing organization (CDMO)
and other externally conducted research and development expense and
a $4.1 million increase in payroll and personnel expenses resulting
from an increase in overall headcount. There was also a $3.2
million dollar increase in allocated facility expenses and a $1.0
million increase in lab expenses. Payroll and personnel expenses
for the three months ended March 31, 2023, includes $2.2 million of
non-cash stock-based compensation expense compared to $1.7 million
during the same period in 2022.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.6 million for the three months ended March 31,
2023, compared to $6.8 million during the same period in 2022. The
$0.2 million decrease is primarily driven by a $0.9 million
decrease in allocated facility and other costs, a $0.1 million
decrease in stock-based compensation and a less than $0.1 million
decrease in professional fees. The decrease was partially offset by
a $0.7 million increase in payroll and personnel expenses. Payroll
and personnel expenses for the three months ended March 31, 2023,
includes $2.6 million of non-cash stock-based compensation expense
compared to $2.6 million during the same period in 2022.
- Net Loss/Income: Net loss for the three months ended
March 31, 2023 was $30.9 million, or a net loss of $0.72 per basic
and diluted share, including non-cash stock-based compensation
expense of $4.8 million, as compared to a net income of $4.6
million during the same period in 2022, or a net income of $0.12
per basic share and $0.10 per diluted share, including non-cash
stock-based compensation expense of $4.4 million.
- Cash Position: Cash and cash equivalents were $231.6
million as of March 31, 2023, compared to $277.9 million during the
same period in 2022. The Company expects that current cash and cash
equivalents as of March 31, 2023, 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 (CARs)
and chimeric antigen adaptors (CAds), to enhance selective tumor
targeting and facilitate innate and adaptive anti-tumor immune
response for durable activity in patients. For more information,
please visit our website at https://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.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements include, but are not limited to, express
or implied statements regarding: preclinical and clinical
development of Adicet’s product candidates, including future plans
or expectations for ADI-001, ADI-925, ADI-270 and Adicet’s
preclinical programs; the potential safety, durability,
tolerability and therapeutic effects of ADI-001; expected plans,
progress and timing for the release of additional clinical data
from Adicet’s ongoing Phase 1 trial of ADI-001 in
relapsed/refractory NHL patients; initiation of a potentially
pivotal study for ADI-001 in the fourth quarter of 2023; planned
discussions with the FDA around our current and future preclinical
and clinical programs; the planned timing and submission of
regulatory filings, including the potential IND for ADI-925 in the
second half of 2023 and other preclinical programs; and Adicet’s
growth as a company, the contributions of its executive officers
and expectations regarding its uses of capital, expenses 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, Adicet’s ability to execute on its
strategy including obtaining the requisite regulatory approvals on
the expected timeline, if at all; that positive results, including
interim results, from a preclinical or clinical study may not
necessarily be predictive of the results of future or ongoing
studies; clinical studies may fail to demonstrate adequate safety
and efficacy of Adicet’s product candidates, which would prevent,
delay, or limit the scope of regulatory approval and
commercialization; regulatory approval processes of the FDA and
comparable foreign regulatory authorities are lengthy,
time-consuming, and inherently unpredictable; Adicet’s ability to
meet production and product release expectations; the effect of
COVID-19 on Adicet’s business and financial results, including with
respect to disruptions to our preclinical and clinical trials,
business operations, employee hiring and retention, and ability to
raise additional capital. 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 Income (Loss)
(in thousands, except share
and per share amounts)
(Unaudited)
Three Months Ended March
31,
2023
2022
Revenue—related party
$
—
$
24,990
Operating expenses:
Research and development
26,756
13,483
General and administrative
6,566
6,801
Total operating expenses
33,322
20,284
Income (loss) from operations
(33,322
)
4,706
Interest income
2,666
32
Interest expense
(19
)
(18
)
Other expense, net
(206
)
(102
)
Income (loss) before income tax
provision
(30,881
)
4,618
Income tax provision
—
—
Net income (loss)
$
(30,881
)
$
4,618
Net income (loss) per share attributable
to common stockholders, basic
$
(0.72
)
$
0.12
Net income (loss) per share attributable
to common stockholders, diluted
$
(0.72
)
$
0.10
Weighted-average common shares used in
computing net income (loss) per share attributable to common
stockholders, basic
42,955,688
39,823,246
Weighted-average common shares used in
computing net income (loss) per share attributable to common
stockholders, diluted
42,955,688
45,958,941
ADICET BIO, INC.
Consolidated Balance Sheet
Information
(in thousands)
(unaudited)
March 31,
December 31,
2023
2022
Cash and cash equivalents
$
231,640
$
257,656
Working capital
216,713
241,331
Total assets
304,974
330,690
Accumulated deficit
(268,995
)
(238,114
)
Total stockholders’ equity
266,215
292,338
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509005978/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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