On track to initiate Phase 1 clinical trial
evaluating ADI-001 in lupus nephritis in 2Q 2024
Presented promising preclinical data on ADI-270
at the American Society of Gene and Cell Therapy (ASGCT) Annual
Meeting; on track to file investigational new drug (IND) in renal
cell carcinoma in 2Q 2024
Strong balance sheet with $247.6 million in
cash and cash equivalents as of March 31, 2024
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for autoimmune diseases and cancer, today reported
financial results and operational highlights for the first quarter
ended March 31, 2024.
“We are poised for a transformational year in 2024 as we advance
our gamma delta T cell platform in autoimmune diseases and prepare
to initiate a Phase 1 study evaluating our lead candidate ADI-001
in lupus nephritis in the second quarter of this year,” said Chen
Schor, President and Chief Executive Officer at Adicet Bio. “We
recently shared encouraging preclinical data on ADI-270 at the
ASGCT annual meeting highlighting its highly differentiated profile
and illustrating ADI-270’s robust anti-tumor activity in multiple
CD70+ solid and hematological cancer indications and supporting
ADI-270’s clinical development. In parallel, we are continuing to
enroll mantle cell lymphoma patients in our ongoing Phase 1 study
of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma and
expect to share a clinical update in the second half of this
year.”
First Quarter 2024 and Recent Operational Highlights:
Autoimmune diseases
- On track to initiate Phase 1 study of ADI-001 in lupus
nephritis in 2Q 2024. In December 2023, the FDA granted
clearance for Adicet's IND application to evaluate ADI-001 in lupus
nephritis. The Company plans to commence a Phase 1 clinical trial
to assess the safety and efficacy of ADI-001 in lupus nephritis in
the second quarter of 2024. Preliminary data from the study are
anticipated during the fourth quarter of 2024 or first quarter of
2025, depending on patient enrollment and study site
activation.
- Continuing to expand ADI-001 into additional autoimmune
diseases. Adicet plans to continue broadening the clinical
applications of ADI-001 to include additional autoimmune
indications. The Company expects to share preliminary clinical data
in the fourth quarter of 2024 or first half of 2025, subject to
regulatory clearances and contingent upon successful site
initiation and patient enrollment in the relevant clinical
protocols.
Hematologic malignancies and solid tumor indications
- Presentation of preclinical data from ADI-270 at the
ASGCT Annual Meeting. In May 2024, Adicet presented promising
preclinical data in an oral presentation at the ASGCT annual
meeting demonstrating robust anti-tumor activity of ADI-270, an
armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy
candidate targeting CD70+ cancers, in multiple CD70+ solid and
hematological tumor indications. Based on ADI-270’s promising
profile in preclinical studies to date, Adicet expects to submit an
IND for ADI-270 in renal cell carcinoma in the second quarter of
2024. Following regulatory clearance and contingent upon study
initiation progress, the Company intends to present clinical data
from a Phase 1 study in the first half of 2025.
- Enrollment of mantle cell lymphoma (MCL) patients in ongoing
ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL
patients in the Phase 1 trial evaluating ADI-001 in relapsed or
refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on
track to provide a clinical update on safety, efficacy and 6-month
complete response data in MCL patients in the second half of
2024.
Financial Results for First Quarter 2024:
- Research and Development (R&D) Expenses: R&D
expenses were $23.9 million for the three months ended March 31,
2024, compared to $26.8 million during the same period in 2023. The
decrease in R&D expenses was primarily due to a net $3.1
million decrease in expenses related to contract development
manufacturing organizations (CDMOs) and other externally conducted
research and development.
- General and Administrative (G&A) Expenses: G&A
expenses were $7.0 million for the three months ended March 31,
2024, compared to $6.6 million during the same period in 2023. The
$0.4 million increase was primarily driven by an increase in
personnel expenses. The increase was partially offset by a $0.2
million decrease in contractor fees as well as a $0.1 million
decrease in professional fees.
- Net Loss: Net loss for the three months ended March 31,
2024 was $28.0 million, or a net loss of $0.35 per basic and
diluted share, including non-cash stock-based compensation expense
of $5.7 million, as compared to a net loss of $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 during the same
period in 2023.
- Cash Position: Cash and cash equivalents were $247.6
million as of March 31, 2024, compared to $231.6 million during the
same period in 2023. The Company expects that current cash and cash
equivalents as of March 31, 2024, will be sufficient to fund its
operating expenses into the second half of 2026.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for autoimmune diseases and cancer. Adicet is advancing a pipeline
of “off-the-shelf” gamma delta T cells, engineered with chimeric
antigen receptors (CARs), to facilitate 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 the 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 and
ADI-270, including the potential submission or timing of clearance
of INDs, and the potential safety, durability, tolerability and
efficacy of these product candidates as well as their potential
promising profiles; the progress, timing and success of the
Company’s ongoing and planned Phase 1 clinical trials of ADI-001 in
autoimmune diseases and cancer, including expectations for site
activation, enrollment and data readouts; the Company’s plan to
expand into other autoimmune indications in the future; the
Company’s expectations regarding regulatory filings and clearances,
including the submission of an IND for ADI-270 in renal cell
carcinoma in the second quarter of 2024; and expectations regarding
the Company’s 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, the effect of global economic
conditions and public health emergencies on Adicet’s business and
financial results, including with respect to disruptions to our
preclinical and clinical studies, 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 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; and regulatory approval
processes of the FDA and comparable foreign regulatory authorities
are lengthy, time-consuming, and inherently unpredictable; and
Adicet’s ability to meet production and product release
expectations. 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 U.S. Securities
and Exchange Commission (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
(in thousands, except share
and per share amounts)
(Unaudited)
Three Months Ended March
31,
2024
2023
Operating expenses:
Research and development
23,897
26,756
General and administrative
6,974
6,566
Total operating expenses
30,871
33,322
Loss from operations
(30,871
)
(33,322
)
Interest income
2,918
2,666
Interest expense
(2
)
(19
)
Other expense, net
(61
)
(206
)
Loss before income tax provision
(28,016
)
(30,881
)
Income tax provision
—
—
Net loss
$
(28,016
)
$
(30,881
)
Net loss per share, basic and diluted
$
(0.35
)
$
(0.72
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
79,071,652
42,955,688
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
(Unaudited)
March 31,
December 31,
2024
2023
Cash and cash equivalents
$
247,589
$
159,711
Working capital
232,889
142,985
Total assets
293,095
207,295
Accumulated deficit
(408,788
)
(380,772
)
Total stockholders’ equity
258,804
170,175
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240514582407/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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