Expanded clinical pipeline into autoimmune
diseases with U.S. Food and Drug Administration (FDA) clearance of
Investigational New Drug Application (IND) for ADI-001; initiation
of Phase 1 clinical trial in lupus nephritis expected in 2Q
2024
On track to file IND for ADI-270 in renal cell
carcinoma in 2Q 2024
Extended projected cash runway into 2H 2026
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 fourth quarter
and year ended December 31, 2023.
“We are excited to explore the potential of our gamma delta T
cell platform in autoimmune diseases following the FDA’s IND
clearance of ADI-001 in lupus nephritis,” said Chen Schor,
President and Chief Executive Officer at Adicet Bio. “We believe
ADI-001 is ideally suited for the treatment of autoimmune diseases
given its robust B-cell depletion consistent with other autologous
CAR T therapies tested in autoimmune diseases, its tissue tropism
potential in autoimmune diseases, and the safety and efficacy data
observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf
availability and safety profile has the potential to make cell
therapy for autoimmune diseases available to patients in community
setting. We look forward to initiating the Phase 1 study in lupus
nephritis in the second quarter of 2024 and are on track to expand
the program to additional autoimmune indications.”
Mr. Schor continued: “In addition, we are continuing to enroll
MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or
refractory non-Hodgkin’s lymphoma. With the completion of the
successful capital raise and other net proceeds from stock sales
under the at-the-market program in January, extending our cash
runway into the second half of 2026, we are well-positioned to
continue clinical execution across our pipeline through multiple
upcoming milestones.”
Fourth Quarter 2023 and Recent Operational
Highlights:
Autoimmune diseases
- IND clearance for ADI-001 in lupus nephritis. In
December 2023, the FDA cleared the Company’s IND application for
ADI-001 in lupus nephritis. Adicet plans to initiate a Phase 1
study to evaluate the safety and efficacy of ADI-001 in lupus
nephritis during the second quarter of 2024. Preliminary clinical
data from the trial are expected in the fourth quarter of 2024 or
first quarter of 2025, pending study site activation progression
and patient enrollment.
- Expansion of ADI-001 development in autoimmune diseases.
Adicet expects to expand into additional autoimmune indications in
the near future. The Company anticipates providing preliminary
clinical data in the fourth quarter of 2024 or first half of 2025,
subject to clearance of INDs in those indications as well as
successful site initiation and patient enrollment in the relevant
clinical protocols.
Hematologic malignancies and solid tumor indications
- Continuing to advance ADI-001 in Phase 1 GLEAN study in
mantle cell lymphoma (MCL). The Phase 1 study of ADI-001 in
relapsed or refractory non-Hodgkin’s lymphoma (NHL) is ongoing,
with enrollment focused on the MCL patient population, which
demonstrated the greatest clinical benefit in the June 2023
clinical update. Adicet expects to provide a clinical update on
safety, efficacy and 6-month complete response data in MCL patients
in the second half of 2024.
- Advancing ADI-270 preclinical development in solid
tumors. ADI-270 is designed to home to solid tumors, with a
highly specific targeting moiety for CD70 and an armoring
technology of dominant negative TGF beta receptor to address
immunosuppressive factors in the tumor microenvironment. Adicet
remains on track to file an IND for ADI-270 in renal cell carcinoma
in the second quarter of 2024 and expects to provide clinical data
from a Phase 1 study in the first half of 2025, following
regulatory clearance and subject to study initiation
progress.
- Presented persistence and pharmacodynamic data from ADI-001
Phase 1 study at the 65th American Society of Hematology (ASH)
Annual Meeting. In December 2023, Adicet presented new
pharmacokinetic and pharmacodynamic data from the Phase 1 study of
ADI-001 at the ASH Annual Meeting. The data demonstrated robust
dose-dependent expansion and persistence in patients with relapsed
or refractory aggressive B-cell NHL. ADI-001’s strong exposure and
persistence profile observed in the study to date further validates
Adicet’s gamma delta T cell technology.
Corporate updates
- Hired Benjamin Hsu, M.D., Ph.D., as Vice President Clinical
Development - Autoimmune. In March 2024, Adicet appointed Dr.
Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development.
Dr. Hsu brings over 20 years of experience in the biotech and
pharmaceutical industry with extensive expertise in immunology and
rheumatology clinical development. Dr. Hsu will lead the clinical
design and execution of the clinical development plan for Adicet’s
gamma delta T cell therapies for autoimmune diseases.
- Extended projected cash runway into 2H 2026. In January
2024, Adicet successfully raised $91.8 million in net proceeds
through an underwritten public offering and received $19.3 million
in net proceeds under its at-the-market (ATM) program.
Financial Results for Fourth Quarter and Full Year
2023:
Three months Ended December 31, 2023
- Research and Development (R&D) Expenses: R&D
expenses were $24.8 million for the three months ended December 31,
2023, compared to $25.0 million during the same period in 2022. The
$0.2 million decrease was primarily driven by a $2.7 million
decrease in expenses related to contract development manufacturing
organizations (CDMOs), contract research organizations (CROs) and
consultant costs related to our lead product candidate ADI-001.
This decrease was partially offset by an increase of $1.3 million
in payroll and personnel expenses, an increase of $0.7 million in
lab expenses and an increase of $0.6 million in facility and other
expenses.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.8 million for the three months ended December 31,
2023, compared to $6.6 million during the same period in 2022. The
$0.2 million increase was primarily driven by an increase of $0.9
million in payroll and personnel expenses. This increase was
partially offset by a $0.4 million decrease in professional fees
and a $0.4 million decrease in facility and other expenses.
- Net Loss: Net loss for the three months ended December
31, 2023 was $29.5 million, or a net loss of $0.69 per basic and
diluted share, including non-cash stock-based compensation expense
of $4.9 million, as compared to a net loss of $29.9 million, or a
net loss of $0.72 per basic and diluted share, including non-cash
stock-based compensation expense of $4.3 million during the same
period in 2022.
Twelve Months Ended December 31, 2023
- Research and Development (R&D) Expenses: R&D
expenses were $106.0 million for the year ended December 31, 2023,
compared to $71.2 million for the year ended December 31, 2022. The
$34.8 million increase was primarily driven by an $11.5 million
increase in payroll and personnel expenses resulting from an
increase in overall headcount, a net $10.7 million increase in
expenses related to CDMOs, CROs and consultant costs related to our
lead product candidate ADI-001, a $8.5 million increase in facility
and other expenses and a $4.1 million increase in lab
expenses.
- General and Administrative (G&A) Expenses: G&A
expenses were $26.5 million for the year ended December 31, 2023,
compared to $26.3 million for the year ended December 31, 2022. The
$0.2 million increase was primarily driven by a $3.3 million
increase in payroll and personnel expenses, which includes an
increase in stock-based compensation of $1.2 million, salaries and
benefits of $1.0 million and contractor fees of $0.9 million and an
increase in recruiting fees of $0.3 million. These increases were
primarily due to increased headcount for the period. The overall
increase was partially offset by a $2.6 million decrease in
facilities and other related expenses.
- Goodwill Impairment: Goodwill was impaired by $19.5
million during the year ended December 31, 2023 following the
results of an interim impairment test conducted during the period.
This represented the entire remaining balance of goodwill.
- Net Loss: Net loss for the year ended December 31, 2023
was $142.7 million, or a net loss of $3.31 per basic and diluted
share, including non-cash stock-based compensation expense of $20.3
million, as compared to a net loss of $69.8 million, or a net loss
of $1.70 per basic and diluted share, including non-cash
stock-based compensation expense of $17.1 million during the same
period in 2022.
- Cash Position: Cash and cash equivalents were $159.7
million as of December 31, 2023, compared to $257.7 million as of
December 31, 2022. Subsequent to December 31, 2023, the Company
received $91.8 million of net proceeds from an underwritten public
offering and $19.3 million of net proceeds under its ATM program.
The Company expects that its cash and cash equivalents as of
December 31, 2023, together with the proceeds raised subsequent to
year end, 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 in autoimmune diseases, and the potential safety,
durability, tolerability and efficacy of these product candidates;
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)
Three Months Ended December
31,
Year Ended December
31,
2023
2022
2023
2022
Revenue—related party
$
—
$
—
$
—
$
24,990
Operating expenses:
Research and development
24,759
25,015
106,043
71,246
General and administrative
6,807
6,550
26,533
26,295
Goodwill impairment
—
—
19,462
—
Total operating expenses
31,566
31,565
152,038
97,541
Loss from operations
(31,566
)
(31,565
)
(152,038
)
(72,551
)
Interest income
2178
2,179
9,978
3,760
Interest expense
—
(26
)
(25
)
(80
)
Other expense, net
(101
)
(463
)
(573
)
(919
)
Loss before income tax provision
(29,489
)
(29,875
)
(142,658
)
(69,790
)
Income tax provision
—
—
—
—
Net loss
$
(29,489
)
$
(29,875
)
$
(142,658
)
$
(69,790
)
Net loss per share, basic and diluted
$
(0.69
)
$
(0.72
)
$
(3.31
)
$
(1.70
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
43,035,315
41,651,298
43,042,405
41,080,286
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
December 31,
December 31,
2023
2022
Cash and cash equivalents
$
159,711
$
257,656
Working capital
142,985
241,331
Total assets
207,295
330,690
Accumulated deficit
(380,772
)
(238,114
)
Total stockholders’ equity
170,175
292,338
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240319090811/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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