Announced encouraging safety and efficacy data
in ongoing Phase 1 study of ADI-001 for the potential treatment of
relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL)
On track to report a clinical update for
ADI-001 in second half of 2024
Plan to file Investigational New Drug
Application (IND) for ADI-925 in H2 2023 and ADI-270 in H1 2024
Strong balance sheet with $205.5 million in
cash and cash equivalents as of June 30, 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 second quarter ended June 30,
2023.
“Throughout the first half of 2023, Adicet has achieved several
clinical, regulatory and scientific milestones. Specifically, we
are encouraged by the clinical results observed in our ongoing
Phase 1 study of ADI-001 in patients heavily pretreated with a
median of 4 prior lines therapy. The results were particularly
meaningful given that 50% of patients enrolled in our study had
previously progressed following autologous CAR T therapy,” said
Chen Schor, President and Chief Executive Officer at Adicet Bio.
“We are initiating an expansion cohort, EXPAND, in post CAR T LBCL
patients based on our Phase 1 GLEAN study, and will continue to
enroll mantle cell lymphoma patients, as we progress towards
initiating our potentially pivotal program in 2024.”
Mr. Schor added, “We declared our third clinical candidate,
ADI-270, which serves as our first foray to solid tumors, starting
with renal cell carcinoma. ADI-270 leverages our gamma delta1 T
cells, which are designed to home to solid tumors as a key
differentiated property, with a highly specific targeting moiety
for CD70 and an armoring technology of dominant negative TGF beta
to address immunosuppressive factors in the tumor microenvironment.
We expect to file an IND for ADI-270 in the first half of 2024,
following our IND for ADI-925 in the second half of 2023.”
Second Quarter 2023 and Recent Operational
Highlights:
- Announced additional safety and efficacy data from ongoing
Phase 1 study of ADI-001. In June, Adicet reported safety and
efficacy data from the Company’s ongoing Phase 1 study of ADI-001
for the potential treatment of relapsed or refractory aggressive
B-cell NHL. As of the May 4, 2023 data-cut date, ADI-001
demonstrated 71% overall response rate (ORR) and 63% complete
response (CR) rate across all dose levels in patients with median 4
prior lines of therapy. ADI-001 was generally well-tolerated in the
study and there were no occurrences of dose-limiting toxicities or
graft vs host disease. In May, the Company completed a Type B
meeting with the U.S. Food and Drug Administration and plans to
transition the ADI-001 program into a potentially pivotal single
arm Phase 2 study in post-CAR T LBCL under an accelerated approval
pathway in 2024. Adicet is initiating an expansion cohort, EXPAND,
in post CAR T LBCL patients based on the Phase 1 study, and will
continue to enroll mantle cell lymphoma patients as the Company
progresses towards initiating its potentially pivotal program in
2024. Adicet expects to provide a clinical update in the second
half of 2024.
- Continuing to advance broad pipeline of CAR and chimeric
antigen adaptor (CAd) gamma delta T cell product candidates.
The Company continues to advance its pipeline of first-in-class CAR
and CAd gamma delta T cell product candidates targeting hematologic
and solid malignancies. Adicet expects to submit an IND for ADI-925
in the second half of 2023. In May, Adicet presented encouraging
preclinical data at the 26th Annual Meeting of the American Society
of Gene & Cell Therapy (ASGCT) demonstrating proof-of-concept
for ADI-270, an armored CD70-targeted allogeneic gamma delta CAR T
cell development candidate. Adicet expects to submit an IND
Application for ADI-270 in the first half of 2024.
- Appointed Katie Peng to Board of Directors. In July,
Adicet announced the appointment of Katie Peng to the Company’s
Board of Directors. Ms. Peng brings extensive industry and
commercial expertise to the Board. She currently serves as Chief
Commercial Officer at Denali Therapeutics Inc., where she is
leading the global commercialization efforts of Denali’s
pipeline.
Financial Results for Second Quarter 2023:
- Research and Development (R&D) Expenses: R&D
expenses were $28.4 million for the three months ended June 30,
2023, compared to $16.2 million during the same period in 2022. The
$12.2 million increase is primarily driven by a $3.7 million
increase in payroll and personnel expenses resulting from an
increase in overall headcount and a $3.4 million increase in
expenses related to contract drug manufacturing organizations and
other externally conducted research and development. There was also
a $2.7 million increase in allocated facility expenses and a $2.1
million increase in laboratory expenses. Payroll and personnel
expenses for the three months ended June 30, 2023 includes $2.4
million of non-cash stock-based compensation expense compared to
$1.9 million during the same period in 2022.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.5 million for the three months ended June 30,
2023, compared to $6.5 million during the same period in 2022.
Payroll and personnel expenses for the three months ended June 30,
2023 includes $2.6 million of non-cash stock-based compensation
expense compared to $2.4 million during the same period in
2022.
- Net Loss: Net loss for the three months ended June 30,
2023 was $32.4 million, or a net loss of $0.75 per basic and
diluted share, including non-cash stock-based compensation expense
of $5.0 million, as compared to a net loss of $22.5 million during
the same period in 2022, or a net loss of $0.56 per basic and
diluted share, including non-cash stock-based compensation expense
of $4.3 million.
- Cash Position: Cash and cash equivalents were $205.5
million as of June 30, 2023, compared to $257.7 million as of
December 31, 2023. The Company expects that current cash and cash
equivalents as of June 30, 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 efficacy of ADI-001 and Adicet’s other product
candidates; the expected progress, timing and success of the Phase
1 study of ADI-001 in relapsed/refractory NHL patients; the
expectations regarding the submission of an IND for ADI-925 in the
second half of 2023 and ADI-270 in the first half of 2024; the plan
to transition ADI-001 into a potentially pivotal Phase 2 study in
2024; the expected timing of additional data in post-CAR T LBCL
patients in the second half of 2024; and Adicet’s growth as a
company, the contributions of its directors and 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, 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 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenue—related party
$
—
$
—
$
—
$
24,990
Operating expenses:
Research and development
28,362
16,178
55,118
29,661
General and administrative
6,528
6,529
13,093
13,330
Total operating expenses
34,890
22,707
68,211
42,991
Loss from operations
(34,890
)
(22,707
)
(68,211
)
(18,001
)
Interest income
2,615
325
5,279
357
Interest expense
(4
)
(18
)
(23
)
(36
)
Other expense, net
(124
)
(138
)
(329
)
(240
)
Loss before income tax provision
(32,403
)
(22,538
)
(63,284
)
(17,920
)
Income tax provision
—
—
—
—
Net loss
$
(32,403
)
$
(22,538
)
$
(63,284
)
$
(17,920
)
Net loss per share, basic and diluted
$
(0.75
)
$
(0.56
)
$
(1.47
)
$
(0.45
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
42,957,035
40,075,060
42,957,242
39,975,503
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
(Unaudited)
June 30,
December 31,
2023
2022
Cash and cash equivalents
$
205,460
$
257,656
Working capital
189,817
241,331
Total assets
277,633
330,690
Accumulated deficit
(301,398
)
(238,114
)
Total stockholders’ equity
239,061
292,338
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809053582/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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