Initiated ADI-001 Phase 1 EXPAND cohort in post
chimeric antigen receptor (CAR) T large B cell lymphoma (LBCL)
Continuing to enroll mantle cell lymphoma (MCL)
patients in ADI-001 Phase 1 study
Prioritizing ADI-270 for solid tumor
applications; on track to file ADI-270 Investigational New Drug
Application (IND) in 1H 2024
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 third quarter ended September 30,
2023.
“Clinical and translational medicine data for our lead asset
ADI-001 in NHL has provided us with valuable insights, which has
guided us as we initiated the EXPAND cohort in post CAR T LBCL and
continue to enroll MCL patients to the clinical study. For patients
with these advanced cancers, the prognosis remains poor and
patients are in need of new, more effective and better tolerated
therapies,” said Chen Schor, President and Chief Executive Officer
at Adicet Bio.
“In addition, over the past several months, we have conducted a
strategic review of our pipeline to focus our resources on programs
with the greatest potential for differentiation and long-term value
creation,” Mr. Schor added. “On the preclinical front, we are
prioritizing the development of ADI-270 as our lead preclinical
candidate in renal cell carcinoma and other solid tumor
indications. ADI-270 has demonstrated a highly differentiated
profile stemming from its unique engineering, including targeting
via a CAR that incorporates CD27, addition of dominant negative TGF
beta receptor armoring, complimentary innate anti-tumor activity of
the gamma delta 1 T cells and tissue tropism to solid tumors. We
remain on track to file an IND for ADI-270 in the first half of
2024. With a focused organization and clear priority for advancing
a pipeline with the highest probability of success, we believe we
are well positioned for long-term success as leaders in the
allogeneic T cell therapy field.”
Recent Operational Highlights:
- Advanced ADI-001 Development. The Company is advancing
the development 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). In November, Adicet
initiated an expansion cohort (EXPAND) to evaluate ADI-001 in
patients with post CAR T LBCL and continues to enroll MCL patients
in the Company’s ongoing Phase 1 study of ADI-001. Recently, the
Company expanded manufacturing capabilities of ADI-001 by
transferring the manufacturing process to an additional contract
development and manufacturing organization (CDMO) that is capable
of operating at a larger scale of production. Subject to data
readouts and regulatory feedback, the Company will evaluate options
to advance ADI-001 into a potentially pivotal single arm Phase 2
study in post CAR T LBCL and/or MCL patients under an accelerated
approval pathway. Adicet continues to expect that it will provide a
clinical update from the Phase 1 study in NHL patients in the
second half of 2024.
- Prioritized ADI-270 Development for Solid Tumors. Adicet
has reprioritized its preclinical pipeline to focus on the
development of ADI-270 as its lead preclinical candidate for renal
cell carcinoma, with potential in other solid tumor indications.
The Company has completed a pre-IND meeting for ADI-270 with the
U.S. Food and Drug Administration and received positive feedback to
support an IND filing in the first half of 2024. 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. The Company expects to file an IND application
for ADI-270 in the first half of 2024. Adicet has paused
preclinical development of ADI-925 to prioritize corporate
resources on IND-enabling activities for ADI-270.
- Presented new preclinical data at the International
Conference on Molecular Targets and Cancer Therapeutics. In
October 2023, Adicet presented new preclinical data building on the
potential of Adicet’s allogeneic gamma delta platform as a
promising approach to target prostate cancer. Details of Adicet’s
lead optimization process and differentiated prostate specific
membrane antigen (PSMA) binding moiety were presented at the
conference. Data demonstrated intrinsic targeting of
patient-derived tumors by gamma delta T cells. Additionally,
Adicet’s novel mode of targeting PSMA demonstrated selective
binding to conformational epitopes and superior function compared
to clinically relevant benchmarks.
- Presented three posters at the Society for Immunotherapy of
Cancer (SITC) 37th Annual Meeting. Earlier in November, Adicet
presented three poster presentations highlighting the therapeutic
value of its broad pipeline of CAR gamma delta T cell product
candidates, including ADI-001, at SITC.
Financial Results for Third Quarter 2023:
- Research and Development (R&D) Expenses: R&D
expenses were $26.2 million for the three months ended September
30, 2023, compared to $16.6 million during the same period in 2022.
The $9.6 million increase is primarily driven by a $4.8 million
increase in expenses related to CDMOs and other externally
conducted research and development as well as a $2.4 million
increase in payroll and personnel expenses resulting from an
increase in overall headcount. There was also a $2.0 million
increase in allocated facility expenses and a $0.4 million increase
in lab expenses.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.6 million for the three months ended September 30,
2023, compared to $6.4 million during the same period in 2022. The
$0.2 million increase is primarily driven by an increase in
stock-based compensation of $0.6 million and an increase in
contractor fees of $0.2 million. The increase was partially offset
by a $0.4 million decrease in allocated facility and other
costs.
- Goodwill Impairment: Goodwill was impaired by $19.5
million during the three months ended September 30, 2023 following
the results of an impairment test conducted during the period. This
represented the entire remaining balance of goodwill.
- Net Loss: Net loss for the three months ended September
30, 2023 was $49.9 million, or a net loss of $1.16 per basic and
diluted share, including non-cash goodwill impairment expense of
$19.5 million and non-cash stock-based compensation expense of $5.6
million. Net loss was $22.0 million during the same period in 2022,
or a net loss of $0.53 per basic and diluted share, including
non-cash stock-based compensation expense of $4.2 million.
- Cash Position: Cash and cash equivalents were $183.3
million as of September 30, 2023, compared to $257.7 million as of
December 31, 2022. The Company expects that current cash and cash
equivalents as of September 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) 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-270 and Adicet’s preclinical
development pipeline; 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, including
expectations around a clinical update in the second half of 2024;
the expectations regarding the submission of an IND for ADI-270 in
the first half of 2024; the plan to transition ADI-001 into a
potentially pivotal Phase 2 study, subject to data readouts and
regulatory feedback; the expected timing of additional data in
post-CAR T LBCL and MCL patients in the second half of 2024;
expectations for Adicet’s additional CDMO and its production
capabilities; 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 September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenue—related party
$
—
$
—
$
—
$
24,990
Operating expenses:
Research and development
26,167
16,570
81,284
46,231
General and administrative
6,633
6,415
19,726
19,745
Goodwill impairment
19,462
—
19,462
—
Total operating expenses
52,262
22,985
120,472
65,976
Loss from operations
(52,262
)
(22,985
)
(120,472
)
(40,986
)
Interest income
2,520
1,224
7,800
1,581
Interest expense
(1
)
(18
)
(25
)
(54
)
Other expense, net
(142
)
(217
)
(472
)
(456
)
Loss before income tax provision
(49,885
)
(21,996
)
(113,169
)
(39,915
)
Income tax provision
—
—
—
—
Net loss
$
(49,885
)
$
(21,996
)
$
(113,169
)
$
(39,915
)
Net loss per share, basic and diluted
$
(1.16
)
$
(0.53
)
$
(2.63
)
$
(0.98
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
42,980,641
41,642,815
43,001,901
40,547,792
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
(unaudited)
September 30,
December 31,
2023
2022
Cash and cash equivalents
$
183,257
$
257,656
Working capital
166,115
241,331
Total assets
233,257
330,690
Accumulated deficit
(351,283
)
(238,114
)
Total stockholders’ equity
194,677
292,338
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231108295662/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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