- Announced interim safety and efficacy data for ADI-001 in
ongoing Phase 1 study for the potential treatment of relapsed or
refractory B-cell non-Hodgkin’s lymphoma (NHL); Next data update
expected in Q2 2023
- Announced preclinical data for differentiated chimeric antigen
receptor (CAR) and chimeric adaptor (CAd) programs at The Society
for Immunotherapy of Cancer (SITC) 37th Annual Meeting and Adicet’s
R&D Pipeline Event
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 fourth quarter and year ended
December 31, 2022.
“In 2022, Adicet demonstrated strong execution in advancing our
gamma delta T cell therapy pipeline and clinical proof of concept
for our therapeutic approach that may provide significant benefit
for people living with cancer. Following the Phase 1 clinical
update in December evaluating ADI-001 for relapsed or refractory
non-Hodgkin’s lymphoma, we are continuing to track and enroll
patients in the study and expect to report additional efficacy,
durability, and safety data in the second quarter of 2023. We plan
to discuss the design of our first potential pivotal study with the
FDA in the second quarter of this year and initiate the pivotal
portion of the study in the second half of the year, potentially in
the third quarter,” said Chen Schor, President and Chief Executive
Officer of Adicet Bio. “In addition, we plan to build on the
preclinical data presented at ISCT, SITC and our R&D event, to
expand our pipeline of first-in-class allogeneic, off-the-shelf
gamma delta CAR T-cell product candidates, and in the second half
of 2023, expect to submit an IND for ADI-925, our novel CAd gamma
delta T cell product candidate.”
Fourth Quarter 2022 and Recent Operational
Highlights:
- Announced Safety & Efficacy Data from Ongoing Phase 1
Study of ADI-001. In December 2022, Adicet reported interim
safety and efficacy data from its ongoing Phase 1 study of ADI-001,
Adicet’s investigational therapy targeting CD20 for the potential
treatment of relapsed or refractory B-cell NHL. As of a December 5,
2022 data-cut date, treatment with ADI-001 demonstrated a 75%
overall response rate (ORR) and a 69% complete response (CR) across
all dose levels with a favorable safety and tolerability profile.
Additionally, in 5/5 large B-cell lymphoma (LBCL) patients that
previously relapsed after prior autologous anti CD-19 CAR T-cell
therapy, treatment with ADI-001 demonstrated a 100% ORR and CR
rate. Enrollment in the trial is currently ongoing to provide
additional durability data and further support the recommended
Phase 2 dose. In the second quarter of 2023, Adicet plans to
discuss the design of its first potential pivotal clinical study
evaluating ADI-001 in post CAR T LBCL patients with the U.S. Food
and Drug Administration (FDA), and initiate the study in the second
half of the year, potentially in the third quarter.
- Presented Preclinical Data for Four New Pipeline Programs at
SITC Annual Meeting. In November 2022 at SITC, Adicet presented
four posters highlighting preclinical data for four differentiated
CAR and CAd gamma delta T cell programs targeting several
hematologic and solid malignancies.
- Hosted R&D Pipeline Event Highlighting Preclinical
Candidates. In November 2022, Adicet hosted an R&D event to
provide additional detail regarding its emerging pipeline of
allogeneic CAR and CAd gamma delta T cell therapy product
candidates for a variety of cancer indications, including solid
tumors. Adicet expects to submit an Investigational New Drug
Application (IND) to the FDA for its lead preclinical candidate,
ADI-925, in the second half of 2023.
- Appointed Nancy Boman, M.D., Ph.D., as Senior Vice President
and Chief Regulatory Officer of Adicet. In November 2022,
Adicet announced the appointment of Dr. Nancy Boman, M.D., Ph.D.,
as Senior Vice President and Chief Regulatory Officer. Dr. Boman
brings nearly 30 years of industry experience in the biotech and
pharmaceutical industry with expertise in regulatory, clinical
development, chemistry, manufacturing and quality, leading more
than 15 drug marketing applications.
- In-House Manufacturing Capacity Established in Redwood City
Facility. In the fourth quarter of 2022, Adicet’s new in-house
manufacturing capabilities in its Redwood City facility became
operational. The facility is designed to enable drug product and
vector manufacturing operations for early clinical development of
Adicet’s pipeline candidates.
Financial Results for Fourth Quarter and Full Year
2022:
Three months Ended December 31, 2022
- Research and Development (R&D) Expenses: R&D
expenses were $25.0 million for the three months ended December 31,
2022, compared to $14.7 million during the same period in 2021. The
$10.3 million increase is primarily driven by a $3.4 million
increase in payroll and personnel expenses, a net increase of $2.8
million for expenses related to contract manufacturing drug
organizations (CDMO), contract research organizations (CRO) and
consultant costs related to our lead product candidate ADI-001, and
a $2.7 million increase in facility allocation. There was also a
$1.0 million increase in lab expenses. Payroll and personnel
expenses for the three months ended December 31, 2022, includes
$1.9 million of non-cash stock-based compensation expense compared
to $1.6 million during the same period in 2021.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.6 million for the three months ended December 31,
2022, compared to $6.4 million during the same period in 2021. The
$0.2 million increase is primarily driven by an increase of $0.5
million of professional fees as well as a $0.2 million increase of
payroll and personnel expenses. This increase was partially offset
by a decrease of $0.1 million in recruiting fees. Payroll and
personnel expenses for the three months ended December 31, 2022,
includes $2.4 million of non-cash stock-based compensation expense
compared to $2.7 million during the same period in 2021.
- Net Loss: Net loss for the three months ended December
31, 2022 was $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, as compared to a net loss of $15.8 million during
the same period in 2021, or a net loss of $0.47 per basic and
diluted share, including non-cash stock-based compensation expense
of $4.3 million.
Twelve Months Ended December 31, 2022
- Research and Development (R&D) Expenses: R&D
expenses were $71.2 million for the year ended December 31, 2022,
as compared to $48.9 million for year ended December 31, 2021. The
increase of $22.3 million in R&D expenses year-over-year was
primarily due to a $9.9 million increase in payroll and personnel
expenses resulting from an increase in overall headcount, a net
$4.4 million increase in expenses related to CDMOs, CROs and
consultant costs related to our lead product candidate ADI-001, a
$4.2 million increase in facility and other expenses and a $2.3
million increase in lab expenses. The increases in facilities and
lab expense are primarily due to the move to new facilities in
Redwood City and setup activities.
- General and Administrative (G&A) Expenses: G&A
expenses were $26.3 million for the year ended December 31, 2022,
compared to $22.2 million for the year ended December 31, 2021. The
increase of $4.1 million was primarily due to a $4.8 million
increase in payroll and personnel expenses, which includes an
increase in stock-based compensation of $2.1 million, salaries and
benefits of $2.0 million and contractor fees of $0.5 million and an
increase in professional fees of $0.4 million. These increases were
primarily due to increased headcount for the period. These
increases were partially offset by a net $1.2 million decrease in
facilities and other related expense.
- Net Loss: Net loss for the year ended December 31, 2022
was $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, as compared to a net loss of $62.0 million during the same
period in 2021, or a net loss of $2.00 per basic and diluted share,
including non-cash stock-based compensation expense of $12.5
million.
- Cash Position: Cash and cash equivalents were $257.7
million as of December 31, 2022 as compared to $277.5 million as of
December 31, 2021. During fiscal year 2022, the Company received
$43.4 million of net proceeds from the sale of common stock through
an "at-the-market" offering and $20 million from the exercise of an
option by Regeneron related to ADI-002. The Company expects that
current cash and cash equivalents securities as of December 31,
2022 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 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 Phase 1
trial of ADI-001 in relapsed/refractory NHL patients, including
ongoing patient enrollment and the identification of a recommended
Phase 2 dose; initiation of a potentially pivotal study in the
second half of 2023, potentially in the third quarter; planned
discussions with the FDA; 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; the utility,
benefits and potential of in-house manufacturing capabilities in
Adicet’s Redwood City facility; 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 Loss
(in thousands, except share
and per share amounts)
(unaudited)
Three Months Ended December
31,
Year Ended December
31,
2022
2021
2022
2021
Revenue—related party
$
—
$
5,468
$
24,990
$
9,730
Operating expenses:
Research and development
25,015
14,658
71,246
48,943
General and administrative
6,550
6,352
26,295
22,220
Total operating expenses
31,565
21,010
97,541
71,163
Loss from operations
(31,565
)
(15,542
)
(72,551
)
(61,433
)
Interest income
2,179
37
3,760
91
Interest expense
(26
)
(25
)
(80
)
(176
)
Other expense, net
(463
)
(294
)
(919
)
(606
)
Loss before income tax provision
(29,875
)
(15,824
)
(69,790
)
(62,124
)
Income tax provision
—
(11
)
—
(125
)
Net loss
$
(29,875
)
$
(15,813
)
$
(69,790
)
$
(61,999
)
Net loss per share, basic and diluted
$
(0.72
)
$
(0.47
)
$
(1.70
)
$
(2.00
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
41,651,298
33,912,230
41,080,286
30,952,152
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
(unaudited)
December 31,
2022
2021
Cash and cash equivalents
$
257,656
$
277,544
Working capital
241,331
266,121
Total assets
330,690
338,938
Contract liabilities – related party,
current
—
4,805
Accumulated deficit
(238,114
)
(168,324
)
Total stockholders’ equity
292,338
303,129
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230315005612/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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