Adicet Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Recent Company Progress
March 15 2022 - 4:00PM
Business Wire
- Complete and near complete responses observed starting at
lowest dose in interim findings from Phase 1 study of ADI-001 in
non-Hodgkin’s lymphoma (NHL); additional interim clinical data
expected in the first half of 2022
- Successfully raised $94.2 million in net proceeds through a
public follow-on offering
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing first-in-class allogeneic gamma
delta chimeric antigen receptor (CAR) T cell therapies for cancer,
today reported financial results and operational highlights for the
fourth quarter and year ended December 31, 2021.
“2022 marks an exciting new chapter for Adicet. Our clinical and
operational accomplishments in the fourth quarter of 2021,
including the presentation of positive clinical data for our lead
asset ADI-001 in NHL, in which we observed complete responses
starting at our lowest dose level, and our subsequent successful
capital raise, serve as a strong foundation to continue to execute
against key upcoming milestones,” said Chen Schor, President and
Chief Executive Officer of Adicet Bio. “We’re pleased to share that
we’ve completed dosing of subjects in dose level two and are
enrolling subjects in dose level three in our Phase 1 trial and
remain on track to report additional interim clinical data in the
first half of 2022, which we hope will further reinforce the
potential of Adicet’s first-in-class allogeneic, off-the-shelf
gamma delta CAR T cell platform for patients living with
cancer.”
Fourth Quarter 2021 and Recent Operational
Highlights:
- Announced positive interim clinical data from Phase 1 study
ADI-001. In December 2021, Adicet reported positive interim
data from its ongoing dose escalation Phase 1 study evaluating the
safety and tolerability of ADI-001, Adicet’s investigational
therapy targeting CD20 for the potential treatment of NHL. Complete
and near complete responses were observed starting at lowest dose
level (30 million CAR+ cells), as well as evidence of in vivo
expansion and circulating pharmacodynamic biomarkers consistent
with ADI-001 activation. Overall, ADI-001 infusions were generally
well-tolerated, with no ADI-001 related serious adverse events,
including Graft Versus Host Disease (GvHD), neurotoxicity or
high-grade Cytokine release syndrome (CRS) reported as of the
November 22, 2021, data cutoff. Adicet has completed dosing of
subjects in dose level two and is currently enrolling subjects in
dose level three. The Company anticipates reporting additional
interim clinical data in the first half of 2022.
- Successfully raised $94.2 million in net proceeds through a
public follow-on offering. In December 2021, Adicet
successfully completed a capital financing of $100.6 million in
aggregate gross proceeds. After deducting underwriting discounts
and commissions and offering expenses, the Company received $94.2
million of net proceeds. The Company plans to utilize the net
proceeds from the financing to advance its pipeline of gamma delta
CAR T cell therapies.
- Regeneron Pharmaceuticals to license the exclusive,
worldwide rights to ADI-002. In January 2022, Regeneron
Pharmaceuticals, Inc. exercised its option to license the
exclusive, worldwide rights to ADI-002, Adicet’s allogeneic gamma
delta CAR T cell therapy directed against Glypican-3. In
conjunction with the exercise of the option, Regeneron paid an
exercise fee of $20.0 million to Adicet.
- ADI-001 preclinical data published in Clinical and
Translational Immunology. In February 2022, Clinical and
Translational Immunology published data highlighting the key
properties of ADI-001, the Company’s investigational therapy
targeting CD20 for the potential treatment of B-cell NHL. These
preclinical findings underscore ADI-001’s potent, rapid targeting
activity, which combines innate, adaptive and CAR-mediated
mechanisms. Preclinical data also demonstrated efficient kinetics
of cell killing compared to traditional CAR T cells, highly durable
and proliferative cell activity, and decreased expression of cell
exhaustion markers, all of which may support high anti-tumor
potency and therapeutic potential.
- Appointed Michael G. Kauffman, M.D., Ph.D., to the Company’s
Board of Directors. In November 2021, Adicet announced the
appointment of Dr. Michael Kauffman to its Board of Directors. Dr.
Kauffman is currently a board member for Karyopharm Therapeutics,
Verastem Oncology and Kezar Life Sciences, and brings over 20 years
of experience in the life sciences industry, including expertise in
preclinical research, clinical development and regulatory strategy
to Adicet’s board.
- Presented Preclinical Data for ADI-002 at the 36th Society
for Immunotherapy of Cancer (SITC) Annual Meeting. In November
2021, Adicet presented preclinical findings for ADI-002 at the SITC
Annual Meeting. The data demonstrated potent gamma delta CAR T cell
activation, cytotoxicity, tumor-specific homing, proliferation, and
enhanced activity without evidence of graft versus host
alloreactivity. ADI-002 is designed specifically to target solid
tumors.
Financial Results for Fourth Quarter and Full Year
2021:
Three months Ended December 31, 2021
- Research and Development (R&D) Expenses: R&D
expenses were $14.7 million for the three months ended December 31,
2021, compared to $9.7 million during the same period in 2020. The
$5.0 million increase is primarily driven by an increase of $1.8
million of payroll and personnel expenses, a net increase of $1.8
million for expenses related to contract manufacturing
organizations (CMO), contract research organizations (CRO) and
consultant costs related to our lead product candidate ADI-001, and
other externally sponsored research expenses, and an increase of
$1.3 million in facility and other expenses. Payroll and personnel
expenses for the three months ended December 31, 2021, includes
$1.6 million of non-cash stock-based compensation expense compared
to $0.6 million during the same period in 2020.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.4 million for the three months ended December 31,
2021, compared to $5.1 million during the same period in 2020. The
$1.3 million increase is primarily driven by an increase of $1.8
million of payroll and personnel expenses, partially offset by a
decrease of $0.5 million of professional fees for legal,
consulting, accounting, tax and other services. Payroll and
personnel expenses for the three months ended December 31, 2021,
includes $2.7 million of non-cash stock-based compensation expense
compared to $1.1 million during the same period in 2020.
- Net Loss: Net loss attributable to common shareholders
for the three months ended December 31, 2021, was $15.8 million, or
a net loss of $0.47 per basic and diluted share, including non-cash
stock-based compensation expense of $4.3 million, as compared to a
net loss of $9.0 million during the same period in 2020, or a net
loss of $0.46 per basic and diluted share, including non-cash
stock-based compensation expense of $1.6 million.
Twelve Months Ended December 31, 2021
- Research and Development (R&D) Expenses: R&D
expenses were $48.9 million for the year ended December 31, 2021,
as compared to $34.3 million for year ended December 31, 2020. The
increase of $14.6 million in R&D expenses year-over-year was
primarily due to an increase of $5.8 million related to payroll and
personnel expenses due to increases in headcount of employees
involved in research and development activities and an increase in
stock-based compensation of $3.1 million. In addition, there was an
increase of $3.7 million in fees incurred for CMO, CRO and
consultant costs due to ramping up manufacturing and clinical
development activities related to our first product candidate
ADI-001 and other externally sponsored research, and an increase of
$4.9 million in facilities and other expenses.
- General and Administrative (G&A) Expenses: G&A
expenses were $22.2 million for the year ended December 31, 2021,
compared to $22.8 million for the year ended December 31, 2020. The
decrease was primarily due to a decrease of $6.3 million in
professional fees related to legal and audit fees incurred due to
our reverse merger in 2020, partially offset by an increase of $3.1
million of payroll and personnel expenses, which included higher
stock-based compensation of $4.2 million and salaries and benefits
of $1.0 million and lower temporary contractor fees of $2.2
million. There was also an increase of $2.8 million in facilities
and other expenses and $0.5 million in other administrative
costs.
- Net Loss: Net loss attributable to common shareholders
for the year ended December 31, 2021, was $62.0 million, or a net
loss of $2.00 per basic and diluted share, including non-cash
stock-based compensation expense of $12.5 million, as compared to a
net loss in 2020 of $36.7 million, or a net loss of $5.01 per basic
and diluted share, including non-cash stock-based compensation
expense of $5.3 million.
- Cash Position: Cash and cash equivalents and marketable
debt securities were $277.5 million as of December 31, 2021,
compared to $94.6 million as of December 31, 2020. In December
2021, the Company successfully completed a public offering
resulting in $94.2 million of net proceeds. The Company expects
that current cash and cash equivalents and marketable debt
securities as of December 31, 2021, will be sufficient to fund its
operating expenses at least into the second half of 2024.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a 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 CAR and T cell receptor-like targeting
moieties to enhance selective tumor targeting, facilitate innate
and adaptive anti-tumor immune response, and improve persistence
for durable activity in patients. For more information, please
visit our website at http://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
including, but 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,
potential safety, tolerability and therapeutic effects of ADI-001
and the timing of the interim clinical data from our Phase 1 trial
of ADI-001 in NHL patients; the potential therapeutic effects of
ADI-002; the contributions resulting from members of the board of
directors; and Adicet’s growth as a company and its expectations
regarding its uses of capital, expenses, future accumulated deficit
and other fourth quarter and year end 2021 financial results. 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 COVID-19 on Adicet’s business and
financial results, including with respect to disruptions to our
clinical trials, 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 timing, if at all;
that positive results from a clinical study may not necessarily be
predictive of the results of future or ongoing clinical studies;
current or future clinical studies may fail to demonstrate adequate
safety and efficacy of our product candidates, which would prevent,
delay, or limit the scope of regulatory approval and
commercialization; as well as those risks and uncertainties set
forth in Adicet’s most recent annual report on Form 10-K and
subsequent filings with the Securities and Exchange Commission
(SEC). 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 its 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
(unaudited)
(in thousands, except share
and per share amounts)
Three Months Ended December
31,
Year ended December
31,
2021
2020
2021
2020
Revenue—related party
$
5,468
$
5,410
$
9,730
$
17,903
Operating expenses:
Research and development
14,658
9,683
48,943
34,334
General and administrative
6,352
5,076
22,220
22,760
Total operating expenses
21,010
14,759
71,163
57,094
Loss from operations
(15,542
)
(9,349
)
(61,433
)
(39,191
)
Interest income
37
81
91
785
Interest expense
(25
)
(50
)
(176
)
(134
)
Other income (expense), net
(294
)
221
(606
)
(953
)
Loss before income tax benefit
(15,824
)
(9,097
)
(62,124
)
(39,493
)
Income tax expense (benefit)
(11
)
(139
)
(125
)
(2,815
)
Net loss
$
(15,813
)
$
(8,958
)
$
(61,999
)
$
(36,678
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.47
)
$
(0.46
)
$
(2.00
)
$
(5.01
)
Weighted-average shares used in computing
net loss per share attributable to common stockholders, basic and
diluted
33,912,230
19,618,469
30,952,152
7,319,977
Adicet Bio, Inc.
Balance Sheet Data
(unaudited)
(in thousands)
December 31,
2021
2020
Cash, cash equivalents and
marketable debt securities
$
277,544
$
94,614
Working capital
266,121
77,857
Total assets
338,938
153,835
Contract liabilities—related party
4,805
13,980
Accumulated deficit
(168,324
)
(106,325
)
Total stockholders' equity (deficit)
303,129
109,827
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version on businesswire.com: https://www.businesswire.com/news/home/20220314005955/en/
Adicet Bio, Inc. Investor and Media Contacts Anne
Bowdidge abowdidge@adicetbio.com
Janhavi Mohite Stern Investor Relations, Inc. 212-362-1200
Adicet Bio (NASDAQ:ACET)
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