Adicet Reports First Quarter 2022 Financial Results and Provides Business Updates
12 Maggio 2022 - 10:10PM
Business Wire
Interim data from ADI-001 Phase 1 trial
accepted for oral presentation at 2022 ASCO Annual Meeting
Strong balance sheet with $277.9 million in
cash and cash equivalents as of March 31, 2022
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
first quarter ended March 31, 2022.
“We made steady progress with the clinical development of our
lead asset ADI-001 during the first quarter of 2022 and look
forward to reporting updated clinical data from our Phase 1 study
of ADI-001 in an oral presentation at the American Society of
Clinical Oncology (ASCO) Annual Meeting in June,” said Chen Schor,
President and Chief Executive Officer at Adicet Bio. “We are also
pleased with the progress of several additional pre-clinical
pipeline programs and expect to share more information about our
growing pipeline in the near future.”
First Quarter 2022 and Recent Operational Highlights:
- Presented ADI-001 Preclinical Data at ISCT. In May,
Adicet announced data from a preclinical evaluation of ADI-001 at
the International Society for Cell and Gene Therapy (ISCT) Annual
Meeting highlighting potential advantages of the non-gene-edited
approach for its investigational allogeneic gamma delta CAR T cell
therapy targeting CD20 for B cell malignancies.
- Granted Fast Track Designation. In April, Adicet
announced that the U.S. Food and Drug Administration granted Fast
Track Designation to ADI-001 for the potential treatment of
relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
- Additional ADI-001 Phase 1 study data to be presented at the
2022 ASCO Annual Meeting. In April, Adicet announced that
Sattva S. Neelapu, M.D., from The University of Texas MD Anderson
Cancer Center will deliver an oral presentation titled, “A phase 1
study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta
(γδ) t cells in adults with B-cell malignancies” at the American
Society of Clinical Oncology (ASCO) during a Clinical Science
Symposium entitled “Beating Bad Blood: The Power of Immunotherapy
in Hematologic Malignancies” from 8:00am to 9:30am CDT on June 6,
2022.
- Publication of ADI-001 preclinical data in Clinical and
Translational Immunology. In February, 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 highlight the anti-tumor mechanism of
ADI-001’s profile by maintaining the TCR gamma repertoire,
preserving the adaptive targeting potential enabling tumor
recognition and killing, as well as maintaining innate targeting
activity. In vitro analysis showed faster kinetics compared to
alpha beta T cells expressing the same CD20 CAR, whereas in vivo
analysis demonstrated potent inhibition of tumor growth with
activated innate and adaptive pathways contributing to the efficacy
profile.
- Regeneron licensed the exclusive, worldwide rights to
ADI-002. In January, Regeneron Pharmaceuticals, Inc.
(Regeneron) exercised its option to license the exclusive,
worldwide rights to ADI-002, an 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 and the Company completed the transfer of the
associated license rights to Regeneron by March 31, 2022.
Financial Results for First Quarter 2022:
- Research and Development (R&D) Expenses: R&D
expenses were $13.5 million for the three months ended March 31,
2022, compared to $11.8 million during the same period in 2021. The
$1.7 million increase is primarily driven by a $0.6 million
increase in payroll and personnel expenses resulting from an
increase in overall headcount, a $0.4 million increase in lab
supplies and consumables expenses and $0.4 million increase in
contract manufacturing organization and other externally sponsored
R&D expense. In addition, there was a $0.4 million increase in
facility and other expenses. This was partially offset by a $0.2
million decrease in contract research organization expense related
to initial setup fees for the Company’s Phase 1 trial. Payroll and
personnel expenses for the three months ended March 31, 2022
includes $1.7 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 $6.8 million for the three months ended March 31,
2022, compared to $5.6 million during the same period in 2021. The
$1.2 million increase is primarily driven by a $1.5 million
increase in payroll and personnel fees, which was partially offset
by a $0.3 million decrease in professional service fees. Payroll
and personnel expenses for the three months ended March 31, 2022
includes $2.6 million of non-cash stock-based compensation expense,
compared to $1.5 million during the same period in 2021.
- Net Income/Loss: Net income attributable to common
shareholders for the three months ended March 31, 2022 was $4.6
million, or a net income per basic share of $0.12 and per diluted
share of $0.10, which includes non-cash stock-based compensation
expense of $4.4 million. Net loss attributable to common
shareholders was $21.3 million during the same period in 2021, or a
net loss of $0.82 per basic and diluted share, including non-cash
stock-based compensation expense of $3.0 million.
- Cash Position: Cash and cash equivalents were $277.9
million as of March 31, 2022, compared to $277.5 as of December 31,
2021. The Company expects that current cash and cash equivalents as
of March 31, 2022 will be sufficient to fund its operating expenses
into the second half of 2024.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical
stage biotechnology company discovering and developing allogeneic
gamma delta T cell therapies for cancer and other diseases. Adicet
is advancing a pipeline of “off-the-shelf” gamma delta T cells,
engineered with chimeric antigen receptors 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, as amended, including, without limitation,
implied and express statements regarding Adicet’s business plans
and focus, strategy, and operations including, but not limited to,
preclinical and clinical development of Adicet’s product
candidates, such as future plans or expectations for ADI-001,
potential safety, tolerability and therapeutic effects of ADI-001
and the planned release of interim clinical data from Adicet’s
Phase 1 trial of ADI-001 in NHL patients; the progress of Adicet’s
pre-clinical pipeline programs; and Adicet’s growth as a company
and its expectations regarding its uses of capital, expenses,
future accumulated deficit and 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 the
Company’s 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;
regulatory approval processes of the FDA and comparable foreign
regulatory authorities are lengthy, time-consuming, and inherently
unpredictable; as well as those risks and uncertainties set forth
in the company’s most recent annual report on Form 10-K and
subsequent filings with the Securities and Exchange Commission. 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 March
31,
2022
2021
Revenue—related party
$
24,990
$
(3,981)
Operating expenses:
Research and development
13,483
11,743
General and administrative
6,801
5,630
Total operating expenses
20,284
17,373
Income (loss) from operations
4,706
(21,354)
Interest income
32
41
Interest expense
(18)
(50)
Other expense, net
(102)
(4)
Income (loss) before income tax
benefit
4,618
(21,367)
Income tax benefit
—
(48)
Net income (loss)
$
4,618
$
(21,319)
Net income (loss) per share attributable
to common stockholders, basic
$
0.12
$
(0.82)
Net income (loss) per share attributable
to common stockholders, diluted
$
0.10
$
(0.82)
Weighted-average common shares used in
computing net income (loss) per share attributable to common
stockholders, basic
39,823,246
26,099,954
Weighted-average common shares used in
computing net income (loss) per share attributable to common
stockholders, diluted
45,958,941
26,099,954
Other comprehensive loss:
Unrealized loss gain on marketable debt
securities, net of tax
—
(22)
Total other comprehensive loss
—
(22)
Comprehensive income (loss)
$
4,618
$
(21,341)
ADICET BIO, INC.
Balance Sheet Data
(in thousands)
(unaudited)
March 31, 2022
December 31,
2021
Cash and cash equivalents
$
277,883
$
277,544
Working capital
271,131
266,121
Total assets
340,151
338,938
Contract liabilities – related party,
current
—
4,805
Accumulated deficit
(163,706)
(168,324)
Total stockholders’ equity
311,084
303,129
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version on businesswire.com: https://www.businesswire.com/news/home/20220512005814/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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