Adicet Reports First Quarter 2021 Financial Results and Provides Business Updates
17 Maggio 2021 - 1:01PM
Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company
discovering and developing first-in-class allogeneic gamma delta T
cell therapies for cancer and other diseases, today reported
financial results for the first quarter ended March 31, 2021.
“The first quarter of 2021 has been highly productive for Adicet
both on the financial and clinical fronts. The successful execution
of our capital raise, and the initiation of the Phase 1 trial of
our lead product candidate, ADI-001, being evaluated for the
treatment of NHL, have put us in a strong position to continue to
build upon our ongoing momentum through the rest of the year,” said
Chen Schor, President and Chief Executive Officer of Adicet Bio.
“We look forward to reporting interim clinical data from the Phase
1 study of ADI-001 later this year as well as continuing to develop
our pipeline of “off-the-shelf” gamma delta T cell product
candidates for the treatment of solid and hematologic tumors.”
First Quarter & Recent Business
Updates:
- Appointed Dr. Blake Aftab as
Vice President of Research. In April 2021, Adicet
announced the appointment of Blake Aftab, Ph.D., as Vice President
of Research and Development. Dr. Aftab will lead Adicet’s research
group and further progress the Company’s gamma delta T cell
platform and pipeline of programs. Dr. Aftab has nearly 20 years of
rich experience in academia, biotech and the pharmaceutical
industry developing multiple therapeutic modalities including cell
therapies, small molecules, biologics and antibody-drug conjugates
through all stages of drug development. Dr. Aftab succeeds Dr.
Stewart Abbot who will be stepping down from his role as Chief
Scientific Officer and moving to an advisory role with the
Company.
- Initiated Phase 1 Trial of ADI-001 for the Treatment of
NHL. In March 2021, Adicet announced the initiation of its
first-in-human Phase I clinical trial evaluating ADI-001, an
investigational first-in-class allogeneic gamma delta T cell
therapy expressing a chimeric antigen receptor (CAR) targeting
CD20, for the treatment of NHL. ADI-001 is believed to be the first
IND-cleared allogeneic CAR gamma-delta T cell therapy to reach
human trials. Patient dosing has commenced in the Phase I trial to
evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of ADI-001, and to determine optimal dosing as a
monotherapy. Preliminary safety and tolerability data expected by
the end of 2021.
- Appointed Andrew Sinclair,
Ph.D., to the Company’s Board of Directors. In March 2021,
Adicet announced the appointment of Andrew Sinclair, Ph.D., to its
Board of Directors. Dr. Sinclair is currently a partner and
portfolio manager at Abingworth LLP, where he has served in various
positions focusing on investments in public and private biotech and
pharmaceutical companies.
- Successfully raised $143.8
million in net proceeds through a public offering and concurrent
private placement. In February 2021, Adicet successfully
completed a capital financing of $152 million in aggregate gross
proceeds. After deducting underwriting discounts and commissions
and offering expenses, the Company received $143.8 million of net
proceeds. The Company plans to utilize the net proceeds from the
financing to advance its gamma delta T cell therapies.
Financial Results for First Quarter 2021:
- Research and Development
(R&D) Expenses: R&D expenses were $11.7 million
for the three months ended March 31, 2021, compared to $7.0 million
during the same period in 2020. The $4.7 million increase is
primarily driven by an increase of $2.7 million of payroll and
personnel expenses due to increases in headcount of employees
involved in research and development activities, an increase of
$1.3 million incurred for contract research organizations and
consultant costs due to ramping up of clinical development
activities related to our first product candidate, ADI-001 and an
increase of $0.7 million in facility and other expenses. Payroll
and personnel expenses for the three months ended March 31, 2021
includes $1.5 million of non-cash stock-based compensation expense
compared to $0.1 million during the same period in 2020.
- General and Administrative
(G&A) Expenses: G&A expenses were $5.6 million for
the three months ended March 31, 2021, compared to $2.5 million
during the same period in 2020. The $3.1 million increase is
primarily driven by an increase of $1.5 million of payroll and
personnel expenses, an increase of $0.4 million of professional
fees for legal, consulting, accounting, tax and other services, and
an increase of $1.1 million in facility and other expenses. Payroll
and personnel expenses for the three months ended March 2021
includes $1.4 million of non-cash stock-based compensation expense
compared to $0.2 million during the same period in 2020.
- Net Loss: Net loss
attributable to common shareholders for the three months ended
March 31, 2021 was $21.3 million, or a net loss of $0.82 per basic
and diluted share, including non-cash stock-based compensation
expense of $3.0 million, as compared to a net loss of $4.5 million
during the same period in 2020, or a net loss of $2.07 per basic
and diluted share, including non-cash stock-based compensation
expense of $0.3 million.
- Cash and Marketable Debt
Securities Position: Cash and cash equivalents and
marketable debt securities were $223.4 million as of March 31,
2021, compared to $94.6 million as of December 31, 2020. The
Company expects that current cash, cash equivalents and marketable
securities as of March 31, 2021 will be sufficient to fund its
operating expenses through the beginning of the second half of
2023.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a 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 antibodies 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 StatementsThis 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 and ADI-002 and potential therapeutic
effects of ADI-001 and ADI-002, the timing and outcome of
discussions with FDA and other regulatory agencies, expectations
regarding the design, implementation, timing, and success of its
current and future clinical studies of ADI-001, and ADI-002
including whether they are pivotal or would support registration,
expectations regarding its other CAR T cell therapy development
activities, Adicet’s growth as a company and the anticipated
contribution of the members of its board of directors to its
operations and progress, and its expectations regarding its uses of
capital, expenses, future accumulated deficit and other first
quarter 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 its clinical trials,
business operations, and ability to raise additional capital;
Adicet’s ability to execute on its strategy; that positive results
from a clinical study may not necessarily be predictive of the
results of future or ongoing clinical studies; 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; regulatory approval
processes of the FDA and comparable foreign regulatory authorities
are lengthy, time-consuming, and inherently unpredictable;
regulatory developments in the United States and foreign countries;
Adicet’s estimates regarding expenses, future revenue, and capital
requirements; 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 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.Investor and Media ContactsAnne
Bowdidgeabowdidge@adicetbio.com
Janhavi MohiteStern Investor Relations,
Inc.212-362-1200janhavi.mohite@sternir.com
Adicet Bio,
Inc.Consolidated Statements of Operations and
Comprehensive Loss(in thousands, except share and
per share amounts)(unaudited)
|
Three Months Ended March 31, |
|
|
2021 |
|
|
|
2020 |
|
Revenue—related party |
$ |
(3,981 |
) |
|
$ |
2,000 |
|
Operating expenses: |
|
|
|
Research and development |
|
11,743 |
|
|
|
7,033 |
|
General and administrative |
|
5,630 |
|
|
|
2,524 |
|
Total operating expenses |
|
17,373 |
|
|
|
9,557 |
|
Loss from operations |
|
(21,353 |
) |
|
|
(7,557 |
) |
Interest income |
|
41 |
|
|
|
322 |
|
Interest expense |
|
(50 |
) |
|
|
— |
|
Other income (expense), net |
|
(4 |
) |
|
|
70 |
|
Loss before income tax
benefit |
|
(21,367 |
) |
|
|
(7,165 |
) |
Income tax expense (benefit) |
|
(48 |
) |
|
|
(2,679 |
) |
Net loss |
$ |
(21,319 |
) |
|
$ |
(4,486 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.82 |
) |
|
$ |
(2.07 |
) |
Weighted-average shares used in
computing net loss per share attributable to common stockholders,
basic and diluted |
|
26,099,954 |
|
|
|
2,163,440 |
|
Adicet Bio, Inc.Balance
Sheet Data(in
thousands)(unaudited)
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
Cash, cash equivalents and marketable debt securities |
|
$ |
223,420 |
|
|
$ |
94,614 |
|
Working capital |
|
|
203,923 |
|
|
|
77,857 |
|
Total assets |
|
|
282,073 |
|
|
|
153,835 |
|
Contract liabilities—related
party |
|
|
17,961 |
|
|
|
13,980 |
|
Accumulated deficit |
|
|
(127,644 |
) |
|
|
(106,325 |
) |
Total stockholders' equity |
|
|
236,259 |
|
|
|
109,827 |
|
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