Adicet Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
March 11 2021 - 4:10PM
Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company
discovering and developing allogeneic gamma delta T cell therapies
for cancer and other diseases, today reported financial results and
provided a business update for the fourth quarter and full year
ended December 31, 2020.
“Over the past year, Adicet achieved several development and
operational milestones including the initiation of our
first-in-human Phase 1 for ADI-001 for the treatment of B cell
non-Hodgkin’s lymphoma, the completion of our merger with
resTORbio, and the expansion of our leadership team with the
appointments of Nick Harvey as Chief Financial Officer, Dr. Don
Healey as Chief Technology Officer and Dr. Bastiano Sanna and Dr.
Andrew Sinclair to our Board of Directors,” said Chen Schor,
President and Chief Executive Officer of Adicet. “Recently, we
successfully raised significant capital to support further
development of our robust pipeline comprising of gamma delta T cell
therapies. These accomplishments have put us in a strong position
to execute on our Phase 1 study of ADI-001, with interim clinical
data expected in 2021, and expand our pipeline of “off-the-shelf”
gamma delta T cell therapies that will potentially provide for a
targeted, durable, and on demand treatment option for solid and
hematologic tumors.”
Full Year 2020 & Recent Business
Updates:
- Successfully raised $143.6
million in net proceeds through a public offering and concurrent
private placement. In February 2021, Adicet Bio
successfully completed a capital financing of $152 million in
aggregate gross proceeds. After deducting underwriting discounts
and commissions and offering expenses, the Company received $143.6
million of net proceeds. The Company plans to utilize the net
proceeds from the financing to advance its gamma delta T cell
therapies.
- Appointed two new members to
the Company’s Board of Directors. In December 2020, Adicet
announced the appointment of Bastiano Sanna, Ph.D., to its Board of
Directors. Dr. Sanna brings significant expertise in advancing
research, development and manufacturing of cell therapies. He
currently serves as Executive Vice President and Chief of Cell and
Genetic Therapies at Vertex Pharmaceuticals. In March 2021, Adicet
announced the appointment of Andrew Sinclair, Ph.D., to its board
of directors. Dr. Sinclair brings significant financial and
scientific experience amassed through his career. He currently
serves as a partner and portfolio manager at Abingworth LLP, a life
sciences investment group.
- Strengthened the management
team with the appointment of Nick Harvey as Chief Financial Officer
and Dr. Don Healey as Chief Technology Officer.
In September 2020, Adicet announced the appointment of Nick
Harvey as Chief Financial Officer. Mr. Harvey leads the execution
of the Company’s financial strategy, as well as manages activities
related to accounting, capital markets and business operations. He
brings over two decades of experience in financial operations,
capital markets, investor relations and M&A transactions to the
Adicet team, as well as extensive experience managing the corporate
growth of life sciences companies.
In October 2020, Adicet announced the appointment of Don Healey,
Ph.D., as Chief Technology Officer. Dr. Healey leads the
development of Adicet’s genetically-modified T cell therapies for
clinical development and commercialization, including
manufacturing, viral vector operations and analytics. Dr. Healey
brings nearly two decades of experience in cell therapy development
and manufacturing to the Adicet team.
- Completed merger with
resTORbio. In September 2020, Adicet announced the
completion of its merger with resTORbio, Inc. and commenced trading
under the ticker symbol “ACET” on the Nasdaq Global Market on
September 16, 2020.
- Received $10 million
product development milestone from Regeneron. In August
2020, Adicet received a $10 million milestone payment associated
with ADI-002 meeting key preclinical development goals, in
accordance with the terms of its strategic collaboration with
Regeneron.
Financial Results for Fourth Quarter and Full Year
2020:
Three months Ended December 31, 2020
- Research and Development
(R&D) Expenses: R&D expenses were $9.7
million for the three months ended December 31, 2020,
compared to $6.5 million during the same period in 2019.
The $3.2 million increase is primarily driven by an increase
of $1.7 million in payroll and personnel expenses due to
increases in headcount of employees involved in research and
development activities and an increase of $1.3 million in
fees incurred for CRO and consultant costs due to initiating and
ramping up clinical development activities related to our first
product candidate ADI-001. Payroll and personnel expenses for the
three months ended December 31, 2020 includes $0.6
million of non-cash stock-based compensation expense compared
to $0.1 million during the same period in 2019.
- General and Administrative
(G&A) Expenses: G&A expenses were $5.1
million for the three months ended December 31, 2020, compared to
$2.6 million during the same period in 2019. The $2.5 million
increase is primarily driven by an increase of $1.0
million of payroll and personnel expenses, an increase
of $0.7 million of professional fees for legal,
consulting, accounting, tax and other services, and an increase
of $0.8 million in facility and other expenses. Payroll
and personnel expenses for the three months ended December
2020 includes $1.1 million of non-cash stock-based
compensation expense compared to $0.2 million during the
same period in 2019.
- Net Loss: Net
loss attributable to common shareholders for the three months
ended December 31, 2020 was $9.0 million, or a net loss
of $0.46 per basic and diluted share, including non-cash
stock-based compensation expense of $1.6 million, as compared
to a net loss of $6.6 million during the same period in
2019, or a net loss of $3.05 per basic and diluted share,
including non-cash stock-based compensation expense of $0.3
million.
Twelve Months Ended December 31, 2020
- Research and Development
(R&D) Expenses: R&D expenses were $34.3 million
for the year ended December 31, 2020, as compared to $23.7 million
for year ended December 31, 2019. The increase of $10.6 million in
R&D expenses year-over-year was primarily due to an increase of
$5.3 million related to payroll and personnel expenses due to
increases in headcount of employees involved in research and
development activities and an increase of $4.6 million in
fees incurred for CMO, CRO and consultant costs due to initiating
and ramping up manufacturing and clinical development activities
related to our first product candidate ADI-001.
- General and Administrative
(G&A) Expenses: G&A expenses were $22.8 million
for the year ended December 31, 2020, compared to $8.7 million for
the year ended December 31, 2019. The increase was primarily due to
an increase of $7.1 million of professional fees for legal,
consulting, accounting, tax and other services related to
transaction costs incurred in connection with the merger with
resTORbio, an increase of $4.1 million of facilities and other
expenses and an increase of $2.7 million of non-cash stock
compensation expense.
- Net Loss: Net loss
attributable to common shareholders for the year ended December 31,
2020 was $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, as compared to a net loss of $28.1 million during
the same period in 2019, or a net loss of $13.15 per basic and
diluted share, including non-cash stock-based compensation expense
of $1.2 million.
- Cash and Marketable Debt
Securities Position: Cash, cash equivalents and marketable
debt securities were $94.6 million as of December 31, 2020 as
compared to $62.4 million as of December 31, 2019. In February
2021, the Company successfully completed a capital financing of
$152 million in aggregate gross proceeds. The Company expects that
current cash, cash equivalents and marketable securities will be
sufficient to fund its operating expenses at least into 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, 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 fourth quarter and
year end 2020 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. 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(unaudited)(in
thousands, except share and per share amounts)
|
Three Months Ended December 31, |
|
Year ended December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue—related party |
$ |
5,410 |
|
|
$ |
1,969 |
|
|
$ |
17,903 |
|
|
$ |
995 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
9,683 |
|
|
|
6,523 |
|
|
|
34,334 |
|
|
|
23,691 |
|
General and administrative |
|
5,076 |
|
|
|
2,623 |
|
|
|
22,760 |
|
|
|
8,692 |
|
Total operating expenses |
|
14,759 |
|
|
|
9,146 |
|
|
|
57,094 |
|
|
|
32,383 |
|
Loss from operations |
|
(9,349 |
) |
|
|
(7,177 |
) |
|
|
(39,191 |
) |
|
|
(31,388 |
) |
Interest income |
|
81 |
|
|
|
377 |
|
|
|
785 |
|
|
|
938 |
|
Interest expense |
|
(50 |
) |
|
|
— |
|
|
|
(134 |
) |
|
|
— |
|
Other income (expense), net |
|
221 |
|
|
|
240 |
|
|
|
(953 |
) |
|
|
2,331 |
|
Loss before income tax
benefit |
|
(9,097 |
) |
|
|
(6,560 |
) |
|
|
(39,493 |
) |
|
|
(28,119 |
) |
Income tax expense (benefit) |
|
(139 |
) |
|
|
18 |
|
|
|
(2,815 |
) |
|
|
19 |
|
Net loss |
$ |
(8,958 |
) |
|
$ |
(6,578 |
) |
|
$ |
(36,678 |
) |
|
$ |
(28,138 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.46 |
) |
|
$ |
(3.05 |
) |
|
$ |
(5.01 |
) |
|
$ |
(13.15 |
) |
Weighted-average shares used in
computing net loss per share attributable to common stockholders,
basic and diluted |
|
19,618,469 |
|
|
|
2,154,790 |
|
|
|
7,319,977 |
|
|
|
2,138,973 |
|
Adicet Bio, Inc.Balance
Sheet Data(unaudited)(in
thousands)
|
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Cash, cash equivalents and
marketable debt securities |
|
$ |
94,614 |
|
|
$ |
72,988 |
|
Working capital |
|
|
77,857 |
|
|
|
49,321 |
|
Total assets |
|
|
153,835 |
|
|
|
81,587 |
|
Contract liabilities—related
party |
|
|
13,980 |
|
|
|
21,883 |
|
Accumulated deficit |
|
|
(106,325 |
) |
|
|
(69,647 |
) |
Total stockholders' equity
(deficit) |
|
|
109,827 |
|
|
|
(60,366 |
) |
|
|
|
|
|
Adicet Bio (NASDAQ:ACET)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adicet Bio (NASDAQ:ACET)
Historical Stock Chart
From Apr 2023 to Apr 2024