Adicet Reports Third Quarter 2020 Financial Results and Provides Business Update
November 05 2020 - 4:10PM
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 third quarter ended September 30, 2020.
“We are extremely proud of the milestones we’ve achieved this
quarter, including the completion of the merger between Adicet Bio
and resTORbio, the clearance of our IND application for ADI-001,
and the expansion of our executive team with the appointment of
Nick Harvey as CFO and, more recently, Don Healey, Ph.D., as CTO,”
said Chen Schor, President and Chief Executive Officer of Adicet.
“Looking ahead, we expect to initiate the Phase 1 clinical trial
for ADI-001 in the first quarter of 2021 for the treatment of
non-Hodgkin’s lymphoma and continue to leverage our γδ T therapy
approach to provide a pipeline of highly differentiated product
candidates with selective tumor targeting, innate and adaptive
anti-tumor immune response, and improved persistence for durable
activity.”
Third Quarter & Recent Business Updates
- IND application cleared by FDA for lead asset, ADI-001,
a first-in-class allogeneic CAR gamma-delta T cell
therapy. In October 2020, Adicet reported that the U.S.
Food and Drug Administration (FDA) accepted the Company’s
Investigational New Drug (IND) application for lead asset, ADI-001,
an allogeneic gamma delta (γδ) T cell therapy expressing a chimeric
antigen receptor (CAR) targeting CD20 for treatment of
non-Hodgkin’s lymphoma (NHL). The Company expects to initiate the
Phase 1 clinical trial in the first quarter of 2021 to evaluate
safety and efficacy of ADI-001 in NHL patients. Site initiation
activities are underway and interim clinical data from this study
are expected in 2021.
- Built out the management team with the appointment of
Nick Harvey as Chief Financial Officer and Don Healey, Ph.D., as
Chief Technology Officer. In September 2020, Adicet
announced the appointment of Nick Harvey as Chief Financial
Officer. Mr. Harvey is responsible for leading the company’s
financial strategy and management of activities related to
accounting, capital markets and business operations. In October
2020, Dr. Healey joined the management team as Chief Technology
Officer, responsible for the development of Adicet’s
genetically-modified T cell therapies for clinical development and
commercialization, including manufacturing, viral vector operations
and analytics.
- Successfully completed merger with resTORbio.
In September 2020, Adicet Bio completed its merger with resTORbio,
Inc. and commenced trading on the Nasdaq Global Market under the
ticker symbol “ACET” on September 16, 2020.
- Received $10 million product development milestone
payment from Regeneron. In August 2020, Adicet announced
that it received a $10 million milestone payment from Regeneron
related to ADI-002 meeting key preclinical development goals, in
accordance with the terms of its strategic collaboration with
Regeneron. ADI-002 is Adicet's allogeneic off-the-shelf γδ T cell
product candidate targeting GPC3 for solid tumors associated with
high GPC3 expression such as hepatocellular carcinoma, the most
prevalent form of liver cancer.
Financial Results for Third Quarter of
2020:
- Research and Development (R&D) Expenses:
R&D expenses increased by $2.6 million to $8.9 million for the
quarter ended September 30, 2020, compared to $6.3 million during
the same period in 2019. This increase is primarily driven by
an increase of $1.9 million in payroll and personnel expenses due
to increases in headcount of employees involved in research and
development activities, an increase of $0.9 million in fees
incurred for CROs and CMOs costs due to initiating and ramping up
manufacturing and preclinical development activities related to our
first product candidate, offset by decrease in costs for other
consultants by $0.3 million. Payroll and personnel expenses for the
quarter ended September 30, 2020 includes $1.0 million of
non-cash stock-based compensation expense compared to $0.1 million
during the same period in 2019 due to an one-time charge of $0.9
million resulting from the modification of stock awards in
connection with the merger.
- General and Administrative (G&A) Expenses:
G&A expenses increased by $5.9 million to $7.7 million for the
quarter ended September 30, 2020, compared to $1.8 million during
the same period in 2019. This increase is primarily driven by an
increase of $3.2 million of payroll and personnel expenses, an
increase of $2.4 million of professional fees for legal,
consulting, accounting, tax and other services, and an increase of
$0.3 million in facility and other expenses. Payroll and personnel
expenses for the quarter ended September 30, 2020
includes $2.0 million of non-cash stock-based
compensation expense compared to $0.3 million during the same
period in 2019 due to an one-time charge of $1.7 million resulting
from the modification of stock awards in connection with the
merger. The increase in professional fees was primarily due to
transaction costs incurred in connection with the merger with
resTORbio of $2.0 million during the quarter ended September 30,
2020.
- Net Loss: Net loss attributable to common
shareholders for the quarter ended September 30, 2020 was $14.8
million, or a net loss of $2.84 per basic and diluted share,
including non-cash stock-based compensation expense of $3.0
million, as compared to $14.8 million during the same period in
2019, or a net loss of $6.87 per basic and diluted share, including
non-cash stock-based compensation expense of $0.4 million.
- Cash Position: Cash and cash
equivalents and marketable debt securities were $108.1 million as
of September 30, 2020, compared to $73.0 million as of December 31,
2019.
About Adicet
Adicet 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 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,
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 future clinical studies of ADI-001,
including whether they are pivotal or would support registration,
expectations regarding its other CAR γδ T cell therapy development
activities, the impact of individual executive officers on Adicet’s
success, and its expectations regarding its uses of capital,
expenses, future accumulated deficit and other third quarter 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.Condensed Consolidated Statements of
Operations and Comprehensive Loss (in thousands,
except share and per share amounts)
(unaudited)
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue—related party |
|
$ |
3,028 |
|
|
$ |
(7,047 |
) |
|
$ |
12,493 |
|
|
$ |
(974 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,942 |
|
|
$ |
6,331 |
|
|
$ |
24,651 |
|
|
$ |
17,168 |
|
General and
administrative |
|
|
7,741 |
|
|
|
1,847 |
|
|
|
17,684 |
|
|
|
6,069 |
|
Total operating expenses |
|
|
16,683 |
|
|
|
8,178 |
|
|
|
42,335 |
|
|
|
23,237 |
|
Loss from operations |
|
|
(13,655 |
) |
|
|
(15,225 |
) |
|
|
(29,842 |
) |
|
|
(24,211 |
) |
Interest income |
|
|
153 |
|
|
|
276 |
|
|
|
704 |
|
|
|
561 |
|
Interest expense |
|
|
(50 |
) |
|
|
— |
|
|
|
(84 |
) |
|
|
— |
|
Other income (expense),
net |
|
|
(1,224 |
) |
|
|
171 |
|
|
|
(1,174 |
) |
|
|
2,091 |
|
Loss before income taxes |
|
|
(14,776 |
) |
|
|
(14,778 |
) |
|
|
(30,396 |
) |
|
|
(21,559 |
) |
Income tax expense
(benefit) |
|
|
3 |
|
|
|
— |
|
|
|
(2,676 |
) |
|
|
1 |
|
Net loss |
|
$ |
(14,779 |
) |
|
$ |
(14,778 |
) |
|
$ |
(27,720 |
) |
|
$ |
(21,560 |
) |
Net loss per share —basic and
diluted |
|
$ |
(2.84 |
) |
|
$ |
(6.87 |
) |
|
$ |
(8.69 |
) |
|
$ |
(10.10 |
) |
Weighted-average number of
common shares used in net loss per share —basic and diluted |
|
|
5,208,887 |
|
|
|
2,149,986 |
|
|
|
3,190,557 |
|
|
|
2,133,645 |
|
ADICET BIO, INC.Balance
Sheet Data (in
thousands)(unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Cash, cash equivalents and marketable debt securities |
|
$ |
108,120 |
|
|
$ |
72,988 |
|
Working capital |
|
|
87,334 |
|
|
|
49,321 |
|
Total assets |
|
|
150,397 |
|
|
|
81,587 |
|
Contract liabilities—related
party |
|
|
19,390 |
|
|
|
21,883 |
|
Accumulated deficit |
|
|
(97,367 |
) |
|
|
(69,647 |
) |
Total stockholders' equity
(deficit) |
|
|
116,930 |
|
|
|
(60,366 |
) |
Adicet Bio,
Inc.Investor and Media ContactsAnne
Bowdidgeabowdidge@adicetbio.com
Janhavi MohiteStern Investor Relations,
Inc.212-362-1200janhavi.mohite@sternir.com
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