Adicet Reports Third Quarter 2022 Financial Results and Provides Business Updates
08 Novembre 2022 - 10:10PM
Business Wire
As of ASH abstract data-cut date, ADI-001
demonstrated a positive safety and efficacy profile; Company to
provide more recent data cut from its ongoing Phase 1 study during
ASH Annual Meeting
Company to host ADI-001 webcast event on
December 11, 2022 at 9:00 a.m. ET
On track to initiate a potentially pivotal
program for ADI-001 in the first half of 2023
Strong balance sheet with $282.7 million in
cash and cash equivalents as of September 30, 2022; Cash runway
into first half of 2025
Company to host R&D webcast event detailing
four new pipeline candidates on November 10, 2022 at 9:00 a.m.
ET
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology
company discovering and developing allogeneic gamma delta T cell
therapies for cancer, today reported financial results and
operational highlights for the third quarter ended September 30,
2022.
“We have continued to make very encouraging clinical progress in
2022, reporting promising safety and efficacy data for our lead
candidate ADI-001 for the potential treatment of relapsed or
refractory B-cell non-Hodgkin’s lymphoma,” said Chen Schor,
President and Chief Executive Officer at Adicet Bio. “We’re
currently enrolling patients in dose level 4 and expect to initiate
a potentially pivotal program with the recommended Phase 2 dose for
ADI-001 in the first half of 2023. We look forward to
providing additional clinical data on ADI-001 at the American
Society of Hematology Annual Meeting in December as well as
promising preclinical data on our emerging pipeline programs at the
upcoming Society for Immunotherapy of Cancer’s Annual Meeting and
our upcoming R&D event.”
Third Quarter 2022 and Recent Operational Highlights:
- Preclinical Data for Four New Pipeline Programs at the
Society for Immunotherapy of Cancer (SITC) 37th Annual
Meeting. Preclinical data from four new pipeline programs will
be presented at the SITC 37th Annual Meeting on November 10-11,
2022.
- Company to Host R&D Webcast Event to Outline Pipeline
Updates. Adicet is hosting an R&D webcast event on
Thursday, November 10, 2022, at 9:00 a.m. ET to provide additional
preclinical data from its newly disclosed pipeline and upcoming
milestones.
- Updated Data from Ongoing Phase 1 Study of ADI-001 at the
2022 American Society of Hematology (ASH) 64th Annual Meeting.
In November, Adicet announced that as of the July 15, 2022 data-cut
date for the ASH abstract, ADI-001 demonstrated a 78% overall
response rate (ORR) and complete response rate (CR) (7/9) and
sustained durability in adults with relapsed or refractory B-cell
non-Hodgkin’s lymphoma (NHL). For the four patients who had prior
autologous CD19 CAR T therapies, the ORR and CR rate was 100%
(4/4). ADI-001 continued to demonstrate a favorable safety and
tolerability profile. Based on data collected on ADI-001, Adicet
expects to establish the recommended Phase 2 dose for ADI-001 in
the second half of 2022. In December 2022, the Company plans to
provide data from a more recent data-cut date from the ongoing
Phase 1 study of ADI-001 in adults with relapsed or refractory
B-cell NHL during the upcoming 2022 ASH Annual Meeting. The Company
will host an ADI-001 webcast on Sunday, December 11, 2022, at 8:00
a.m. CT / 9:00 a.m. ET to discuss data from the ongoing study.
- Establishing In-House Manufacturing Capacity in Redwood City
Facility. Adicet’s new in-house manufacturing capabilities in
the Redwood City facility, which is designed to enable
manufacturing for early clinical development of its pipeline
candidates, is expected to be operational in the fourth quarter of
2022.
Financial Results for Third Quarter 2022:
- Research and Development (R&D) Expenses: R&D
expenses were $16.6 million for the three months ended September
30, 2022, compared to $11.9 million during the same period in 2021.
The $4.6 million increase is primarily driven by a $3.2 million
increase in payroll and personnel expenses resulting from an
increase in overall headcount and a $1.2 million increase in
contract manufacturing organizations and other externally conducted
research and development expense. Payroll and personnel expenses
for the three months ended September 30, 2022 includes $1.7 million
of non-cash stock-based compensation expense compared to $0.8
million during the same period in 2021.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.4 million for the three months ended September 30,
2022, compared to $5.2 million during the same period in 2021. The
$1.2 million increase is primarily driven by an increase of $1.3
million of payroll and personnel expenses. Payroll and personnel
expenses for the three months ended September 30, 2022 includes
$2.4 million of non-cash stock-based compensation expense compared
to $1.7 million during the same period in 2021.
- Net Loss: Net loss for the three months ended September
30, 2022 was $22.0 million, or a net loss of $0.53 per basic and
diluted share, including non-cash stock-based compensation expense
of $4.2 million, as compared to a net loss of $14.0 million during
the same period in 2021, or a net loss of $0.44 per basic and
diluted share, including non-cash stock-based compensation expense
of $2.5 million.
- Cash Position: Cash and cash equivalents were $282.7
million as of September 30, 2022, compared to $277.5 million as of
December 31, 2021. The Company expects that current cash and cash
equivalents as of September 30, 2022, will be sufficient to fund
its operating expenses into the first half of 2025.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage 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 chimeric antigen receptors (CARs)
and adaptors (CAds), to enhance selective tumor targeting and
facilitate innate and adaptive anti-tumor immune response for
durable activity in patients. For more information, please visit
our website at https://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 Adicet’s preclinical programs and
potential safety, durability, tolerability and therapeutic effects
of ADI-001; expected plans and timing for the release of additional
clinical data from Adicet’s Phase 1 trial of ADI-001 in NHL
patients; future progress of the Phase 1 trial, including ongoing
patient enrollment in the dose level 4 cohort; the anticipated
timing for the selection of a recommended Phase 2 dose and
expectations around initiation of a potentially pivotal study for
ADI-001; the launch of in-house manufacturing capabilities in
Adicet’s Redwood City facility; and Adicet’s growth as a company
and expectations regarding its uses of capital, expenses and
financial results, including the expected cash runway. 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
preclinical and clinical trials, business operations, employee
hiring and retention, and ability to raise additional capital;
Adicet’s ability to execute on its strategy; Adicet’s ability to
meet production and product release expectations; 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 Loss
(in thousands, except share
and per share amounts)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Revenue—related party
$
—
$
3,429
$
24,990
$
4,262
Operating expenses:
Research and development
16,570
11,926
46,231
34,285
General and administrative
6,415
5,213
19,745
15,868
Total operating expenses
22,985
17,139
65,976
50,153
Loss from operations
(22,985
)
(13,710
)
(40,986
)
(45,891
)
Interest income
1,224
4
1,581
54
Interest expense
(18
)
(50
)
(54
)
(151
)
Other expense, net
(217
)
(246
)
(456
)
(312
)
Loss before income tax provision
(21,996
)
(14,002
)
(39,915
)
(46,300
)
Income tax provision
—
11
—
(114
)
Net loss
$
(21,996
)
$
(14,013
)
$
(39,915
)
$
(46,186
)
Net loss per share, basic and diluted
$
(0.53
)
$
(0.44
)
$
(0.98
)
$
(1.54
)
Weighted-average common shares used in
computing net loss per share, basic and diluted
41,642,815
31,876,016
40,547,792
29,954,616
Other comprehensive loss:
Unrealized loss on marketable debt
securities, net of tax
—
—
—
(24
)
Total other comprehensive loss
—
—
—
(24
)
Comprehensive loss
$
(21,996
)
$
(14,013
)
$
(39,915
)
$
(46,210
)
ADICET BIO, INC.
Consolidated Balance
Sheets
(in thousands)
(unaudited)
September 30, 2022
December 31, 2021
Cash and cash equivalents
$
282,679
$
277,544
Working capital
268,516
266,121
Total assets
354,303
338,938
Contract liabilities – related party,
current
—
4,805
Accumulated deficit
(208,240
)
(168,324
)
Total stockholders’ equity
317,658
303,129
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version on businesswire.com: https://www.businesswire.com/news/home/20221108005509/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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