Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage
biopharmaceutical company focused on developing a pipeline of novel
therapies, today reported its fourth quarter and full year 2023
financial results and provided a corporate update.
Recent Highlights:
- Announced entering into a strategic collaboration to develop an
autologous folate receptor α (FRα)-CoStAR enhanced TIL for a
potential investigator-initiated trial (IIT) in non-small cell lung
cancer in China
- Announced a strategic update to the ITIL-306 program, including
closure of Instil’s UK manufacturing and cessation of ITIL-306
clinical trial activities
- Exploring opportunities to in-license/acquire and develop novel
therapeutic candidates in diseases with significant unmet medical
need
- Cash runway expected beyond 2026
Fourth Quarter and
Full Year 2023
Financial and Operating Results:
As of December 31, 2023, Instil had $175.0 million in
total cash, cash equivalents, restricted cash, marketable
securities and long-term investments, which consisted of
$9.2 million in cash and cash equivalents, $1.5 million
in restricted cash, $141.2 million in marketable securities
and $23.2 million in long-term investments, compared to $260.9
million in total cash, cash equivalents and marketable securities,
which consisted of $43.7 million in cash and cash equivalents and
$217.2 million in marketable securities, as of December 31,
2022. Instil expects that its cash, cash equivalents, marketable
securities and long-term investments as of December 31, 2023
will enable it to fund its operating plan beyond 2026.
Research and development expenses were $2.0 million and $39.6
million for the fourth quarter and full year ended
December 31, 2023, respectively, compared to $20.7 million and
$141.1 million for the fourth quarter and full year ended
December 31, 2022, respectively.
General and administrative expenses were $10.9 million and $47.6
million for the fourth quarter and full year ended
December 31, 2023, respectively, compared to $12.9 million and
$62.2 million for the fourth quarter and full year ended
December 31, 2022, respectively.
Restructuring and impairment charges were $0.2 million and $72.0
million for the fourth quarter and full year ended
December 31, 2023, respectively, compared to $23.2 million for
the fourth quarter and full year ended December 31, 2022.
Net loss per share, basic and diluted were $1.99 and $24.00 for
the fourth quarter and full year ended December 31, 2023,
respectively, compared to $8.29 and $34.46 for the fourth quarter
and full year ended December 31, 2022. Non-GAAP net loss per
share, basic and diluted were $1.26 and $10.14 for the fourth
quarter and full year ended December 31, 2023, respectively,
compared to $3.70 and $26.18 for the fourth quarter and full year
ended December 31, 2022.
Note Regarding Use of Non-GAAP Financial
Measures
In this press release, Instil has presented certain financial
information that has not been prepared in accordance with U.S.
generally accepted accounting principles (“GAAP”). These non-GAAP
financial measures include non-GAAP net loss and non-GAAP net loss
per share, which are defined as net loss and net loss per share,
respectively, excluding restructuring and impairment charges and
non-cash stock-based compensation expense. Instil believes that
these non-GAAP financial measures, when considered together with
the GAAP figures, can enhance an overall understanding of Instil’s
financial performance. The non-GAAP financial measures are included
with the intent of providing investors with a more complete
understanding of Instil’s operating results. In addition, these
non-GAAP financial measures are among the indicators Instil’s
management uses for planning purposes and to measure Instil’s
performance. These non-GAAP financial measures should be considered
in addition to, and not as a substitute for, or superior to,
financial measures calculated in accordance with GAAP. The non-GAAP
financial measures used by Instil may be calculated differently
from, and therefore may not be comparable to, non-GAAP financial
measures used by other companies. Please refer to the below
reconciliation of these non-GAAP financial measures to the
comparable GAAP financial measures.
About Instil Bio
Instil Bio Inc. (Nasdaq: TIL) is a clinical-stage
biopharmaceutical company focused on developing a pipeline of novel
therapies. Instil seeks to in-license/acquire and develop novel
therapeutic candidates in diseases with significant unmet medical
need. For more information visit www.instilbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “expects,” “future,”
“intends,” “may,” “plans,” “potential,” “projects,” “exploring” and
“will” or similar expressions are intended to identify
forward-looking statements. Forward-looking statements include
statements concerning or implying our ability to acquire and
develop new product candidates with compelling data, the
therapeutic potential of our product candidates, our research,
development and regulatory plans for our product candidates,
including the timing of our ongoing and potential future
preclinical studies and future clinical trials and the availability
of data therefrom, our expectations concerning the closure of our
UK manufacturing and clinical operations and the related reduction
in force and the benefits thereof, expectations concerning our
collaboration and the generation of preclinical and clinical data
therefrom, our expectations regarding our capital position,
resources, and balance sheet, and the potential impact thereof on
development of any product candidates, and other statements that
are not historical fact. Forward-looking statements are based on
management's current expectations and are subject to various risks
and uncertainties that could cause actual results to differ
materially and adversely from those expressed or implied by such
forward-looking statements, including risks and uncertainties
associated with acquiring product candidates, the costly and
time-consuming product development process and the uncertainty of
clinical success; the risks inherent in successfully manufacturing
cell therapy products and relying on collaborators and other third
parties for manufacturing; the risks and uncertainties related to
successfully initiating, enrolling, completing and reporting data
from clinical studies, including a collaborator-led IIT in China,
as well as the risks that results obtained in clinical trials to
date may not be indicative of results obtained in ongoing or future
trials and that our product candidates may otherwise not be
effective treatments in their planned indications; risks associated
with reliance on third-party collaborators, and our ability to
achieve the expected benefits of the closure of our UK
manufacturing and clinical operations; risks related to
macroeconomic conditions, including as a result of international
conflicts, U.S.-China trade and political tensions, interest rates,
inflation, and other factors, which could materially and adversely
affect our business and operations; the risks and uncertainties
associated with the time-consuming and uncertain regulatory
approval process and the sufficiency of our cash resources; and
other risks and uncertainties affecting Instil and our plans and
development programs, including those discussed in the section
titled “Risk Factors” in our Annual Report on Form 10-K for the
year ended December 31, 2023 to be filed with the SEC, as well
as our other filings with the SEC. Additional information will be
made available in other filings that we make from time to time with
the SEC. Accordingly, these forward-looking statements do not
constitute guarantees of future performance, and you are cautioned
not to place undue reliance on these forward-looking statements.
These forward-looking statements speak only as the date hereof, and
we disclaim any obligation to update these statements except as may
be required by law.
Contacts:
Investor
Relations:1-972-499-3350
investorrelations@instilbio.comwww.instilbio.com
INSTIL BIO, INC.SELECTED FINANCIAL
DATA (Unaudited; in thousands, except share and per share
amounts)Consolidated Statements of Operations |
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
1,983 |
|
|
$ |
20,722 |
|
|
$ |
39,604 |
|
|
$ |
141,056 |
|
General and administrative |
|
10,872 |
|
|
|
12,910 |
|
|
|
47,553 |
|
|
|
62,235 |
|
Restructuring and impairment charges |
|
165 |
|
|
|
23,167 |
|
|
|
72,012 |
|
|
|
23,167 |
|
Total operating expenses |
|
13,020 |
|
|
|
56,799 |
|
|
|
159,169 |
|
|
|
226,458 |
|
Loss from operations |
|
(13,020 |
) |
|
|
(56,799 |
) |
|
|
(159,169 |
) |
|
|
(226,458 |
) |
Interest income |
|
2,195 |
|
|
|
1,796 |
|
|
|
8,866 |
|
|
|
3,655 |
|
Interest expense |
|
(1,980 |
) |
|
|
(745 |
) |
|
|
(5,209 |
) |
|
|
(1,883 |
) |
Other (expense) income,
net |
|
(120 |
) |
|
|
1,299 |
|
|
|
(575 |
) |
|
|
(564 |
) |
Loss before income tax
benefit |
|
(12,925 |
) |
|
|
(54,449 |
) |
|
|
(156,087 |
) |
|
|
(225,250 |
) |
Income tax benefit |
|
— |
|
|
|
605 |
|
|
|
— |
|
|
|
2,073 |
|
Net loss |
$ |
(12,925 |
) |
|
$ |
(53,844 |
) |
|
$ |
(156,087 |
) |
|
$ |
(223,177 |
) |
Net loss per share, basic and
diluted |
$ |
(1.99 |
) |
|
$ |
(8.29 |
) |
|
$ |
(24.00 |
) |
|
$ |
(34.46 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
6,503,913 |
|
|
|
6,493,641 |
|
|
|
6,503,913 |
|
|
|
6,475,631 |
|
Selected Consolidated Balance Sheet Data |
|
|
December 31,2023 |
|
December 31,2022 |
Cash, cash equivalents, restricted cash, marketable securities and
long-term investments |
$ |
175,018 |
|
$ |
260,920 |
Total assets |
$ |
325,630 |
|
$ |
482,128 |
Total liabilities |
$ |
99,801 |
|
$ |
118,523 |
Convertible preferred stock
and stockholders’ equity |
$ |
225,829 |
|
$ |
363,605 |
Reconciliation of GAAP to Non-GAAP Financial
Measures(Unaudited; in thousands, except share and per
share amounts) |
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
$ |
(12,925 |
) |
|
$ |
(53,844 |
) |
|
$ |
(156,087 |
) |
|
$ |
(223,177 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
4,553 |
|
|
|
6,643 |
|
|
|
18,166 |
|
|
|
30,441 |
|
Restructuring and impairment charges |
|
165 |
|
|
|
23,167 |
|
|
|
72,012 |
|
|
|
23,167 |
|
Non-GAAP net loss |
$ |
(8,207 |
) |
|
$ |
(24,034 |
) |
|
$ |
(65,909 |
) |
|
$ |
(169,569 |
) |
Net loss per share, basic and
diluted |
$ |
(1.99 |
) |
|
$ |
(8.29 |
) |
|
$ |
(24.00 |
) |
|
$ |
(34.46 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
|
0.70 |
|
|
|
1.02 |
|
|
|
2.79 |
|
|
|
4.70 |
|
Restructuring and impairment charges |
|
0.03 |
|
|
|
3.57 |
|
|
|
11.07 |
|
|
|
3.58 |
|
Non-GAAP net loss per share,
basic and diluted* |
$ |
(1.26 |
) |
|
$ |
(3.70 |
) |
|
$ |
(10.14 |
) |
|
$ |
(26.18 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
6,503,913 |
|
|
|
6,493,641 |
|
|
|
6,503,913 |
|
|
|
6,475,631 |
|
|
|
|
|
|
|
|
|
* Non-GAAP net loss per share, basic and diluted may not total
due to rounding.
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