Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage
biopharmaceutical company focused on developing tumor infiltrating
lymphocyte, or TIL, therapies for the treatment of patients with
cancer, today reported its fourth quarter and full-year 2022
financial results and provided a corporate update.
Fourth Quarter
2022 Highlights and Anticipated
Milestones:
- Instil confirms cash runway beyond 2026 with
consolidation of R&D operations to the UK: In January
2023, the Company announced the consolidation of the Phase 1
clinical trial and related manufacturing of CoStAR-TIL™ to its
active operations in Manchester, UK leading to an extension of the
expected cash runway to beyond 2026. Instil’s Manchester, U.K.
operations have extensive experience and success in the manufacture
and development of TIL and other cell therapy products since 2011.
Instil continues to pursue a potential lease or sale of its
commercial manufacturing facility in Tarzana, California. Under the
current operating plan, starting in the second half of 2023, we
expect quarterly cash burn of less than $10 million through the end
of 2024.
- ITIL-306 phase 1 study in UK anticipated to initiate in
2H'2023: Instil anticipates initiating a phase 1 study of
ITIL-306 in the United Kingdom in the second half of 2023 following
anticipated Clinical Trial Application, or CTA, clearance from the
Medicines and Healthcare products Regulatory Agency, or MHRA.
Instil anticipates initial clinical data from the ITIL-306 program
in 2024.
- Prioritization of ITIL-306 after discontinuation of
ITIL-168 and subsequent consolidation to the UK for
manufacturing: After a voluntary pause of the DELTA-1
trial for ITIL-168 in October 2022 due to a decreased rate of
successful manufacturing of ITIL-168, the Company discontinued the
program in December 2022 and announced a reduction in U.S.
headcount and prioritization of CoStAR-TIL programs, including
ITIL-306.
Fourth Quarter
2022 Financial and Operating
Results:
As of December 31, 2022, Instil had $260.9 million in
total cash and cash equivalents and marketable securities,
comprised of $43.7 million in cash and cash equivalents and
$217.2 million in marketable securities, compared to $454.1
million in total cash and cash equivalent and marketable
securities, comprised of $37.6 million in cash and cash equivalents
and $416.5 million in marketable securities, as of
December 31, 2021. Instil expects that its cash, cash
equivalents and marketable securities as of December 31, 2022
will enable it to fund its operating plan beyond 2026.
Research and development expenses were $20.7 million and $141.1
million for the fourth quarter and full year ended
December 31, 2022, respectively, compared to $42.6 million and
$107.3 million for the fourth quarter and full year ended
December 31, 2021, respectively.
General and administrative expenses were $12.9 million and $62.2
million for the fourth quarter and full year ended
December 31, 2022, respectively, compared to $11.2 million and
$48.3 million for the fourth quarter and full year ended
December 31, 2021, respectively.
Restructuring and impairment charges were $23.2 million for the
fourth quarter and full year ended December 31, 2022.
INSTIL BIO, INC.SELECTED FINANCIAL
DATA (Unaudited; in thousands, except share and per share
amounts)Statements of Operations |
|
|
|
|
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ 20,722 |
|
$ 42,577 |
|
$ 141,056 |
|
$ 107,251 |
General and administrative |
12,910 |
|
11,175 |
|
62,235 |
|
48,309 |
Restructuring and impairment charges |
23,167 |
|
— |
|
23,167 |
|
— |
Total operating
expenses |
56,799 |
|
53,752 |
|
226,458 |
|
155,560 |
Loss from
operations |
(56,799) |
|
(53,752) |
|
(226,458) |
|
(155,560) |
Interest
income |
1,796 |
|
35 |
|
3,655 |
|
80 |
Interest
expense |
(745) |
|
— |
|
(1,883) |
|
— |
Other income
(expense), net |
1,299 |
|
(573) |
|
(564) |
|
(1,275) |
Loss before income
tax expense |
(54,449) |
|
(54,290) |
|
(225,250) |
|
(156,755) |
Income tax benefit
(expense) |
605 |
|
(1,060) |
|
2,073 |
|
(39) |
Net loss |
$ (53,844) |
|
$ (55,350) |
|
$ (223,177) |
|
$ (156,794) |
Net loss per
share, basic and diluted |
$ (0.41) |
|
$ (0.43) |
|
$ (1.72) |
|
$ (1.48) |
Weighted-average
shares used in computing net loss per share, basic and diluted |
129,872,810 |
|
128,952,362 |
|
129,512,610 |
|
105,993,230 |
Selected Balance Sheet Data |
|
|
|
|
|
December 31, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and
marketable
securities |
$ |
260,920 |
|
$ |
454,099 |
Total
assets |
$ |
482,128 |
|
$ |
609,983 |
Total
liabilities |
$ |
118,523 |
|
$ |
54,784 |
Convertible preferred stock
and stockholders’
equity |
$ |
363,605 |
|
$ |
555,199 |
Note Regarding Use of Non-GAAP Financial
Measures
In this press release, Instil Bio 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 non-cash stock-based compensation
expense. Instil Bio believes that these non-GAAP financial
measures, when considered together with the GAAP figures, can
enhance an overall understanding of Instil Bio’s financial
performance. The non-GAAP financial measures are included with the
intent of providing investors with a more complete understanding of
Instil Bio’s operating results. In addition, these non-GAAP
financial measures are among the indicators Instil Bio’s management
uses for planning purposes and to measure Instil Bio’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 Bio 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.
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Net loss |
$ (53,844) |
|
$ (55,350) |
|
$ (223,177) |
|
$ (156,794) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
6,643 |
|
8,904 |
|
30,441 |
|
26,197 |
Non-GAAP net
loss |
$ (47,201) |
|
$ (46,446) |
|
$ (192,736) |
|
$ (130,597) |
Non-GAAP net loss
per share, basic and diluted |
$ (0.41) |
|
$ (0.43) |
|
$ (1.72) |
|
$ (1.48) |
Adjustments |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
0.05 |
|
0.07 |
|
0.24 |
|
0.25 |
Non-GAAP net loss
per share, basic and diluted*. |
$ (0.36) |
|
$ (0.36) |
|
$ (1.48) |
|
$ (1.23) |
Weighted-average
shares used in computing net loss per share, basic and diluted |
129,872,810 |
|
128,952,362 |
|
129,512,610 |
|
105,993,230 |
* Non-GAAP net loss per share, basic and diluted may not total
due to rounding.
About Instil Bio
Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage
biopharmaceutical company focused on developing TIL therapies for
the treatment of patients with cancer. Instil has assembled an
accomplished management team with a successful track record in the
research, development and manufacture of cell therapies. Using its
proprietary and optimized manufacturing processes at its in-house
manufacturing facilities, Instil is developing a novel class of
genetically engineered TIL therapies using its Co-Stimulatory
Antigen Receptor, or CoStAR™, platform, including ITIL-306, a
next-generation, genetically-engineered TIL therapy using the
CoStAR platform, for multiple solid tumors. 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,” "plans," "potential," “projects,” and “will” or similar
expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or
implying the therapeutic potential of our product candidates, our
research, development and regulatory plans for our product
candidates, including our expectations of CTA clearance from the
MHRA, the timing of our ongoing and potential future clinical
trials and studies and the availability of data therefrom,
including our expectations concerning the initiation of, and timing
of updates, on our ITIL-306 clinical trial in the United Kingdom,
the potential for us to make submissions concerning, and for our
product candidates to receive, regulatory approval from the FDA,
MHRA or equivalent foreign regulatory agencies and whether, if
approved, these product candidates will be successfully distributed
and marketed, the anticipated sale or lease of our Tarzana,
California manufacturing facility, our cash runway and quarterly
cash burn, 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 the costly and
time-consuming cell therapy product development process and the
uncertainty of clinical success, including risks related to failure
or delays in successfully initiating, enrolling, reporting data
from or completing clinical studies, 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 Instil's
product candidates may otherwise not be effective treatments in
their planned indications; macroeconomic conditions, including as a
result of the ongoing COVID-19 pandemic, the ongoing conflict
between Russia and Ukraine, bank failures and other factors, which
could materially and adversely affect Instil's business and
operations, including Instil's ability to timely initiate, enroll
and complete its ongoing and future clinical trials; the
time-consuming and uncertain regulatory approval process; risks
inherent in manufacturing and testing of cell therapy products; the
sufficiency of Instil's cash resources, and other risks and
uncertainties affecting Instil and its 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,
2022 to be filed 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 |
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