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 third quarter 2023 financial results and
provided a corporate update.
Recent Highlights and Anticipated
Milestones:
- Presented novel preclinical data at SITC 2023 Annual Meeting
demonstrating that its CoStimulatory Antigen Receptor (CoStAR)
enhances activity of CD4+ T cells in multiple ways to broaden
anti-tumor response and support CD8+ T cells
- Publication of ITIL-306 manuscript in Frontiers in Immunology
(https://www.frontiersin.org/articles/10.3389/fimmu.2023.1256491/full),
demonstrating that CoStAR enhances T cell activity and augments
tumor reactivity of TILs in preclinical studies
- Initial data from ITIL-306-202, a Phase 1 clinical trial of
ITIL-306 in non-small cell lung cancer, anticipated in 2024
- Cash runway expected beyond 2026
Third Quarter
2023 Financial and Operating
Results:
As of September 30, 2023, Instil had cash, cash
equivalents, restricted cash and marketable securities of
$184.5 million, which consisted of $9.1 million in cash
and cash equivalents, $1.0 million in restricted cash and
$174.3 million in marketable securities, compared to
$260.9 million in cash, cash equivalents and marketable
securities as of December 31, 2022, consisting of $43.7
million in cash and cash equivalents and $217.2 million in
marketable securities. Instil expects that its cash, cash
equivalents and marketable securities as of September 30, 2023
will enable it to fund its operating plan beyond 2026.
Research and development expenses were $8.5 million and $37.6
million for the three and nine months ended September 30,
2023, respectively, compared to $39.7 million and $120.3 million
for the three and nine months ended September 30, 2022,
respectively.
General and administrative expenses were $11.9 million and $36.7
million for the three and nine months ended September 30,
2023, respectively, compared to $17.0 million and $49.3 million for
the three and nine months ended September 30, 2022,
respectively.
Restructuring and impairment charges were $46.3 million and
$71.8 million for the three and nine months ended
September 30, 2023, respectively. There were no restructuring
and impairment charges for the three and nine months ended
September 30, 2022.
INSTIL BIO, INC.SELECTED
FINANCIAL DATA
Selected Consolidated Balance Sheet
Data(Unaudited; in thousands)
|
September 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents, restricted cash and marketable
securities |
$ |
184,461 |
|
|
$ |
260,920 |
|
Total assets |
$ |
340,272 |
|
|
$ |
482,128 |
|
Total liabilities |
$ |
106,248 |
|
|
$ |
118,523 |
|
Total stockholders’
equity |
$ |
234,024 |
|
|
$ |
363,605 |
|
|
|
|
|
|
|
|
|
Consolidated Statements of
Operations(Unaudited; in thousands, except share and per
share amounts)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
8,492 |
|
|
$ |
39,660 |
|
|
$ |
37,621 |
|
|
$ |
120,334 |
|
General and administrative |
|
11,941 |
|
|
|
16,989 |
|
|
|
36,681 |
|
|
|
49,325 |
|
Restructuring and impairment charges |
|
46,283 |
|
|
|
— |
|
|
|
71,847 |
|
|
|
— |
|
Total operating expenses |
|
66,716 |
|
|
|
56,649 |
|
|
|
146,149 |
|
|
|
169,659 |
|
Loss from operations |
|
(66,716 |
) |
|
|
(56,649 |
) |
|
|
(146,149 |
) |
|
|
(169,659 |
) |
Interest income |
|
2,313 |
|
|
|
1,276 |
|
|
|
6,671 |
|
|
|
1,859 |
|
Interest expense |
|
(2,003 |
) |
|
|
(807 |
) |
|
|
(3,229 |
) |
|
|
(1,138 |
) |
Other expense, net |
|
(1,026 |
) |
|
|
(415 |
) |
|
|
(455 |
) |
|
|
(1,863 |
) |
Loss before income tax
benefit |
|
(67,432 |
) |
|
|
(56,595 |
) |
|
|
(143,162 |
) |
|
|
(170,801 |
) |
Income tax benefit |
|
— |
|
|
|
371 |
|
|
|
— |
|
|
|
1,468 |
|
Net loss |
$ |
(67,432 |
) |
|
$ |
(56,224 |
) |
|
$ |
(143,162 |
) |
|
$ |
(169,333 |
) |
Net loss per share, basic and
diluted |
$ |
(0.52 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.31 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
130,079,097 |
|
|
|
129,680,217 |
|
|
|
130,079,097 |
|
|
|
129,391,225 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 non-cash stock-based compensation expense
and building and construction in progress impairment 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.
INSTIL BIO,
INC.Reconciliation of GAAP to Non-GAAP Net
Loss (Unaudited; in thousands, except share and per share
amounts)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
$ |
(67,432 |
) |
|
$ |
(56,224 |
) |
|
$ |
(143,162 |
) |
|
$ |
(169,333 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
4,670 |
|
|
7,982 |
|
|
13,613 |
|
|
23,798 |
|
Building and construction work in progress impairment |
41,542 |
|
|
— |
|
|
41,542 |
|
|
— |
|
Non-GAAP net loss |
$ |
(21,220 |
) |
|
$ |
(48,242 |
) |
|
$ |
(88,007 |
) |
|
$ |
(145,535 |
) |
Net loss per share, basic and
diluted |
$ |
(0.52 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.31 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
0.04 |
|
|
0.06 |
|
|
0.10 |
|
|
0.18 |
|
Building and construction work in progress impairment |
0.32 |
|
|
— |
|
|
0.32 |
|
|
— |
|
Non-GAAP net loss per share,
basic and diluted* |
$ |
(0.16 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.68 |
) |
|
$ |
(1.13 |
) |
Weighted-average shares
outstanding, basic and diluted |
130,079,097 |
|
|
129,680,217 |
|
|
130,079,097 |
|
|
129,391,225 |
|
* 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 facility, 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 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 the timing of our ongoing and potential
future clinical trials and studies and the availability and
presentation of data therefrom, including our expectations
concerning our ITIL-306-202 clinical trial, 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, our product
candidates will be successfully distributed and marketed, our
expectations regarding Instil's cash runway, capital position,
resources, and balance sheet, and the potential impact thereof on
our development of ITIL-306, 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 conflicts in
Ukraine and in the Middle East, interest rates, inflation, 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 and the risk that Instil’s manufacturing
process improvements do not ultimately result in enhancements to
its product candidates; 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” Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023 available on the SEC’s website at
www.sec.gov, and in our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2023 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
Relations1-972-499-3350investorrelations@instilbio.comwww.instilbio.com
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