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 2024
financial results and provided a corporate update.
Recent Highlights:
- Clinical data for AXN-2510 (formerly SYN-2510) /IMM2510
anticipated in 1H 2025: Instil announced today that
ImmuneOnco anticipates providing a clinical data update for
AXN-2510/IMM2510 monotherapy in relapsed or refractory (R/R)
non-small cell lung cancer (“NSCLC”) in the first half of 2025.
Instil anticipates that ImmuneOnco will also release safety data
from a total of approximately 100 patients treated with
AXN-2510/IMM2510 as monotherapy across multiple solid tumors.
- Initiation by ImmuneOnco of Phase 1b/2 trial of
AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in
China: ImmuneOnco announced enrollment of the first
patient in the safety run-in of a Phase 1b/2 trial of
AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China
in January 2025. ImmuneOnco anticipates enrollment of first-line
NSCLC patients in this study to initiate in Q2 2025, with initial
clinical data anticipated in 2H 2025.
- U.S. clinical study of AXN-2510/IMM2510 in combination
with chemotherapy in 1L NSCLC anticipated to commence before the
end of 2025: Instil anticipates initiating a U.S. clinical
trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L
NSCLC patients before the end of 2025, assuming the necessary
regulatory approvals are obtained.
Fourth Quarter and Full Year 2024 Financial and
Operating Results:
As of December 31, 2024, Instil had $115.1 million in
total cash, cash equivalents, restricted cash and marketable
securities, which consisted of $8.8 million in cash and cash
equivalents, $1.8 million in restricted cash and
$104.5 million in marketable securities, compared to $175.0
million in total cash, cash equivalents, restricted cash and
marketable securities, 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, as of December 31, 2023. Instil expects that its
cash, cash equivalents, restricted cash and marketable securities
as of December 31, 2024 will enable it to fund its current
operating plan beyond 2026.
In-process research and development expenses were nil and
$10.0 million for the fourth quarter and full year ended
December 31, 2024, respectively, compared to nil for the
fourth quarter and full year ended December 31, 2023.
Research and development expenses were $1.1 million and $11.8
million for the fourth quarter and full year ended
December 31, 2024, respectively, compared to $2.0 million and
$39.6 million for the fourth quarter and full year ended
December 31, 2023, respectively.
General and administrative expenses were $10.4 million and $44.2
million for the fourth quarter and full year ended
December 31, 2024, respectively, compared to $10.9 million and
$47.6 million for the fourth quarter and full year ended
December 31, 2023, respectively.
Restructuring and impairment charges were $0.3 million and $7.5
million for the fourth quarter and full year ended
December 31, 2024, respectively, compared to $0.2 million and
$72.0 million for the fourth quarter and full year ended
December 31, 2023, respectively.
Net loss per share, basic and diluted was $1.82 and $11.39 for
the fourth quarter and full year ended December 31, 2024,
respectively, compared to $1.99 and $24.00 for the fourth quarter
and full year ended December 31, 2023, respectively. Non-GAAP
net loss per share, basic and diluted was $1.08 and $7.59 for the
fourth quarter and full year ended December 31, 2024,
respectively, compared to $1.26 and $10.14 for the fourth quarter
and full year ended December 31, 2023, respectively.
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 restructuring and impairment charges. 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 is a clinical-stage biopharmaceutical company focused
on developing a pipeline of novel therapies. Instil's lead asset,
AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific
antibody in development for the treatment of 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,”
“exploring,” “future,” “intends,” “may,” “plans,” “potential,”
“projects,” “targets” and “will” or similar expressions are
intended to identify forward-looking statements. Forward-looking
statements include express or implied statements regarding our
expectations with respect to the license and collaboration
agreement with ImmuneOnco; the therapeutic potential of
AXN-2510/IMM2510; clinical development of AXN-2510/IMM2510,
including the initiation of clinical trials for AXN-2510/IMM2510
and the generation of clinical data for AXN-2510/IMM2510 and the
timing thereof; our research, development, regulatory and clinical
plans for AXN-2510/IMM2510; our expectations regarding our capital
position, resources, and balance sheet, including our cash runway;
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 drug
product development process and the uncertainty of clinical
success; the risks inherent in relying on collaborators and other
third parties, including for manufacturing and generating clinical
data, and the ability to rely on any such data from clinical trials
in China in regulatory filings submitted to regulatory authorities
outside of China; the risks and uncertainties related to
successfully making regulatory submissions and initiating,
enrolling, completing and reporting data from clinical studies,
particularly collaborator-led clinical trials, as well as the risks
that results obtained in any 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 related to macroeconomic
conditions, including as a result of international conflicts and
U.S.-China trade and political tensions, as well as interest rates,
inflation, and other factors, which could materially and adversely
affect our business and operations and those of our collaborators;
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 us 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, 2024 to be filed with the SEC,
as well as our other filings with the SEC. 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:1-972-499-3350investorrelations@instilbio.comwww.instilbio.com
|
INSTIL BIO, INC. |
|
SELECTED FINANCIAL DATA |
|
(Unaudited; in thousands, except share and per share amounts) |
|
|
|
Selected Consolidated Balance Sheet Data |
| |
|
|
|
| |
December 31, 2024 |
|
December 31, 2023 |
|
Cash, cash equivalents, restricted cash, marketable securities and
long-term investments |
$ |
115,145 |
|
|
$ |
175,018 |
|
| Total assets |
$ |
263,567 |
|
|
$ |
325,630 |
|
| Total liabilities |
$ |
94,131 |
|
|
$ |
99,801 |
|
| Total stockholders’
equity |
$ |
169,436 |
|
|
$ |
225,829 |
|
|
Consolidated Statements of Operations |
| |
|
|
|
| |
Three Months Ended December
31, |
|
Year Ended December 31, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
| Operating expenses: |
|
|
|
|
|
|
|
|
In-process research and development |
$ |
— |
|
|
$ |
— |
|
|
$ |
10,000 |
|
|
$ |
— |
|
|
Research and development |
|
1,099 |
|
|
|
1,983 |
|
|
|
11,838 |
|
|
|
39,604 |
|
|
General and administrative |
|
10,373 |
|
|
|
10,872 |
|
|
|
44,210 |
|
|
|
47,553 |
|
|
Restructuring and impairment charges |
|
348 |
|
|
|
165 |
|
|
|
7,493 |
|
|
|
72,012 |
|
| Total operating expenses |
|
11,820 |
|
|
|
13,020 |
|
|
|
73,541 |
|
|
|
159,169 |
|
| Loss from operations |
|
(11,820 |
) |
|
|
(13,020 |
) |
|
|
(73,541 |
) |
|
|
(159,169 |
) |
| Interest income |
|
1,352 |
|
|
|
2,195 |
|
|
|
6,987 |
|
|
|
8,866 |
|
| Interest expense |
|
(3,005 |
) |
|
|
(1,980 |
) |
|
|
(8,992 |
) |
|
|
(5,209 |
) |
| Other rental income |
|
2,774 |
|
|
|
— |
|
|
|
4,267 |
|
|
|
— |
|
| Other expense, net |
|
(1,196 |
) |
|
|
(120 |
) |
|
|
(2,856 |
) |
|
|
(575 |
) |
| Net loss |
$ |
(11,895 |
) |
|
$ |
(12,925 |
) |
|
$ |
(74,135 |
) |
|
$ |
(156,087 |
) |
| Net loss per share, basic and
diluted |
$ |
(1.82 |
) |
|
$ |
(1.99 |
) |
|
$ |
(11.39 |
) |
|
$ |
(24.00 |
) |
| Weighted-average shares used
in computing net loss per share, basic and diluted |
|
6,525,885 |
|
|
|
6,503,913 |
|
|
|
6,510,138 |
|
|
|
6,503,913 |
|
|
Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss
per Share |
|
(Unaudited; in thousands, except share and per share amounts) |
| |
|
|
|
| |
Three Months Ended December
31, |
|
Year Ended December 31, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
Net loss |
$ |
(11,895 |
) |
|
$ |
(12,925 |
) |
|
$ |
(74,135 |
) |
|
$ |
(156,087 |
) |
| Adjustments: |
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
4,501 |
|
|
|
4,553 |
|
|
|
17,257 |
|
|
|
18,166 |
|
|
Restructuring and impairment charges |
|
348 |
|
|
|
165 |
|
|
|
7,493 |
|
|
|
72,012 |
|
| Non-GAAP net loss |
$ |
(7,046 |
) |
|
$ |
(8,207 |
) |
|
$ |
(49,385 |
) |
|
$ |
(65,909 |
) |
| Net loss per share, basic and
diluted |
$ |
(1.82 |
) |
|
$ |
(1.99 |
) |
|
$ |
(11.39 |
) |
|
$ |
(24.00 |
) |
| Adjustments: |
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
|
0.69 |
|
|
|
0.70 |
|
|
|
2.65 |
|
|
|
2.79 |
|
|
Restructuring and impairment charges |
|
0.05 |
|
|
|
0.03 |
|
|
|
1.15 |
|
|
|
11.07 |
|
| Non-GAAP net loss per share,
basic and diluted* |
$ |
(1.08 |
) |
|
$ |
(1.26 |
) |
|
$ |
(7.59 |
) |
|
$ |
(10.14 |
) |
| Weighted-average shares
outstanding, basic and diluted |
|
6,525,885 |
|
|
|
6,503,913 |
|
|
|
6,510,138 |
|
|
|
6,503,913 |
|
______________________________________________________________* Non-GAAP
net loss per share, basic and diluted may not total due to
rounding.
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