Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage
biopharmaceutical company focused on developing a pipeline of novel
therapies, today reported its second quarter 2024 financial results
and provided a corporate update.
“We have expanded our pipeline with a pair of
clinical-stage, potentially best-in-class therapeutics by
in-licensing SYN-2510 and SYN-27M,” said Bronson Crouch, CEO of
Instil. “By executing a 15-year lease of our Tarzana cell therapy
manufacturing facility, we have strengthened our financial
foundation to support Instil’s near-term clinical development of
these assets.”
Recent Highlights:
- In-licensed SYN-2510 and
SYN-27M: In August 2024, SynBioTx, Inc., a wholly owned
subsidiary of Instil, entered into a license and collaboration
agreement with ImmuneOnco (HKEX:1541) for the exclusive global
development and commercialization rights outside of Greater China
of SYN-2510, a potentially best-in-class PD-L1xVEGF bispecific
antibody, and SYN-27M, a next-generation ADCC-enhanced CTLA-4
antibody. SYN-2510 and SYN-27M have completed Phase 1a dose
escalation studies in multiple solid tumor types in China, and
ImmuneOnco is continuing patient enrollment in both programs to
support dose optimization and dose expansion.
- Executed lease of our cell
therapy manufacturing facility to AstraZeneca Pharmaceuticals
LP: In July 2024, Instil reported the execution of a lease
of its U.S. cell therapy manufacturing facility to AstraZeneca
Pharmaceuticals LP. Under the terms of the agreement, initial base
rent is greater than $7.5 million annually, and escalates at 3% per
annum, with the tenant also required to pay certain operating
expenses and tax expenses, subject to certain rent abatement in the
first year of the 15-year lease term.
- Exploring
further opportunities to in-license or acquire novel therapeutic
candidates: Instil continues to explore further
opportunities to in-license or otherwise acquire novel therapeutic
candidates with first-in-class or best-in-class potential.
- Cash runway expected beyond
2026.
Second Quarter 2024 Financial and Operating
Results:
As of June 30, 2024, Instil had cash, cash
equivalents, marketable securities and long-term investments of
$152.6 million, which consisted of $6.8 million in cash
and cash equivalents, $141.8 million in marketable securities,
and $4.0 million in long-term investments, compared to
$175.0 million in cash, cash equivalents, marketable
securities and long-term investments as of December 31, 2023,
consisting 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.
Instil expects that its cash, cash equivalents, marketable
securities and long-term investments as of June 30, 2024 will
enable it to fund its operating plan beyond 2026.
Research and development expenses were $2.9 million
and $10.2 million for the three and six months ended June 30,
2024, respectively, compared to $8.5 million and $29.1 million for
the three and six months ended June 30, 2023,
respectively.
General and administrative expenses were $10.7
million and $23.1 million for the three and six months ended
June 30, 2024, respectively, compared to $11.5 million and
$24.7 million for the three and six months ended June 30,
2023, respectively.
Restructuring and impairment charges were $0.5
million and $4.8 million for the three and six months ended
June 30, 2024, respectively, compared to $1.0 million and
$25.6 million for three and six months ended June 30, 2023,
respectively.
Net loss per share, basic and diluted were $2.29
and $6.03 for the three and six months ended June 30, 2024,
respectively, compared to $2.87 and $11.64 for the three and six
months ended June 30, 2023, respectively. Non-GAAP net loss
per share, basic and diluted, were $1.57 and $3.95 for the three
and six months ended June 30, 2024, respectively, compared to
$2.03 and $6.33 for the three and six months ended June 30,
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, SYN-2510, is a novel and differentiated
PD-L1xVEGF bispecific antibody in development for the treatment of
multiple solid tumor cancers. 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,” “expected,” “exploring,” “future,” “intends,” “may,”
“plans,” “potential,” “projects,” 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 SYN-2510 and SYN-27M, clinical development of SYN-2510 and
SYN-27M and the generation of clinical data for SYN-2510 and
SYN-27M; concerning or implying our ability to acquire and develop
additional product candidates; our research, development and
regulatory plans for our product candidates; our expectations
regarding our capital position, resources, and balance sheet and
the expected impact of the lease of our U.S. manufacturing facility
with respect thereto, and the potential impact thereof on the
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 additional product candidates, 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 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; 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 Quarterly Report on Form 10-Q for the quarter ended
June 30, 2024 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)Selected Condensed Consolidated Balance Sheet
Data |
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
|
Cash, cash equivalents, restricted cash, marketable securities and
long-term investments |
$ |
152,578 |
|
$ |
175,018 |
|
Total assets |
$ |
294,316 |
|
$ |
325,630 |
|
Total liabilities |
$ |
99,297 |
|
$ |
99,801 |
|
Total stockholders’ equity |
$ |
195,019 |
|
$ |
225,829 |
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
Three Months Ended |
|
Six Months Ended |
| |
June 30, |
|
June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
2,921 |
|
|
$ |
8,459 |
|
|
$ |
10,177 |
|
|
$ |
29,129 |
|
|
General and administrative |
|
10,706 |
|
|
|
11,518 |
|
|
|
23,130 |
|
|
|
24,740 |
|
|
Restructuring and impairment charges |
|
508 |
|
|
|
1,010 |
|
|
|
4,783 |
|
|
|
25,564 |
|
|
Total operating expenses |
|
14,135 |
|
|
|
20,987 |
|
|
|
38,090 |
|
|
|
79,433 |
|
|
Loss from operations |
|
(14,135 |
) |
|
|
(20,987 |
) |
|
|
(38,090 |
) |
|
|
(79,433 |
) |
|
Interest income |
|
1,919 |
|
|
|
2,287 |
|
|
|
3,981 |
|
|
|
4,358 |
|
|
Interest expense |
|
(1,999 |
) |
|
|
(590 |
) |
|
|
(3,980 |
) |
|
|
(1,226 |
) |
|
Other (expense) income, net |
|
(702 |
) |
|
|
628 |
|
|
|
(1,130 |
) |
|
|
571 |
|
|
Net loss |
$ |
(14,917 |
) |
|
$ |
(18,662 |
) |
|
$ |
(39,219 |
) |
|
$ |
(75,730 |
) |
|
Net loss per share, basic and diluted |
$ |
(2.29 |
) |
|
$ |
(2.87 |
) |
|
$ |
(6.03 |
) |
|
$ |
(11.64 |
) |
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
6,503,913 |
|
|
|
6,503,913 |
|
|
|
6,503,913 |
|
|
|
6,503,913 |
|
|
INSTIL BIO, INC.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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
Net loss |
$ |
(14,917 |
) |
|
$ |
(18,662 |
) |
|
$ |
(39,219 |
) |
|
$ |
(75,730 |
) |
|
Adjustments: |
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
4,173 |
|
|
|
4,413 |
|
|
|
8,688 |
|
|
|
8,943 |
|
|
Restructuring and impairment charges |
|
508 |
|
|
|
1,010 |
|
|
|
4,783 |
|
|
|
25,564 |
|
|
Non-GAAP net loss |
$ |
(10,236 |
) |
|
$ |
(13,239 |
) |
|
$ |
(25,748 |
) |
|
$ |
(41,223 |
) |
|
Net loss per share, basic and diluted |
$ |
(2.29 |
) |
|
$ |
(2.87 |
) |
|
$ |
(6.03 |
) |
|
$ |
(11.64 |
) |
|
Adjustments: |
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
|
0.64 |
|
|
|
0.68 |
|
|
|
1.34 |
|
|
|
1.38 |
|
|
Restructuring and impairment charges per share |
|
0.08 |
|
|
|
0.16 |
|
|
|
0.74 |
|
|
|
3.93 |
|
|
Non-GAAP net loss per share, basic and diluted* |
$ |
(1.57 |
) |
|
$ |
(2.03 |
) |
|
$ |
(3.95 |
) |
|
$ |
(6.33 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
6,503,913 |
|
|
|
6,503,913 |
|
|
|
6,503,913 |
|
|
|
6,503,913 |
|
* Non-GAAP net loss per share, basic and diluted
may not total due to rounding.
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