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 second quarter 2023 financial results
and provided a corporate update.
“Successful manufacturing of ITIL-306 in our Manchester, UK
facility is a major milestone on our path to clinical development
of ITIL-306,” said Mark Dudley, Chief Scientific Officer of Instil
Bio. “We have implemented improvements to the manufacturing process
of ITIL-306 that were shown to result in a doubling of the number
of CoStAR-TILs in the final product, which we believe could be
meaningful for the therapeutic profile of ITIL-306 in patients with
advanced cancer.”
Second Quarter
2023 Highlights and Anticipated
Milestones:
- ITIL-306, first CoStAR-TIL in clinical development,
anticipated to start clinical trial ITIL-306-202 in 2H
2023: Instil anticipates initiating phase 1 clinical trial
ITIL-306-202 with an updated trial design versus ITIL-306-201; the
ITIL-306-202 trial design has received positive initial feedback
from the Medicines and Healthcare products Regulatory Agency, or
MHRA in the United Kingdom. Instil expects Clinical Trial
Application, or CTA, clearance from the MHRA in the second half of
2023 and initial clinical data from the ITIL-306-202 clinical trial
in 2024.
- ITIL-306 operational in Manchester, UK manufacturing
facility: Instil has successfully established ITIL-306,
including multiple successful verification runs, in its Manchester,
UK manufacturing facility. Instil has designed and implemented
manufacturing process improvements that resulted in a doubling of
the final yield of CoStAR-TILs from verification runs.
- Cash runway beyond 2026: Instil Bio confirms
its previous guidance of cash runway beyond 2026.
Second Quarter
2023 Financial and Operating
Results:
As of June 30, 2023, Instil had cash, cash equivalents,
restricted cash and marketable securities of $202.9 million,
which consists of $21.8 million in cash and cash equivalents,
$1.2 million in restricted cash and $179.9 million in
marketable securities, compared to $260.9 million in total
cash and cash equivalents and marketable securities, consisting 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 and marketable securities
as of June 30, 2023 will enable it to fund its operating plan
beyond 2026.
Research and development expenses were $8.5 million and $29.1
million for the three and six months ended June 30, 2023,
respectively, compared to $41.5 million and $80.7 million for the
three and six months ended June 30, 2022, respectively.
General and administrative expenses were $11.5 million and $24.7
million for the three and six months ended June 30, 2023,
respectively, compared to $17.2 million and $32.3 million for the
three and six months ended June 30, 2022, respectively.
Restructuring and impairment charges were $1.0 million and $25.6
million for the three and six months ended June 30, 2023,
respectively.
INSTIL BIO, INC.SELECTED FINANCIAL
DATA (Unaudited; in thousands, except share and per share
amounts)Selected Balance Sheet Data |
|
|
June 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents, restricted cash and marketable
securities |
$ |
202,860 |
|
|
$ |
260,920 |
|
Total assets |
$ |
408,310 |
|
|
$ |
482,128 |
|
Total liabilities |
$ |
111,794 |
|
|
$ |
118,523 |
|
Stockholders’ equity |
$ |
296,516 |
|
|
$ |
363,605 |
|
|
Statements of Operations(Unaudited; in thousands,
except share and per share amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
8,459 |
|
|
$ |
41,500 |
|
|
$ |
29,129 |
|
|
$ |
80,674 |
|
General and administrative |
|
11,518 |
|
|
|
17,224 |
|
|
|
24,740 |
|
|
|
32,336 |
|
Restructuring and impairment charges |
|
1,010 |
|
|
|
— |
|
|
|
25,564 |
|
|
|
— |
|
Total operating expenses |
|
20,987 |
|
|
|
58,724 |
|
|
|
79,433 |
|
|
|
113,010 |
|
Loss from operations |
|
(20,987 |
) |
|
|
(58,724 |
) |
|
|
(79,433 |
) |
|
|
(113,010 |
) |
Interest income |
|
2,287 |
|
|
|
486 |
|
|
|
4,358 |
|
|
|
583 |
|
Interest expense |
|
(590 |
) |
|
|
(331 |
) |
|
|
(1,226 |
) |
|
|
(331 |
) |
Other income (expense),
net |
|
628 |
|
|
|
(1,032 |
) |
|
|
571 |
|
|
|
(1,448 |
) |
Loss before income tax
benefit |
|
(18,662 |
) |
|
|
(59,601 |
) |
|
|
(75,730 |
) |
|
|
(114,206 |
) |
Income tax benefit |
|
— |
|
|
|
609 |
|
|
|
— |
|
|
|
1,097 |
|
Net loss |
$ |
(18,662 |
) |
|
$ |
(58,992 |
) |
|
$ |
(75,730 |
) |
|
$ |
(113,109 |
) |
Net loss per share, basic and
diluted |
$ |
(0.14 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.88 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
130,079,097 |
|
|
|
129,367,833 |
|
|
|
130,079,097 |
|
|
|
129,244,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
INSTIL BIO, INC.Reconciliation of GAAP to
Non-GAAP Net Loss (Unaudited; in thousands, except share
and per share amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
$ |
(18,662 |
) |
|
$ |
(58,992 |
) |
|
$ |
(75,730 |
) |
|
$ |
(113,109 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
4,413 |
|
|
|
8,323 |
|
|
|
8,943 |
|
|
|
15,816 |
|
Non-GAAP net loss |
$ |
(14,249 |
) |
|
$ |
(50,669 |
) |
|
$ |
(66,787 |
) |
|
$ |
(97,293 |
) |
Net loss per share, basic and
diluted |
$ |
(0.14 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.88 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
|
0.03 |
|
|
|
0.06 |
|
|
|
0.07 |
|
|
|
0.12 |
|
Non-GAAP net loss per share,
basic and diluted* |
$ |
(0.11 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.76 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
130,079,097 |
|
|
|
129,367,833 |
|
|
|
130,079,097 |
|
|
|
129,244,334 |
|
* 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 and presentation 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, 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 conflict between Russia and Ukraine, 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 March 31, 2023 available on
the SEC’s website at www.sec.gov, and in our Quarterly Report on
Form 10-Q for the quarter ended June 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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