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 2022 financial results and
provided a corporate update.
Third Quarter
2022 Highlights and
Anticipated Milestones:
- DELTA-1 manufacturing and regulatory update:
As previously announced, enrollment in DELTA-1 was voluntarily
paused following the observation of decreased rates of successful
manufacturing of ITIL-168. Our ongoing investigation of the
manufacturing failures identified a central source of contamination
in the cell media. In conjunction with this pause, we are also
evaluating opportunities to increase the robustness of our
manufacturing process. In addition, in October 2022, we notified
the FDA and other regulatory agencies that an unplanned review of
the data for the initial patients that had been dosed with ITIL-168
in the DELTA-1 trial was conducted in order to review risk-benefit.
This review was inconclusive because the response data were not
mature. Subsequently, the Data Safety Monitoring Board’s
prespecified review found no safety concerns. We plan to discuss
next steps for the DELTA-1 trial with the FDA and other regulatory
agencies, and after such discussions, or as a result of our ongoing
investigation of our manufacturing process, we may be required to
modify, delay or restart our ITIL-168 clinical development program.
We plan to provide an update on our ITIL-168 clinical development
program in the first quarter of 2023.
- DELTA-2 clinical update: The Company is
deferring enrollment in the DELTA-2 study to focus resources toward
higher-priority clinical programs.
- First patient dosed in Phase 1 dose escalation study of
ITIL-306, Instil’s first CoStAR-TIL: Instil recently
announced dosing of the first patient with non-small cell lung
cancer in the Phase 1 dose escalation study of ITIL-306 for the
treatment of multiple solid tumors. The ITIL-306 product contained
the target dose of approximately 1 billion CoStAR-TILs in addition
to unmodified TILs. The CoStAR platform introduces a genetic
modification which is designed to enhance the activity of TILs
within the tumor microenvironment. The Phase 1 trial of ITIL-306
excludes the high-dose interleukin-2 regimen after ITIL-306
infusion. The Company remains committed to the CoStAR platform and
expects to report initial clinical data from the trial in
2023.
- Appointment of Head of Research and
Development: Instil announced the appointment of Robert
Hawkins, M.B.B.S., Ph.D., as Head of Research and Development. Dr.
Hawkins is a world-renowned oncologist and biotechnology innovator,
with a focus on development of novel cell and gene therapies. Dr.
Hawkins was the founder and CEO of Immetacyte Ltd., a cell therapy
company spun out of the University of Manchester where Dr. Hawkins
served as Professor of Medical Oncology. Immetacyte Ltd. generated
the foundational TIL technology and clinical data on which Instil
was founded.
- Resignation of Chief Medical Officer: Instil
announced that, pursuant to a separation agreement, Zachary
Roberts, M.D., Ph.D., Chief Medical Officer of the Company, has
resigned effective November 11, 2022 to pursue other opportunities.
The company appreciates Dr. Roberts’ contributions and wishes him
the best in his future endeavors.
- Company confirms cash-runway into 2025 with anticipated
sale-leaseback transaction of its Tarzana manufacturing
facility
Third Quarter 2022 Financial and Operating
Results:
As of September 30, 2022, we had $303.3 million in
total cash and cash equivalents and marketable securities,
comprised of $41.1 million in cash and cash equivalents and
$262.2 million in marketable securities, compared to
$454.1 million in total cash and cash equivalents 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. The Company expects that its cash, cash
equivalents and marketable securities as of September 30, 2022
will enable it to fund its operating plan into 2025 upon completion
of the anticipated sale-leaseback of its Tarzana, CA manufacturing
site.
Research and development expenses were $39.7 million and $120.3
million for the three and nine months ended September 30,
2022, respectively, compared to $29.1 million and $64.7 million for
the three and nine months ended September 30, 2021,
respectively.
General and administrative expenses were $17.0 million and $49.3
million for the three and nine months ended September 30,
2022, respectively, compared to $14.0 million and $37.1 million for
the three and nine months ended September 30, 2021,
respectively.
INSTIL BIO, INC.SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)
Selected Balance Sheet Data
|
September 30, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and marketable securities |
$ |
303,287 |
|
$ |
454,099 |
Total assets |
$ |
532,741 |
|
$ |
609,983 |
Total liabilities |
$ |
122,153 |
|
$ |
54,784 |
Stockholders’ equity |
$ |
410,588 |
|
$ |
555,199 |
Statements of Operations
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
39,660 |
|
|
$ |
29,064 |
|
|
$ |
120,334 |
|
|
$ |
64,674 |
|
General and administrative |
|
16,989 |
|
|
|
13,960 |
|
|
|
49,325 |
|
|
|
37,134 |
|
Total
operating expenses |
|
56,649 |
|
|
|
43,024 |
|
|
|
169,659 |
|
|
|
101,808 |
|
Loss
from operations |
|
(56,649 |
) |
|
|
(43,024 |
) |
|
|
(169,659 |
) |
|
|
(101,808 |
) |
Interest income |
|
1,276 |
|
|
|
22 |
|
|
|
1,859 |
|
|
|
45 |
|
Interest expense |
|
(807 |
) |
|
|
— |
|
|
|
(1,138 |
) |
|
|
— |
|
Other expense, net |
|
(415 |
) |
|
|
(661 |
) |
|
|
(1,863 |
) |
|
|
(702 |
) |
Loss
before income tax benefit |
|
(56,595 |
) |
|
|
(43,663 |
) |
|
|
(170,801 |
) |
|
|
(102,465 |
) |
Income
tax benefit |
|
371 |
|
|
|
658 |
|
|
|
1,468 |
|
|
|
1,021 |
|
Net
loss |
$ |
(56,224 |
) |
|
$ |
(43,005 |
) |
|
$ |
(169,333 |
) |
|
$ |
(101,444 |
) |
Net loss
per share, basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.03 |
) |
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
129,680,217 |
|
|
|
128,794,142 |
|
|
|
129,391,225 |
|
|
|
98,256,027 |
|
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 below for a 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 EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Net
loss—GAAP |
$ |
(56,224 |
) |
|
$ |
(43,005 |
) |
|
$ |
(169,333 |
) |
|
$ |
(101,444 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
7,982 |
|
|
|
8,734 |
|
|
|
23,798 |
|
|
|
17,293 |
|
Net
loss—Non-GAAP |
$ |
(48,242 |
) |
|
$ |
(34,271 |
) |
|
$ |
(145,535 |
) |
|
$ |
(84,151 |
) |
Net loss
per share, basic and diluted—GAAP |
$ |
(0.43 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.03 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense per share |
|
0.06 |
|
|
|
0.07 |
|
|
|
0.18 |
|
|
|
0.18 |
|
Net loss
per share, basic and diluted—Non-GAAP |
$ |
(0.37 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.13 |
) |
|
$ |
(0.85 |
) |
Weighted-average shares outstanding, basic and diluted |
|
129,680,217 |
|
|
|
128,794,142 |
|
|
|
129,391,225 |
|
|
|
98,256,027 |
|
About Instil Bio
Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage
biopharmaceutical company focused on developing tumor infiltrating
lymphocyte, or TIL, therapies for the treatment of patients with
cancer. Instil has assembled an accomplished management team with a
successful track record in the development, manufacture, and
commercialization of cell therapies. Using Instil's proprietary,
optimized, and scalable manufacturing processes at its in-house
manufacturing facilities, Instil is advancing its lead TIL product
candidate, ITIL-168, for the treatment of advanced melanoma and
other solid tumors as well as 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 potential of our product candidates to positively
impact quality of life and alter the course of disease in the
patients we seek to treat, our research, development and regulatory
plans for our product candidates, the timing of our ongoing and
potential future clinical trials and studies and the availability
of data therefrom, including our expectations concerning the timing
of updates on our ITIL-306 clinical trial and the deferral of
enrollment in our DELTA-2 clinical trial, our plans to discuss the
DELTA-1 trial with the FDA and other regulatory agencies, the
investigation into our manufacturing process and expectations
concerning the outcome thereof and updates related thereto, the
potential for us to make submissions concerning, and for our
product candidates to receive, regulatory approval from the FDA or
equivalent foreign regulatory agencies and whether, if approved,
these product candidates will be successfully distributed and
marketed, the anticipated sale-leaseback of our Tarzana, CA
manufacturing facility, 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 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; the
ongoing COVID-19 pandemic, 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, including the risk that our investigation
into our manufacturing process will not yield conclusive or
actionable results; 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 Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 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, 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. Such risks may be amplified by the
impacts of the COVID-19 pandemic. 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 of the date hereof, and we disclaim any obligation to
update these statements except as may be required by law.
Contacts:
Janhavi MohiteStern Investor
Relations1-212-362-1200janhavi.mohite@sternir.com |
Investor
Relations1-972-499-3350investorrelations@instilbio.comwww.instilbio.com |
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