Instil Bio Reports Second Quarter 2021 Financial Results and Provides Corporate Update
August 12 2021 - 7:00AM
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 2021 financial results
and provided a corporate update.
“We confirm our commitment to initiating a Phase 2 trial of
ITIL-168 in advanced melanoma in the second half of 2021,” said
Bronson Crouch, Chief Executive Officer of Instil. “With the
installation and ongoing qualification of modular clean room pods
at our Tarzana, California facility and our progress toward
activating additional manufacturing capabilities in Manchester,
U.K., we expect increased clinical manufacturing capacity in late
2021 and early 2022 to support our clinical development plans for
ITIL-168 and ITIL-306. Our commitment to innovation in
manufacturing continues with the development of a shortened 21-day
manufacturing process with robust levels of TIL transduction
efficiency for ITIL-306, our first genetically engineered
CoStAR-TIL. We expect to pursue further enhancements to both
ITIL-168 and ITIL-306 manufacturing processes in the future.”
Second Quarter 2021 Highlights and Anticipated
Milestones:
Clinical Development:
- Presented Clinical Data in Advanced Melanoma at
AACR: Instil presented clinical data demonstrating a 67%
objective response rate and 19% complete response rate from a
compassionate use program of TILs for the treatment of metastatic
melanoma as a late-breaking e-Poster at the AACR virtual meeting in
April 2021.
- Orphan Drug Designation: On April 27, 2021,
ITIL-168 received orphan drug designation from the U.S. Food and
Drug Administration (FDA) for the treatment of melanoma stages IIB
to IV.
- Phase 2 Clinical Trial Initiation of ITIL-168:
Instil expects to start a Phase 2 clinical trial of ITIL-168 for
the treatment of advanced melanoma in the second half of 2021.
Topline safety and efficacy data would be expected in 2023,
followed by submission of a BLA to the FDA and a Marketing
Authorization Application to the European Medicines Agency expected
in 2023 and 2024, respectively.
- Phase 1 Clinical Trial Initiation of ITIL-306:
Instil expects to start a Phase 1 clinical trial of ITIL-306 for
the treatment of FOLR1-expressing cancer in the first half of
2022.
Manufacturing and Technical Operations:
- Facility Readiness for Clinical Trials:
Current manufacturing capacity in the U.K. is sufficient to support
capacity needs at the start of the expected upcoming Phase 2
clinical trial of ITIL-168. Further expansion of our U.K.
manufacturing capacity is expected later this year. Instil has also
installed and begun qualification of its modular clean room pods at
its Tarzana, California facility. These pods will support U.S.
regional manufacturing and are expected to begin producing clinical
batches in the first half of 2022.
- ITIL-306 Manufacturing Process: Instil’s focus
on continued improvements in manufacturing is highlighted by the
development of a 21-day manufacturing process for ITIL-306. This
process is capable of achieving high TIL transduction efficiencies
that are well in excess of published literature.
Second Quarter 2021 Financial and Operating
Results:
As of June 30, 2021, cash and cash equivalents totaled
$566.7 million, compared to $241.7 million as of December 31,
2020. The Company expects that its cash and cash equivalents as of
June 30, 2021 will enable it to fund its operating plan into
2023.
Research and development expenses were $21.2 million and $35.6
million for the three and six months ended June 30, 2021,
compared to $2.2 million and $4.2 million for the three and six
months ended June 30, 2020.
General and administrative expenses were $14.2 million and $23.2
million for the three and six months ended June 30, 2021,
compared to $2.4 million and $4.3 million for the three and six
months ended June 30, 2020.
INSTIL BIO, INC.SELECTED
FINANCIAL DATA (Unaudited; in thousands, except share and
per share amounts)
Statements of Operations
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue |
$ |
— |
|
|
|
$ |
42 |
|
|
|
$ |
— |
|
|
|
$ |
87 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
21,186 |
|
|
|
2,237 |
|
|
|
35,610 |
|
|
|
4,245 |
|
|
General and administrative |
14,195 |
|
|
|
2,398 |
|
|
|
23,174 |
|
|
|
4,298 |
|
|
Total operating expenses |
35,381 |
|
|
|
4,635 |
|
|
|
58,784 |
|
|
|
8,543 |
|
|
Loss from operations |
(35,381 |
) |
|
|
(4,593 |
) |
|
|
(58,784 |
) |
|
|
(8,456 |
) |
|
Interest and other expense,
net |
(89 |
) |
|
|
(4,609 |
) |
|
|
(18 |
) |
|
|
(4,835 |
) |
|
Loss before income tax
benefit |
$ |
(35,470 |
) |
|
|
$ |
(9,202 |
) |
|
|
$ |
(58,802 |
) |
|
|
(13,291 |
) |
|
Income tax benefit |
159 |
|
|
|
— |
|
|
|
363 |
|
|
|
— |
|
|
Net loss |
$ |
(35,311 |
) |
|
|
$ |
(9,202 |
) |
|
|
$ |
(58,439 |
) |
|
|
$ |
(13,291 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.27 |
) |
|
|
$ |
(0.55 |
) |
|
|
$ |
(0.71 |
) |
|
|
$ |
(0.89 |
) |
|
Weighted-average shares used in
computing net loss per share, basic and diluted |
128,743,123 |
|
|
|
16,846,552 |
|
|
|
82,478,284 |
|
|
|
14,942,479 |
|
|
Selected Balance Sheet Data
|
June 30, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
$ |
566,725 |
|
|
$ |
241,714 |
|
|
Total assets |
672,670 |
|
|
319,012 |
|
|
Total liabilities |
37,198 |
|
|
26,645 |
|
|
Total stockholders’ equity
(deficit) |
635,472 |
|
|
(39,599 |
) |
|
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. The Company has assembled an accomplished management team
with a successful track record in the development, manufacture, and
commercialization of cell therapies. Using the Company’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 for multiple solid tumors. For
more information visit www.instilbio.com and LinkedIn.
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,”
“intends,” “projects,” and “future” 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 potential for these product candidates to receive
regulatory approval from the FDA or equivalent foreign regulatory
agencies, whether, if approved, these product candidates will be
successfully distributed and marketed, our plans to expand clinical
manufacturing capabilities, and the potential benefits of orphan
drug designation to ITIL-168. 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. 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. Risks regarding our business are
described in detail in our Securities and Exchange Commission
(“SEC”) filings, including in our prospectus dated March 18, 2021,
as filed with the SEC on March 22, 2021, pursuant to Rule 424(b)
under the Securities Act of 1933, as amended, which is available on
the SEC’s website at www.sec.gov. 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. 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:
Brendan PayneStern Investor
Relations1-212-362-1200brendan.payne@sternir.com |
Media Contact:1-833-446-7845 Ext.
1009mediarelations@instilbio.com |
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