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GRAIL is Building and Scaling a
Groundbreaking New Cancer Screening Technology
GRAIL, Inc. (NASDAQ: GRAL, formerly GRAIL, LLC), a healthcare
company whose mission is to detect cancer early when it can be
cured, today announced its spin-off from Illumina (NASDAQ: ILMN) is
complete, and GRAIL will be listed and commence regular-way trading
on the Nasdaq under the symbol “GRAL” as of tomorrow, June 25,
2024.
“With this spin-off, GRAIL is taking another important step in
our journey to shift the paradigm in early cancer detection,” said
Bob Ragusa, Chief Executive Officer at GRAIL. “There is nothing
acceptable about the status quo in cancer screening today. At
GRAIL, we have an unprecedented opportunity to establish a new
standard of care through Galleri® – our clinically-validated,
commercially available multi-cancer early detection test, which
screens for many of the deadliest cancers, including those with no
recommended screening tests today. As a publicly traded company, we
will continue our important work to address one of society’s
biggest healthcare challenges, and to establish and maintain a
market leading position in cancer detection. We have built a strong
foundation and track record of innovation, which we will leverage
to deliver value for patients, healthcare providers, healthcare
systems, shareholders and our employees.”
GRAIL’s strengths include:
- Galleri is setting the standard for multi-cancer early
detection (MCED) when added to recommended single cancer screening
tests: Galleri is a leading clinically validated, commercially
available MCED test that enables screening for some of the most
deadly types of cancer, such as pancreatic, esophageal, ovarian,
liver and others.
- Our established commercial leadership is driving the
development of a significant market: As of March 31, 2024, we have
sold more than 180,000 commercial tests and established over 100
commercial partnerships.
- Our clinical program includes population scale clinical studies
and real-world experience, with more than 385,000 participants
across eight clinical studies.
- Our highly-differentiated methylation platform enables product
opportunities across the cancer care continuum, including
symptomatic detection and precision oncology.
- Our highly experienced and multidisciplinary team has enabled
us to make significant progress towards improving cancer care.
- Our significant investments in scientific discovery, clinical
evidence, scaling our laboratory operations, assay enhancements and
commercial execution.
GRAIL’s core strategy and catalyst opportunities for long-term
growth include:
- Establishing Galleri as the population MCED standard and
establishing commercial leadership in large global markets.
- Expanding access to our products by pursuing FDA approval and
reimbursement and coverage from Medicare and commercial
payors.
- Defining, leading and expanding MCED adoption.
- Driving cutting edge science and technology to continuously
improve existing products and develop new products.
- Leveraging our existing infrastructure to enable and scale our
growing business.
As part of the spin-off, Illumina has provided GRAIL with
funding to pursue GRAIL’s long-range plan. Illumina will maintain a
minority share of 14.5% in GRAIL.
“We would like to thank Illumina for their support and
commitment to advancing multi-cancer early detection, and we look
forward to the continued relationship,” added Ragusa.
Latham & Watkins served as legal advisor and Morgan Stanley
& Co. LLC served as financial advisor to GRAIL for the
transaction.
About GRAIL, Inc.
GRAIL, Inc., is a healthcare company whose mission is to detect
cancer early, when it can be cured. GRAIL is focused on alleviating
the global burden of cancer by using the power of next-generation
sequencing, population-scale clinical studies, and state-of-the-art
machine learning, software, and automation to detect and identify
multiple deadly cancer types in earlier stages. GRAIL’s targeted
methylation-based platform can support the continuum of care for
screening and precision oncology, including multi-cancer early
detection in symptomatic patients, risk stratification, minimal
residual disease detection, biomarker subtyping, treatment and
recurrence monitoring. GRAIL is headquartered in Menlo Park, CA
with locations in Washington, D.C., North Carolina, and the United
Kingdom.
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early detection test is a proactive
tool in finding cancer early. With a simple blood draw, the Galleri
test can identify DNA shed by cancer cells (unique “fingerprints”)
to help screen for some of the deadliest cancers that don’t have
recommended screening today, such as pancreatic, esophageal,
ovarian, liver, and others.* The Galleri test can be used to screen
for cancer before a person becomes symptomatic, when cancer may be
more easily treated and potentially curable. The Galleri test can
indicate the origin of the cancer, giving healthcare providers a
roadmap of where to explore further. The Galleri test requires a
prescription from a licensed healthcare provider and should be used
in addition to recommended cancer screenings such as mammography,
colonoscopy, prostate-specific antigen (PSA) test, or cervical
cancer screening. It is recommended for people over the age of 50,
or those with an elevated risk for cancer due to genetics, family
history, environmental exposure, or other risk factors.
For more information about Galleri, visit galleri.com.
*Sensitivity in study participants with – Pancreas cancer: 83.7%
overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9%
stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7%
stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1%
overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7%
stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I,
70.0% stage II, 100% stage III, 100% stage IV).
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an
elevated risk for cancer, such as those aged 50 or older. The
Galleri test does not detect all cancers and should be used in
addition to routine cancer screening tests recommended by a
healthcare provider. Galleri is intended to detect cancer signals
and predict where in the body the cancer signal is located. Use of
Galleri is not recommended in individuals who are pregnant, 21
years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the
context of medical history, clinical signs and symptoms. A test
result of Cancer Signal Not Detected does not rule out cancer. A
test result of Cancer Signal Detected requires confirmatory
diagnostic evaluation by medically established procedures (e.g.,
imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean
that cancer is not present or testing was insufficient to detect
cancer, including due to the cancer being located in a different
part of the body. False-positive (a cancer signal detected when
cancer is not present) and false-negative (a cancer signal not
detected when cancer is present) test results do occur. Rx
only.
Laboratory/Test Information
The GRAIL clinical laboratory is certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and accredited by
the College of American Pathologists. The Galleri test was
developed, and its performance characteristics were determined by
GRAIL. The Galleri test has not been cleared or approved by the
U.S. Food and Drug Administration. The GRAIL clinical laboratory is
regulated under CLIA to perform high-complexity testing. The
Galleri test is intended for clinical purposes.
Forward Looking Statements
This press release contains forward-looking statements. In some
cases, you can identify these statements by forward-looking words
such as “aim,” “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“potential,” “predict,” “should,” “would,” or “will,” the negative
of these terms, and other comparable terminology. These
forward-looking statements, which are subject to risks,
uncertainties, and assumptions about us, may include expectations
and projections of our future financial performance, future tests
or products, technology, clinical studies, regulatory compliance,
potential market opportunity, anticipated growth strategies, and
anticipated trends in our business and our spin-off from
Illumina.
These statements are only predictions based on our current
expectations and projections about future events and trends. There
are important factors that could cause our actual results, level of
activity, performance, or achievements to differ materially and
adversely from those expressed or implied by the forward-looking
statements, including those factors discussed under the section
entitled “Risk Factors” in the Registration Statement on Form 10
filed by GRAIL (the “Form 10”), as may be further amended.
Moreover, we operate in a dynamic and rapidly changing environment.
New risks emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results, level of
activity, performance, or achievements to differ materially and
adversely from those contained in any forward-looking statements we
may make.
Forward-looking statements relate to the future and,
accordingly, are subject to inherent uncertainties, risks, and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Although we believe the
expectations and projections expressed or implied by the
forward-looking statements are reasonable, we cannot guarantee
future results, level of activity, performance, or achievements.
Our actual results and financial condition may differ materially
from those indicated in the forward-looking statements. Except to
the extent required by law, we undertake no obligation to update
any of these forward-looking statements after the date of this
press release to conform our prior statements to actual results or
revised expectations or to reflect new information or the
occurrence of unanticipated events.
This press release shall not constitute an offer of any
securities for sale, nor shall there be any offer, sale or
distribution of securities in any jurisdiction in which such offer,
sale or distribution would be unlawful prior to appropriate
registration or qualification under the securities laws of such
jurisdiction.
For additional information with respect to GRAIL and the
separation from Illumina, please refer to the Form 10.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240624532884/en/
For GRAIL Corporate Communications Kristen Davis Cammy
Duong pr@grail.com
Investor Relations Alex Dobbin Alexis Tosti ir@grail.com
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