GRAIL Leadership to Outline Early Cancer Detection Market Opportunity, Business Strategy, and Financial Profile

GRAIL, LLC., a healthcare company whose mission is to detect cancer early when it can be cured, today will host a virtual Capital Markets Day. Members from GRAIL’s management team will outline growth drivers for Galleri^®, a clinically validated, commercially available multi-cancer early detection test, as well as the Company’s scientific expertise, addressable market opportunity, business strategy, and financial profile. GRAIL’s presenters will include Bob Ragusa, Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Joshua Ofman MD, MSHS, President, and Sir Harpal Kumar, President of Biopharma & Europe.

Illumina has communicated its goal to finalize divestment terms for GRAIL by the end of the second quarter of 2024. If the contemplated spin-off transaction is executed, GRAIL would become a publicly traded company and its common stock will be listed on the Nasdaq Stock Exchange and traded under the ticker “GRAL.”

“We believe multi-cancer early detection is one of the most significant opportunities in healthcare, helping to address one of society’s biggest health issues. At GRAIL, we are advancing our mission to detect cancer early, when it can be cured, on behalf of patients every day,” said Bob Ragusa, CEO at GRAIL. “We have built strong groups across GRAIL - including our executive leadership team, scientific talent, and commercial organization - poised to establish a new standard of care for population cancer screening with Galleri. We look forward to building on our progress to shift the paradigm in early cancer detection and drive value for our stakeholders.”

The presentation will highlight GRAIL’s track record of strengths:

• Galleri is setting the standard for multi-cancer early detection (MCED): Galleri is a leading clinically validated, commercially available MCED test and 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 in precision oncology and symptomatic detection.
• Our highly experienced and multidisciplinary team has enabled us to make significant progress towards improving cancer care.

GRAIL leadership will outline the Company’s core strategy and catalysts for long-term growth, including:

• Establishing the Galleri test 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 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

Presentation and Webcast Information

The live webcast will begin at 10:00 a.m. ET and can be accessed on GRAIL’s website at https://grail-capital-markets-day-2024.open-exchange.net/. The presentation and a replay of the webcast will also be available on GRAIL’s website.

About GRAIL

GRAIL 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. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) and currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.

For more information, visit grail.com.

About Galleri^®

The Galleri multi-cancer early detection test is a new proactive tool to screen for cancer. It is a blood test that can help screen for many of the most deadly types of cancer that don’t have recommended screening today, such as pancreatic, esophageal, ovarian, and liver.* The Galleri test can identify DNA shed by cancer cells (unique “fingerprints”) to screen for some of the deadliest cancers before they become symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test provides direction to doctors on the cancer's origin and helps guide next steps for diagnosis. 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. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.

For more information, visit galleri.com.

*Editor’s note: 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

GRAIL’s 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. GRAIL’s 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 proposed separation from Illumina, please refer to the Form 10.

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