GRAIL Completes $110 Million Equity Financing With Samsung Entities
Pursuant to the definitive agreement, the Samsung entities invested
"This investment from the Samsung entities further strengthens our balance sheet and extends our cash runway as we advance key priorities, including securing regulatory approval and reimbursement for Galleri® in
As previously announced,
"GRAIL is at a pivotal moment in its mission to transform early cancer detection. This investment in GRAIL, together with the strategic business collaboration, represents a significant milestone in advancing
About
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
For more information, visit grail.com.
About Galleri®
The Galleri® multi-cancer early detection (MCED) test screens for more than 50 cancer types, including many deadly cancers that currently lack screening options, such as pancreatic, ovarian and liver/bile duct cancers1. The Galleri test is the only MCED test clinically proven through a randomized controlled trial to increase earlier cancer detection (Stage I-III) and reduce Stage IV diagnoses - enabling more patients to have access to potentially curative treatment options2. When added to standard-of-care screening, the Galleri test reduced Stage IV diagnosis by more than 20% after the first year of screening across all stageable cancers2,*. The Galleri test increased cancer detection by screening four times versus standard of care screening alone2. The Galleri test has the lowest false positive rate among MCED tests** and the ability to predict the Cancer Signal of Origin with greater than 90% accuracy, helping guide efficient diagnostic evaluation1-3. The Galleri test is backed by a robust clinical evidence program, with more than 380,000 participants across multiple studies, including the NHS-Galleri trial, the first and only randomized controlled trial for an MCED test. The Galleri test has delivered consistent performance across these studies. 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, cervical or lung 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.
*A statistically significant reduction was not observed in combined stage III–IV diagnoses across three screening rounds for 12 cancer types responsible for around two-thirds of cancer mortality in the US and UK.
**Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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 No Cancer Signal 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 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.
GRAIL 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 about future collaborations among us, Samsung entities or Samsung investors including Samsung C&T Corporation, future initial testing, future reimbursement, future potential additional collaborations, our ability to commercialize Galleri in other geographies, and our cash runway and the sufficiency of cash on hand to finance our business and anticipated trends in our business.
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 and numerous associated risks discussed under the sections entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2024 and in our Quarterly Report on Form 10-Q for the period ended September 30, 2025 (the "Form 10-Q"). 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, financial condition and success in our business strategies and operations 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.
1 Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
2 Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2.
3 GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256]
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SOURCE GRAIL, Inc.
GRAIL Contacts: Corporate Communications, Kristen Davis, Trish Rowland, pr@grail.com; Investor Relations, Alex Dobbin, Alexis Tosti, ir@grail.com