GRAIL, Inc. 10-K filed Mar 12, 2026

Modified · Our Company

We are an innovative commercial-stage healthcare company focused on saving lives and shifting the paradigm in early cancer detection at population scale. We believe screening individuals for many types of cancer with a single test represents a significant opportunity to reduce the global burden of cancer. Our Galleri test is a commercially available screening test for early detection of multiple types of cancer, which we termed multi-cancer early detection (“MCED”). We believe Galleri is clinically validated based on the results of its clinical studies completed to date, including the results of its foundational case-control Circulating Cell-free Genome Atlas test (“CCGAGalleri”) study and interventional PATHFINDER study, which together enrolled more than 21,000 participants. In these studies, Galleri demonstrated an ability to detect a shared cancer signal through analysis can screen for many types of cell-free DNA in the bloodstreamcancer, accurately predictpredicting the specific organ or tissue type where the cancer signal originated (the “Cancer Signal of Origin”, and yield or “CSO”), with high positive predictive values (“PPV”) and low false positive rates, all from a simple blood draw. Galleri results can help guide next steps for a diagnosis of cancer by healthcare providers in required follow-up diagnostic testing. We launched Galleri in the United States in mid-2021. As of December 31, 2024, we have sold more than 290,000 commercial tests, more than 137,000 of which were sold in 2024, and established commercial partnerships with stakeholders including leading healthcare systems, employers, payors, and life insurance providers. Commercial use of Galleri has detected some of the most aggressive cancers in early stages includinghas detected some of the most aggressive cancers in early stages including, among others, endometrial, esophageal, gastrointestinal, head and neck, liver, pancreatic, and rectal cancers. We have conducted what we believe is the largest clinical program in genomic medicine to date with data from over 385,000 participants that we believe demonstrate the clinical validation and clinical utility of Galleri in its intended use population. We have deep operational experience with over 800,000 tests processed across this clinical program and from our commercial experience, among others, endometrial, esophagealincluding through partnerships with leading healthcare systems, gastrointestinalemployers, head and neckdigital health platforms, liverpayors, pancreatic, and rectal cancerslife insurance providers.