GRAIL (GRAL) investor relations material

Key clinical results and trial updates

• NHS-Galleri trial showed a 20% reduction in stage IV cancer and a 4x improvement in detection rate compared to standard-of-care, but did not meet the primary endpoint of reducing combined stage III and IV cancers.

• Substantial decrease in emergency cancer presentations was observed in the NHS-Galleri trial.

• FDA is expected to focus on performance and safety rather than stage III/IV endpoints, with strong evidence from both PATHFINDER 2 and NHS-Galleri trials.

• Detailed data, including individual cancer performance, will be presented at ASCO, with plans for further publication.

• The REACH study in the Medicare population is ongoing, with stage IV reduction as the primary endpoint.

Regulatory and reimbursement outlook

• FDA approval process is underway, with a PMA submitted in January and anticipated decision in the first half of next year.

• CMS reimbursement will depend on clinical utility, stage shift, and cancer detection rates, with NHS-Galleri and REACH studies providing key evidence.

• Medicare may consider coverage with evidence development, leveraging ongoing studies in the Medicare population.

• USPSTF and international guideline inclusion are being pursued as parallel long-term pathways.

Commercial strategy and market dynamics

• The multi-cancer early detection (MCED) test is designed for pan-cancer detection, with the ability to report on all cancers regardless of label specifics.

• Self-pay market is significant and growing, with repeat test rates over 30% and strong adoption beyond concierge medicine into brick-and-mortar physician offices.

• Digital health partnerships (e.g., Hims & Hers, Function, Everlywell) are expected to drive further growth in the consumer health segment.

• International expansion is supported by diverse data from NHS-Galleri and PATHFINDER 2, reducing the need for large new studies abroad.