GRAIL (GRAL) investor relations material

Clinical evidence and adoption

• Clinical evidence is the primary driver for broader adoption, FDA approval, and payer coverage.

• Recent trials, including NHS-Galleri and PATHFINDER 2, showed Galleri detects more early-stage cancers and reduces Stage IV diagnoses, though not all endpoints were met.

• High positive predictive value (over 60%) and sensitivity for cancers causing most mortality were demonstrated.

• Real-world and external data from health systems like Mayo and Dana-Farber align with clinical trial results.

• Education and workflow improvements, such as EHR integration and partnerships, are key to increasing routine use.

Regulatory and payer landscape

• FDA approval is expected to clarify the market, increase physician and payer confidence, and open doors for broader coverage.

• Labeling will likely focus on intended use in adults 50+, with transparency about cancer types and continued guideline screening.

• CMS engagement is ongoing, with the REACH study in Medicare populations supporting future NCD review.

• Commercial insurers are expected to expand coverage post-FDA approval, with pilots and tailored data generation planned.

Competitive differentiation and future development

• Galleri is distinguished by the scale and depth of its clinical and real-world data, as well as rigorous FDA-reviewed validation.

• Ongoing R&D aims to improve performance, personalize testing, and reduce costs, leveraging AI and large-scale infrastructure.

• International expansion is supported by partnerships like Samsung, with FDA approval aiding regulatory discussions abroad.