GRAIL (GRAL) investor relations material

Strategic positioning and market leadership

• First-mover advantage established through early validation and large-scale evidence generation since 2015.

• Maintains a significant lead by conducting rigorous interventional and randomized clinical trials, aiming for FDA approval as a key differentiator.

• Machine learning-based test continually improved with extensive real-world and clinical trial data.

• Built advanced laboratory infrastructure ahead of broad market access to support anticipated demand.

• Ongoing R&D efforts focus on performance improvement and cost reduction.

Regulatory and reimbursement outlook

• Modular PMA submission to FDA expected to complete in Q1 2026, with over 100,000 subjects included.

• Multiple potential FDA labeling options under consideration, reflecting the test's ability to detect over 50 cancer types.

• Medicare coverage contingent on pending MCED legislation, with reimbursement likely to begin in 2027-2028 if passed.

• Current reimbursement mix: 60% self-pay, 30-40% enterprise (employers, insurers), with broad payer access expected post-approval.

• Anticipated pricing changes for blood-based diagnostics as Medicare sets new benchmarks.

Clinical performance and public health impact

• Adding the test to standard screening increases cancer detection rate by sevenfold, with minimal increase in false positives.

• Over half of detected cancers in PATHFINDER 2 were stage 1 or 2, and 70% were stage 1-3.

• False positive rate is 0.4%, significantly lower than other screening tests; positive predictive value is 62%.

• Sensitivity for deadly cancers is about 70% in interventional trials.

• Only test validated in multiple interventional studies in the intended screening population.