GRAIL (GRAL) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Mission and strategic focus

• Aims to detect cancer early through multi-cancer early detection (MCED), targeting cancers responsible for 80% of deaths, beyond standard single-cancer screening approaches.

• Galleri test has been on the market for over three years, providing cancer signal of origin and broad detection.

• Emphasizes high positive predictive value (PPV) and yield as key clinical measures for MCED.

• Multi-cancer approach chosen over single-cancer due to impracticality of combining multiple single-cancer tests and high false positive rates.

• PATHFINDER study showed PPV north of 40% and more than doubled cancers found compared to standard screening.

Clinical studies and regulatory pathway

• PATHFINDER 2 (35,000 patients) focuses on performance and safety, with interim readout expected in the second half of 2025.

• NHS Galleri trial (140,000 patients) is a randomized, controlled study measuring reduction in late-stage cancers; full readout expected in 2026.

• FDA PMA submission will include data from PATHFINDER 2 and NHS Galleri, with no established MCED precedent at FDA.

• CMS coverage depends on pending legislation or USPSTF grade A/B recommendation post-FDA approval.

Commercialization and operational strategy

• Over 250,000 Galleri tests ordered in the first half of the year, with most volume from clinical self-pay and telemedicine channels.

• Enterprise channels (employers, insurers) make up 25-33% of volume; annual testing interval modeled as optimal.

• Commercial footprint streamlined, focusing on productive channels and scaling back less effective employer/life insurance segments.

• Physician and patient support maintained despite restructuring; sales and medical science liaison ratios preserved.