other material
confidence high
sentiment neutral
materiality 0.80
NHS-Galleri trial misses primary endpoint but shows Stage IV reduction; Q4 rev $43.6M
GRAIL, Inc.
- Primary endpoint of significant Stage III-IV reduction not met; substantial Stage IV reduction observed across 12 deadly cancers.
- Adding Galleri to standard care yielded four-fold higher cancer detection rate and increased Stage I-II detection of deadly cancers.
- Q4 total revenue $43.6M (+14% YoY); US Galleri revenue $41.3M (+31% YoY). Full year revenue $147.2M (+17% YoY).
- Net loss Q4 $99.2M (incl. $34.6M amort.); full year net loss $408.4M (incl. $138.3M amort. and $28M impairment).
- Galleri PMA submitted to FDA; U.S. sales force to expand based on NHS-Galleri and PATHFINDER 2 results.