GRAIL Inc.

Second quarter revenue was $44.7 million, up $9.1 million or 26% from Q2 2025. Screening revenue was $42.6 million, up 24%, with more than 61,000 Galleri tests sold, up 35% year over year; the first half of 2026 saw Galleri test revenue growth of 30% to more than $80 million and test volume growth of 42% to more than 117,000 tests. Net loss was $110.2 million, a 3% improvement versus Q2 2025. Non-GAAP adjusted gross profit was $21.6 million, up $5.4 million or 34%, and adjusted EBITDA was negative $90.3 million, an increase in loss of $11.9 million or 15%. GRAIL ended the quarter with $861.6 million of cash, including the $110 million Samsung investment that closed in June. Guidance-wise, management did not give numeric revenue guidance; instead it said the FDA PMA remains under iterative review, an advisory committee is expected in the fall, and potential approval timing remains expected in the first part of 2027. The Illumina royalty is expected to resume toward the end of Q4 and management said it should have minimal impact in Q4.

Josh Ofman framed the quarter around clinical validation and regulatory momentum, arguing that Galleri remains the only MCED with extensive evidence from large interventional studies. He emphasized the ASCO presentation of PATHFINDER 2 and NHS-Galleri, the focus on FDA approval and reimbursement, and the view that Galleri is highly differentiated because of its low false positive rate and methylation-based technology. His tone was confident and promotional, but he also repeatedly acknowledged uncertainty around FDA timing, CMS coverage, and the broader MCED market.

Aaron Freidin highlighted the financial bridge from revenue growth to operating losses: Q2 revenue of $44.7 million, adjusted gross profit of $21.6 million, net loss of $110.2 million, and adjusted EBITDA loss of $90.3 million. He said gross margin benefited from improved fixed-cost leverage from higher volumes and lower sample reprocessing costs, partly offset by lower ASPs. He also pointed to a strengthened balance sheet with $861.6 million in cash after the $110 million Samsung investment, which he said gives GRAIL flexibility as it pursues regulatory approval and reimbursement.

Analysts pressed management on the expected FDA advisory committee, whether the timing could slip into next year, and what the agency might focus on; management said it has long expected an AdCom, has not been given public timing, and believes the FDA division it is working with has been stable and productive. On pricing and competition, Andrew Partridge said the Q2 ASP decline was driven by more digital health volume and planned lower employer pricing tied to stronger partnership commitments, while also noting that newer MCED entrants are causing confusion because they lack screening-population data and have higher false positive rates. Questions also covered sales force expansion, publications, Samsung’s international rollout, and the resumption of the Illumina royalty; management said the sales force build is now largely complete, publications are under active review, and the royalty should not materially affect Q4.