GRAL · GRAIL, Inc.

GRAIL’s Q1 2026 results reflect strong top-line growth and improving operational discipline amid ongoing commercial scaling and pivotal regulatory advancement. Total revenue increased 28% YoY to $40.8 million, driven almost entirely by Galleri revenue ($39.8 million, +37% YoY), which now represents 97% of total revenue—underscoring the product’s centrality to the business. Test volume surged 50% YoY to over 56,000, indicating robust clinician and patient uptake. While GAAP net loss remained substantial at $93.2 million, the 12% YoY improvement—and corresponding 19% improvement in non-GAAP adjusted EBITDA to $(79.9) million—reflects disciplined cost management and growing scale efficiencies. Notably, gross loss improved 28% YoY to $14.3 million, while non-GAAP adjusted gross profit rose 38% to $19.7 million, suggesting meaningful progress in unit economics despite high fixed infrastructure costs. Management attributed momentum to new partnerships, including the announced integration with Epic EHR—a strategic move expected to embed Galleri directly into clinical workflows across thousands of U.S. health systems by year-end. Critically, the FDA’s acceptance of the PMA application—backed by data from PATHFINDER 2 and the landmark NHS-Galleri trial—marks a de-risking inflection point: regulatory approval would unlock broader payer coverage, reimbursement pathways, and long-term commercial sustainability. With $823.1 million in cash as of March 31, 2026, GRAIL maintains ample liquidity to fund operations through key upcoming catalysts, including ASCO 2026 presentations of final trial data in late May and potential PMA decision timing.