GRAIL — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $37.5 million, an increase of 4% year-over-year compared to $36.2 million in the prior period.
• Galleri test revenue grew 14% year-over-year to $37.3 million.
• Net loss for the quarter was $103.6 million, an increase of 16% year-over-year compared to $89.0 million.
• Gross loss was $18.1 million, an increase of 32% year-over-year compared to $13.7 million.
• Non-GAAP adjusted gross profit was $15.9 million, a decrease of 20% year-over-year compared to $20.0 million.
• Non-GAAP adjusted gross margin was 42%, down from 55% in the prior year period.
• Non-GAAP adjusted EBITDA was $(92.6) million, representing an increase in loss of 29% year-over-year compared to $(71.7) million.
• Cash, cash equivalents, and short-term marketable securities totaled $788.7 million as of September 30, 2026.
• For the nine months ended September 30, 2026, total revenue was $123.0 million, an increase of 19% year-over-year compared to $103.6 million.
• Total Galleri test volume for the nine months ended September 30, 2026, grew 36% year-over-year to more than 174,000 tests.
• Total Galleri revenue for the nine months ended September 30, 2026, grew 24% year-over-year to $119.7 million.
• Net loss for the nine months ended September 30, 2026, was $307.0 million, compared to $309.2 million in the prior year period.

Guidance and Future Outlook:

• The company anticipates an FDA decision regarding the Galleri test by early Q1 2027.
• Management indicated continued commercial momentum driven by positive advancements, consistent market education, and promotional pricing initiatives.
• The company is on a path toward potential regulatory approval, broader access, and reimbursement for the Galleri test.

Business Segments and Product Lines:

• The Galleri multi-cancer early detection test volume increased approximately 24% year-over-year to more than 56,000 tests in the third quarter.
• Screening revenue was $37.3 million, while development services revenue was $0.3 million for the quarter.
• The Galleri test is intended for adults with an elevated risk for cancer, such as those aged 50 or older, and requires a prescription.
• The GRAIL clinical laboratory is certified under CLIA and accredited by the College of American Pathologists.

Market and Competitive Landscape:

• Recent publications in The New England Journal of Medicine, Nature Medicine, and Nature Medicine reported results from approximately 175,000 participants across the UK and North America.
• Data from the NHS-Galleri trial demonstrated substantially increased cancer detection (4-6.5x more cancers detected) with robust performance and a favorable safety profile.
• The NHS-Galleri trial showed a >20% reduction in Stage IV diagnoses of 12 prespecified aggressive cancers and a 25% reduction in cancers diagnosed after emergency presentation in the Galleri arm compared to the control arm.
• Galleri added to standard-of-care screening detected more Stage I-II cancers than the UK national screening program found across all stages.

Risks and Challenges:

• The press release notes that the Galleri test has not been cleared or approved by the FDA as of the report date.
• Forward-looking statements are subject to risks, uncertainties, and assumptions regarding potential regulatory decision timelines, outcomes, reimbursement, and commercial expansion plans.
• Actual results may differ materially from expectations due to factors including dynamic market conditions and emerging risks.

Management Commentary and Tone:

• Josh Ofman, MD, MSHS, Chief Executive Officer, stated that the favorable FDA Advisory Committee vote strengthens the foundation for Galleri.
• Management highlighted significant milestones achieved this quarter, including the FDA Advisory Committee vote and continued commercial momentum.
• The tone reflects confidence in the clinical utility of the test and the potential for population-scale screening to identify cancers when they are potentially curable.

Other Key Points:

• The FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee voted in favor of approval of the Galleri test in September.
• Final results from the PATHFINDER 2 study were published in Nature Medicine.
• The company operates with a mission to detect cancer early when it can be cured, utilizing next-generation sequencing and machine learning.
• The company is headquartered in Sunnyvale, Calif., with locations in Washington, D.C., North Carolina, and the United Kingdom.
• A conference call and webcast were held on November 4, 2026, to discuss these results.