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Grail (GRAL) guidance and outlook

Grail's 10-Q filed Nov 5, 2026 makes 38 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 5, 2026

• We expect a final decision by the FDA on our PMA by early first quarter of 2027.
• We expect to continue to incur operating losses for at least the next several years as we invest in research and development and the commercialization of existing products.
• We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including:
• Our performance will be impacted by the extent to which we can secure reimbursement and coverage for Galleri.
• Prior to broader coverage and reimbursement in the United States, we will continue our work with clinics, health systems, and digital health platforms to accelerate utilization, and with self-insured employers and health insurers to offer and cover Galleri.
• The FDA convenes advisory committees to obtain independent expert advice and is not bound by the advisory committee’s recommendations, though it takes such recommendations into consideration when making its final decision on our PMA, which is expected by early first quarter of 2027.
• If we obtain FDA approval, we expect to pursue coverage through this new law and, subsequently, inclusion of Galleri in the United States Preventive Services Task Force (“USPSTF”) guideline recommendation, although such inclusion may take years and is not certain even with FDA approval.
• We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.
• We expect to continue selectively engaging with international opportunities over time.
• Our ability to expand into new regions and jurisdictions, drive commercial sales and growth within those regions and jurisdictions and navigate economic, political, regulatory, and other risks, including geopolitical conflict associated with international operations, will be an important driver of our performance.
• We make significant efforts to educate these key stakeholders regarding the benefits of MCED and the clinical and economic value of our products, which we believe will continue to drive awareness of MCED and expand the commercial opportunity for our products.
• There has been a significant increase in competition in the market for MCED testing and in cancer screening tests generally, and we expect this trend of increasing competition to continue.

Grail's latest quarter

Questions

What does Grail expect?

We expect a final decision by the FDA on our PMA by early first quarter of 2027. We expect to continue to incur operating losses for at least the next several years as we invest in research and development and the commercialization of existing products. We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including:

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.