On February 19, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the fourth quarter and full year 2025 and provided business updates.
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Fourth quarter total revenue grew 14% year-over-year to $43.6 million, and U.S. Galleri revenue grew 31% year over year to $41.3 million. Net loss was $99.2 million, which includes amortization of Illumina acquisition-related intangible items of $34.6 million. Gross loss was $11.1 million. Non-GAAP adjusted gross profit was $23.1 million, and non-GAAP adjusted EBITDA was $(71.8) million.1
For the full year total revenue grew 17% year over year to $147.2 million, and U.S. Galleri revenue grew 26% year over year to $136.8 million. Net loss was $408.4 million, which includes amortization of Illumina acquisition-related intangible items of $138.3 million and intangible assets impairment of $28.0 million. Gross loss was $62.6 million. Non-GAAP adjusted gross profit was $73.6 million, and non-GAAP adjusted EBITDA was $(320.6) million.
"2025 was a year of significant commercial growth for GRAIL, and we’re excited by the building momentum for multi-cancer early detection. In the fall, we presented positive results from the first ~25,000 participants in the PATHFINDER 2 study, and we subsequently raised more than $435 million, which provides financial flexibility as we continue to drive towards broad access for Galleri," said Bob Ragusa, Chief Executive Officer at GRAIL. "Our teams completed Galleri’s PMA submission to the FDA in January. And today, we announced topline results for the NHS-Galleri trial and completion of the analysis of the full 35k participant PATHFINDER 2 study. We remain on track for continued commercial growth in 2026 with new and expanding partnerships in digital health and further integration into health systems. We anticipate presenting detailed results from both PATHFINDER 2 and the NHS-Galleri trial in mid-2026."
For the three months ended December 31, 2025, as compared to the three months ended December 31, 2024, GRAIL reported:
Revenue: Total revenue, comprised of screening and development services revenue, was $43.6 million, an increase of $5.3 million or 14%.
Net loss: Net loss was $99.2 million, an increase of $2.1 million or 2%.
Gross loss: Gross loss was $11.1 million, an improvement of $4.8 million or 30%.
Adjusted gross profit1: Adjusted gross profit was $23.1 million, an increase of $5.2 million or 29%.
Adjusted EBITDA1: Adjusted EBITDA was $(71.8) million, an improvement of $12.2 million or 15%.
For the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024, GRAIL reported:
Revenue: Total revenue, comprised of screening and development services revenue, was $147.2 million, an increase of $21.6 million or 17%.
Net loss: Net loss was $408.4 million, an improvement of $1.6 billion or 80%.
Gross loss: Gross loss was $62.6 million, an improvement of $15.4 million or 20%.
Adjusted gross profit1: Adjusted gross profit was $73.6 million, an increase of $15.8 million or 27%.
Adjusted EBITDA1: Adjusted EBITDA was $(320.6) million, an improvement of $163.0 million or 34%.
Cash position: Cash, cash equivalents, and short-term marketable securities totaled $904.4 million as of December 31, 2025.
Additional business highlights include:
Announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual screening with the Galleri test in England’s National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The results show that adding Galleri to standard of care screening resulted in a substantial reduction in Stage IV cancer diagnoses, increased Stage I and II detection of deadly cancers, and four-fold higher cancer detection rate when compared to standard of care alone. While there was a trend towards reduction in combined Stage III and IV, the trial did not meet the primary endpoint of a statistically significant reduction.
Completed analysis of the full 35,000 participant PATHFINDER 2 study, demonstrating performance consistent with the 25,000 patient analysis presented in October and a strong safety profile. Full data from this study will be submitted for presentation at a conference later this year.
The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R 842 / S.339) became federal law, establishing a Medicare coverage pathway for multi-cancer early detection tests.
Completed submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Galleri in January. The PMA submission is focused on test performance and safety results from 25,490 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any multi-cancer early detection (MCED) test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in registrational trials to the updated version that has been submitted to the FDA for premarket approval.
Expanded access to Galleri through digital health platforms with the launch of the Hims & Hers Multi-Cancer Test by Galleri. The availability of Galleri through Hims & Hers Labs platform is additive to access provided through other leading digital health and wellness platforms including Function Health and Everlywell.
Conference Call and Webcast
A webcast and conference call will be held today, February 19, 2026, at 2:00 p.m. PT / 5:00 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.
(Press release, Grail, FEB 19, 2026, View Source [SID1234662803])