GRAIL (NASDAQ:GRAL) executives highlighted commercial growth for the Galleri multi-cancer early detection (MCED) blood test in 2025, shared top-line results from the randomized NHS-Galleri trial in the U.K., and reviewed progress toward FDA premarket approval during the company’s fourth quarter 2025 earnings call.
Top-line NHS-Galleri results show stage shift but miss primary endpoint
Management said the company issued a press release with top-line results from the NHS-Galleri trial, a randomized study with more than 142,000 participants. Chief Scientific Officer Sir Harpal Kumar said the study did not meet its primary endpoint of a statistically significant reduction in combined Stage III and Stage IV cancers through the trial, though he described a favorable trend after the prevalent screening round.
Kumar said no serious safety concerns were reported among approximately 70,000 participants who received the Galleri test across three rounds of testing. He described the dataset as the first randomized MCED dataset at this scale to demonstrate a population-level stage shift and reduction in metastatic disease.
Looking ahead, Kumar said detailed NHS-Galleri results will be submitted for presentation at ASCO in late May, and additional analyses are underway. He also said the company plans to extend data collection by six to 12 months and reevaluate impact with more mature data, citing an observation of higher-than-anticipated Stage III incidence and a view that longer follow-up could strengthen the observed effect.
PATHFINDER 2 update and plans to present full data in mid-2026
Ragusa said the company also disclosed full results from all 35,000 participants in PATHFINDER 2 and characterized them as consistent with data previously presented from the first 25,000 participants at ESMO. Management said it anticipates presenting full data from both NHS-Galleri and PATHFINDER 2 in mid-2026.
FDA PMA submission completed; company anticipates ~12-month review
President Josh Ofman said GRAIL completed submission of the final module of its premarket approval (PMA) application to the FDA for Galleri at the end of January. He said the PMA focuses on test performance and safety results from two large registrational studies: PATHFINDER 2 (first 25,000 participants with one-year follow-up) and the prevalent screening round (first year) of NHS-Galleri.
Ofman also said the PMA is supported by a bridging analysis comparing the version of Galleri used in registrational trials with the updated version submitted for premarket approval. He noted the test received Breakthrough Device designation in 2018 and said the company anticipates about a 12-month review period.
In Q&A, executives were asked whether the NHS-Galleri miss on the primary stage-shift endpoint could affect FDA approval. Ofman said the FDA’s focus is expected to be on effectiveness and safety in the submission and stated there was “not an obvious correlation or obvious impact” between the final NHS-Galleri results and the FDA’s view, since the submission includes PATHFINDER 2 and the prevalent round of NHS-Galleri. He also said the FDA has been clear in public comments that its focus is on clinical validation rather than clinical utility.
Executives added that labeling discussions would be worked through with the agency if needed, but Ofman said the company believes it has a “strong and compelling evidence package” for its intended use in adults at elevated risk for cancer, such as adults over age 50.
Commercial performance and planned sales expansion
Ragusa reiterated previously shared 2025 commercial metrics for Galleri in the U.S., including:
- U.S. Galleri test volume grew 36% to more than 185,000 tests
- U.S. Galleri revenue grew 26%
- Prescriber base reached approximately 17,000 providers, up 30% year over year
- Nearly 500,000 Galleri tests sold since launch through Dec. 31
Ragusa said growth in 2026 is expected to be supported by new and expanding partnerships, including digital health opportunities and further integration into health systems. He also said the company is focused on expanding awareness of MCED and Galleri’s performance and capability differentiation.
Based on results from NHS-Galleri and PATHFINDER 2, management said it plans to expand its field sales and medical team. Chief Commercial Officer Andy Partridge said market research and customer feedback suggest the magnitude of the Stage IV reduction and the fourfold increase in cancer detection rate will be meaningful to customers and could increase both the depth and breadth of prescribing.
Financial results, cash position, and 2026 guidance reiterated
CFO Aaron Freidin reported fourth quarter 2025 revenue of $43.6 million, up 14% year over year, including $42.3 million of screening revenue and $1.3 million of development services revenue. For the full year, total revenue was $147.2 million, up 17% from 2024, including screening revenue of $138.6 million (up 28%) and development services revenue of $8.6 million (down 49%). Freidin said more than 57,000 tests were sold in the fourth quarter.
Net loss for the fourth quarter was $99.2 million, and full-year net loss was $408.4 million. Freidin noted that 2024 results included $1.4 billion of goodwill and intangible asset impairment, and that both 2025 and 2024 included $138.3 million of amortization of Illumina acquisition-related intangible assets.
On profitability measures, Freidin reported fourth-quarter non-GAAP adjusted gross profit of $23.1 million and full-year adjusted gross profit of $73.6 million, attributing improvement primarily to revenue mix and scale efficiencies from higher volume. Adjusted EBITDA was -$71.8 million in the quarter and -$320.6 million for the year.
The company ended the quarter with $904.4 million in cash, which Freidin said included $436 million in proceeds from a private placement in October and an at-the-market equity issuance program in November and December. He reiterated a long-term gross margin target of 50%–60% at scale and noted that, under a supply agreement with Illumina, royalty payments on revenues are suspended until December 2026 and are expected to resume in the high single digits beginning in 2027, impacting gross margins.
Freidin said the company is reiterating its previously shared 2026 outlook of 22%–32% Galleri sales growth and cash burn for 2026 of no more than $300 million. He added that the company’s cash runway extends into 2030.
Management also pointed to a policy milestone, noting that the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, establishing a Medicare coverage pathway for FDA-approved MCED tests. In Q&A, executives said CMS would evaluate a robust evidence package following FDA approval, including registrational trials and NHS-Galleri findings, along with real-world evidence, a clinical surveillance program, and the REACH study in Medicare patients.
About GRAIL (NASDAQ:GRAL)
GRAIL, Inc (NASDAQ: GRAL) is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri™ test, which aims to identify more than 50 types of cancer at their earliest stages. The company’s platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up.
Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom.
-inc-logo-1200x675.jpg&h=45&w=95&zc=2){kind=logo}
-logo-1200x675.png?v=20241015084625&h=45&w=95&zc=2){kind=logo}
