GRAIL (NASDAQ:GRAL) reported second-quarter revenue growth driven by higher Galleri test volumes, while outlining continued efforts to secure FDA approval, expand its commercial organization and build international distribution partnerships.
Revenue totaled $44.7 million in the second quarter, up 26% from the prior-year period, Chief Financial Officer Aaron Freidin said. Screening revenue contributed $42.6 million, an increase of 24%, while development services revenue was $2 million.
Financial results and cash position
GRAIL reported a net loss of $110.2 million for the second quarter, a 3% decrease from the second quarter of 2025. Adjusted gross profit rose 34% to $21.6 million, which Freidin attributed primarily to greater fixed-cost leverage from higher volume and lower sample reprocessing costs. Those gains were partly offset by a lower average selling price.
Adjusted EBITDA was negative $90.3 million, compared with a loss of $78.4 million a year earlier. The company ended the quarter with $861.6 million in cash, including a $110 million strategic investment from Samsung that closed in June.
Freidin said the Samsung investment provides financial flexibility as GRAIL pursues regulatory approval and reimbursement for Galleri in the U.S. The company has begun work with Samsung C&T Corporation on a collaboration to commercialize Galleri in South Korea, with potential expansion into Japan, Singapore and other Asian markets. Freidin said discussions on distribution and longer-term strategic engagement were just beginning following the completion of a CFIUS review.
FDA review remains underway
Chief Executive Officer Josh Ofman said GRAIL submitted its premarket approval application for Galleri to the FDA in early 2026 and remains in an “ongoing iterative review process.” The company expects the FDA to convene an advisory committee in the fall, although the agency has not announced timing.
Ofman said GRAIL’s expected timing for a potential approval remains unchanged, with the company anticipating a decision in the first part of 2027. He said the company has responded to a series of FDA questions and completed inspections as part of what he characterized as a standard PMA review process.
The PMA submission is based on performance and safety findings from approximately 25,000 PATHFINDER 2 participants with one year of follow-up, along with data from the first-year prevalent screening round of the NHS-Galleri trial. It also includes a bridging analysis comparing the Galleri version used in clinical studies with the version submitted for FDA approval.
Ofman said the company believes an FDA approval could prompt more substantive discussions with payers and employers. Chief Growth Officer Andy Partridge said payers and employers have indicated that they are awaiting FDA approval before engaging more seriously on Galleri coverage and adoption.
Clinical data and commercial expansion
GRAIL presented data from its PATHFINDER 2 and NHS-Galleri studies at the American Society of Clinical Oncology annual meeting in May. Ofman said that, across both studies, adding Galleri to standard-of-care screening increased cancer detection rates by four to 6.5 times. He said the test showed a false-positive rate below 0.5% and positive predictive values ranging from 50% to 60%.
The company acknowledged that the NHS-Galleri trial did not meet its primary endpoint of reducing the combined incidence of stage III and stage IV cancers. However, Ofman said GRAIL believes other study findings demonstrated performance, safety and clinical utility. He said approximately 40% to 50% of cancers detected by Galleri across the two studies were stage I or II, while roughly 70% were stage I through III.
GRAIL has submitted publications on both studies to top-tier journals, according to Chief Scientific Officer Harpal Kumar, who said the papers remain under active review and that the company is hopeful for publication in the near future.
The company substantially completed a planned expansion of its field sales and medical teams by the end of the second quarter. Partridge said the added personnel were trained after ASCO and are now engaging physicians and employer customers with the clinical data. He said management expects to see the fuller benefit of the expanded sales organization over the remainder of the year.
Partridge said self-pay purchases represented about 70% of Galleri sales, with most volume coming from brick-and-mortar physicians. GRAIL added roughly 1,000 ordering providers during the quarter. Electronic ordering integrations with Quest Diagnostics and athenahealth are also supporting new prescriber adoption and deeper utilization, he said.
Pricing, partnerships and market competition
Partridge said the second-quarter decline in average selling price reflected expansion in digital-health volume and planned lower pricing for employers. In exchange for lower employer pricing, GRAIL has sought commitments such as marketing support and blood-draw events, he said.
The company also announced a collaboration with Priority Health that enables employer groups to add Galleri to existing screening coverage. Priority Health has more than 1.4 million members in Michigan and nearby states and had launched Galleri coverage in certain plans during 2025, according to GRAIL.
Management addressed growing competition in the multi-cancer early detection market, arguing that competing tests have generally been supported by observational or case-control data rather than interventional studies in asymptomatic screening populations. Ofman said GRAIL expects a potential FDA approval to distinguish Galleri from tests that have not yet established their risk-benefit profile in intended-use populations.
GRAIL also said an Illumina royalty is expected to resume toward the end of the fourth quarter. Freidin said it would not have a meaningful effect on fourth-quarter results and referred investors to the company’s financial disclosures for details on the royalty.
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.
