GRAIL (GRAL) Company Report

GRAIL reported Q4 2025 revenue of $43.6 million and full-year 2025 total revenue of $147.2 million, with U.S. Galleri revenue growing 26% to $136.8 million for the full year. The company ended Q4 2025 with a cash position of $904.4 million.
The U.S. Galleri tests volume grew 36% to over 185,000 in 2025, and the prescriber base increased by 30% to approximately 17,000 providers.
Top-line results from the NHS-Galleri trial showed a substantial reduction in stage 4 cancer diagnosis and a fourfold higher cancer detection rate, although it did not meet the primary endpoint of statistically significant reduction in combined stage 3 and 4 cancers.
GRAIL completed its PMA submission with the FDA for Galleri at the end of January 2026, anticipating a 12-month review period. Additionally, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, establishing a Medicare coverage pathway for FDA-approved multi-cancer early detection tests.
The company reiterated its 2026 guidance for Galleri sales growth of 22%-32% and cash burn of no more than $300 million, with a cash runway extending into 2030.

Feb 19, 2026, 10:00 PM

Transcript

GRAIL Reports Q4 and Full-Year 2025 Financials, Updates on NHS-Galleri Trial, and FDA Submission

GRAL

Earnings

New Projects/Investments

GRAIL reported Q4 2025 revenue of $43.6 million, a 14% increase from Q4 2024, and full-year 2025 revenue of $147.2 million, up 17% from 2024, with U.S. Galleri revenue growing 26% to $136.8 million. The company concluded the year with a cash position of $904.4 million.
Top-line results from the NHS-Galleri trial demonstrated a substantial reduction in Stage IV cancer diagnoses and a fourfold higher cancer detection rate, but the trial did not meet its primary endpoint of statistically significant reduction in combined Stage III and IV cancers. GRAIL plans to extend data collection for an additional 6 to 12 months.
GRAIL completed its PMA submission with the FDA for Galleri in late January, with an anticipated 12-month review period. The company believes the FDA's focus on clinical performance and safety means the NHS-Galleri trial's primary endpoint miss will not impact approvability.
The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, establishing a Medicare coverage pathway for FDA-approved multi-cancer early detection tests.

Feb 19, 2026, 10:00 PM

Transcript

GRAIL Reports Q4 and Full-Year 2025 Results, Highlights Regulatory Progress and Clinical Trial Outcomes

GRAL

Earnings

Guidance Update

New Projects/Investments

GRAIL reported Q4 2025 revenue of $43.6 million and full-year 2025 total revenue of $147.2 million, representing increases of 14% and 17% respectively from the prior year. U.S. Galleri revenue grew 26% to $136.8 million in 2025, with test volume increasing 36% to over 185,000 tests. The company ended 2025 with a net loss of $408.4 million and a cash position of $904.4 million.
GRAIL completed its PMA submission with the FDA for Galleri, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, establishing a Medicare coverage pathway for FDA-approved multi-cancer early detection tests.
Top-line results from the NHS-Galleri trial showed a substantial reduction in stage 4 cancer diagnosis and a fourfold higher cancer detection rate, although it did not meet the primary endpoint of statistically significant reduction in combined stage 3 and 4 cancers. Full data from NHS-Galleri and PATHFINDER 2 are anticipated in mid-2026.
For 2026, GRAIL projects Galleri sales growth of 22%-32% and a cash burn of no more than $300 million, with its cash runway extending into 2030.

Feb 19, 2026, 10:00 PM

Transcript

GRAIL Reports Q4 and Full Year 2025 Financial Results and Key Clinical Trial Updates

GRAL

Earnings

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL reported total revenue of $43.6 million for Q4 2025, a 14% year-over-year increase, and $147.2 million for the full year 2025, up 17% year-over-year.
The company posted a net loss of $99.2 million for Q4 2025 and $408.4 million for the full year 2025.
GRAIL completed the Premarket Approval (PMA) submission for Galleri to the FDA in January and announced topline results from the NHS-Galleri trial, which demonstrated a substantial reduction in Stage IV cancer diagnoses and a four-fold higher cancer detection rate.
As of December 31, 2025, GRAIL maintained a strong financial position with $904.4 million in cash, cash equivalents, and short-term marketable securities, projecting cash into 2030.

Feb 19, 2026, 9:18 PM

8-K

GRAIL Reports Fourth Quarter and Full Year 2025 Financial Results

GRAL

Earnings

Guidance Update

New Projects/Investments

GRAIL reported total revenue of $43.6 million for the fourth quarter of 2025, an increase of 14% year-over-year, and $147.2 million for the full year 2025, an increase of 17% year-over-year.
U.S. Galleri revenue grew 31% year-over-year to $41.3 million in Q4 2025 and 26% year-over-year to $136.8 million for the full year 2025, with over 185,000 Galleri tests sold in 2025.
The company completed the Premarket Approval (PMA) submission to the FDA for Galleri in January.
GRAIL announced topline results from the NHS-Galleri trial and completed the analysis of the full 35,000 participant PATHFINDER 2 study.
GRAIL ended 2025 with a strong financial position, holding $904.4 million in cash, cash equivalents, and short-term marketable securities as of December 31, 2025, which is projected to provide cash into 2030.

Feb 19, 2026, 9:02 PM

Press Release

GRAIL Submits FDA Premarket Approval Application for Galleri Test

GRAL

Product Launch

New Projects/Investments

GRAIL, Inc. submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri® multi-cancer early detection (MCED) test on January 29, 2026.
The FDA had previously designated the Galleri test as a Breakthrough Device in 2018.
The PMA submission is supported by test performance and safety results from the US-based PATHFINDER 2 study (25,490 participants) and the NHS-Galleri trial, the largest randomized, controlled trial of an MCED test with over 140,000 participants.
This submission is considered a critical step toward making Galleri available to more people and advancing early detection, addressing the fact that cancer is the leading killer of adults over 50 years old in the U.S..

Jan 30, 2026, 12:25 AM

Press Release

GRAIL, Inc. Reports Preliminary FY 2025 Results and Provides 2026 Guidance

GRAL

Earnings

Guidance Update

Revenue Acceleration/Inflection

GRAIL, Inc. reported preliminary unaudited total revenue of $147-148 million for fiscal year 2025 and a cash position of $904 million as of December 31, 2025.
The company provided 2026 guidance for total Galleri revenue growth of 22-32% and a cash burn of less than $300 million, projecting a cash runway into 2030.
GRAIL achieved over 185,000 total Galleri test volume in 2025, representing 35% growth over 2024, and plans to complete its Pre-market Approval (PMA) submission in Q1 2026.

Jan 12, 2026, 3:30 PM

8-K

GRAIL Reports Strong 2025 Growth and Outlines 2026 Milestones

GRAL

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL reported 2025 revenue between $147 million and $148 million, representing 17%-18% growth over 2024, with U.S. Galleri revenue up 25%-26% to between $136 million and $137 million.
The company ended 2025 with a strong capital position of $904 million in cash after raising approximately $435 million in Q4 2025 and announcing a $110 million equity investment by Samsung expected to close in January 2026.
For 2026, GRAIL expects total Galleri revenue to grow 22%-32% and cash burn to be less than $300 million, providing a cash runway into 2030.
GRAIL plans to complete its PMA filing in Q1 2026 and present full data from the 140,000-person NHS-Galleri study and the 35,000-person PATHFINDER 2 study mid-year 2026.
Commercial test volume for Galleri was over 185,000 tests in 2025, reflecting a 35% growth volume and an increase in the prescriber base of 30% to over 17,000 prescribers.

Jan 12, 2026, 3:30 PM

Transcript

GRAL Updates on Financial Performance, 2026 Guidance, and Galleri Milestones

GRAL

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL reported $147-148 million in total revenue for FY 2025, representing a 17-18% year-over-year growth, and a cash position of $904 million as of December 31, 2025.
The company provided 2026 guidance for total Galleri revenue growth of 22-32% over $138-139 million in 2025, with cash burn expected to be less than $300 million, extending its cash runway into 2030.
GRAIL plans to complete its modular PMA submission in Q1 2026 and present full data from the NHS-Galleri trial and PATHFINDER 2 study in mid-2026.
The Galleri MCED test has been in market for over 4 years, with over 800,000 clinical and commercial tests completed to date, and over 475,000 commercial tests sold.

Jan 12, 2026, 3:30 PM

Presentation

GRAIL Provides 2025 Financial Results and 2026 Outlook, Highlights Clinical and Commercial Progress

GRAL

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL reported $147 million to $148 million in revenue for full year 2025, an 17%-18% growth over 2024, and projects total Galleri revenue growth of 22%-32% in 2026.
The company ended 2025 with $904 million in cash, bolstered by approximately $435 million raised in Q4 2025 and an additional $110 million equity investment from Samsung expected in January 2026. Cash burn was reduced to approximately $274 million in 2025 and is guided to be less than $300 million in 2026, extending the cash runway into 2030.
GRAIL expects to complete its modular PMA submission in Q1 2026 and will present full data from the 140,000-person NHS-Galleri randomized clinical trial and the 35,000-participant PATHFINDER 2 study in mid-2026.
Commercial momentum for Galleri in 2025 included a 35% growth in volume, over 185,000 commercial tests sold, and a 30% increase in the prescriber base to over 17,000.