third quarter of 2026
Filed Nov 4, 2026GRAIL Reports Third Quarter 2026 Financial Results; FDA Advisory Committee Voted in Favor of Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test
Galleri test volume increased approximately 24% and Galleri test revenue grew 14% year-over-year, while total revenue grew 4%, adjusted gross profit declined 20%, adjusted gross margin fell to 42%, and net loss increased 16%.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Q3 screening revenue (amounts in thousands)GAAP | $37.27M | – | – |
| Q3 development services revenue (amounts in thousands)GAAP | $266K | – | – |
| Q3 total revenue (amounts in thousands)GAAP | $37.53M | – | 4% |
| Q3 Galleri test revenueother | $37.3M | – | 14% |
| Q3 cost of screening revenue, exclusive of amortization of intangible assets (amounts in thousands)GAAP | 22.03M | – | – |
| Q3 cost of development services revenue (amounts in thousands)GAAP | 141K | – | – |
| Q3 cost of revenue, amortization of intangible assets (amounts in thousands)GAAP | 33.47M | – | – |
| Q3 research and development expense (amounts in thousands)GAAP | 44.07M | – | – |
| Q3 sales and marketing expense (amounts in thousands)GAAP | 41.70M | – | – |
| Q3 general and administrative expense (amounts in thousands)GAAP | 40.74M | – | – |
| Q3 total costs and operating expenses (amounts in thousands)GAAP | 182.2M | – | – |
| Q3 loss from operations (amounts in thousands)GAAP | −144.6M | – | – |
| Q3 interest income (amounts in thousands)GAAP | 7.84M | – | – |
| Q3 other income (expense), net (amounts in thousands)GAAP | −545K | – | – |
| Q3 total other income, net (amounts in thousands)GAAP | 7.30M | – | – |
| Q3 loss before income taxes (amounts in thousands)GAAP | −137.3M | – | – |
| Q3 benefit from income taxes (amounts in thousands)GAAP | 33.75M | – | – |
| Q3 net loss (amounts in thousands)GAAP | −$103.6M | – | 16% |
| Q3 net loss per share, basic and dilutedGAAP | $ (2.21) | – | – |
| Q3 weighted-average shares of common stock used in computing net loss per shareGAAP | 46,777,729 | – | – |
| Q3 gross loss (amounts in thousands)GAAP | −$18.11M | – | 32% |
| Q3 adjusted gross profit (amounts in thousands)non-GAAP | $15.91M | – | 20% |
| Q3 adjusted gross marginnon-GAAP | 42% | – | – |
| Q3 adjusted EBITDA (amounts in thousands)non-GAAP | −$92.58M | – | 29% |
| Nine months screening revenue (amounts in thousands)GAAP | $119.7M | – | 24% |
| Nine months development services revenue (amounts in thousands)GAAP | $3.26M | – | – |
| Nine months total revenue (amounts in thousands)GAAP | $123.0M | – | – |
| Nine months total costs and operating expenses (amounts in thousands)GAAP | 577.2M | – | – |
| Nine months loss from operations (amounts in thousands)GAAP | −454.2M | – | – |
| Nine months net loss (amounts in thousands)GAAP | −$307.0M | – | – |
| Nine months net loss per share, basic and dilutedGAAP | $ (6.84) | – | – |
| Nine months gross loss (amounts in thousands)GAAP | −$44.98M | – | – |
| Nine months adjusted gross profit (amounts in thousands)non-GAAP | $57.17M | – | – |
| Nine months adjusted gross marginnon-GAAP | 46% | – | – |
| Nine months adjusted EBITDA (amounts in thousands)non-GAAP | −$262.8M | – | – |
| Q3 Galleri test volumeother | more than 56,000 tests | – | approximately 24% |
| Nine months Galleri test volumeother | more than 174,000 tests | – | 36% |
| Nine months Galleri test revenueother | $119.7M | – | 24% |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| Screening revenueGalleri test revenue for the third quarter grew 14% year-over-year to $37.3 million, and Galleri test volume grew approximately 24% year-over-year to more than 56,000 tests. | $37.27M | – | – |
| Development services revenueDevelopment services revenue was $ 266 for the three months ended September 30, 2026, compared with $ 3,387 for the three months ended September 30, 2025. | $266K | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
early Q1 2027 outlook
- NoteThe company anticipates an FDA decision by early Q1 2027.
What drove it
- Galleri test volume increased approximately 24% year-over-year to more than 56,000 tests in the third quarter.
- The company cited positive advancements, consistent market education, and promotional pricing initiatives as gaining traction.
- The FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee voted favorably for approval of Galleri in September.
- Publications from the NHS-Galleri trial and PATHFINDER 2 reported clinical utility, test performance, and safety results from approximately 175,000 participants enrolled in the UK and North America.
Concerns
- Total revenue grew 4% year-over-year, below the 14% growth reported for Galleri test revenue.
- Development services revenue was $ 266 in the third quarter, compared with $ 3,387 in the prior-year quarter.
- Gross loss increased 32% to $18.1 million, while adjusted gross profit decreased 20% to $15.9 million.
- Adjusted gross margin was 42%, compared with 55% in the prior-year quarter.
- Net loss increased 16% to $103.6 million and adjusted EBITDA loss increased 29% to $(92.6) million.
- The Galleri test has not been cleared or approved by the Food and Drug Administration.
What to watch
- FDA decision timing, which the company anticipates by early Q1 2027.
- Whether commercial momentum, promotional pricing initiatives, and market education continue to support Galleri test volume and revenue growth.
- Adjusted gross margin after the decline to 42% from 55% in the prior-year quarter.
- Sales and marketing expense, which was 41,695 in the third quarter compared with 25,503 in the prior-year quarter (amounts in thousands).
- Cash, cash equivalents, and short-term marketable securities, which totaled $788.7 million as of September 30, 2026.
Balance sheet and cash flow
- Cash, cash equivalents, and short-term marketable securities totaled $788.7 million as of September 30, 2026.
- Cash and cash equivalents were $ 28,976 as of September 30, 2026 (amounts in thousands).
- Short-term marketable securities were 759,700 as of September 30, 2026 (amounts in thousands).
- Total assets were $ 2,730,562 as of September 30, 2026 (amounts in thousands).
- Total liabilities were 277,043 as of September 30, 2026 (amounts in thousands).
- Total stockholders' equity was 2,453,519 as of September 30, 2026 (amounts in thousands).
- No operating cash flow or free cash flow was reported.
Analysis
GRAIL reported third-quarter total revenue of $37.5 million, up 4% year-over-year, with Galleri test revenue of $37.3 million, up 14%. Galleri test volume increased approximately 24% year-over-year to more than 56,000 tests. For the nine months ended September 30, 2026, total Galleri test volume grew 36% year-over-year to more than 174,000 tests and Galleri test revenue grew 24% to $119.7 million. Screening revenue was $ 37,269 in the third quarter, while development services revenue was $ 266, compared with $ 3,387 in the prior-year quarter, in amounts in thousands.
Profitability weakened despite the volume and Galleri revenue growth. Gross loss increased 32% to $18.1 million, adjusted gross profit declined 20% to $15.9 million, and adjusted gross margin declined to 42% from 55%. Cost of screening revenue, exclusive of amortization of intangible assets, was 22,032 compared with 15,910 in the prior-year quarter, while sales and marketing expense increased to 41,695 from 25,503, in amounts in thousands.
Net loss was $103.6 million, an increase of $14.6 million or 16%, and loss from operations was (144,619), compared with (125,291), in amounts in thousands. Adjusted EBITDA was $(92.6) million, with the adjusted EBITDA loss increasing $20.9 million or 29%. The company held cash, cash equivalents, and short-term marketable securities totaling $788.7 million as of September 30, 2026. No operating cash flow, free cash flow, debt balance, share repurchases, or dividends were reported.
The principal strategic development was the favorable September vote for approval of Galleri from the FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee. GRAIL anticipates an FDA decision by early Q1 2027. The release also highlighted NHS-Galleri and PATHFINDER 2 publications reporting results from approximately 175,000 participants, including substantially increased cancer detection, a favorable safety profile, and clinical performance results. Regulatory status and the ability to translate commercial momentum into improved gross margin and narrower losses remain the central reported items to monitor.
Management, verbatim
GRAIL achieved significant milestones this quarter including a favorable vote for approval of Galleri at the FDA Advisory Committee.
Josh Ofman, MD, MSHS, Chief Executive Officer of GRAIL
This achievement strengthens the foundation for Galleri as we continue on our path towards potential regulatory approval, broader access and reimbursement.
Josh Ofman, MD, MSHS, Chief Executive Officer of GRAIL
We are seeing continued commercial momentum as a number of positive advancements, consistent market education, and promotional pricing initiatives gain traction.
Josh Ofman, MD, MSHS, Chief Executive Officer of GRAIL
Not in the filing
stated, not guessed- Prior-quarter revenue, profitability, EPS, volume, and cash-flow comparisons were not reported.
- GAAP gross margin was not reported.
- Operating cash flow was not reported.
- Free cash flow was not reported.
- Debt balance was not reported.
- Share repurchases and dividends were not reported.
- Financial revenue, gross margin, operating expense, or tax-rate guidance was not reported.
- Prior earnings outlook was not provided, so no comparison with prior guidance is available.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.