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Sold More Than 185,000 Galleri® Tests in 2025, Growing U.S. Galleri Revenue 26% Year-Over-Year to $136.8 Million
Completed Galleri PMA Submission to FDA
Shared Topline Results from the NHS-Galleri Trial
Completed Analysis of the Full 35k Participant PATHFINDER 2 Study
Strong Financial Position with Cash into 2030
MENLO PARK, Calif., Feb. 19, 2026 /PRNewswire/ — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the fourth quarter and full year 2025 and provided business updates.
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.1
_________________________
1 See “Non-GAAP Disclosure” and the associated reconciliations for important information about our use of non-GAAP measures.
“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:
For the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024, GRAIL reported:
Cash position: Cash, cash equivalents, and short-term marketable securities totaled $904.4 million as of December 31, 2025.
Additional business highlights include:
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.
A replay of the webcast will be available on GRAIL’s website for 30 days.
About GRAIL
GRAIL, Inc. is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL’s targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL’s common stock is listed under the ticker symbol “GRAL” on the Nasdaq Stock Exchange.
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable2. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer2,*. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market1,2,3,4,**. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up4,5,6. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
For more information, visit galleri.com.
* The Galleri test performance metrics were derived from the outcomes of an interventional clinical study of patients presenting for screening without clinical suspicion of cancer, a study population that reflects the intended use population.
** Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.
Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
Non-GAAP Disclosure
In addition to our financial results, this press release also includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Our non-GAAP financial disclosure includes Adjusted Gross Profit and Adjusted EBITDA. We encourage investors to carefully consider our results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations.
Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form below.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “should,” “would,” or “will,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, restructuring and stock-based compensation costs, impact of the restructuring on our operations and growth and anticipated trends in our business.
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2025 (the “Form 10-K”). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
References:
GRAIL, Inc.
Consolidated Balance Sheets
(in thousands, except per share data)
December 31, 2025
December 31, 2024
Assets
(unaudited)
Current assets:
Cash and cash equivalents
$ 249,727
$ 214,234
Short-term marketable securities
654,703
549,236
Accounts receivable, net
18,295
20,312
Supplies
16,017
18,632
Prepaid expenses and other current assets
15,107
17,447
Total current assets
953,849
819,861
Property and equipment, net
51,813
69,061
Operating lease right-of-use assets
52,070
66,373
Restricted cash
6,974
3,349
Intangibles assets, net
1,850,556
2,016,890
Other non-current assets
6,753
7,773
Total assets
$ 2,922,015
$ 2,983,307
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$ 2,083
$ 4,844
Accrued liabilities
63,945
57,241
Operating lease liabilities, current portion
11,715
13,260
Other current liabilities
1,927
1,580
Total current liabilities
79,670
76,925
Operating lease liabilities, net of current portion
43,148
54,881
Deferred tax liabilities, net
218,583
345,860
Other non-current liabilities
2,752
2,236
Total liabilities
344,153
479,902
Stockholders’/member’s equity:
Preferred stock, par value of $0.001 per share; 50,000,000 shares
authorized, no shares issued and outstanding as of December 31, 2025
and December 31, 2024
—
—
Common stock $0.001 par value per share, 1,500,000,000 shares
authorized, 40,331,360 and 33,893,409 shares issued and outstanding
as of December 31, 2025 and 2024 respectively.
40
34
Additional paid-in capital
12,786,848
12,305,250
Accumulated other comprehensive income
2,655
1,451
Accumulated deficit
(10,211,681)
(9,803,330)
Total stockholders’ equity
2,577,862
2,503,405
Total liabilities and stockholders’ equity
2,922,015
2,983,307
GRAIL, Inc.
Consolidated Statements of Operations
(Unaudited)
Three Months Ended
Year Ended
(in thousands except per share data)
December 31,
2025
December 31,
2024
December 31,
2025
December 31,
2024
Revenue:
Screening revenue
$ 42,282
$ 31,551
$ 138,601
$ 108,627
Development services revenue
1,315
6,701
8,571
16,968
Total revenue
43,597
38,252
147,172
125,595
Costs and operating expenses:
Cost of screening revenue (exclusive of
amortization of intangible assets)
20,872
17,803
73,251
63,284
Cost of development services revenue
389
2,945
2,605
6,444
Cost of revenue — amortization of intangible
assets
33,472
33,472
133,889
133,889
Research and development
46,896
48,328
195,794
322,380
Sales and marketing
27,672
30,525
116,693
153,958
General and administrative
38,707
42,117
159,103
213,862
Goodwill and intangible assets impairment
—
—
28,000
1,420,936
Total costs and operating expenses
168,008
175,190
709,335
2,314,753
Loss from operations
(124,411)
(136,938)
(562,163)
(2,189,158)
Other income (expense):
Interest income
7,957
9,366
28,652
26,733
Other expense (income), net
(64)
578
(993)
64
Total other income, net
7,893
9,944
27,659
26,797
Loss before income taxes
(116,518)
(126,994)
(534,504)
(2,162,361)
Benefit from income taxes
17,342
29,928
126,153
135,356
Net loss
$ (99,176)
$ (97,066)
$ (408,351)
$ (2,027,005)
Net loss per share — Basic and Diluted
$ (2.44)
$ (2.89)
$ (11.11)
$ (63.54)
Weighted average shares of common stock—
basic and diluted
40,725,561
33,612,372
36,753,751
31,901,259
GRAIL, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
Year Ended
(in thousands)
December 31,
2025
December 31,
2024
Net cash used by operating activities
$ (299,007)
$ (577,156)
Net cash used by investing activities
(85,049)
(551,011)
Net cash provided by financing activities
423,321
1,244,300
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
(147)
(62)
Net increase in cash, cash equivalents, and restricted cash
$ 39,118
$ 116,071
Cash, cash equivalents and restricted cash — beginning of period
$ 217,583
$ 101,512
Cash, cash equivalents and restricted cash — end of period
$ 256,701
$ 217,583
GRAIL, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
Three Months Ended
Year Ended
(in thousands)
December 31,
2025
December 31,
2024
December 31,
2025
December 31,
2024
Gross loss (1)
$ (11,136)
$ (15,968)
$ (62,573)
$ (78,022)
Amortization of intangible assets
33,472
33,472
133,889
133,889
Stock-based compensation
812
432
2,262
1,954
Adjusted Gross Profit
$ 23,148
$ 17,936
$ 73,578
$ 57,821
___________
(1) Gross loss is calculated as total revenue less cost of revenue (exclusive of amortization of intangible assets), cost of development services revenue, and cost of revenue — amortization of intangible assets.
GRAIL, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
Three Months Ended
Year Ended
(in thousands)
December 31,
2025
December 31,
2024
December 31,
2025
December 31,
2024
Net loss
$ (99,176)
$ (97,066)
$ (408,351)
$ (2,027,005)
Adjusted to exclude the following:
Amortization of intangible assets (1)
34,584
34,583
138,334
138,333
Stock-based compensation (2)
13,765
13,582
58,283
86,084
Depreciation
4,324
4,858
18,010
19,723
Goodwill and intangible assets impairment (3)
—
—
28,000
1,420,936
Restructuring (4)
—
(694)
(34)
18,313
Interest income
(7,957)
(9,366)
(28,652)
(26,733)
Benefit from income tax expense
(17,342)
(29,928)
(126,153)
(135,356)
Illumina/GRAIL merger & divestiture
legal and professional services costs (5)
—
—
—
22,158
Adjusted EBITDA
$ (71,802)
$ (84,031)
$ (320,563)
$ (483,547)
___________
(1) Represents amortization of intangible assets, including developed technology and trade names.
(2) Represents all stock-based compensation recognized on our standalone financial statements for the periods presented.
(3) Reflects impairment of goodwill and intangible assets recognized as a result of the Acquisition.
(4) Represents employee severance, benefits, payroll taxes, and other costs associated with the Restructuring Plan.
(5) Represents legal and professional services costs associated with the Acquisition and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and legal and professional services costs associated with the divestiture.
SOURCE GRAIL, Inc.
GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced topline results from…
GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, announced today that it will issue…
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