GRAIL Reports Third Quarter 2025 Financial Results
Q3 U.S. Galleri Revenue Grew 28% Year-Over-Year to $32.6 Million
Q3 Galleri Tests Sold Grew 39% Year-Over-Year to More Than 45,000
Galleri PMA Submission to FDA Now Anticipated in Q126
Cash Position of More Than $850 Million Includes Recently Completed Private Placement
MENLO PARK, Calif., Nov. 12, 2025 /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 third quarter of 2025.
Total revenue in the third quarter grew 26% year-over-year to $36.2 million, and Galleri revenue grew 29% year-over-year to $32.8 million. U.S. Galleri revenue was $32.6 million, representing 28% growth year-over-year. Net loss for the quarter was $89.0 million. Gross loss was $13.7 million. Non-GAAP adjusted gross profit was $20.0 million, and non-GAAP adjusted EBITDA was $(71.7) million. 1
"We remain very pleased by Galleri's commercial uptake with 39% growth in Galleri test volume in the third quarter. Our teams continue to build awareness of Galleri among providers and patients, and recent data from our registrational PATHFINDER 2 study adds to the evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have also made key recent strides in opportunities beyond the U.S., led by our strategic collaboration with Samsung to bring Galleri to key Asian markets, as well as Galleri's commercial introduction in Canada. Looking ahead, we anticipate completing our PMA submission for Galleri to the FDA in the first quarter of 2026."
For the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, GRAIL reported:
Recent business highlights include:
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures.
Conference Call and Webcast
A webcast and conference call will be held today, Nov. 12, 2025, at 1:30 p.m. PT / 4:30 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.
GRAIL Analyst Day 2025 Tomorrow
GRAIL will host its Analyst Day 2025 tomorrow, Nov. 13, 2025, at the Company's central laboratories in Research Triangle Park, North Carolina beginning at 8:00 a.m. PT / 11:00 a.m. ET.
The live webcast and recorded replay will be available at the investor relations section of GRAIL's website at investors.grail.com and at https://grail-analyst-day-2025.open-exchange.net/registration.
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, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others. The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. 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.
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 provided throughout this press release that are determined in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release also includes financial measures that are not calculated in accordance with GAAP. Our non-GAAP financial disclosure includes Adjusted Gross Profit (Loss) 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, patient awareness of our products, technology, clinical studies, safety results, regulatory compliance, potential market opportunity, anticipated growth strategies, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, satisfaction of closing conditions and negotiation of definitive agreements in the Samsung collaboration, 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 sections entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2024 and in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2025, June 30, 2025 and September 30, 2025. 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.
GRAIL, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(amounts in thousands, except share and per share data)
September 30,
2025
December 31,
2024
Assets
Current assets:
Cash and cash equivalents
$ 126,892
$ 214,234
Short-term marketable securities
413,238
549,236
Accounts receivable, net
16,282
20,312
Supplies
18,390
18,632
Prepaid expenses and other current assets
14,579
17,447
Total current assets
589,381
819,861
Property and equipment, net
56,180
69,061
Operating lease right-of-use assets
56,061
66,373
Restricted cash
6,974
3,349
Intangible assets, net
1,885,140
2,016,890
Other non-current assets
7,295
7,773
Total assets
$ 2,601,031
$ 2,983,307
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
$ 3,407
$ 4,844
Accrued liabilities
58,076
57,241
Operating lease liabilities, current portion
14,022
13,260
Other current liabilities
1,928
1,580
Total current liabilities
77,433
76,925
Operating lease liabilities, net of current portion
44,568
54,881
Deferred tax liability, net
236,265
345,860
Other non-current liabilities
2,802
2,236
Total liabilities
361,068
479,902
Preferred stock, par value of $0.001 per share; 50,000,000 shares
authorized, no shares issued and outstanding as of September 30,
2025 and December 31, 2024
—
—
Common stock $0.001 par value per share, 1,500,000,000 shares
authorized, 36,160,998 shares issued and outstanding as of
September 30, 2025, 33,893,409 shares issued and outstanding as of
December 31, 2024
36
34
Additional paid-in capital
12,349,976
12,305,250
Accumulated other comprehensive income
2,456
1,451
Accumulated deficit
(10,112,505)
(9,803,330)
Total stockholders' equity
2,239,963
2,503,405
Total liabilities and stockholders' equity
$ 2,601,031
$ 2,983,307
GRAIL, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(amounts in thousands, except share and per share data)
Three Months Ended
Nine Months Ended
September 30,
2025
September 30,
2024
September 30,
2025
September 30,
2024
Revenue:
Screening revenue
$ 32,807
$ 25,374
$ 96,319
$ 77,076
Development services revenue
3,387
3,278
7,256
10,267
Total revenue
36,194
28,652
103,575
87,343
Costs and operating expenses:
Cost of screening revenue (exclusive of
amortization of intangible assets)
15,910
15,970
52,379
45,481
Cost of development services revenue
544
1,442
2,216
3,499
Cost of revenue — amortization of intangible
assets
33,473
33,473
100,417
100,417
Research and development
48,647
78,231
148,898
274,052
Sales and marketing
25,503
35,625
89,021
123,433
General and administrative
37,408
47,418
120,396
171,745
Goodwill and intangible assets impairment
—
—
28,000
1,420,936
Total costs and operating expenses
161,485
212,159
541,327
2,139,563
Loss from operations
(125,291)
(183,507)
(437,752)
(2,052,220)
Other income:
Interest income
6,107
11,661
20,695
17,367
Other income (expense), net
466
(561)
(929)
(514)
Total other income, net
6,573
11,100
19,766
16,853
Loss before income taxes
(118,718)
(172,407)
(417,986)
(2,035,367)
Benefit from income taxes
29,741
46,719
108,811
105,428
Net loss
$ (88,977)
$ (125,688)
$ (309,175)
$ (1,929,939)
Net loss per share — Basic and Diluted
$ (2.46)
$ (3.94)
$ (8.73)
$ (61.61)
Weighted-average shares of common stock
used in computing net loss per share:
36,124,256
31,880,054
35,415,266
31,326,117
GRAIL, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited)
(amounts in thousands)
Three Months Ended
Nine Months Ended
September 30,
2025
September 30,
2024
September 30,
2025
September 30,
2024
Gross loss (1)
$ (13,733)
$ (22,233)
$ (51,437)
$ (62,054)
Amortization of intangible assets
33,473
33,473
100,417
100,417
Stock-based compensation
271
578
1,450
1,522
Adjusted Gross Profit
$ 20,011
$ 11,818
$ 50,430
$ 39,885
(1)
Gross loss is calculated as total revenue less cost of screening 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)
(amounts in thousands)
Three Months Ended
Nine Months Ended
September 30,
2025
September 30,
2024
September 30,
2025
September 30,
2024
Net loss
$ (88,977)
$ (125,688)
$ (309,175)
$ (1,929,939)
Adjusted to exclude the following:
Interest income
(6,107)
(11,661)
(20,695)
(17,367)
Benefit from income tax expense
(29,741)
(46,719)
(108,811)
(105,428)
Amortization of intangible assets (1)
34,583
34,583
103,750
103,750
Depreciation
4,399
4,647
13,686
14,865
Goodwill and intangible impairment (2)
—
—
28,000
1,420,936
Illumina/GRAIL merger & divestiture
legal and professional services costs (3)
—
226
—
22,158
Stock-based compensation (4)
14,139
17,449
44,518
72,502
Restructuring (5)
—
19,007
(34)
19,007
Adjusted EBITDA
$ (71,704)
$ (108,156)
$ (248,761)
$ (399,516)
(1)
Represents amortization of intangible assets, including developed technology and trade names.
(2)
Reflects impairment of goodwill and intangible assets recognized as a result of the Acquisition.
(3)
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.
(4)
Represents all stock-based compensation recognized on our standalone financial statements for the periods presented.
(5)
Represents employee severance, benefits, payroll taxes, and other costs associated with the Restructuring Plan.
SOURCE GRAIL, Inc.