GRAIL Reports Third Quarter 2026 Financial Results
Cash, cash equivalents and short-term marketable securities totaled $788.7 million at September 30, 2026.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
GRAIL (Nasdaq: GRAL) reported third-quarter 2026 revenue of $37.5 million, up 4% year over year, alongside a wider net loss. Galleri revenue rose 14% to $37.3 million, with test volume up approximately 24% to more than 56,000. Net loss increased 16% to $103.6 million, while gross loss widened 32% to $18.1 million. Non-GAAP adjusted gross profit fell 20% to $15.9 million, and adjusted EBITDA loss widened 29% to $92.6 million.
An FDA advisory committee voted in favor of Galleri approval; GRAIL anticipates an FDA decision by early Q1 2027. Galleri is not yet FDA-approved. Published NHS-Galleri results showed a reduction of >20% in Stage IV diagnoses of 12 prespecified aggressive cancers and a 25% reduction in cancers diagnosed after emergency presentation in the Galleri arm versus control. Nine-month Galleri revenue grew 24% to $119.7 million, with volume up 36% to more than 174,000 tests.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointGalleri Q3 revenue grew 14% year over year to $37.3 million.
- Moderate pointQ3 Galleri volume increased approximately 24% year over year to more than 56,000 tests.
- Moderate pointFDA advisory committee voted in favor of Galleri approval in September.
- Moderate pointNHS-Galleri Stage IV diagnoses fell >20% for 12 prespecified aggressive cancers versus control.
- Moderate pointNHS-Galleri cancers diagnosed after emergency presentation declined 25% in the Galleri arm versus control.
10 minor points
- Minor pointTotal Q3 revenue rose 4% year over year to $37.5 million.
- Minor pointNine-month Galleri revenue rose 24% year over year to $119.7 million.
- Minor pointNine-month Galleri volume grew 36% year over year to more than 174,000 tests.
- Minor pointNine-month total revenue increased to $123.007 million from $103.575 million a year earlier.
- Minor pointNHS-Galleri plus standard screening detected more Stage I–II cancers than UK national screening detected across all stages.
- Minor pointNine-month net loss narrowed to $307.002 million from $309.175 million a year earlier.
- Minor pointNet loss per share narrowed year over year: Q3 $2.21 versus $2.46; nine months $6.84 versus $8.73.
- Minor pointNine-month gross loss narrowed to $44.984 million from $51.437 million a year earlier.
- Minor pointNine-month adjusted gross profit rose to $57.167 million from $50.430 million a year earlier.
- Minor pointResearch and development expenses declined year over year: Q3 $44.073 million versus $48.647 million; nine months $139.523 million versus $148.898 million.
Negative
- Moderate pointQ3 net loss widened 16% year over year to $103.6 million.
- Moderate pointQ3 gross loss widened 32% year over year to $18.1 million.
- Moderate pointQ3 adjusted EBITDA loss widened 29% year over year to $92.6 million.
- Moderate pointQ3 adjusted gross profit fell 20% year over year to $15.9 million.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Galleri FDA approval remains pending; GRAIL anticipates a decision by early Q1 2027.
- Moderate pointSales and marketing expenses rose year over year: Q3 $41.695 million versus $25.503 million; nine months $110.020 million versus $89.021 million.
- Moderate pointOperating loss widened year over year: Q3 $144.619 million versus $125.291 million; nine months $454.167 million versus $437.752 million.
- Moderate pointCommon shares outstanding increased to 44,753,179 from 40,331,360 at December 31, 2025.
5 minor points
- Minor pointAdjusted gross margin fell year over year: Q3 42% versus 55%; nine months 46% versus 49%.
- Minor pointCash and short-term securities fell to $788.676 million from $904.430 million at December 31, 2025.
- Minor pointDevelopment services revenue declined year over year: Q3 $0.266 million versus $3.387 million; nine months $3.264 million versus $7.256 million.
- Minor pointScreening costs excluding intangible amortization rose year over year: Q3 $22.032 million versus $15.910 million; nine months $66.623 million versus $52.379 million.
- Minor pointGeneral and administrative expenses rose year over year: Q3 $40.740 million versus $37.408 million; nine months $134.217 million versus $120.396 million.
News Explained
At September 30, 2026, GRAIL reported $788.7 million in cash, equivalents and short-term securities; its higher share count reduces existing holders’ percentage ownership absent offsets.
GRAIL reported third-quarter results; its common shares issued and outstanding increased between
At
Details
Market Reaction – GRAL
On Nov 4, the day this news came out, the latest delayed price for GRAL is 11.11% below the previous close. Argus tracked a trough of -6.4% from its starting point during tracking. Our momentum scanner has recorded 15 alerts for this stock so far that day. The latest delayed price is $127.70.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FDA Advisory Committee Voted in Favor of Approval of GRAIL's Galleri Multi-Cancer Early Detection Test
Q3 Galleri®Test Volume Increased ~
Q3 Galleri Revenue Grew
Galleri test revenue for the third quarter grew
"GRAIL achieved significant milestones this quarter including a favorable vote for approval of Galleri at the FDA Advisory Committee," said 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. We are seeing continued commercial momentum as a number of positive advancements, consistent market education, and promotional pricing initiatives gain traction."
For the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, GRAIL reported:
- Revenue: Total revenue, comprised of screening and development services revenue, was
$37.5 million $1.3 million 4% . - Net loss: Net loss was
$103.6 million $14.6 million 16% . - Gross loss: Gross loss was
$18.1 million $4.4 million 32% . - Adjusted gross profit1: Adjusted gross profit was
$15.9 million $4.1 million 20% . - Adjusted EBITDA1: Adjusted EBITDA was
$(92.6) million $20.9 million 29% . - Cash position: Cash, cash equivalents, and short-term marketable securities totaled
$788.7 million
|
______________________________ |
|
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures. |
Recent business highlights include:
- Announced a favorable vote for approval of the Galleri test from the FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee (the "Advisory Committee") in September. The company anticipates an FDA decision by early Q1 2027.
- Published results from the NHS-Galleri trial in The New England Journal of Medicine and Nature Medicine, and final results from the PATHFINDER 2 study in Nature Medicine. The publications report clinical utility, test performance, and safety results from approximately 175,000 participants enrolled in the
UK andNorth America . The results across the studies demonstrated:- Substantially increased cancer detection (4-6.5x more cancers detected) with robust performance, a favorable safety profile and consistent clinical performance across the two large trials.
- Additionally, the NHS-Galleri trial demonstrated a substantial reduction of >
20% in Stage IV diagnoses of 12 prespecified aggressive cancers and a25% reduction in cancers diagnosed after emergency presentation in the Galleri arm compared to the control arm. - In the NHS-Galleri trial, Galleri added to standard-of-care screening detected more Stage I-II cancers than the
UK national screening program found all cancers across all stages.
These data support the potential of multi-cancer early detection screening at population scale to identify cancers before symptoms appear — when they can be treated more easily and are potentially curable.
Conference Call and Webcast
A webcast and conference call will be held today, Nov. 4, 2026, 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.
About GRAIL
GRAIL 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
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
The GRAIL 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 Food and Drug Administration. The GRAIL 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, Adjusted Gross Margin 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.
- Adjusted Gross Profit and Adjusted Gross Margin are key performance measures that our management uses to assess our operational performance, as they represent the results of revenues and direct costs, which are key components of our operations. We believe that these non-GAAP financial measures are useful to investors and other interested parties in analyzing our financial performance because they reflect the gross profitability of our operations, and exclude the costs associated with our sales and marketing, product development, general and administrative activities and the impact of our financing methods and income taxes.
We calculate Adjusted Gross Profit as gross profit (loss) (as defined below) adjusted to exclude amortization of intangible assets and stock-based compensation allocated to cost of revenue. Adjusted Gross Profit should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other GAAP measures of income (loss) or profitability. Gross profit (loss) (as defined below) is the most directly comparable financial measure calculated in accordance with GAAP. We calculate Adjusted Gross Margin as Adjusted Gross Profit divided by total revenue.
- Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of net loss to Adjusted EBITDA, helps investors make comparisons between our company and other companies that may have different capital structures, different tax rates, different operational and ownership histories, and/or different forms of employee compensation.
Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income (loss) or income (loss) from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.
The Company defines Adjusted EBITDA as net loss adjusted for amortization of intangible assets, stock-based compensation, depreciation, intangible and other assets impairment, benefit from income taxes, interest income and restructuring expenses. These adjustments include non-cash items, significant non-recurring charges and/or other non-operating expenses that we do not believe are indicative of ongoing or future business operations.
Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other U.S. GAAP measures of income (loss). Additionally, it is not intended to be a measure of free cash flow for management's discretionary use, as it does not consider certain cash requirements such as interest and tax payments. Further, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable among companies. Net loss is the most directly comparable financial measure calculated in accordance with GAAP.
Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form following the Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations.
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 statements related to the potential benefits, uses and impacts of the Galleri test, comparability of clinical study results to a real world setting, benefits of population screening with existing or future versions of Galleri, commercial and expansion plans, growth trends and reimbursement, potential regulatory decision timeline and outcome, and impacts of our commercial strategies, among others.
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 year ended December 31, 2025 and our subsequent Quarterly Reports on Form 10-Q. 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, financial condition and success in our business strategies and operations 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, |
|
December 31, |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ 28,976 |
|
$ 249,727 |
|
Short-term marketable securities |
759,700 |
|
654,703 |
|
Accounts receivable, net |
18,998 |
|
18,295 |
|
Supplies |
18,475 |
|
16,017 |
|
Prepaid expenses and other current assets |
16,649 |
|
15,107 |
|
Total current assets |
842,798 |
|
953,849 |
|
Property and equipment, net |
42,691 |
|
51,813 |
|
Operating lease right-of-use assets |
84,073 |
|
52,070 |
|
Restricted cash |
6,943 |
|
6,974 |
|
Intangible assets, net |
1,746,806 |
|
1,850,556 |
|
Other non-current assets |
7,251 |
|
6,753 |
|
Total assets |
$ 2,730,562 |
|
$ 2,922,015 |
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ 10,209 |
|
$ 2,083 |
|
Accrued liabilities |
76,305 |
|
63,945 |
|
Operating lease liabilities, current portion |
6,272 |
|
11,715 |
|
Other current liabilities |
1,546 |
|
1,927 |
|
Total current liabilities |
94,332 |
|
79,670 |
|
Operating lease liabilities, net of current portion |
79,576 |
|
43,148 |
|
Deferred tax liability, net |
99,742 |
|
218,583 |
|
Other non-current liabilities |
3,393 |
|
2,752 |
|
Total liabilities |
277,043 |
|
344,153 |
|
Preferred stock, par value of |
— |
|
— |
|
Common stock |
45 |
|
40 |
|
Additional paid-in capital |
12,970,363 |
|
12,786,848 |
|
Accumulated other comprehensive income |
1,794 |
|
2,655 |
|
Accumulated deficit |
(10,518,683) |
|
(10,211,681) |
|
Total stockholders' equity |
2,453,519 |
|
2,577,862 |
|
Total liabilities and stockholders' equity |
$ 2,730,562 |
|
$ 2,922,015 |
|
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, |
|
September 30, |
|
September 30, |
|
September 30, |
|
Revenue: |
|
|
|
|
|
|
|
|
Screening revenue |
$ 37,269 |
|
$ 32,807 |
|
$ 119,743 |
|
$ 96,319 |
|
Development services revenue |
266 |
|
3,387 |
|
3,264 |
|
7,256 |
|
Total revenue |
37,535 |
|
36,194 |
|
123,007 |
|
103,575 |
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
Cost of screening revenue (exclusive of |
22,032 |
|
15,910 |
|
66,623 |
|
52,379 |
|
Cost of development services revenue |
141 |
|
544 |
|
951 |
|
2,216 |
|
Cost of revenue — amortization of intangible |
33,473 |
|
33,473 |
|
100,417 |
|
100,417 |
|
Research and development |
44,073 |
|
48,647 |
|
139,523 |
|
148,898 |
|
Sales and marketing |
41,695 |
|
25,503 |
|
110,020 |
|
89,021 |
|
General and administrative |
40,740 |
|
37,408 |
|
134,217 |
|
120,396 |
|
Intangible and other assets impairment |
— |
|
— |
|
25,423 |
|
28,000 |
|
Total costs and operating expenses |
182,154 |
|
161,485 |
|
577,174 |
|
541,327 |
|
Loss from operations |
(144,619) |
|
(125,291) |
|
(454,167) |
|
(437,752) |
|
Other income: |
|
|
|
|
|
|
|
|
Interest income |
7,843 |
|
6,107 |
|
23,059 |
|
20,695 |
|
Other income (expense), net |
(545) |
|
466 |
|
(444) |
|
(929) |
|
Total other income, net |
7,298 |
|
6,573 |
|
22,615 |
|
19,766 |
|
Loss before income taxes |
(137,321) |
|
(118,718) |
|
(431,552) |
|
(417,986) |
|
Benefit from income taxes |
33,753 |
|
29,741 |
|
124,550 |
|
108,811 |
|
Net loss |
$ (103,568) |
|
$ (88,977) |
|
$ (307,002) |
|
$ (309,175) |
|
Net loss per share — Basic and Diluted |
$ (2.21) |
|
$ (2.46) |
|
$ (6.84) |
|
$ (8.73) |
|
Weighted-average shares of common stock |
46,777,729 |
|
36,124,256 |
|
44,858,893 |
|
35,415,266 |
|
GRAIL, Inc Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited) (amounts in thousands) |
|||||||
|
|
|||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
Gross loss (1) |
$ (18,111) |
|
$ (13,733) |
|
$ (44,984) |
|
$ (51,437) |
|
Amortization of intangible assets |
33,473 |
|
33,473 |
|
100,417 |
|
100,417 |
|
Stock-based compensation |
552 |
|
271 |
|
1,734 |
|
1,450 |
|
Adjusted Gross Profit |
$ 15,914 |
|
$ 20,011 |
|
$ 57,167 |
|
$ 50,430 |
|
Adjusted Gross Margin (2) |
42 % |
|
55 % |
|
46 % |
|
49 % |
|
(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. |
|
(2) |
Adjusted Gross Margin is calculated as adjusted gross profit divided by total revenue. Three Months Ended Nine Months Ended |
|
GRAIL, Inc Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited) (amounts in thousands) |
|||||||
|
|
|||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
Net loss |
$ (103,568) |
|
$ (88,977) |
|
$ (307,002) |
|
$ (309,175) |
|
Adjusted to exclude the following: |
|
|
|
|
|
|
|
|
Amortization of intangible assets (1) |
34,583 |
|
34,583 |
|
103,750 |
|
103,750 |
|
Stock-based compensation |
14,109 |
|
14,139 |
|
50,459 |
|
44,518 |
|
Intangible and other assets impairment (2) |
— |
|
— |
|
25,423 |
|
28,000 |
|
Depreciation |
3,892 |
|
4,399 |
|
12,207 |
|
13,686 |
|
Benefit from income taxes |
(33,753) |
|
(29,741) |
|
(124,550) |
|
(108,811) |
|
Interest income |
(7,843) |
|
(6,107) |
|
(23,059) |
|
(20,695) |
|
Restructuring |
— |
|
— |
|
— |
|
(34) |
|
Adjusted EBITDA |
$ (92,580) |
|
$ (71,704) |
|
$ (262,772) |
|
$ (248,761) |
|
(1) |
Represents amortization of intangible assets, including developed technology and trade names. |
|
(2) |
Represents the impairment charge related to the deferred asset recognized in connection with the Samsung SPA in the second quarter of 2026 and the in-process research and development ("IPR&D") impairment charge in the prior period. |
View original content to download multimedia:https://www.prnewswire.com/news-releases/grail-reports-third-quarter-2026-financial-results-302929752.html
SOURCE GRAIL, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were GRAIL's third-quarter 2026 financial results?
GRAIL reported $37.5 million in revenue, up 4% year over year, and a net loss of $103.6 million, up 16%. Galleri revenue increased 14% to $37.3 million. Non-GAAP adjusted gross profit declined 20% to $15.9 million, while adjusted EBITDA loss widened 29% to $92.6 million.
When does GRAIL expect an FDA decision on Galleri?
GRAIL anticipates an FDA decision on Galleri by early Q1 2027. The FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee voted in favor of approval in September. Galleri has not been cleared or approved by the FDA.
Where were GRAIL's NHS-Galleri and PATHFINDER 2 results published?
NHS-Galleri results were published in The New England Journal of Medicine and Nature Medicine, and final PATHFINDER 2 results appeared in Nature Medicine. The publications report clinical utility, test performance and safety results from approximately 175,000 participants enrolled in the UK and North America.