GRAIL (NASDAQ: GRAL) posts 28% Q1 growth and advances Galleri PMA
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
GRAIL, Inc. reported strong first-quarter 2026 growth, with total revenue of $40.8 million, an increase of 28% year over year. Galleri test revenue reached $39.8 million, up 37%, as test volume grew 50% to more than 56,000 tests.
The company recorded a net loss of $93.2 million, an improvement of 12%, and a gross loss of $14.3 million. Non-GAAP adjusted gross profit was $19.7 million, while adjusted EBITDA was a loss of $79.9 million, a 19% improvement.
GRAIL ended the quarter with $823.1 million in cash, cash equivalents, and short-term marketable securities. The FDA accepted its Premarket Approval application for the Galleri test, and GRAIL plans to integrate Galleri into Epic’s electronic health record platform to broaden access.
Positive
- Total revenue grew 28% to $40.8 million, driven largely by Galleri, which delivered $39.8 million of revenue and 37% year-over-year growth, while test volume increased 50% to more than 56,000 tests.
- Profitability metrics improved meaningfully, with net loss improving 12% to $93.2 million and non-GAAP adjusted EBITDA loss improving 19% to $79.9 million, indicating better operating leverage.
- GRAIL ended the quarter with $823.1 million in cash, cash equivalents, and short-term marketable securities, providing substantial liquidity to fund clinical programs and commercialization.
- The FDA accepted the Premarket Approval application for Galleri, and GRAIL announced planned integration of Galleri into Epic’s EHR platform, steps that support future regulatory and commercial expansion.
Negative
- GRAIL remains deeply unprofitable, reporting a Q1 2026 net loss of $93.2 million and a GAAP gross loss of $14.3 million, highlighting continued heavy spending relative to current revenue.
Insights
GRAIL posted strong Galleri growth, narrowed losses, and advanced FDA review.
GRAIL grew Q1 2026 revenue to $40.8M, up 28% year over year, with Galleri revenue of $39.8M rising 37% and test volume up 50% to more than 56,000. This shows expanding commercial adoption of its multi-cancer early detection test.
Losses remain significant, but trends improved. Net loss was $93.2M, a 12% improvement, and adjusted EBITDA loss narrowed 19% to $79.9M. Cash, cash equivalents, and short-term marketable securities totaled $823.1M as of March 31, 2026, supporting ongoing R&D and commercialization.
Regulatory and partnership milestones add strategic weight. The FDA accepted the Galleri Premarket Approval application, and GRAIL plans Epic EHR integration, with broad availability expected by the end of 2026. Upcoming PATHFINDER 2 and NHS-Galleri data at the 2026 ASCO Annual Meeting may further clarify clinical performance and market potential.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Total revenue: $40.8 million
Galleri revenue: $39.8 million
Galleri test volume: More than 56,000 tests
+5 more
8 metrics
Total revenue
$40.8 million
Q1 2026, up 28% year over year
Galleri revenue
$39.8 million
Q1 2026, up 37% year over year
Galleri test volume
More than 56,000 tests
Q1 2026, 50% year-over-year growth
Net loss
$93.2 million
Q1 2026, 12% improvement year over year
Adjusted EBITDA
-$79.9 million
Q1 2026, 19% improvement year over year
Cash, cash equivalents and short-term securities
$823.1 million
As of March 31, 2026
Gross loss
$14.3 million
Q1 2026 GAAP gross loss
Adjusted gross profit
$19.7 million
Q1 2026 non-GAAP adjusted gross profit
Key Terms
Premarket Approval (PMA), Adjusted EBITDA, Adjusted Gross Profit, multi-cancer early detection (MCED), +2 more
6 terms
Premarket Approval (PMA) regulatory
"The Premarket Approval (PMA) application for Galleri was submitted to the U.S. Food and Drug Administration (FDA) in January and accepted by FDA for review."
Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.
Adjusted EBITDA financial
"Adjusted EBITDA was $(79.9) million, an improvement of $18.8 million or 19%."
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
Adjusted Gross Profit financial
"Adjusted gross profit1: Adjusted gross profit was $19.7 million, an increase of $5.4 million or 38%."
Adjusted gross profit is a company’s revenue from selling goods or services minus the direct costs of producing them, with one-time or unusual items added back or removed to show the core margin. Investors use it like a cleaned-up snapshot of how much a business actually earns on its products, similar to measuring body weight after removing heavy clothes, because it helps compare performance across periods and companies without noise from rare events.
multi-cancer early detection (MCED) medical
"the largest, and only, randomized, controlled intended use trial of any multi-cancer early detection (MCED) test."
A multi-cancer early detection (MCED) test is a single medical test, often a blood test, designed to screen for signs of many different cancers at once rather than targeting one type. Investors care because successful MCEDs could reshape healthcare by catching disease earlier, expanding screening markets, cutting long-term treatment costs, and creating large commercial and regulatory opportunities similar to how a single smartphone can replace many separate devices.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulatory
"GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists."
A federal program that sets quality and certification rules for U.S. clinical laboratories that perform tests on human specimens, ensuring accuracy, reliability and proper personnel and equipment—think of it as a safety inspection and licensing system for medical testing labs. For investors, CLIA status signals whether a lab’s test results meet regulatory standards, which affects a lab’s ability to bill insurers, sell diagnostic services, expand testing, and avoid fines or shutdowns.
non-GAAP financial measure financial
"this press release also includes financial measures that are not calculated in accordance with GAAP. Our non-GAAP financial disclosure includes Adjusted Gross Profit and Adjusted EBITDA."
A non-GAAP financial measure is a way companies present their financial results that excludes certain expenses or income to show how they believe their core business is performing. It matters because it can give a clearer picture of how the company is really doing, but it can also be used to make results look better than they actually are.
Earnings Snapshot
Total revenue: $40.8 million
Q1 2026
Total revenue
$40.8 million
+28% year over year
Galleri revenue
$39.8 million
+37% year over year
Galleri test volume
More than 56,000
+50% year over year
Net loss
$93.2 million
12% improvement year over year
Adjusted EBITDA
-$79.9 million
19% improvement year over year
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________
FORM 8-K
_____________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2026
_____________________________________________
(Exact Name of Registrant as Specified in Charter)
___________________________________________
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (833 ) 694-2553
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
___________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 | Results of operations and financial condition. | ||||
On May 5, 2026, GRAIL, Inc. (the “Company” or “GRAIL”) issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in Item 2.02 of this Current Report on Form 8-K and the exhibits attached hereto are intended to be “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Except as shall be expressly set forth by specific reference in such filing, the information contained herein and in the accompanying exhibits shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 | Exhibits. | ||||
(d) Exhibits
| Exhibit No. | Description | |||||||
99.1 | Press Release of GRAIL, Inc. dated May 5, 2026 (GRAIL Reports First Quarter 2026 Financial Results) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GRAIL, INC. | ||||||||||||||
| Date: | May 5, 2026 | By: | /s/ Aaron Freidin | |||||||||||
| Name: | Aaron Freidin | |||||||||||||
| Title: | Chief Financial Officer | |||||||||||||
NEWS RELEASE Exhibit 99.1
GRAIL Reports First Quarter 2026 Financial Results
Q1 Galleri® Revenue Grew 37% Year-Over-Year to $39.8 Million, and Test Volume Increased 50% to More Than 56,000
Announced Plans to Integrate the Galleri Test Into Epic Electronic Health Record Platform to Expand Access Nationwide
New Data From the NHS-Galleri Trial and PATHFINDER 2 Study to be Presented at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
MENLO PARK, Calif. — May 5, 2026 — 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 first quarter of 2026.
Total revenue in the first quarter grew 28% year over year to $40.8 million, and Galleri revenue grew 37% year-over-year to $39.8 million. Galleri test volume for the quarter grew 50% year-over-year to more than 56,000. Net loss for the quarter was $93.2 million. Gross loss was $14.3 million. Non-GAAP adjusted gross profit was $19.7 million, and non-GAAP adjusted EBITDA was $(79.9) million.1
“GRAIL continues to execute commercially, with strong volume growth in Q1. We continue to build new partnerships to support demand and were pleased to announce our collaboration with Epic, which will expand access to Galleri for physicians and patients,” said Bob Ragusa, Chief Executive Officer at GRAIL. “We are looking forward to our upcoming presentations of detailed results from our 35,000 PATHFINDER 2 study and the 140,000 NHS-Galleri trial, which were accepted for presentation at the 2026 ASCO Annual Meeting in late May.”
For the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, GRAIL reported:
•Revenue: Total revenue, comprised of screening and development services revenue, was $40.8 million, an increase of $8.9 million or 28%.
•Net loss: Net loss was $93.2 million, an improvement of $13.0 million or 12%.
•Gross loss: Gross loss was $14.3 million, an improvement of $5.6 million or 28%.
•Adjusted gross profit1: Adjusted gross profit was $19.7 million, an increase of $5.4 million or 38%.
•Adjusted EBITDA1: Adjusted EBITDA was $(79.9) million, an improvement of $18.8 million or 19%.
Cash position: Cash, cash equivalents, and short-term marketable securities totaled $823.1 million as of March 31, 2026.
1 See “Non-GAAP Disclosure” and the associated reconciliations for important information about our use of non-GAAP measures.
Recent business highlights include:
•The Premarket Approval (PMA) application for Galleri was submitted to the U.S. Food and Drug Administration (FDA) in January and accepted by FDA for review. The PMA submission is focused on test performance and safety results from 25,000 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the 140,000 participant NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any multi-cancer early detection (MCED) test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in clinical trials to the updated version that has been submitted to the FDA for premarket approval.
•Announced planned integration of the Galleri test into Epic’s electronic health record (EHR) platform to expand access nationwide. Epic is a leading EHR platform used by many large and advanced health systems. Integration through Epic Aura will allow health systems and their healthcare providers to order the Galleri test directly at the point of care, receive structured results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Broad availability in Epic EHR platform is expected by the end of 2026.
•Data presentations at the American Association of Cancer Research (AACR) 2026 Annual Meeting in April:
◦An analysis of the association between emergency department involvement in the diagnosis of cancer and overall survival across different cancer types in the Medicare population. Emergency department involvement was associated with a significant fraction of overall mortality in patients with cancer. Emergency department involvement at diagnosis remained a strong independent predictor of mortality after adjusting for sociodemographics, comorbidities, and stage at diagnosis.
◦An analysis of adherence to mammography screening before and after MCED testing. showed that women who received a negative MCED result maintained high adherence to guideline-recommended mammography, with >80% undergoing screening in the 24 months after MCED testing, similar to rates in the 24 months before testing. These findings suggest that MCED testing does not negatively impact participation in guideline-recommended cancer screening.
•Announced new data from both the NHS-Galleri trial and the PATHFINDER 2 study will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 29 - June 2, 2026:
◦Detailed NHS-Galleri Trial results will be presented as a late-breaking abstract in an oral presentation during a clinical science symposium on Saturday, May 30.
◦Final PATHFINDER 2 study results will be presented as a late-breaking abstract in an oral presentation on Sunday, May 31.
◦More than 174,000 participants enrolled across both studies, demonstrating the scientific rigor of the Galleri clinical development program.
Conference Call and Webcast
A webcast and conference call will be held today, May 5, 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.
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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.
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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 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 is a key performance measure that our management uses to assess our operational performance, as it represents the results of revenues and direct costs, which are key components of our operations. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it reflects the gross profitability of our operations, and excludes 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 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.
•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.
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, 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.
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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.
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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, planned presentations at upcoming conferences, 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 in the Samsung collaboration, planned integration with EHR systems, 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, 2025 and in the Quarterly Report on Form 10-Q that we plan to file for the period ended March 31, 2026. 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 Contacts
Corporate Communications
Kristen Davis
Trish Rowland
pr@grail.com
Investor Relations
Alex Dobbin
Alexis Tosti
ir@grail.com
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GRAIL, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(amounts in thousands, except share and per share data)
| March 31, 2026 | December 31, 2025 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 69,344 | $ | 249,727 | |||||||
| Short-term marketable securities | 753,761 | 654,703 | |||||||||
| Accounts receivables, net | 20,345 | 18,295 | |||||||||
| Supplies | 17,194 | 16,017 | |||||||||
| Prepaid expenses and other current assets | 16,703 | 15,107 | |||||||||
| Total current assets | 877,347 | 953,849 | |||||||||
| Property and equipment, net | 47,853 | 51,813 | |||||||||
| Operating lease right-of-use assets | 48,055 | 52,070 | |||||||||
| Restricted cash | 6,974 | 6,974 | |||||||||
| Intangible assets, net | 1,815,972 | 1,850,556 | |||||||||
| Other non-current assets | 7,273 | 6,753 | |||||||||
| Total assets | $ | 2,803,474 | $ | 2,922,015 | |||||||
| Liabilities and stockholders’ equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 4,668 | $ | 2,083 | |||||||
| Accrued liabilities | 58,267 | 63,945 | |||||||||
| Operating lease liabilities, current portion | 9,939 | 11,715 | |||||||||
| Other current liabilities | 1,835 | 1,927 | |||||||||
| Total current liabilities | 74,709 | 79,670 | |||||||||
| Operating lease liabilities, net of current portion | 41,091 | 43,148 | |||||||||
| Deferred tax liability, net | 184,035 | 218,583 | |||||||||
| Other non-current liabilities | 2,953 | 2,752 | |||||||||
| Total liabilities | 302,788 | 344,153 | |||||||||
Preferred stock, par value of $0.001 per share; 50,000,000 shares authorized, no shares issued and outstanding as of March 31, 2026 and December 31, 2025 | — | — | |||||||||
Common stock $0.001 par value per share, 1,500,000,000 shares authorized as of March 31, 2026 and December 31, 2025 and 41,134,219 and 40,331,360 shares issued and outstanding as of March 31, 2026 and December 31, 2025 | 41 | 40 | |||||||||
| Additional paid-in capital | 12,803,640 | 12,786,848 | |||||||||
| Accumulated other comprehensive income | 1,873 | 2,655 | |||||||||
| Accumulated deficit | (10,304,868) | (10,211,681) | |||||||||
| Total stockholders' equity | 2,500,686 | 2,577,862 | |||||||||
| Total liabilities and stockholders' equity | $ | 2,803,474 | $ | 2,922,015 | |||||||
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GRAIL, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(amounts in thousands, except share and per share data)
| Three Months Ended | |||||||||||
| March 31, 2026 | March 31, 2025 | ||||||||||
| Revenue: | |||||||||||
| Screening revenue | $ | 39,832 | $ | 29,133 | |||||||
| Development services revenue | 953 | 2,704 | |||||||||
| Total revenue | 40,785 | 31,837 | |||||||||
| Costs and operating expenses: | |||||||||||
| Cost of screening revenue (exclusive of amortization of intangible assets) | 21,244 | 17,123 | |||||||||
| Cost of development services revenue | 376 | 1,171 | |||||||||
| Cost of revenue — amortization of intangible assets | 33,472 | 33,472 | |||||||||
| Research and development | 48,021 | 53,625 | |||||||||
| Sales and marketing | 30,668 | 34,979 | |||||||||
| General and administrative | 42,769 | 45,074 | |||||||||
| Total costs and operating expenses | 176,550 | 185,444 | |||||||||
| Loss from operations | (135,765) | (153,607) | |||||||||
| Other income: | |||||||||||
| Interest income | 7,986 | 7,779 | |||||||||
| Other income (expense), net | 256 | (584) | |||||||||
| Total other income, net | 8,242 | 7,195 | |||||||||
| Loss before income taxes | (127,523) | (146,412) | |||||||||
| Benefit from income taxes | 34,336 | 40,199 | |||||||||
| Net loss | $ | (93,187) | $ | (106,213) | |||||||
| Net loss per share — Basic and Diluted | $ | (2.29) | $ | (3.10) | |||||||
| Weighted-average shares of common stock used in computing net loss per share: | 40,640,879 | 34,308,435 | |||||||||
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GRAIL, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited)
(amounts in thousands)
| Three Months Ended | |||||||||||
| March 31, 2026 | March 31, 2025 | ||||||||||
Gross loss (1) | $ | (14,307) | $ | (19,929) | |||||||
| Amortization of intangible assets | 33,472 | 33,472 | |||||||||
| Stock-based compensation | 533 | 762 | |||||||||
| Adjusted Gross Profit | $ | 19,698 | $ | 14,305 | |||||||
(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.
9
GRAIL, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited)
(amounts in thousands)
| Three Months Ended | |||||||||||
| March 31, 2026 | March 31, 2025 | ||||||||||
| Net loss | $ | (93,187) | $ | (106,213) | |||||||
| Adjusted to exclude the following: | |||||||||||
Amortization of intangible assets (1) | 34,584 | 34,584 | |||||||||
| Stock-based compensation | 16,793 | 16,211 | |||||||||
| Depreciation | 4,210 | 4,695 | |||||||||
| Benefit from income tax expense | (34,336) | (40,199) | |||||||||
| Interest income | (7,986) | (7,779) | |||||||||
| Restructuring | — | (34) | |||||||||
| Adjusted EBITDA | $ | (79,922) | $ | (98,735) | |||||||
(1)Represents amortization of intangible assets, including developed technology and trade names.
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FAQ
How did GRAIL (GRAL) perform financially in Q1 2026?
GRAIL reported Q1 2026 revenue of $40.8 million, up 28% year over year, driven mainly by Galleri. Net loss improved to $93.2 million, a 12% improvement, while adjusted EBITDA loss narrowed to $79.9 million, a 19% improvement.
How fast is GRAIL’s Galleri test business growing?
Galleri revenue reached $39.8 million in Q1 2026, growing 37% year over year. Test volume increased 50% to more than 56,000 tests, reflecting rising clinical adoption and demand for GRAIL’s multi-cancer early detection offering.
What is GRAIL’s cash position after Q1 2026?
As of March 31, 2026, GRAIL held $823.1 million in cash, cash equivalents, and short-term marketable securities. This sizable liquidity base supports ongoing clinical trials, regulatory activities, and commercialization efforts for the Galleri test and related programs.
What progress has GRAIL (GRAL) made with the FDA for Galleri?
GRAIL’s Premarket Approval (PMA) application for the Galleri test was submitted in January and accepted by the U.S. Food and Drug Administration for review, based on data from PATHFINDER 2 and the NHS-Galleri trial and supporting bridging analyses.
What is the significance of GRAIL’s planned Epic EHR integration?
GRAIL plans to integrate the Galleri test into Epic’s electronic health record platform, allowing providers to order tests and receive results within existing workflows. Broad Epic availability is expected by the end of 2026, potentially expanding nationwide access.
What upcoming clinical data will GRAIL present for Galleri?
GRAIL will present new data from the NHS-Galleri trial and PATHFINDER 2 at the 2026 ASCO Annual Meeting. Detailed NHS-Galleri results and final PATHFINDER 2 data will be shared in late-breaking oral presentations in Chicago.