GRAIL reports Q3 2026 financial results

Results of operations and financial condition.

On November 4, 2026, GRAIL, Inc. (the "Company" or "GRAIL") issued a press release announcing its financial results for the third quarter ended September 30, 2026¹. A copy of the press release is furnished as Exhibit 99.1² 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 1934², 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.

Exhibits.

(d) Exhibits

Exhibit No. Description

99.1

Press Release of GRAIL, Inc. dated November 4 , 2026 (GRAIL Reports Third 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: November 4, 2026 By: /s/ Aaron Freidin

Name: Aaron Freidin

Title: Chief Financial Officer

NEWS RELEASE Exhibit 99.1

GRAIL Reports Third Quarter 2026 Financial Results

FDA Advisory Committee Voted in Favor of Approval of GRAIL's Galleri Multi-Cancer Early Detection Test

SUNNYVALE, Calif. — Nov. 4, 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 third quarter of 2026.

Galleri test revenue for the third quarter grew 14% year-over-year to $37.3 million, and total revenue grew 4% year-over-year to $37.5 million.³ Galleri test volume for the third quarter grew approximately 24% year-over-year to more than 56,000 tests.⁴ Total Galleri test volume and revenue for the nine months ended September 30, 2026 grew 36% year-over-year to more than 174,000 tests⁵ and 24% to $119.7 million, respectively. Net loss for the third quarter was $103.6 million. Gross loss was $18.1 million.⁷ Non-GAAP adjusted gross profit was $15.9 million, and non-GAAP adjusted EBITDA was $(92.6) million.⁸ 1

"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, an increase of $1.3 million or 4%.

• Net loss: Net loss was $103.6 million, an increase of $14.6 million or 16%.⁶

• Gross loss: Gross loss was $18.1 million, an increase of $4.4 million or 32%.

• Adjusted gross profit 1 : Adjusted gross profit was $15.9 million, a decrease of $4.1 million or 20%.

• Adjusted EBITDA 1 : Adjusted EBITDA was $(92.6) million, an increase in adjusted EBITDA loss of $20.9 million or 29%.

• Cash position: Cash, cash equivalents, and short-term marketable securities totaled $788.7 million as of September 30, 2026.⁹

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.¹⁰ The company anticipates an FDA decision by early Q1 2027.¹¹

• 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.¹² The publications report clinical utility, test performance, and safety results from approximately 175,000 participants enrolled in the UK and North 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 a 25% 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 Sunnyvale, Calif. 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