GRAIL, Inc.

GRAIL operates in the rapidly evolving field of multi-cancer early detection, a new approach to cancer screening that presents a number of novel and complex issues for FDA review, as the FDA has never cleared or approved a multi-cancer detection test. The company estimates that more than 70% of cancer deaths result from cancers that have no recommended screening guidelines, and an analysis published in Data estimated that diagnosing cancer early could result in $26 billion in annual cost-savings in the United States. The industry is highly competitive, with market participants including Exact Sciences Corporation, Guardant Health, Inc., Caris Life Sciences, Clearnote Health, Natera, Inc., and others in the United States, and Insighta, Mirxes, and Seekin, Inc. outside the United States.

GRAIL believes it currently has the largest share of the market for MCED testing. The company's competitive advantages include its clinically-validated, commercially available MCED screening test Galleri, its established commercial leadership, its unprecedented clinical studies and real-world experience with over 800,000 tests processed, its highly-differentiated methylation platform, its intellectual property portfolio of approximately 408 granted patents globally exclusively licensed and more than 221 issued patents owned or co-owned, and its highly experienced and multidisciplinary team of approximately 910 full-time employees.

GRAIL generates revenue primarily through the sale of its multi-cancer early detection test, Galleri, which is a screening test that detects a cancer signal shared by over 50 types of cancer from a simple blood draw. The company also derives revenue from development services, which consist of research services provided to biopharmaceutical and clinical customers, including support of ongoing clinical studies, pilot testing, research, and therapy development. As of December 31, 2025, the company had sold more than 475,000 commercial tests, including more than 185,000 tests in 2025, and established commercial partnerships with leading healthcare systems, employers, digital health platforms, payors, and life insurance providers.

GRAIL's primary product is Galleri, a multi-cancer early detection screening test that can screen for many types of cancer and accurately predict the specific organ or tissue type where the cancer signal originated with high positive predictive values and low false positive rates. In the PATHFINDER 2 Initial Results, Galleri demonstrated a PPV of 61.6% ¹, a CSO accuracy of 92% ², and a false positive rate of 0.4% ³. The company also has a precision oncology portfolio consisting of a research-use-only targeted methylation-based platform with customizable classifiers for applications including minimal residual disease detection and recurrence monitoring. For the year ended December 31, 2025, screening revenue was $138.601 million ⁴ and development services revenue was $8.571 million ⁵.

In October 2025, GRAIL entered into a stock purchase agreement with Samsung C&T Corporation and Samsung Electronics Singapore Pte. Ltd. for the issuance and sale of 1,570,308 ⁶ shares of common stock at a purchase price of $70.05 ⁷ per share, for aggregate gross proceeds of approximately $110.0 million ⁸, subject to closing conditions including regulatory approvals. On October 18, 2025, the company entered into a securities purchase agreement for a private placement of 2,640,970 ⁹ shares of common stock and pre-funded warrants to purchase 1,998,573 ¹⁰ shares, closing on October 21, 2025, with aggregate net proceeds of $311.3 million ¹¹ after issuance costs of $13.7 million ¹². On November 14, 2025, the company established an At the Market Equity Distribution Program to offer and sell shares of common stock having an aggregate offering price of $300.0 million ¹³ or up to 6,900,000 ¹⁴ shares, and during 2025 issued 1,169,218 ¹⁵ shares for net proceeds of $107.5 million ¹⁶ after issuance costs of $3.2 million ¹⁷. The company also implemented a restructuring plan on August 9, 2024, which included a reduction in headcount of approximately 30% ¹⁸, inclusive of 350 ¹⁹ then full-time employees, or approximately 25% ²⁰ of the workforce, and incurred $18.3 million ²¹ of total charges through the fourth quarter of 2024.

For the year ended December 31, 2025, total revenue was $147.172 million ²², compared to $125.595 million ²³ in 2024 and $93.105 million ²⁴ in 2023. Net loss was $408.351 million ²⁵ for 2025, compared to $2.027 billion ²⁶ for 2024 and $1.466 billion ²⁷ for 2023. The net loss for 2024 included goodwill and intangible asset impairment charges of $1.421 billion ²⁸, while 2025 included $28.0 million ²⁹ of such impairments. Adjusted EBITDA, a non-GAAP measure, was $(320.6) million ³⁰ for 2025, compared to $(483.5) million ³¹ for 2024 and $(523.9) million ³² for 2023.

GRAIL is pursuing FDA approval for Galleri to help support broad access in the United States, having submitted a pre-market approval application in January 2026. The company believes that FDA approval could unlock broad coverage by large commercial payors in the United States. In February 2026, a new law created a Medicare coverage benefit category for MCED tests, with authority for CMS to initiate coverage as early as January 1, 2029 ³³ for the aged 50-65 ³⁴ Medicare population, expanding by one age-year annually. In the United Kingdom, the NHS will evaluate the final results from the NHS-Galleri Trial before determining whether to implement the Galleri test in the NHS, with the company planning to share final results from the full three-year trial in mid-2026. The company has begun entering select international markets through distributor partners, including Israel and Canada, and intends to enter South Korea through its partnership with Samsung, with a possible extension into other Asian geographies including Japan and Singapore.

GRAIL is pursuing inclusion of Galleri in the USPSTF's guideline recommendation, although such inclusion is not certain even with FDA approval and may take several years. The company also plans to leverage its proprietary methylation platform for additional applications, including its precision oncology portfolio, and has partnered with a number of leading oncology therapeutics companies to test applications of biomarkers with the goal of optimizing the use of therapeutic interventions.

The company expects research and development expenses to decrease over the next three years as it decreases investment in product programs beyond Galleri and as most of its large clinical trials progress into the data follow-up phase. GRAIL expects sales and marketing expenses to increase following the release of positive study results as it invests in initiatives to drive awareness and demand generation, but to continue to decrease as a percentage of revenue over the next three years and long term. General and administrative expenses are expected to increase as the company continues to invest in corporate infrastructure to support public company operations, but to continue to decrease as a percentage of revenue over the next three years and long term.

GRAIL has made significant investments to build a scalable infrastructure capable of meeting significant demand of up to one million tests per year at its Durham, North Carolina facility, which is CAP-accredited and CLIA-certified. In late 2024, the company began use of a new version of Galleri in commercial channels which incorporates significant automation and is intended to enable it to scale more efficiently with future demand. The company's lab operates 16 hours a day, seven days a week, and uses automation and other technology to reduce staff exposure to complicated work.

For the year ended December 31, 2025, research and development expenses were $195.794 million ³⁵, compared to $322.380 million ³⁶ in 2024. Capital expenditures for property and equipment were $0.909 million ³⁷ in 2025, compared to $5.208 million ³⁸ in 2024. The company does not pay dividends and does not anticipate paying any cash dividends in the foreseeable future. As of December 31, 2025, $189.3 million ³⁹ worth of shares of common stock remained available for sale pursuant to the ATM program.

The NHS-Galleri Trial did not meet its primary endpoint of statistically significant combined stage 3 and 4 reduction, which may negatively impact perceptions of the clinical utility of the Galleri test among healthcare providers, payors, regulators, potential commercial partners, and the investment community. The company faces risks related to its reliance on Illumina as a sole supplier for next-generation sequencers and associated reagents, Madison Industries as a sole supplier of blood collection tubes, and Twist Bioscience Corporation as a sole supplier of DNA panels. The company also faces risks from its limited operating history, having commenced operations in January 2016, and has incurred significant net losses in each period since inception, with an accumulated deficit of $10.2 billion ⁴⁰ as of December 31, 2025.

The company faces risks related to the regulatory environment for laboratory developed tests, as the FDA's final rule that would have subjected LDTs to medical device requirements was vacated by a federal court in March 2025 and rescinded by the FDA in September 2025, creating uncertainty about the FDA's authority to regulate LDTs. GRAIL also faces risks related to the potential for its products to fail to achieve market acceptance, the lengthy and expensive clinical study process with uncertain outcomes, and the need to obtain adequate coverage and reimbursement from third-party payors, including Medicare, which does not currently cover Galleri.

The company faces material risks including its reliance on Illumina as a sole supplier for next-generation sequencers and reagents, with the Illumina Supply Agreement scheduled to expire on February 28, 2027 ⁴¹, and its obligation to pay Illumina a 9% ⁴² royalty in perpetuity on net sales, subject to a floor of 7% ⁴³, which is suspended until December 24, 2026 ⁴⁴ or any earlier change of control. The NHS-Galleri Trial did not meet its primary endpoint of statistically significant combined stage 3 and 4 reduction, which could adversely affect the company's ability to obtain regulatory approvals, coverage and reimbursement, or achieve commercial adoption. The company has incurred significant net losses since inception, with an accumulated deficit of $10.2 billion ⁴⁵ as of December 31, 2025, and expects to continue incurring net losses for the coming years. The company relies on a limited number of suppliers, including Madison Industries as a sole supplier of blood collection tubes and Twist Bioscience Corporation as a sole supplier of DNA panels. The company's ability to obtain FDA approval for Galleri is uncertain, as the FDA has never cleared or approved a multi-cancer detection test, and obtaining PMA approval can take several years from the time an application is submitted.

Management's message emphasizes the company's mission to detect cancer early when it can be cured and its position as an innovative commercial-stage healthcare company focused on shifting the paradigm in early cancer detection at population scale. Key strategic priorities include establishing Galleri as the population multi-cancer screening standard and extending commercial leadership in large global markets, expanding access to products by pursuing FDA approval and reimbursement and coverage from payors, defining, leading, and expanding adoption of MCED, leveraging existing infrastructure to enable and scale the growing business, driving cutting edge science and technology to continuously improve existing products and develop new products, and sustaining a patient-first corporate culture that attracts top talent. The company submitted a PMA to the FDA in January 2026 and announced topline results from the NHS-Galleri Trial in February 2026, which demonstrated a substantial reduction in stage 4 cancer diagnoses including greater than 20% ⁴⁶ reduction in the second and third screening rounds, increased stage 1 and 2 detection of deadly cancers, and four-fold higher cancer detection rate when compared to recommended screenings alone, although the primary endpoint of statistically significant combined stage 3 and 4 reduction was not observed.