GRAIL (GRAL) FY2025 10-K Risk Factors: 10 New, 10 Dropped

What the changes say

The failed NHS-Galleri trial endpoints dominate new disclosures, threatening commercial adoption, reimbursement, and stock price stability.

What changed since the prior 10-K

New

NewRisks Relating to Our Business and Industry
Our NHS-Galleri Trial did not meet its stated primary endpoint, which may adversely affect our business, stock price, and ability to obtain regulatory approvals, coverage and reimbursement, or achieve commercial adoption
The February 2026 failure of the 140,000-participant NHS-Galleri trial to meet its primary endpoint threatens regulatory approvals, reimbursement, and commercial adoption.
NewRisks Relating to Our Business and Industry
Our products or future products may not perform as expected, and the results of our clinical studies may not be replicated in the post-market or real-world setting
Real-world performance of Galleri or precision oncology products may fail to match previous study results, as seen in the failed NHS-Galleri trial.
NewRisks Relating to Our Business and Industry
statistical power for our endpoints, our product development, commercialization activities, and our ability to seek regulatory clearance or approval for our products could be delayed, require modification, or be prevented
The FDA may require additional studies or larger patient enrollments for PMA approval, delaying commercialization and increasing development costs.
NewRisks Relating to Our Business and Industry
which could materially affect our business, financial condition, results of operations, and growth prospects and cause the price of our common stock to decline
Tax Matters Agreement restrictions with Illumina and contingent Samsung investment terms may limit our ability to raise necessary financing.
NewRisks Relating to Our Business and Industry
financial, regulatory, or intellectual property position. Even if we establish new collaborations, they may not result in the successful development or commercialization of our products or technology
We had 910 employees as of December 31, 2025, and scaling our sales organization to increase Galleri adoption may prove difficult.
NewRisks Relating to Our Business and Industry
cycles. Failure to execute remediations effectively or within established timelines could result in persistent control deficiencies, increasing our exposure to regulatory sanctions, cybersecurity incidents, or data breaches, which would amplify the risks otherwise described
Cyberattacks could cause data breaches or loss of clinical study data, delaying regulatory approvals and increasing costs.
NewRisks Relating to Regulation and Legal Compliance
Our business may be affected by the evolving regulatory framework for AI Technologies
Evolving federal, state, and foreign regulations regarding artificial intelligence and automated decision-making may restrict our use of AI technologies.
NewRisks Relating to Regulation and Legal Compliance
operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so
Violating state laboratory licensing laws and medical device manufacturing registrations could result in fines, suspensions, or imprisonment.
NewRisks Relating to Regulation and Legal Compliance
The EU IVDR requirements are in active implementation and may change as the European Commission adopts additional implementing acts and considers targeted revisions to related IVD rules
EU IVDR transition rules have lengthened notified body review times, and failure to report adverse medical events to the FDA could bring sanctions.
NewRisks Relating to Regulation and Legal Compliance
Changes in funding, leadership, resources or prioritization, or other disruptions, in the U.S. or international government, including at the FDA, other government agencies, and notified bodies, could hinder our ability to develop, approve, certify, commercialize or receive reimbursement for our test
U.S. and international government budget levels, shutdowns, or staffing issues at the FDA and notified bodies could delay product approvals and reimbursements.

Dropped

DroppedRisks Relating to Our Business and Industry
of our future expenditures and our ability to generate additional revenue. Moreover, our net losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good or reliable indication of our future performance
DroppedRisks Relating to Our Business and Industry
of our PMA submission for Galleri, which would negatively impact our business, financial condition, results of operations, and growth prospects
DroppedRisks Relating to Our Business and Industry
validating or generating revenue from our precision oncology offering, and we could experience reputational or other harms
Quarterly net loss fluctuations and ongoing operating expenses.
DroppedRisks Relating to Our Business and Industry
require us to supplement or revise the information contained in any PMA or other application, which could increase our costs and delay our efforts to obtain approval for Galleri, and could delay our implementation of the material into our workflow
Potential FDA requests for additional clinical studies delaying PMA submission.
DroppedRisks Relating to Our Business and Industry
diagnostic development and commercialization. Our reliance on certain of these third parties reduces our control over our product development activities
Risks of validating or generating revenue from the precision oncology offering.
DroppedRisks Relating to Regulation and Legal Compliance
Liechtenstein, and also generally applicable in Türkiye). Non-compliance with the above requirements would also prevent us from selling our products in these three countries
DroppedRisks Relating to Regulation and Legal Compliance
Bioresearch Monitoring (“BIMO”) program, of our studies or associated data, can require substantial amounts of time, personnel, and other resources to comply with, and may not be anticipated
DroppedRisks Relating to Regulation and Legal Compliance
intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EU for in vitro diagnostic medical devices and ensure a high level of safety and health while supporting innovation
DroppedRisks Relating to Regulation and Legal Compliance
otherwise prevent new or modified products from being developed, approved, certified, or commercialized in a timely manner or at all
DroppedRisks Relating to Our Common Stock
an active market may make it more difficult for shareholders to sell our shares and could lead to our share price being depressed or volatile

Reworded

100% rewrittenRisks Relating to Our Business and Industry
If our products do not receive adequate coverage and reimbursement, if at all, from third-party payors, our ability to expand access to our products and our overall commercial success beyond our existing sales channels will be limited
Added specific mentions of self-insured employers, Medicare, Medicaid, and private health insurers regarding coverage and reimbursement for Galleri.
Was: expand access to our products beyond our existing sales channels will be limited and our overall commercial success will be limited.”
91% rewrittenRisks Relating to Our Common Stock
Prior to June 24, 2024, no market for our common stock existed and an active trading market may not be sustained after the Spin-Off. Our stock price has fluctuated and may fluctuate significantly
Added explicit warning that common stock price has been highly volatile since the spin-off.
90% rewrittenRisks Relating to Our Business and Industry
A substantial majority of our revenue is generated from sales of Galleri and we are highly dependent on it for our success
Updated cross-references and formatting without altering core revenue dependence on Galleri.
87% rewrittenRisks Relating to Regulation and Legal Compliance
Data from our clinical trials that we announce or publish from time to time before our trials are complete may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
Minor phrasing adjustments regarding preliminary clinical data and audit procedures.
84% rewrittenRisks Relating to Our Business and Industry
If we cannot maintain our current collaborations or partnerships and enter into new collaborations or partnerships in a timely manner and on acceptable terms, our efforts to develop and commercialize our products could be delayed or adversely affected
Added explicit statement that reliance on third parties reduces control over product development activities.
76% rewrittenRisks Relating to Our Common Stock
We could be subject to additional securities class action litigation
Added specific disclosure regarding the February 2026 NHS-Galleri trial failure and subsequent stock price decline triggering class action risk.
75% rewrittenRisks Relating to Our Business and Industry
We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses for the coming years
Updated financial figures, showing a net loss of $408.4 million and accumulated deficit of $10.2 billion as of December 31, 2025.
67% rewrittenRisks Relating to Our Business and Industry
We may be unable to develop and commercialize new products, including enhanced versions of current products
Added warning about potential failure in transitioning products to new versions or achieving required characteristics.
67% rewrittenRisks Relating to Our Business and Industry
Our information technology systems, or those used by our third-party collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents or cyberattacks
58% rewrittenRisks Relating to Regulation and Legal Compliance
Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations
56% rewrittenRisks Relating to Regulation and Legal Compliance
Healthcare reform and data protection measures, including legislation reforming the U.S. healthcare system, could cause significant harm to our business, operations and financial condition
51% rewrittenRisks Relating to Our Business and Industry
If similar third-party products are developed and do not perform as intended or cause harm or injury to patients, the market for our products could be impaired
50% rewrittenRisks Relating to Our Business and Industry
If our products result in direct or indirect participant or patient harm or injury, we could be subject to significant reputational and liability risks
48% rewrittenRisks Relating to Our Business and Industry
If we fail to obtain additional financing, we may be unable to expand our commercialization efforts or to develop and commercialize additional products
Was: If we fail to obtain additional financing, we may be unable to expand our commercialization efforts with respect to Galleri and any other products that we successfully develop and commercialize, or to develop additional products
47% rewrittenRisks Relating to Our Business and Industry
Our business is subject to economic, political, regulatory, and other risks associated with international operations
43% rewrittenRisks Relating to Regulation and Legal Compliance
To obtain and maintain FDA approvals or clearances, our products will need to be manufactured in accordance with federal and state regulations, and we could be forced to recall our devices or terminate production if we or our partners fail to comply with these regulations
32% rewrittenRisks Relating to Regulation and Legal Compliance
The biopharmaceutical and medical device industries are subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities
29% rewrittenRisks Relating to Our Common Stock
Substantial sales of our common stock by Illumina or other significant shareholders could cause our stock price to decline
28% rewrittenRisks Relating to Our Business and Industry
Our business and results of operations will suffer if we fail to perform effectively
20% rewrittenRisks Relating to Our Business and Industry
In addition, as our strategy evolves, we may opt to discontinue, deprioritize, or dispose of assets, technologies, or acquired businesses

All 67 risk factors

Headings as the filing states them, in filing order.

Risks Relating to Our Business and Industry

01We operate in a rapidly evolving field and have a limited operating history, which make it difficult to evaluate our current business and predict our future performance
02We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses for the coming years75% rewritten
03Our NHS-Galleri Trial did not meet its stated primary endpoint, which may adversely affect our business, stock price, and ability to obtain regulatory approvals, coverage and reimbursement, or achieve commercial adoptionNew
04Our products or future products may not perform as expected, and the results of our clinical studies may not be replicated in the post-market or real-world settingNew
05statistical power for our endpoints, our product development, commercialization activities, and our ability to seek regulatory clearance or approval for our products could be delayed, require modification, or be preventedNew
06A substantial majority of our revenue is generated from sales of Galleri and we are highly dependent on it for our success90% rewritten
07If our products do not receive adequate coverage and reimbursement, if at all, from third-party payors, our ability to expand access to our products and our overall commercial success beyond our existing sales channels will be limited100% rewritten
08Our commercial products may fail to achieve the degree of market acceptance necessary for commercial success
09Failure to achieve broad market acceptance of our products would materially harm our business, financial condition, and results of operations
10We may be unable to develop and commercialize new products, including enhanced versions of current products67% rewritten
11If similar third-party products are developed and do not perform as intended or cause harm or injury to patients, the market for our products could be impaired51% rewritten
12If we fail to obtain additional financing, we may be unable to expand our commercialization efforts or to develop and commercialize additional products48% rewritten
13which could materially affect our business, financial condition, results of operations, and growth prospects and cause the price of our common stock to declineNew
14If our products result in direct or indirect participant or patient harm or injury, we could be subject to significant reputational and liability risks50% rewritten
15If our facilities become inoperable, our ability to provide our products will be significantly impaired and our business will be harmed
16We depend on third parties for information technology, telecommunication systems, the collection, processing, transport, and storage of samples, and other patient-facing services. Any disruption in these services or operations could materially adversely harm our business and operations
17If we are unable to scale our operations successfully to support demand for our products, our business could suffer
18Our business and results of operations will suffer if we fail to perform effectively28% rewritten
19If we cannot maintain our current collaborations or partnerships and enter into new collaborations or partnerships in a timely manner and on acceptable terms, our efforts to develop and commercialize our products could be delayed or adversely affected84% rewritten
20financial, regulatory, or intellectual property position. Even if we establish new collaborations, they may not result in the successful development or commercialization of our products or technologyNew
21If we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
22Our business is subject to economic, political, regulatory, and other risks associated with international operations47% rewritten
23Our information technology systems, or those used by our third-party collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents or cyberattacks67% rewritten
24cycles. Failure to execute remediations effectively or within established timelines could result in persistent control deficiencies, increasing our exposure to regulatory sanctions, cybersecurity incidents, or data breaches, which would amplify the risks otherwise describedNew
25If we are sued for product or professional liability, we could face substantial liabilities that exceed our resources and insurance coverage
26Our quarterly results of operations may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
27Acquisitions or other strategic transactions may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
28In addition, as our strategy evolves, we may opt to discontinue, deprioritize, or dispose of assets, technologies, or acquired businesses20% rewritten

Risks Relating to Regulation and Legal Compliance

29Our business may be affected by the evolving regulatory framework for AI TechnologiesNew
30If we or our partners fail to comply with federal, state, and foreign laboratory and other applicable licensing and registration requirements, we could be prevented from performing our tests or experience disruptions to our business
31operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing soNew
32Data from our clinical trials that we announce or publish from time to time before our trials are complete may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data87% rewritten
33Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations58% rewritten
34The EU IVDR requirements are in active implementation and may change as the European Commission adopts additional implementing acts and considers targeted revisions to related IVD rulesNew
35To obtain and maintain FDA approvals or clearances, our products will need to be manufactured in accordance with federal and state regulations, and we could be forced to recall our devices or terminate production if we or our partners fail to comply with these regulations43% rewritten
36Any of these actions could significantly and negatively affect the supply of our products. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs
37Healthcare reform and data protection measures, including legislation reforming the U.S. healthcare system, could cause significant harm to our business, operations and financial condition56% rewritten
38Obtaining and maintaining regulatory authorization of our products in one jurisdiction does not mean that we will be successful in obtaining regulatory authorization of our products in other jurisdictions
39Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
40If we fail to comply with healthcare and other applicable laws and regulations, we could face substantial penalties and our business, reputation, and operations and financial condition could be adversely affected
41If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
42Changes in funding, leadership, resources or prioritization, or other disruptions, in the U.S. or international government, including at the FDA, other government agencies, and notified bodies, could hinder our ability to develop, approve, certify, commercialize or receive reimbursement for our testNew
43Our business activities are subject to the FCPA and similar anti-bribery and anti-corruption laws
44The biopharmaceutical and medical device industries are subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities32% rewritten

Risks Relating to Intellectual Property

45If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
46Our use of open-source software could subject our proprietary technology to unwanted open-source license conditions that could negatively impact our business
47Developments in patent law could have a negative impact on our business
48Patent terms may be inadequate to protect our position on our products for an adequate amount of time
49Issued patents covering our products and other technologies could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States and abroad
50We may not be able to protect our intellectual property rights throughout the world
51We may be subject to claims by third parties asserting that our employees or we have infringed or misappropriated intellectual property rights, or to assertions by third parties or employees claiming ownership of what we regard as our own intellectual property
52If we are unable to protect the confidentiality of our trade secrets, our business and market position would be harmed
53Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline
54We may become involved in lawsuits to protect or enforce or defend our patents, which could be expensive, time-consuming, and unsuccessful
55If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Relating to the Spin-Off

56We could have an indemnification obligation to Illumina if the Distribution were determined not to qualify for non-recognition treatment for U.S. federal tax purposes
57We have agreed to numerous restrictions to preserve the non-recognition treatment of the Spin-Off, which may reduce our strategic and operating flexibility
58Our historical financial data is not necessarily representative of the results that we would have achieved if we had been a separate, publicly traded company and may not be a reliable indicator of our future results

Risks Relating to Our Common Stock

59Prior to June 24, 2024, no market for our common stock existed and an active trading market may not be sustained after the Spin-Off. Our stock price has fluctuated and may fluctuate significantly91% rewritten
60If securities analysts publish negative evaluations of our stock, the price of our stock could decline
61Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or our products
62We are an emerging growth company and the information we provide shareholders may be different from information provided by other public companies, which may result in a less active trading market for our common stock and higher volatility in our stock price
63Substantial sales of our common stock by Illumina or other significant shareholders could cause our stock price to decline29% rewritten
64We do not expect to pay any dividends for the foreseeable future
65We will incur increased costs as a result of operating as a public company. Our management will be required to devote substantial time to new compliance initiatives and corporate governance practices
66Certain provisions in our Certificate of Incorporation and Bylaws and Delaware law may discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock
67We could be subject to additional securities class action litigation76% rewritten

Other GRAIL 10-Ks

FY2024 10-K risk factors
67 risks
Grail faces massive net losses, reaching $2.0 billion in fiscal 2024, driven by research and commercialization of its Galleri cancer test.
Filed Mar 05, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.