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Item 1A. Risk Factors

2026-03-12 compared with 2025-03-05 · 407 added, 331 removed, 1271 unchanged (37% of the section changed)

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Risks Relating to Our Business and Industry

We operate in a rapidly evolving field and have a limited operating history, which makes it difficult to evaluate our current business and predict our future performance.

We 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.

We operate in a rapidly evolving field and, having commenced operations in January 2016, have a limited operating history.

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We have funded our operations to date primarily with the proceeds from the sale of equity securities and capital contributions from Illumina and, to a lesser extent, revenue derived from sales of Galleri and biopharmaceutical business revenue.

Our short operating history as a company, evolving business strategies, rapid growth and significant events such as our separation from Illumina and the Restructuring Plan may make it difficult to evaluate our current business or our future success and the risks and challenges we may encounter, and may increase the risk that we will not continue to grow at or near historical rates.

Our short operating history as a company, evolving business strategies, rapid growth and significant events such as our separation from Illumina and the restructuring plan (“Restructuring Plan”) approved by our Board of Directors (the “Board”) designed to reprioritize our resources to focus on our core MCED business and reduce overall spend as we pursue a PMA approval from the FDA for Galleri and broad reimbursement, may make it difficult to evaluate our current business or our future success and the risks and challenges we may encounter, and may increase the risk that we will not continue to grow at or near historical rates.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations” for more information about the Restructuring Plan.

If we fail to address the risks and difficulties that we face, including those described elsewhere in this “Risk Factors” section, our business, financial condition, results of operations, and growth prospects could be materially adversely affected.

If we fail to address the risks and difficulties that we face, including those described elsewhere in this Item 1A.

“Risk Factors” section, our business, financial condition, results of operations, and growth prospects could be materially adversely affected.

We have encountered in the past, and expect to encounter in the future, risks and difficulties frequently experienced by companies with limited operating histories in new and rapidly evolving fields.

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Since our inception, we have incurred significant net losses.

Our net loss was $2.0 billion for fiscal year 2024, $1.5 billion for fiscal year 2023, and $5.4 billion for fiscal year 2022.

Substantially all of our net losses since inception have resulted from our research and development programs, commercialization efforts, investments in our facilities, payments to licensors, and general and administrative costs associated with our operations, as well as intangible asset amortization and the impairments of $1.4 billion, $0.7 billion and $4.7 billion for fiscal year 2024, fiscal year 2023 and fiscal year 2022, respectively, related to the intangible assets and goodwill recorded by Illumina upon the Acquisition of GRAIL.

Our net loss was $408.4 million for 2025, $2.0 billion for 2024, and $1.5 billion for 2023.

Substantially all of our net losses since inception have resulted from our research and development programs, commercialization efforts, investments in our facilities, payments to licensors, and general and administrative costs associated with our operations, as well as intangible asset amortization and the impairments of $28.0 million, $1.4 billion and $0.7 billion for 2025, 2024 and 2023, respectively, related to the intangible assets and goodwill recorded by Illumina upon the Acquisition of GRAIL.

As of December 31, 2025, we had an accumulated deficit of $10.2 billion and intangible assets of $1.9 billion.

We have invested significant financial resources in research and development activities, including to develop our methylation platform, and to develop our products, such as Galleri and our precision oncology portfolio.

We have invested significant financial resources in research and development activities, including developing our methylation platform, and developing our products, such as Galleri and our precision oncology portfolio.

We have also invested significant resources to conduct large scale clinical studies to evaluate and improve Galleri and current and future products, and to commercialize Galleri and plan for potential commercial launches of our future and current products in other markets.

The amount of our future net losses will depend, in part, on the level

of our future expenditures and our ability to generate additional revenue.

The amount of our future net losses will depend, in part, on the level 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.

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• support international commercial expansion of our products;

• continue to engage the medical community and others to drive awareness and adoption of multi-cancer early detection (“MCED”) testing;

• continue to engage the medical community and others to drive awareness and adoption of MCED testing;

• meet the requirements and demands of being a public company.

Our products or future products may not perform as expected, and the results of our clinical studies may not support the launch or use of our products or future products and may not comply with the requirements, or be replicated in later studies or in the post-market or real-world setting, required to support a commercial opportunity or for any necessary or desirable regulatory clearances, approvals, or certifications, or reimbursement or coverage.

Our success depends on our ability to provide reliable, high-quality products that perform as indicated in our product labeling, marketing, and advertising material, as well as our ability to complete clinical studies and comply with applicable regulatory requirements that enable us to commercialize our products and future products.

Our commercial product, Galleri, which we have launched as a laboratory developed test (“LDT”) in the United States and for which we are pursuing a premarket approval application (“PMA”) with the U.S.

Food and Drug Administration (the “FDA”) and our precision oncology portfolio, which we currently offer on a research-use-only basis, and any future products in development, may not perform as expected.

Results from our ongoing or future studies, or from the post-market or real-world setting, involving current or future products or our methylation platform may be inconsistent with certain results obtained from our previous studies, or from interim results initially

reported on those studies.

In addition, results from our ongoing or future studies may not support certain product launch opportunities.

For example, the NHS evaluated results of an early analysis from the first screening test (the prevalent screening round) in the NHS-Galleri Trial to determine whether the results were compelling enough to commence an implementation pilot in England prior to the final trial results.

The results of this early analysis represented limited information from only one year of results out of the three-year trial period, and final results from the full three-year period may differ from the early analysis for a variety of reasons.

In May 2024, the NHS determined not to initiate the pilot on the basis of those available data and will evaluate the final results from the NHS-Galleri Trial, which are expected to be available in 2026, before determining whether to implement the Galleri test in the NHS.

We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.

It is possible that the final results will be unsuitable or unavailable, which could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our brand and reputation, our business, and our growth prospects.

Furthermore, other studies have been or may be conducted in populations (such as our SUMMIT study which was conducted in a population of tobacco users) or under other circumstances which make their results more complicated to interpret or result in data that is more difficult to compare.

In addition, as Galleri and our research-use-only offering are currently available to customers and others, any studies, including those conducted by third parties, that use our current or future products, or that examine elements of our methylation platform, may produce results that are inconsistent to evaluate independently or comparatively from our own studies.

If any such inconsistent results were to be produced, either before or after launch of a product or future product, our reputation, business, financial condition, results of operations, and growth prospects would suffer.

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.

In February 2026, we announced topline results from our NHS-Galleri Trial, which enrolled approximately 140,000 participants in England between 2021 and 2024, and which did not meet its primary endpoint of statistically significant combined Stage 3 and 4 reduction.

Not meeting the stated primary endpoint may negatively impact perceptions of the clinical utility of the Galleri test among healthcare providers, payors, regulators, potential commercial partners, and the investment community.

This could adversely affect our ability to obtain coverage and reimbursement from Medicare, Medicaid, and commercial third-party payors, secure implementation of Galleri screening in the NHS in England or other international single-payor healthcare systems, achieve broad commercial adoption of Galleri among healthcare providers and patients in the United States, or enter into partnerships or collaborations on favorable terms.

Additionally, although the submission package submitted for our PMA includes only the NHS-Galleri Prevalent Round Results, data from the PATHFINDER 2 Initial Results and the Bridging Analysis, nevertheless it is possible that not meeting the stated primary endpoint in the NHS-Galleri Trial could impact our ability to achieve FDA approval of our pending PMA application, or result in approval with more limited indications or labeling than we seek.

We are undertaking additional analyses and plan to extend the trial's follow-up period by 6-12 months to further understand the data and other endpoints.

However, there can be no assurance that such analyses will produce more favorable conclusions or that any additional data will change perceptions of the trial results among the groups identified above.

Any adverse impact from the primary endpoint results could materially harm our business, results of operations, financial condition, and stock price.

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.

Our commercial product, Galleri, which we have launched as a laboratory developed test (“LDT”) in the United States and for which we are pursuing approval of a PMA from the FDA and our precision oncology portfolio, which we currently offer on a research-use-only basis, and any future products in development, may not perform as expected.

For example, in February 2026, we announced topline results from the NHS-Galleri Trial, which did not achieve its primary endpoint of statistically significant combined Stage 3 and 4 cancer reduction.

Not meeting the stated primary endpoint may lead healthcare providers, payors, regulators, and the investment community to question the clinical utility of Galleri.

Any perception that our products do not perform as expected, even if clinically meaningful benefits were demonstrated, could materially harm our ability to obtain regulatory approvals, secure reimbursement, achieve commercial adoption, and maintain the market price of our common stock.

Our products require a number of complex and sophisticated biochemical and bioinformatics processes, which could be adversely impacted by a number of different factors.

An operational or technological failure in one of these complex processes or fluctuations in external variables may result in performance characteristics, such as sensitivity or specificity rates, that are lower than we anticipate or that vary between test runs or in a higher than anticipated number of tests that fail to produce results.

In addition, we continue to evaluate and refine our algorithms and other processes under development.

These refinements may inadvertently result in unanticipated issues that may reduce our performance characteristics, such as sensitivity or specificity rates, or otherwise adversely affect the performance of our tests and their results.

Galleri was launched in the United States as an LDT in mid-2021 and an updated version was launched in December 2024.

The FDA has granted breakthrough device designation for Galleri.

We plan to complete a PMA submission for a further updated version of our Galleri test.

We may also be required or decide voluntarily to seek clearance or approval from the FDA for future products.

However, the FDA recently finalized a regulation pursuant to which it plans to subject LDTs to medical device requirements through a phase-out of its historical policy of enforcement discretion over LDTs over a period of four years.

The phase-in of medical device requirements to LDTs, including the potential requirement for FDA marketing authorization, if it imposes new, different or earlier significant obligations, will be costly and time-consuming, and if we fail to comply with such requirements, or if we cannot ultimately obtain marketing authorization for our LDTs where required, our business will be substantially harmed.

Moreover, FDA, other regulators, and notified bodies may require that we generate additional clinical data to support such clearance, approval, or certification, which could result in delays, increased costs, or other limitations or negative impacts on our ability to receive such clearance, approval, or certification, if at all, including narrowed indication or labeling than expected or desired.

For additional information, see “—Risks Relating to Regulation and Legal Compliance—The regulatory clearance, approval, or certification processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and unpredictable.

If we are ultimately unable to obtain any necessary or desirable regulatory approvals, clearances, or certifications, or if such approvals, clearances, or certifications are significantly delayed, our business will be substantially harmed.”

Further, we plan to improve our products to enhance performance, offerings, scalability, and/or cost of goods.

Our clinical trials to date have been conducted on an earlier version of Galleri.

We have in the past improved, and intend in the future to improve, our products to enhance performance, offerings, scalability, and/or cost of sales, including through the launches of new versions.

However, we may not be successful in transitioning our products to a new or enhanced version or iteration.

Product development involves a lengthy and complex process and we may be unable to commercialize, validate, or improve performance of any of our products on a timely basis, or at all.

For example, to the extent an enhanced version of an existing product is developed, we may be required to conduct a non-inferiority study involving such enhanced version as compared to the relevant then-current version of the test using data (for example, clinical data and/or real world evidence data obtained through Galleri’s commercial use as an LDT), or could be required to undertake other regulatory requirements if the enhanced version is not considered similar enough to the then-

current version to conduct a non-inferiority study.

With respect to Galleri, we intend to conduct one or more bridging studies to measure and evaluate concordance, performance and safety of the subsequent, updated version of Galleri (for which we are submitting our PMA) using previously collected clinical study data and other samples.

Any such bridging study will need to be agreed upon with regulatory authorities and may be unsuccessful or insufficient to support approval.

If unsuccessful or insufficient, we would be required to revert to the existing version of the test and forego, or be delayed in, implementing any perceived or potential updates, including enhancements.

Reverting to the existing version of the test may cause delays in our PMA submission timeline.

Additionally, planned improvements to our products may cause unintentional technical, logistical or other issues.

For example, in late 2024, we began use of a new version of Galleri in commercial channels which incorporates significant automation and is intended to enable us to scale more efficiently with future demand.

In connection with implementation of this new version of Galleri, we have experienced increased turnaround times and order cancellations.

If we are unable to adequately prevent these issues from occurring, or to adequately identify and remedy these issues, we may experience reputational harm, lose customers, need to offer discounts, or suffer other negative consequences.

These improvements may be made through evaluation, refinement or enhancement of our laboratory process or our algorithms and other processes.

Before implementing a new version, we conduct a non-inferiority or bridging study (for example, using clinical data and/or real-world evidence data obtained through Galleri’s commercial use as an LDT) to establish performance, safety and concordance between the new version and the existing version.

Even if determined to be non-inferior or concordant, these refinements and improvements may inadvertently result in unanticipated issues that may reduce our performance characteristics, such as sensitivity or specificity rates, increase our turnaround time or failure rate or otherwise adversely affect the performance of our tests and their results.

For example, in late 2024, we began use of an updated commercial version of Galleri in commercial channels.

This version incorporates an industrial scale platform with significant automation and is intended to enable us to scale more efficiently with future demand.

In connection with implementation of this new version of Galleri, we initially experienced and may continue to experience increased turnaround times, re-processing costs and sample failures.

We continually monitor and evaluate laboratory operations and performance in an effort to achieve our intended sample processing metrics and costs;

however from time to time, processing issues may arise that could impact our operations.

If we are unable to adequately prevent these issues from occurring, or to adequately identify and remedy these issues, we may experience reputational harm, lose customers and revenue, need to offer discounts, require additional expenditures, delay or prevent PMA approval, or suffer other negative consequences.

Our failure to successfully develop new and/or improved products (including new versions of existing products) on a timely basis could have a material adverse effect on our results of operations and business.

The clinical study process is lengthy and expensive with uncertain outcomes.

We have encountered delays and may encounter future delays in, or unexpected data from, our clinical studies, and may therefore be unable to complete our clinical studies on the timelines we expect, if at all, which could materially and adversely impact our ability to launch our products and seek regulatory clearance or approval, or coverage and reimbursement.

We have encountered delays and may encounter future delays in, or unexpected, uncertain or negative data from, our clinical studies, and may therefore be unable to complete our clinical studies on the timelines we expect, if at all, which could materially and adversely impact our ability to launch our products and seek regulatory clearance or approval, or coverage and reimbursement.

Clinical testing is expensive, time-consuming, and subject to uncertainty.

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Products in later future clinical studies may fail to show the desired safety and efficacy despite having success in previous clinical studies.

For example, in May 2025 we disclosed positive top-line results from the NHS-Galleri Trial prevalent screening round (the first round of blood draws from a total of three blood draws with one year follow up each), which is included in our PMA submission to the FDA.

The NHS will evaluate the final results from the NHS-Galleri Trial before determining whether to implement the Galleri test in the NHS.

Under our agreement with the NHS, these results have met certain success criteria and missed others.

As a result, we and NHS England will convene meetings of our joint steering committee to discuss how best to proceed with deployment to the UK population, if at all, considering deployment approaches and which population groups would most benefit.

We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.

Various factors are likely to cause the final results to differ from a review of the first round results only.

For example, cancer screening trials designed to show clinical utility are commonly conducted over three years with an annual screening period, because data from the first screening round only can be influenced by the fact that screening detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed.

In addition, as Galleri and our research-use-only offering are currently available to customers and others, any analyses or studies, including those conducted by third parties, that use our current or future products, or that examine elements of our methylation platform, may produce results that are inconsistent to evaluate independently or comparatively from our own studies.

In addition, we cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all, or within the anticipated budget.

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Additionally, we may encounter delays as a result of the administrative complexities in managing and recruiting for studies of this scope and size.

If we are unable to recruit sufficient participants for our clinical studies, including our Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (“REACH” or “Galleri-Medicare”) study, or if we are unable to maintain sufficient participation of enrolled participants to maintain 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.

For example, our PMA submission for Galleri requires clinical data, including certain data from our ongoing PATHFINDER 2 study, which we are conducting under an FDA-approved Investigational Device Exemption (“IDE”) application and our NHS-Galleri Trial.

We may encounter difficulties enrolling or maintaining a sufficient number of participants in our current or future studies.

Delays in our studies would cause us to delay completion

of our PMA submission for Galleri, which would negatively impact our business, financial condition, results of operations, and growth prospects.

Further, the FDA may require that we conduct additional studies or expand the enrollment of completed or ongoing studies to support our PMA, which would add significant time delay to our PMA submission, which would negatively impact our business, financial condition, results of operations, and growth prospects,

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.

Further, the FDA may require that we conduct additional studies or expand the enrollment or follow-up of completed or ongoing studies to support our PMA, which would delay potential approval of our PMA submission, which would negatively impact our business, financial condition, results of operations, and growth prospects.

The initiation and completion of clinical studies may be prevented, delayed, or halted for numerous reasons, including as a result of the following:

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• the inability to rely on previously-collected data on earlier versions of our products, such as Galleri, in support of the launch or submission for marketing authorization (or certification) of the later or enhanced versions of our products, including Galleri, or our other products and future products;

• the requirement to submit an IDE or comparable foreign application to the FDA or comparable foreign regulatory authorities, which must become effective prior to commencing certain human clinical studies of medical devices, and which the FDA or comparable foreign regulatory authorities may disapprove;

• the requirement to submit an Investigational Device Exemption (“IDE”) or comparable foreign application to the FDA or comparable foreign regulatory authorities, which must become effective prior to commencing certain human clinical studies of medical devices, and which the FDA or comparable foreign regulatory authorities may disapprove;

• delays caused by participants withdrawing from clinical studies or failing to return for follow-up or by institutions failing to submit data, including follow-up data, to us;

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• failure to perform in accordance with good clinical practice (“GCP”) and good laboratory practice (“GLP”) requirements, and/or other applicable regulations and requirements of the FDA or other applicable governmental authorities;

failure to comply with applicable data privacy and security laws, including laws related to processing of special categories of personal data clinical studies such as the European Union’s (“EU”) General Data Protection Regulation (“EU GDPR”) or United Kingdom’s General Data Protection Regulation and the Data Protection Act 2018 (“UK GDPR”) (the UK GDPR and EU GDPR together referred to as the “GDPR”);

failure to comply with applicable data privacy and security laws, including laws related to processing of special categories of personal data clinical studies such as the EU GDPR or UK GDPR;

• challenges caused by transferring personal information or biological samples from the EU, United Kingdom, or other countries to our systems or facilities in the United States for processing or to regulatory authorities;

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In addition, our precision oncology offering is highly dependent on collaborations with select, leading biopharmaceutical companies.

To the extent our collaborators experience any of delays, halts, unexpected data or other issues in the trials they collaborate on with us, we may be similarly delayed or halted in

validating or generating revenue from our precision oncology offering, and we could experience reputational or other harms.

For example, in late 2025, one of our pharmaceutical partners terminated its phase 3 trial due to low enrollment, for which our methylation technology was used as a potential companion diagnostic for enrolling participants.

To the extent our collaborators experience any of delays, halts, unexpected data or other issues in the trials they collaborate on with us, we may be similarly delayed or halted in validating or generating revenue from our precision oncology offering, and we could experience reputational or other harms.

Any inability to initiate or complete clinical studies successfully could result in additional costs to us, slow down or prevent our product development and receipt of positive reimbursement coverage decisions, or impair our ability to generate revenue.

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We cannot assure you that Galleri will continue to maintain or gain market acceptance, and any failure to do so would harm our business and results of operations.

One of the key elements of our strategy is to expand access to our tests by pursuing coverage and reimbursement from third-party payors, both private and government payors.

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 beyond our existing sales channels will be limited and our overall commercial success will be limited.

We have established private reimbursement for Galleri from a number of third-party payors in the United States, but do not currently have broader coverage and reimbursement by government healthcare programs, such as Medicare.

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.

We have established coverage and reimbursement for Galleri from a number of self-insured employers and other third-party payors in the United States, but do not currently have broader coverage and reimbursement by government healthcare programs, such as Medicare.

A key element of our strategy is to expand access to our tests by pursuing broad coverage and reimbursement by third-party payors, including government payors.

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payor and a particularly important payor for many cancer-related laboratory services given the demographics of the Medicare population.

Traditional fee-for-service Medicare

generally does not cover screening tests, which are considered preventive services, that are performed in the absence of signs or symptoms of illness or injury, unless there is a statutory provision that explicitly authorizes coverage of the test.

The Medicare Improvements for Patients and Providers Act of 2008 authorizes the CMS to cover additional preventive services that are not expressly covered by the statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, and (c) appropriate for Medicare beneficiaries under Part A or Part B.

CMS establishes coverage through a national coverage determination (“NCD”) process, which generally requires, or is significantly more likely following, FDA approval.

Traditional fee-for-service Medicare generally does not cover screening tests, which are considered preventive services, that are performed in the absence of signs or symptoms of illness or injury, unless there is a statutory provision that explicitly authorizes coverage of the test.

In February 2026, the Nancy Gardner Sewell Medicare MCED Coverage Act became law and created a Medicare coverage benefit category for multi-cancer early detection tests.

The law included certain standards, including that CMS would establish coverage through a national coverage determination (“NCD”) process under “reasonable and necessary” evidentiary requirements.

An NCD typically involves a multi-step review that can include evidence assessment by CMS staff, consultation with external technology assessment organizations, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting, and opportunities for public comment.

CMS may issue an NCD to provide coverage for MCED tests that are cleared under 510(k), classified under 513(f)(2) or approved by the FDA, with authority to initiate coverage as early as January 1, 2029.

Coverage eligibility is phased in, with those aged 50-65 eligible under the law in 2029, expanding by one age-year annually.

The payment rate for covered MCED tests would be in alignment with methodologies under the Protecting Access to Medicare Act (PAMA), which incorporates private market rates.

The NCD process can be lengthy and resource-intensive, and its timing, outcome, and scope are inherently uncertain, which may affect the availability, extent, and conditions of Medicare reimbursement for applicable products or services.

Because of the novelty of the statutory authority and of MCED technology, it is uncertain what evidence will be required in order to achieve an NCD, or if the evidence we have collected through our completed, ongoing or planned clinical studies and commercial practice will be sufficient to support such determination.

Additionally, the Medicare Improvements for Patients and Providers Act of 2008 authorizes the CMS to cover additional preventive services that are not expressly covered by the statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, and (c) appropriate for Medicare beneficiaries under Part A or Part B.

CMS establishes coverage through an NCD process, which generally requires, or is significantly more likely following, FDA approval of specific screening products.

In its discretion, the USPSTF generally waits for FDA authorization before it considers undertaking reviews of novel technology.

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Historically, USPSTF has only provided grade A or B recommendations on the basis of evidence packages that include mortality data, which would require significant long-term follow up.

Medicare coverage can also be changed by statute, and another possible pathway for Medicare reimbursement would be to amend the Medicare statute to cover MCED testing.

This process would generally require new legislation to expressly authorize CMS to cover FDA-approved early cancer screening and detection tests.

We are working with stakeholders to advance and shape the public reimbursement landscape, including through proposed legislation with bipartisan sponsorship, to reflect that additional scope of coverage.

However, even if we are successful in obtaining an NCD on the basis of the new reimbursement landscape envisioned by this legislation, we intend to seek a USPSTF grade for Galleri.

However, even if we are successful in obtaining an NCD on the basis of the new MCED benefit category, the coverage would only apply to a relatively small portion of the overall

Medicare population due to the age restriction and annual phase in requirement.

Accordingly, we would intend to seek a USPSTF grade for Galleri and, potentially, an NCD as additional preventative services.

If we receive an NCD for Galleri or our other products and subsequently receive a USPSTF grade lower than A or B, it is possible that CMS would rescind the NCD.

Further, the political climate is dynamic, and support for this legislation among legislators and stakeholders may change over time and such legislation may never be enacted, may be significantly delayed in being enacted, or may be enacted in a different form, including narrower or less favorable terms, any of which could have a material adverse effect on our business, financial condition, results of operations, and growth prospects.

For example, bipartisan supported legislation backed by stakeholders has been discussed for inclusion in multiple bills but has not yet been included in the final version of any bill put forward for a vote.

Any of these efforts, individually and together, require significant investments and resources, and may ultimately be unsuccessful or may take several years, if at all, to achieve.

If the USPSTF does not recommend any of our products with a grade of A or B, CMS declines to initiate an NCD, CMS decides to rescind a prior NCD, or the decision regarding an NCD is negative, the impacted product would not be eligible for fee-for-service Medicare coverage in the absence of a new statutory provision providing for coverage.

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In addition, effective January 1, 2018, a new Medicare payment methodology went into effect for clinical laboratory tests, under which laboratory-reported private payor rates are used to establish Medicare payment rates for tests reimbursed via the Medicare Clinical Laboratory Fee Schedule.

The new methodology implements Section 216 of the Protecting Access to Medicare Act of 2014

(“PAMA”) and requires laboratories that meet certain requirements related to volume and type of Medicare revenues to report to CMS their private payor payment rates for each test they perform, the volume of tests paid at each rate, and the HCPCS code associated with the test.

The new methodology implements Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) and requires laboratories that meet certain requirements related to volume and type of Medicare revenues to report to CMS their private payor payment rates for each test they perform, the volume of tests paid at each rate, and the HCPCS code associated with the test.

CMS uses the reported information to set the payment rate for each test at the weighted median private payor rate.

Most affected tests are revalued every three years.

A series of legislative amendments delayed the next PAMA reporting period to January 1, 2024 through March 31, 2024, which will cover the original data collection period of January 1, 2019 through June 30, 2019.

New CLFS rates for clinical diagnostic laboratory tests (“CDLTs”) will be established based on that data beginning in 2025, subject to phase-in limits.

As a result, Medicare payment rates determined by data reported in 2017 continued through December 31, 2024.

In addition, under PAMA, as amended, the payment reduction cap will be 15% per test per year in each of the years 2024 through 2026.

Most affected tests are reevaluated every three years.

A series of legislative amendments delayed the next PAMA reporting period to February 1, 2026 through April 30, 2026, which will cover the original data collection period of January 1, 2019 through June 30, 2019.

New CLFS rates for clinical diagnostic laboratory tests (“CDLTs”) will be established based on that data, effective January 1, 2027, subject to phase-in limits.

In addition, under PAMA, as amended, the payment reduction cap is 15% per test per year from January 31, 2026 through 2028.

PAMA also authorized the adoption of new, temporary billing codes and unique test identifiers for FDA-cleared or approved tests, as well as advanced diagnostic laboratory tests (“ADLTs”).

The AMA’s CPT Editorial Panel approved a proposal to create a new section of billing codes called Proprietary Laboratory Analyses (“PLA”) codes, to facilitate implementation of this section of PAMA.

The full impact of the PAMA rate-setting methodology and its applicability to our products remains uncertain at this time.

Congress is currently considering additional reforms to the PAMA reporting system.

The full impact of the PAMA rate-setting methodology and its applicability to our products, including interactions with potential establishment of a Medicare MCED benefit category under consideration in Congress, remains uncertain at this time.

Coverage and reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that a product is appropriate, medically necessary, and cost-effective.

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If third-party payors do not provide adequate coverage and reimbursement for our products, our ability to succeed commercially will be limited.

In determining whether to provide coverage and reimbursement for Galleri, payors may consider the results of our clinical studies, including the NHS-Galleri Trial.

The NHS-Galleri Trial did not meet its primary endpoint of statistically significant combined Stage 3 and 4 reduction.

Even though the trial demonstrated a substantial reduction in stage 4 cancer diagnoses, increased stage 1 and 2 detection of deadly cancers, and four-fold higher cancer detection rate when compared to recommended screenings alone, payors may view the overall trial outcome unfavorably, which could adversely impact coverage decisions or reimbursement rates for Galleri.

Any inability to secure favorable coverage and reimbursement decisions as a result of the NHS-Galleri Trial results, or otherwise, could materially harm our revenue and growth prospects.

Even if we establish relationships with payors to provide our products at negotiated rates, such agreements would not obligate any healthcare providers to order our products or guarantee that we would receive reimbursement for our products from these or any other payors at adequate levels.

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• with respect to Galleri, which was launched as an LDT in the United States for use in an asymptomatic population, the concern that the product could lead to unnecessary medical screening procedures or a high false positive rate and the associated costs of unnecessary workups resulting from false positives;

• the belief of providers, patients, and others that the use of Galleri in its intended use population is clinically appropriate, and not restricting its use to a narrower intended population;

• the belief of providers, patients, CMS and others that the use of Galleri in its intended use population is clinically appropriate, and not restricting its use to a narrower intended population;

• the introduction or market acceptance of future third-party products, including the expansion of the capabilities of existing products and tests that are reimbursed;

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• the strength of our marketing and distribution support and patient-facing service providers;

• the perception among healthcare providers, payors, regulators, and the investment community regarding the clinical significance of clinical trial results, including instances where a trial does not meet its primary endpoint, even if clinically meaningful secondary endpoints are achieved, as occurred in our NHS-Galleri Trial;

• the willingness of healthcare providers and payors to prescribe or cover Galleri in light of the NHS-Galleri Trial not meeting its primary endpoint of statistically significant combined Stage 3 and 4 reduction, notwithstanding favorable secondary endpoint data.

The failure of our products, once introduced, to be listed in physician guidelines or of our studies to produce favorable and consistent results or to be published in peer-reviewed journals could limit the adoption of our products.

In addition, healthcare providers and third-party payors, including the Centers for Medicare and Medicaid Services (“CMS”), may rely on physician guidelines issued by industry groups, medical societies, and other key organizations, such as the United States Preventive Services Task Force (“USPSTF”), an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, before utilizing or reimbursing the cost of any diagnostic or screening test.

Although we have completed our PATHFINDER study and have a number of a clinical studies underway designed to evaluate the clinical validity of Galleri, our product is not yet, and may never be, listed in any such guidelines, even if approved by the FDA.

Although we have completed our PATHFINDER study, PATHFINDER 2 study and NHS-Galleri Trial, and have additional clinical studies underway designed to evaluate the clinical validity of Galleri, our product is not yet, and may never be, listed in any such guidelines, even if approved by the FDA.

Further, if our products or the technology underlying them do not receive sufficient favorable exposure in peer-reviewed publications, the rate of physician and market acceptance of our products and positive reimbursement coverage decisions for our products could be negatively affected.

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Additionally, we believe that FDA approval for Galleri may provide clinical and regulatory credibility and validation in the view of providers, third-party payors, and others, and our failure to achieve FDA approval, at all or within our anticipated timelines or with an adequate approved label, could limit adoption of Galleri, even if we continue to publish data on its clinical validity and utility in peer-reviewed journals.

Our PMA submission and a potential subsequent rejection or material delay, including a requirement by the FDA to conduct additional studies or expand the enrollment of completed or ongoing studies, may reflect negatively on Galleri and the ongoing and

planned clinical studies used to support our PMA submission, which could lead healthcare providers, payors, and others to lose confidence in the utility or benefit of Galleri and our other products and future products.

Potential rejection or material delay of our PMA submission, including a requirement by the FDA to conduct additional studies or expand the enrollment of completed or ongoing studies, may reflect negatively on Galleri and the clinical studies used to support our PMA submission, which could lead healthcare providers, payors, and others to lose confidence in the utility or benefit of Galleri and our other products and future products.

Failure to achieve broad market acceptance of our products would materially harm our business, financial condition, and results of operations.

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The commercialization of any new products, including enhanced versions of current products, will require the completion of certain clinical development activities, regulatory activities, and the expenditure of additional cash resources.

We cannot assure you that we can successfully complete these activities for any such products.

However, we may not be successful in transitioning our products to a new or enhanced version or iteration, or achieving the required characteristics in a new product.

Product development involves a lengthy and complex process and we may be unable to commercialize, validate, or improve performance of any of our products on a timely basis, or at all.

For example, to the extent an enhanced version of an existing product is developed, we intend to undertake one or more bridging studies to measure and evaluate concordance, performance and safety of the subsequent, enhanced version of our product versus the existing product, using previously collected clinical study data and other samples.

Any such bridging study will need to be agreed upon with regulatory authorities and may be unsuccessful or insufficient to support approval of any such subsequent, enhanced version of our products.

Any such bridging study will need to be agreed upon with the FDA or other regulatory authorities, in particular where we are modifying an FDA approved product or seeking FDA approval of a new product, and may be unsuccessful or insufficient to support approval of any such subsequent, enhanced version of our products.

If unsuccessful or insufficient, we would be required to revert to a prior version of the test and forgo, or be delayed in, implementing any perceived or potential updates, including enhancements, or further enhance, modify or update to a new version of the test and run additional bridging studies.

Reverting to a prior version of the test or running additional bridging studies may cause delays in our efforts to obtain PMA approval for Galleri or any new product.

Additionally, planned improvements to our products may cause unintentional technical, logistical or other issues.

In late 2024, we began use of an updated commercial version of Galleri in commercial channels.

This version incorporates an industrial scale platform with significant automation and is intended to enable us to scale more efficiently with future demand.

In connection with implementation of this new version of Galleri, we initially experienced and may continue to experience increased turnaround times, re-processing costs and sample

We continually monitor and evaluate laboratory operations and performance in an effort to achieve our intended sample processing metrics and costs;

however from time to time, processing issues may arise that could impact our operations.

We are pursuing a PMA with the FDA for a further updated version of Galleri, and, in January 2026, we submitted a PMA to the FDA including the full prevalent screening round analysis from the NHS-Galleri Trial, together with performance and safety data focused on the first approximately 25,000 participants in the PATHFINDER 2 study.

While we have announced positive topline NHS-Galleri Prevalent Round Results and presented positive results from our PATHFINDER 2 study at ESMO in October 2025, each of these studies was conducted on an earlier version of Galleri.

Our PMA submission to the FDA also includes a bridging analysis comparing and measuring concordance of the version of Galleri used in the NHS-Galleri Trial and PATHFINDER 2 study with the updated version of the Galleri test submitted to the FDA for premarket approval.

The version that has been submitted to the FDA for approval may have different performance, safety, operational or other characteristics, and the FDA’s approval, if at all, will depend on the results of the bridging study, which could result in different labelling than our commercially available product.

We cannot ensure that we will generate sufficient revenue from products that we successfully commercialize or otherwise mitigate the risks associated with our business to raise enough capital to develop and commercialize new products.

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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.

Many companies are attempting to develop competing cancer detection tests and technologies focused on improving cancer care with early cancer detection tests and post-diagnostic products.

Many companies have recently launched or are attempting to develop competing cancer detection tests and technologies focused on improving cancer care with early cancer detection tests and post-diagnostic products.

If any of these tests do not perform to expectations or cause harm or injury to patients, it may result in lower clinical and consumer confidence in early cancer detection and precision medicine in general, which could potentially adversely affect confidence in our products.

In particular, to-date other MCED tests on the market have been launched based on case-controlled data only, and have not been tested in an intended use population or in an interventional trial.

Case controlled studies do not always translate into an intended use population, for example because case controlled studies often have a higher number of cancer cases, a different mix of types of cancer and stronger cancer signal in the cancer samples as compared to a prospective study in an intended use population.

As a result, the failure of any competing products to perform as expected could significantly adversely affect public perception about cancer detection tests generally, including our products, and could significantly impair our reputation and operating results.

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.

If we fail to obtain additional financing, we may be unable to expand our commercialization efforts or to develop and commercialize additional products.

Our operations have required substantial amounts of cash since inception.

To date, we have financed our operations primarily through the sale of equity securities and capital contributions from Illumina and, to a lesser extent, revenue derived from Galleri sales and precision oncology portfolio revenue.

Our product development and clinical study activities are expensive, and we expect to continue to spend substantial amounts as we expand our commercialization efforts with respect to Galleri, including pursuing broader coverage and reimbursement, continue to enhance our core technology platform, broaden the applications of our technology platform, and develop new products in the future.

To date, we have financed our operations primarily through the sale of equity securities, including in our recent private placement transaction and at-the-market sales, and capital contributions from Illumina and, to a lesser extent, revenue derived from Galleri sales and precision oncology portfolio revenue.

Our product development, commercialization and clinical study activities are expensive, and we expect to continue to spend substantial amounts as we expand our commercialization efforts with respect to Galleri, including pursuing broader coverage and reimbursement, continue to enhance our core technology platform, broaden the applications of our technology platform, and develop new products in the future.

In addition, obtaining any necessary or desirable regulatory approvals, clearances, or certifications, as well as coverage and reimbursement, for our products will require substantial additional funding.

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• the emergence of new technologies, products, or services and other adverse market developments;

• costs associated with extending the NHS-Galleri Trial follow-up period by 6-12 months, and any additional clinical studies or analyses that may be required to further demonstrate clinical utility following the trial’s failure to meet its primary endpoint;

• potential increased costs of development and commercialization activities if the NHS-Galleri Trial results adversely impact our ability to obtain regulatory approval, coverage and reimbursement, or commercial partnerships on favorable terms;

• other potential adverse developments.

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Debt financing, if available, may include restrictive covenants that could limit how we conduct our business and limit our ability to further raise capital, and if available, may be available only on undesirable terms, particularly as we would borrow as an independent company and not a subsidiary of Illumina.

If adequate capital is not available to us on a timely basis, we may be required to significantly delay, scale back, or discontinue the commercialization of our products or research and development programs, or be unable to continue or expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition, results of operations, and growth prospects and cause the price of our common stock to decline.

which could materially affect our business, financial condition, results of operations, and growth prospects and cause the price of our common stock to decline.

As a result of the Spin-Off, we are subject to a number of limitations and risks that may impact our ability to obtain additional financing.

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In addition, certain terms of the Spin-Off may impact our ability to successfully obtain financing on favorable terms or at all.

For example, in connection with the Spin-Off, Illumina provided us with disposal funding in the amount of $932.3 million in accordance of the Separation and Distribution Agreement, subject to a clawback feature in the event that the Company (i) consummates a GRAIL Change of Control, or (ii) (1) pays any dividend on, or makes any other distribution in respect of, any shares of its capital stock or other equity or voting interests (other than a stock dividend or a stock split), or otherwise consummates a return of capital from GRAIL to any of its equity holders or (2) redeems, purchases or otherwise acquires any of its outstanding shares of capital stock or other equity or voting interests, in each case prior to the 15-month anniversary of the Distribution Date.

If the Company consummates a transaction described in the foregoing clause (i) prior to the 15-month anniversary of the Distribution Date, the Company must return to Illumina a cash amount calculated by reference to the number of months which have elapsed since June 24, 2024 at the time of the public announcement of the event giving rise to such transaction.

If the Company consummates a transaction described in the foregoing clause (ii) prior to the 15-month anniversary of the Distribution Date, the Company must return to Illumina a cash amount equal to the payments made by the Company in connection with such transaction up to an aggregate maximum amount equal to the amount of the initial disposal funding subject to a clawback feature in the event of a change in control, or the Company (1) pays any dividend on, or makes any other distribution in respect of, any shares of its capital stock or other equity or voting interests (other than a stock dividend or a stock split), or otherwise consummates a return of capital from GRAIL to any of its equity holders or (2) redeems, purchases or otherwise acquires any of its outstanding shares of capital stock or other equity or voting interests, prior to September 24, 2025.

If these clawback features are triggered, we must return to Illumina the aggregate amount of payments to equity holders as a result of or in connection with such a transaction.

Additionally, in connection with certain change of control transactions prior to September 24, 2025, we must return to Illumina a cash amount decreasing over time calculated by reference to the number of months which have elapsed since June 24, 2024 at the time of the public announcement of the event giving rise to the change of control.

These restrictions under these agreements may impact our ability to obtain additional financing when needed, if at all, and, if we are required to repay any disposal funds to Illumina under the clawback provision, our cash balance will be reduced and we may have greater need for additional financing.

The Samsung Investment is subject to closing conditions, including conditions beyond our control, and no assurance can be given that closing will take place on the timeline currently anticipated, or at all, or that we will achieve our goals under the collaboration agreements to be entered into with Samsung C&T and/or Samsung Electronics.

Any failure to close the Samsung Investment or achieve such goals could adversely impact our business, financial conditions, results of operations and liquidity.

On October 16, 2025, we entered into a stock purchase agreement (the “Samsung Stock Purchase Agreement”) with Samsung C&T Corporation (“Samsung C&T”), Samsung Electronics Singapore Pte.

(together with Samsung C&T, the “Samsung Investors”) and Samsung Electronics Co., Ltd.

(“Samsung Electronics”), providing for the issuance and sale by us to the Samsung Investors in a private placement of an aggregate of 1,570,308 shares of our common stock, at a purchase price of $70.05 per share, upon the terms and conditions set forth in the Samsung Stock Purchase Agreement (the “Samsung Investment”).

The Samsung Investment is subject to the satisfaction of certain closing conditions set forth in the Samsung Stock Purchase Agreement, including, but not limited to the satisfaction of certain regulatory approvals or clearances, including with respect to the Committee on Foreign Investment in the United States (“CFIUS”).

Additionally, we have entered into a Business Collaboration Agreement with Samsung C&T and a Strategic Opportunities Collaboration Agreement with Samsung Electronics in satisfaction of certain closing conditions under the Samsung Stock Purchase Agreement, which will become automatically effective upon the closing of the Samsung Stock Purchase Agreement.

We have experienced delays, and may experience further delays and difficulties in satisfying the conditions for closing of the Samsung Investment, and no assurance can be given that closing will take place on the timeline currently anticipated or at all.

Some of the closing conditions are outside of our control and it is possible that not all of the closing conditions for the Samsung Investment will be satisfied or that we will not receive the expected proceeds on the timeline currently anticipated or at all.

For example, the Samsung Investment is subject to, among others, certain regulatory approvals and clearances, including with respect to CFIUS.

In October 2025, we and the Samsung Investors filed a declaration for CFIUS clearance of the Samsung Investment.

In January 2026, CFIUS requested that we and the Samsung Investors file a joint voluntary notice, which provides CFIUS up to an additional 90 days to review the Samsung Investment.

Government funding shortfalls may delay this timing.

While we remain confident that we can obtain CFIUS clearance for the Samsung Investment, there can be no assurance of this, nor that we will receive clearance within the 90-day review and investigation periods.

In addition, even though we have executed the Business Collaboration Agreement with Samsung C&T and the Strategic Opportunities Collaboration Agreement with Samsung Electronics, there is no assurance that these agreements or the collaborations they govern will achieve our goals or be on terms that prove to be economically or strategically beneficial to us.

For example, we may not recognize or accomplish our strategic objectives under the Business Collaboration Agreement or Strategic Opportunities Collaboration Agreement and we may ultimately find ourselves restricted by the terms that we have negotiated under such agreements.

Any such adverse developments, including any failure to close the Samsung Investment, could adversely impact our business, financial condition, results of operations and liquidity.

If our products result in direct or indirect participant or patient harm or injury, we could be subject to significant reputational and liability risks.

Our success will depend on the market’s confidence that our products, including Galleri and, if successfully developed and launched, further enhanced versions of Galleri, and our precision oncology portfolio can provide reliable, high-quality results.

We believe that participants, patients, customers, physicians, and regulators are

likely to be sensitive to errors in the use of our products or failure of our products to perform as described, and there can be no guarantee that our products will meet expectations.

We believe that participants, patients, customers, physicians, and regulators are likely to be sensitive to errors in the use of our products or failure of our products to perform as described, and there can be no guarantee that our products will meet expectations.

Galleri is intended to be used to detect a cancer signal in individuals, but its results are not intended to be diagnostic.

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Because the product cannot detect all cancer signals, and may not detect signals for all cancer types, a negative test does not rule out the presence of cancer.

Additionally, an individual undergoing unnecessary diagnostic tests on the basis of a false positive result or an erroneous cancer signal origin result could expose us to reputational risks and potential liability.

Additionally, an individual undergoing unnecessary diagnostic tests on the basis of a false positive result or an erroneous CSO result could expose us to reputational risks and potential liability.

Similarly, an individual who receives a cancer diagnosis shortly following a “no cancer signal detected” test result may create negative publicity about our product, which would discourage adoption.

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If our products result in direct or indirect participant or patient harm or injury, we could be subject to significant reputational and liability risks, and our reputation, business, financial condition, results of operations, and growth prospects could be materially adversely affected.

We rely on Illumina as a sole supplier for our next-generation sequencers and associated reagents, Madison Industries (“Madison”) (who acquired our blood collection tube manufacturer, Streck, Inc., in 2023) as a sole supplier of our blood collection tubes, and Twist Bioscience Corporation (“Twist”) as a sole supplier of our DNA panels.

We rely on Illumina as a sole supplier for our next-generation sequencers and associated reagents, Madison Industries (“Madison”) as a sole supplier of blood collection tubes, and Twist Bioscience Corporation (“Twist”) as a sole supplier of DNA panels.

Additionally, we rely on a limited number of suppliers for some of our laboratory instruments and reagents, and we may not be able to immediately find replacements if necessary.

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Any such disruption or interruption in supply, quality, or servicing would adversely affect our commercial partnerships, our ability to continue supporting clinical studies and conduct new studies, our reputation, and could impact our timing for regulatory authorization and coverage and reimbursement.

Further, we are in the process of submitting a PMA for Galleri to the FDA.

We may similarly seek FDA authorization for future products.

For products or components supplied to us by Illumina, we have not negotiated the use of all of their products in any product we intend to submit for an FDA marketing authorization.

We are cooperating with Madison to obtain FDA clearance or approval for their blood collection tubes for use with our products.

Further, we have submitted a PMA for Galleri to the FDA, and we may similarly seek FDA authorization for future products.

For RUO products or components supplied to us by any supplier, including Illumina, we would be required to validate for IVD purposes and submit to FDA as part of our marketing authorization.

We are cooperating with Madison to obtain FDA authorization as part of our PMA application for their blood collection tubes to be used with our Galleri test.

In some cases, use of these third-party products in any FDA-cleared or approved product we may seek to commercialize will be conditioned on these suppliers having obtained FDA clearance or approval for their products for the uses of those third-party products as intended with ours.

Before we pursue approval for our products that incorporate or use materials supplied to us by these suppliers, we will need to negotiate and execute agreements with these parties and in some cases may need to ensure these products have obtained the requisite clearances or approvals for the intended uses with our products.

Before we pursue approval for our products that incorporate or use materials supplied to us by these suppliers, we will need

to negotiate and execute agreements with these parties and in some cases may need to ensure these products have obtained the requisite clearances or approvals for the intended uses with our products.

Any failures or delays in negotiating agreements with our suppliers on reasonable terms, or their inability to obtain any required clearances or approvals, may increase our costs or delay or prevent us from obtaining approval of, and thus successfully commercializing, our products.

For example, any changes to the material used in our laboratory workflow may

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.

For example, any changes to the material used in our laboratory workflow may 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.

Moreover, products supplied to us for use in our LDT products may be currently available to us as RUO products, which means, among other things, that the third-party supplier intends for the products not to be used for clinical use and that the products must be labeled “For Research Use Only.

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If we encounter delays or difficulties in securing, reconfiguring or revalidating the equipment, reagents, and other materials that we require for our tests, laboratory operations and sample collection and processing, we would likely face significant delays in ongoing clinical studies or conducting new studies, commercializing our products and our reputation, business, financial condition, results of operations, and growth prospects would be adversely affected.

Even where we have long term supply agreements in place, these agreements are periodically up for renewal, and may not be renewed or may be terminated.

For example, the initial term of the Illumina Supply Agreement is scheduled to expire on February 28, 2027.

The Illumina Supply Agreement will automatically renew for two year terms unless we or Illumina provide written notice of nonrenewal at least 120 days prior to the end of the then-current term.

If Illumina determined not to renew the Illumina Supply Agreement, we could lose certain preferential pricing under that agreement and other beneficial terms.

Even if we were to negotiate a replacement supply agreement with Illumina, it may not provide pricing or other terms that are as beneficial to us.

Our royalty obligations under the Illumina Supply Agreement will survive any termination.

If our facilities become inoperable, our ability to provide our products will be significantly impaired and our business will be harmed.

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It would be difficult, time-consuming, and expensive to rebuild our facilities, particularly in light of the licensure, permits, and accreditation requirements for clinical laboratories like ours.

For example, the development and commercial test processing activities for Galleri, and future potential commercial launch of future products, are dependent on the operation of our Durham, North Carolina laboratory, which received Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certification to perform high-complexity training, and College of American Pathologists (“CAP”) accreditation.

In particular, as part of the Restructuring Plan, we have consolidated the processing of commercial Galleri tests in this facility and no longer process commercial Galleri tests in our Menlo Park Facility.

As a result, any disruption at our North Carolina facility could materially adversely affect our ability to process tests and return results to patients, and our revenue, operations, business and prospects could be

materially harmed.

Although we carry insurance for damage to our properties and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

Our operations and business are materially dependent on various third parties, including information technology, sample collection, processing, transfer facilities, and other patient-facing service providers, any of which could experience disruption, failure, or interruption.

We depend on third parties for information technology, telecommunication systems, the collection, processing, transport, and storage of sample, and other patient-facing services.

We 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.

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and general administrative activities.

In connection with becoming a public company, we expect to expand and strengthen a number of enterprise software systems that affect a broad range of business processes and functions, including, for example, systems handling human resources, financial controls and reporting, customer relationship management, regulatory compliance, security controls, and other infrastructure operations.

These expansions may prove more difficult than we expect and could cause disruptions in our operations or additional expense.

As a public company, we continue to work to expand and strengthen a number of enterprise software systems that affect a broad range of business processes and functions, including, for example, systems handling human resources, financial controls and reporting, customer relationship management, regulatory compliance, security controls, and other infrastructure operations.

These expansions may prove more difficult than we expect and could cause disruptions in our operations or additional expenses.

Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts, and natural disasters.

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Any disruption or loss of information technology or telecommunications systems on which critical aspects of our operations depend could have an adverse effect on our business, reputation, results of operation, financial condition, and growth prospects.

Our business also depends on our ability to reliably sequence blood samples that we collect, which are transported to our Menlo Park or Durham facility for analysis.

Our business also depends on our ability to reliably sequence blood samples that we collect, which are transported to our Durham facility for analysis.

Within the United Kingdom, our samples are initially collected, processed, frozen, and stored at several off-site facilities.

Any disruption to the operations of these facilities could compromise the integrity of our samples and impede our ability to access and accurately sequence the data.

For example, Event Marketing Solutions Ltd (“EMS”) is responsible for collection of our NHS-Galleri Trial samples and ships those samples to UK Biocentre Ltd (“UKBC”) for, among other things, receipt, storage, and management.

If any natural or man-made disaster, accident, or break-in were to affect the UKBC facility or EMS’ collection or shipping operations, our NHS-Galleri samples could be lost, destroyed, compromised, or otherwise adversely affected.

In addition, we maintain samples from our clinical studies for several years.

It is possible that the long-term stability of these samples may not be maintained with the passage of time, which could negatively impact our ability to use such samples to validate our products.

We maintain samples from our clinical studies for several years.

It is possible that the long-term stability of these samples may not be maintained with the passage of time, or could be damaged or lost through a natural or man-made disaster, accident, or break-in, which could negatively impact our ability to use such samples to validate our

Further, interruptions in collection, processing, freezing, or transportation of samples performed by patient-facing service providers and other third parties, whether due to labor disruptions, bad weather, natural disaster, terrorist acts, threats, or for other reasons could adversely affect the samples and our ability to process the samples in a timely manner, which could negatively affect our ongoing research studies and harm our business.

This is particularly true for transport of our samples, which generally must be delivered to our facilities for processing within seven days of blood draw.

This is particularly true for the transport of our samples, which generally must be delivered to our facilities for processing within seven days of blood draw.

We also depend on third-party telemedicine providers for certain referrals and follow up services with patients.

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If these telemedicine or phlebotomist vendors fail to perform services, or if services are performed poorly or perceived to be performed poorly, we may suffer reputational harm, need to replace a provider, limit our ability to reach patients, result in loss of samples, failure to receive samples in a timely manner, insufficient quality of samples, or other harms.

Finally, the facilities of any of our third-party collaborators, consultants, contractors, vendors, suppliers, and service providers could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, tornadoes, hurricanes, fires, extreme weather conditions, medical epidemics, pandemics, and

other natural or man-made disasters or business interruptions.

In addition, they may be affected by government shutdowns, changes to applicable laws, regulations, and policies, or funding shortages.

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In Europe, on August 1, 2024, the EU Artificial Intelligence Act (the “EU AI Act”) entered into force, and establishes a comprehensive, risk-based governance framework for AI in the EU market.

The majority of the substantive requirements will apply from August 2, 2026.

The majority of the substantive requirements will apply from August 2, 2026 at the earliest (although this deadline may be further extended).

The EU AI Act applies to companies that develop, use and/or provide AI in the EU and, depending on the use case, includes requirements around transparency, conformity assessments and monitoring, risk assessments, human oversight, security, accuracy, general purpose AI and foundation models, and fines for breaches up to 7% of an undertaking’s worldwide annual turnover.

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Once fully applicable, the EU AI Act and the EU Product Liability Directive will have a material impact on the way AI is regulated in the EU.

The EU AI Act and its future interpretation and application may affect our use of AI technologies and our ability to provide, improve or commercialize our services, require additional compliance measures and changes to our operations and processes, result in increased compliance costs and potential increases in civil claims against us, and could adversely affect our business, operations and financial condition.

The EU AI Act and its future interpretation and application may affect our use of AI technologies and our ability to provide, improve or

commercialize our services, require additional compliance measures and changes to our operations and processes, result in increased compliance costs and potential increases in civil claims against us, and could adversely affect our business, operations and financial condition.

It is also possible that further laws and regulations will be adopted in the United States and in other non-U.S.

jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI technologies for our business, or require us to change the way we use AI technologies.

For example, Colorado passed the Colorado Artificial Intelligence Act and Utah passed the Utah Artificial Intelligence Policy Act, both of which will have implications on the ways that businesses can use AI technologies.

For example, a number of U.S.

states have or are considering new legislation relating to AI, including the Colorado Artificial Intelligence Act in Colorado and the Utah Artificial Intelligence Policy Act in Utah, all of which will have implications on the ways that businesses can use AI technologies.

We currently host all of our data on, and conduct a significant portion of our data analysis through, Amazon Web Services (“AWS”) cloud-based hosting facilities.

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A variety of factors, including infrastructure changes, human or software errors, viruses, malware, cybersecurity incidents or attacks, fraud, spikes in customer usage, or denial of service issues could cause interruptions in our service.

Such service interruptions may reduce or inhibit our ability to provide our

products, process tests, operate our laboratory, delay our clinical studies, and damage our relationships with our customers.

Such service interruptions may reduce or inhibit our ability to provide our products, process tests, operate our laboratory, delay our clinical studies, and damage our relationships with our customers.

We could also be exposed to potential lawsuits, liability claims, reputational impact, or regulatory actions, for example if AWS experienced a data privacy or cybersecurity incident.

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If we are unable to scale our operations successfully to support demand for our products, our business could suffer.

As and to the extent test volumes grow, we may need to ramp up laboratory capacity, including increasing the processing of Galleri in our Durham, North Carolina facility by increased operations.

While we have heavily invested in our scalability, including by expanding our Durham facility laboratory capacity, further buildout of our Durham facility may be needed, as well as further new infrastructure, data processing capabilities, customer service, billing and systems processes, and expanding our internal quality assurance program and information technology to support testing on a larger scale.

As and to the extent test volumes grow, we may need to ramp up laboratory capacity, including expanding the processing of Galleri in our Durham, North Carolina facility by increased operations.

While we have heavily invested in our scalability, including by expanding our Durham facility laboratory capacity, further buildout of our Durham facility may be needed, as well as further new infrastructure, data processing capabilities, customer service, billing and systems processes, and expanding our internal quality assurance program and cybersecurity and information technology to support testing on a larger scale.

We will also need additional equipment, and certified and licensed laboratory personnel to process higher volumes of tests.

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This may be challenging due to significant startup costs, difficulty recruiting, and lack of familiarity with the local jurisdiction, among other reasons.

If we are unable to build and operate laboratories internationally, our ability to expand internationally may be limited, and have a negative impact on our business and results of operations.

If we are unable to build and operate laboratories internationally, or ship samples in or out of international jurisdictions due to privacy, export/import controls, or other applicable laws, our ability to expand internationally may be limited, and have a negative impact on our business and results of operations.

In addition, our growth may place a significant strain on our management, operating and financial systems, research and development, and our sales, marketing, and administrative resources.

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Our business and results of operations will suffer if we fail to perform effectively.

There are market participants in the cancer detection space both in the United States and abroad, including Adela, Inc., DELFI Diagnostics, Inc., Exact Sciences Corporation, Exai Bio, Inc., Freenome Inc., Guardant Health, Inc., Harbinger Health and Natera, Inc.

There are market participants in the cancer detection space both in the United States and abroad, including Exact Sciences Corporation (recently announced to be acquired by Abbott Laboratories) and Guardant Health, Inc., who have each introduced MCED products into the market in 2025.

In addition, Adela, Inc., Caris Life Sciences, ClearNote Health, DELFI Diagnostics, Inc., Exai Bio, Inc., Freenome Inc.

and Harbinger Health and Natera, Inc.

within the United States and AnchorDx, Anpac Bio-Medical Science Co., Ltd., Burning Rock Biotech Limited, Datar Cancer Genetics, Elypta AB, Gene Solutions JSC, Insighta, Singlera Genomics, Inc.

and Seekin, Inc.

outside of the United States, among others, that have stated that they are attempting to develop tests designed to detect certain types of cancer, including some that will use cell free DNA (“cfDNA”) analyses.

The precision oncology market includes companies such as Roche/Foundation Medicine, Inc., Natera, Inc., Guardant, Inc., Tempus AI, Inc., Clearnote Health, NeoGenomics Laboratories, Personalis, Inc.,

Twist Bioscience Corp.

outside of the United States, among others, have stated that they are attempting to develop tests designed to detect certain types of cancer, including some that will use cell free DNA (“cfDNA”) analyses.

The precision oncology market includes companies such as Exact Sciences Corporation (recently announced to be acquired by Abbott Laboratories), Roche/Foundation Medicine, Inc., Natera, Inc., Guardant, Inc., Tempus AI, Inc., Clearnote Health, NeoGenomics Laboratories, Personalis, Inc., Twist Bioscience Corp.

and Adaptive Biotechnologies Corp., among others.

These companies have or may have greater financial, technical, and other resources, such as larger research and development staff, well-established marketing and sales forces, existing integrated systems connected to health practices’ electronic health or medical records to facilitate product ordering and results delivery, or may operate in jurisdictions where lower standards of evidence are required to bring products to market.

These companies may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, tests or services that are more effective, have higher performance, or are less costly than our products.

These companies have or may have greater financial, technical, and other resources, such as larger research and development staff, well-established marketing and sales forces, existing integrated systems connected to health practices’ electronic health or medical records to facilitate product ordering and results delivery, may have different strategies to obtain reimbursement for their products, may deploy more effective sales and marketing campaigns or may operate in jurisdictions where lower standards of evidence are required to bring products to market.

These companies may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, or providers, payers, patients and other stakeholders may believe that these companies or other new market entrants may have tests or services that are more effective, have higher performance, or are less costly than our products.

In addition, established medical technology, biotechnology, or pharmaceutical companies may invest to accelerate discovery and development of tests that could make our products less successful than we anticipate.

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Our ability to perform successfully will depend largely on our ability to:

• successfully expand commercialization efforts for our products;

• demonstrate compelling advantages in the performance and convenience of our products, including on a cost efficient basis;

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• achieve adequate coverage and reimbursement by third-party payors for our products;

• differentiate our product from future tests and products of and third parties;

• differentiate our product from future tests and products of third parties;

• attract qualified scientific, data science, clinical development, product development, and commercial personnel;

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We rely, and expect to continue to rely, on collaborative partners to help us develop our products and enhance our research and development efforts.

For example, we have collaborated with pharmaceutical companies, research institutions, and academic centers.

For example, we have collaborated with research institutions, and academic centers.

Additionally, our RUO offering has formed the basis of biopharmaceutical partnerships with several leading oncology companies.

These partnerships leverage our RUO offering to test applications of biomarkers with the goal of optimizing the use of therapeutic interventions.

Partnerships may also include development of customized applications to support clinical studies and companion

diagnostic development and commercialization.

Partnerships may also include development of customized applications to support clinical studies and companion diagnostic development and commercialization.

Our reliance on certain of these third parties reduces our control over our product development activities.

If any of our collaborators or partners were to breach or terminate their agreements with us or otherwise fail to conduct the contracted activities successfully and in a timely manner, the research and development activities of certain of our products could be delayed or terminated.

For example, in late 2025, AstraZeneca terminated its phase 3 TROPION-Lung12 trial due to low enrollment, for which our methylation technology was used as a potential companion diagnostic for enrolling participants.

Further, our collaborators or partners may fail to properly protect our intellectual property rights, may infringe the intellectual property rights of third parties, may misappropriate our trade secrets, or may use our proprietary information or others’ in such a way as to expose us to litigation and potential liability.

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In addition, establishing collaborations is difficult, time-consuming and may require our significant financial investment.

Potential collaborators may elect not to work with us based on their assessment of our financial, regulatory, or intellectual property position.

Potential collaborators may elect not to work with us based on their assessment of our

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.

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If we are not able to effectively expand our organization by hiring new employees, we may not be able to successfully implement the tasks necessary to commercialize our products, which would have a negative impact on our business and results of operations.

We are highly dependent on our key personnel.

If we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

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As a result of the RSU Conversion mechanics and limitations our 2024 RSU grants, the perceived value to employees of these awards may be insufficient to retain certain key executives and other valuable employees, who may receive more lucrative offers from other companies.

we have employment agreements with certain key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice.

Although we have employment agreements with certain key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice.

If we are unable to attract and incentivize highly qualified personnel on acceptable terms in a timely manner, or at all, our business and results of operations may suffer.

For additional information, see - “Our business is subject to economic, political, regulatory, and other risks associated with international operations.”

Our business is subject to economic, political, regulatory, and other risks associated with international operations.

Our business is subject to risks associated with conducting business internationally.

For example, some of our suppliers and parties with whom we have collaborative relationships are located outside the United States, including in the United Kingdom and Israel.

For example, some parties with whom we have collaborative relationships are located outside the United States, including in the United Kingdom, Canada, South Korea and Israel.

Additionally, while a significant majority of our supplier spend is with vendors located within the United States, whose products are produced in the United States, we also rely on suppliers and vendors located outside of the United States or who produce the products that we use outside the United States, including in China, Mexico, South Africa and various European Union member states.

We expect to continue to increase our international presence over time, which could increase these risks or introduce new risks.

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companies’ ability to enter into joint ventures with non-U.S.

• compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;

• compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad, or for non-U.S.

employees in the United States;

• workforce uncertainty in countries where labor unrest is more common than in the United States;

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• potential liability under the Foreign Corrupt Practices Act (“FCPA”) or comparable foreign laws;

• business interruptions resulting from geopolitical actions, including war and terrorism, such as recent conflicts in the Middle East, pandemics, or natural disasters more common in certain regions, including earthquakes, typhoons, floods, and fires.

• business interruptions resulting from geopolitical actions, including war and terrorism, such as recent conflicts in the Middle East like the war involving the United States, Israel and Iran, pandemics, or natural disasters more common in certain regions, including earthquakes, typhoons, floods, and fires;

• negative consequences to our relationships with our customers, partners, and other collaborators in the event of impact to suppliers or our business internationally due to restrictive actions by U.S.

governments or changes in U.S.

In addition, in recent years, U.S.

administrations have publicly supported potential trade proposals that may affect U.S.

administrations, including the current administration, have publicly announced or adopted trade proposals that may affect U.S.

trade relations with other countries.

It is unclear at this point how, if at all, such actions or other potential actions, including under the new U.S.

Presidential administration, may impact our business or

operations, and the uncertainty surrounding these matters might create difficulties in our efforts to partner with certain healthcare providers, suppliers, and insurance carriers.

As of the date of this Annual Report, discussions remain ongoing in respect of certain trade restrictions and tariffs on imports from Canada, China and Mexico, as well as retaliatory tariffs enacted in response to such actions.

Should significant tariffs be implemented and sustained for an extended period of time, they could have a material adverse effect on the broader economy, which may be exacerbated by additional tariffs in the United States or retaliatory tariffs imposed by other governments.

While we have not experienced significant impact from tariffs to date and do not have significant sensitivity to tariffs, it is uncertain at this point how, if at all, such actions or other potential actions, may impact our business or operations, in particular if there are changes in our supply chain, or tariffs if rates are increased or are more targeted at countries where our suppliers are located.

Policy changes or legal challenges could lead to further volatility in rates, coverage, and enforcement.

Such actions could increase our expenses, reduce our margins or increase our prices, make it difficult to obtain inputs we need for our products or have a material adverse effect on the broader economy.

These risks and impacts may be exacerbated by retaliatory tariffs imposed by governments in response to any initial tariff policy.

Our success depends in part on our ability to attract and retain the best available personnel with the necessary qualifications, which in a competitive global market means that our recruitment efforts should not be limited entirely to the United States.

To the extent U.S.

immigration-related policies, laws, rules, proclamations or orders restrict our ability to attract, or increase the cost of attracting, international talent, this could adversely impact our business and results of operations.

For example, on September 19, 2025, the H-1B visa process in the

United States was changed to require a payment of $100,000 for new petitions, which could hamper our recruitment efforts for any new personnel who require such a visa or require significant additional employment costs for those individuals.

Additional changes in U.S.

immigration policies, rules, laws or orders could further increase our recruitment costs or delay key projects that require specialized expertise.

In addition, restrictions or delays in the issuance of other visas or in immigration processing could adversely affect our ability to collaborate effectively with our employees outside the United States and to retain the qualified personnel needed for our operations.

Moreover, future operational expansion into other geographies will subject us to additional political and regulatory regimes that will require us to invest further in compliance efforts and may result in additional risks, including, among others, exposure to various and potentially conflicting regulations, international sanctions and compliance rules, country-specific requirements for testing, approval, and processing of patient information and biological samples, as well as the risks associated with political and macroeconomic climates in any such geographies.

For example, the potential commercialization of Galleri with the NHS, subject to the results of the NHS-Galleri Trial, may be delayed or otherwise impacted if there is a change in the government in the United Kingdom.

For example, the potential commercialization of Galleri with the NHS, subject to the full results of the NHS-Galleri Trial which we expect to report in mid-2026, will be considered by the government of the United Kingdom and may be delayed or otherwise impacted depending on the circumstances and the composition of the government at the time of consideration.

These and other risks associated with our planned international operations may materially and adversely affect our business, costs and growth prospects.

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Finally, our ability to expand internationally may be limited by the availability of international laboratory space or requirements that will permit us to store, collect, and analyze biological samples required for current or future products, including space that could be made available through potential partners in such countries or regions.

These and other unknown risks which make it difficult for us to assess the potential success of our international expansion and the costs associated therewith.

These and other unknown risks make it difficult for us to assess the potential success of our international expansion and the costs associated therewith.

For additional information, see “—Risks Relating to Regulation and Legal Compliance.”

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We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business.

In the ordinary course of our business, we collect, store, and transmit large amounts of confidential information, including intellectual property, proprietary business information, personal, financial, and health information of patients and personal and financial information of our employees and contractors.

As we expand our direct engagement with patients, our data collection, processing, and storage activities may increase in volume and complexity, including the creation of additional copies of patient data across systems and platforms, heightening the risk of unauthorized access, disclosure, or misuse of patient information.

It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such Confidential Information.

Despite the implementation of security and back-up measures, our information technology systems as well as those of our third-party collaborators, consultants, contractors, suppliers, and service providers, may be vulnerable to attack, damage, or interruption from physical or electronic break-ins, computer viruses, malware, malicious code, ransomware, denial or degradation of service, hacking, phishing attacks, and other cyber-attacks, natural disasters, terrorism, war, telecommunication and electrical failures, instructions and attacks from sophisticated nation-state and nation-state-supported actors (including advanced persistent threat intrusions), or other disruptive incidents that could result in unauthorized access to, use or disclosure of, corruption of, or loss of sensitive, and/ or proprietary data, including personal information, protected health information, and other sensitive information, and could subject us to significant liabilities and regulatory and enforcement actions, and

reputational damage.

Despite the implementation of security and back-up measures, our information technology systems as well as those of our third-party collaborators, consultants, contractors, suppliers, and service providers, may be vulnerable to attack, damage, or interruption from physical or electronic break-ins, computer viruses, malware, malicious code, ransomware, misconfigurations, “bugs” or other vulnerabilities, denial or degradation of service attacks, hacking, phishing attacks, and other cyber-attacks, natural disasters, terrorism, war, telecommunication and electrical failures, instructions and attacks from sophisticated nation-state and nation-state-supported actors (including advanced persistent threat intrusions), or other disruptive incidents that could result in unauthorized access to, use or disclosure of, corruption of, or loss of sensitive, and/ or proprietary data, including personal information, protected health information, and other sensitive information, and could subject us to significant liabilities and regulatory and enforcement actions, and reputational damage.

We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information.

As we increasingly leverage third-party digital health platforms and service providers to support our operations and patient-facing capabilities, we may become subject to cybersecurity risks outside of our direct control.

As a part of these relationships, these third parties may store or process certain types of confidential or patient data.

These third parties may not maintain cybersecurity practices, expertise, certifications, or controls that are equivalent to our own, which could increase the risk of security incidents, data breaches, or service disruptions that could adversely affect our business, operations, or reputation.

The risk of a cybersecurity incident or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased and evolved.

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For example, laws in the European Economic Area (“EEA”), the United Kingdom, and all 50 U.S.

states may require businesses to notify regulators within specific timeframes that an incident affecting personal information has occurred and/or to provide notice to individuals whose personal information has been impacted as a result of such incident.

As part of our growth strategy, we have expanded into multiple jurisdictions outside of the United States, including the United Kingdom and Israel, and intend to continue expansions in 2025 and beyond.

states may require businesses to notify regulators within specific timeframes that an incident affecting personal information has occurred and/or to provide notice and, in some circumstances, one year of credit monitoring services to individuals whose personal information has been impacted as a result of such incident.

As part of our growth strategy, we have expanded into multiple jurisdictions outside of the United States, including the United Kingdom, Canada, and Israel, and intend to continue expansions in 2026 and beyond, including through our partnership with Samsung.

This growth will subject us to additional regulatory regimes and increase the amount of cybersecurity requirements for compliance in multiple geographies.

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Moreover, even security measures that are deemed appropriate, reasonable, or otherwise in accordance with applicable legal requirements may not be able to protect the information we maintain.

In connection with the Restructuring Plan, we have made reductions to the number of employees and amount of resources dedicated to these matters, and to our information technology efforts more broadly, and there may be further reductions to resources in the future.

In addition to the number of employees allocated to these matters, if we fail to identify and retain qualified key personnel in these areas or fail to appropriately allocate responsibilities across remaining personnel, the quality of our cybersecurity efforts may be compromised.

Due to the technical nature of cybersecurity work, it is important for GRAIL to employ highly skilled cybersecurity professionals.

If we fail to identify and retain qualified key personnel in these areas or fail to appropriately allocate responsibilities or dedicate sufficient headcount or resources to these areas, the quality of our cybersecurity efforts may be compromised.

Even if we do allocate and effectively manage the resources necessary to build and sustain the proper technology and cybersecurity infrastructure, we could nevertheless suffer significant business disruption, including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, data loss, or the loss of or damage to intellectual property or other confidential or proprietary information.

As a part of our cybersecurity program, we conduct a number of internal evaluations and independent third-party audits and reviews.

For example, as part of our overall public company preparedness efforts in connection with the Spin-Off in 2024, we underwent third-party reviews of our cybersecurity program against the NIST CSF 2.0 and NIST Privacy Framework, along with our ordinary course annual reviews under ISO 27001, SOC2 Type 2, PCI DSS, and other standards, in order to identify capabilities, gaps, and recommendations for improvement, and to compare our cybersecurity program to applicable requirements.

These assessments generate numerous findings and opportunities that we intend to utilize in order to improve and mature our cybersecurity practices and promote continuous improvement in our cybersecurity and privacy programs.

However, these improvements and maturation efforts may take a number of months or years to fully realize.

Should these improvement and maturation efforts fail to improve or maintain our level of effectiveness in a timely manner or at all, or correct any observed gaps, we may be at risk of regulatory findings, cybersecurity attacks or data breaches, which would amplify the risks otherwise described.

As a part of our cybersecurity program, we conduct a number of internal evaluations and independent, external third-party audits and reviews, including under the NIST CSF 2.0 and NIST Privacy Frameworks, along with our annual reviews under ISO 27001, SOC2 Type 2, PCI DSS, HIPAA, and other standards, in order to identify capabilities, gaps, and recommendations for improvement, and to compare our cybersecurity program to applicable requirements.

These assessments generate findings and opportunities that we integrate into a formal remediation roadmap designed to mature our security posture and drive continuous improvement.

However, these improvements and maturation efforts require sustained resource allocation and may span multiple reporting

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.

We, along with companies with whom we engage in data sharing, including our service providers, are from time to time subject to cyberattacks and other cybersecurity incidents.

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For example, the loss of clinical study data from completed or ongoing clinical studies could result in delays in any regulatory clearance, approval, or certification efforts and significantly increase our costs to recover or reproduce the data, and subsequently commercialize our products.

information, we may have to notify physicians, patients, partners, collaborators, government authorities, and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions, and litigation, any of which could harm our business and reputation.

If we or our third-party collaborators, consultants, contractors, suppliers, or service providers were to suffer a cybersecurity incident or attack, for example, that resulted in the unauthorized access to or use or disclosure of personal or health information, we may have to notify physicians, patients, partners, collaborators, government authorities, and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions, and litigation, any of which could harm our business and reputation.

Likewise, we rely on our third-party research institution collaborators and other third parties to conduct clinical studies, and similar events relating to their computer systems could also have a material adverse effect on our business.

It could also expose us to risks, including an inability to provide our services and fulfill contractual demands, and could cause management distraction and the obligation to devote significant financial and other resources to mitigate such problems, which would increase our future information security costs, including through organizational changes, deploying additional personnel, reinforcing administrative, physical, and technical safeguards, further training of employees, changing third-party vendor control practices, and engaging third-party subject matter experts and consultants and reduce the demand for our technology and services.

Further, there can also be no assurance that our and our third-party service providers’, strategic partners’, contractors’, consultants’, CROs’ and collaborators’ cybersecurity risk management program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems, networks and Confidential Information.

To the extent that any disruption or cybersecurity incident were to result in a loss of, or damage to, our data or systems, or inappropriate or unauthorized access to or disclosure or use of confidential, proprietary, or other sensitive, personal, or health information, we could incur liability, we could be exposed to the risk of litigation, our market position could be harmed, we could suffer reputational harm, and the development and commercialization of our products could be delayed.

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We may also experience cybersecurity incidents that may remain undetected for an extended period.

Even if identified, we may be unable to adequately investigate or remediate cybersecurity incidents due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

While we maintain cybersecurity insurance, our insurance policies may not be adequate to compensate us for the potential losses arising from such disruptions, failure, or cybersecurity incident.

Even if identified, we may be unable to adequately investigate or remediate cybersecurity incidents due to attackers increasingly using tools and techniques – including artificial intelligence – that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

While we maintain cybersecurity insurance, our insurance policies may not be adequate to compensate us for the potential losses arising from such disruptions, failure, or cybersecurity incidents.

In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all.

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• the cost of performing next-generation sequencing;

• the timing and amount of royalty payments, including the expected end of the suspension period of the Illumina royalty on December 24, 2026;

• the extent to which our products are deemed eligible or ineligible for coverage and reimbursement from third-party payors;

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For example, in July 2023, Illumina was informed that the staff of the SEC was conducting an investigation relating to Illumina and was requesting documents and communications primarily related to Illumina’s acquisition of GRAIL and certain statements and disclosures concerning GRAIL, our products and the Acquisition, and related to the conduct and compensation of certain members of Illumina and GRAIL management, among other things.

GRAIL is cooperating with the SEC in this investigation.

On May 9, 2025, the Company confirmed with the SEC that the SEC has closed its investigation into this matter.

In addition, our acquisition by Illumina and subsequent litigation resulted in the filing of three securities class actions in the United States District Court for the Southern District of California:

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On September 13, 2024 the plaintiffs further amended the complaint.

On November 12, 2024, the Company and other defendants filed a motion to dismiss the second amended consolidated complaint.

On December 20, 2024, the Lead Plaintiffs filed their opposition to the motion to dismiss.

The defendants’ final reply brief was filed on February 3, 2025.

No hearing date has been set.

On November 12, 2024, we moved to dismiss Lead Plaintiffs’ second amended complaint for failure to state a claim under Sections 10(b) and 20(a) of the Exchange Act.

Lead Plaintiffs filed their opposition to the motion to dismiss on December 20, 2024, and we filed our reply in support of its motion to dismiss on February 3, 2025.

On September 26, 2025, the court granted the motion to dismiss for failure to state a claim with leave to amend, and ordered the plaintiffs to file an amended complaint.

On October 27, 2025, the Lead Plaintiffs filed their third amended complaint and on December 12, 2025, we filed a motion to dismiss Lead Plaintiffs’ third amended complaint.

We deny the allegations in the complaints and intend to vigorously defend the litigation.

See Note 10 — Legal And Regulatory Proceedings for additional details.

See Note 11 — Legal And Regulatory Proceedings in Item 8.

Financial Statements of this Annual Report on Form 10-K for additional details.

In the event that any of the matters described above result in one or more adverse judgments or settlements, we may experience an adverse impact on our financial condition, results of operations or stock price.

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Risks Relating to Regulation and Legal Compliance

We have launched Galleri as a laboratory developed test (“LDT”) in the United States.

The FDA recently finalized a regulation pursuant to which it plans to subject LDTs to medical device requirements through a phase-out of its historical policy of enforcement discretion over LDTs over a period of four years.

While we plan to complete our PMA submission seeking regulatory approval from the FDA for Galleri, we launched Galleri in the United States as an LDT.

We have launched Galleri as an LDT in the United States.

In 2024, the FDA finalized a regulation that has been successfully challenged in federal court, pursuant to which the FDA planned to subject LDTs to medical device requirements through a phase-out of its historical policy of enforcement discretion over LDTs over a period of four years.

A federal court recently vacated this rule.

While we recently submitted our PMA seeking regulatory approval from the FDA for Galleri, we initially launched Galleri in the United States as an LDT in 2021.

LDTs are in vitro diagnostic (“IVD”) tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory certified for high complexity testing under CLIA.

Although LDTs are classified by the FDA as medical devices and the FDA has asserted statutory authority to ensure that medical devices, including LDTs, are safe and effective for their intended uses, the FDA has historically exercised enforcement discretion and has not enforced certain otherwise applicable FDA requirements, including premarket review, with respect to LDTs, with certain exceptions such as in the case of tests for public health emergencies, where the tests are available directly to the consumer, where the tests represented a significant public health concern, or where the FDA has concerns that a company’s performance claims related to its tests are not sufficiently validated by clinical data.

Even under that enforcement discretion policy, the FDA has issued warning letters to and safety communications about IVD device manufacturers for commercializing laboratory tests that were purported to be LDTs but that the FDA alleged failed to meet the definition of an LDT or otherwise were not subject to the FDA’s enforcement discretion policy.

The FDA has for a number of years stated its intention to modify its enforcement discretion policy with respect to LDTs and impose applicable medical device requirements to LDTs more broadly.

The FDA proposed an amendment to its regulations in October 2023 to clarify the FDA’s historical view that LDTs are medical devices subject to the requirements applicable to other IVDs, and to phase out its enforcement discretion policy over a period of four years from issuance of the final rule, which would involve a phase-in of medical device requirements to these products over this time period.

The FDA finalized this rule on May 6, 2024, which would subject our products currently marketed as LDTs and any future products that we may market as LDTs in the future to the FDA’s standard regulatory requirements applicable to medical devices in accordance with this phase-in period, potentially, including the potential requirement for FDA marketing authorization (the “LDT Final Rule”).

In connection with the LDT Final Rule, the FDA established certain new, targeted enforcement discretion policies, including, among others, for LDTs marketed as of the date of publication of the final rule (May 6, 2024), as well as for LDTs that have received approval from New York State’s Clinical Laboratory Evaluation Program (“NY CLEP”).

Specifically, the FDA intends to exercise enforcement discretion and not enforce certain medical device requirements (including the requirements for marketing authorization and compliance with certain elements of the Quality System Regulation (“QSR”)) with respect to LDTs that were marketed as of the date of the LDT Final Rule’s publication, although such products must still comply with certain other FDA requirements, including registration and listing, portions of the QSR, medical device reporting, labeling, and corrections and removals reporting.

However, where these tests are modified in certain ways from the version of the test marketed as of the LDT Final Rule’s publication date, this enforcement discretion policy will no longer apply and the FDA intends to enforce all applicable FDA requirements (including premarket review and marketing authorization requirements) consistent with the phase-in policy.

In addition, for LDTs that receive approval from NY CLEP, the FDA intends not to enforce marketing authorization requirements when these requirements are phased in more generally at either three and a half or four years following the date of publication of the LDT Final Rule.

However, these tests will still be subject to the remaining medical device requirements, including registration and listing, medical device reporting, and quality system requirements, at the time that such requirements are phased in more generally.

Notwithstanding these new targeted enforcement discretion policies, depending on the kinds of future changes we make to our currently-marketed LDT or any NY CLEP-approved LDT we offer, we may become subject to the application of the phase-in of all FDA medical device requirements (including the need to seek and obtain marketing authorization) at the time that those medical device requirements are phased in more generally.

If we are unable to comply with the phase-in of medical device requirements applicable to our LDTs over the phase-in period, we may be required to cease marketing any products that we market as LDTs.

In addition, efforts by the FDA to actively regulate LDTs could create a negative public perception about the validity, safety, effectiveness, or performance of LDTs, including our products, that could adversely affect patient, provider, and customer perception about, and confidence in, our products.

Moreover, the FDA may assert that we are improperly marketing our LDTs and may take enforcement action against us and/or require premarket review and marketing authorizations, even before the deadline for phasing in medical device requirements to LDTs.

The FDA may request that we provide additional analyses and information beyond that which we intend to produce based on the designs of our current and planned clinical studies, or that we modify or narrow our intended use or product claims.

It is possible that the FDA, among other things, may disagree with our interpretation of data we have relied on to support our LDT launches for our intended uses.

The FDA historically exercised enforcement discretion with respect to LDTs, pursuant to which it did not seek to enforce certain potentially applicable FDA requirements, including premarket review, with certain exceptions.

Even for those LDTs that were subject to the historical enforcement discretion policy, the FDA for a number of years stated its intention to modify this policy and impose applicable medical device requirements to LDTs more broadly.

To this end, on May 6, 2024, the FDA issued a final rule in an effort to clarify the FDA’s historical view that LDTs are medical devices subject to the requirements applicable to other IVDs (the “LDT Final Rule”), and to phase out its enforcement discretion policy over a period of four years from issuance of the LDT Final Rule.

However, on March 31, 2025, the United States District Court for the Eastern District of Texas vacated the LDT Final Rule, reasoning that LDTs are not medical devices, and remanded the matter to the FDA for further consideration.

The decision was not appealed, and in September 2025, the FDA rescinded the LDT Final Rule.

Accordingly, it is uncertain whether or when the FDA may be able to otherwise exercise its medical device authority with respect to LDTs.

This uncertainty could adversely affect the FDA’s ability to apply and enforce its medical device requirements with respect to any LDTs for which a sponsor may plan to obtain a PMA.

Such uncertainty and the FDA’s actions in response could have a material adverse effect on our business and operations.

In light of this uncertainty, we do not know if or when our offerings could become or will remain subject to FDA medical device requirements, including the need to seek and obtain marketing authorization.

If we were unable to comply with any medical device requirements applicable to LDTs if and when any such requirements become applicable, we could be required to cease marketing any solutions that we market as LDTs.

In addition, further efforts by the FDA or Congress to impose more regulation on LDTs could create a negative public perception about the validity, safety, effectiveness, or performance of LDTs, including our solutions, which could adversely affect patient, provider, and customer perception about, and confidence in, our solutions.

Notwithstanding the withdrawal of the LDT Final Rule, the FDA may assert that we are improperly marketing our tests, including Galleri, as LDTs and may assert we do not comply with applicable medical device requirements, and in such cases may take enforcement action against us and/or require us to seek premarket review and obtain marketing authorizations, which may require that we cease marketing any LDT products until

such marketing authorizations are obtained or the relevant applications are submitted.

There can be no assurance that we will be able to obtain any required marketing authorization for our tests or that any labeling claims will be consistent with the claims we have made or intend to make for such products when launched as LDTs, or that such claims would be adequate to support continued adoption of and reimbursement for our products.

In the event we are required to seek FDA marketing authorization for any current or planned products, the FDA may request that we provide additional analyses and information beyond that which we intend to produce based on the designs of our current and planned clinical studies, or that we modify or narrow our intended use or product claims.

It is possible that the FDA, among other things, could disagree with our interpretation of data we have relied on to support our LDT launches for our intended uses.

If we are required to provide additional analyses or additional data or perform additional clinical studies beyond those we currently contemplate to support the intended uses of our products or future products, our planned commercial launches may be delayed and we may be required to cease commercialization of any products we currently market as LDTs.

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For example, most recently, in March 2023, the Verifying Accurate Leading-edge IVCT Development Act of 2023 (the “VALID Act”) was introduced.

The bill would have established a risk-based approach to imposing requirements related to premarket review, quality systems, and labeling requirements on all IVCTs, including LDTs, but would grandfather certain LDTs marketed before the effective date

of the bill and exempt them from certain requirements.

It is unclear whether the VALID Act or any other or similar legislative proposals (including any proposals that would, in contrast, reduce FDA oversight of LDTs) will be passed by Congress or signed into law by the President.

It is unclear whether legislative proposals such as the VALID Act (including any proposals that would, in contrast, reduce FDA oversight of LDTs) will be introduced or passed by Congress or signed into law by the President.

Depending on the approach adopted under any potential legislation or regulation, certain LDTs (likely those of higher risk) may be required to undergo some form of premarket review, potentially with a transition period for compliance and a grandfathering provision.

Any such legislation could substantially alter our commercial offering and marketing of LDTs and negatively impact our financial condition and results of operations.

Furthermore, there is increased uncertainty regarding the FDA’s implementation of the FDA’s LDT final rule under the new U.S.

Presidential administration.

In particular, the LDT Final Rule has been the subject of significant recent litigation, and it remains possible that under the new U.S.

Presidential administration, FDA may abandon or delay the implementation of the LDT Final Rule, or that the administration may not defend the LDT Final Rule against current or future litigation challenges.

If the LDT Final Rule is successfully challenged, abandoned or delayed, the regulatory environment around LDTs could be significantly relaxed, which could increase competition and reduce the effectiveness of our regulatory and reimbursement strategy.

Nevertheless, as the FDA begins to phase out its policy of enforcement discretion for LDTs as recently described in the LDT Final Rule, or if it asserts that our LDTs are not eligible for application of its new, targeted enforcement discretion policies, or if Congress enacts legislation such as the VALID Act to subject LDTs to affirmative FDA oversight as IVCTs, we may be required to obtain marketing authorization for our LDT products from the FDA prior to initially launching our future products or may be required to cease marketing any commercially marketed products that are marketed as LDTs until such marketing authorization is obtained or the applications are submitted.

There can be no assurance that we will be able to obtain such marketing authorization or that any labeling claims will be consistent with the claims we have made or intend to make for such products when launched as LDTs, or that such claims will be adequate to support continued adoption of and reimbursement for our products.

Even if our products are allowed to remain on the market prior to any required marketing authorization, demand or reimbursement for our products may decline if there is uncertainty about our products, if we are required by the FDA to label our products as investigational, or if the FDA limits the labeling claims we are permitted to make for our products.

As a result, we could experience significantly increased development costs and a delay in generating additional revenue from our products, or from other future products now in development, which could reduce our revenues or increase our costs and adversely affect our business, results of operations, financial condition, or growth prospects.

Additionally, as a result of the District Court decision the regulatory environment around LDTs could be significantly relaxed, which could increase competition and reduce the effectiveness of our regulatory and reimbursement strategy.

The regulatory clearance, approval, or certification processes of the FDA and comparable foreign regulatory authorities or notified bodies are lengthy, time-consuming, and unpredictable.

We have not yet obtained FDA clearance or approval for any of our products or products in development.

We are in the process of seeking PMA approval from the FDA for Galleri, while we market Galleri as an LDT.

While we have submitted a PMA to the FDA for approval of Galleri, we have not yet obtained FDA clearance or approval for any of our products or products in development and we currently market Galleri as an LDT.

We may also seek FDA approval or clearance for other products in the future.

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Even if we believe our data are sufficient to support marketing authorization, regulatory authorities may disagree, or may require the generation and submission of additional data or analyses, which could significantly delay or preclude marketing authorization.

Before a new medical device can be marketed in the United States, a company must first submit an application for and receive 510(k) clearance pursuant to a premarket notification submitted under Section 510(k) of the FDCA, approval of a PMA application, or grant of a de novo classification request from the FDA, unless an

exemption applies.

Before a new medical device can be marketed in the United States, a company must first submit an application for and receive 510(k) clearance pursuant to a premarket notification submitted under Section 510(k) of the FDCA, approval of a PMA, or grant of a de novo classification request from the FDA, unless an exemption applies.

In the process of obtaining PMA approval, which we are pursuing for Galleri, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, analytical validation, preclinical, clinical trial, manufacturing, and labeling data.

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For example, certain modifications to a PMA-approved device may require approval of a new PMA or a PMA supplement, or alternatively a notification or other submission to the FDA.

If we obtain PMA approvals from the FDA, we may make modifications or add additional features in the future that we believe do not require approval of a PMA application or supplement or other regulatory submission.

If we obtain PMA approvals from the FDA, we may make modifications or add additional features in the future that we believe do not require approval of a PMA or supplement or other regulatory submission.

If the FDA disagrees with our determination and requires us to seek new marketing authorizations for the modifications for which we have concluded that new marketing authorizations are unnecessary, we may be required to cease marketing and/or to recall the modified product until we obtain such marketing authorization, and we may be subject to significant regulatory fines or penalties.

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If we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU, and any delays in coming into compliance with these laws and regulations could prevent or delay our ability to launch Galleri in Europe.

The aforementioned EU rules are generally applicable in the EEA (which consists of the 27 EU member states plus Iceland, Norway and

Liechtenstein, and also generally applicable in Türkiye).

The aforementioned EU rules are generally applicable in the EEA (which consists of the 27 EU member states plus Iceland, Norway and 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.

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Ongoing compliance with both sets of regulatory requirements may result in increased costs for our business.

Furthermore, on December 16, 2024, the UK government published an amendment to the UK MDR to clarify and strengthen the post-market surveillance requirements for medical devices (including IVDs) in Great Britain.

This amendment will come into force on June 16, 2025.

Furthermore, on December 16, 2024, the UK government passed an amendment to the UK MDR to clarify and strengthen the post-market surveillance requirements for medical devices (including IVDs) in Great Britain.

This amendment became applicable on June 16, 2025.

In addition, the MHRA launched a consultation from November 14, 2024 to January 5, 2025 on proposed changes to the pre-market requirements for medical devices in Great Britain.

The MHRA has stated that it will incorporate feedback to this consultation into new UK legislation on pre-market requirements for medical devices in Great Britain.

The new legislation is expected to come into force in 2026.

On July 22, 2025, the MHRA published a response to the consultation confirming that it will incorporate feedback to this consultation into new UK legislation on pre-market requirements for medical devices in Great Britain.

A draft of the new legislation is expected to be published in 2026.

Under the UK MDR, in order to be lawfully placed on the Great Britain market, Class A (non-sterile) IVDs need to be United Kingdom Conformity Assessment (“UKCA”) certified by a UK approved body.

However, certain IVDs in compliance with either the EU IVDD or IVDR can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030.

However, certain IVDs in compliance with:

(a) the EU IVDD can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030;

and (b) the EU IVDR can continue to be placed on the Great Britain market until June 30, 2030.

IVDs also need to bear a physical UKCA mark in order to be lawfully placed on the Great Britain market.

We have UKCA self-certified our Galleri test and it bears a UKCA mark.

However, one of the key areas in the consultation was to obtain feedback on whether to remove the requirement for a medical device and its labelling (i.e.

However, the MHRA has confirmed in its response to the consultation on pre-market requirements for medical devices in Great Britain that it intends to remove the requirement for a medical device or an IVD and their labelling (i.e.

packaging and instructions for use) in Great Britain to bear a physical UKCA mark.

Instead of requiring a medical device and its labelling to bear a UKCA mark, manufacturers would be required to assign a unique design identification (“UDI”) to medical devices before they are placed on the Great Britain market.

If this change is implemented, we may no longer be required to affix the physical UKCA mark to our devices, but we may need to assign and affix a UDI.

Instead of requiring a medical device or an IVD and their labelling to bear a UKCA mark, manufacturers would be required to assign a unique design identification (“UDI”) to such devices and register the UDI in a publicly accessible database before they are placed on the Great Britain market.

If this change is implemented, we may no longer be required to affix the physical UKCA mark to our devices, but we may need to assign and affix a UDI and register the UDI in a publicly accessible database.

Understanding and ensuring compliance with any new requirements is likely to lead to further complexity and increased costs to our business.

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• the approval (or certification) policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval or certification.

We are engaged in ongoing discussions with the FDA regarding the clinical studies and data that will be needed to support a successful PMA for a multi-cancer test for our planned indications, based on the designs of our current and planned clinical studies.

There can be no assurance that our existing or future products for which we may seek clearance, approval, or certification will be approved, cleared, or certified by the FDA, a comparable foreign regulatory authority or a notified body on a timely basis, if at all.

We engaged in discussions with the FDA regarding the clinical studies and data that would be needed to support a successful PMA for a multi-cancer test for our targeted indications, based on the designs of our current and planned clinical studies.

Notwithstanding any FDA feedback, there can be no assurance that our existing or future products for which we may seek clearance, approval, or certification will be approved, cleared, or certified by the FDA, a comparable foreign regulatory authority or a notified body on a timely basis, if at all.

If our products or future products receive clearance, approval, or certification but there is uncertainty about such products among providers or payors, reimbursement may be adversely affected and we may not be able to sell our products.

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If the approved, cleared, or certified indication or other labeling claims the FDA or a comparable foreign regulatory authority or notified body allows us to make are more limited than we expect, or are more limited than current claims made with respect to Galleri, our business, prospects, and growth may be adversely affected and we may be limited in our ability to sell, or unable to sell, our products.

As part of our PMA submission to the FDA for Galleri, we included a bridging analysis between the version of Galleri used in the PATHFINDER 2 study and NHS-Galleri Trial and the version we have submitted to the FDA for PMA approval.

The results of this bridging analysis will likely impact any labeling claims, and may differ from previously reported performance results from those studies.

If we are not able to obtain FDA approval for desired uses or indications for our current and future products, we may not market or promote them for those indications and uses, and our business, financial condition, results of operations, stock price and prospects could be materially harmed.

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The FDA has never granted marketing authorization for a multi-cancer detection test.

Additionally, in March 2020, the FDA held a public workshop to discuss the clinical, scientific, and regulatory challenges associated with circulating tumor DNA cancer screening tests, and we expect the FDA to continue to gather input from a variety of industry, academic, and clinical stakeholders to inform its thinking on how to assess these types of tests, including potentially convening an Advisory Committee meeting

during review of a PMA for Galleri (or another company’s PMA for a multi-cancer early detection test, should it precede ours).

In fact, on November 29, 2023, the FDA held a meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss and make recommendations on the design of multi-cancer detection in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of multi-cancer detection screening tests.

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Similarly, other companies seeking to develop a multi-cancer early detection test would need to satisfy these requirements in order to obtain approval of a PMA from the FDA, and to the extent the requirements that the FDA adopts are less stringent than we expect, it may be easier for potential competitors to enter this market.

We continue to interact with the FDA regarding the data we must provide the FDA to support our PMA submission for a multi-cancer detection test based on a proposed intended use.

As part of our ongoing interactions, the FDA has provided feedback regarding how it plans to assess the safety and effectiveness of Galleri based on potential intended use statements.

In addition, we have made pre-submissions to the FDA detailing the clinical and analytical studies intended to support our PMA submission for Galleri, including related to limit of detection, reproducibility, repeatability and other analytical validation studies.

Subsequent to these pre-submissions, we met with the FDA and the FDA provided written and verbal feedback, documented in minutes, evaluating the use and size of certain of our proposed studies in our PMA submission and requesting or suggesting changes to certain of our proposed studies.

While we plan to continue interactions with the FDA, including regarding the FDA’s feedback, requests and suggestions to date, the FDA may raise additional questions or request additional information in connection with the submission of a marketing application.

Given the novel nature and complexity of our multi-cancer detection tests, and the fact that the FDA has never granted marketing authorization for a multi-cancer detection test, we cannot be certain whether we will receive FDA approval for Galleri and we cannot provide assurances that the studies we have conducted, are currently conducting, or plan to conduct, will be sufficient to provide the data that the FDA requires to support a proposed intended use.

For example, we plan on providing evidence from our PATHFINDER 2 study and NHS-Galleri Trial to support a PMA as our pivotal study data, as well as supplemental data from other clinical studies, and certain clinical data in the post-approval setting.

We may be required to conduct additional studies or expand the enrollment of completed or ongoing studies to support our PMA, as study design and enrollment continue to be discussed with the FDA.

For example, we provided results from our PATHFINDER 2 study and NHS-Galleri Trial to support our PMA, as well as supplemental data from other clinical studies, and certain clinical data in the post-approval setting.

We may be required to conduct additional studies or expand the enrollment of completed or ongoing studies to support approval of a PMA, as study design and enrollment continue to be discussed with the FDA.

The FDA may require us to perform new analyses of our clinical data.

These and other efforts that we may be required to undertake could delay the submission of our PMA or delay or prevent approval, lead to a more limited intended use statement or approved labeling, and/or lead to significant post-approval limitations or restrictions, if approval is obtained at all.

If the FDA determines that the data we plan to submit in our PMA are insufficient to support approval of our proposed intended use, our PMA submission could be delayed and we need to generate more data from additional participants, in which case we may not receive approval or may receive an inadequate approved label, and may need to resubmit a PMA following completion of additional new or expanded clinical studies.

Our use and disclosure of personal information, including individually identifiable health information, and biologic samples and related data are subject to federal, state and foreign privacy and security regulations.

These and other efforts that we may be required to undertake could delay the review of our PMA or delay or prevent approval, lead to a more limited intended use statement or approved labeling, and/or lead to significant post-approval limitations or restrictions, if approval is obtained at all.

If the FDA determines that the data we submitted in our PMA are insufficient to support approval of our proposed intended use, the FDA’s review of the application could be delayed and we need to generate more data from additional participants, in which case we may not receive approval or may receive an inadequate approved label, and may need to resubmit a PMA or supplement following completion of additional new or expanded clinical studies.

Our use and disclosure of personal information, including individually identifiable health information, and biological samples and related data are subject to federal, state and foreign privacy and security regulations.

Data privacy rules are evolving and new legislation concerning privacy and data use may limit our ability to use such data and specimens.

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Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or perception of their requirements may have on our business.

This evolution may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use and share personal information,

This evolution may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use and disclose personal information,

necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us.

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Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, consents and authorizations, our internal or publicly facing policies and procedures or our contracts governing our processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, results of operation, and financial condition.

We receive, store, process and use personal information as part of our business and as our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities.

We receive, store, process and disclose personal information as part of our business and as our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities.

In the United States, numerous state and federal laws and regulations govern the collection, dissemination, use, disclosure, privacy, confidentiality, security, availability and integrity of personal information, including health-related information.

We are a covered entity under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations that implement both laws (collectively, “HIPAA”).

HIPAA establishes, among other things, a set of national privacy and security standards relating to the privacy, security, transmission, and breach reporting of individually identifiable health information, by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, the business associates with whom such covered entities contract for services that involve creating, receiving, maintaining, or transmitting protected health information, and the subcontractors of such business associates.

We are a covered entity under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations implemented thereunder (collectively, “HIPAA”).

HIPAA establishes, among other things, a set of national privacy and security standards relating to the privacy, security, transmission, and breach reporting of individually identifiable health information, by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, the business associates with whom such covered entities contract for services that involve creating, receiving, maintaining, or transmitting protected health information (“PHI”), and the subcontractors of such business associates.

In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA.

HIPAA requires covered entities and business associates to develop and maintain policies with respect to the protection of, use and disclosure of protected health information (“PHI”), including the adoption of administrative, physical and technical safeguards to protect such information, and certain notification requirements in the event of a breach of unsecured PHI.

HIPAA requires covered entities and business associates to develop and maintain policies with respect to the protection of, use and disclosure of PHI, including the adoption of administrative, physical and technical safeguards to protect such information, and certain notification requirements in the event of a breach of unsecured PHI.

Additionally, under HIPAA, covered entities must report breaches of unsecured PHI to affected individuals without unreasonable delay, not to exceed 60 days following discovery of the breach by a covered entity or its agents.

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these laws are not preempted by HIPAA to the extent that they are more stringent than HIPAA.

Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners.

For example, the California Consumer Privacy Act as amended by the California Privacy Rights Act (“CPRA” and, collectively, the “CCPA”) requires covered businesses that process the personal information of California residents to, among other things:

Such laws and regulations are and will continue to be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners.

For example, the California Consumer Privacy Act, as amended by the California Privacy Rights Act (collectively, the “CCPA”) requires covered businesses that process the personal information of California residents to, among other things:

(i) provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information;

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Additional compliance investment

and potential business process changes may also be required.

and potential business process changes may also be required as the statute and regulations continue to evolve.

Although there are limited exemptions for certain health-related data, including clinical trial data and PHI subject to HIPAA, the CCPA may increase our compliance costs and potential liability.

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We also expect that there will continue to be new laws, regulations and industry standards concerning privacy, data protection and information security proposed and enacted in various jurisdictions.

For example, Washington State has enacted a broadly applicable law to protect the privacy of personal health information known as the “My Health My Data Act,” which generally requires affirmative consent for the collection, use, or sharing of any “consumer health data.” Consumer health data is defined to include personal information that is linked or reasonably linkable to a consumer and that identifies a consumer’s past, present, or future physical or mental health status;

For example, Washington State has enacted a broadly applicable law to protect the privacy of personal health information known as the “My Health My Data Act,” which broadly defines “consumer health data”, creates a private right of action to allow individuals to sue for violations of the law, imposes stringent consent requirements, and grants consumers certain rights with respect to their health data, including to request deletion of their information.

Consumer health data is defined to include personal information that is linked or reasonably linkable to a consumer and that identifies a consumer’s past, present, or future physical or mental health status;

consumer health data also includes information that is derived or extrapolated from non-health information, such as algorithms and machine learning.

Other states, including Connecticut and Nevada, have also passed consumer health data laws, and given the increased focus on the use of health data by entities that are not subject to HIPAA, additional states are expected to pass consumer health privacy laws.

Other states, including, but not limited to, Connecticut, Virginia and Nevada, have also passed laws governing the privacy of consumer health data, and given the increased focus on the use of health data by entities that are not subject to HIPAA, additional states are expected to pass consumer health privacy laws.

The enactment of such laws could have potentially conflicting requirements that would make compliance challenging.

We could be adversely affected if HIPAA, the CCPA and other state or federal legislation or regulations applicable to GRAIL require changes in our business practices, our use, receipt, or transfer of health information, or our privacy policies, or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively affect our business, financial condition and results of operations.

The Federal Trade Commission (“FTC”) also has authority to initiate enforcement actions against entities that mislead customers about HIPAA compliance, make deceptive statements about privacy and data sharing in privacy policies, fail to limit third-party use of personal health information, fail to implement policies to protect personal health information or engage in other unfair practices that harm customers or that may violate Section 5 of the Federal Trade Commission Act (“FTC Act”).

The Federal Trade Commission (“FTC”) also has authority to initiate enforcement actions against entities that mislead customers about HIPAA compliance, make deceptive statements about privacy and data sharing in privacy policies, fail to limit third-party use of health information, fail to implement policies to protect personal health information or engage in other unfair practices that harm customers or that may violate Section 5 of the Federal Trade Commission Act (“FTC Act”).

Even when HIPAA does not apply, according to the FTC, violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of the FTC Act.

The FTC also expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Personal health information is considered sensitive data that merits stronger safeguards.

Additionally, federal and state consumer protection laws are increasingly being applied by FTC and states’ attorneys general to regulate the collection, use, storage, and disclosure of health-related and other personal information through websites or otherwise, and to regulate the presentation of website content.

We strive to comply with applicable laws, regulations, policies and other legal obligations relating to privacy, data protection and information security.

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maintaining a record of data processing;

providing detailed disclosures about how personal information is collected and processed (in a concise, intelligible and easily accessible form);

providing detailed disclosures

about how personal information is collected and processed (in a concise, intelligible and easily accessible form);

demonstrating that appropriate legal bases are in place to justify data processing activities;

complying with rights

for data subjects in regard to their personal information (including data access, erasure (the right to be “forgotten”) and portability);

complying with rights for data subjects in regard to their personal information (including data access, erasure (the right to be “forgotten”) and portability);

ensuring appropriate safeguards are in place where personal information is transferred out of the EEA and the UK;

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Further, the regulatory landscape of data and digital laws in the UK and EU is under constant development, and in the future we may be required to adapt our processes, or change the way we engage with health data.

Among other requirements, the GDPR regulates the transfer of personal information outside of the EEA and the UK.

Among other requirements, the GDPR regulates the transfer of personal information outside of the EEA and the UK and we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue, and international transfers to the United States, China, and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators.

As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints and/or regulatory investigations or fines;

we may have to stop using certain tools and vendors and make certain operational changes, including to implement other/revised relevant documentation for data transfers within required time frames;

we may have to stop using certain tools and vendors and make certain operational changes, we may have to implement alternative data transfer mechanisms under the GDPR and/ or take additional compliance and operational measures;

and/or it could otherwise affect the manner in which we provide our services, and could adversely affect our business, operations and financial condition.

Penalties and fines for failure to comply with the GDPR are significant, including fines of up to €20 million/ £17.5 million or 4% of a noncompliant company’s global turnover for the preceding year, whichever is higher.

Since we are subject to the supervision of relevant data protection authorities under both the UK GDPR and the EU GDPR, we could be fined under each of those regimes independently in respect of the same non-compliance.

Since we are subject to the supervision of relevant data protection authorities under both the UK GDPR and the EU GDPR, we could be fined under those regimes independently and in respect of the same non-compliance.

As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business.

Noncompliance with applicable foreign privacy laws, such as the GDPR, would also adversely affect public perception of GRAIL’s data stewardship practices and policies, which could impair our business and prospects with other foreign health systems and governments.

In addition to potential fines, noncompliance with applicable foreign privacy laws, such as the GDPR, may result in regulatory investigations, orders to cease/ change our data processing activities, enforcement notices, assessment notices (for a compulsory audit), civil claims (including class actions) and/or damage to the public perception of GRAIL’s data stewardship practices and policies, which could impair our business and prospects with other foreign health systems and governments.

Our business may be affected by the evolving regulatory framework for AI Technologies.

The regulatory framework for artificial intelligence (“AI”), machine learning, and automated decision-making technologies (collectively, “AI Technologies”) is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations.

Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of our AI Technologies.

It is possible that new laws and regulations will be adopted in the United States and in other non-U.S.

jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies.

We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions.

Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies).

Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.

If 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.

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We also hold a CAP accreditation for our Durham facility.

While we have completed validation studies for the version of Galleri currently marketed as an LDT, we are continuing our validation efforts for the version of Galleri that we intend to submit for PMA approval.

We may not successfully complete such validation.

Certain product additions to our test menu require notification to the regulatory and accrediting bodies that regulate our laboratory (e.g., CMS, the California Department of Public Health Laboratory Field Services (“CALFS”) and CAP) that we are adding a new specialty to our assay offerings.

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Further, if we test specimens originating from other states and return patient-specific results, our clinical laboratory must satisfy such states’ licensure laws as well to the extent that such laws regulate out-of-state laboratories that test specimens originating in such states.

For example, to be able to receive specimens originating from New York, we must maintain a New York State Department of Health clinical laboratory permit and obtain approval of Galleri, which we achieved.

For example, to be able to receive specimens originating from New York, we must maintain a NYSDoH clinical laboratory permit and obtain approval of Galleri, which we achieved.

Research testing, however, does not require licensure if patient-specific results are not generated and/or returned for diagnostic purposes.

We have obtained New York State Department of Health clinical laboratory permits for our Durham facility for our initial commercial version of Galleri and conditional approval for our new version of Galleri, which authorize us to accept and generate for diagnosis or treatment purposes patient-specific results on specimens originating from New York at the applicable facility, as well as having obtained New York State Department of Health approval (or, with respect to the new version of Galleri, conditional approval) to offer Galleri to residents of the State of New York.

We have obtained NYSDoH clinical laboratory permits for our Durham facility for our initial commercial version of Galleri and approval for our new version of Galleri, which authorize us to accept and generate for diagnosis or treatment purposes patient-specific results on specimens originating from New York at the applicable facility, as well as having obtained NYSDoH approval (or, with respect to the new version of Galleri, conditional approval) to offer Galleri to residents of the State of New York.

Applicable New York laws and regulations establish standards for day-to-day operation of a clinical laboratory, including training and skill levels required of laboratory personnel, physical requirements of a facility, equipment, and validation and quality control.

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CMS also has the authority to impose a wide range of sanctions, including suspension, limitation, or revocation of the CLIA certification, termination of Medicare and Medicaid participation, civil money penalties, and a bar on the ownership or operation of a CLIA-certified laboratory by any owners or operators of the deficient laboratory.

If we fail to obtain any required state licensure, or lose CLIA certification, CAP accreditation, or licensure, we would not be able to operate our clinical laboratory and offer our products in full or in particular states, which would adversely impact our business and results of 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.

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As a result, topline and preliminary data should be viewed with caution until the final data are available.

Audits, internal or external, including by the FDA’s

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.

From time to time, we may also disclose interim data from our clinical studies.

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Further, disclosure of interim data by us or by third parties could result in volatility in the price of our common stock.

In particular, in the United Kingdom, we are working with NHS England to complete our NHS-Galleri Trial.

It is possible that the early preliminary, interim or final data may not be as we expect, may be inconsistent with prior NHS-Galleri data, or with other studies we have conducted, or may be unsuitable to the NHS, any of which could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our ability to achieve CMS or private payor reimbursement or coverage, our brand and reputation, our business, and our growth prospects.

For example, we recently announced the topline results of our NHS-Galleri Trial in the United.

In May 2024, the NHS determined, based on data from an early analysis of Galleri test performance results in the intervention arm from the prevalent screening round of the NHS-Galleri Trial, not to initiate an implementation pilot in England prior to the final trial results.

We submitted to NHS England and to the FDA information from the prevalent screening round.

Various factors are likely to cause the final results to differ from the prevalent screening round results.

Further, it is possible that the early preliminary, interim or final data may not be as we expect, may be inconsistent with prior NHS-Galleri Trial data, or with other studies we have conducted, or may be unsuitable to the NHS or the FDA.

Importantly, preliminary or interim data may be focused on different endpoints than the overall study.

The prevalent screening round results that we announced and provided to the NHS and FDA were predominantly focused on performance characteristics of the Galleri test, whereas the primary endpoint and a number of secondary endpoints of the trial were focused on clinical utility measures like cancer stage shift that can only be measured through annual testing over a number of years.

Similarly, in October 2025, performance and safety results from the first approximately 25,000 participants of the PATHFINDER 2 study were presented at the ESMO Congress 2025.

PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri test when added to standard of care single cancer screening in 35,878 adults aged 50 years and older with no clinical suspicion of cancer.

Results from the full approximately 35,000 participants in the PATHFINDER 2 study were generally consistent with the results presented at ESMO.

While we did not include full performance and safety data from the additional 10,000 patients in our initial PMA submission, it is possible that the FDA could require these data to confirm study performance.

Any unexpected, unsuitable, or inconsistent results could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our ability to achieve CMS or private payor reimbursement or coverage, our brand and reputation, our business, and our growth prospects.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, and our ability to receive regulatory clearance or approval or commercialize a particular product and our company in general.

In addition, the information we choose to publicly disclose regarding a particular study or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business.

In addition, the information we choose to publicly

disclose regarding a particular study or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business.

If the data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to commercialize or obtain regulatory clearance or approval for our products may be harmed, which could harm our reputation, business, operating results, prospects or financial condition.

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In addition, clearance, approval, or certification may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the test or device.

After clearance, approval, or certification, discovery of problems with our product, suppliers, vendors, or

contract manufacturers, or manufacturing processes (including software validation), and/or failure to comply with regulatory requirements, may result in actions such as:

After clearance, approval, or certification, discovery of problems with our product, suppliers, vendors, or contract manufacturers, or manufacturing processes (including software validation), and/or failure to comply with regulatory requirements, may result in actions such as:

• restrictions on operations of our laboratories;

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In addition, the FDA may change its clearance or approval policies, adopt additional regulations or revise existing regulations, or take other actions.

For example, on February 23, 2024, the FDA issued a final rule to amend the Quality System Regulation (“QSR”), which establishes current good manufacturing practice requirements for medical devices, to align more closely with the International Organization for Standardization standards.

Specifically, this final rule, which the FDA expects to go into effect on February 2, 2026, replaces the QSR with the Quality Management System Regulation (“QMSR”), and among other things, incorporates by reference the quality management system requirements of ISO 13485:2016.

Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the QSR, it is unclear the extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise create market pressure that may negatively affect our business.

If we are unable to comply with the QMSR, once effective, or with any other changes in the laws or regulations enforced by the FDA or comparable regulatory authorities, we may be subject to adverse actions of the FDA which may result in any of the sanctions described above.

For example on February 2, 2026, the FDA’s final rule implementing the FDA’s Quality Management System Regulation (“QMSR”) became effective.

The QMSR, which replaced the FDA’s former Quality System Regulation (“QSR”), sets forth the FDA’s cGMP requirements for medical devices, and among other things, incorporates by reference certain elements of the quality management system requirements of ISO 13485:2016.

Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the QSR, and although our quality management system is designed to comply with ISO:13485, the FDA has indicated that ISO:13485 certification alone will not ensure compliance under the QMSR, nor will ISO certification exempt manufacturers from FDA inspection.

The QMSR also includes certain compliance obligations, such as those relating to unique device identification, product traceability, and maintenance of complaint and service records, that align more closely with the FDA’s existing medical device requirements than with ISO standards.

Accordingly, it remains unclear the extent to which the QMSR may impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise negatively affect our business.

Such changes may also occur in foreign jurisdictions where we intend to market our products or future products.

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Unlike directives, which must be implemented into the national laws of the EU member states, regulations are directly applicable (i.e., without the need for adoption of EU member state laws implementing them) in all EU member states and are intended to eliminate current differences in the regulation of medical devices among EU member states.

The EU IVDR, among other things, is

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.

The EU IVDR, among other things, is 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.

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.

These modifications may have an effect on the way we intend to develop our business in the EU and the EEA.

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The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

For products for which we obtain FDA clearance or approval or that are otherwise subject to affirmative FDA oversight, we will be subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury.

which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury.

The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event.

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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.

For the FDA to approve or clear a medical device marketing application, the methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.

For the FDA to approve or clear a medical device marketing application, the methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QMSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.

Furthermore, to obtain FDA clearance or approval, we are required to verify that our suppliers maintain facilities, procedures and operations that comply with our quality standards and applicable regulatory requirements.

The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors.

The FDA enforces the QMSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors.

Similar state regulations and various laws and regulations of foreign countries governing manufacturing also apply to our products.

Our third-party manufacturers may not take the necessary steps to comply with applicable regulations, which could cause delays in the availability of our products or a delay in obtaining FDA authorization of our marketing application.

In addition, the FDA issued a final rule to amend the QSR, which establishes current good manufacturing practice requirements for medical devices, to align more closely with the International Organization for Standardization standards.

In addition, on February 2, 2026, the FDA’s final rule implementing the QMSR became effective.

The QMSR, which replaced the FDA’s former Quality System Regulation, sets forth the FDA’s cGMP requirements for medical devices, and among other things, incorporates by reference certain elements of the quality management

system requirements of ISO 13485:2016.

Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the QSR, and although our quality management system is designed to comply with ISO:13485 the FDA has indicated that ISO:13485 certification alone will not ensure compliance under the QMSR, nor will ISO certification exempt manufacturers from FDA inspection.

If we or our third party manufacturers are unable to comply with the QMSR, once effective, or with any other applicable FDA requirements or if we or a third party manufacturer discovers previously unknown problems with our products or manufacturing processes, these could result in, among other things:

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and criminal prosecution of us, our suppliers, or our employees.

Any of these actions could significantly and negatively affect supply of our products.

Any 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.

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There may be increased risk of injury to patients if physicians attempt to use our products off-label, which could harm our reputation in the marketplace among physicians and patients.

If, after FDA authorization or certification, the FDA or any foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction,

seizure, civil fine or criminal penalties.

It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

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The FTC has instituted enforcement actions against certain healthcare testing companies for making false or misleading advertising claims and for failing to adequately substantiate claims made in advertising.

These enforcement actions may result in warning letters, consent decrees, and the payment of civil penalties and/or restitution by the companies involved.

These enforcement actions may result in warning

letters, consent decrees, and the payment of civil penalties and/or restitution by the companies involved.

Should the FTC determine that our claims are false or misleading or unsubstantiated, we could be subject to FTC enforcement action and may face significant penalties which may result in a material adverse effect on our reputation, business, financial condition, results of operations, and growth prospects.

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The impact of this payment system on rates for our tests, including any current or future tests we may develop, is uncertain.

For more information, see above and the section entitled “Risks Relating to Our Business and Industry—One of the key elements of our strategy is to expand access to our tests by pursuing coverage and reimbursement from third-party payors, both private and government payors.

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 beyond our existing sales channels will be limited and our overall commercial success will be limited.”

For more information, see above and the section entitled “Risks Relating to Our Business and Industry.

More recently, the One Big Beautiful Bill Act (the “OBBBA”) included significant reforms to Medicaid, including an estimated $1 trillion in reduced federal Medicaid spending from 2025 through 2034, the imposition of work requirements for certain adult enrollees, more frequent eligibility redeterminations, and increased cost-sharing for beneficiaries.

These changes are expected to reduce overall Medicaid enrollment and access to care.

Although the effect on our business is currently unknown, any decrease in the number of insured patients or reimbursement levels for our tests could adversely affect our revenue and commercial prospects.

We cannot predict whether or when these or other recently enacted healthcare initiatives will be implemented at the federal or state level or in foreign jurisdictions or how any such legislation or regulation may affect us.

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or report financial information or data accurately or to disclose unauthorized activities to us.

For example, in June 2023, our third- party telemedicine provider experienced a software issue that resulted in erroneous test reports being delivered to patients.

For example, in June 2023, our third- party telemedicine provider experienced a software issue that resulted in

erroneous test reports being delivered to patients.

And as we continue to partner with digital health partners, we will face increased risk where Galleri is offered through third party telemedicine platforms, related to, for example, reputational considerations, promotional and marketing considerations, cybersecurity considerations, and compliance with applicable laws.

Since we began commercializing Galleri in the United States, our potential exposure under such laws has increased significantly, and our costs associated with compliance with such laws have, and will likely continue to, increase.

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A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation, and many courts have interpreted that statute as being violated if merely one purpose of any arrangement is to induce referrals or purchases.

In 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), which establishes an all-payor anti-kickback prohibition for, among other things, knowingly and willfully paying or offering any remuneration directly or indirectly to induce a referral of an individual to a clinical laboratory.

• the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), which establishes an all-payor anti-kickback prohibition for, among other things, knowingly and willfully paying or offering any remuneration directly or indirectly to induce a referral of an individual to a clinical laboratory.

Violations of EKRA may result in fines, imprisonment, or both, for each occurrence.

The law includes a limited number of exceptions, some of which closely align with corresponding Anti-Kickback Statute exceptions and safe harbors, and others that materially differ.

Currently, there is no regulation interpreting or implementing EKRA, nor any guidance released by a federal agency regarding the scope of EKRA.

Based on the plain language of EKRA and recent case law, certain sales-based incentive

compensation models may present risk while others may fall outside the scope of EKRA, depending on the facts and circumstances.

Certain sales-based incentive compensation models may present risk while others may fall outside the scope of EKRA, depending on the facts and circumstances.

Accordingly, we cannot guarantee that our relationships with providers, sales representatives, or customers will not be subject to scrutiny or will withstand regulatory challenge under EKRA;

• the federal physician self-referral prohibition, commonly known as the Stark Law, which, in the absence of an applicable exception, prohibits a physician from making a referral for certain designated health services covered by the Medicare or Medicaid program, including clinical laboratory services, if the physician or an immediate family member of the physician has a financial relationship with the entity providing the designated health services.

providing the designated health services.

The Stark Law also prohibits the entity furnishing the designated health services from billing, presenting or causing to be presented a claim for the designated health services furnished pursuant to the prohibited referral;

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state laws that require healthcare companies to comply with the medical device industry’s voluntary compliance guidelines, the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers, and other potential referral sources or state-specific standards on financial interactions with healthcare providers;

state laws that require healthcare companies to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensation, and other remuneration and items of value provided to healthcare professionals and entities;

and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

and state laws that require healthcare companies to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensation, and other remuneration and items of value provided to healthcare professionals and entities.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available and lack of clear guidance, it is possible that some of our business activities could, despite our efforts to comply, be subject to challenge under one or more of such laws.

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We or those in our industry could face litigation for our ESG or diversity policies and/or programs and if we were sued under any of these claims, our financial condition, reputation or business could be adversely impacted.

Changes in funding, global health concerns or disruptions at the FDA, other government agencies, and notified bodies could hinder their ability to hire and retain key leadership and other personnel, or

otherwise prevent new or modified products from being developed, approved, certified, or commercialized in a timely manner or at all.

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.

Our ability to develop, approve, certify, commercialize or receive reimbursement for our test depends on interactions with, decisions of and approvals and payments by the U.S.

and other governments.

The ability of the FDA, foreign regulatory agencies, and notified bodies to review and clear, approve, or certify new products or changes to existing products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s, foreign regulatory agencies’, and notified bodies’ ability to hire and retain key personnel and accept the payment of user fees, government shutdowns, and other events that may otherwise affect the FDA’s, foreign regulatory agencies’ and notified bodies’ ability to perform routine functions.

For example, in January 2025, federal employees were offered the option to make a deferred resignation, which, if a significant number of employees elect, could impact the workforce and resources of the FDA available to review products such as ours.

Average review times at the FDA, foreign regulatory agencies, and notified bodies have fluctuated in recent years as a result of these factors.

Disruptions at the FDA, other agencies, and notified bodies may also slow the time necessary for new medical devices or modifications to cleared, approved, or certified medical devices to be reviewed and/or approved, or certified by necessary government agencies or notified bodies, which would adversely affect our business.

For example, in recent years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Recently, In addition, during the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.

If a prolonged government shutdown occurs, or if new global health concerns prevent the FDA, other regulatory authorities, or notified bodies from conducting their regular activities, it could significantly impact the ability of the FDA, other regulatory authorities, or notified bodies to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA, notified bodies and other agencies may also slow the time necessary for new medical devices or modifications to approved, cleared, or certified medical devices to be reviewed and cleared, approved, or certified

by necessary government agencies, which would adversely affect our business.

For example, the current U.S.

administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S.

administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

In addition, in recent years, the U.S.

government has shut down several times, and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities, including during an extended shutdown between October 1, 2025 and November 12, 2025.

Similar shutdowns could have a broad range of negative effects on our business.

Disruptions at the FDA, other agencies, and notified bodies caused by these or other shutdowns, may also slow the time necessary for new medical devices or modifications to be cleared and approved, or certified medical devices to be reviewed and/or approved, or certified by necessary government agencies or notified bodies, or delay payment for currently reimbursed research, such as our REACH study, or reimbursed products in the future, which would adversely affect our business.

We also receive certain government reimbursement payments for tests provided to patients in our REACH clinical trial, and these payments may be delayed or not provided if the government remains shutdown, or they are not budgeted for as part of any continuing resolution.

In the future, this risk could be amplified as we continue to seek, and hope to achieve, additional government reimbursement for our test.

If a prolonged government shutdown occurs, or if funding shortages, staffing limitations or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

In the EU, for example, notified bodies must be officially designated to certify products and services in accordance with the EU IVDR.

Their designation process, which is significantly stricter under the new Regulation, has experienced considerable delays due to the COVID-19 pandemic.

Their designation process, which is significantly stricter under the new Regulation, has experienced considerable delays in the past.

Despite a recent increase in designations, the current number of notified bodies designated under the new Regulation remains significantly lower than the number of notified bodies designated under the previous regime.

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therefore, our dealings with these providers and purchasers are subject to regulation under the FCPA.

There is significant uncertainty whether the new U.S.

presidential administration, including as a result of President Trump’s recent executive order pausing all investigations and prosecutions under the FCPA, will continue robust anti-corruption enforcement in our industry.

There is significant uncertainty whether the current U.S.

administration, including as a result of the recent executive order pausing all investigations and prosecutions under the FCPA, will continue robust anti-corruption enforcement in our industry.

In any case, there is no certainty that all of our employees, agents, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws.

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In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles.

For example, the current presidential administration’s commitment to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS, FDA, and CMS.

Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.

Similarly, the current political climate could impact regulation affecting our business, including the implementation of the LDT Final Rule, and administration decisions to delay, abandon or rescind rules impacting our business, or decisions to choose not to appeal litigation challenges, could lead to abrupt changes in regulation of our industry and the effectiveness of our regulatory and reimbursement strategy.

For example, there have been recent reductions in government spending and reductions in the workforces of certain government agencies, such as HHS, FDA, and CMS.

Further limitations may result in reductions to agency budgets, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.

Similarly, the current political climate could impact regulation affecting our business could lead to abrupt changes in regulation of our industry and the effectiveness of our regulatory and reimbursement strategy.

Risks Relating to Intellectual Property

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Moreover, while we have applied for patents that protect aspects of our technology in the United States and numerous other countries, we cannot assure you that our intellectual property position, including our owned and exclusively licensed pending and issued patents, will not be challenged or that all patents for which we have applied will be issued on a timely basis or at all, or that such patents will protect our technology, in whole or in part, or be issued in a form that will provide us with meaningful protection.

been, and others in the future may be, challenged in the courts or patent offices in the United States or abroad.

Although patents are presumed valid and enforceable upon issuance, a patent may be challenged as to its inventorship, scope, validity, or enforceability, and certain of our owned or exclusively in-licensed patents have been, and others in the future may be, challenged in the courts or patent offices in the United States or abroad.

For example, certain of our in-licensed and owned European patents have been subject to oppositions in Europe, as described below.

As a result of such challenges, our pending or future patent applications may not result in issued patents, or the scope of existing or future patents may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours, or our issued patents may be held invalid or unenforceable.

As a result of such challenges, our pending or future patent applications may not result in

issued patents, or the scope of existing or future patents may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours, or our issued patents may be held invalid or unenforceable.

It is also possible that we may fail to identify patentable technologies in a timely fashion, which could impair our ability to obtain patent protection on such technology at all.

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These lawsuits and proceedings would be costly and could affect our results of operations and divert the attention of our managerial, legal, and scientific personnel.

There is a risk that a court or administrative body

would decide that our owned or exclusively in-licensed patents are invalid or not infringed by a third party’s activities, or that the scope of certain issued claims must be limited.

There is a risk that a court or administrative body would decide that our owned or exclusively in-licensed patents are invalid or not infringed by a third party’s activities, or that the scope of certain issued claims must be limited.

An adverse outcome in a litigation or proceeding involving our owned or exclusively in-licensed patents could limit our ability to assert our patents against third parties, affect our ability to receive royalties or other licensing consideration from our licensees or sublicensees, and may curtail or preclude our ability to exclude third parties from making, using and selling similar products.

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In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.

We may also license our trademarks and trade names to third parties, such as distributors.

We may also license our trademarks and trade names to third parties, such as distributors, or may partner with distributors to market our test under different names.

Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and trade names by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.

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Notwithstanding this ruling and opinion, if the Spin-Off were determined not to qualify for non-recognition of gain and loss under Sections 355 and 368 of the Code, we could be required, under certain circumstances, to indemnify Illumina for certain taxes and related expenses.

In addition, current tax law generally creates a presumption that the Spin-Off would be taxable to Illumina, but not to holders, if we or our shareholders were to engage in transactions that result in a 50% or greater change by vote or value in the ownership of our stock during the four-year period beginning on the date that begins two years before the date of the Distribution, unless it were established that such transactions and the Distribution were not part of a plan or series of related transactions giving effect to such a change in ownership.

In addition, current tax law generally creates a presumption that the Spin-Off would be taxable to Illumina, but not to holders, if we or our shareholders were to engage in transactions that result in a 50% or greater change by vote or value in the ownership of our stock during the four-year period ending on June 24, 2026, unless it were established that such transactions and the Distribution were not part of a plan or series of related transactions giving effect to such a change in ownership.

If the Distribution were taxable to Illumina due to such a 50% or greater change in ownership of our stock, we could, under certain circumstances, be required under the Tax Matters Agreement to indemnify Illumina for some or all of the tax on such gain and related expenses.

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We agreed in the Tax Matters Agreement to certain covenants and indemnification obligations (including restrictions on share issuances, redemptions or repurchases, business combinations, sales of assets, and similar transactions) that address compliance with the intended tax treatment of the Spin-Off.

Certain of these restrictions

will apply for the two-year period after the Spin-Off unless Illumina obtains an opinion from counsel or a ruling from the IRS generally to the effect that a restricted action will not cause the Spin-Off or certain related transactions to fail to qualify for its intended tax treatment, or Illumina gives its consent for us to take a restricted action.

Certain of these restrictions will apply for the two-year period after the Spin-Off unless Illumina obtains an opinion from counsel or a ruling from the IRS generally to the effect that a restricted action will not cause the Spin-Off or certain related transactions to fail to qualify for its intended tax treatment, or Illumina gives its consent for us to take a restricted action.

These covenants and indemnification obligations may limit our ability to pursue strategic transactions or engage in new businesses or other transactions that may otherwise maximize the value of our business, and might discourage or delay a strategic transaction that our shareholders may consider favorable.

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From August 18, 2021 until June 24, 2024, we operated as a wholly owned subsidiary of Illumina.

In connection with the legal and regulatory matters described under “Legal Proceedings” our business was held and operated separately and independently from Illumina and Illumina was required to fund our operations and development.

In connection with the legal and regulatory involvement of the Federal Trade Commission and European Commission, our business was held and operated separately and independently from Illumina and Illumina was required to fund our operations and development.

We derived the historical financial data included in this Annual Report on Form 10-K, in part, from our consolidated financial statements and accounting records prepared as a wholly owned subsidiary of Illumina, and this data does not necessarily reflect the financial condition, results of operations, or cash flows that we would have achieved as a separate, publicly traded company during the periods presented or those that we will achieve in the future.

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As such, our historical financial data may not be indicative of our future performance as a separate, publicly traded company.

For additional information about our past financial performance and the basis of presentation of our financial statements, see “,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report on Form 10-K and our Consolidated Financial Statements and the notes thereto included in this Annual Report on Form 10-K.

For additional information about our past financial performance and the basis of presentation of our financial statements, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report on Form 10-K and our Consolidated Financial Statements and the notes thereto included in this Annual Report on Form 10-K.

Risks Relating to Our Common Stock

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Although our common stock is listed on Nasdaq, an active trading market for our common stock may not be sustained in the future.

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.

The lack of 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.

The market price of our common stock has been highly volatile since the Spin-Off.

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• general economic, industry, and market conditions;

• the other factors described in this “Risk Factors” section.

• the other factors described in this Item 1A.

“Risk Factors” section.

Additionally, in recent years, stock markets in general, and the market for healthcare companies in particular (including companies in the biotechnology, diagnostics, and related sectors), have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose stock is experiencing those price and volume fluctuations.

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We expect to seek additional capital, and may pursue fundraising paths that could include public and private equity offerings, debt financings, strategic partnerships, and alliances and licensing arrangements.

indirectly, our stockholders, will bear the cost of issuing and servicing securities issued in any such transactions.

We, and indirectly, our stockholders, will bear the cost of issuing and servicing securities issued in any such transactions.

Because our decision to issue debt or equity securities will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future financings.

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• the date on which we have, during the prior three-year period, issued more than $1.0 billion in non-convertible debt;

• the last day of the fiscal year in which we (i) have an aggregate worldwide market value of common stock held by non-affiliates of $700 million or more (measured at the end of each fiscal year) as of the last business day of our most recently completed second fiscal quarter and (ii) have been a reporting company under the Exchange Act for at least one year (and filed at least one annual report under the Exchange Act);

• the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933 (the “Securities Act”).

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Our election not to take advantage of the extended transition period is irrevocable.

We expect to cease to be an “emerging growth company” effective December 31, 2026.

Substantial sales of our common stock by Illumina or other significant shareholders could cause our stock price to decline.

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Illumina is not required to hold any retained shares for any minimum period following the Spin-Off.

We are unable to predict with certainty when Illumina will dispose of a substantial number of shares of common stock.

During the fourth quarter of 2025, Illumina sold 2,000,000 shares of the Company’s common stock, reducing its ownership to 2,502,126 shares, which represented approximately 6.0% of the Company’s outstanding common stock as of December 31, 2025.

On February 17, 2026, Illumina filed a Schedule 13G reporting beneficial ownership of 1,302,126 shares of our common stock.

We are unable to predict with certainty when Illumina will dispose of additional substantial numbers of shares of common stock.

The sales of significant amounts of our common stock by Illumina or any other significant shareholders, or the perception in the market that this will occur, may decrease the market price of our common stock.

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We cannot predict or estimate the amount of additional costs we may incur or the timing of such costs.

and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to SOX Section 404, we will be required to furnish a report by our management on our internal control over financial reporting beginning with our second filing of an Annual Report on Form 10-K with the SEC after we become a public company.

Pursuant to SOX Section 404, we are required to furnish a report by our management on our internal control over financial reporting beginning with this filing of our Annual Report on Form 10-K.

However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

To achieve compliance with SOX Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting.

Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed time frame or at all, that our internal control over financial reporting is effective as required by SOX Section 404.

To achieve compliance with SOX Section 404 within the prescribed period, we are engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we have and will need to continue to dedicate internal resources, engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting.

Despite our efforts, there is a risk that we will not be able to continuously conclude that our internal control over financial reporting is effective as required by SOX Section 404.

If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

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This risk is especially relevant for us, because healthcare companies have experienced significant stock price volatility in recent years.

Our stock price may be volatile and may decline significantly in response to the announcement of clinical trial results, including results that do not meet their primary endpoints or that are perceived unfavorably by the investment community.

For example, in February 2026, we announced that the NHS-Galleri Trial did not meet its primary endpoint of statistically significant combined Stage 3 and 4 reduction and experienced a decline in our stock price on the following day.

The announcement of these results, or any future announcements of clinical trial results that do not meet expectations, could cause significant volatility or decline in the market price of our common stock.

If we face such litigation, it could result in substantial costs and a diversion of our management’s attention and resources, which could harm our business.

In addition, any perceived or actual decline in our business prospects or stock price following the NHS-Galleri Trial results or other adverse developments could invite shareholder activism.

Responding to shareholder activism can be costly and time-consuming, disrupt our operations, and divert the attention of our management and board of directors.

Furthermore, activist shareholders may attempt to influence or change our strategic direction, capital allocation, or governance practices, which could adversely affect our business and stock price.

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What changed 10-K

Item 1A. Risk Factors