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Registered number: 12227768 (England and Wales)
ANNUAL REPORT AND FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
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COMPANY INFORMATION
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CONTENTS
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STRATEGIC REPORT
FOR THE YEAR ENDED 31 DECEMBER 2025
The directors present their Strategic Report for the year ended 31 December 2025. This Strategic Report has been prepared for the shareholders of GRAIL BIO UK Limited. Unless the context otherwise requires, references to “we,” “us,” and the "Company" refer to GRAIL BIO UK Limited.
The Company is a wholly-owned subsidiary of GRAIL, Inc. (formerly GRAIL, LLC., ‘GRAIL’). The Company undertakes clinical trials in collaboration with the NHS, and provides development and support services to its parent company. GRAIL is a healthcare group whose mission is to detect cancer early, when it can be cured. In clinical studies, GRAIL’s Galleri® multi-cancer early detection test has demonstrated an ability to detect a shared cancer signal through analysis of cell-free DNA in the bloodstream, accurately predict the specific organ or tissue type where the cancer signal originated, and yield high positive predictive values and low false positive rates, all from a simple blood draw. GRAIL has conducted what it believes is the largest clinical program in genomic medicine to date with data from over 385,000 participants that it believes demonstrates the clinical validation and clinical utility of Galleri in its intended use population. GRAIL has deep operational experience with over 800,000 tests processed across this clinical program, including from the NHS-Galleri Trial, and from its commercial experience. Commercial use of Galleri® has detected some of the most aggressive cancers in early stages including, among others, endometrial, oesophageal, gastrointestinal, head and neck, liver, pancreatic, and rectal cancers.
GRAIL also leverages its proprietary platform for additional applications, including its precision oncology portfolio. GRAIL launched a research use only (“RUO”) targeted methylation platform with customizable classifiers in 2023. GRAIL has partnered with a number of leading oncology therapeutics companies to test applications of biomarkers with the goal of optimizing the use of therapeutic interventions. Some of GRAIL’s partnerships also include development of customized applications to support clinical studies and companion diagnostic development and commercialization. Applications for GRAIL’s technology in its precision oncology partnerships include pre-treatment prognosis, post-treatment prognosis or minimal residual disease, biomarker discovery, detection of recurrence, and clinical monitoring. On 24 June 2024, GRAIL completed a spin-off transaction, the result of which was our immediate parent company, GRAIL, Inc., was divested from Illumina, Inc., and became a standalone public company listed in the United States on the NASDAQ exchange. We work closely with our parent company to discuss financing strategies and overall business strategy. Any financing risks are mitigated by the substantial amount of cash, cash equivalents and short-term marketable securities held on the parent company balance sheet, which were $904.4m as of December 31, 2025.
Operations are focused on the execution of clinical trials, potential launch in the UK private market and preparations for initiation of a screening program in collaboration with the NHS. The trials are designed to evaluate the use of the Galleri® test in asymptomatic patients and to evaluate GRAIL’s methylation technology in symptomatic individuals that have been referred to oncology diagnostic centers with non-specific symptoms. The trial for asymptomatic patients is ongoing. The trial for symptomatic individuals was completed in 2024. Revenues in 2025 are comprised of fees charged to GRAIL, Inc. for the execution of the clinical trials and related software development.
During the year, sales decreased by £15.7m (-48%) and costs decreased by £14.6m (47%). The decrease in costs is due to the operational phase of the asymptomatic clinical trial finishing in July 2024. This reduction in costs drives the reduction in sales as GRAIL, Inc. reimburses the Company for its costs plus a 8% mark-up. This is in line with expectations. The profit for the year, after taxation, amounted to £3,609,925 (2024 profit: £3,857,908).
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STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2025
The Company's key financial indicators are as follows:
The Company is a healthcare company with limited commercial experience operating in a rapidly evolving field and has a limited operating history with limited product sales, which makes it difficult to evaluate our current business and predict our future performance. At the parent company level, we do not expect near-term revenue to offset our ongoing operating expenses and the company may never be profitable.
The Group headed by GRAIL, Inc. has incurred significant net losses in each period since our inception and anticipates that it will continue to incur net losses for the foreseeable future. We plan to fund our cash needs in the near-to-intermediate term from the GRAIL cash and investments balance. Product risk Our products may not perform as expected, and the results of our clinical studies may not support the launch or use of our products commercially. Clinical trials may be necessary to validate our products to launch them commercially, and to support future product submissions to regulatory authorities or designated assessment bodies. The clinical trial process, including the NHS Galleri trial, is lengthy and expensive with uncertain outcomes, and often requires the enrolment of large numbers of patients. Even with the commercial launch of Galleri® or with the future commercial launch of our products, these products may fail to achieve the degree of market acceptance necessary for commercial success. We may be unable to develop and commercialize new products. Payor Risk 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 acted to mitigate this risk by contracting with the NHS and others to conduct the NHS-Galleri Trial, which could form a foundation for broad coverage of our test by the NHS. Commercialisation Risk The commercial success of products or future products will depend on the degree of market acceptance by consumers, including self-insured employers, health systems, healthcare providers, life insurance companies, patients, and third-party payors. The degree of market acceptance of our products will depend on a number of factors, including performance, clinical validation and utility, reimbursement and multiple other factors. Moreover, we operate in a rapidly evolving field and have a limited operating history. GRAIL has limited operating experience as a commercial stage company, and the Company has not yet made commercial sales. We have mitigated these risks through GRAIL’s commercial organization, by clinical trial efforts, pursuing reimbursement for Galleri®, and other actions.
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STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2025
Supplier risk
We rely on sole or a limited number of suppliers for some of our laboratory instruments and reagents, and we may not be able to find replacements or immediately transition to alternative suppliers if necessary. We have mitigated this risk by identifying alternative suppliers where we can, and by focusing on maintaining these supplier relationships where necessary. Regulatory risk The regulatory clearance or approval processes of regulatory authorities or designated assessment bodies are lengthy, time-consuming, and unpredictable. If we are ultimately unable to obtain any necessary or desirable regulatory approvals or clearances, or if such approvals or clearances are significantly delayed, our business will be substantially harmed. We have acted to mitigate the above risks by assembling an experienced team to guide us in these novel areas. Intellectual Property If we are unable to obtain and maintain intellectual property protection for our technology, or if the scope of the intellectual property protection we obtain is not sufficiently broad, our competitors could develop and commercialize technology and tests similar or identical to ours, and our ability to successfully commercialize our products may be impaired. We have acted to mitigate this risk by aiming to build a broad and protective patent portfolio. Our success depends on our ability to develop and commercialize our technology without infringing, misappropriating, or otherwise violating the intellectual property of third parties. Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, and if they prevail, could block sales of our products and force us to make large damages and/or royalty payments, which could have a material adverse effect on the success of our business. We have acted to mitigate this risk by working with outside counsel on appropriate development and commercialization strategies. Going concern risk We are dependent on our immediate parent company, GRAIL, Inc., for substantially all our funding needs and expect to continue to receive the funding necessary for at least the next 12 months. Credit and foreign exchange risk We have minimal credit risk as substantially all the Company’s cash and cash equivalents are deposited in accounts with an accredited financial institution that management believes is of high-credit quality. We have not experienced any losses. Our company has minimal foreign exchange risk as most of its costs are in GBP. However, there are some costs which are borne at the parent company (USD) and we are subject to translation differences.
This report was approved by the board and signed on its behalf.
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DIRECTORS' REPORT
FOR THE YEAR ENDED 31 DECEMBER 2025
The directors present their report and the financial statements for the year ended 31 December 2025. Certain information required to be included in the Directors' Report has been included in the Strategic Report in accordance with section 414C (11) of the Companies Act 2006.
The directors who served during the year were:
The profit for the year, after taxation, amounted to £3,609,925 (2024 - £3,857,908).
The directors have not proposed a dividend for the current year (2024: £NIL).
The directors are responsible for preparing the Strategic Report, the Directors' Report and the financial statements in accordance with applicable law and regulations.
In preparing these financial statements, the directors are required to:
∙select suitable accounting policies for the Company's financial statements and then apply them consistently;
∙make judgements and accounting estimates that are reasonable and prudent; and
∙prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.
The directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Company's transactions and disclose with reasonable accuracy at any time the financial position of the Company and to enable them to ensure that the financial statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.
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GRAIL BIO UK LIMITED
DIRECTORS' REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2025
As explained in the Strategic Report, the Company is currently engaged in clinical studies in collaboration with the NHS. In the future, we expect to launch Galleri® in the United Kingdom, following any positive NHS evaluation of the final results from the NHS-Galleri Trial.
There were no adjusting or non-adjusting post balance sheet events occurring between the end of the reporting period and the date these financial statements were approved.
This report was approved by the board and signed on its behalf.
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INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF GRAIL BIO UK LIMITED
We have audited the financial statements of GRAIL BIO UK Limited (the 'Company') for the year ended 31 December 2025, which comprise the Statement of Comprehensive Income, the Balance Sheet, the Statement of Changes in Equity and the related notes, including a summary of significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and United Kingdom Accounting Standards, including Financial Reporting Standard 102 ‘The Financial Reporting Standard applicable in the UK and Republic of Ireland' (United Kingdom Generally Accepted Accounting Practice).
We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditors' responsibilities for the audit of the financial statements section of our report. We are independent of the Company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the United Kingdom, including the Financial Reporting Council's Ethical Standard and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
In auditing the financial statements, we have concluded that the directors' use of the going concern basis of accounting in the preparation of the financial statements is appropriate.
Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast significant doubt on the Company's ability to continue as a going concern for a period of at least twelve months from when the financial statements are authorised for issue.
Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report.
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GRAIL BIO UK LIMITED
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF GRAIL BIO UK LIMITED (CONTINUED)
The other information comprises the information included in the Annual Report other than the financial statements and our Auditors' Report thereon. The directors are responsible for the other information contained within the Annual Report. Our opinion on the financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.
We have nothing to report in this regard.
In our opinion, based on the work undertaken in the course of the audit:
∙the information given in the Strategic Report and the Directors' Report for the financial year for which the financial statements are prepared is consistent with the financial statements; and
∙the Strategic Report and the Directors' Report have been prepared in accordance with applicable legal requirements.
In the light of the knowledge and understanding of the Company and its environment obtained in the course of the audit, we have not identified material misstatements in the Strategic Report or the Directors' Report.
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GRAIL BIO UK LIMITED
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF GRAIL BIO UK LIMITED (CONTINUED)
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an Auditors' Report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below.
Our approach to identifying and assessing the risks of material misstatement in respect of irregularities, including fraud and non-compliance with laws and regulations, was as follows:
∙the responsible individual ensured that the engagement team collectively had the appropriate competence, capabilities and skills to identify or recognise non-compliance with applicable laws and regulations;
∙we identified the laws and regulations applicable to the Company through discussions with management, and from our commercial knowledge and experience;
∙we focused on specific laws and regulations which we considered may have a direct material effect on the financial statements or the operations of the Company, including the Companies Act 2006, and taxation legislation;
∙we assessed the extent of compliance with the laws and regulations identified above through making enquiries of management and inspecting legal correspondence; and
∙identified laws and regulations were communicated within the audit team regularly and the team remained alert to instances of non-compliance throughout the audit.
We assessed the susceptibility of the Company’s financial statements to material misstatement, including obtaining an understanding of how fraud might occur, by:
∙making enquiries of management as to where they considered there was susceptibility to fraud, their knowledge of actual, suspected and alleged fraud; and
∙considering the internal controls in place to mitigate risks of fraud and non-compliance with laws and regulations.
To address the risk of fraud through management bias and override of controls, we:
∙performed analytical procedures to identify any unusual or unexpected relationships;
∙tested journal entries to identify unusual transactions;
∙assessed whether judgements and assumptions made in determining the accounting estimates were indicative of potential bias; and
∙investigated the rationale behind significant or unusual transactions.
In response to the risk of irregularities and non-compliance with laws and regulations, we designed procedures which included, but were not limited to:
∙agreeing financial statement disclosures to underlying supporting documentation;
∙enquiring of management as to actual and potential litigation and claims; and
∙reviewing correspondence with HMRC.
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GRAIL BIO UK LIMITED
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF GRAIL BIO UK LIMITED (CONTINUED)
There are inherent limitations in our audit procedures described above. The more removed that laws and regulations are from financial transactions, the less likely it is that we would become aware of non-compliance. Auditing standards also limit the audit procedures required to identify non-compliance with laws and regulations to enquiry of the directors and other management and the inspection of regulatory and legal correspondence, if any.
Material misstatements that arise due to fraud can be harder to detect than those that arise from error as they may involve deliberate concealment or collusion.
A further description of our responsibilities for the audit of the financial statements is located on the Financial Reporting Council's website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our Auditors' Report.
This report is made solely to the Company's shareholders, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the Company's shareholders those matters we are required to state to them in an Auditors' Report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company and the Company's shareholders, as a body, for our audit work, for this report, or for the opinions we have formed.
for and on behalf of
Chartered Accountants and Statutory Auditors
Birchin Court 5th Floor
19-25 Birchin Lane
London
EC3V 9DU
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STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2025
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BALANCE SHEET
AS AT 31 DECEMBER 2025
The financial statements were approved and authorised for issue by the board and were signed on its behalf by:
The notes on pages 13 to 25 form part of these financial statements.
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STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2025
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
GRAIL BIO UK Limited is a private company limited by shares and incorporated in the United Kingdom and registered in England and Wales under the Companies Act 2006. Its registered office is Birchin Court, 5th Floor, 19-25 Birchin Lane, London, United Kingdom, EC3V 9DU. The nature of the Company's operations are set out in the Directors' Report.
2.Accounting policies
The financial statements have been prepared under the historical cost convention unless otherwise specified within these accounting policies and in accordance with Financial Reporting Standard 102, the Financial Reporting Standard applicable in the UK and the Republic of Ireland and the Companies Act 2006.
The preparation of financial statements in compliance with FRS 102 requires the use of certain critical accounting estimates. It also requires management to exercise judgement in applying the Company's accounting policies (see note 3).
The following principal accounting policies have been applied:
The Company has taken advantage of the following disclosure exemptions in preparing these financial statements, as permitted by the FRS 102 "The Financial Reporting Standard applicable in the UK and Republic of Ireland":
∙the requirements of Section 7 Statement of Cash Flows;
∙the requirements of Section 3 Financial Statement Presentation paragraph 3.17(d);
∙the requirements of Section 11 Financial Instruments paragraphs 11.42, 11.44 to 11.45, 11.47, 11.48(a)(iii), 11.48(a)(iv), 11.48(b) and 11.48(c);
∙the requirements of Section 12 Other Financial Instruments paragraphs 12.26 to 12.27, 12.29(a), 12.29(b) and 12.29A;
∙the requirements of Section 26 Share-based Payment paragraphs 26.18(b), 26.19 to 26.21 and 26.23;
∙the requirements of Section 33 Related Party Disclosures paragraph 33.7.
This information is included in the consolidated financial statements of GRAIL, Inc. as at 31 December 2025 and these financial statements may be obtained from https://investors.grail .com /node/8391/html.
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
2.Accounting policies (continued)
The Company is in a net asset position supported by a receivable due from its parent company, GRAIL, Inc. to whom it provides support services. Since incorporation the Company has undertaken clinical trials in collaboration with the NHS, and has provided development services to its parent company. Following the completion of the active phase of the NHS Galleri Trial, the Company has continued to provide clinical study, software development and business development services to the parent group headed by GRAIL, Inc. The Company is wholly reliant upon the continued support provided through the development and support services agreement with GRAIL, Inc. to remain a going concern.
In preparing these financial statements the directors have considered the forward-looking information for GRAIL, Inc. and its ability to support the Company until such point that the Company can generate its own cash flows through commercial opportunities. The Company has received written confirmation from GRAIL, Inc. that it will continue to provide financial support to the Company for a period of at least 12 months from the date of signing these financial statements.
Functional and presentation currency
Transactions and balances
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
2.Accounting policies (continued)
Intercompany turnover is recognised when all of the following conditions are satisfied: A 5% gross profit margin is required on implementation turnover. As such, an adjustment is made to intercompany revenue to ensure the appropriate margin is achieved.
All expenditure on research and development is recognised as an expense when it is incurred.
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
2.Accounting policies (continued)
Where RSU's and performance-based options are awarded to employees, the fair value of the units at the date of grant is charged to profit or loss over the vesting period. Non-market vesting conditions are taken into account by adjusting the number of equity instruments expected to vest at each balance sheet date so that, ultimately, the cumulative amount recognised over the vesting period is based on the number of units that eventually vest. Market vesting conditions are factored into the fair value of the options granted. The cumulative expense is not adjusted for failure to achieve a market vesting condition. The fair value of the award also takes into account non-vesting conditions. These are either factors beyond the control of either party (such as a target based on an index) or factors which are within the control of one or other of the parties (such as the Company keeping the scheme open or the employee maintaining any contributions required by the scheme). Where the terms and conditions of options are modified before they vest, the increase in the fair value of the options, measured immediately before and after the modification, is also charged to profit or loss over the remaining vesting period.
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
2.Accounting policies (continued)
Depreciation is charged so as to allocate the cost of assets less their residual value over their estimated useful lives, using the straight-line method.
The estimated useful lives range as follows:
The assets' residual values, useful lives and depreciation methods are reviewed, and adjusted prospectively if appropriate, or if there is an indication of a significant change since the last reporting date.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognised in profit or loss.
Short term creditors are measured at the transaction price.
The estimates and assumptions that have a significant risk of causing material adjustment to the carrying amount of assets and liabilities are addressed below. Restricted stock units ("RSU's") and performance-based options The directors review the outstanding RSU's annually to assess the probability of vesting and exercise. The directors have concluded that the RSU's with a service vesting condition are likely to vest and as such an expense has been recognised in profit or loss. The directors have concluded that the performance-based options are not likely to be realised in the near future and as such no expense has been recognised in profit or loss.
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
3.Judgements in applying accounting policies (continued)
The directors review the contracts entered into with third parties in respect of the clinical trial operations and assess the project completion as at the reporting date. The directors have assessed the estimated expenditure incurred to date which has been recognised in profit or loss.
Analysis of turnover by country of destination:
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
9.Taxation (continued)
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
In 2020, certain employees of the Company were granted options over shares in GRAIL, Inc., the Company's then parent. In 2021, the group was acquired by Illumina, Inc. and as a result the options were accelerated and settled by way of cash and equity.
Unvested performance-based options were converted at acquisition and continue to vest along the original vesting schedule. An expense equivalent to the fair value of the share options granted is recognised evenly over the vesting period when it is considered probable that the performance measures will be met with a corresponding amount being recognised in the capital contribution reserve. No expense has been recognised as the performance conditions were not considered probable of being achieved. In 2021, after the acquisition, the parent company granted certain employees of the Company cash-based equity appreciation awards. 25% of the awards vest annually over a four year period. An expense equivalent to the fair value of the awards granted, as at the grant date, is recognised evenly over the vesting period with a corresponding amount being recognised as a liability. The liability is subsequently remeasured and adjusted at each reporting date. Upon the divesture of GRAIL, LLC. from Illumina, Inc. in June 2024, the cash based incentive awards held by employees over shares in GRAIL, LLC. were converted into RSUs in GRAIL, Inc. The outstanding liability based on the cash-based awards was transferred to the capital contribution reserve and the RSUs continue to vest along the original vesting schedule. An expense equivalent to the fair value of the converted RSUs granted is recognised evenly over the remaining vesting period with a corresponding amount being recognised in the capital contribution reserve.
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NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2025
GRAIL, Inc. is the parent of the smallest group for which consolidated financial statements are drawn up of which the Company is a member. The registered office of the parent company is 1525 O'Brien Drive, Menlo Park, CA 94025.
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