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Volition(VNRX) - 2024 Q4 - Annual Report

Cautionary Note Regarding Forward-Looking Statements This section outlines the nature and inherent risks of forward-looking statements within the report, emphasizing their susceptibility to known and unknown uncertainties and various impacting factors Forward-Looking Statements Overview This section highlights that the Annual Report on Form 10-K contains forward-looking statements, which are subject to considerable risks and uncertainties. These statements are identified by specific terminology and relate to predictions of financial items, development activities, business strategy, regulatory approvals, market acceptance, industry trends, and liquidity. The company cautions that these statements are based on current assumptions and projections and cannot guarantee accuracy due to substantial known and unknown risks - Forward-looking statements are identified by words such as 'aim,' 'anticipate,' 'believe,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'should,' 'will,' and similar expressions16 - Key areas of forward-looking statements include predictions of earnings, revenues, expenses, development activities, business strategy, regulatory approvals, commercialization, market acceptance, industry trends, demand for products, manufacturing forecasts, R&D costs/benefits, accounting policies, liquidity, and financing plans16 - The company's forward-looking statements are based on current assumptions, expectations, and projections about business and industry trends, but their accuracy cannot be guaranteed due to substantial known and unknown risks and uncertainties17 Significant Factors Impacting Estimates The company identifies several significant factors that may impact its estimates and forward-looking statements, including the inability to generate significant revenue or achieve profitability, the need for additional capital, difficulties in managing growth, dependence on third-party distributors, limited sales and marketing experience, and the 'going concern' opinion from auditors - Significant factors impacting estimates and forward-looking statements include18 - Inability to generate significant revenue or achieve profitability - Need to raise additional capital in the future - Difficulties in managing growth due to expansion of product development and sales/marketing capabilities - Dependence on third-party distributors - Limited experience with sales and marketing - Possibility of not being able to continue to operate, as indicated by the 'going concern' opinion from auditors - Ability to successfully develop, manufacture, market, and sell future products - Ability to timely obtain necessary regulatory clearances or approvals - Market acceptance of future products - Highly competitive and rapidly changing nature of the diagnostics market - Protection of patents, intellectual property, and trade secrets - Reliance on third parties for manufacturing and supply - Material weaknesses in internal control over financial reporting - Pressures related to macroeconomic and geopolitical conditions Part I Item 1. Business VolitionRx Limited is a multi-national epigenetics company focused on developing innovative, cost-effective blood tests for early diagnosis and monitoring of life-altering diseases like cancer and sepsis. The company leverages patented Nucleosomics™ technology and has a diverse product portfolio including Nu.Q® Vet, Nu.Q® NETs, Nu.Q® Discover, Nu.Q® Cancer, and Capture-PCR™/Capture-Seq™. Volition operates globally with R&D and production facilities in Belgium and offices in the US and UK, employing over 80 dedicated staff. Its commercialization strategy relies on partnerships and licensing to established diagnostic companies, aiming for broad market accessibility and affordability - VolitionRx Limited is a multi-national epigenetics company developing simple, easy-to-use, cost-effective blood tests for early diagnosis and monitoring of diseases like cancer and sepsis242526 - Core Technology: Patented Nucleosomics™ technology uses chromosomal structures (nucleosomes) and transcription factors as biomarkers to detect characteristic changes from the earliest stages of disease25 - Global Presence: Grown from a lab bench in Belgium to a 17,000 sq ft lab and 10,000 sq ft production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London, and Nevada2729 - Workforce: Over 80 dedicated employees across various disciplines25 - Stakeholder Relationships: Fostered ties with academic institutions, clinical centers, diagnostic and pharmaceutical companies, and financial institutions worldwide27 VolitionRx Product Portfolio | Product Pillar | Description | | :------------- | :---------- | | Nu.Q® Vet | Cost-effective, easy-to-use blood tests for dogs and other companion animals; Nu.Q® Vet Cancer Test is commercially available for cancer screening in dogs | | Nu.Q® NETs | Detects diseases associated with NETosis, such as sepsis; CE-marked diagnostic solution | | Nu.Q® Discover | Complete solution for profiling nucleosomes, empowering drug developers and scientists for rapid epigenetic profiling in R&D and clinical studies | | Nu.Q® Cancer | Blood-based assays for cancer screening, diagnosis, staging, therapy decision, treatment monitoring, and disease progression | | Capture-PCR™ / Capture-Seq™ | Novel method for liquid biopsy, physically isolating tumor-derived circulating DNA fragments from blood for rapid, cost-effective early cancer detection, obviating expensive sequencing and bioinformatics | - Manufacturing Strategy: Focus on manufacturing key components (antibodies, positive controls, ELISA kits) at Silver One facility in Belgium, with a portion of ELISA kit production outsourced to a U.S. third-party manufacturer for large-scale production and logistics5354 - Commercialization Strategy: Guided by principles of low capital/operating expenditures, affordability, and worldwide accessibility. Driven by in-house R&D, IP monetization (licensing, distribution contracts with upfront/milestone payments, royalties, kit sales), and commercialization via global and regional partners5657585960 - Key Partnerships: Master license and product supply agreement with Heska (now Antech Company) for exclusive worldwide rights to sell Nu.Q® Vet Cancer Test at point-of-care for companion animals, and non-exclusive rights for central reference labs. Licensing and supply agreement with IDEXX for global reference laboratory network. Launched Nu.Q® Vet Cancer Test in UK, Ireland, and Japan through distributors616263646566 - Market Opportunity: Large, given the wide-ranging nature of products in development for human and animal diseases, with potential to become the first method of choice due to ease of use and cost-efficiency6869 - Competition: Faces competition from numerous human-focused healthcare, pharmaceutical, and diagnostic companies (e.g., Exact Sciences, Guardant Health, Roche Diagnostics) and veterinary companies (e.g., One Health Company). Aims for competitive edge through accuracy, cost-effectiveness, government reimbursement attractiveness, ease of use, non-invasiveness, technological advancement, immunoassay compatibility, strong IP, and suitability for mass screenings71727374 - Government Regulations: Subject to extensive federal, state, local, and foreign regulations (e.g., FDA clearance/approval in US, CE marking/EU IVDR in Europe, CFDA in China). Compliance is costly and critical for market entry and continued operations. Belgian Volition maintains ISO 13485 certification77787980 - Intellectual Property: Strong patent portfolio with 52 patent families (plus 3 in-licensed), 75 granted patents worldwide (13 US, 20 Europe, 42 other), and 128 pending applications. IP strategy aims for broad coverage through at least 20438283 - Employees: 85 full-time equivalent personnel as of December 31, 2024, down from 110 in 2023, reflecting cash utilization prioritization. Focus on competitive compensation, talent pipeline, and diversity8283 - Corporate History: Incorporated in Delaware in 1998 as Standard Capital Corporation, renamed VolitionRx Limited in 2011 after acquiring Singapore Volition. Subsidiaries include Belgian Volition SRL, Volition Diagnostics UK Limited, Volition America, Inc., and Volition Veterinary Diagnostics Development LLC8283 Item 1A. Risk Factors The company faces substantial risks, many beyond its control, that could materially and adversely affect its business, financial condition, and stock value. Key risks include the inability to achieve profitability, the need for significant additional capital, intense competition in the diagnostics market, and material weaknesses in internal control over financial reporting, which have led to a 'going concern' opinion from auditors. Other risks relate to product development, commercialization, regulatory approvals, intellectual property protection, and stock price volatility - Investing in the company's common stock involves substantial risk due to numerous unpredictable factors85 - Financial Risks: Inability to generate significant revenue or achieve profitability, requiring additional capital which may dilute existing stockholders, and difficulty in forecasting future performance88919293 - Operational Risks: Highly competitive and rapidly changing diagnostics market, dependence on key personnel, potential disruptions to facilities or IT systems, need to comply with stringent quality standards, and negative impacts from declining global economic conditions or unsuccessful acquisitions959798103105106110111 - Product Development & Commercialization Risks: Market non-acceptance of products, failure to successfully develop/commercialize diagnostic products, unreliability of pre-clinical/clinical trial results, difficulties in obtaining samples or enrolling patients, reliance on third parties for development/manufacturing/sales, challenges in managing growth, and product defects115117118119120122123124125126130131134136137 - Regulatory & Reimbursement Risks: Failure to obtain necessary regulatory clearances/approvals (FDA, CE, CFDA), reductions or changes in reimbursement policies, and potential violations of patient health information privacy and security laws142143147150 - Intellectual Property Risks: Inadequate patent protection, potential infringement claims by third parties, and inability to protect trade secrets154155157 - Securities-Related Risks: Volatile stock prices, identified material weaknesses in internal control over financial reporting, a 'going concern' opinion from auditors, risk of NYSE American delisting, anti-takeover provisions, no expected dividends, potential future stock dilution, and reduced analyst coverage159160164167168169172173 Item 1B. Unresolved Staff Comments The company reports that there are no unresolved staff comments from the Securities and Exchange Commission - No unresolved staff comments174 Item 1C. Cybersecurity VolitionRx maintains an information security and cybersecurity program, including a governance framework, to protect its systems and manage risks like operational disruptions, intellectual property theft, and privacy violations. The program involves routine risk assessments, incident response processes, and regular oversight by management and the Audit Committee of the board of directors - Cybersecurity Program: Maintains an information security and cybersecurity program with a governance framework to protect information systems against operational risks, IP theft, fraud, harm to employees/customers, privacy violations, and reputational risks175176 - Risk Management: Implemented a cybersecurity risk management program to protect confidentiality, integrity, and availability of critical systems, detect/contain incidents, and comply with legal obligations. Routine risk assessments evaluate potential impacts on business, operations, financial stability, and reputation177178 - Incident Response: Program includes processes to triage, assess severity, escalate, contain, investigate, and remediate incidents, with defined steps for material cybersecurity incidents181 - Governance: Board of directors actively oversees cybersecurity risks, discussing programs and policies at least annually. The Audit Committee is delegated authority to oversee and review the adequacy of cybersecurity, information, and technology security, and data privacy programs, receiving regular updates from management and engaging with the Group IT Manager182183 Item 2. Properties VolitionRx operates several facilities globally, including owned research and development and manufacturing sites in Namur, Belgium, and leased offices for sales, marketing, and administration in London, UK, Henderson, Nevada, and Carlsbad, California Company Facilities as of December 31, 2024 | Location | Primary Function | Approx. Square Feet | Leased or Owned | | :--------------- | :----------------- | :------------------ | :-------------- | | Namur, Belgium (1) | Research and development | 17,300 | Owned | | Namur, Belgium (2) | Manufacturing | 9,688 | Owned | | London, UK (3) | Sales and marketing | 323 | Leased, expiring 2026 | | Henderson, Nevada (4) | Administration | 301 | Leased, expiring 2026 | | Carlsbad, California (5) | Research and development | 6,645 | Leased, expiring 2027 | Item 3. Legal Proceedings The company is not currently aware of any threatened or pending litigation that is expected to have a material adverse effect on its business operations, financial condition, or results of operations - The company is not aware of any threatened or pending litigation that is expected to have a material adverse effect on its business operations, financial condition, or results of operations186 Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - This item is not applicable188 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities VolitionRx's common stock is traded on the NYSE American under the symbol 'VNRX'. As of March 20, 2025, there were 96,543,744 shares outstanding held by 168 record holders. The company has not declared or paid cash dividends since inception and does not anticipate doing so in the foreseeable future, intending to reinvest earnings into business development. No equity securities were repurchased during the fourth quarter of 2024 - Market Information: Common stock is traded on the NYSE American under the symbol 'VNRX'190 - Holders: As of March 20, 2025, there were 96,543,744 shares of common stock issued and outstanding, held by 168 record holders191 - Dividends: No cash dividends have been declared or paid since inception, and none are anticipated in the foreseeable future, with earnings expected to be reinvested in business development192 - Repurchase of Equity Securities: No equity securities were repurchased during the fourth quarter of 2024194 Item 6. [Reserved] This item is reserved and contains no information - This item is reserved195 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations VolitionRx is transitioning from R&D to commercialization, focusing on its epigenetics-based diagnostic products. The company faces a 'going concern' uncertainty due to substantial losses and minimal revenues, relying on external financing, grants, and licensing to sustain operations. For the year ended December 31, 2024, the company reported a net loss of $27.3 million, an improvement from $35.7 million in 2023, driven by increased revenues and decreased operating expenses, particularly in R&D, G&A, and sales and marketing - Company Overview: Volition is a multi-national epigenetics company developing patented technologies for early diagnosis and monitoring of diseases like cancer and sepsis, with key product pillars including Nu.Q® Vet, Nu.Q® NETs, Nu.Q® Discover, Nu.Q® Cancer, and Capture-PCR™197198199 - Going Concern: The company has incurred substantial losses ($229.5 million accumulated deficit as of December 31, 2024), negative cash flows from operations, and minimal revenues, raising substantial doubt about its ability to continue as a going concern. Management plans to secure additional grant funds, obtain financing through debt/equity, grant licenses, and commercialize products efficiently while exercising tight cost controls202203 - Cash and Cash Equivalents: $3.3 million as of December 31, 2024, down from $20.7 million as of December 31, 2023205206 - Net Cash Used in Operating Activities: Increased to $25.9 million in 2024 from $18.1 million in 2023, primarily due to a $13 million deferred revenue receipt in the prior year, partially offset by lower payroll and supplier costs207208 - Net Cash Used in Investing Activities: Decreased to $0.6 million in 2024 from $1.1 million in 2023, mainly due to reduced purchases of laboratory equipment210211 - Net Cash Provided by Financing Activities: Decreased to $8.7 million in 2024 from $29.0 million in 2023. 2024 financing included $0.7 million from 'at-the-market' facility, $6.3 million from an August 2024 registered direct offering, and $1.9 million from a December 2024 registered direct offering. 2023 financing included $8.0 million and $17.6 million from public offerings, $2.7 million from a private placement, and $1.8 million from loans214215216 Approximate Contractual Payments Due by Year (as of December 31, 2024) | Description | Total ($) | 2025 - 2029 ($) | Greater than 5 years ($) | | :-------------------------- | :-------- | :-------------- | :----------------------- | | Financing lease liabilities | 410,563 | 278,359 | 132,204 | | Operating lease liabilities | 688,188 | 688,188 | - | | Grants repayable | 422,221 | 252,108 | 170,113 | | Long-term debt | 5,856,017 | 5,679,706 | 176,311 | | Collaborative agreements | 1,120,518 | 1,120,518 | - | | Total | 8,497,507 | 8,018,879 | 478,628 | Results of Operations (Years Ended December 31, 2024 vs. 2023) | Metric | 2024 ($) | 2023 ($) | Change ($) | Percentage Change (%) | | :-------------------------- | :------- | :------- | :--------- | :-------------------- | | Royalty Revenue | - | 1,369 | (1,369) | (100%) | | Service Revenue | 228,138 | 175,476 | 52,662 | 30% | | Product Revenue | 1,005,373 | 598,457 | 406,916 | 68% | | Total Revenues | 1,233,511 | 775,302 | 458,209 | 59% | | Research and development | 14,406,486 | 19,551,523 | (5,145,037) | (26%) | | General and administrative | 8,487,562 | 10,368,314 | (1,880,752) | (18%) | | Sales and marketing | 5,364,433 | 6,843,160 | (1,478,727) | (22%) | | Total Operating Expenses | 28,258,481 | 36,762,997 | (8,504,516) | (23%) | | Grant income | 103,368 | 214,451 | (111,083) | (52%) | | Loss on disposal of fixed assets | (34,731) | (15,843) | (18,888) | <(100%) | | Interest income | 9,947 | 93,324 | (83,377) | (89%) | | Interest expense | (340,362) | (221,622) | 118,740 | 54% | | Gain on change in fair value of warrant liability | 28,763 | 240,311 | 211,548 | (88%) | | Total Other Income (Expenses) | (233,015) | 310,621 | (543,636) | <(100%) | | Net Loss | (27,257,985) | (35,677,074) | (8,419,089) | (24%) | - Critical Accounting Policies: Key policies and estimates include deferred income tax asset valuation allowances, useful lives of property and equipment/intangible assets, deferred revenue valuation, revenue recognition, warrant liability, borrowing rate for operating leases, impairment analysis of intangible assets, and stock-based compensation232233234235236237238[239](index=239&type=chunk] - Recently Issued Accounting Pronouncements: Adopted ASU 2023-07 (Segment Reporting) retrospectively on December 31, 2024, with no material impact. Evaluating ASU 2023-05 (Business Combinations – Joint Venture Formations), ASU 2023-09 (Income Taxes), and ASU 2024-03 (Income Statement – Expense Disaggregation) for future impact328329330331[332](index=332&type=chunk] Item 7A. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, VolitionRx is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, VolitionRx is not required to disclose quantitative and qualitative information about market risk240 Item 8. Financial Statements and Supplementary Data This section presents the audited consolidated financial statements of VolitionRx Limited for the years ended December 31, 2024, and 2023, prepared in conformity with U.S. GAAP. The independent auditor's report includes an explanatory paragraph regarding the company's ability to continue as a going concern due to recurring losses and negative cash flows. The financial statements detail the company's assets, liabilities, equity, operational results, and cash flows, along with comprehensive notes on accounting policies, commitments, and subsequent events - Auditor's Opinion: Sadler, Gibb & Associates, LLC issued an unqualified opinion on the financial statements but included an explanatory paragraph regarding substantial doubt about the company's ability to continue as a going concern due to recurring losses, negative cash flows, and minimal revenues244245246247[248](index=248&type=chunk] - Basis of Presentation: Consolidated financial statements prepared in accordance with U.S. GAAP, expressed in US dollars, with a fiscal year end of December 31. Management makes estimates and assumptions affecting reported amounts263264265[266](index=266&type=chunk] - Principles of Consolidation: Includes accounts of VolitionRx Limited and its wholly-owned subsidiaries (Singapore Volition Pte. Limited, Volition Global Services SRL, Belgian Volition SRL, Volition Diagnostics UK Limited, Volition America, Inc.) and majority-owned subsidiary (Volition Veterinary Diagnostics Development LLC). All intercompany balances and transactions are eliminated267268269270271272273[274](index=274&type=chunk] - Cash and Cash Equivalents: $3,264,429 as of December 31, 2024, and $20,729,983 as of December 31, 2023. Significant amounts held in domestic and foreign accounts exceed insured limits276277278[279](index=279&type=chunk] - Accounts Receivable: Net of an allowance for current expected credit losses (CECL) of $31,735 as of December 31, 2024 (vs. $0 in 2023). Two largest customer balances represented over 65% of total outstanding accounts receivable as of December 31, 2024280281282283284285286287288[289](index=289&type=chunk] - Property and Equipment, net: $4,429,152 as of December 31, 2024, down from $5,523,013 in 2023. Total capital expenditure was $0.3 million in 2024 and $1.1 million in 2023, primarily for laboratory equipment. Depreciation expense was $1.1 million for both years291292293294295296[297](index=297&type=chunk] - Intangible Assets, net: $313,747 as of December 31, 2024, up from $23,886 in 2023. Consist mainly of patents amortized over 8 to 20 years. No impairment losses recognized in 2024 or 2023299300301302[303](index=303&type=chunk] - Warrant Liability: $97,886 as of December 31, 2024, down from $126,649 in 2023. Classified as a liability and marked to market each period due to specific terms failing equity classification guidance305306307308309310311312313314315316317318319320321322323324325[326](index=326&type=chunk] - Revenue Recognition: Total revenues were $1,233,511 in 2024 (up 59% YoY) and $775,302 in 2023. Main sources are product sales (Nu.Q® Vet Cancer Test) and service revenue (Nu.Q® Discover). Licensing revenue from Heska agreement ($23.0 million deferred revenue as of Dec 31, 2024) is recognized over time based on product supply333334336337[338](index=338&type=chunk] - Research and Development Expenses: Decreased to $14.4 million in 2024 from $19.6 million in 2023 (26% decrease), primarily due to decreased clinical research costs and lower personnel expenses (FTEs decreased by 14 to 52)341342343344345346347348349350351352353354355356357358359[360](index=360&type=chunk] - General and Administrative Expenses: Decreased to $8.5 million in 2024 from $10.4 million in 2023 (18% decrease), mainly due to lower personnel expenses, legal/professional fees, and stock-based compensation (FTEs decreased by 3 to 19)362363364365[366](index=366&type=chunk] - Sales and Marketing Expenses: Decreased to $5.4 million in 2024 from $6.8 million in 2023 (22% decrease), primarily due to decreased personnel expenses and lower stock-based compensation (FTEs decreased by 8 to 14)368369370371372[373](index=373&type=chunk] - Net Loss: $27.3 million in 2024, an improvement from $35.7 million in 2023 (24% decrease)375[376](index=376&type=chunk] - Stock-Based Compensation: Total stock-based compensation expense was $1,268,543 in 2024 and $2,289,545 in 2023. Includes warrants, stock options, and Restricted Stock Units (RSUs)378379[380](index=380&type=chunk] - Commitments and Contingencies: Includes finance lease liabilities ($375,075), operating lease liabilities ($632,441), grants repayable ($422,221), long-term debt ($4,813,069), and collaborative agreement obligations ($1,120,518) as of December 31, 2024. Also includes commitments related to Volition Vet and a royalty agreement for a former subsidiary382383384385386387388[389](index=389&type=chunk] - Subsequent Events (Jan 1 - Mar 20, 2025): Sold 348,706 common shares for $210,104 under the 2022 EDA. Issued 97,553 shares from RSU vesting. Granted 191,912 RSUs to directors, advisors, and consultants. Modified 545,000 options to extend expiry dates, resulting in $103,573 expense. Cancelled 78,550 RSUs and 26,200 options. Completed a registered direct offering on March 24, 2025, raising $2.3 million (net) from 4,102,723 common shares and 1,739,087 warrants391392393394395397398400401402403405406407408409411412414415417418419421422424425428429430433434435436439440442443444446448449450451452453454456457458459460461462463464466467468470471472473474475476478479481482483484485486487488489490[491](index=491&type=chunk]493494495496497[498](index=498&type=chunk] Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure The company reports that there have been no changes in or disagreements with its accountants on accounting and financial disclosure matters - No changes in or disagreements with accountants on accounting and financial disclosure500 Item 9A. Controls and Procedures VolitionRx's management concluded that its disclosure controls and procedures were not effective as of December 31, 2024, due to material weaknesses in internal control over financial reporting, specifically insufficient written documentation of internal control policies and procedures. The company is actively implementing remediation plans, including centralizing accounting, engaging consultants for risk assessment and control design, and enhancing corporate oversight - Disclosure Controls Ineffectiveness: Management, including the Principal Executive Officer and Principal Financial Officer, concluded that disclosure controls and procedures were not effective as of December 31, 2024, due to material weaknesses in internal control over financial reporting501502 - Material Weakness Identified: Insufficient written documentation of internal control policies and procedures, particularly regarding the correct application of GAAP and SEC disclosure requirements503504 - Management's Report on Internal Control: Management concluded that internal control over financial reporting was not effective as of December 31, 2024, due to material weaknesses505506 - Remediation Plans: Ongoing efforts include replacing outside service providers to centralize accounting, engaging internal control consultants for risk assessment and control design, preparing written documentation of policies, and engaging external consultants for complex GAAP applications. The company aims to enhance corporate oversight and believes the plan will remediate the identified weaknesses507508[509](index=509&type=chunk] - Limitations: Management acknowledges that control systems provide only reasonable, not absolute, assurance and can be circumvented by error, collusion, or management override511[512](index=512&type=chunk] Item 9B. Other Information The company reports that there is no other information required to be disclosed under this item - No other information to disclose513 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections This item is not applicable to the company - This item is not applicable514 Part III Item 10. Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance, including the company's insider trading policy, is incorporated by reference from the definitive Proxy Statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive Proxy Statement for the 2025 Annual Meeting of Stockholders517 - The company maintains an insider trading policy and procedures designed to promote compliance with insider trading laws, rules, and regulations516 Item 11. Executive Compensation Information regarding executive compensation is incorporated by reference from the definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement518 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information concerning security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from the definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement519 Item 13. Certain Relationships and Related Transactions, and Director Independence Information regarding certain relationships and related transactions, as well as director independence, is incorporated by reference from the definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement520 Item 14. Principal Accountant Fees and Services Information regarding principal accountant fees and services is incorporated by reference from the definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement521 Part IV Item 15. Exhibits and Financial Statement Schedules This section lists the documents filed as part of the report, including financial statements, financial statement schedules (omitted as not applicable), and a comprehensive list of exhibits. The exhibits cover various agreements, corporate documents, and certifications, with some portions redacted for confidentiality - Financial Statements: Included in Part II, Item 8 of this Report and incorporated by reference525 - Financial Statement Schedules: Omitted as not applicable or information shown in financial statements/notes526 - Exhibits: A detailed list of exhibits is provided, including agreements for share sale/purchase, equity incentive plans, employment agreements, license and supply agreements, equity distribution agreements, underwriting agreements, and various corporate governance documents and certifications. Some exhibits contain redacted portions527528529531532533534535536537538[539](index=539&type=chunk] Item 16. Form 10-K Summary The company states that there is no Form 10-K summary provided - No Form 10-K summary is provided540 Signatures Report Signatures The Annual Report on Form 10-K is signed on behalf of VolitionRx Limited by its President, Chief Executive Officer, and Director, Cameron Reynolds, and other directors and officers, as duly authorized, as of March 31, 2025. A Power of Attorney is included, granting authority to Cameron Reynolds and Rodney Rootsaert to sign amendments - The report is signed by Cameron Reynolds (President, CEO, and Director) and Terig Hughes (CFO and Treasurer) as principal executive and financial officers, respectively, along with other directors, as of March 31, 2025542543545[547](index=547&type=chunk] - A Power of Attorney is included, authorizing Cameron Reynolds and Rodney Rootsaert to sign amendments to the report544