Financial Data and Key Metrics Changes - Total operating expenses for Q1 2025 declined by 35% compared to Q1 2024, reflecting effective cost management across all spending categories [5][6][8] - Net cash used in operating activities was £4.3 million for Q1 2025, down 48% from £8.3 million in Q1 2024 [6][8] - Revenue for the quarter was approximately $250,000, representing a growth of 44% over Q1 2024, including the first revenue from human product sales [6][8] Business Line Data and Key Metrics Changes - The Nu. Q technology for human diagnostics is in confidential discussions with over 10 companies for licensing, with a combined market value exceeding $600 billion [9][10] - The total addressable market for cancer and sepsis diagnostics is estimated at $25 billion annually, presenting substantial revenue opportunities [10][15] - The Nu. Q Nets technology is expected to have a total addressable market exceeding $10 billion annually, with significant clinical applications [15][20] Market Data and Key Metrics Changes - The company is making significant strides in the commercialization of its cancer diagnostic pillar, with two major companies in active negotiations [12][13] - The pivotal lung cancer screening study in Taiwan has enrolled over 100 patients, with interim analysis expected to be presented at a major conference [13] - The Nu. Q Nets test has recorded its first revenue from sales in Europe, with nine hospital networks in five countries placing orders [17][18] Company Strategy and Development Direction - The company aims to secure multiple licensing agreements in the human diagnostic space, similar to its successful strategy in the veterinary market [10][31] - A focus on central lab automation is seen as crucial for accelerating revenue growth and ensuring consistent delivery [22][23] - The long-term goal is to enable precision therapy for patients by identifying specific epigenetic signatures associated with disease states [28] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining low operating costs while focusing on commercialization [37][39] - The company is optimistic about the progress made in licensing discussions and the potential for significant revenue generation from its technology [30][32] - Despite a challenging macroeconomic environment, the company is focused on cutting costs and delivering on milestones [68][69] Other Important Information - The company has received milestone payments of $23 million from its veterinary licensing agreements, contributing to ongoing revenue streams [30] - The first commercial sale of a high throughput synthetic sepsis model was achieved, supporting the development of new therapies [29] Q&A Session Summary Question: Is the current low level of operating expenses sustainable for the rest of 2025? - Management confirmed that maintaining tight control over costs is a priority and that the current expense levels are sustainable [38][40] Question: Update on the feline cancer test expected to generate a milestone payment? - Progress has been made on pre-analytics in cats, with a paper accepted for publication, and the team is moving on to clinical data [41][44] Question: What is the operational engagement with partners like Texas A&M and IDEXX? - The company has multiple partners, but detailed sales flow information is typically commercially sensitive and not disclosed [50][51] Question: Will marketing expenses remain flat for the rest of the year? - A lower level of spending is planned, with costs managed by attending conferences without hiring booths [56][58] Question: When will revenues from the human study contract in Nu. Q Discover be seen? - The clinical study will run over two years, with revenues expected to be spread out over that period [61][62]

Financial Data and Key Metrics Changes - Total operating expenses for Q1 2025 declined by 35% compared to Q1 2024, reflecting strong cost management across all spending categories [5][6][8] - Net cash used in operating activities was £4.3 million for Q1 2025, down from £8.3 million in Q1 2024, indicating improved cash flow management [6][10] - Revenue for the quarter was approximately $250,000, representing a 44% increase year-on-year, including the first revenue from human product sales [6][7][8] - Cash and cash equivalents at the end of Q1 2025 totaled approximately $2.6 million, down from $3.3 million at the end of 2024 [7] Business Line Data and Key Metrics Changes - The Nu. Q technology is being commercialized in the human diagnostic market, with significant licensing discussions ongoing with over 10 companies [11][12] - The Nu. Q cancer diagnostic pillar is progressing, with two major companies in active negotiations and a pivotal lung cancer screening study in Taiwan enrolling over 100 patients [14][15] - The Nu. Q NETs technology is also advancing, with a total addressable market for testing and monitoring intensive care patients estimated at $1 billion annually [17][18] Market Data and Key Metrics Changes - The combined market value of seven companies in licensing discussions exceeds $600 billion, highlighting the potential reach of the technology [12] - The total addressable market for cancer and sepsis diagnostics is estimated at $25 billion annually, presenting substantial revenue opportunities [12] Company Strategy and Development Direction - The company aims to achieve cash neutrality for the full year 2025, with a focus on reducing expenses and securing multiple licensing agreements in the human diagnostic space [5][10][36] - The strategy includes leveraging existing partnerships and expanding the global reach of the Nu. Q Vet cancer test while automating central labs to enhance revenue growth [24][25][36] - The company is focused on commercializing its technology quickly to make it accessible worldwide, with a mission to save lives and improve outcomes [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining low operating costs while focusing on commercialization efforts [41][44] - The company is optimistic about the progress made in licensing discussions and the potential for significant revenue generation from ongoing clinical studies [33][36] Other Important Information - The company recorded its first revenue from a regulated human product in the EU, marking a significant milestone [72] - Discussions are ongoing with several national lung screening programs, indicating strong interest in the company's diagnostic solutions [34] Q&A Session Summary Question: Is the current low level of operating expenses sustainable for the rest of 2025? - Management confirmed that maintaining low costs is a priority and that they have made significant progress in controlling expenses across all categories [41][42][44] Question: Update on the progress of the feline cancer test? - Management reported that pre-analytics work for the feline cancer test has been completed, and clinical data collection is underway [45][48] Question: What is the operational engagement with partners like Texas A&M and IDEXX? - Management indicated that while they know the volume of purchases, detailed sales flow information is typically not shared due to commercial sensitivity [54][55] Question: Will marketing expenses remain flat for the rest of the year? - Management stated that while they plan to spend less overall, there may be fluctuations in spending due to conference attendance and other marketing activities [58][60] Question: When will revenues from the human study contract in Nu. Q Discover be recognized? - Management noted that the clinical study will run over two years, with revenues expected to be spread out over that period [64][65]

Core Insights - VolitionRx Limited is focusing on commercializing its Nu.Q® platform in the human diagnostics market, with ongoing discussions with over ten companies, whose combined market value exceeds $600 billion [2] - The company aims to secure multiple licensing agreements in the human diagnostics space this year, similar to its strategy in the veterinary market [3] - Volition recorded its first revenue from sales of its CE-marked Nu.Q® NETs automated product in Europe in Q1 2025, marking a significant commercial milestone [4] Financial Highlights - Volition reported approximately $0.25 million in revenue for Q1 2025, a 44% increase compared to the same quarter in the previous year [8] - The net cash used in operating activities averaged $1.4 million per month, nearly 50% lower than in Q1 2024 [8] - The company received $4.3 million in funding during Q1 2025, with about $1.8 million from non-dilutive funding [8] - As of March 31, 2025, cash and cash equivalents totaled approximately $2.6 million, down from $3.3 million as of December 31, 2024 [8] - A convertible loan note was finalized post-quarter end, providing $6.25 million in gross proceeds, repayable over 24 months [8] - The goal for 2025 is to achieve cash neutrality, where income matches expenditure on a cash basis [8]

Financial Performance - Total revenues for Q1 2025 were $246,385, a 43.6% increase from $171,535 in Q1 2024[24] - Service revenues increased significantly to $115,476 in Q1 2025 from $2,938 in Q1 2024[24] - Operating loss for Q1 2025 was $5,521,720, improved from a loss of $8,384,504 in Q1 2024[24] - Net loss attributable to VolitionRx stockholders for Q1 2025 was $5,423,759, compared to $8,367,388 in Q1 2024[24] - The net loss for the three months ended March 31, 2025, was $5,476,627, a 35% improvement compared to a net loss of $8,472,005 in the same period in 2024[162] - The company's net loss was $5.5 million, a decrease of approximately $3.0 million compared to a net loss of $8.5 million for the three months ended March 31, 2024[172] Cash and Liquidity - Cash and cash equivalents decreased to $2,600,342 as of March 31, 2025, down from $3,264,429 at the end of 2024[21] - The company experienced a net cash used in operating activities of $4,298,018 in Q1 2025, an improvement from $8,342,384 in Q1 2024[30] - As of March 31, 2025, the company had cash and cash equivalents of $2.6 million and an accumulated deficit of $235.0 million[48] - The company has determined there is substantial doubt about its ability to continue as a going concern without further financing[173] - The company plans to seek additional capital through the sale of debt or equity securities, which may dilute existing stockholders' ownership[175] Expenses and Cost Management - Research and development expenses for Q1 2025 were $2,607,444, down from $4,629,527 in Q1 2024[24] - Total operating expenses reduced to $5.8 million for the three months ended March 31, 2025, down from $8.6 million in the same period in 2024, reflecting a 33% decrease[162][164] - General and administrative expenses decreased to $2.2 million from $2.3 million, a decline of about 2.2% for the three months ended March 31, 2025, compared to the same period in 2024[167] - Sales and marketing expenses decreased to $0.9 million from $1.7 million, a decrease of approximately 46.1% for the three months ended March 31, 2025, compared to the same period in 2024[169] - The company continues to exercise tight cost controls to conserve cash, including directors and employees exchanging part of their fees for RSUs[50] Stock and Financing Activities - The company raised $2,384,654 from issuances of common stock in Q1 2025, compared to $15,733 in Q1 2024[30] - The company raised net proceeds of $2.3 million from the issuance of 4,102,723 shares at an offering price of $0.55 per share in March 2025[67] - In August 2024, the company raised net proceeds of $6.4 million from the sale of 9,170,000 shares and warrants, with a combined offering price of $0.55 per share[68] - The Company entered into a Capital On DemandTM Sales Agreement to sell shares of common stock with an aggregate offering price of up to $7.5 million[128] - The Company entered into a Securities Purchase Agreement with Lind Global Asset Management for $6,250,000 in funding, issuing a Senior Secured Convertible Promissory Note of $7,500,000 and a warrant for 13,020,834 shares at $0.672 per share[150] Assets and Liabilities - Total current liabilities increased to $8,273,099 as of March 31, 2025, compared to $7,790,747 at the end of 2024[21] - The company reported a total stockholders' deficit of $29,026,675 as of March 31, 2025, compared to $26,107,736 at the end of 2024[23] - The total balance for long-term debt payable was $6,394,857, with $1,065,503 due in 2025 and $3,220,798 due in 2028[105] - The total property and equipment as of March 31, 2025, was $9.76 million, with a net value of $4.35 million after accumulated depreciation[55] Research and Development - The company launched the Nu.Q® Vet Cancer Test in the UK and Ireland in November 2023 and in Japan in July 2024, expanding its market presence[148][149] - The company received a $10 million upfront payment from Heska for exclusive rights to sell the Nu.Q® Vet Cancer Test for companion animals, with potential additional milestone payments[144] - The number of full-time equivalent personnel in the research and development division decreased by 14 to 52 compared to the prior year period[165] Internal Controls and Compliance - The company identified a material weakness in its internal controls over financial reporting and is actively working on remediation plans[187] - The company has no known legal proceedings that it believes will have a material adverse effect on its financial position[115]

Financial Performance - VolitionRx Limited reported financial results for Q1 2025, with a total revenue of $2.5 million, representing a 25% increase compared to Q1 2024[6] Business Strategy - The company confirmed a conference call scheduled for May 16, 2025, to discuss these results and business updates[6] - VolitionRx is focusing on expanding its product offerings and enhancing its technology for better market penetration[6]

Volition is a multi-national company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, disease and treatment monitoring. Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detec ...

Core Insights - VolitionRx Limited is focusing on commercializing its Nu.Q® platform in the human diagnostics market, with ongoing discussions with over ten companies, whose combined market value exceeds $600 billion [2][25]. - The Total Addressable Market (TAM) for cancer and sepsis diagnostics is approximately $25 billion annually, presenting substantial revenue opportunities for the company and its partners [3][25]. - The company has successfully raised $4.2 million through direct registered offerings, primarily from existing shareholders, demonstrating strong insider support [4]. Cancer Diagnostics - Significant progress has been made in the commercialization of cancer diagnostics, with two major companies in active negotiations regarding Nu.Q® and Capture-Seq™ technologies [5]. - A pivotal lung cancer screening study in Taiwan is advancing, with the potential market for the Nu.Q® test exceeding $1 billion across Taiwan, the U.S., U.K., and France [6][25]. - The Nu.Q® NETs program has shown strong clinical promise, with two large-scale studies completed, indicating a strong mortality signal and a link to organ failure [7]. Commercialization Efforts - Licensing discussions for Nu.Q® NETs are progressing well, with several companies completing technology transfers [8]. - The company recorded its first revenue for the CE-Marked Nu.Q® NETs automated product in Europe, with nine hospitals placing orders [9]. - The expansion of the Nu.Q® Vet Cancer Test is a priority, with supply agreements in place with leading industry players [10]. Revenue Growth Strategies - Central lab automation is being implemented to enhance revenue growth and meet increasing demand for the Nu.Q® Vet Cancer Test [11][12]. - The Nu.Q® Discover platform has achieved commercial milestones, including the first sale of a High Throughput Synthetic Sepsis Model, with discussions ongoing for additional projects [13][14]. - A collaboration with a leading pharmaceutical company for a human clinical study utilizing Volition's biomarkers has been established, highlighting the value of biomarkers in drug development [15]. Future Outlook - The company aims to double revenue in the Nu.Q® Discover pillar in 2025, supported by a growing customer base [16]. - The focus for the remainder of 2025 is to secure multiple licensing agreements in the human diagnostics space, mirroring the successful strategy in the veterinary market [19]. - The company is committed to achieving commercial partnerships for human applications, which is a long-term mission [20].

Financial Data and Key Metrics Changes - In 2024, the company recorded $1.2 million in revenue, a growth of 59% over 2023 [28] - Revenue from the NUQ VET cancer test was $0.8 million, growing by 75% compared to the prior year [28] - Operating expenses were reduced by 23% year-on-year, with second-half operating expenses down 31% [30][34] - Net cash used in operating activities was $25.9 million in 2024, compared to $18.1 million in 2023 [31] Business Line Data and Key Metrics Changes - Approximately 120,000 NUQ VET cancer tests were sold in 2024, more than double the prior year [28] - Revenue from the NUQ Discover pillar was approximately $400,000, with year-on-year growth of 40% [29] - The company recorded its first revenue from NUQ NETS, marking a significant milestone [29] Market Data and Key Metrics Changes - The NUQ VET cancer test is now available in over 20 countries, expanding access significantly [18] - The point-of-care market is noted to be less than 20% of the total market, indicating growth potential [22] Company Strategy and Development Direction - The company aims to sign multiple licensing deals in 2025, focusing on human applications [11][68] - There is a strong interest in out-licensing and supply agreements for both NUQ NETS and the oncology portfolio [12][69] - The strategy includes raising non-dilutive funds, ramping revenues, reducing expenses, and signing commercial deals with large industry players [74] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash neutrality on a full-year basis by 2025 [27] - The company is at a pivotal juncture, ready to revolutionize diagnostics for both animals and humans [12] - Management highlighted the importance of automation in centralized labs to accelerate growth [22] Other Important Information - The company received approximately $1.8 million in non-dilutive funding from Belgian institutions during 2024 [33] - Significant progress was made in clinical studies, with multiple large independent studies completed [10][36] Q&A Session Summary Question: Update on the feline cancer testing program - The feline cancer testing program is on track for completion later this year, with a milestone payment of $5 million expected upon completion [80] Question: Discussion on the Leon study and its implementation - The Leon study is expected to lead to prospective studies and potential implementation in screening regimens [85][90] Question: Insights on quarterly sales trends and outlook for 2025 - Sales were volatile due to large customers ordering in batches, but overall growth was solid with 120,000 tests sold [100][102] Question: Approach to managing financing risks - The company plans to maintain tight control over expenses and cash flows while focusing on licensing agreements [112] Question: Activity in data sharing and licensing agreements - The company has established data rooms for oncology and NETS, which have energized discussions with major companies [118][120]

Financial Data and Key Metrics Changes - In 2024, the company recorded $1.2 million in revenue, a growth of 59% over 2023 [28] - Revenue from the NUQ VET cancer test was $0.8 million, growing by 75% compared to the prior year [28] - Operating expenses were reduced by 23% year-on-year, with second half operating expenses down 31% [30] - Net cash used in operating activities was $25.9 million in 2024, compared to $18.1 million in 2023 [31] Business Line Data and Key Metrics Changes - Approximately 120,000 NUQ VET cancer tests were sold in 2024, more than double the sales in 2023 [28] - Revenue from the NUQ Discover pillar was approximately $400,000, with a year-on-year growth of 40% [29] - The company recorded its first revenue from the NUQ NETS, marking a significant milestone [29] Market Data and Key Metrics Changes - The NUQ VET cancer test is now available in over 20 countries, expanding access significantly [18] - The point-of-care market is noted to be less than 20% of the total market, indicating growth potential [22] Company Strategy and Development Direction - The company aims to sign multiple licensing deals in 2025, focusing on human applications of its technology [11] - There is a strong interest in potential out-licensing and supply agreements for both NUQ NETS and the oncology portfolio [12] - The strategy includes raising non-dilutive funds, ramping revenues, reducing expenses, and signing commercial deals with large industry players [74] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash neutrality on a full-year basis by 2025 [27] - The company is at a pivotal juncture, ready to revolutionize diagnostics for both animals and humans [12] - Management highlighted the importance of automation in centralized labs to accelerate growth [22] Other Important Information - The company received approximately $1.8 million in non-dilutive funding from Belgian institutions during 2024 [33] - The NUQ platform has shown broad applicability across various established platforms, enhancing its market potential [14] Q&A Session Summary Question: Update on the feline cancer testing program - Management confirmed that the feline cancer testing program is on track for completion later this year, with a milestone payment of $5 million expected upon completion [80] Question: Discussion on the Leon study and its implementation - Management indicated that there are plans for prospective studies following the results of the Leon study, with potential rapid adoption in cancer programs [86][90] Question: Insights on quarterly sales trends and outlook for 2025 - Management noted that sales were lumpy due to large customers ordering in batches, but solid growth was achieved with 120,000 tests sold [100] - Automation in central labs is expected to open up larger opportunities in 2025 [101] Question: Approach to managing financing risks - Management emphasized a tight grip on expenses and cash flows while focusing on securing licensing agreements [112] Question: Activity and interest in data rooms for licensing agreements - Management reported that the data generated exceeded expectations and has been crucial in energizing discussions with major companies [118]

[Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) 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](index=3&type=section&id=Forward-Looking%20Statements%20Overview) 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 expressions[16](index=16&type=chunk) - 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 plans[16](index=16&type=chunk) - 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 uncertainties[17](index=17&type=chunk) [Significant Factors Impacting Estimates](index=3&type=section&id=Significant%20Factors%20Impacting%20Estimates) 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 include[18](index=18&type=chunk) - 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](index=4&type=section&id=Item%201%2E%20Business) 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 sepsis[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - **Core Technology:** Patented Nucleosomics™ technology uses chromosomal structures (nucleosomes) and transcription factors as biomarkers to detect characteristic changes from the earliest stages of disease[25](index=25&type=chunk) - **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 Nevada[27](index=27&type=chunk)[29](index=29&type=chunk) - **Workforce:** Over **80 dedicated employees** across various disciplines[25](index=25&type=chunk) - **Stakeholder Relationships:** Fostered ties with academic institutions, clinical centers, diagnostic and pharmaceutical companies, and financial institutions worldwide[27](index=27&type=chunk) 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 logistics[53](index=53&type=chunk)[54](index=54&type=chunk) - **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 partners[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) - **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 distributors[61](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - **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-efficiency[68](index=68&type=chunk)[69](index=69&type=chunk) - **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 screenings[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - **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 certification[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - **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 **2043**[82](index=82&type=chunk)[83](index=83&type=chunk) - **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 diversity[82](index=82&type=chunk)[83](index=83&type=chunk) - **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 LLC[82](index=82&type=chunk)[83](index=83&type=chunk) [Item 1A. Risk Factors](index=10&type=section&id=Item%201A%2E%20Risk%20Factors) 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 factors[85](index=85&type=chunk) - **Financial Risks:** Inability to generate significant revenue or achieve profitability, requiring additional capital which may dilute existing stockholders, and difficulty in forecasting future performance[88](index=88&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - **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 acquisitions[95](index=95&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk)[103](index=103&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) - **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 defects[115](index=115&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[134](index=134&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - **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 laws[142](index=142&type=chunk)[143](index=143&type=chunk)[147](index=147&type=chunk)[150](index=150&type=chunk) - **Intellectual Property Risks:** Inadequate patent protection, potential infringement claims by third parties, and inability to protect trade secrets[154](index=154&type=chunk)[155](index=155&type=chunk)[157](index=157&type=chunk) - **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 coverage[159](index=159&type=chunk)[160](index=160&type=chunk)[164](index=164&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Item 1B. Unresolved Staff Comments](index=24&type=section&id=Item%201B%2E%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments from the Securities and Exchange Commission - No unresolved staff comments[174](index=174&type=chunk) [Item 1C. Cybersecurity](index=24&type=section&id=Item%201C%2E%20Cybersecurity) 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 risks[175](index=175&type=chunk)[176](index=176&type=chunk) - **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 reputation[177](index=177&type=chunk)[178](index=178&type=chunk) - **Incident Response:** Program includes processes to triage, assess severity, escalate, contain, investigate, and remediate incidents, with defined steps for material cybersecurity incidents[181](index=181&type=chunk) - **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 Manager[182](index=182&type=chunk)[183](index=183&type=chunk) [Item 2. Properties](index=25&type=section&id=Item%202%2E%20Properties) 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](index=25&type=section&id=Item%203%2E%20Legal%20Proceedings) 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 operations[186](index=186&type=chunk) [Item 4. Mine Safety Disclosures](index=26&type=section&id=Item%204%2E%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item is not applicable[188](index=188&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=26&type=section&id=Item%205%2E%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=190&type=chunk) - **Holders:** As of March 20, 2025, there were **96,543,744 shares** of common stock issued and outstanding, held by **168 record holders**[191](index=191&type=chunk) - **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 development[192](index=192&type=chunk) - **Repurchase of Equity Securities:** No equity securities were repurchased during the fourth quarter of 2024[194](index=194&type=chunk) [Item 6. [Reserved]](index=27&type=section&id=Item%206%2E%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[195](index=195&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%207%2E%20Management%27s%20Discussion%20and%20Analysis%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) 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™[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - **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 controls[202](index=202&type=chunk)[203](index=203&type=chunk) - **Cash and Cash Equivalents:** **$3.3 million** as of December 31, 2024, down from **$20.7 million** as of December 31, 2023[205](index=205&type=chunk)[206](index=206&type=chunk) - **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 costs[207](index=207&type=chunk)[208](index=208&type=chunk) - **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 equipment[210](index=210&type=chunk)[211](index=211&type=chunk) - **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 **$1.8 million** from loans[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) Approximate Contractual Payments Due by Year (as of December 31, 2024) | Description | Total ($) | 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 compensation[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk)[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 impact[328](index=328&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk] [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%207A%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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 risk[240](index=240&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=33&type=section&id=Item%208%2E%20Financial%20Statements%20and%20Supplementary%20Data) 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 revenues[244](index=244&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk)[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 amounts[263](index=263&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk)[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 eliminated[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[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 limits[276](index=276&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk)[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, 2024[280](index=280&type=chunk)[281](index=281&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk)[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 years[291](index=291&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk)[296](index=296&type=chunk)[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 2023[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk)[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 guidance[305](index=305&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk)[311](index=311&type=chunk)[312](index=312&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk)[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk)[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 supply[333](index=333&type=chunk)[334](index=334&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk)[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**)[341](index=341&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk)[348](index=348&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk)[351](index=351&type=chunk)[352](index=352&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk)[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**)[362](index=362&type=chunk)[363](index=363&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk)[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**)[368](index=368&type=chunk)[369](index=369&type=chunk)[370](index=370&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk] - **Net Loss:** **$27.3 million** in 2024, an improvement from **$35.7 million** in 2023 (**24% decrease**)[375](index=375&type=chunk)[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)[378](index=378&type=chunk)[379](index=379&type=chunk)[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 subsidiary[382](index=382&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk)[385](index=385&type=chunk)[386](index=386&type=chunk)[387](index=387&type=chunk)[388](index=388&type=chunk)[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 warrants**[391](index=391&type=chunk)[392](index=392&type=chunk)[393](index=393&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk)[397](index=397&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk)[401](index=401&type=chunk)[402](index=402&type=chunk)[403](index=403&type=chunk)[405](index=405&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk)[409](index=409&type=chunk)[411](index=411&type=chunk)[412](index=412&type=chunk)[414](index=414&type=chunk)[415](index=415&type=chunk)[417](index=417&type=chunk)[418](index=418&type=chunk)[419](index=419&type=chunk)[421](index=421&type=chunk)[422](index=422&type=chunk)[424](index=424&type=chunk)[425](index=425&type=chunk)[428](index=428&type=chunk)[429](index=429&type=chunk)[430](index=430&type=chunk)[433](index=433&type=chunk)[434](index=434&type=chunk)[435](index=435&type=chunk)[436](index=436&type=chunk)[439](index=439&type=chunk)[440](index=440&type=chunk)[442](index=442&type=chunk)[443](index=443&type=chunk)[444](index=444&type=chunk)[446](index=446&type=chunk)[448](index=448&type=chunk)[449](index=449&type=chunk)[450](index=450&type=chunk)[451](index=451&type=chunk)[452](index=452&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk)[456](index=456&type=chunk)[457](index=457&type=chunk)[458](index=458&type=chunk)[459](index=459&type=chunk)[460](index=460&type=chunk)[461](index=461&type=chunk)[462](index=462&type=chunk)[463](index=463&type=chunk)[464](index=464&type=chunk)[466](index=466&type=chunk)[467](index=467&type=chunk)[468](index=468&type=chunk)[470](index=470&type=chunk)[471](index=471&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk)[474](index=474&type=chunk)[475](index=475&type=chunk)[476](index=476&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk)[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk)[486](index=486&type=chunk)[487](index=487&type=chunk)[488](index=488&type=chunk)[489](index=489&type=chunk)[490](index=490&type=chunk)[491](index=491&type=chunk][493](index=493&type=chunk)[494](index=494&type=chunk)[495](index=495&type=chunk)[496](index=496&type=chunk)[497](index=497&type=chunk)[498](index=498&type=chunk] [Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure](index=83&type=section&id=Item%209%2E%20Changes%20In%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) 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 disclosure[500](index=500&type=chunk) [Item 9A. Controls and Procedures](index=83&type=section&id=Item%209A%2E%20Controls%20and%20Procedures) 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 reporting[501](index=501&type=chunk)[502](index=502&type=chunk) - **Material Weakness Identified:** Insufficient written documentation of internal control policies and procedures, particularly regarding the correct application of GAAP and SEC disclosure requirements[503](index=503&type=chunk)[504](index=504&type=chunk) - **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 weaknesses[505](index=505&type=chunk)[506](index=506&type=chunk) - **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 weaknesses[507](index=507&type=chunk)[508](index=508&type=chunk)[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 override[511](index=511&type=chunk)[512](index=512&type=chunk] [Item 9B. Other Information](index=84&type=section&id=Item%209B%2E%20Other%20Information) The company reports that there is no other information required to be disclosed under this item - No other information to disclose[513](index=513&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=84&type=section&id=Item%209C%2E%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) This item is not applicable to the company - This item is not applicable[514](index=514&type=chunk) Part III [Item 10. Directors, Executive Officers and Corporate Governance](index=85&type=section&id=Item%2010%2E%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) 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 Stockholders[517](index=517&type=chunk) - The company maintains an insider trading policy and procedures designed to promote compliance with insider trading laws, rules, and regulations[516](index=516&type=chunk) [Item 11. Executive Compensation](index=85&type=section&id=Item%2011%2E%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[518](index=518&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=85&type=section&id=Item%2012%2E%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters%2E) 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 Statement[519](index=519&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=85&type=section&id=Item%2013%2E%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) 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 Statement[520](index=520&type=chunk) [Item 14. Principal Accountant Fees and Services](index=85&type=section&id=Item%2014%2E%20Principal%20Accountant%20Fees%20and%20Services) 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 Statement[521](index=521&type=chunk) Part IV [Item 15. Exhibits and Financial Statement Schedules](index=86&type=section&id=Item%2015%2E%20Exhibits%20and%20Financial%20Statement%20Schedules) 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 reference[525](index=525&type=chunk) - **Financial Statement Schedules:** Omitted as not applicable or information shown in financial statements/notes[526](index=526&type=chunk) - **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 portions[527](index=527&type=chunk)[528](index=528&type=chunk)[529](index=529&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk)[533](index=533&type=chunk)[534](index=534&type=chunk)[535](index=535&type=chunk)[536](index=536&type=chunk)[537](index=537&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk] [Item 16. Form 10-K Summary](index=92&type=section&id=Item%2016%2E%20Form%2010-K%20Summary) The company states that there is no Form 10-K summary provided - No Form 10-K summary is provided[540](index=540&type=chunk) Signatures [Report Signatures](index=93&type=section&id=Report%20Signatures) 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, 2025[542](index=542&type=chunk)[543](index=543&type=chunk)[545](index=545&type=chunk)[547](index=547&type=chunk] - A Power of Attorney is included, authorizing Cameron Reynolds and Rodney Rootsaert to sign amendments to the report[544](index=544&type=chunk)