[FORM 8-K Filing Details](index=1&type=section&id=FORM%208-K%20Filing%20Details) This section provides essential identification details of VolitionRx Limited as the registrant and outlines its securities and filing status [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides the fundamental identification details of VolitionRx Limited as the registrant for this Form 8-K filing, including its incorporation state, SEC file number, IRS Employer Identification Number, principal executive offices, and telephone number - Registrant Name: **VolitionRx Limited**[1](index=1&type=chunk) - State of Incorporation: **Delaware**[1](index=1&type=chunk) - Principal Executive Offices: **1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014**[1](index=1&type=chunk) [Securities and Filing Status](index=1&type=section&id=Securities%20and%20Filing%20Status) This section outlines the company's registered securities and its status regarding specific SEC filing provisions, including its trading symbol and exchange, and confirms it is not an emerging growth company Registered Securities Information | Title of Each Class | Trading Symbol(s) | Name of Each Exchange on which Registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.001 per share | VNRX | NYSE American, LLC | - The registrant is **not an emerging growth company**[3](index=3&type=chunk) [Current Report Items](index=2&type=section&id=Current%20Report%20Items) This section details the company's financial results announcement and lists the accompanying exhibits for the Form 8-K filing [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) VolitionRx Limited announced its financial results and business updates for the quarter ended June 30, 2025, through a press release issued on August 14, 2025; a conference call is scheduled for August 15, 2025, to discuss these results, with the press release furnished as Exhibit 99.1 - VolitionRx Limited issued a press release on **August 14, 2025**, announcing financial results and business updates for the quarter ended **June 30, 2025**[6](index=6&type=chunk) - A conference call is scheduled for **August 15, 2025**, at **8:30 a.m. U.S. Eastern Time**[6](index=6&type=chunk) - The press release is furnished as **Exhibit 99.1**[6](index=6&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, specifically the press release detailing financial results and an interactive data file Exhibits Included | Exhibit Number | Description | | :------------- | :---------- | | 99.1 | Press Release of VolitionRx Limited, dated August 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document) | [Signatures and Exhibit Index](index=2&type=section&id=Signatures%20and%20Exhibit%20Index) This section includes the official signature confirming the report's authorization and a comprehensive index of all accompanying exhibits [Signature](index=2&type=section&id=Signature) The report is officially signed on behalf of VolitionRx Limited by its Chief Executive Officer & President, Cameron Reynolds, on August 14, 2025, confirming due authorization - The report was signed by **Cameron Reynolds**, Chief Executive Officer & President[11](index=11&type=chunk) - Date of signature: **August 14, 2025**[11](index=11&type=chunk) [Exhibit Index](index=2&type=section&id=Exhibit%20Index) This section provides a final listing of the exhibits included in the Form 8-K filing, specifically referencing the press release Exhibit Listing | Exhibit Number | Description | | :------------- | :---------- | | 99.1 | Press Release of VolitionRx Limited, dated August 14, 2025 |

Core Insights - 2025 is a crucial year for Volition as it aims to commercialize its Nu.Q® platform in the human diagnostics market, currently in discussions with over ten companies [1][2] - The company is progressing through various stages of partnership development, including due diligence and contract finalization, with expectations to sign its first agreement in the human diagnostics space this quarter [2][4] - Volition's Nu.Q® technology shows strong clinical evidence for applications in cancer and sepsis, which are areas of increasing interest for pharmaceutical companies [3][4] Business Strategy - The goal for 2025 includes securing multiple licensing agreements in the human diagnostics sector, similar to its successful strategy in the veterinary market, with diverse deal structures anticipated [4] - The company expects potential for upfront and milestone payments, as well as future recurring revenue from these agreements [4] Financial Performance - Volition recorded over $0.4 million in revenue for Q2 2025, marking a 15% growth compared to the same period last year [8] - The net loss decreased by 11% for the quarter and 24% for the first half of 2025 compared to the previous year [8] - Cash used in operating activities for the first half of 2025 was $10.6 million, down 30% year-over-year, with cash and cash equivalents totaling approximately $2.3 million as of June 30, 2025 [8]

Core Viewpoint - VolitionRx Limited will host a conference call on August 15, 2025, to discuss its Q2 2025 financial and operational results, along with a business update [1][2]. Group 1: Conference Call Details - The conference call is scheduled for August 15, 2025, at 8:30 a.m. U.S. Eastern Time [2]. - Key executives participating in the call include Louise Batchelor (Group Chief Marketing & Communications Officer), Cameron Reynolds (President and Group CEO), Terig Hughes (Group CFO), and Dr. Andrew Retter (Chief Medical Officer) [2]. - A live audio webcast will be available, and a telephone replay will be accessible until August 29, 2025 [3]. Group 2: Company Overview - Volition is a multinational company focused on advancing epigenetics to improve outcomes for individuals and animals with serious diseases through early detection and monitoring [4]. - The company is developing cost-effective blood tests for detecting and monitoring various diseases, including certain cancers and conditions related to NETosis, such as sepsis [5]. - Research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [5].

Core Viewpoint - VolitionRx Limited has announced definitive agreements for the purchase and sale of common stock, aiming to raise approximately $1.21 million in gross proceeds, with potential additional proceeds of about $1.3 million from warrants if fully exercised [1][3]. Group 1: Stock Offering Details - The company will sell 156,250 shares of common stock to insiders at $0.64 per share, and 1,734,375 shares along with warrants to other existing stockholders at the same price [1][2]. - Each warrant has an exercise price of $0.768, is immediately exercisable, and expires five years from the issuance date [1][2]. Group 2: Financial Implications - The total gross proceeds from the offering are expected to be $1.21 million before expenses, with an additional potential of $1.3 million from the exercise of warrants [3]. - The net proceeds will be utilized for research, product development, clinical studies, commercialization, working capital, and potential strategic acquisitions [3]. Group 3: Regulatory Information - The offering is conducted under a shelf registration statement filed with the SEC, and the related prospectus will be available on the SEC's website [4]. Group 4: Company Overview - VolitionRx is a multinational company focused on advancing epigenetics, aiming to improve early detection and monitoring of diseases, including cancers and conditions related to NETosis [6][7]. - The company's research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [8].

Core Insights - VolitionRx Limited has successfully demonstrated the ability to quantify nucleosomes in whole venous blood using a simple lateral flow device, which can provide rapid results in minutes [1] - The study involved 25 hospital patients and showed strong correlation with Volition's established Nu.Q® nucleosome assay, indicating potential for early detection of immune disruptions in conditions like sepsis [1][3] - The technology represents a significant advancement as it allows for quantitative results rather than just positive/negative outcomes, facilitating better clinical decision-making [3] Company Overview - VolitionRx is a multi-national epigenetics company focused on developing blood tests for early disease detection and monitoring, particularly in conditions associated with NETosis, such as sepsis [6][7] - The company aims to improve patient outcomes through earlier detection and monitoring, which can prolong life and enhance quality of life [7] - Volition's research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [8] Technological Innovation - The SUMMIT program is focused on developing a capillary blood-based lateral flow test for early sepsis diagnosis, supported by the Walloon Region [3] - The lateral flow test technology is designed for ease of use, allowing for immediate testing in various settings without the need for specialized equipment [4] - The Nu.Q® nucleosome assay is a chemiluminescent immunoassay that is already available in 27 European countries and is CE marked for disease detection [5] Market Potential - The rapid identification of high-risk patients at the point-of-care could lead to quicker clinical decisions and improved patient outcomes, particularly in critical conditions like sepsis [2] - The technology has the potential to be particularly beneficial in lower-income countries where laboratory infrastructure may be lacking [2]

Company Overview and Strategy - VolitionRx focuses on advancing low-cost, early detection, and treatment monitoring tests in cancer and sepsis[7] - The company's strategy involves licensing its IP to major players, following a low CapEx/low OpEx model similar to its Nu.Q® Vet business[11, 20] - Volition aims to be cash neutral on a full-year basis in 2025, balancing income with expenditure[87] Veterinary Commercial Progress - The Nu.Q® Vet Cancer test is available in over 20 countries[20] - Approximately 120,000 Nu.Q® Vet Cancer tests and test components were sold in 2024[20, 39] - The company has received $23 million in upfront and milestone payments to date, with an additional $5 million milestone payment anticipated in 2025[20] Expansion into Human Diagnostics - Volition is targeting licensing deals in the human sepsis and cancer space in 2025[10] - The company sees a $4 billion opportunity in lung cancer screening, prognostics, and MRD, and a $1 billion+ opportunity in sepsis testing and monitoring[21] - First revenue was recorded for CE-marked product in Q1 2025[85] Financial Performance - Volition recorded approximately $0.25 million in revenue in Q1 2025, a 44% increase over the first quarter of the prior year[87] - Net cash used in operating activities averaged $1.4 million a month, almost 50% lower than the first quarter of 2024[87]

Core Insights - VolitionRx Limited announced the publication of a clinical study indicating that the Nu.Q® H3.1 biomarker can aid in assessing sepsis, organ failure, and subphenotypes in critically ill ICU patients [1][4] - The study involved 1713 patients and demonstrated that H3.1 nucleosomes are biologically specific markers of NETosis, with implications for prognostic enrichment and therapeutic targeting [2][5] - The findings suggest that H3.1 nucleosomes are associated with sepsis and organ dysfunction, highlighting their potential role in treating excessive NETosis in patients [3][4] Company Overview - VolitionRx is a multi-national epigenetics company focused on developing blood tests for early detection and monitoring of diseases, including cancers and conditions related to NETosis [6][7] - The company aims to improve patient outcomes through earlier detection and monitoring, which can enhance both the quality and longevity of life for patients [7][8] - Volition's research and development activities are primarily based in Belgium, with additional operations in the U.S. and London [8]

Core Insights - VolitionRx Limited is presenting its Nu.Q® Vet Cancer Test at the Asian Meeting of Animal Medicine Specialties (AMAMS 2025) in Thailand, highlighting its potential as a diagnostic tool for veterinary oncology [1][2] - The test has shown promise in differentiating between benign and malignant conditions, particularly Canine Chronic Enteropathy and Gastrointestinal Lymphoma, according to Dr. Masahiko Sato [2] - The company aims to enhance awareness and adoption of the Nu.Q® Vet Cancer Test through clinical research and presentations by leading veterinarians [2] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics to improve outcomes for people and animals with life-altering diseases through earlier detection and monitoring [3] - The company is developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis, with the goal of prolonging life and improving quality of life for patients [4] - Volition's research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [5]

Core Insights - VolitionRx Limited has published a study on nucleosome detection in healthy cats, marking a significant advancement in veterinary diagnostics [1][3] - The study indicates the potential for cancer screening and monitoring in cats, which could represent a substantial commercial opportunity for the company [2][4] Company Developments - The study confirms that H3.1 nucleosomes can be quantified from blood samples of healthy cats, establishing a protocol for sample collection and processing [3] - Volition's initial target product focuses on feline lymphoma, the most prevalent cancer in cats, with clinical studies already in progress [4] Market Potential - There are over 60 million cats in the U.S., with 25% classified as senior cats, indicating a significant market for annual health checks [2] - The development of Nu.Q® products for cats opens new avenues for Volition in the veterinary diagnostics market [2][4] Research and Development - Volition's R&D activities are primarily based in Belgium, with additional facilities in the U.S. and London, emphasizing the company's international presence [6]

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]