[FORM 8-K Filing Information](index=1&type=section&id=FORM%208-K%20Filing%20Information) This section details the foundational information for the Form 8-K filing, including registrant identification and securities status [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides the fundamental identification details for VolitionRx Limited as the registrant, including its legal and operational addresses, and contact information for the current report filing - Registrant: VolitionRx Limited[1](index=1&type=chunk) - Jurisdiction 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) [Filing Status and Securities](index=1&type=section&id=Filing%20Status%20and%20Securities) This part clarifies the company's filing status, indicating it is not an emerging growth company, and lists the securities registered under Section 12(b) of the Exchange Act - The registrant is not an emerging growth company[3](index=3&type=chunk) Securities Registered Pursuant to Section 12(b) of the Act | 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 | [Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition) This section reports the announcement of VolitionRx Limited's financial performance and business updates for the quarter and fiscal year ended December 31, 2024 [Announcement of Financial Results](index=2&type=section&id=Announcement%20of%20Financial%20Results) VolitionRx Limited announced its financial results and business updates for the quarter and fiscal year ended December 31, 2024, via a press release issued on March 31, 2025. The company also confirmed a conference call to discuss these results - VolitionRx Limited issued a press release on March 31, 2025, announcing financial results and business updates for Q4 and fiscal year ended December 31, 2024[6](index=6&type=chunk) - A conference call was scheduled for March 31, 2025, at 4:30 p.m. U.S. Eastern Time[6](index=6&type=chunk) - The press release is furnished as Exhibit 99.1 and is incorporated by reference[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 details the supplementary documents and data files included as exhibits to the Form 8-K filing [Exhibits List](index=2&type=section&id=Exhibits%20List) This section lists the exhibits accompanying the Form 8-K filing, primarily the press release detailing the financial results and an interactive data file Exhibits Furnished with Form 8-K | Exhibit Number | Description | | :------------- | :----------------------------------------------------------------------- | | 99.1 | Press Release of VolitionRx Limited, dated March 31, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [SIGNATURE](index=2&type=section&id=SIGNATURE) This section confirms the official authorization and signing of the Form 8-K report by the company's executive leadership [Report Authorization](index=2&type=section&id=Report%20Authorization) The Form 8-K report was duly signed on behalf of VolitionRx Limited by its Chief Executive Officer & President, Cameron Reynolds, on March 31, 2025, confirming compliance with Securities Exchange Act requirements - The report was signed on March 31, 2025[12](index=12&type=chunk) - Signed by Cameron Reynolds, Chief Executive Officer & President of VolitionRx Limited[12](index=12&type=chunk)

Core Insights - The company aims to generate sufficient clinical data in 2024 to convince major players in the diagnostic and liquid biopsy markets of the significance of its Nu.Q® platform in oncology and sepsis [1] - In 2025, the focus will shift to signing multiple licensing deals for human indications, with strong interest from large companies for potential out-licensing and supply agreements [2] Financial Highlights - The company reported revenue of $1.2 million for 2024, representing a 59% increase compared to the previous year [7] - Nu.Q® Vet revenue increased by 75%, while Nu.Q® Discover revenue rose by 40% compared to 2023 [7] - Operating expenses decreased by 23% year-over-year, with a 31% reduction in the second half of 2024 [7] - Cash and cash equivalents as of December 31, 2024, totaled approximately $3.3 million, with additional funding of $1.8 million received post-year-end [7] Product Development and Market Expansion - Approximately 120,000 Nu.Q® Vet Cancer Tests were sold in 2024, with the test now available in over 20 countries [6] - A range of independent studies demonstrating the value of the Nu.Q® platform in sepsis and oncology has been completed [6] - The company is advancing several commercial discussions with significant players in the human diagnostic and liquid biopsy markets, which are valued in the multibillion-dollar range [6] Leadership and Governance - The Board of Directors was strengthened with the appointment of Timothy Still as Chair and Dr. Ethel Rubin as Independent Director, both bringing significant experience in the diagnostic sector [6]

Core Insights - VolitionRx Limited presents two studies at the European Lung Cancer Congress 2025, highlighting the potential of its Nu.Q® H3K27Me3 biomarker combined with circulating tumor DNA to enhance prognostic value for overall survival in Non-Small Cell Lung Cancer (NSCLC) [1] - The studies also showcase Volition's Nu.Q® H3.1, a low-cost immunoassay aimed at early identification of individuals at high risk for cancer [1] Group 1: Event Details - The European Lung Cancer Congress 2025 (ELCC 2025) is held in Paris, France from March 26-29, 2025 [2] - Two poster sessions are scheduled for March 28, 2025, featuring presentations on early detection and prognostic biomarkers in NSCLC [3] Group 2: Company Overview - Volition is a multi-national company focused on advancing epigenetics to improve early detection and monitoring of diseases, including cancer [4] - The company aims to develop cost-effective blood tests to enhance patient outcomes and quality of life through early detection [5] - Volition's research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [6]

Core Insights - VolitionRx Limited will host a virtual investor event on April 9, 2025, featuring key executives discussing the company's progress and commercialization efforts [1][2] Company Overview - VolitionRx is a multi-national epigenetics company focused on advancing the science of epigenetics to improve early detection and monitoring of diseases [11][12] - The company is developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis [12] Market Opportunity - The Total Annual Accessible Market for lung cancer management is estimated at approximately $4 billion, presenting a significant revenue opportunity for Volition [3] - The potential market for liquid biopsy for multi-cancer early detection in the U.S. is valued at $20 billion, indicating a substantial growth opportunity for the company [5] Product Development - The Nu.Q® platform has shown promise in detecting common cancers with an overall AUC of 86% and low false positive rates, as reported in a paper currently under peer review [4] - The upcoming webinar will provide insights into the completion of large independent studies supporting the Nu.Q® platform's value in cancer detection [2] Leadership Team - Gael Forterre, Chief Commercial Officer, is focused on commercialization strategies and has extensive experience in scaling companies [6][7] - Dr. Andrew Retter, Chief Medical Officer, has a strong background in clinical trials and has published over 50 articles in peer-reviewed journals [8] - Dr. Jake Micallef, Chief Scientific Officer, is a founding scientist with expertise in diagnostics and has contributed to the development of Volition's Nucleosomics™ technology [9][10]

Core Viewpoint - VolitionRx Limited will host a conference call on March 31, 2025, to discuss its financial and operational results for Q4 and the full fiscal year 2024, along with a business update [1][2]. Group 1: Conference Call Details - The conference call is scheduled for March 31, 2025, at 4:30 p.m. U.S. Eastern Time [1][2]. - Dial-in numbers for the call include a toll-free option for the U.S. and Canada at 1-877-407-9716, and an international toll number at 1-201-493-6779 [2]. - The call will be hosted by key executives including the Group Chief Marketing & Communications Officer, the President and Group CEO, the Group CFO, and the Chief Medical Officer [2]. Group 2: Company Overview - Volition is a multinational company focused on advancing epigenetics to improve early detection and monitoring of diseases [4][5]. - The company is developing cost-effective blood tests for 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 Insights - VolitionRx Limited has developed an automated Nu.Q® Cancer test that accurately detects 21 different types of cancers with high specificity and low false positive rates, potentially serving as a standalone pan-cancer test or in conjunction with other liquid biopsy technologies [1][4][5] - The company aims to disrupt the $20 billion annual market for liquid biopsy in the U.S. by providing early cancer detection solutions [2] - Volition is in discussions with large diagnostic and liquid biopsy companies to establish multiple licensing agreements, which may include milestone payments and ongoing revenue [3] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics to improve early detection and monitoring of diseases, including cancer [6][7] - The company’s research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [8] Study Details - The study involved 229 cancer patients (including 70 early-stage patients) and 150 healthy subjects, demonstrating an overall AUC of 86% for detecting common fatal cancers such as lung, breast, prostate, colon, and liver cancers [4][5] - The Nu.Q® Cancer test is designed to be run on existing automated chemiluminescence platforms, making it accessible without the need for new hardware [4] Future Prospects - The company is focused on leveraging its existing technology to make Nu.Q® Cancer testing widely accessible through licensing and partnership arrangements [4] - There is potential for the Nu.Q® platform to be used not only for early cancer detection but also in the management of cancer patients, particularly in assessing treatment efficacy [5]

Core Viewpoint - VolitionRx Limited aims to transform the lung cancer diagnosis and monitoring landscape with its Nu.Q® Cancer Test, targeting the $4 billion lung cancer market [1][4]. Company Overview - VolitionRx Limited is a multi-national epigenetics company focused on advancing early detection and monitoring of diseases, including cancer [6][7]. - The company is developing cost-effective blood tests that can be administered easily, utilizing small blood samples [1][7]. Product Development - The Nu.Q® Cancer assays are designed to improve early detection and monitoring of lung cancer, potentially enhancing patient outcomes [1][3]. - A retrospective study involving 1,050 patients with Non-Small Cell Lung Cancer is set to be published, supporting the efficacy of Nu.Q® Cancer [4]. Market Opportunity - The total annual accessible market for lung cancer screening, prognostication, and minimal residual disease identification is estimated at approximately $4 billion [4]. - VolitionRx is in discussions with large diagnostics and liquid biopsy companies to establish multiple licensing agreements this year [4]. Commercial Strategy - The company's nucleosome assays can be utilized on existing automated chemiluminescence platforms, eliminating the need for new hardware [5]. - VolitionRx aims to make Nu.Q® Cancer testing widely accessible through licensing and partnership arrangements [5].

Core Viewpoint - VolitionRx Limited is participating as a silver sponsor at the 44th Annual ISICEM Congress in Brussels, showcasing its Nu.Q® H3.1 epigenetic screening technology, which has significant implications for sepsis care and critical care medicine [1][2][3] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics, dedicated to improving outcomes for patients with life-altering diseases through earlier detection and monitoring [9][10] - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including cancers and conditions associated with NETosis, such as sepsis [10] Market Opportunity - The developments presented at ISICEM highlight a market opportunity exceeding $1 billion in sepsis care, positioning Volition at the forefront of advancements in critical care medicine [3] Presentations at ISICEM - Multiple presentations will feature the Nu.Q® H3.1 technology, including topics such as circulating NETs levels, functional endotyping in sepsis, and the role of H3.1 in early recognition of sepsis [3][4][5] - Notable speakers include Professor Djillali Annane and Professor Evangelos Giamarellos-Bourboulis, who will present on various aspects of sepsis and its management [4][5] Educational Impact - The ISICEM congress aims to enhance the care of critically ill patients through education and research, attracting over 5,000 participants globally [8]

Core Viewpoint - VolitionRx Limited has expanded its supply agreement with Fujifilm Vet Systems in Japan to include an automated version of its Nu.Q® Vet Cancer Test, aiming for a launch in summer 2025 [1][2][3] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics and improving outcomes for people and animals through early detection of diseases [7][8] - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including cancers [8] Product Details - The Nu.Q® Vet Cancer Test is designed for regular check-ups of older dogs (seven years and older) or younger high-risk breeds, priced at an average of $11 per test for central lab testing [4] - The test is non-invasive and aims to aid in early cancer detection, which is crucial as cancer is the leading cause of adult canine deaths [3][4] Market Opportunity - There are approximately seven million pet dogs in Japan, presenting a significant revenue opportunity for Volition through its partnership with Fujifilm Vet Systems, a leading provider of diagnostic tests in the country [2] - Since the launch of the Nu.Q® Vet Cancer Test in July 2024, over 1,000 veterinary hospitals in Japan have registered to use the test, indicating strong demand [2][3] Partnership Dynamics - Fujifilm Vet Systems will validate and verify the automated platform for canine cancer screening, enhancing the efficiency and throughput of the testing process [1][2] - The agreement allows Fujifilm Vet Systems to sell and perform the Nu.Q® Vet Cancer Test across its network of central reference laboratories in Japan [3]

Core Insights - VolitionRx Limited has initiated a clinical study to evaluate its Nu.Q® Cancer technology for differentiating between malignant and benign pulmonary nodules in patients undergoing low-dose computed tomography (LDCT) screening for lung cancer [1][5] - The study, in collaboration with National Taiwan University Hospital, aims to enroll 500 patients and is expected to be completed by the end of 2025 [1][2] - Previous studies indicate that the Nu.Q® Cancer test can accurately identify malignant nodules with high sensitivity, which could lead to its inclusion in national lung cancer screening programs [4][5] Company Overview - VolitionRx is a multi-national epigenetics company focused on advancing the science of epigenetics and improving outcomes for patients through earlier detection of diseases [8][9] - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including cancers [9] - Volition's research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [9] Industry Context - Lung cancer is a leading cause of cancer-related deaths globally, and LDCT is recognized as the gold standard for lung cancer screening [3] - The high sensitivity of LDCT can lead to false positives and unnecessary invasive procedures for patients with benign nodules, highlighting the need for more accurate diagnostic tools [3][6] - A blood-based test that can distinguish between cancerous and non-cancerous nodules would significantly enhance clinical practice and lung cancer screening programs [7]