HENDERSON, Nev., Jan. 8, 2026 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, announced today that it has entered into an amended and restated securities purchase agreement (the "Amended Agreement") with Lind Global Asset Management XII LLC (the "Investor"), an investment fund managed by The Lind Partners, a New York-based institutional fund manager. Under the Amended Agreement, the Company will receive aggregate gross proceeds of ...

Gael Forterre, Chief Commercial Officer, Volition commented: Paves the Way for World's First Feline Liquid Biopsy Test for Cancer Detection 12 HENDERSON, Nev., Jan. 8, 2026 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces results from a clinical study demonstrating the high accuracy of its Nu.Q® Vet Feline assay in detecting lymphoma in cats, the most common cancer in the species. At 100% specificity, i.e. no false positives, the assay de ...

Company Overview - VolitionRx is focused on saving lives and improving outcomes through low-cost testing in cancer, sepsis, and veterinary applications[4, 5] - The company operates with a low capex, low opex business model, emphasizing commercial partnerships and out-licensing[21] - VolitionRx leverages its IP Powerhouse with 56 patent families and a team with hundreds of years of experience[5] Commercialization and Licensing - The company received $10 million upfront and $13 million in milestone payments from an exclusive Element i+ in-house analyzer licensing partnership[29] - In 2024, Volition sold over 120,000 Nu.Q® Vet Cancer Tests & Components[40] - The company is targeting multiple licensing deals in the human space in 2026, focusing on upfront, milestone, and recurring revenue[25] Products and Market - Nu.Q® Vet is available in the United States, Europe, and Asia, detecting 76% of systemic cancers at 97% specificity[38, 40] - The company estimates a $170 million non-regulated animal testing licensing market, a $4 billion lab-developed screening/management market, and a >$3 billion ICU/ED CE Mark/FDA NETosis sales & licensing market[36] - Lung cancer screening and disease management with Nu.Q® is forecasted to reach over 3 million tests by 2035[63]

Core Insights - VolitionRx Limited has made significant progress in 2025, focusing on the commercialization of its Nu.Q® platform for human diagnostics, with key milestones achieved in cancer and sepsis detection [2][3][4] Group 1: Business Developments - The company received its first order for Nu.Q® Cancer assays for clinical certification in lung cancer and included the Nu.Q® NETs assay in a government-backed program in France for early sepsis detection, valued at approximately $7.3 million [3][4] - Volition signed two licensing agreements with major companies, Werfen and Hologic, marking a strategic move into the human diagnostics market [5] - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies to secure additional licensing agreements, anticipating announcements throughout 2026 [6][7] Group 2: Financial Opportunities - The Total Addressable Markets (TAMs) for Volition's technologies are substantial, including $2.3 billion for lung cancer screening, $23 billion for multi-cancer early detection, and $2.8 billion for sepsis early detection [11] - The company aims to replicate its successful licensing strategy in the veterinary market within the human diagnostics space, with potential for diverse deal structures and recurring revenue [7][10] Group 3: Scientific and Clinical Progress - Volition's Nu.Q® NETs assay is being evaluated in over 20 hospitals across 10 countries for various clinical use cases, indicating its potential to become a routine blood test [8] - The company has achieved significant scientific advancements, including the development of a lateral flow test for quantifying nucleosomes, which aids in clinical decision-making [10] - A large-scale study demonstrated that the Nu.Q® NETs H3.1 biomarker is an independent predictor of mortality in sepsis patients, showcasing the assay's clinical relevance [10]

Core Insights - VolitionRx Limited has announced a new manuscript detailing a novel method, Capture-Seq™, for detecting cancer biomarkers through the analysis of transcription factor protected cfDNA in plasma, which promises accurate and low-cost cancer tests [1][3][4] Technology and Methodology - The new method allows for the physical enrichment of ultrashort DNA fragments bound to transcription factors, achieving a 180-fold enrichment (18,000%) compared to traditional methods that lose the DNA's chromosomal context [2][4] - By isolating ultrashort transcription factor-bound DNA, Volition's technology effectively removes 99% of background DNA, addressing the challenge of interference in liquid biopsy tests for early-stage cancer [4][5] Clinical Results - In a small training cohort of 70 individuals, including 49 cancer patients, the analysis demonstrated 100% sensitivity and specificity in detecting cancer, including early-stage cases [7] Commercial Potential - The company sees significant commercial opportunities with a Total Addressable Market estimated at approximately $23 billion annually, and is actively seeking partnerships to accelerate the technology's integration and launch [9][10] Company Overview - VolitionRx is focused on advancing epigenetics and developing cost-effective blood tests for early disease detection and monitoring, with research and development activities centered in Belgium and additional offices in the U.S. and London [10][11]

Core Insights - VolitionRx Limited's Nu.Q® NETs H3.1 assay has been included in the DETECSEPS program, aimed at early detection of sepsis, which is a significant public health concern [1][3][5] - The DETECSEPS Consortium has received approximately €6.3 million (~$7.3 million) in funding from the French government as part of the France 2030 plan [1][11] - The program seeks to reduce the socio-economic burden of sepsis, which affects around 166 million people globally and resulted in 21.4 million deaths in 2021 [4][11] Company Overview - VolitionRx is a multi-national epigenetics company focused on developing blood tests for early detection and monitoring of diseases, including sepsis [22][23] - The company aims to operationalize its understanding of epigenetics in clinical practice, particularly through the use of the H3.1 biomarker [9] - Volition's collaboration with Euroimmun will utilize the IDS i10® automated analyzer for routine measurement of H3.1 levels, providing results within one hour [8][9] Industry Context - Sepsis presents a heavy social, economic, and health burden, with significant long-term complications for survivors, including high rates of re-admission and mortality [4][10] - The DETECSEPS program is expected to implement an innovative early screening strategy combining clinical scores and the Nu.Q® H3.1 biomarker, which has shown strong diagnostic performance [5][7] - The potential market for sepsis testing is substantial, with the opportunity representing a multi-billion dollar total addressable market [11]

Core Insights - VolitionRx Limited has made its first sale of Nu.Q® Cancer assays to Hospices Civils de Lyon, a leading cancer center in Europe, marking a significant milestone in the commercialization of its cancer diagnostic technology [1][3]. Company Developments - The order from Hospices Civils de Lyon is intended to complete the internal certification process before the test is introduced into routine clinical practice for cancer management [2]. - The collaboration with the Lyon team has resulted in strong scientific and clinical evidence supporting the use of Nu.Q® in managing cancer patients, particularly in Non-Small Cell Lung Cancer [3]. Product Impact - Nu.Q® Cancer technology is designed to enhance clinical decision-making by providing valuable information on survival and progression-free survival, thus improving patient outcomes [3]. - The technology aims to empower clinicians with better monitoring capabilities throughout the patient journey, ultimately supporting patient-centered care [3]. Market Position - This sale represents a major step for Volition in the human cancer diagnostics market, aligning with the company's mission to save lives through earlier detection and improved treatment monitoring [3][4]. - Volition is focused on developing cost-effective blood tests for various diseases, including cancers, which could significantly enhance early detection and patient quality of life [4].

Financial Data and Key Metrics Changes - Revenue for Q3 2025 grew 32% year-over-year, reaching $0.6 million [20] - Operating expenses decreased by 10% year-over-year, and net cash used in operating activities was down 33% compared to the prior year [20][21] - Net loss improved by 8% for the quarter and down 20% for the first three quarters compared to the prior year [20][21] Business Line Data and Key Metrics Changes - The company signed two significant agreements: one with Werfen for anti-phospholipid syndrome (APS) and another with Hologic for co-marketing the Nu.Q Discover service [4][8] - The Nu.Q NETs assay is being validated by Werfen for clinical utility in APS patients, with early results showing promise [5][6] - Hologic has already made its first sale of the Nu.Q Discover service, indicating strong initial traction [34] Market Data and Key Metrics Changes - The total addressable market (TAM) for APS is estimated at approximately $85 million annually, which is a strategic entry point for the company's NETs platform [8][27] - The combined TAM for cancer and sepsis diagnostics is approximately $25 billion annually, presenting substantial revenue opportunities [25] Company Strategy and Development Direction - The company aims to achieve cash neutrality by aligning income with expenditures through licensing agreements and milestone payments [21][24] - There is a focus on expanding the Nu.Q VET cancer test globally, with centralized lab automation being a key priority to accelerate revenue growth [22][23] - The company is actively pursuing additional licensing agreements in the human diagnostic space, mirroring its successful strategy in the veterinary market [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the partnerships with Werfen and Hologic, viewing them as transformative for future growth [34][36] - The company anticipates significant progress in clinical utility studies and expects to see more licensing deals in the near future [11][39] - Management acknowledged the challenges of the current market but emphasized the importance of delivering on commercialization plans [81][83] Other Important Information - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies for potential partnerships [10] - The CAPTCHA-seq technology is expected to revolutionize liquid biopsy methods, with promising early results in cancer detection [12][16] Q&A Session Summary Question: Size of the anti-phospholipid syndrome market - The TAM for APS is estimated at $85-$90 million annually, which is a good starting point for the company's NETs platform [27][28] Question: Contribution of the Werfen partnership to Q3 revenue - The Werfen partnership has not yet contributed to revenue as they are still validating the assay on clinical samples [32] Question: Expectations for additional partnerships in 2026 - Management expects to close several additional partnerships in 2026, although the timing is uncertain [37][39] Question: Breakdown of product revenues - Product revenues are still lumpy, with significant contributions from both the Nu.Q VET tests and the Discover kits [45] Question: Conditions for milestone payments related to feline cancer testing - Milestone payments are contingent upon the publication of a paper, which is currently in progress [66][72]

Financial Performance - Total revenues for Q3 2025 reached $627,277, a 32.2% increase from $474,522 in Q3 2024[25] - Product revenues increased to $538,381 in Q3 2025, up 32.5% from $406,088 in Q3 2024[25] - The company reported a net comprehensive loss of $5,387,443 for Q3 2025, compared to $6,010,558 in Q3 2024[26] - For the nine months ended September 30, 2025, the net loss was $17,200,488, a decrease of 19.5% compared to the net loss of $21,400,758 for the same period in 2024[32] - The net loss for the three months ended September 30, 2025, was approximately $5.4 million, an 8% improvement from a net loss of $5.9 million in 2024[195] - The net loss for the nine months ended September 30, 2025, was approximately $17.2 million, a 20% improvement from a net loss of $21.4 million in 2024[207] Expenses - Operating loss for Q3 2025 was $5,100,990, a slight improvement from a loss of $5,868,707 in Q3 2024[25] - Research and development expenses decreased to $2,285,907 in Q3 2025, down 34.2% from $3,473,782 in Q3 2024[25] - General and administrative expenses rose by 37% to $2,483,793 for the three months ended September 30, 2025, compared to $1,815,863 in 2024[185] - Research and development expenses decreased by 36% to $7.6 million from $11.8 million in the prior year, primarily due to reduced clinical trial activity[199] - General and administrative expenses increased by 21% to $7.7 million from $6.4 million, driven by higher stock-based compensation and legal fees[202] - Sales and marketing expenses fell by 29% to $2.9 million from $4.1 million, attributed to reduced personnel and marketing costs[204] Cash Flow and Liquidity - Cash and cash equivalents significantly decreased to $199,407 as of September 30, 2025, from $3,264,429 at December 31, 2024[21] - Operating cash used was $14,191,467 for the nine months ended September 30, 2025, compared to $20,461,849 for the same period in 2024, indicating improved cash management[33] - Net cash used in operating activities was $14.2 million for the nine months ended September 30, 2025, a decrease from $20.6 million in the same period of 2024[175] - Net cash provided by financing activities increased to $11.0 million for the nine months ended September 30, 2025, compared to $6.4 million in 2024[177] - The company expressed substantial doubt about its ability to continue as a going concern without obtaining additional financing[208] Financing Activities - The company raised $4,454,633 from the issuance of common stock during the nine months ended September 30, 2025, down from $6,565,422 in the same period of 2024[33] - In March 2025, the company raised $2.3 million from a registered direct offering, selling 2,363,636 shares at $0.55 per share[68] - In August 2025, the company raised $1.21 million from another registered direct offering, selling 1,734,375 shares at $0.64 per share[69] - In September 2025, the company completed a private placement, raising $0.3 million by selling 483,870 shares at $0.62 per share[70][71] - The company raised approximately $880,862 through the sale of 1,386,223 shares under the 2025 ATM Sales Agreement from April 22, 2025, to September 30, 2025[75] - The company amended the 2025 ATM Sales Agreement to increase the maximum aggregate offering price from $7.5 million to $30.0 million[76] Stock and Compensation - The weighted average shares outstanding for Q3 2025 were 108,213,068, an increase from 87,886,012 in Q3 2024[26] - The company reported stock-based compensation of $1,872,586 for the nine months ended September 30, 2025, compared to $942,805 for the same period in 2024, indicating increased compensation expenses[32] - Total stock-based compensation expense related to RSUs for the nine months ended September 30, 2025, was $1,769,014, compared to $937,567 for the same period in 2024[101] - The company has unrecognized compensation expense of $979,980 related to RSUs from grants in 2025, with $224,055 vesting in 2026, $355,907 in 2027, and $400,018 in 2028[147][148] Assets and Liabilities - Total current assets decreased to $1,332,077 as of September 30, 2025, from $4,056,808 at December 31, 2024[21] - Total liabilities increased to $42,398,447 as of September 30, 2025, compared to $35,507,259 at December 31, 2024[23] - The Company's total property and equipment as of September 30, 2025, was $10.5 million, with accumulated depreciation of $6.3 million, resulting in a net value of $4.2 million[51] - The Company's intangible assets, primarily patents, totaled $1.5 million as of September 30, 2025, with accumulated amortization of $1.2 million, leading to a net value of $301,033[53] Strategic Initiatives - The company launched the Nu.Q® Vet Cancer Test in the UK and Ireland in November 2023, and in Japan in July 2024, now available in over twenty countries[170] - The company entered into a master license and product supply agreement with Heska, receiving a $10 million upfront payment and potential additional payments based on milestone achievements[168] - The company aims to partner with established diagnostic companies to market and sell its tests, leveraging their networks and expertise[165] - The company has committed to issuing 2,868,000 RSUs under the 2024 Plan, contingent on achieving various corporate goals[146] Legal and Compliance - The company is not aware of any legal proceedings that would materially affect its financial position[142] - The company adopted ASU 2023-05 on January 1, 2025, which did not have a material impact on its financial statements, indicating proactive compliance with new accounting standards[40] - The company is currently evaluating the impact of new accounting standards on its consolidated financial statements, including ASU 2024-03 and ASU 2025-05[42][43]

Core Viewpoint - VolitionRx Limited reported significant progress in commercializing its Nu.Q® platform for human diagnostics, with new agreements and positive financial results for Q3 2025 [2][4][8]. Financial Highlights - Revenue for Q3 2025 was $0.6 million, reflecting a 32% increase compared to the same quarter last year [8]. - Operating expenses decreased by 10% year-on-year, and by 18% for the first three quarters of 2025 [8]. - Net loss reduced by 8% for the quarter and by 20% for the first three quarters compared to the previous year [8]. - Net cash used in operating activities was $3.6 million for the quarter, down 33% from the same period last year [8]. - The company received approximately $6.1 million in net proceeds from a public offering after the quarter ended [8]. Business Developments - Volition signed two significant agreements: a Research License and Exclusive Commercial Option Rights Agreement for Antiphospholipid Syndrome with Werfen, and a Co-Marketing and Services Agreement with Hologic [2][3]. - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies, indicating potential for further licensing deals [4]. - Volition aims to replicate its successful licensing strategy in the veterinary market within the human diagnostics space, anticipating diverse deal structures [6]. Technology and Research - The Nu.Q® technology shows promise in critical areas such as cancer and sepsis, with ongoing publications expected in the coming quarters [5]. - The company is focused on developing blood tests for early detection and monitoring of diseases, which could significantly improve patient outcomes [12].