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].

Core Points - VolitionRx Limited will host a conference call on November 14, 2025, at 8:30 a.m. U.S. Eastern Time to discuss its third-quarter financial and operating results and provide a business update [1][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 Scientific Officer [2] - A live audio webcast of the conference call will be available, and a telephone replay will be accessible until November 28, 2025 [3] Company Overview - Volition is a multi-national company focused on advancing the science of epigenetics, aiming to save lives and improve outcomes for individuals and animals with life-altering diseases through earlier detection and monitoring [4] - The company is developing and commercializing cost-effective blood tests for the detection and monitoring of various diseases, including certain cancers and conditions associated with NETosis, such as sepsis [5] - Volition's research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [6]

Core Points - VolitionRx Limited and its subsidiary donated the Nu.Q® Vet Cancer Test to support crisis response dogs at the HOPE AACR Annual Conference, emphasizing their commitment to corporate social responsibility [1][3][4] - The Nu.Q® Vet Cancer Test is designed for preventive check-ups in older dogs and high-risk breeds, aiming to improve early cancer detection and enhance the quality of life for both dogs and their owners [2][9] - The test is non-invasive, cost-effective, and has been sold in over 20 countries, with more than 100,000 tests sold in 2024 [9][10] Company Overview - Volition is a multinational epigenetics company focused on advancing the science of epigenetics to improve outcomes for people and animals through early disease detection [10][11] - The company is developing and commercializing blood tests for diagnosing and monitoring various diseases, including cancers and conditions associated with NETosis [11][12] - Volition's research and development activities are based in Belgium, with additional offices in the U.S. and London [12]

[DEFINITIONS](index=1&type=section&id=ARTICLE%20I) This article defines key legal, financial, and operational terms for clarity in the Underwriting Agreement [Definitions](index=1&type=section&id=1.1%20Definitions) This section defines key terms, entities, dates, and financial/legal concepts for the public offering - The 'Company' refers to VolitionRx Limited and its subsidiaries and affiliates, while the 'Underwriter' or 'Newbridge' refers to Newbridge Securities Corporation[1](index=1&type=chunk) - The 'Public Securities' collectively include the 'Closing Securities' and, if applicable, the 'Option Securities'[36](index=36&type=chunk) - The 'Closing Date' is the Trading Day when all conditions precedent for the purchase and sale of Closing Securities are satisfied or waived, but no later than 10:00 a.m. (New York City time) on the second Trading Day following the agreement date[9](index=9&type=chunk) - The 'Warrants' are redeemable warrants to purchase one share of Common Stock, exercisable for five years from the Closing Date at a price of **$0.60**[48](index=48&type=chunk) [PURCHASE AND SALE](index=5&type=section&id=ARTICLE%20II) This article details the purchase and sale of common stock and warrants, including initial closing, over-allotment, and underwriter's warrants [Closing](index=5&type=section&id=2.1%20Closing) This section outlines the Company's agreement to sell and the Underwriter's agreement to purchase Closing Securities (Common Stock and Warrants) at a specified combined unit price on the Closing Date Closing Securities Purchase Details | Security Type | Quantity | | :------------ | :------- | | Common Stock | 11,550,000 shares | | Warrants | 11,550,000 warrants | | Total Closing Purchase Price | $5,585,580.00 | | Combined Purchase Price (Share + Warrant) | $0.4836 | | Allocated Value per Warrant | $0.0093 | [Over-Allotment Option](index=5&type=section&id=2.2%20Over-Allotment%20Option) Grants the Underwriter an option to purchase up to an additional 1,732,500 shares of Common Stock and 1,732,500 accompanying Warrants (Option Securities) at the same Securities Purchase Price, exercisable within 30 days of the Execution Date Over-Allotment Option Details | Security Type | Quantity | | :------------ | :------- | | Option Shares | Up to 1,732,500 shares | | Option Warrants | Up to 1,732,500 warrants | | Exercise Period | Within 30 days after Execution Date | [Underwriter's Securities](index=6&type=section&id=2.3%20Underwriter's%20Securities) Stipulates the issuance of Underwriter's Warrants to the Underwriter (or its designees) for up to 808,500 shares of Common Stock (7.0% of Closing/Option Shares). These warrants are exercisable 180 days from the Closing Date for five years at $0.63 per share, subject to FINRA lock-up restrictions Underwriter's Warrants Details | Feature | Detail | | :------ | :----- | | Shares | Up to 808,500 Common Stock (7.0% of Closing/Option Shares) | | Exercisability | Commencing 180 days from Closing Date | | Expiration | Five-year anniversary of Closing Date | | Initial Exercise Price | $0.63 per share | | Lock-up Restriction | 180 days from commencement of sales of Closing Securities (FINRA Rule 5110) | [Deliveries](index=6&type=section&id=2.4%20Deliveries) Specifies the documents and securities the Company must deliver to the Underwriter on the Closing Date and any Option Closing Date, including the Closing/Option Securities, legal opinions, comfort letters, officer's and secretary's certificates, and lock-up agreements - The Company is required to deliver Closing Securities and, if applicable, Option Securities via The Depository Trust Company Deposit or Withdrawal at Custodian system[56](index=56&type=chunk) - Legal opinions from Company Counsel, cold comfort letters from the Company Auditor, and duly executed Officer's, Secretary's, and Chief Financial Officer's Certificates are mandatory deliveries[57](index=57&type=chunk)[58](index=58&type=chunk) - Underwriter's Warrants must be delivered within **five Business Days** of the Closing Date, and Lock-Up Agreements contemporaneously with the main agreement[57](index=57&type=chunk)[58](index=58&type=chunk) [Closing Conditions](index=7&type=section&id=2.5%20Closing%20Conditions) Details the conditions that must be met for the Underwriter's obligations at closing, including the accuracy of Company representations and warranties, performance of obligations, delivery of specified items, effectiveness of the Registration Statement, FINRA clearance, and listing approval for the shares on the Trading Market - All representations and warranties of the Company must be accurate in all material respects, and all Company obligations, covenants, and agreements must be performed[59](index=59&type=chunk) - The Registration Statement must be effective, with no stop orders issued or pending, and FINRA clearance for Underwriter compensation must be received if required[59](index=59&type=chunk) - The Closing Shares and Option Shares, along with the Common Stock underlying the warrants, must be approved for listing on the Trading Market[60](index=60&type=chunk) - There must be no material adverse change in the Company's condition or prospects, and no material litigation or proceedings pending or threatened[60](index=60&type=chunk) [REPRESENTATIONS AND WARRANTIES](index=7&type=section&id=ARTICLE%20III) This article contains detailed representations and warranties by the Company to the Underwriter, covering business, legal standing, financial condition, and regulatory compliance [Representations and Warranties of the Company](index=7&type=section&id=3.1%20Representations%20and%20Warranties%20of%20the%20Company) The Company makes extensive representations and warranties to the Underwriter as of the Execution Date, Closing Date, and any Option Closing Date, covering its subsidiaries, organization, authorization, absence of conflicts, required filings, registration statement, issuance of securities, capitalization, SEC reports, material changes, litigation, labor relations, compliance, regulatory permits, title to assets, intellectual property, insurance, affiliate transactions, internal controls, certain fees, investment company status, registration rights, listing requirements, takeover protections, disclosure, integrated offering, solvency, stock option plans, tax status, foreign corrupt practices, accountants, FDA compliance, OFAC, U.S. real property holding corporation status, Bank Holding Company Act, money laundering, D&O questionnaires, FINRA affiliation, officer's certificates, Board of Directors composition, cybersecurity, and environmental laws [Subsidiaries](index=8&type=section&id=(a)%20Subsidiaries) The Company represents that all its subsidiaries are duly listed in SEC reports, and it owns their capital stock free of liens - All direct and indirect Subsidiaries of the Company are set forth in the SEC Reports[63](index=63&type=chunk) - The Company owns all capital stock or other equity interests of each Subsidiary free and clear of any Liens[63](index=63&type=chunk) - All issued and outstanding shares of capital stock of each Subsidiary are validly issued, fully paid, non-assessable, and free of preemptive and similar rights[63](index=63&type=chunk) [Organization and Qualification](index=8&type=section&id=(b)%20Organization%20and%20Qualification) The Company and its subsidiaries are duly organized, validly existing, in good standing, and possess the necessary authority to conduct business, without violating organizational documents - The Company and each Subsidiary are duly incorporated or organized, validly existing, and in good standing under applicable laws[64](index=64&type=chunk) - They possess the requisite power and authority to own assets and conduct business as currently conducted[64](index=64&type=chunk) - Neither the Company nor any Subsidiary is in violation or default of its organizational documents, and each is duly qualified in necessary jurisdictions, except where failure would not result in a Material Adverse Effect[64](index=64&type=chunk) [Authorization; Enforcement](index=8&type=section&id=(c)%20Authorization%3B%20Enforcement) The Company has the corporate power and authority to enter into and consummate the transactions, which have been duly authorized and constitute valid, binding, and enforceable obligations - The Company has the requisite corporate power and authority to enter into and consummate the transactions contemplated by the Agreement and other Transaction Documents[65](index=65&type=chunk) - The execution and delivery of these documents have been duly authorized by all necessary Company action, requiring no further action from the Board or stockholders other than Required Approvals[65](index=65&type=chunk) - The Agreement and Transaction Documents constitute valid and binding obligations of the Company, enforceable in accordance with their terms (subject to general equitable principles and bankruptcy laws)[65](index=65&type=chunk) [No Conflicts](index=8&type=section&id=(d)%20No%20Conflicts) The execution and performance of the Transaction Documents and the issuance of Public Securities will not conflict with organizational documents, create liens, or violate laws, unless such conflicts are not material - The execution, delivery, and performance of the Transaction Documents and the issuance/sale of Public Securities will not conflict with organizational documents, create Liens, or violate any laws or regulations, except where such conflicts would not result in a Material Adverse Effect[66](index=66&type=chunk) [Filings, Consents and Approvals](index=8&type=section&id=(e)%20Filings%2C%20Consents%20and%20Approvals) The Company is not required to obtain any governmental or third-party consents or make filings, other than those related to SEC registration, Trading Market listing, and state securities laws - The Company is not required to obtain any governmental or third-party consents, waivers, authorizations, or orders, nor make any filings or registrations, other than: (i) filing the Preliminary Prospectus and Prospectus with the Commission, (ii) applying to the Trading Market for listing, and (iii) making required state securities law filings[67](index=67&type=chunk) [Registration Statement](index=9&type=section&id=(f)%20Registration%20Statement) The Company's Registration Statement (Form S-3, effective April 18, 2025) for Public Securities is effective, with no stop orders, and neither party will use unapproved free writing prospectuses - The Company filed the Registration Statement (Form S-3, effective **April 18, 2025**) for

Core Viewpoint - VolitionRx Limited has announced a public offering of 11,550,000 shares of common stock and warrants, aiming to raise approximately $6.0 million in gross proceeds before expenses [1][3]. Offering Details - The public offering price is set at $0.52 per share, with each warrant priced at $0.01, and an exercise price of $0.60 per share [1]. - The underwriter has a 30-day option to purchase an additional 1,732,500 shares and warrants to cover overallotments [2]. - If the warrants are fully exercised, the additional gross proceeds could reach approximately $6.9 million [3]. Use of Proceeds - The net proceeds from the offering will be utilized for research, product development, clinical studies, commercialization, working capital, and potential strategic acquisitions [4]. Company Overview - Volition is a multinational company focused on advancing epigenetics, aiming to improve early detection and monitoring of diseases [8]. - The company is developing cost-effective blood tests for various diseases, including certain cancers and conditions associated with NETosis [9]. - Research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [10].