Company Performance - Apogee Enterprises Inc. reported better-than-expected second-quarter financial results, with shares gaining 1.4% to $42.00 in after-hours trading [2] - Levi Strauss & Co. reported third-quarter earnings of 34 cents per share, exceeding the analyst consensus estimate of 31 cents per share, and quarterly sales of $1.543 billion, surpassing the estimate of $1.501 billion; however, shares fell 7.7% to $22.65 in after-hours trading [2] - VolitionRX Ltd. announced a public offering of common stock and common stock warrants, leading to a 20% dip in shares to $0.48 in after-hours trading [2] - USANA Health Sciences Inc. reported preliminary third-quarter results with an adjusted loss of 15 cents per share and sales of $214.00 million, resulting in an 11.4% decline in shares to $23.26 in after-hours trading [2] - Nurix Therapeutics Inc. reported worse-than-expected third-quarter financial results, causing shares to fall 5.7% to $10.24 in after-hours trading [2]

, /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi- national epigenetics company, announced today that it is proposing to offer and sell, in an underwritten public offering, shares of its common stock and accompanying common stock purchase warrants. In addition, Volition intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock and warrants offered in the offering at the public offering price, l ...

PresentationYou may type in a question at any time during the webinar, you can do this through the Q&A panel, which appears on the right side of the webinar presentation. If you look to the bottom tray of your window, there is a series of widgets to enhance your webinar experience. And with that, I'll turn it over to Marielle.Great. Good morning, everyone. I'm Alexandra Byrne. I'm a reporter at GenomeWeb, and I will be your moderator for today's webinar. The title of today's webinar is beyond the genome: Me ...

Summary of the Webinar on Epigenetic Modifications for Biomarker and Drug Discovery Industry and Company Involved - **Industry**: Biotechnology focusing on epigenetic modifications and cancer diagnostics - **Companies**: Volition and HelioGenomics Core Points and Arguments 1. **Overview of Volition**: Volition is a multinational company with R&D labs in Belgium and the U.S., aiming to save lives through innovative diagnostic technologies [2][3] 2. **Nucleosomes and Epigenetic Modifications**: Nucleosomes, composed of DNA and histone proteins, undergo various post-translational modifications (PTMs) that regulate gene expression and are implicated in diseases like cancer [3][4] 3. **Nuclear Assays**: Volition's nuclear assays quantitatively measure circulating nucleosomes and their modifications, with a portfolio of 14 assays targeting specific epigenetic features [4][5] 4. **Diagnostic Potential**: H3K27 trimethylation levels were significantly elevated in non-small cell lung cancer (NSCLC) patients, showing a 3.7 to 2.9-fold increase compared to healthy controls, indicating its potential as a diagnostic biomarker [11][12] 5. **Prognostic Value**: Elevated levels of H3K27 trimethyl nucleosomes were associated with worse outcomes in NSCLC, with a hazard ratio of 3.56, suggesting its use as a prognostic biomarker [41] 6. **Combination with ctDNA**: Combining H3K27 trimethyl status with circulating tumor DNA (ctDNA) improved patient identification by 15.1%, enhancing the sensitivity of blood-based assays [13][50] 7. **EZH2 Inhibitors**: EZH2 inhibitors, such as ORIC-944, show promise in treating cancers by targeting the PRC2 complex, with ongoing clinical trials demonstrating their efficacy [16][17] 8. **Immunogenicity Enhancement**: EZH2 inhibition can increase tumor visibility to the immune system, enhancing the efficacy of immunotherapies by promoting T cell infiltration and activation [27][55] 9. **Clinical Trials**: Multiple clinical trials are investigating the combination of EZH2 inhibitors with immune checkpoint blockade therapies, indicating a strategic shift towards immunoepigenetic combinations [30][57] Other Important but Possibly Overlooked Content 1. **Assay Development Support**: Volition offers support for customizing assays tailored to specific drug programs and matrices, indicating a collaborative approach with pharmaceutical partners [54] 2. **Toxicity Detection**: The H3.1 nuclear assay can serve as an early indicator of systemic cell death, providing a sensitive method for detecting toxicity during drug development [42] 3. **Logistical Considerations**: Proper sample collection and processing are crucial for assay accuracy, with specific recommendations for handling plasma samples [48][58] 4. **Specificity of Assays**: The assays are designed to specifically detect intact circulating nucleosomes without cross-reactivity to other histone modifications [46][53] This summary encapsulates the key insights from the webinar, highlighting the advancements in epigenetic assays and their implications for cancer diagnostics and treatment.

Details of the Webinar: Beyond the Genome: Measuring Epigenetic Modifications Across Matrices for Biomarker and Drug Discovery Accessibility StatementSkip Navigation HENDERSON, Nev., Oct. 2, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the sponsorship of a GenomeWeb webinar entitled "Beyond the Genome: Measuring Epigenetic Modifications Across Matrices for Biomarker and Drug Discovery" on Wednesday, October 8 (details can b ...

Accessibility StatementSkip Navigation HENDERSON, Nev., Sept. 29, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces that it has signed an agreement with Hologic Diagenode ("Hologic") for the co-marketing of Volition's Nu.Q Discover service. The Nu.Q Discover service provides drug developers and scientists with a range of state-of-the-art assays for rapid epigenetic profiling in disease model development, preclinical testing, and ...

Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]

Core Insights - VolitionRx Limited has signed a Research License and Exclusive Commercial Option Rights Agreement for Antiphospholipid Syndrome (APS) with Werfen's Immunoassay Technology Center, a leader in specialized diagnostics [1][2][3] Company Overview - VolitionRx is a multi-national epigenetics company focused on advancing the science of epigenetics and developing cost-effective blood tests for early detection and monitoring of diseases [13][14] - Werfen is a family-owned company founded in 1966, specializing in diagnostics in areas such as Hemostasis and Autoimmunity, with worldwide sales of €2.2 billion in 2024 [12] Agreement Details - The agreement allows Werfen to access Volition's proprietary Nu.Q® H3.1 NETs assay to investigate its clinical utility in managing APS patients [3][4] - Werfen has the option to negotiate exclusive commercial rights for launching the product [3] Clinical Implications - APS affects approximately four million people globally and is associated with increased risks of blood clots and complications such as stroke and heart attack [5][10] - The Nu.Q® NETs test is being investigated as a potential biomarker for APS, which could improve diagnostic information and patient monitoring [7][8] Technological Advancements - Early results from the Nu.Q® NETs assay on Werfen's ACL AcuStar® platform show promising detection levels in APS patients [4] - The collaboration aims to validate the clinical utility of the Nu.Q® test as a risk indicator for thrombosis in APS patients [4][6]

Financial Data and Key Metrics Changes - Total operating expenses for Q2 2025 declined by 9% compared to 2024, primarily due to lower personnel and research and development costs [6] - Net cash used in operating activities was $6,300,000 for Q2 2025, down from $6,700,000 in 2024, with total cash used in operations for the first half of 2025 totaling $10,600,000, a 30% decrease year-over-year [6][7] - Revenue for Q2 2025 was over $400,000, bringing total revenue for the first half of 2025 to a little over $650,000, representing a 15% increase compared to the same period in 2024 [6][7] Business Line Data and Key Metrics Changes - The company recorded its first revenue from sales of a human product, Nu. Q Net, marking a significant milestone in its commercialization efforts [6] - The Nu. Q Cancer and Nu. Q Nets pillars have shown significant progress, with independent studies confirming the effectiveness of their biomarkers [9][14] - The Nu. Q Vet cancer test continues to expand globally, with supply agreements in place with leading industry players [34][35] Market Data and Key Metrics Changes - The total addressable market for cancer and sepsis diagnostics is estimated at approximately $25 billion annually, presenting substantial revenue opportunities for the company and its partners [21] - The potential market for the Nu. Q test in lung cancer screening could exceed $1 billion annually across Taiwan, the U.S., U.K., and France [24] Company Strategy and Development Direction - The company aims to achieve cash neutrality for the full year 2025 by executing licensing agreements with significant upfront payments and reducing expenditures [5] - The focus for 2025 is on commercializing the Nu. Q platform in the human diagnostic market, with ongoing discussions with over 10 companies [19][20] - The strategy includes leveraging existing CE Marked products for NETosis-related diseases while expanding into new markets through licensing agreements [26][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in licensing discussions and the potential for significant revenue generation from upcoming deals [19][20] - The company is confident in the robustness and reliability of its platform, which has applications across various clinical areas, including cancer and sepsis [92] - Management anticipates that the next few quarters will be pivotal for securing licensing agreements and advancing commercialization efforts [42][92] Other Important Information - The company has made substantial progress in its clinical study programs, with ongoing collaborations and studies expected to yield further validation of its products [9][12] - The company is exploring co-marketing partnerships to enhance the reach of its Nu. Q Discover platform [41] Q&A Session Summary Question: Which uses of the Nu. Q platform have attracted the most attention from potential partners in the human health space? - Management indicated that interest spans across all areas, including Discover, NETosis, and oncology, with significant engagement from major diagnostic and pharmaceutical companies [46][49] Question: How will the company utilize capital from executed deals to drive revenues? - The company plans to use capital to achieve revenue neutrality and expects varying deal structures across different applications, with some anticipated to yield large payments and ongoing revenues [55][56] Question: Can details be provided on the first human deal's indication or application? - While specifics were not disclosed due to confidentiality, management emphasized that all deals will leverage the robust and reliable Nu. Q test [63][65] Question: What is the expected timeline from licensing a deal to commercialization? - The timeline varies, with immediate revenue possible for some deals, while others may take two to three years for regulatory approval [70][73] Question: Are there any regulatory bodies that need to approve the Taiwan screening program before full production? - Management confirmed that the current validation study is ongoing, and if successful, the test could be launched quickly in a clear lab setting [77][80]

PART I FINANCIAL INFORMATION This section provides unaudited condensed consolidated financial statements and management's analysis for VolitionRx Limited [Item 1. FINANCIAL STATEMENTS (UNAUDITED)](index=4&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) This section presents the unaudited condensed consolidated financial statements of VolitionRx Limited, including balance sheets, statements of operations and comprehensive loss, stockholders' deficit, and cash flows, along with detailed notes explaining the basis of presentation, liquidity, asset details, equity transactions, commitments, and subsequent events [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Summary | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Total Assets | 8,704,790 | 9,399,523 | | Total Liabilities | 41,803,112 | 35,507,259 | | Total Stockholders' Deficit | (33,098,322) | (26,107,736) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents the unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024 Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 653,073 | 567,332 | 85,741 | 15% | | Operating Loss | (11,819,197) | (15,374,923) | 3,555,726 | (23%) | | Net Loss | (11,790,697) | (15,532,180) | 3,741,483 | (24%) | | Net Loss Per Share – Basic and Diluted | (0.12) | (0.19) | 0.07 | (37%) | Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 406,688 | 395,797 | 10,891 | 3% | | Operating Loss | (6,297,807) | (6,990,419) | 692,612 | (10%) | | Net Loss | (6,314,070) | (7,060,175) | 746,105 | (11%) | | Net Loss Per Share – Basic and Diluted | (0.06) | (0.08) | 0.02 | (25%) | [Condensed Consolidated Statements of Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Deficit) This section details changes in stockholders' deficit for the six months ended June 30, 2025, including common stock, additional paid-in capital, and accumulated deficit Changes in Stockholders' Deficit (Six Months Ended June 30, 2025) | Metric | Balance, Dec 31, 2024 ($) | Common Stock Issued for Cash ($) | Stock-based Compensation ($) | Foreign Currency Translation ($) | Net Loss for Period ($) | Balance, Jun 30, 2025 ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Common Stock Amount | 96,098 | 2,281 | - | - | - | 103,982 | | Additional Paid-in Capital | 204,154,994 | 2,440,385 | 1,263,419 | - | - | 209,777,146 | | Accumulated Other Comprehensive Income | 385,631 | - | - | (829,925) | - | (444,294) | | Accumulated Deficit | (229,544,343) | - | - | - | (11,707,837) | (241,252,180) | | Total Stockholders' Deficit | (26,107,736) | 2,447,258 | 1,263,419 | (829,925) | (11,707,837) | (33,098,322) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the unaudited condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024, detailing operating, investing, and financing activities Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | (10,560,707) | (15,074,388) | | Net Cash Used In Investing Activities | (78,591) | (239,256) | | Net Cash Provided By Financing Activities | 9,337,104 | 764,037 | | Net change in cash and cash equivalents | (1,008,433) | (14,731,055) | | Cash and cash equivalents – End of the Period | 2,255,996 | 5,998,928 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes explaining the basis of presentation, liquidity, asset details, equity transactions, commitments, and subsequent events for the financial statements [Note 1 – Basis of Presentation and other information](index=8&type=section&id=Note%201%20%E2%80%93%20Basis%20of%20Presentation%20and%20other%20information) This note details the basis of preparing the unaudited condensed consolidated financial statements in accordance with GAAP, outlines the fair value measurements for derivative and warrant liabilities, explains the calculation of basic and diluted net loss per share, and discusses recently adopted and issued accounting pronouncements Fair Value Measurements at June 30, 2025 | Description | Level 1 ($) | Level 2 ($) | Level 3 ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Derivative Liability | - | - | 623,790 | 623,790 | | Warrant liability | - | 140,612 | - | 140,612 | | Total | - | 140,612 | 623,790 | 764,402 | - As of June 30, 2025, **58,234,651 potential common shares equivalents** from warrants, options, and restricted stock units were excluded from diluted EPS calculations due to their anti-dilutive effect[40](index=40&type=chunk) - The Company adopted ASU 2023-05 on January 1, 2025, which did not have a material impact on its financial statements[41](index=41&type=chunk) - The Company is currently evaluating the impact of ASU 2023-09 (effective for fiscal years beginning after December 15, 2025) and ASU 2024-03 (effective for annual periods beginning after December 15, 2026) on its consolidated financial statements[42](index=42&type=chunk)[43](index=43&type=chunk) [Note 2 – Liquidity and Going Concern Assessment](index=10&type=section&id=Note%202%20%E2%80%93%20Liquidity%20and%20Going%20Concern%20Assessment) This note highlights the Company's ongoing operating losses and negative cash flows, indicating substantial doubt about its ability to continue as a going concern. Management plans to address this through licensing, additional financing, grants, and cost controls, but acknowledges no assurance of success - For the six months ended June 30, 2025, the Company incurred a net loss of **$11.8 million** and used **$10.6 million** in cash flows from operating activities[47](index=47&type=chunk) - As of June 30, 2025, the Company had cash and cash equivalents of **$2.3 million** and an accumulated deficit of **$241.3 million**[47](index=47&type=chunk) - Management plans to address going concern by granting licenses, obtaining additional debt or equity financing, securing grants, and efficient product commercialization, alongside tight cost controls[48](index=48&type=chunk) - The Company concluded that its plans do not alleviate the substantial doubt about its ability to continue as a going concern beyond one year from the financial statement issuance date[50](index=50&type=chunk) [Note 3 – Property and Equipment](index=11&type=section&id=Note%203%20%E2%80%93%20Property%20and%20Equipment) This note provides a breakdown of the Company's property and equipment, net, as of June 30, 2025, and December 31, 2024, and reports the depreciation expense for the six-month periods Property and Equipment, Net | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Total property and equipment, net | 4,500,065 | 4,429,152 | - Depreciation expense recognized was **$492,925** for the six months ended June 30, 2025, compared to **$545,128** for the same period in 2024[52](index=52&type=chunk) [Note 4 – Intangible Assets](index=12&type=section&id=Note%204%20%E2%80%93%20Intangible%20Assets) This note details the Company's intangible assets, primarily patents, their amortization schedule, and the review for impairment Patents and Licenses, Net | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Total Patents and Licenses, net | 306,377 | 313,747 | - Amortization expense was **$11,704** for the six months ended June 30, 2025, compared to **$(12,624)** for the same period in 2024[55](index=55&type=chunk) Annual Estimated Amortization Schedule for Intangible Assets | Year | Amount ($) | | :--- | :--- | | 2025 - Remaining | 10,236 | | 2026 | 20,305 | | 2027 | 20,305 | | 2028 | 20,305 | | 2029 | 20,305 | | Greater than 5 years | 214,921 | | Total Intangible Assets | 306,377 | [Note 5 – Related-Party Transactions](index=12&type=section&id=Note%205%20%E2%80%93%20Related-Party%20Transactions) This note refers to other sections for details on common stock, stock options, warrants, and RSUs issued to related parties, and mentions agreements for consultancy services - The Company has agreements with related parties for the purchase of consultancy services, accrued under management and directors' fees payable[57](index=57&type=chunk) [Note 6 – Common Stock](index=12&type=section&id=Note%206%20%E2%80%93%20Common%20Stock) This note provides details on the Company's common stock, including the number of shares authorized, issued, and outstanding, as well as activities related to stock options, RSU settlements, and various equity capital raises in 2024 and 2025 - As of June 30, 2025, **103,982,020 shares** of common stock were issued and outstanding, up from **96,097,485 shares** as of December 31, 2024[58](index=58&type=chunk) - During the six months ended June 30, 2025, **249,213 vested stock options** were cancelled[60](index=60&type=chunk)[61](index=61&type=chunk) - On May 1, 2025, **1,958,273 shares** of common stock were purchased through the partial exercise of Pre-Funded Warrants, generating **$1,958** in gross proceeds[62](index=62&type=chunk) - A total of **982,793 RSUs** under the 2015 Plan and **225,000 RSUs** under the 2024 Plan vested and settled during the six months ended June 30, 2025[64](index=64&type=chunk)[66](index=66&type=chunk) - The March 2025 Equity Capital Raise generated **$2.3 million** in net proceeds from the issuance of **4,102,723 shares** of common stock and **1,739,087 common stock purchase warrants**[67](index=67&type=chunk)[68](index=68&type=chunk) - The August 2024 Equity Capital Raise generated **$6.4 million** in net proceeds from the issuance of common stock, pre-funded warrants, and common stock warrants[69](index=69&type=chunk) - The December 2024 Registered Direct Offering generated **$1.9 million** in net proceeds from the issuance of **3,303,037 shares** of common stock and **4,286,082 common stock purchase warrants**[70](index=70&type=chunk) - Under the 2025 ATM Sales Agreement, the Company raised approximately **$161,075** net proceeds from the sale of **321,562 shares** of common stock from April 22, 2025, through June 30, 2025[72](index=72&type=chunk) - The 2022 Equity Distribution Agreement was terminated effective April 20, 2025, having raised approximately **$262,484** net proceeds from the sale of **448,706 shares** during the six months ended June 30, 2025[75](index=75&type=chunk) [Note 7 – Stock-Based Compensation](index=15&type=section&id=Note%207%20%E2%80%93%20Stock-Based%20Compensation) This note details the Company's stock-based compensation, including changes in common stock warrants, stock options, and restricted stock units (RSUs) under both the 2015 and 2024 Plans, along with their associated compensation expenses and fair value measurements Common Stock Warrants Outstanding | Metric | December 31, 2024 | June 30, 2025 | | :--- | :--- | :--- | | Number of Warrants Outstanding | 34,542,219 | 47,343,867 | | Weighted Average Exercise Price ($) | 0.581 | 0.618 | - The Lind Offering on May 15, 2025, included a Common Stock Purchase Warrant for **13,020,834 shares** at an exercise price of **$0.672**, with **$1,998,869** allocated to the warrants based on their relative fair value[79](index=79&type=chunk) Options Outstanding | Metric | December 31, 2024 | June 30, 2025 | | :--- | :--- | :--- | | Number of Options Outstanding | 4,637,748 | 4,348,535 | | Weighted Average Exercise Price ($) | 3.88 | 3.88 | - An amendment on January 29, 2025, extended the expiration date for **545,000 outstanding options** to February 11, 2029, resulting in an additional options expense of **$103,573**[84](index=84&type=chunk) RSUs Outstanding (2015 Plan) | Metric | December 31, 2024 | June 30, 2025 | | :--- | :--- | :--- | | RSUs Outstanding () | 3,392,316 | 2,806,371 | | Weighted Average Grant Date Fair Value Share Price ($) | 0.8000 | 0.7657 | - Stock-based compensation expense related to RSUs (2015 Plan) was **$1,159,847** for the six months ended June 30, 2025, with **$2,565,365** remaining unrecognized[96](index=96&type=chunk) RSUs Outstanding (2024 Plan) | Metric | December 31, 2024 | June 30, 2025 | | :--- | :--- | :--- | | RSUs Outstanding () | 1,000,000 | 3,735,878 | | Weighted Average Grant Date Fair Value Share Price ($) | 0.2070 | 0.5850 | | Exercisable at June 30, 2025 | - | - | - RSUs granted under the 2024 Plan during the six months ended June 30, 2025, totaled **3,247,678**, with an RSU compensation expense of **$1,845,594**[99](index=99&type=chunk) [Note 8 – Commitments and Contingencies](index=21&type=section&id=Note%208%20%E2%80%93%20Commitments%20and%20Contingencies) This note details the Company's various financial commitments and contingencies, including finance and operating lease obligations, grants repayable, long-term debt, the convertible note payable (Lind Note), collaborative research agreements, other commitments, legal proceedings, and performance-based RSU awards Future Minimum Lease Payments Under Finance Leases (as of June 30, 2025) | Year | Amount ($) | | :--- | :--- | | 2025 - Remaining | 31,654 | | 2026 | 63,311 | | 2027 | 63,310 | | 2028 | 63,309 | | 2029 | 63,309 | | Greater than 5 years | 150,344 | | Total | 435,237 | | Less: Amount representing interest | (35,104) | | Present value of minimum lease payments | 400,133 | Operating Lease Liabilities (as of June 30, 2025) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Operating right-of-use assets | 635,041 | 599,816 | | Total operating lease liabilities | 669,028 | 632,441 | | Weighted average remaining lease (months) | 47 | 48 | | Weighted average discount rate | 4.22% | 3.70% | Grants Repayable (as of June 30, 2025) | Year | Amount ($) | | :--- | :--- | | 2025 - Remaining | 69,345 | | 2026 | 48,110 | | 2027 | 53,412 | | 2028 | 90,225 | | 2029 | 58,714 | | Greater than 5 years | 193,450 | | Total Grants Repayable | 513,256 | Long-Term Debt Payable (as of June 30, 2025) | Year | Amount ($) | | :--- | :--- | | 2025 - Remaining | 972,512 | | 2026 | 1,158,277 | | 2027 | 2,117,356 | | 2028 | 3,503,457 | | 2029 | 144,762 | | Greater than 5 years | 200,504 | | Total | 8,096,868 | | Less: amount representing interest | (1,308,145) | | Total Long-Term Debt | 6,788,723 | - On May 15, 2025, the Company issued a Senior Secured Convertible Promissory Note (Lind Note) for **$7.5 million**, repayable in 18 monthly installments starting six months from issuance, with conversion options for Lind[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) Estimated Future Minimum Principal Payments of Convertible Note Payable (as of June 30, 2025) | Year Ending December 31 | Amount ($) | | :--- | :--- | | 2025 - Remaining | 833,334 | | 2026 | 5,000,000 | | 2027 | 1,666,666 | | Total Payments | 7,500,000 | Total Collaborative Agreement Obligations (as of June 30, 2025) | Agreement | Total Amount Remaining ($) | 2025 - Remaining ($) | | :--- | :--- | :--- | | National University of Taiwan | 510,000 | 510,000 | | MD Anderson Cancer Center | 245,319 | 245,319 | | Guys and St Thomas | 144,786 | 144,786 | | Xenetic Biosciences | 81,447 | 81,447 | | National University of Taiwan | 281,575 | 281,575 | | Gustave Roussy | 119,923 | 119,923 | | Total Collaborative Obligations | 1,383,050 | 1,383,050 | - As of June 30, 2025, the Company had recognized total compensation expense of **$1,487,472** for RSUs from 2022 grants, with **$37,264** remaining unrecognized[135](index=135&type=chunk) - As of June 30, 2025, the Company had recognized total compensation expense of **$564,977** for RSUs from 2023 grants, with **$109,420** remaining unrecognized[136](index=136&type=chunk) - As of June 30, 2025, the Company had recognized total compensation expense of **$260,586** for RSUs from 2025 grants, with **$1,210,956** remaining unrecognized[139](index=139&type=chunk) [Note 9 – Subsequent Events](index=27&type=section&id=Note%209%20%E2%80%93%20Subsequent%20Events) This note reports on key events that occurred after the reporting period of June 30, 2025, including various RSU settlements and issuances, the exercise of pre-funded warrants, cancellation of stock options, and an amendment to the 2025 ATM Sales Agreement to increase its capacity - Between July 1 and August 1, 2025, several RSU settlements resulted in the issuance of **317,915 shares** of common stock and the withholding of **59,896 shares** for taxes[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) - Effective July 24, 2025, **300,000 RSUs** were issued to executive officers, subject to stock price targets and time-based vesting[144](index=144&type=chunk) - On July 7, 2025, **991,000 shares** of common stock were purchased through the partial exercise of Pre-Funded Warrants, generating **$991** in gross proceeds[145](index=145&type=chunk) - On July 23, 2025, **292,000 vested stock options** were cancelled[146](index=146&type=chunk) - From July 1, 2025, through August 7, 2025, the Company sold **410,881 shares** of common stock under the 2025 ATM Sales Agreement, generating approximately **$285,972** in net proceeds[147](index=147&type=chunk) - On August 14, 2025, the 2025 ATM Sales Agreement was amended to increase the maximum aggregate gross sales price from **$7.5 million** to **$30.0 million**[149](index=149&type=chunk) - On August 1, 2025, a registered direct offering generated **$1.21 million** in net proceeds from the sale of **1,890,625 shares** of common stock and **1,734,375 common stock purchase warrants**[150](index=150&type=chunk) [Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=28&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides an overview of VolitionRx Limited's business, its commercialization strategy, and a detailed analysis of its financial condition and results of operations for the three and six months ended June 30, 2025, compared to the prior year. It also addresses liquidity, going concern, future financings, and critical accounting policies [Overview](index=28&type=section&id=Overview) This section provides an overview of VolitionRx Limited's business, focusing on its epigenetics technology and key product pillars for disease diagnosis and monitoring - Volition is a multi-national epigenetics company developing innovative, cost-effective blood tests for early disease diagnosis and monitoring, particularly for cancer and NETosis-associated diseases like sepsis[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - Key product pillars include Nu.Q® Vet (cancer screening for companion animals), Nu.Q® NETs (detects NETosis-associated diseases), Nu.Q® Discover (nucleosome profiling), Nu.Q® Cancer (screening, diagnosis, monitoring), and Capture-PCR™ (circulating tumor-derived DNA isolation)[156](index=156&type=chunk)[166](index=166&type=chunk) [Commercialization Strategy](index=29&type=section&id=Commercialization%20Strategy) This section outlines the Company's commercialization strategy, emphasizing low capital expenditure, affordability, global accessibility, and strategic partnerships for marketing and sales - The commercialization strategy focuses on products that result in low capital/operating expenditures, are affordable, and accessible worldwide[166](index=166&type=chunk) - The Company aims to partner with established diagnostic and liquid biopsy companies for marketing, sales, and processing, leveraging their networks and expertise[158](index=158&type=chunk)[160](index=160&type=chunk) - Key partnerships include exclusive worldwide rights to Heska for Nu.Q® Vet Cancer Test at point-of-care (with **$23.0 million** received in upfront/milestone payments and up to **$5.0 million** additional), and non-exclusive rights to IDEXX for global reference laboratory network[161](index=161&type=chunk)[162](index=162&type=chunk) - The Nu.Q® Vet Cancer Test is now available in **sixteen countries**, including recent launches in the UK, Ireland, and Japan[163](index=163&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes the Company's liquidity and capital resources, including cash and cash equivalents, net cash flows from operating, investing, and financing activities, and future contractual payment obligations - As of June 30, 2025, the Company had cash and cash equivalents of approximately **$2.3 million**[164](index=164&type=chunk) Net Cash Flow from Activities (Six Months Ended June 30) | Activity | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Operating Activities | (10.6 million) | (15.1 million) | 4.5 million (decrease in cash used) | | Investing Activities | (0.1 million) | (0.2 million) | 0.1 million (decrease in cash used) | | Financing Activities | 9.3 million | 0.8 million | 8.5 million (increase in cash provided) | - The increase in cash from financing activities was primarily due to **$6.3 million** from a senior secured convertible note and **$2.4 million** from a registered direct offering in March 2025[168](index=168&type=chunk) Approximate Contractual Payments Due by Year (as of June 30, 2025) | Description | Total ($) | 2025 - Remaining ($) | 2026 - 2029 ($) | Greater than 5 years ($) | | :--- | :--- | :--- | :--- | :--- | | Financing lease liabilities | 435,237 | 31,654 | 253,239 | 150,344 | | Operating lease liabilities and short-term lease | 764,897 | 184,751 | 580,146 | - | | Grants repayable | 513,256 | 69,345 | 250,461 | 193,450 | | Long-term debt | 8,096,868 | 972,512 | 6,923,852 | 200,504 | | Collaborative agreements obligations | 1,383,050 | 1,383,050 | - | - | | Convertible Note | 7,500,000 | 833,334 | 6,666,666 | - | | Total | 18,693,308 | 3,474,646 | 14,674,364 | 544,298 | - The Company expects to rely on additional future financing (licensing, grants, equity/debt sales) to fund research, development, and commercialization activities, with no assurance of success[171](index=171&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the Company's financial performance for the three and six months ended June 30, 2025, versus the prior year, analyzing revenues, operating expenses, and net loss [Comparison of the Three Months Ended June 30, 2025 and June 30, 2024](index=30&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%20June%2030%2C%202024) For the three months ended June 30, 2025, total revenues increased by 3% to $406,688, primarily driven by Nu.Q Discover services. Total operating expenses decreased by 9% to $6.7 million, mainly due to reduced R&D and sales & marketing expenses. The net loss decreased by 11% to $6.3 million Key Financials (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 406,688 | 395,797 | 10,891 | 3% | | Total Operating Expenses | 6,704,495 | 7,386,216 | (681,721) | (9%) | | Net Loss | (6,314,070) | (7,060,175) | 746,105 | (11%) | - Research and development expenses decreased by **27%** to **$2.7 million**, primarily due to reduced personnel expenses and lower direct clinical trial activity[180](index=180&type=chunk) - General and administrative expenses increased by **29%** to **$2.9 million**, mainly due to higher stock-based compensation and legal/professional fees[182](index=182&type=chunk)[183](index=183&type=chunk) - Sales and marketing expenses decreased by **25%** to **$1.0 million**, driven by lower personnel expenses and stock-based compensation[185](index=185&type=chunk) - Other income (expenses) improved from **$(69,756)** in 2024 to **$(16,263)** in 2025, mainly due to a gain on change in fair value of derivative liability, offset by debt discount amortization and warrant liability loss[187](index=187&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and June 30, 2024](index=32&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%20June%2030%2C%202024) For the six months ended June 30, 2025, total revenues increased by 15% to $653,073, primarily from Nu.Q® Discover services. Total operating expenses decreased by 22% to $12.5 million, mainly due to significant reductions in R&D and sales & marketing expenses. The net loss decreased by 24% to $11.8 million Key Financials (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 653,073 | 567,332 | 85,741 | 15% | | Total Operating Expenses | 12,472,270 | 15,942,255 | (3,469,985) | (22%) | | Net Loss | (11,790,697) | (15,532,180) | (3,741,483) | (24%) | - Research and development expenses decreased by **36%** to **$5.3 million**, primarily due to decreased direct R&D expenses from reduced clinical trial activity and lower personnel expenses[193](index=193&type=chunk) - General and administrative expenses increased by **14%** to **$5.2 million**, mainly due to higher stock-based compensation and legal/professional fees[195](index=195&type=chunk) - Sales and marketing expenses decreased by **36%** to **$2.0 million**, primarily due to reduced personnel expenses and direct marketing/professional fees[198](index=198&type=chunk) - Other income (expenses) improved significantly from **$(157,257)** in 2024 to **$28,500** in 2025, mainly due to increased grant income and a gain on change in fair value of derivative liability, offset by debt discount amortization and warrant liability loss[200](index=200&type=chunk) [Going Concern](index=34&type=section&id=Going%20Concern) This section addresses the Company's ability to continue as a going concern, highlighting substantial doubt due to ongoing unprofitable operations and the need for external financing - Management has determined there is substantial doubt about the Company's ability to continue as a going concern without further external financing, due to ongoing unprofitable operations[202](index=202&type=chunk) [Off-Balance Sheet Arrangements](index=34&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms that there have been no material changes to the Company's off-balance sheet arrangements during the reporting period - There have been no material changes to the Company's off-balance sheet arrangements[203](index=203&type=chunk) [Future Financings](index=34&type=section&id=Future%20Financings) This section discusses the Company's potential need for future capital through debt or equity sales, including 'at the market' offerings, acknowledging no assurance of favorable terms - The Company may seek additional capital through debt or equity securities sales, including 'at the market' offerings, but there is no assurance of obtaining such capital on favorable terms or at all[204](index=204&type=chunk) [Critical Accounting Policies and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms that there have been no material changes to the Company's critical accounting policies and key estimates disclosed in its Annual Report - The preparation of financial statements requires management to make estimates and assumptions affecting reported amounts, with no material changes to critical accounting policies and key estimates disclosed in the Annual Report[205](index=205&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section states that the Company has implemented all applicable new accounting pronouncements and anticipates no material impact from others not yet effective - The Company has implemented all applicable new accounting pronouncements and does not believe any other issued but not yet effective pronouncements will have a material impact[209](index=209&type=chunk) [Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=35&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, VolitionRx Limited is not required to provide quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to disclose quantitative and qualitative information about market risk[210](index=210&type=chunk) [Item 4. CONTROLS AND PROCEDURES](index=35&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) This section discusses the evaluation of the Company's disclosure controls and procedures, identifies a material weakness in internal control over financial reporting, outlines the planned remediation efforts, and acknowledges the inherent limitations of control systems [Evaluation of Disclosure Controls and Procedures](index=35&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports that the Company's disclosure controls and procedures were not effective as of June 30, 2025, due to identified material weaknesses in internal control over financial reporting - As of June 30, 2025, the Company's disclosure controls and procedures were not effective due to identified material weaknesses in internal control over financial reporting[212](index=212&type=chunk) - A material weakness was identified due to insufficient written documentation of internal control policies and procedures, particularly regarding GAAP and SEC disclosure requirements[213](index=213&type=chunk) [Changes in Internal Control over Financial Reporting](index=35&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section confirms no material changes in internal control over financial reporting during the period, apart from ongoing remediation efforts for identified material weaknesses - No changes in internal control over financial reporting materially affected or are reasonably likely to materially affect internal control over financial reporting during the period, except for the ongoing remediation of the material weakness[213](index=213&type=chunk)[216](index=216&type=chunk) [Planned Remediation of Material Weakness](index=35&type=section&id=Planned%20Remediation%20of%20Material%20Weakness) This section outlines the Company's ongoing remediation efforts for the material weakness, including replacing service providers, engaging consultants, and documenting policies - Remediation efforts are ongoing and include replacing outside service providers to centralize accounting, engaging internal control consultants, preparing written documentation of policies, and engaging external consultants for complex GAAP applications[214](index=214&type=chunk)[215](index=215&type=chunk) [Limitations of the Effectiveness of Disclosure Controls and Internal Controls](index=36&type=section&id=Limitations%20of%20the%20Effectiveness%20of%20Disclosure%20Controls%20and%20Internal%20Controls) This section acknowledges that control systems provide only reasonable assurance and are subject to inherent limitations such as human error, circumvention, and management override - Management acknowledges that control systems provide only reasonable, not absolute, assurance and are subject to inherent limitations such as faulty judgments, errors, circumvention by individuals or collusion, and management override[217](index=217&type=chunk)[218](index=218&type=chunk) PART II OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, unregistered equity sales, defaults, and other disclosures [Item 1. LEGAL PROCEEDINGS](index=36&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) The Company is not aware of any material, existing or pending legal proceedings against it, nor is it involved as a plaintiff in any material litigation - The Company knows of no legal proceedings which it believes will have a material adverse effect on its financial position[134](index=134&type=chunk)[220](index=220&type=chunk) [Item 1A. RISK FACTORS](index=36&type=section&id=Item%201A.%20RISK%20FACTORS) There have been no material changes in the Company's assessment of risk factors since those presented in its Annual Report on Form 10-K - No material changes in risk factors affecting the business since the Annual Report[221](index=221&type=chunk) [Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=36&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section details the Company's recent unregistered sales of equity securities, specifically the May 2025 financing with Lind Global Asset Management XII LLC, and confirms no repurchases of equity securities [Recent Sales of Unregistered Securities](index=36&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities) This section details the May 2025 financing with Lind Global Asset Management XII LLC, involving a Senior Secured Convertible Promissory Note and a Common Stock Purchase Warrant - On May 20, 2025, the Company received **$6.25 million** in funding from Lind Global Asset Management XII LLC in exchange for a **$7.5 million** Senior Secured Convertible Promissory Note and a Common Stock Purchase Warrant for **13,020,834 shares**[222](index=222&type=chunk) - The Lind Note is repayable in **18 consecutive monthly installments of $416,666**, starting six months from issuance, and can be converted by Lind at **$0.72 per share**[224](index=224&type=chunk)[225](index=225&type=chunk) - Issuance of shares upon repayment or conversion is subject to an ownership limitation equal to **4.99%** (or **9.99%** under certain conditions) and stockholder approval for amounts exceeding **19.99%** of outstanding common stock[226](index=226&type=chunk) [Repurchase of Equity Securities](index=37&type=section&id=Repurchase%20of%20Equity%20Securities) This section confirms that no equity securities were repurchased by the Company during the three months ended June 30, 2025 - No equity securities were repurchased during the three months ended June 30, 2025[228](index=228&type=chunk) [Item 3. DEFAULTS UPON SENIOR SECURITIES](index=37&type=section&id=Item%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) The Company reported no defaults upon senior securities during the period - No defaults upon senior securities[229](index=229&type=chunk) [Item 4. MINE SAFETY DISCLOSURES](index=37&type=section&id=Item%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[230](index=230&type=chunk) [Item 5. OTHER INFORMATION](index=37&type=section&id=Item%205.%20OTHER%20INFORMATION) This section includes information on the amendment to the 2025 ATM Sales Agreement, increasing its maximum aggregate gross sales price, and confirms no changes in Rule 10b5-1 trading arrangements by directors or officers [Amendment to 2025 ATM Sales Agreement](index=37&type=section&id=Amendment%20to%202025%20ATM%20Sales%20Agreement) This section details the August 14, 2025, amendment to the 2025 ATM Sales Agreement, increasing the maximum aggregate gross sales price of common stock to $30.0 million - On August 14, 2025, Amendment No. 1 to the 2025 ATM Sales Agreement increased the maximum aggregate gross sales prices of common stock from **$7.5 million** to **$30.0 million**[231](index=231&type=chunk) [Rule 10b5-1 Trading Arrangements](index=38&type=section&id=Rule%2010b5-1%20Trading%20Arrangements) This section confirms that no directors or officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - During the three months ended June 30, 2025, none of the Company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement[235](index=235&type=chunk) [Item 6. EXHIBITS](index=38&type=section&id=Item%206.%20EXHIBITS) This section lists all exhibits filed as part of the Form 10-Q, including organizational documents, legal opinions, sales agreements, and certifications - The report includes various exhibits such as the Certificate of Incorporation, Bylaws, Description of Capital Stock, Legal Opinion, ATM Sales Agreements, Securities Purchase Agreement, Convertible Promissory Note, Common Stock Purchase Warrant, Security Agreement, Guaranty, Pledge Agreement, and CEO/CFO Certifications[236](index=236&type=chunk)[237](index=237&type=chunk) [SIGNATURES](index=39&type=section&id=SIGNATURES) The report is duly signed by the President and Chief Executive Officer, and the Chief Financial Officer and Treasurer of VolitionRx Limited - The report is signed by Cameron Reynolds, President and Chief Executive Officer, and Terig Hughes, Chief Financial Officer and Treasurer, on August 14, 2025[240](index=240&type=chunk)