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)

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

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

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

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

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

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

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

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

Clinical Paper Published in BMC Veterinary Research HENDERSON, Nev., May 19, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the publication of "Evaluation of plasma nucleosome concentrations and the effect of pre-analytical variables in healthy cats" in BMC Veterinary Research. This is the first study to report the detection of nucleosomes in cats: previously nucleosome levels have been shown to increase in dogs and humans in ...