Volition(VNRX) - 2019 Q4 - Annual Report

PART I Business Overview VolitionRx is a multinational epigenetics company developing blood tests for diagnosing cancer and other diseases using its Nucleosomics platform Overview - VolitionRx is a multi-national epigenetics company that develops simple, easy-to-use, and cost-effective blood tests to help diagnose a range of cancers and other diseases using its Nucleosomics platform[26] Our Solution/ Science - The company's tests are based on the science of Nucleosomics, which identifies and measures nucleosomes in the blood or other bodily fluids to indicate the presence of disease[27] - The epigenetic signal structures of cancer cells differ from those of healthy cells, and these changes occur early and drive cancer development, providing a larger signal for early detection[41] - The company is developing Nu.Q immunoassays, Nu.Q capture technology, and synthetic nucleosomes to improve detection accuracy and application scope, extending into the veterinary diagnostics field[38][43][47] Commercialization Strategy - The company plans to launch products first in Europe and Asia, followed by the U.S. market, and commercialize globally through partners and/or distributors[48] - Commercialization models include intellectual property licensing (for RUO sales, LDT services, clinical products), sales of clinical products through distribution networks, direct research services, and veterinary clinical services and product sales[55] The Market Opportunity - Cancer is a leading cause of death worldwide, with over 18 million new cases annually, projected to grow rapidly to 29.5 million cases by 2040[50] - The global in-vitro diagnostics (IVD) market was $64.5 billion in 2017 and is expected to reach $93.6 billion by 2025, with a compound annual growth rate of 4.8%[52] - The U.S. is the largest veterinary market globally, with a relatively faster regulatory pathway, providing a quicker route to revenue for veterinary products[53] Competition - The company expects to face competition from medical, pharmaceutical, and diagnostic companies such as Exact Sciences Corporation, Guardant Health, and GRAIL Inc[55] - The company anticipates its future products will have competitive advantages in being accurate, cost-effective, easy to use, non-invasive, technologically advanced, compatible with immunoassay systems, based on strong intellectual property, and suitable for mass screening[56] Government Regulations - The healthcare industry is subject to extensive federal, state, local, and foreign regulations, including FDA approval in the U.S. and the CE marking system in Europe[58][59][61] - The new EU In Vitro Diagnostic Regulation (EU IVDR), effective May 25, 2017, will impose stricter regulatory requirements on IVD device manufacturers, including product classification and performance evaluation[62] Intellectual Property - The company's patent portfolio includes 23 patent families, with 44 granted patents related to diagnostic tests (including veterinary applications), comprising 8 in the U.S., 9 in Europe, and 27 in other global regions[69] - The company also has 105 patent applications pending, with 13 in the U.S., 10 in Europe, and 82 in other global regions[69] - The company's strategy is to protect its technology through patents to gain market exclusivity in Europe, the U.S., and other strategic countries, with products related to Nu.Q-X, Nu.Q-V, and Nu.Q-A technologies expected to be protected until at least 2031[70] Corporate History - The company was incorporated in Delaware on September 24, 1998, as "Standard Capital Corporation" and changed its name to "VolitionRX Limited" on September 22, 2011[72] - The company operates through the acquisition of Singapore Volition Pte. Limited and its subsidiaries, including Belgian Volition SPRL, Volition Diagnostics UK Limited, Volition America, Inc., and Volition Veterinary Diagnostics Development LLC[72] Risk Factors The company faces multiple risks including financial viability, product development, regulatory approval, market acceptance, and intense competition Risks Associated with our Company - The company has not generated significant revenue since inception, with an accumulated deficit of approximately $89.8 million as of December 31, 2019, and expects future expenses to increase significantly, potentially never achieving profitability[78] - The company requires additional capital to fully fund its strategic plans and may be forced to curtail operations or seek other solutions if funding is unavailable[79][80] - The company identified material weaknesses in internal control as of December 31, 2019, including inadequate segregation of duties in finance, IT oversight, and monitoring of complex transaction accounting[89][90][334][335] - The auditor has expressed substantial doubt about the company's ability to continue as a going concern, which may limit its ability to raise additional funds[91] Risks Associated with our Business - The company faces risks of failure in product development, manufacturing, marketing, and sales, as well as unpredictable clinical trial outcomes, regulatory delays, changing reimbursement policies, and insufficient market acceptance[93][95][96][97][100][101] - The cancer diagnostics market is highly competitive with rapid technological change, posing a risk that the company's products may become obsolete or fail to gain significant market share[102][103][104] - The company will rely on third-party manufacturers, suppliers, and distributors, and any disruption or issue could have a significant negative impact on product supply and business operations[107][108][110][111] - Inadequate intellectual property protection, patent infringement disputes, and failure to effectively protect trade secrets could harm the company's competitive advantage and profitability[112][113][114][116][117][118] Risks Associated with our Common Stock - The market price and trading volume of the company's common stock may be highly volatile, influenced by factors such as competition, analyst commentary, key personnel changes, operating performance, industry developments, and macroeconomic factors[120][121][122] - The equity ownership of executives and directors (approximately 14.9%) could make a third-party acquisition or change in control more difficult[123] - The company does not intend to pay dividends in the foreseeable future, meaning investors will not receive returns through dividends[125] - Future issuances of additional common stock could result in dilution of existing shareholders' ownership and may cause the stock price to decline[126][127] Unresolved Staff Comments The company has no unresolved staff comments as of the end of the reporting period - The company has no unresolved staff comments[131] Properties The company owns or leases several facilities globally, including a research lab in Belgium and offices in the UK, Singapore, and the US Properties Overview | Location | Primary Function | Approx. Square Feet | Leased or Owned | |---|---|---|---| | Namur, Belgium | Research and development | 17,300 | Owned | | London, UK | Sales and marketing | 690 | Leased, expiring 2021 | | Shaw Centre, Singapore | Sales and marketing | 150 | Leased, expiring 2020 | | Austin, Texas | Executive suite | 1,228 | Leased, expiring 2022 | Legal Proceedings The company is not aware of any pending or threatened litigation that would materially impact its business, financial condition, or operations - The company has not identified any threatened or pending litigation expected to have a material adverse effect on its business operations, financial condition, or results of operations[133] Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[134] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on the NYSE American under "VNRX", with no dividends paid and details on recent unregistered securities sales - The company's common stock is listed on the NYSE American under the trading symbol "VNRX"[137] - As of February 17, 2020, the company had 41,204,685 shares of common stock outstanding, held by 153 registered stockholders[138] - The company has not declared or paid cash dividends since its inception and does not intend to do so in the foreseeable future[139] - From October 1 to December 31, 2019, the company issued 371 and 29,392 shares of common stock through the exercise of stock options and warrants, respectively, receiving cash proceeds[141][142] - The company did not repurchase any of its equity securities[144] Selected Financial Data As a smaller reporting company, this disclosure is not required - As a smaller reporting company, the company is not required to disclose selected financial data[145] Management's Discussion and Analysis of Financial Condition and Results of Operations The company remains in the R&D stage with minimal revenue, significant net losses, and a reliance on external financing to sustain operations Overview - The company's future as a going concern depends on its ability to obtain sufficient capital investment, financing, and/or generate revenue[148] - Management plans to address funding needs by obtaining additional grants, equity or debt financing, licensing to third parties, and accelerating product development and commercialization[148] Liquidity and Capital Resources - As of December 31, 2019, the company had cash and cash equivalents of $16,966,168[150] Cash Flow Activities (2019 vs 2018) | Cash Flow Type | 2019 ($) | 2018 ($) | |:---|:---|:---| | Net Cash Used in Operating Activities | (12,700,000) | (14,700,000) | | Net Cash Used in Investing Activities | (500,000) | (300,000) | | Net Cash Provided by Financing Activities | 16,900,000 | 18,000,000 | - The decrease in cash used in operating activities in 2019 was primarily due to reduced R&D activities and lower stock-based compensation, partially offset by increased personnel costs[151] - The increase in cash used in investing activities in 2019 was mainly due to increased purchases of laboratory equipment for the Belgian R&D facility[152] - The decrease in cash provided by financing activities in 2019 was due to reduced debt and equity financing and lower debt payments[153] Contractual Payment Schedule as of December 31, 2019 | Description | Total ($) | 2020 ($) | 2021-2024 ($) | 2025 and thereafter ($) | |:---|:---|:---|:---|:---| | Finance lease liabilities | 812,497 | 114,649 | 252,517 | 445,331 | | Operating lease liabilities | 418,906 | 281,965 | 136,941 | - | | Grants repayable | 337,286 | 52,879 | 166,046 | 118,361 | | Long-term debt | 3,164,547 | 777,648 | 2,212,861 | 174,038 | | Collaboration agreement obligations | 2,688,267 | 1,699,767 | 988,500 | - | | Total | 7,421,503 | 2,926,908 | 3,756,865 | 737,730 | Results of Operations Comparison of Operating Results (2019 vs 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | |:---|:---|:---|:---|:---| | Total revenues | 17,096 | 0 | 17,096 | 100% | | Research and development expenses | 10,363,253 | 10,906,871 | (543,618) | (5%) | | General and administrative expenses | 4,731,054 | 5,821,072 | (1,090,018) | (19%) | | Sales and marketing expenses | 965,713 | 1,169,756 | (204,043) | (17%) | | Net loss | (16,099,055) | (18,008,623) | (1,909,568) | (11%) | | Net loss per share (basic and diluted) | (0.41) | (0.57) | (0.16) | (28%) | - R&D expenses decreased by 5% in 2019, primarily due to lower research and collaboration expenditures and chemical and biological costs, partially offset by increased laboratory costs[163] - General and administrative expenses decreased by 19% in 2019, mainly due to favorable foreign exchange costs, reduced legal fees related to financing, and lower stock-based compensation[165] - Sales and marketing expenses decreased by 17% in 2019, primarily due to reduced stock-based compensation and personnel costs[167] - The net loss for 2019 was $16.1 million, an 11% decrease from the $18.0 million loss in 2018, primarily driven by the factors mentioned above[170] Going Concern - The company has not yet achieved profitability and relies on external financing to continue its operations and strategic plans, leading management to conclude there is substantial doubt about its ability to continue as a going concern[171] Critical Accounting Policies - Critical accounting policies include stock-based compensation, impairment of long-lived assets, foreign currency translation, and the use of estimates[176][178][179][180] - The company accounts for stock-based compensation in accordance with ASC 718 and ASC 505-50 and tests long-lived assets for impairment under ASC 360[176][178] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, this disclosure is not required - As a smaller reporting company, the company is not required to disclose quantitative and qualitative information about market risk[182] Financial Statements and Supplementary Data This section presents the audited consolidated financial statements for 2019 and 2018, accompanied by an auditor's report with a going concern uncertainty Report of Independent Registered Public Accounting Firm - The independent registered public accounting firm issued an unqualified opinion on the consolidated financial statements for the years ended December 31, 2019, and 2018[188] - The auditor's report includes an explanatory paragraph regarding the company's ability to continue as a going concern, citing its history of recurring losses, negative cash flows from operations, and minimal revenue, which raise substantial doubt about its going concern ability[189] Consolidated Balance Sheets Consolidated Balance Sheets (2019 vs 2018) | Metric | Dec 31, 2019 ($) | Dec 31, 2018 ($) | |:---|:---|:---| | Cash and cash equivalents | 16,966,168 | 13,427,222 | | Total assets | 21,291,292 | 17,488,966 | | Total liabilities | 7,092,726 | 5,348,510 | | Total stockholders' equity | 14,198,566 | 12,140,456 | | Accumulated deficit | (89,821,856) | (73,722,801) | Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Operations and Comprehensive Loss (2019 vs 2018) | Metric | 2019 ($) | 2018 ($) | |:---|:---|:---| | Total revenues | 17,096 | - | | Total operating expenses | 16,060,020 | 17,897,699 | | Loss from operations | (16,042,924) | (17,897,699) | | Net loss | (16,099,055) | (18,008,623) | | Net comprehensive loss | (16,197,036) | (17,655,629) | | Net loss per share (basic and diluted) | (0.41) | (0.57) | Consolidated Statements of Stockholders' Equity Consolidated Statements of Stockholders' Equity (2019 vs 2018) | Metric | Dec 31, 2019 ($) | Dec 31, 2018 ($) | |:---|:---|:---| | Common stock, shares | 41,125,303 | 35,335,378 | | Common stock, amount | 41,125 | 35,335 | | Additional paid-in capital | 103,853,627 | 85,604,271 | | Accumulated other comprehensive income | 125,670 | 223,651 | | Accumulated deficit | (89,821,856) | (73,722,801) | | Total stockholders' equity | 14,198,566 | 12,140,456 | Consolidated Statements of Cash Flows Consolidated Statements of Cash Flows (2019 vs 2018) | Cash Flow Type | 2019 ($) | 2018 ($) | |:---|:---|:---| | Net cash used in operating activities | (12,739,455) | (14,733,027) | | Net cash used in investing activities | (511,266) | (301,805) | | Net cash provided by financing activities | 16,929,527 | 17,967,087 | | Cash and cash equivalents at end of period | 16,966,168 | 13,427,222 | Notes to Consolidated Financial Statements - The notes detail the company's business nature, going concern, significant accounting policies, property, intangible assets, related party transactions, common stock, warrants and options, income taxes, and commitments and contingencies[203][205][210][228][233][235][236][237][238][242][246][250][253][266][291][295][299][307][311][315] - In 2019, the company issued a significant number of common shares through the exercise of warrants and options and received approximately $16.6 million in cash proceeds from Cotterford Company Limited[256][257][258][259][271] - As of December 31, 2019, the company had 23 patent families, comprising 44 granted patents and 105 pending patent applications[69] - In January 2020, the company acquired epigenetic reagent company Octamer GmbH to secure the supply of a key component for its Nu.Q tests[323] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company had no changes in or disagreements with its accountants on accounting and financial disclosure - The company had no changes in or disagreements with its accountants on accounting and financial disclosure[327] Controls and Procedures Disclosure controls and procedures were deemed ineffective as of year-end 2019 due to material weaknesses in internal control over financial reporting - As of December 31, 2019, the company's disclosure controls and procedures were determined to be ineffective due to material weaknesses in internal control[329] - Identified material weaknesses include: inadequate segregation of duties in finance, insufficient IT oversight, and deficient monitoring of complex transaction accounting[334][335] - Management has concluded that the company did not maintain effective internal control and is implementing a remediation plan, including hiring additional financial resources, contracting internal audit resources, and recruiting IT and HR specialists[335][336][341] Other Information The company amended a clinical study agreement with the University of Michigan to validate its Nu.Q colorectal cancer screening test - On February 17, 2020, Volition America, Inc. amended a clinical study agreement with the Regents of the University of Michigan to initiate a new clinical study[340] - The new study involves approximately 1,800 asymptomatic screening samples to validate Volition's Nu.Q colorectal cancer screening test for U.S. regulatory use at no additional cost[340] PART III Directors, Executive Officers and Corporate Governance This information is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders[343] Executive Compensation This information is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders[344] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters This information is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders[345] Certain Relationships and Related Transactions, and Director Independence This information is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders[346] Principal Accountant Fees and Services This information is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2020 Annual Meeting of Stockholders[347] PART IV Exhibits, Financial Statement Schedules This section lists all exhibits filed with the report, including corporate documents, agreements, and required certifications - This report includes financial statements, omitted financial statement schedules, and various exhibits[351] - Exhibits include the company's articles of incorporation, equity incentive plans, lease agreements, clinical study agreements, equity purchase agreements, equity distribution agreements, and various certifications[351][352][353][354] Form 10-K Summary This report does not include a Form 10-K summary - This report does not contain a Form 10-K summary[355] Signatures The report is duly signed by the company's principal executive and financial officers, as well as by a majority of the board of directors - This report has been signed by Cameron Reynolds, President, Chief Executive Officer, and Director, and David Vanston, Chief Financial Officer and Treasurer of VolitionRx Limited[360][363] - Other directors have also co-signed the report in compliance with the requirements of the Securities Exchange Act of 1934[362][363]