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What changed in VOLITIONRX LTD's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of VOLITIONRX LTD's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+110 added−113 removedSource: 10-K (2025-03-31) vs 10-K (2024-03-25)

Top changes in VOLITIONRX LTD's 2024 10-K

110 paragraphs added · 113 removed · 97 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeWe are currently focusing on manufacturing our key components such as the antibodies and positive controls at Silver One, as well as ELISA kits. We have also outsourced a portion of the production of our ELISA kits to a third-party manufacturer in the U.S. to facilitate logistics and to aim for large-scale production.
Biggest changeManufacturing Capabilities and Strategy Our manufacturing facility in Belgium, known as Silver One, offers cutting edge, purpose-built manufacturing and processing facilities. We are currently focusing on manufacturing our key components such as the antibodies and positive controls at Silver One, as well as ELISA kits.
Current ctDNA detection methods involve DNA extraction, sequencing of all (cancer and normal) circulating DNA and analysis of the sequencing data using sophisticated computer bioinformatics to tell them apart. Our patented Capture-PCR TM is a novel method for liquid biopsy involving the first reported physical isolation of a class of tumor-derived ctDNA fragments from blood.
Current ctDNA detection methods involve DNA extraction, sequencing of all (cancer and normal) circulating DNA and analysis of the sequencing data using sophisticated computer bioinformatics to tell them apart. Our patented Capture-PCR™ is a novel method for liquid biopsy involving the first reported physical isolation of a class of tumor-derived ctDNA fragments from blood.
The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built 17,000 square foot lab and 10,000 square foot production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London, Singapore and Nevada.
The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built 17,000 square foot lab and 10,000 square foot production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London and Nevada.
We are currently conducting ongoing research regarding Nu.Q ® Vet in pursuit of the following goals: · Broadening the range of cancers detected, · Differential diagnosis, · Pre-analytics for the use of Nu.Q ® Vet in the feline population, · Use of the Nu.Q ® platform in NETosis in canines, and · Use of Capture-PCR TM in canines.
We are currently conducting ongoing research regarding Nu.Q ® Vet in pursuit of the following goals: · Broadening the range of cancers detected, · Differential diagnosis, · Pre-analytics for the use of Nu.Q ® Vet in the feline population, · Use of the Nu.Q ® platform in NETosis in canines, and · Use of Capture-PCR ™ in canines.
We aim to replace unpleasant, invasive, and often expensive screening and diagnostic tests with blood tests, helping to save lives and to reduce overall health care costs. 4 Table of Contents We have two technologies: · Nucleosome Quantification (“Nu.Q ® ”) · Capture-PCR TM Chromosome, nucleosome and transcription factor structures represent a major mechanism for epigenetic control.
We aim to replace unpleasant, invasive, and often expensive screening and diagnostic tests with blood tests, helping to save lives and to reduce overall health care costs. 4 Table of Contents We have two technologies: · Nucleosome Quantification (“Nu.Q ® ”) · Capture-PCR™ and Capture-Seq™ Chromosome, nucleosome and transcription factor structures represent a major mechanism for epigenetic control.
We anticipate that because of their ease of use and cost efficiency of our tests they have the potential to become the first method of choice for disease detection and monitoring in both humans and animals. 7 Table of Contents Our Competition We face competition primarily from other human-focused healthcare, pharmaceutical and diagnostic companies such as Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc., and Immunexpress Inc., and from companies such as PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.
We anticipate that because of their ease of use and cost efficiency of our tests they have the potential to become the first method of choice for disease detection and monitoring in both humans and animals. 7 Table of Contents Our Competition We face competition primarily from other human-focused healthcare, pharmaceutical and diagnostic companies such as Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc., and Immunexpress Inc., and from companies such as One Health Company (Fidocure) in the veterinary space.
Our Market Opportunity Volition applies its technologies through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases for both humans and animals including certain cancers and diseases associated with NETosis such as sepsis and COVID-19.
Our Market Opportunity Volition applies its technologies through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases for both humans and animals including certain cancers and diseases associated with NETosis such as sepsis.
There are an estimated 6 million pet dogs diagnosed with cancer each year. Earlier cancer detection can improve outcomes, including the quality of life of the dog and its owner. Yet, as of today, there are few single assay cancer blood tests on the veterinary market.
There are an estimated 6 million pet dogs diagnosed with cancer each year in the US. Earlier cancer detection can improve outcomes, including the quality of life of the dog and its owner. Yet, as of today, there are few single assay cancer blood tests on the veterinary market.
Capture-PCR TM Based on over a decade of work on the chemistry of circulating chromatin fragments, we have also developed a transformational wet chemistry pathway that identifies and physically isolates chromatin fragments that we know are tumor-derived from background DNA of the same sequence, using Chromatin Immunoprecipitation (“ChIP”).
Capture-PCR™ / Capture-Seq™ Based on over a decade of work on the chemistry of circulating chromatin fragments, we have also developed a transformational wet chemistry pathway that identifies and physically isolates chromatin fragments that we know are tumor-derived from background DNA of the same sequence, using Chromatin Immunoprecipitation (“ChIP”).
We aim to partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise. We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, they could potentially be used throughout the world.
We aim to partner with established diagnostic companies and/or liquid biopsy companies to market, sell, and process our tests, leveraging their networks and expertise. We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, they could potentially be used throughout the world.
We have fostered ties with leading academic institutions, clinical centers of excellence, multi-national pharmaceutical companies and financial institutions across the globe. Volition’s Solution and the Science Behind It We are dedicated to revolutionizing the diagnosis and monitoring of life-altering diseases by advancing the science of epigenetics.
We have fostered ties with leading academic institutions, clinical centers of excellence, multi-national diagnostic and pharmaceutical companies and financial institutions across the globe. Volition’s Solution and the Science Behind It We are dedicated to revolutionizing the detection and monitoring of life-altering diseases by advancing the science of epigenetics.
Quantitative real-time PCR (“qPCR”) testing is undertaken to establish whether cancer is present. This breakthrough method obviates expensive, time-consuming DNA sequencing and bioinformatics - allowing for rapid, cost-effective detection in a routine blood test. It may also be suitable for automation, enabling application in hospital laboratories.
Either quantitative real-time PCR (“qPCR”) testing or Sequencing (“Seq”) is then undertaken to establish whether cancer is present. This breakthrough method obviates expensive, time-consuming DNA sequencing and bioinformatics - allowing for rapid, cost-effective detection in a routine blood test. It may also be suitable for automation, enabling application in hospital laboratories.
Our team has worked tirelessly for more than a decade to evolve and master our understanding of the rich, complex information encoded in circulating chromatin and in particular, in circulating nucleosomes and transcription factors. Our tests are platform agnostic and can be adapted to any workflow setting – manual, reference laboratory and point-of-care.
Our team has worked tirelessly for more than a decade to evolve and master our understanding of the rich, complex information encoded in cell-free chromatin and in particular, in cell free nucleosomes and transcription factors, all circulating in the blood. Our tests are platform agnostic and can be adapted to any workflow setting – manual, reference laboratory and point-of-care.
The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis and COVID-19. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.
The tests offered by Volition and its subsidiaries are designed to detect and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.
The patent filings on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2043. Employees As of December 31, 2023, we had 110 full-time equivalent (“FTE”) personnel compared to 104 as of December 31, 2022, reflecting the growth in our commercial and production activities.
The patent filings on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2043. Employees As of December 31, 2024, we had 85 full-time equivalent (“FTE”) personnel compared to 110 as of December 31, 2023, reflecting the need to prioritize the cash utilization in our commercial and production activities.
To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska.
To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska, now an Antech Company.
The time needed for a Technical Documentation assessment of a device by our Notified Body (“TÜV SÜD”) is expected to last for nine months at a minimum. Any new devices introduced to the market will undergo EU IVDR assessment.
The time needed for a Technical Documentation assessment of a device by our Notified Body (“TÜV SÜD”) is expected to last for nine months at a minimum.
In November 2023, we launched the Nu.Q ® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories.
In November 2023, we launched the Nu.Q ® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. In July 2024, we launched the Nu.Q® Vet Cancer Test in Japan with Fujifilm Vet Systems Co. Ltd.
Being able to use epigenetic information from the nucleosomes of tumor cells could help physicians: · Predict treatment response for each patient, · Monitor treatment response and disease progression, and · Promptly amend a patient’s cancer treatment regimen to achieve a better outcome. Nu.Q ® Cancer could also play a pivotal role in MRD monitoring.
Being able to use epigenetic information from the nucleosomes of tumor cells could help physicians: · Predict treatment response for each patient, · Monitor treatment response and disease progression (including identifying Minimal Residual Disease) and · Promptly amend a patient’s cancer treatment regimen to achieve a better outcome.
In 2015, the Company’s common stock was listed on the New York Stock Exchange (VNRX). We now have a team of over 100 dedicated employees, spanning a wide range of disciplines; all united in our mission to improve outcomes for patients. Cultivating successful, ongoing relationships with stakeholders worldwide has been fundamental to Volition’s development.
We now have a team of over 80 dedicated employees, spanning a wide range of disciplines; all united in our mission to improve outcomes for patients. Cultivating successful, ongoing relationships with stakeholders worldwide has been fundamental to Volition’s development.
Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited, a private limited company formed under the laws of England and Wales (“Volition Diagnostics”), which was formed in November 2015, Volition America, Inc., a Delaware corporation (“Volition America”), which was formed on in February 2017, Volition Veterinary Diagnostics Development LLC, a Texas limited liability company (“Volition Vet”), which was formed in June 2019, and Volition Germany GmbH (formerly Octamer GmbH, or “Octamer” and now “Volition Germany”), a Munich, Germany-based epigenetic reagent company that it acquired in January 2020.
Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited, a private limited company formed under the laws of England and Wales (“Volition Diagnostics”), which was formed in November 2015, Volition America, Inc., a Delaware corporation (“Volition America”), which was formed on in February 2017 and Volition Veterinary Diagnostics Development LLC, a Texas limited liability company (“Volition Vet”), which was formed in June 2019.
Our patent portfolio includes 50 patent families (plus two in-licensed families) and a total 79 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 19 patents granted in Europe, and a further 48 patents granted worldwide. Additionally, we have a total of 132 patent applications currently pending, worldwide.
Our patent portfolio includes 52 patent families (plus three in-licensed families) and a total 75 patents granted related to our diagnostic tests (including veterinary applications), with 13 patents granted in the United States, 20 patents granted in Europe, and a further 42 patents granted worldwide. Additionally, we have a total of 128 patent applications currently pending, worldwide.
The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs. · Nu.Q ® NETs - monitoring the immune system to save lives. · Nu.Q ® Discover - a complete solution to profiling nucleosomes. · Nu.Q ® Cancer - monitoring disease progression, response to treatment and Minimal Residual Disease (“MRD”). · Capture-PCR TM - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.
The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs. · Nu.Q ® NETs - detects diseases associated with NETosis such as sepsis. · Nu.Q ® Discover - a complete solution to profiling nucleosomes. · Nu.Q ® Cancer - from screening, diagnosis and staging, therapy decision, planning and treatment to monitoring response to treatment and disease progression. · Capture-PCR™ - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.
Commercialization Strategy We are guided by three underlying principles to our commercialization strategy – ensuring our products: · Result in low capital expenditures for licensors and end users and low operating expenses for Volition, · Are affordable, and · Are accessible worldwide.
We have also outsourced a portion of the production of our ELISA kits to a third-party manufacturer in the U.S. to facilitate logistics and to aim for large-scale production. 6 Table of Contents Commercialization Strategy We are guided by three underlying principles to our commercialization strategy – ensuring our products: · Result in low capital expenditures for licensors and end users and low operating expenses for Volition, · Are affordable, and · Are accessible worldwide.
In practice, the conformity assessment procedure for our products requires a combination of Quality Management System (“QMS”) audits and Technical Documentation assessments. To support the conformity to the new IVDR, Belgian Volition has implemented a QMS, conforming to the internationally agreed standard ISO 13485 that sets out the QMS requirements specific to the medical devices industry.
To support the conformity to the new IVDR, Belgian Volition has implemented a QMS, conforming to the internationally agreed standard ISO 13485 that sets out the QMS requirements specific to the medical devices industry. Belgian Volition has maintained its ISO certification since 2015.
We may incur significant costs to comply with such laws and regulations in the future, and lack of compliance could have material adverse effects on our operations. We believe we have structured our business operations to comply with applicable legal requirements.
We will also be required to comply with numerous other federal, state, and local laws relating to matters such as safe working conditions, industrial safety, and labor laws. We may incur significant costs to comply with such laws and regulations in the future, and lack of compliance could have material adverse effects on our operations.
However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise, which could have a material adverse impact on our business. Intellectual Property Volition is developing clinical products based on the enrichment and analysis of circulating chromatin using immunoassay, mass spectrometry, DNA sequencing and other methods.
Intellectual Property Volition is developing clinical products based on the enrichment and analysis of circulating chromatin using immunoassay, mass spectrometry, DNA sequencing and other methods.
Our test can be easily integrated into preventive care programs and used alongside other routine bloodwork during regular wellness visits. The Nu.Q ® Vet Cancer Test is available to veterinarians in the United States, Europe, and Asia through our distributors, which include IDEXX Laboratories, Inc.
Our test can be easily integrated into preventive care programs and used alongside other routine bloodwork during regular wellness visits.
(“IDEXX”), a global leader in pet healthcare innovation, and Heska Corporation (“Heska”), a leading global provider of advanced veterinary diagnostics, and now part of Mars Petcare, one of the largest pet health companies in the world. Transfer of the Nu.Q ® Vet Cancer Test onto Heska’s in-house diagnostic platform (the element i+) was completed in 2023.
The Nu.Q ® Vet Cancer Test is available to veterinarians in the United States, Europe, and Asia through our distributors, which include Antech Diagnostics ("Antech") a leading global provider of advanced veterinary diagnostics, and part of Mars Petcare, one of the largest pet health companies in the world and IDEXX Laboratories, Inc. (“IDEXX”), a global leader in pet healthcare innovation.
Removed
The concept of MRD refers to the proportion of remaining cancer cells among otherwise normal bone marrow or, more rarely, among circulating blood cells after any given treatment of blood cancer. MRD monitoring has proven to be an independent prognostic factor and an important instrument for therapeutic decisions.
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Our test is also available in Japan through Fujifilm Vet Systems Co. Ltd, a leading provider of veterinary testing services in Japan and through other regional and national distributors such as Vita Genomics, DNA Tech, Nationwide Laboratories, The Veterinary Pathology Group etc.
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Cancer-derived ctDNA fragments are then extracted after removal of all normal background DNA of the same sequence for detection with a simple, low-cost PCR test. 6 Table of Contents Manufacturing Capabilities and Strategy Our manufacturing facility in Belgium, known as Silver One, offers cutting edge, purpose-built manufacturing and processing facilities.
Added
Transfer of the Nu.Q ® Vet Cancer Test onto Antech’s in-house diagnostic platform (the element i+) was completed in 2023.
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We have completed inspections in 2023 with the TÜV SÜD and our QMS is in compliance with the EU IVDR.
Added
Any new devices introduced to the market will undergo EU IVDR assessment. 8 Table of Contents In practice, the conformity assessment procedure for our products requires a combination of Quality Management System (“QMS”) audits and Technical Documentation assessments.
Removed
Belgian Volition has maintained its ISO certification since 2015. 8 Table of Contents We will also be required to comply with numerous other federal, state, and local laws relating to matters such as safe working conditions, industrial safety, and labor laws.
Added
We believe we have structured our business operations to comply with applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise, which could have a material adverse impact on our business.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

31 edited+6 added−5 removed186 unchanged
Biggest changeRisks Related to Our Securities · The market prices and trading volume of our stock may be volatile. · We have identified material weaknesses in our internal control over financial reporting that have not yet been remediated, and although we are working to address such weaknesses, the failure to address these material weaknesses, or the identification of any others, could impact the reliability of our financial reporting and harm investors’ views of us, which could adversely impact our stock price. · We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate. 11 Table of Contents · Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders. · Our corporate governance documents, and certain corporate laws applicable to us, and share ownership by executive officers and directors, could make a takeover attempt, which may be beneficial to our stockholders, more difficult. · We do not expect to pay dividends in the foreseeable future. · We may in the future issue additional shares of our common stock which would reduce investors’ ownership interests in the Company, and which may cause our stock price to decline. · Future sales of our common stock could depress the market price of our common stock. · If equity research analysts do not publish research or reports about our business, or if they do publish such reports but issue unfavorable commentary or downgrade our common stock, the price and trading volume of our common stock could decline. · If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. · We are a smaller reporting company and a non-accelerated filer, and we cannot be certain if the reduced disclosure requirements applicable to our filing status, as well as the exemption from the requirement to provide an auditor’s attestation report regarding the effectiveness of our internal controls, will make our common stock less attractive to investors.
Biggest changeRisks Related to Our Intellectual Property · If the patents we rely on to protect our intellectual property prove to be inadequate, our ability to successfully commercialize our products will be harmed and we may never be able to operate our business profitably. · If third parties assert that we have infringed their patents and proprietary rights or challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and delay or prevent the development or commercialization of our products. · If we are unable to protect our trade secrets, we may be unable to protect our interests in proprietary technology, processes and know-how that is not patentable or for which we have elected not to seek patent protection. 11 Table of Contents Risks Related to Our Securities · The market prices and trading volume of our stock may be volatile. · We have identified material weaknesses in our internal control over financial reporting that have not yet been remediated, and although we are working to address such weaknesses, the failure to address these material weaknesses, or the identification of any others, could impact the reliability of our financial reporting and harm investors’ views of us, which could adversely impact our stock price. · We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate. · If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. · Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders. · Our corporate governance documents, and certain corporate laws applicable to us, and share ownership by executive officers and directors, could make a takeover attempt, which may be beneficial to our stockholders, more difficult. · We do not expect to pay dividends in the foreseeable future. · We may in the future issue additional shares of our common stock which would reduce investors’ ownership interests in the Company, and which may cause our stock price to decline. · Future sales of our common stock could depress the market price of our common stock. · If equity research analysts do not publish research or reports about our business, or if they do publish such reports but issue unfavorable commentary or downgrade our common stock, the price and trading volume of our common stock could decline. · We are a smaller reporting company and a non-accelerated filer, and we cannot be certain if the reduced disclosure requirements applicable to our filing status, as well as the exemption from the requirement to provide an auditor’s attestation report regarding the effectiveness of our internal controls, will make our common stock less attractive to investors.
As defined in Exchange Act Rule 13a-15(f), internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: · pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and dispositions of assets; · provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and/or directors; and · provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. 22 Table of Contents We have determined that we have material weaknesses in our internal control over financial reporting as of December 31, 2023.
As defined in Exchange Act Rule 13a-15(f), internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: · pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and dispositions of assets; · provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and/or directors; and · provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. 22 Table of Contents We have determined that we have material weaknesses in our internal control over financial reporting as of December 31, 2024.
If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations. · It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably. · The diagnostics market is highly competitive and subject to rapid technological change; accordingly, we will face fierce competition, including from companies with greater resources and experience than us, and our intended products may not achieve significant market penetration and/or may become obsolete. · Our management has broad discretion over the use of our available cash and might not allocate cash in ways that increase the value of your investment. · Our future success depends on our ability to retain our officers and directors, scientists, and other key employees and to attract, retain and motivate qualified personnel. · If any of our facilities or our laboratory equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed. · Failure in our information technology, storage systems or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts and subject us to liability. · Our business and reputation will suffer if we are unable to establish and comply with stringent quality standards to assure that the highest level of quality is observed in the performance of our tests. · Declining global economic or business conditions may have a negative impact on our business. · We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources. 10 Table of Contents Risks Related to Product Development, Commercialization and Sales of Our Products · If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business. · Our business is dependent on our ability to successfully develop and commercialize diagnostic products.
If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations. · We have incurred significant losses, and we may never achieve profitability. · It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably. · The diagnostics market is highly competitive and subject to rapid technological change; accordingly, we will face fierce competition, including from companies with greater resources and experience than us, and our intended products may not achieve significant market penetration and/or may become obsolete. · Our management has broad discretion over the use of our available cash and might not allocate cash in ways that increase the value of your investment. · Our future success depends on our ability to retain our officers and directors, scientists, and other key employees and to attract, retain and motivate qualified personnel. · If any of our facilities or our laboratory equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed. · Failure in our information technology, storage systems or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts and subject us to liability. · Our business and reputation will suffer if we are unable to establish and comply with stringent quality standards to assure that the highest level of quality is observed in the performance of our tests. · Declining global economic or business conditions may have a negative impact on our business. · We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources. 10 Table of Contents Risks Related to Product Development, Commercialization and Sales of Our Products · If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business. · Our business is dependent on our ability to successfully develop and commercialize diagnostic products.
The continued listing of our common stock on the NYSE American is subject to our continued compliance with certain listing requirements, including requirements related to corporate governance, our financial condition and operating results, the trading price of our common stock, number of stockholders and our market capitalization.
Our common stock is listed on the NYSE American. The continued listing of our common stock on the NYSE American is subject to our continued compliance with certain listing requirements, including requirements related to corporate governance, our financial condition and operating results, the trading price of our common stock, number of stockholders and our market capitalization.
Our competitors include large multinational corporations and their operating units, including Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc. and Immunexpress Inc., and from companies such as PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.
Our competitors include large multinational corporations and their operating units, including Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc. and Immunexpress Inc., and from companies such as One Health Company (Fidocure) focused on the veterinary space.
We may in the future issue additional shares of our common stock which would reduce investors’ ownership interests in the Company, and which may cause our stock price to decline. Our Second Amended and Restated Certificate of Incorporation authorizes the issuance of 100,000,000 shares of common stock, par value $0.001 per share.
We may in the future issue additional shares of our common stock which would reduce investors’ ownership interests in the Company, and which may cause our stock price to decline. Our Second Amended and Restated Certificate of Incorporation authorizes the issuance of 175,000,000 shares of common stock, par value $0.001 per share.
Although we are investing in direct marketing to support these commercial launches, we may rely on third party resources such as Heska’s global network of veterinarians and IDEXX’s reference laboratory network to successfully market this test and generate revenue.
Although we are investing in direct marketing to support these commercial launches, we may rely on third party resources such as Antech’s global network of veterinarians and IDEXX’s reference laboratory network to successfully market this test and generate revenue.
For example, Heska has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians at the point of care and we engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
For example, Antech has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians at the point of care and we engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
These provisions and circumstances may discourage potential acquisition proposals and could delay or prevent a change of control, including under circumstances in which our stockholders might otherwise receive a premium over the market price of our common stock. We do not expect to pay dividends in the foreseeable future.
These provisions and circumstances may discourage potential acquisition proposals and could delay or prevent a change of control, including under circumstances in which our stockholders might otherwise receive a premium over the market price of our common stock. 23 Table of Contents We do not expect to pay dividends in the foreseeable future.
Further, we have engaged with others including DNAtech, Portugal, and, through our agreement with Heska, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe.
Further, we have engaged with others including DNAtech, Portugal, and, through our agreement with Antech, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe.
Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” and as a “non-accelerated filer” may make it harder for investors to analyze our results of operations and financial prospects and may make our common stock a less attractive investment.
Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” and as a “non-accelerated filer” may make it harder for investors to analyze our results of operations and financial prospects and may make our common stock a less attractive investment. 24 Table of Contents
For example, Heska has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians worldwide at the point of care pursuant to our exclusive global supply and licensing agreement. We have also engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
For example, Antech has commenced sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians worldwide at the point of care pursuant to our exclusive global supply and licensing agreement. We have also engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
As of December 31, 2023, we had approximately $20.7 million in combined cash and cash equivalents compared to approximately $10.9 million as of December 31, 2022. Our management expects to deploy these resources primarily to expand our commercialization activities, to fund our product development efforts and for general corporate and working capital purposes.
As of December 31, 2024, we had approximately $3.3 million in combined cash and cash equivalents compared to approximately $20.7 million as of December 31, 2023. Our management expects to deploy these resources primarily to expand our commercialization activities, to fund our product development efforts and for general corporate and working capital purposes.
The issuance of common stock for future services or acquisitions or other corporate actions may have the effect of diluting the percentage ownership of our stockholders and, depending upon the prices at which such shares are sold or issued, on their investment in our common stock and, therefore, could have an adverse effect on any trading market for our common stock. 23 Table of Contents Future sales of our common stock could depress the market price of our common stock.
The issuance of common stock for future services or acquisitions or other corporate actions may have the effect of diluting the percentage ownership of our stockholders and, depending upon the prices at which such shares are sold or issued, on their investment in our common stock and, therefore, could have an adverse effect on any trading market for our common stock.
Additional risks and uncertainties not presently known to us, which we currently deem immaterial, or which are similar to those faced by other companies in our industry or business in general, may also impair our business operations.
Additional risks and uncertainties not presently known to us, which we currently deem immaterial, or which are similar to those faced by other companies in our industry or business in general, may also impair our business operations. Risk Factor Summary Risks Related to Our Business and Business Strategy · We may need to raise additional capital in the future.
The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may not have favorable results in later studies or trials which, in turn, could have a material adverse effect on our business.
Failure to achieve any of the foregoing would have a material adverse effect on our business, financial condition, and results of operations. 16 Table of Contents The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may not have favorable results in later studies or trials which, in turn, could have a material adverse effect on our business.
If we are unable to obtain financing on terms favorable to us, we may be unable to execute our plan of operations and we may be required to cease or reduce development or commercialization of any future products, sell some or all of our technology or assets or merge with another entity. 12 Table of Contents It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
If we are unable to obtain financing on terms favorable to us, we may be unable to execute our plan of operations and we may be required to cease or reduce development or commercialization of any future products, sell some or all of our technology or assets or merge with another entity.
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition. 15 Table of Contents Risks Related to Product Development, Commercialization and Sales of Our Products If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business.
Risks Related to Product Development, Commercialization and Sales of Our Products If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business.
Our patent portfolio includes 50 patent families (plus two in-licensed families) and a total 79 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 19 patents granted in Europe and a further 48 patents granted worldwide. Additionally, we have 132 patent applications pending, worldwide.
Our patent portfolio includes 52 patent families (plus three in-licensed families) and a total 75 patents granted related to our diagnostic tests (including veterinary applications), with 13 patents granted in the United States, 20 patents granted in Europe and a further 42 patents granted worldwide. Additionally, we have 128 patent applications pending, worldwide.
Potential and completed acquisitions and investments involve numerous risks, including the following: · we may be unable to successfully integrate the acquired business(es) into our business; · we may be unable to realize the anticipated benefits of the acquisition; · the acquisition may not strengthen our competitive position; and · our future results may suffer if we do not effectively manage our expanded operations.
Potential and completed acquisitions and investments involve numerous risks, including the following: · we may be unable to successfully integrate the acquired business (es) into our business; · we may be unable to realize the anticipated benefits of the acquisition; · the acquisition may not strengthen our competitive position; and · our future results may suffer if we do not effectively manage our expanded operations. 15 Table of Contents We do not know if we will be able to identify future acquisitions or investments we deem suitable, whether we will be able to successfully complete any such acquisitions or investments on favorable terms or at all, or whether we will be able to successfully integrate any acquired products or technologies into our business.
In November 2023, we launched the Nu.Q ® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories.
In November 2023, we launched the Nu.Q ® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. Our test is also available in Japan through Fujifilm Vet Systems Co. Ltd, a leading provider of veterinary testing services in Japan.
If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. Our common stock is listed on the NYSE American.
Investors should consider our independent registered public accountant’s comments when deciding whether to invest in the Company. If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
We may need to raise additional capital in the future. If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations. We may require additional capital to fully fund our current strategic plan, which includes successfully commercializing our Nu.Q ® pipeline and developing future products.
Risks Related to Our Business and Business Strategy We may need to raise additional capital in the future. If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations.
The failure of clinical trials to demonstrate the safety and effectiveness of our clinical candidates for the desired indication(s) would preclude the successful development of those candidates for such indication(s), in which event our business, prospects, results of operations and financial condition may be adversely affected. 16 Table of Contents Our research and development efforts will be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future clinical trials.
The failure of clinical trials to demonstrate the safety and effectiveness of our clinical candidates for the desired indication(s) would preclude the successful development of those candidates for such indication(s), in which event our business, prospects, results of operations and financial condition may be adversely affected.
Risks Related to Our Business and Business Strategy We have incurred significant losses, and we may never achieve profitability. We are a clinical stage company and have incurred losses since our formation. As of December 31, 2023, we have an accumulated total deficit of approximately $202.6 million.
We have incurred significant losses, and we may never achieve profitability. We are a clinical stage company and have incurred losses since our formation. As of December 31, 2024, we have an accumulated total deficit of approximately $229.5 million. As we continue the discovery and development of our future diagnostic products, we expect our expenses to increase significantly.
Access to human and animal sample types, such as blood is necessary for our research and product development. Acquiring samples from individuals / animals with clinical diagnoses or associated clinical outcomes through purchase or clinical studies is necessary. Lack of available samples can delay development timelines and increase costs of development.
Acquiring samples from individuals / animals with clinical diagnoses or associated clinical outcomes through purchase or clinical studies is necessary. Lack of available samples can delay development timelines and increase costs of development. Generally, the agreements under which we gain access to human and animal samples are non-exclusive. Other companies may compete with us for access.
Investors should consider our independent registered public accountant’s comments when deciding whether to invest in the Company. Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
As we continue the discovery and development of our future diagnostic products, we expect our expenses to increase significantly. Even as we begin to market and sell our intended products, we expect our losses to continue as a result of ongoing research and development expenses, as well as increased manufacturing, sales and marketing expenses.
Even as we begin to market and sell our intended products, we expect our losses to continue as a result of ongoing research and development expenses, as well as increased manufacturing, sales and marketing expenses. These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets and stockholders’ deficit.
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we are unable to achieve and then maintain profitability, our business, financial condition and results of operations will be negatively affected, and the market value of our common stock will decline.
If we are unable to achieve and then maintain profitability, our business, financial condition and results of operations will be negatively affected, and the market value of our common stock will decline. 12 Table of Contents It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
Supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could also negatively impact our cost of materials and production processes. We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets and stockholders’ equity. Because of the numerous risks and uncertainties associated with our product development and commercialization efforts, we are unable to predict when or if we will become profitable.
Because of the numerous risks and uncertainties associated with our product development and commercialization efforts, we are unable to predict when or if we will become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
Removed
Risk Factor Summary Risks Related to Our Business and Business Strategy · We have incurred significant losses, and we may never achieve profitability. · We may need to raise additional capital in the future.
Added
We may require additional capital to fully fund our current strategic plan, which includes successfully commercializing our Nu.Q ® pipeline and developing future products.
Removed
Risks Related to Our Intellectual Property · If the patents we rely on to protect our intellectual property prove to be inadequate, our ability to successfully commercialize our products will be harmed and we may never be able to operate our business profitably. · If third parties assert that we have infringed their patents and proprietary rights or challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and delay or prevent the development or commercialization of our products. · If we are unable to protect our trade secrets, we may be unable to protect our interests in proprietary technology, processes and know-how that is not patentable or for which we have elected not to seek patent protection.
Added
Separately, proposals to implement new tariffs or other trade restrictions in the U.S. could impact the products we import into the U.S. and also result in retaliatory measures in international markets where we sell our products.
Removed
We do not know if we will be able to identify future acquisitions or investments we deem suitable, whether we will be able to successfully complete any such acquisitions or investments on favorable terms or at all, or whether we will be able to successfully integrate any acquired products or technologies into our business.
Added
Although we cannot predict whether and in what form such measures will be adopted or implemented, these proposals for tariffs or other trade restrictions could increase our cost of goods sold and negatively impact our business and operating results.
Removed
Failure to achieve any of the foregoing would have a material adverse effect on our business, financial condition, and results of operations.
Added
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition.
Removed
Generally, the agreements under which we gain access to human and animal samples are non-exclusive. Other companies may compete with us for access.
Added
Our research and development efforts will be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future clinical trials. Access to human and animal sample types, such as blood is necessary for our research and product development.
Added
Future sales of our common stock could depress the market price of our common stock.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeSquare Feet Leased or Owned Namur, Belgium (1) Research and development 17,300 Owned Namur, Belgium (2) Manufacturing 9,688 Owned London, UK (3) Sales and marketing 323 Leased, expiring 2024 Triple One, Singapore (4) Sales and marketing 192 Leased, expiring 2024 Henderson, Nevada (5) Administration 301 Leased, expiring 2024 Carlsbad, California (6) Research and development 6,645 Leased, expiring 2027 (1) Belgian Volition purchased property located in Namur, Belgium, in October 2016, to be used as a laboratory facility for R&D.
Biggest changeSquare Feet Leased or Owned Namur, Belgium (1) Research and development 17,300 Owned Namur, Belgium (2) Manufacturing 9,688 Owned London, UK (3) Sales and marketing 323 Leased, expiring 2026 Henderson, Nevada (4) Administration 301 Leased, expiring 2026 Carlsbad, California (5) Research and development 6,645 Leased, expiring 2027 (1) Belgian Volition purchased property located in Namur, Belgium, in October 2016, to be used as a laboratory facility for R&D.
ITEM 2. PROPERTIES Listed below are our current facilities as of December 31, 2023: Location Primary Function Approx.
ITEM 2. PROPERTIES Listed below are our current facilities as of December 31, 2024: Location Primary Function Approx.
(6) Volition America signed a sixty-two month lease for this property, commencing on February 1, 2022, located at 6086 Corte Del Cedro, Carlsbad, California 92011 at an annual rent of $91,704.
(5) Volition America signed a sixty-two month lease for this property, commencing on February 1, 2022, located at 6086 Corte Del Cedro, Carlsbad, California 92011 at an annual rent of $99,714.
(3) Volition Diagnostics signed a new 24-month lease for this property located at 93-95 Gloucester Place, London, W1U 6JQ, United Kingdom, commencing February 1, 2022 until January 31, 2024, at an annual rent of £64,800 GBP.
(3) Volition Diagnostics signed a new 12-month lease for this property located at 93-95 Gloucester Place, London, W1U 6JQ, United Kingdom, commencing February 1, 2025 until January 31, 2026, at an annual rent of £69,300 GBP.
(5) Volition America signed a one-year lease for this property, commencing on April 1, 2022, located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014, at an annual rent of $14,868. Volition America entered into a new one-year lease for this property, commencing April 1, 2023, at an annual rent of $16,308.
(4) Volition America signed a new one-year lease for this property, commencing on April 1, 2024, located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014, at an annual rent of $19,308. Volition America entered into a new one-year lease for this property, commencing April 1, 2025, at an annual rent of $20,748.
Removed
(4) Singapore Volition signed a one-year lease for this property, commencing July 1, 2023, located at 111 Somerset Road, Level 3, Triple One, Somerset, Singapore 238164, at an annual rent of SGD 77,580.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe shares were issued in book entry form with a restrictive legend to such effect. Repurchase of Equity Securities No equity securities were repurchased during the fourth quarter of 2023.
Biggest changeRecent Sales of Unregistered Securities None. Repurchase of Equity Securities No equity securities were repurchased during the fourth quarter of 2024.
Holders As of March 15, 2024, there were 82,068,442 shares of our common stock outstanding held by 160 holders of record, based on information provided by our transfer agent.
Holders As of March 20, 2025, there were 96,543,744 shares of our common stock outstanding held by 168 holders of record, based on information provided by our transfer agent.
Removed
Recent Sales of Unregistered Securities On December 4, 2023, the Company issued 3,205,431 shares of its common stock to a non-U.S. investor for an aggregate purchase price of approximately $2.67 million in a private placement transaction.
Removed
Such shares were issued in reliance on the exemption from registration under Regulation S promulgated under the Securities Act as the offer or sale was made in an offshore transaction and no directed selling efforts were made in the United States by the issuer, a distributor, any of their respective affiliates, or any person acting on behalf of any of the foregoing.
Removed
In addition, the investor certified that it is not a U.S. Person, as defined in Regulation S, and is not acquiring the securities for the account or benefit of any U.S.
Removed
Person and agreed to resell such securities only in accordance with the provisions of Regulation S, pursuant to registration under the Securities Act, or pursuant to an available exemption from registration, and agreed not to engage in hedging transactions with regard to such securities unless in compliance with the Securities Act.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThis compares with $6.4 million in net cash received from the issuance of approximately 3.5 million shares of common stock in a registered public offering in August 2022, before deducting offering expenses of $0.2 million paid by the Company and a $1.0 million (€1.0 million) loan received in August 2022 from Namur Invest, a $0.5 million loan received in December 2022 from Namur Invest, and $0.8 million in cash received from the issuance of shares of common stock under our “at-the-market” facilities during the year, before deducting offering expenses of $0.2 million.
Biggest changeNet cash provided by financing activities in 2024 consisted of $0.7 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended December 31, 2024, $6.3 million in cash received before deducting offering expenses of $0.2 million from the issuance and sale of the shares of common stock, pre-funded warrants and common warrants in a registered direct offering that closed in August 2024, and a further $1.9 million in cash received before deducting offering expenses of $0.1 million from the issuance and sale of common stock and common warrants in a registered direct offering to certain directors and executive officers of the Company as well as other investors that closed in December 2024.
For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2023, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern. 29 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2023 and December 31, 2022 The following table sets forth our results of operations for the years ended on December 31, 2023, and December 31, 2022, respectively (expressed in United Stated Dollars, except outstanding share numbers and percentages).
For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2024, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern. 29 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2024 and December 31, 2023 The following table sets forth our results of operations for the years ended on December 31, 2024, and December 31, 2023, respectively (expressed in United Stated Dollars, except outstanding share numbers and percentages).
This discussion includes an analysis of our financial condition and results of operations for the years ended December 31, 2023 and 2022 and year-over-year comparisons between those periods. Certain statements made in this section constitute “forward-looking statements,” which are subject to numerous risks and uncertainties including those described in this section.
This discussion includes an analysis of our financial condition and results of operations for the years ended December 31, 2024 and 2023 and year-over-year comparisons between those periods. Certain statements made in this section constitute “forward-looking statements,” which are subject to numerous risks and uncertainties including those described in this section.
We also regularly evaluate estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets and valuations of stock-based compensation.
We also regularly evaluate estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, deferred revenue valuation, revenue recognition, warrant liability, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets and valuations of stock-based compensation.
The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis and COVID-19. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.
The tests offered by Volition and its subsidiaries are designed to detect and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.
The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
Recently Issued Accounting Pronouncements The Company has implemented all applicable new accounting pronouncements that are in effect. The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
Revenue for the year ended December 31, 2023 was $775,302 compared with $306,392 for the year ended December 31, 2022. The main source of revenues during the years ended December 31, 2023 and December 31, 2022, was product sales of the Nu.Q® Vet Cancer Test and services revenue from our Nu.Q ® Discover offering.
Revenue for the year ended December 31, 2024 was $1,233,511 compared with $775,302 for the year ended December 31, 2023. The main source of revenues during the years ended December 31, 2024 and December 31, 2023, was product sales of the Nu.Q® Vet Cancer Test and services revenue from our Nu.Q ® Discover offering.
Impairment of Long-Lived Assets In accordance with ASC 360, “Prop erty Plant and Equipment” , the Company tests long-lived assets or asset groups for recoverability when events or changes in circumstances indicate that their carrying amount may not be recoverable.
Restricted stock units are valued based on the closing stock price on the date of grant. Impairment of Long-Lived Assets In accordance with ASC 360, “Prop erty Plant and Equipment” , the Company tests long-lived assets or asset groups for recoverability when events or changes in circumstances indicate that their carrying amount may not be recoverable.
Operating Expenses Total operating expenses increased to $36.8 million from $32.1 million for the years ended December 31, 2023 and December 31, 2022, respectively, as a result of the factors described below. 30 Table of Contents Research and Development Expenses Research and development expenses increased to $19.6 million from $15.3 million for the years ended December 31, 2023 and December 31, 2022, respectively.
Operating Expenses Total operating expenses decreased to $28.3 million from $36.8 million for the years ended December 31, 2024 and December 31, 2023, respectively, as a result of the factors described below. 30 Table of Contents Research and Development Expenses Research and development expenses decreased to $14.4 million from $19.6 million for the years ended December 31, 2024 and December 31, 2023, respectively.
The increase in overall general and administrative expenditures during 2023 was primarily due to higher personnel expenses and legal and professional fees offset by lower stock-based compensation.
The decrease in overall general and administrative expenditures during 2024 was primarily due to lower personnel expenses, legal and professional fees and stock-based compensation.
The increase in overall sales and marketing expenditures was primarily due to increased personnel expenses offset by lower stock-based compensation.
The decrease in overall sales and marketing expenditures was primarily due to decreased personnel expenses and lower stock-based compensation.
The decrease in cash used in investing activities during 2023 was primarily due to reduced purchases of laboratory equipment as compared to 2022. Net cash provided by financing activities after associated costs was $29.0 million and $6.9 million for the years ended December 31, 2023 and December 31, 2022, respectively.
Net cash used in investing activities was $0.6 million and $1.1 million for the years ended December 31, 2024 and December 31, 2023, respectively. The decrease in cash used in investing activities during 2024 was primarily due to reduced purchases of laboratory equipment as compared to 2023.
If we are unable to obtain adequate capital, we could be forced to cease operations. Liquidity and Capital Resources We have financed our operations since inception primarily through private placements and public offerings of our common stock.
If we are unable to obtain adequate capital, we could be forced to cease operations. 28 Table of Contents Liquidity and Capital Resources We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of December 31, 2024, we had cash and cash equivalents of approximately $3.3 million.
The increase in overall research and development expenditures during 2023 was primarily related to higher personnel expenses and clinical research costs.
The decrease in overall research and development expenditures during 2024 was primarily related to decreased clinical research costs and lower personnel expenses.
The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs. · Nu.Q ® NETs - monitoring the immune system to save lives. · Nu.Q ® Discover - a complete solution to profiling nucleosomes. · Nu.Q ® Cancer - monitoring disease progression, response to treatment and Minimal Residual Disease. · Capture-PCR TM - isolating and capturing circulating tumor derived DNA from plasma samples for early cancer detection.
The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs. · Nu.Q ® NETs - detects diseases associated with NETosis such as sepsis. · Nu.Q ® Discover - a complete solution to profiling nucleosomes. · Nu.Q ® Cancer - from screening, diagnosis and staging, therapy decision, planning and treatment to monitoring response to treatment and disease progression. · Capture-PCR™ - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.
This decrease in other income was primarily due to reduced grant income received of approximately $0.2 million during 2023 compared to $1.2 million in 2022.
This decrease in other income was primarily due to reduced grant income received of approximately $0.1 million during 2024 compared to $0.2 million in 2023 and a gain in the fair value of the warrant liability during 2023.
Net Loss For the year ended December 31, 2023, the Company’s net loss was $35.7 million, an increase of approximately $5.1 million, in comparison to a net loss of $30.6 million for the year ended December 31, 2022. The change was a result of the factors described above.
Net Loss For the year ended December 31, 2024, the Company’s net loss was $27.3 million, a decrease of approximately $(8.4) million, in comparison to a net loss of $35.7 million for the year ended December 31, 2023. The change was a result of the factors described above.
An impairment loss is recognized when the carrying amount is not recoverable and exceeds fair value. Impairment losses of $nil and $nil were recognized during the years ended December 31, 2023 and December 31, 2022, respectively. Foreign Currency Translation The Company has functional currencies in Euros, U.S. Dollars and British Pounds Sterling and its reporting currency is the U.S. Dollar.
An impairment loss is recognized when the carrying amount is not recoverable and exceeds fair value. Foreign Currency Translation The Company has functional currencies in Euros, U.S. Dollars and British Pounds Sterling and its reporting currency is the U.S. Dollar. Management has adopted ASC 830-20, “ Foreign Currency Matters – Foreign Currency Transactions ”.
Management has adopted ASC 830-20, “ Foreign Currency Matters – Foreign Currency Transactions ”. All assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. For revenues and expenses, the weighted average exchange rate for the period is used.
All assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. For revenues and expenses, the weighted average exchange rate for the period is used. Gains and losses arising on translation of foreign currency denominated transactions are included in Other Comprehensive Income.
The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built lab in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London, Singapore and Nevada. In 2015 the Company’s common stock was listed on the New York Stock Exchange (VNRX).
The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built 17,000 square foot lab and 10,000 square foot production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London and Nevada.
We now have a team of over 100 dedicated employees, spanning a wide range of disciplines; all united in its mission to improve outcomes for patients.
We now have a team of over 80 dedicated employees, spanning a wide range of disciplines; all united in our mission to improve outcomes for patients. Cultivating successful, ongoing relationships with stakeholders worldwide has been fundamental to Volition’s development.
The increase in net cash provided by financing activities for the 2023, when compared to 2022 was primarily due to the following $8.0 million in net proceeds received from the sale and issuance of common stock in a registered public offering in February 2023, before deducting offering expenses of $0.2 million, $17.6 million in net proceeds received from the sale and issuance of common stock in a registered public offering in June 2023, before deducting offering expenses of $0.1 million and $2.7 million (€2.5 million) in net proceeds received from the sale and issuance of common stock in a private placement in December 2023, also in June 2023 a $0.2 million loan was received from Namur Invest and in December 2023 a $1.6 million loan was received from Wallonie Entreprendre S.A.
This compares with $8.0 million in net proceeds received from the sale and issuance of common stock in a registered public offering in February 2023, before deducting offering expenses of $0.2 million, $17.6 million in net proceeds received from the sale and issuance of common stock in a registered public offering in June 2023, before deducting offering expenses of $0.1 million and $2.7 million (€2.5 million) in net proceeds received from the sale and issuance of common stock in a private placement in December 2023.
The FTE personnel number within this division increased by three to twenty two in 2023 compared to the prior year period. 2023 2022 Change $ $ $ Personnel expenses 5,046,282 4,400,092 646,190 Stock-based compensation 732,422 1,068,222 (335,800 ) Other sales and marketing expenses 1,012,868 1,053,807 (40,939 ) Depreciation and amortization 51,588 54,125 (2,537 ) Total sales and marketing expenses 6,843,160 6,576,246 266,914 31 Table of Contents Other Income (Expenses) For the year ended December 31, 2023, other income decreased to approximately $0.3 million compared to other income of approximately $1.2 million for the year ended December 31, 2022.
The FTE personnel number within this division decreased by eight to fourteen during 2024 compared to the prior year period. 2024 2023 Change $ $ $ Personnel expenses 4,104,101 5,046,282 (942,181 ) Stock-based compensation 289,069 732,422 (443,353 ) Other Sales & Marketing expenses 922,602 1,012,868 (90,266 ) Depreciation and amortization 48,661 51,588 (2,927 ) Total sales and marketing expenses 5,364,433 6,843,160 (1,478,727 ) 31 Table of Contents Other Income (Expenses) For the year ended December 31, 2024, other income decreased to approximately $(0.2) million compared to other income of approximately $0.3 million for the year ended December 31, 2023.
As of December 31, 2023, we had cash and cash equivalents of approximately $20.7 million. 28 Table of Contents Net cash used in operating activities was $18.1 million and $15.3 million for the years ended December 31, 2023 and December 31, 2022, respectively.
Net cash used in operating activities was $25.9 million and $18.1 million for the years ended December 31, 2024 and December 31, 2023, respectively.
The increase in cash used in operating activities during 2023 when compared to 2022 was primarily due to higher payroll costs and higher amounts paid to suppliers during the period. Net cash used in investing activities was $1.1 million and $1.6 million for the years ended December 31, 2023 and December 31, 2022, respectively.
The increase in cash used in operating activities during 2024 when compared to 2023 was primarily due to the deferred revenue receipt of $13 million in the prior year offset by lower payroll costs and amounts paid to suppliers during the period.
FTE personnel numbers within this division increased by three to sixty six during 2023 compared to the prior year period. 2023 2022 Change $ $ $ Personnel expenses 9,207,822 7,125,017 2,082,805 Stock-based compensation 617,710 652,653 (34,943 ) Direct research and development expenses 7,641,571 5,662,957 1,978,614 Other research and development 964,843 1,052,749 (87,906 ) Depreciation and amortization 1,119,577 839,613 279,964 Total research and development expenses 19,551,523 15,332,989 4,218,534 General and Administrative Expenses General and administrative expenses increased to $10.4 million from $10.2 million for the years ended December 31, 2023 and December 31, 2022, respectively.
FTE personnel numbers within this division decreased by fourteen to fifty two during 2024 compared to the prior year period. 2024 2023 Change $ $ $ Personnel expenses 7,463,938 9,207,822 (1,743,884 ) Stock based compensation 233,014 617,710 (384,696 ) Direct research and development expenses 4,397,828 7,641,571 (3,243,743 ) Other research and development 1,221,903 964,843 257,060 Depreciation and amortization 1,089,803 1,119,577 (29,774 ) Total research and development expenses 14,406,486 19,551,523 (5,145,037 ) General and Administrative Expenses General and administrative expenses decreased to $8.5 million from $10.4 million for the years ended December 31, 2024 and December 31, 2023, respectively.
For additional information on our “at the market facilities,” refer to Note 7, Common Stock – Equity Distribution Agreements, of the Notes to consolidated financial statements included within this Report. The following table summarizes our approximate contractual payments due by year as of December 31, 2023.
Additionally, in June 2023 a $0.2 million loan was received from Namur Invest and in December 2023 a $1.6 million loan was received from Wallonie Entreprendre S.A. For additional information on our “at the market facility,” refer to Note 7, Common Stock – Equity Distribution Agreements, of the Notes to consolidated financial statements included within this Report.
The FTE personnel number within this division remained at twenty two in 2023 compared to the prior year period. 2023 2022 Change $ $ $ Personnel expenses 5,492,705 5,047,242 445,463 Stock-based compensation 939,412 1,393,784 (454,372 ) Legal and professional fees 2,116,494 1,954,798 161,696 Other general and administrative 1,579,241 1,486,722 92,519 Depreciation and amortization 240,462 294,683 (54,221 ) Total general and administrative expenses 10,368,314 10,177,229 191,085 Sales and Marketing Expenses Sales and marketing expenses increased to $6.8 million from $6.6 million for the years ended December 31, 2023 and December 31, 2022, respectively.
The FTE personnel number within this division decreased by three to nineteen during 2024 compared to the prior year period. 2024 2023 Change $ $ $ Personnel expenses 4,220,539 5,492,705 (1,272,166 ) Stock-based compensation 746,459 939,412 (192,953 ) Legal and professional fees 1,909,076 2,116,494 (207,418 ) Other general and administrative 1,447,719 1,579,241 (131,522 ) Depreciation and amortization 163,769 240,462 (76,693 ) Total general and administrative expenses 8,487,562 10,368,314 (1,880,752 ) Sales and Marketing Expenses Sales and marketing expenses decreased to $5.4 million from $6.8 million for the years ended December 31, 2024 and December 31, 2023, respectively.
Increase Percentage Increase 2023 2022 (Decrease) (Decrease) $ $ $ % Royalty 1,369 2,911 (1,542 ) (53 %) Service 175,476 92,488 82,988 90 % Product 598,457 210,993 387,464 >100 % Total Revenues 775,302 306,392 468,910 >100 % Research and development 19,551,523 15,332,989 4,218,534 28 % General and administrative 10,368,314 10,177,229 191,085 2 % Sales and marketing 6,843,160 6,576,246 266,914 4 % Total Operating Expenses 36,762,997 32,086,464 4,676,533 15 % Grant income 214,451 1,229,425 (1,014,974 ) (83 %) Loss on disposal of fixed assets (15,843 ) - (15,843 ) %) Interest income 93,324 125,265 (31,941 ) (25 %) Interest expense (221,622 ) (173,087 ) 48,535 28 % Gain on change in fair value of warrant liability 240,311 - 240,311 >100 % Total Other Income (Expenses) 310,621 1,181,603 (870,982 ) (74 %) Net Loss (35,677,074 ) (30,598,469 ) 5,078,605 17 % Revenues Our operations are still transitioning from a research and development stage to a commercialization stage.
Increase Percentage Increase 2024 2023 (Decrease) (Decrease) $ $ $ % Royalty - 1,369 (1,369 ) (100 %) Service 228,138 175,476 52,662 30 % Product 1,005,373 598,457 406,916 68 % Total Revenues 1,233,511 775,302 458,209 59 % Research and development 14,406,486 19,551,523 (5,145,037 ) (26 %) General and administrative 8,487,562 10,368,314 (1,880,752 ) (18 %) Sales and marketing 5,364,433 6,843,160 (1,478,727 ) (22 %) Total Operating Expenses 28,258,481 36,762,997 (8,504,516 ) (23 %) Grant income 103,368 214,451 (111,083 ) (52 %) Loss on disposal of fixed assets (34,731 ) (15,843 ) (18,888 ) %) Interest income 9,947 93,324 (83,377 ) (89 %) Interest expense (340,362 ) (221,622 ) 118,740 54 % Gain on change in fair value of warrant liability 28,763 240,311 211,548 (88 %) Total Other Income (Expenses) (233,015 ) 310,621 (543,636 ) %) Net Loss (27,257,985 ) (35,677,074 ) (8,419,089 ) (24 %) Revenues Our operations are still transitioning from a research and development stage to a commercialization stage.
Approximate Payments (Including Interest) Due by Year Total 2024 2025 - 2028 2029 + Description $ $ $ $ Financing lease liabilities 497,250 59,374 237,500 200,376 Operating lease liabilities and short-term lease 646,662 256,768 389,894 - Grants repayable 478,562 55,855 186,218 236,489 Long-term debt 5,791,541 1,481,023 3,986,716 323,802 Collaborative agreements obligations 1,273,692 1,110,146 163,546 - Total 8,687,707 2,963,166 4,963,874 760,667 We intend to use our cash reserves to predominantly fund further research and development, and commercialization activities.
Approximate Payments (Including Interest) Due by Year Total 2025 - 2029 Greater than 5 years Description $ $ $ Financing lease liabilities 410,563 278,359 132,204 Operating lease liabilities and short-term lease 688,188 688,188 - Grants repayable 422,221 252,108 170,113 Long-term debt 5,856,017 5,679,706 176,311 Collaborative agreements obligations 1,120,518 1,120,518 - Total 8,497,507 8,018,879 478,628 We intend to use our cash reserves to predominantly fund further research and development, and commercialization activities.
Removed
Restricted stock units are valued based on the closing stock price on the date of grant, refer to Note 8 of the consolidated financial statements for further details.
Added
We have fostered ties with leading academic institutions, clinical centers of excellence, multi-national diagnostic and pharmaceutical companies and financial institutions across the globe.
Removed
Gains and losses arising on translation of foreign currency denominated transactions are included in Other Comprehensive Income. Recently Issued Accounting Pronouncements The Company has implemented all applicable new accounting pronouncements that are in effect.
Added
Net cash provided by financing activities after associated costs was $8.7 million and $29.0 million for the years ended December 31, 2024 and December 31, 2023, respectively.
Added
The following table summarizes our approximate contractual payments due by year as of December 31, 2024.

Other VNRX 10-K year-over-year comparisons