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What changed in VOLITIONRX LTD's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of VOLITIONRX LTD's 2024 and 2025 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 2025 report.

+187 added−147 removedSource: 10-K (2026-03-31) vs 10-K (2025-03-31)

Top changes in VOLITIONRX LTD's 2025 10-K

187 paragraphs added · 147 removed · 127 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeWe aim to remain an IP powerhouse in the epigenetic space and expect to monetize our IP and technologies through licensing and distribution contracts with companies that have established distribution networks and expertise on a worldwide or regional basis, in both human and animal care across platforms (centralized labs and point-of-care / in-house diagnostics).
Biggest changeWe believe, that given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, subject to clinical validation, regulatory authorization, and successful commercialization, our tests have the potential for use throughout the world. 5 Table of Contents We aim to remain an IP powerhouse in the epigenetic space and expect to monetize our IP and technologies through licensing and distribution contracts with companies that have established distribution networks and expertise on a worldwide or regional basis, in both human and animal care across platforms (centralized labs and point-of-care / in-house diagnostics).
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.
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, automated reference laboratory and point-of-care.
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.
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.
Cancer is a devastating disease that touches many peoples’ lives, accounting for approximately 10 million deaths worldwide each year. It is the second leading cause of death globally and exerts an enormous burden on families, communities, and health systems. Survival rates are improving in countries with strong health systems, thanks to advances in cancer detection and treatment.
Cancer is a devastating disease that touches many people’s lives, accounting for approximately 10 million deaths worldwide each year. It is the second leading cause of death globally and exerts an enormous burden on families, communities, and health systems. Survival rates are improving in countries with strong health systems, thanks to advances in cancer detection and treatment.
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 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. 2 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.
The Nu Q ® Vet Cancer Test is an accessible and affordable screening test to aid in the early detection of cancer in dogs. It’s a simple, cost effective, easy to use screening blood test recommended for older dogs (7 years and older) and those breeds at increased risk of developing cancer in their lifetimes (from 4 years).
The Nu.Q ® Vet Cancer Test is an accessible and affordable screening test to aid in the early detection of cancer in dogs. It is a simple, cost effective, easy to use screening blood test recommended for older dogs (7 years and older) and those breeds at increased risk of developing cancer in their lifetimes (from 4 years).
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”).
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-associated from background DNA of the same sequence, using Chromatin Immunoprecipitation (“ChIP”).
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.
We now have a team of over 75 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 determination of whether a 510(k) or a PMA is necessary will depend in part on the proposed indications for use and the FDA’s assessment of the risk associated with the use of the IVD for a particular indication. A similar system operates in China through the CFDA.
The determination of whether a 510(k) or a PMA is necessary will depend in part on the proposed indications for use and the FDA’s assessment of the risk associated with the use of the IVD for a particular indication. A similar system operates in China through the NMPA.
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.
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.
However, access to timely diagnostics and therapies remains limited for cancer patients in low and middle-income countries. Nu.Q ® Cancer can detect characteristic epigenetic changes in nucleosomes that occur during the earliest stages of cancer and has potential applications beyond cancer detection.
However, access to timely diagnostics and therapies remains limited for cancer patients in low and middle-income countries. 4 Table of Contents Nu.Q ® Cancer can detect characteristic epigenetic changes in nucleosomes that occur during the earliest stages of cancer and has potential applications beyond cancer detection.
Drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their longer-term, drug development needs. In this way, Nu.Q® Discover is able to unlock value from Volition’s IP portfolio by helping us to commercialize the areas we are not going to drive ourselves.
Drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their longer-term, drug development needs. In this way, Nu.Q ® Discover is able to unlock value from Volition’s intellectual property (“IP”) portfolio by helping us to commercialize the areas we are not going to drive ourselves.
We intend to continue our development of the Nucleosomics™ technologies and will continue to apply for patents for future product developments. Our IP strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries.
We intend to continue our development of the Nucleosomics™, Capture-PCR and Capture-Seq™ technologies and will continue to apply for patents for future product developments. Our IP strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries.
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.
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 with a particular focus on lung cancer. · Capture-Seq™/ Capture-PCR™ - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.
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.
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™ / Capture-Seq™ technologies are novel methods for liquid biopsy involving the first reported physical isolation of a class of tumor-derived ctDNA fragments from blood.
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.
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, The Veterinary Pathology Group, among others.
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.
The patent filings on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2045. Employees As of December 31, 2025, we had 75 full-time equivalent (“FTE”) personnel compared to 85 as of December 31, 2024, reflecting the need to prioritize the cash utilization in our commercial and production activities.
We aim to offer competitive compensation (including salary, incentive bonus, and equity) and benefits packages to each of our employees around the globe as assessed with internal and external benchmarking data. We aim to build a pipeline for talent to create more opportunities for workplace diversity and to support greater representation within the Company.
We aim to offer competitive compensation and benefits packages to each of our employees around the globe as assessed with internal and external benchmarking data. We aim to build a pipeline for talent to create more opportunities for workplace diversity and to support greater representation within the Company.
Our principal executive office is located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014. Our telephone number is +1 (646) 650-1351. Our website is located at www.volition.com . The information that can be accessed through our website is not incorporated by reference into this Report and should not be considered to be a part hereof.
Our principal executive office is located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014. Our telephone number is +1 (512) 774-8930. Our website is located at www.volition.com . The information that can be accessed through our website is not incorporated by reference into this Report and should not be considered to be a part hereof.
It has had an enormous impact on the practice of medicine, revolutionizing the way doctors identify people with inherited conditions, diagnose cancer, and, increasingly, design personalized treatment plans.
The sequencing of the human genome has had an enormous impact on the practice of medicine, revolutionizing the way doctors identify people with inherited conditions, diagnose cancer, and, increasingly, design personalized treatment plans.
Commercialization of our future products in the clinical in vitro diagnostic (“IVD”) market (e.g. for patient diagnosis in hospitals, clinics, etc.) requires government approval (CE marking in Europe, FDA approval in the United States, and Chinese Food and Drug Administration (“CFDA”) approval in China).
Commercialization of our future products in the clinical in vitro diagnostic (“IVD”) market (e.g. for patient diagnosis in hospitals, clinics, etc.) requires government approval (CE marking in Europe, FDA approval in the United States, and National Medical Products Administration (“NMPA”) (formerly known as the Chinese Food and Drug Administration) approval in China).
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.
Our patent portfolio includes 54 patent families (plus three in-licensed families) and a total of 68 patents granted related to our diagnostic tests (including veterinary applications), with 13 patents granted in the United States, 17 patents granted in Europe, and a further 38 patents granted worldwide. Additionally, we have a total of 132 patent applications currently pending worldwide.
Risk of death increases by 7.6% for every hour of treatment delay. Early detection and treatment of sepsis has the potential to improve survival – and improve the quality of life of survivors. Imagine if a simple blood test could help diagnose sepsis and identify those patients more likely to deteriorate.
Early detection and treatment of sepsis has the potential to improve survival – and improve the quality of life of survivors. Imagine if a simple blood test could help diagnose sepsis and identify those patients more likely to deteriorate.
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.
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.
We predict our future products will have a competitive edge compared to those offered by competitors on the basis that our tests are developed to be accurate, cost-effective, attractive from a government reimbursement perspective, easy to use, non-invasive, technologically advanced, and compatible with immunoassay systems, based on strong intellectual property and to be used for mass screenings.
We predict our future products will have a competitive edge compared to those offered by competitors on the basis that our tests are developed to be accurate, cost-effective, attractive from a government reimbursement perspective, easy to use, non-invasive, technologically advanced, and compatible with immunoassay systems, based on strong intellectual property and to be used for mass screenings. 7 Table of Contents Many of our competitors have substantially greater financial, technical, and other resources and larger, more established marketing, sales and distribution systems than we have.
Moreover, our competitors may make rapid technological developments that may result in our intended technologies and products becoming obsolete before we are able to enter the market, recover the expenses incurred to develop them or generate significant revenue.
Many of our competitors also offer broad product lines outside of the diagnostic testing market and have brand recognition. Moreover, our competitors may make rapid technological developments that may result in our intended technologies and products becoming obsolete before we are able to enter the market, recover the expenses incurred to develop them or generate significant revenue.
Nu.Q ® Discover Nu.Q ® Discover is a complete solution to profiling nucleosomes which empowers drug developers and scientists, offering rapid epigenetic profiling in disease model development, preclinical testing, and clinical studies – from drug discovery to market launch.
We are preparing to submit an IVDR application in 2026 for CE marking in Europe. Nu.Q ® Discover Nu.Q ® Discover is a complete solution to profiling nucleosomes which empowers drug developers and scientists, offering rapid epigenetic profiling in disease model development, preclinical testing, and clinical studies – from drug discovery to market launch.
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 Competition We face competition primarily from other human-focused healthcare, pharmaceutical and diagnostic companies such as Exact Sciences Corporation, Guardant Health, GRAIL Inc., Natera, Caris Life Sciences, 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.
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 are currently conducting ongoing research regarding Nu.Q ® Vet in pursuit of the following goals: · The use of Nu.Q ® Vet in the feline population, · Use of the Nu.Q ® platform in NETosis in canines, and · Use of Capture-Seq ™ in canines.
Our biomarkers support the entire drug discovery and development process from pre-clinical testing to market-readiness. We aim to assess disease severity, monitor treatment response, and enhance the understanding of disease pathology and treatments. Nu.Q ® Cancer Our Nu.Q ® Cancer pillar encapsulates a range of simple, cost effective blood-based assays.
Our biomarkers are designed to support the entire drug discovery and development process from pre-clinical testing to market-readiness. We aim to assess disease severity, monitor treatment response, and enhance the understanding of disease pathology and treatments.
Our Nu.Q ® NETs assay is the only analytically validated assay to quantify the level of NETs. It is platform agnostic so it can be adapted to any workflow/clinical setting – including central lab and point of care.
It is platform agnostic so it can be adapted to any workflow/clinical setting – including central lab and point of care.
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.
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.
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.
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.
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.
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.
Just under half of all survivors are left with psychological and/or physical effects. Sepsis, also known as ‘blood poisoning’, is hard to identify. Initial symptoms of sepsis are difficult to distinguish from most infections and there is currently no test to diagnose it. Without prompt treatment, it can lead to multiple organ failure and death.
Initial symptoms of sepsis are difficult to distinguish from most infections and there is currently no test to diagnose it. Without prompt treatment, it can lead to multiple organ failure and death. Risk of death increases by approximately 7.6% for every hour of treatment delay.
Although NETs play a critical role in our normal immune response, elevated levels of NETs are a complicating factor associated with poor patient outcomes in sepsis, cancer, and a range of other diseases. 5 Table of Contents Sepsis is the number one cause of death in hospitals worldwide.
Our assay can be used to identify patients with clinically relevant elevated levels of circulating Neutrophil Extracellular Traps (NETs) and enable physicians to rapidly treat these patients. Although NETs play a critical role in our normal immune response, elevated levels of NETs are a complicating factor associated with poor patient outcomes in sepsis, cancer, and a range of other diseases.
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.
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. 8 Table of Contents 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.
Transfer of the Nu.Q ® Vet Cancer Test onto Antech’s in-house diagnostic platform (the element i+) was completed in 2023.
Transfer of the Nu.Q ® Vet Cancer Test onto Antech’s in-house diagnostic platform (the element i+) was completed in 2023. Validation and verification of the chemiluminescent immunoassay (“ChLIA”) version of the Nu.Q® Vet Cancer Test was completed in the first quarter of 2026 with Fujifilm Vet Systems, allowing use of full automation rather than manual plates in central laboratories.
To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska, now an Antech Company.
We are in active discussions with approximately ten leading diagnostics and liquid biopsy companies for both Nu.Q® and Capture-Seq™, including ongoing technology evaluations. Veterinary On March 28, 2022, Volition entered into a master license and product supply agreement with Heska, now an Antech Company.
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Nu.Q ® NETs Our Nu.Q ® NETs assay is a groundbreaking CE-marked diagnostic solution that clinicians can use to detect NETosis. Our assay can be used to identify patients with clinically relevant elevated levels of circulating Neutrophil Extracellular Traps (NETs) and enable physicians to rapidly treat these patients.
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In May 2025, we reported the publication of a pre-analytics paper and the detection of nucleosomes in cats, and subsequently, in January 2026, reported breakthrough clinical data for the detection of lymphoma, the most common cancer for the species. We believe this represents a significant commercial opportunity for Volition.
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It kills an estimated 11 million people a year, which is more than cancer or coronary disease. In 2017, there were an estimated 49 million cases worldwide, with over half of all cases occurring among children and accounting for 2.9 million deaths in children under five years old.
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Subject to the publication of this study in a peer reviewed journal, we expect to receive a $5 million contractual milestone payment, and we anticipate generating ongoing revenue from this development. 3 Table of Contents Nu.Q ® NETs Our Nu.Q ® NETs assay is a groundbreaking CE-marked diagnostic solution that clinicians can use to detect NETosis.
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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.
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Sepsis is the number one cause of death in hospitals worldwide.
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Many of our competitors have substantially greater financial, technical, and other resources and larger, more established marketing, sales and distribution systems than we have. Many of our competitors also offer broad product lines outside of the diagnostic testing market and have brand recognition.
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In 2021, there were an estimated 166 million sepsis cases worldwide which killed an estimated 21 million people that year, more than cancer or coronary disease., Moreover, even survivors of sepsis go on to have significant health problems with 33% mortality within one year, 40% of survivors being re-admitted to hospital within 90 days of discharge, and approximately 17% of survivors experiencing significant morbidity such as functional limitations.
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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.
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The Nu.Q ® NETs assay is the sole biomarker in “DETECSEPS”, a real-world evaluation of early detection of sepsis, funded by the French government. As of the end of our fiscal year 2025, our Nu.Q ® NETs assay is the only analytically validated assay to quantify the level of NETs.
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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.
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NETosis is implicated in a wide range of diseases – both chronic and acute conditions and studies have demonstrated that our biomarker-driven solution, Nu.Q ® NETs, may enable clinicians and researchers to anticipate disease, help guide treatment decisions, and monitor patients over time, across both acute and chronic conditions, advancing personalized care.
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In addition to biomarkers we have developed and commercialized a High Throughput Model that measures Neutrophil Extracellular Traps “NETs” activation and inhibition in whole blood in real time, helping companies develop new therapeutics to combat sepsis and other NETs-related disease. Nu.Q ® Cancer Our Nu.Q ® Cancer pillar encapsulates a range of simple, cost effective blood-based assays.
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As of the end of fiscal year 2025, a manuscript detailing our findings is undergoing peer review and is available to read on the preprint service: ResearchSquare. We believe this technology represents a significant advantage in pure liquid biopsy methodologies.
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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.
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There are several routes to market, including (1) licensing, (2) leveraging our existing CE-marked Nu.Q ® NETs test, and (3) rolling out the Nu.Q ® Lung cancer test: 1. Licensing We are partnering with established diagnostic companies and liquid biopsy companies to market, sell, and process our tests, leveraging their networks and expertise.
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In the human space we have agreements with Werfen, Hologic and Revvity. In the veterinary space, we have agreements with Antech, IDEXX and Fujifilm Vet Systems, as well as a number of country-specific distributors.
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Human In September 2025, we signed a Research License and Exclusive Commercial Option Rights Agreement for Antiphospholipid Syndrome, or APS, with Werfen, a global leader in the field of in specialized diagnostics for hemostasis, thrombosis and other NETs-related indications.
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Full terms of the agreement are confidential, but Werfen will gain access to the components of Volition’s proprietary Nu.Q ® H3.1 NETs assay and will investigate its clinical utility in the management of APS patients on its platforms. Werfen also has an option to negotiate terms with Volition for it to launch the product commercially under an exclusive license.
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Also in September 2025, Volition signed an agreement with Hologic Diagenode (NASDAQ: HOLX) (“Hologic”), for the co-marketing of Volition’s Nu.Q ® Discover service. Under the agreement, Hologic will co-market Nu.Q ® Discover services with Hologic customers for an initial one-year term.
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If successful, the aim is for Hologic to be appointed as an exclusive provider of those services, subject to further terms being agreed. The intention of this agreement is to expand customer access to our proprietary Nu.Q ® Discover assays.
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As of the 2025 fiscal year end the Nu.Q ® Vet Cancer Test is available in over twenty countries.
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In March 2025, we signed first ever Nu.Q ® Vet Cancer Test Automation Agreement with Fujifilm Vet Systems to include Volition’s ChLIA version of the test via the Immunodiagnostic Systems (“IDS”) i10 ® automated analyzer platform, for a new five year initial term.
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Fujifilm Vet Systems will be the first in the world to utilize this centralized lab automation for the Nu.Q ® Vet Cancer Test which will enable a more rapid turnaround and high throughput to meet increasing demands. 2.
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Leverage our existing CE-marked Nu.Q® NETs test The second prong of our strategy is to leverage our granted CE mark, which has been approved in the EU for any NETs related diseases. Our ChLIA version of the CE-marked Nu.Q ® NETs Test is via the IDS-i10TM automated analyzer platform from Immunodiagnostic Systems, a subsidiary of Revvity.
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Our aim is to sell this product, either directly or in conjunction with Immunodiagnostic Systems, to institutions for use in the very wide range of clinical applications where NETosis plays a critical role.
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In a significant commercial milestone, we recorded our first revenue from sales of our CE-Marked Nu.Q ® NETs automated product in Europe in the first quarter of 2025. This is the first revenue generated from a regulated clinically approved product.
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As of December 31 st 2025 we have 12 hospital clients evaluating our Nu.Q ® NETs test for a range of diseases. In collaboration with Revvity, we aim to submit a reimbursement application for the Nu.Q ® NETs test in 2026. 6 Table of Contents 3.
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Roll-out the Nu.Q® Lung Cancer test In the fourth quarter of 2025, we received our first order for the Nu.Q ® Cancer assays for clinical certification ahead of routine clinical use in lung cancer and in January 2026 were delighted to announce that preparation of the reimbursement submission is underway, actively supported by the Hospices Civils de Lyon (“HCL”), France’s second largest university hospital system and two other French institutions.
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Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q ® in the human cancer field. Once achieved, we anticipate the introduction into routine clinical use in France by the fourth quarter of 2026.
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Our vision and plan is for our tests to be used first by millions, then by tens, then hundreds of millions of people and animals a year, with our platform licensed to a range of large diagnostic and liquid biopsy companies (and governments) worldwide.
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Combining our technology with their installed base of laboratories, analyzer machines and sales forces around the world will achieve the optimal outcome for us – large companies have the resources to realize the opportunities better than Volition could on its own.
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We anticipate that because of the 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.
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We believe that the total addressable markets (“TAMs”) for our technologies, on an annualized basis, are considerable, multi-billion-dollar opportunities, for Volition and our licensing partners: · $2.3 billion Lung Cancer Screening & Management · $23 billion Multi-Cancer Early Detection / Liquid Biopsy · $2.8 billion Sepsis Early Detection & Management · $1 billion Broader NETosis (Trauma, Antiphospholipid Syndrome, Hidradenitis Suppurativa) · $128 million Canine and Feline Cancer Screening · $991 million Pharma Companion Diagnostic Our market size estimates are management’s estimates based on a combination of publicly available data and internal analyses as of the 2025 fiscal year end.
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These estimates are subject to uncertainty and may not be realized, and actual addressable markets will depend on clinical performance, regulatory clearances, adoption and reimbursement in each jurisdiction.
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Belgian Volition has maintained its ISO certification since 2015. 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.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf 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.
Biggest changeIf we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations. · The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors. · 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. · Servicing our existing and future debt, including the Lind Notes, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness. · 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 not only on our ability to successfully develop and commercialize diagnostic products but also the ability of our licensing partners.
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.
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) and focused on the veterinary space.
If we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. · Failure to successfully develop, manufacture, market, and sell our future products will have a material adverse effect on our business, financial condition, and results of operations. · 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. · 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. · If the third parties on which we increasingly rely to assist us with our current and anticipated pre-clinical development or clinical trials do not perform as expected, we may not be able to obtain regulatory clearance or approval or commercialize our products. · We expect to expand our product development, research and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. · We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage third party providers for such services, could have a material adverse effect on our business. · We rely on third parties to manufacture and supply our intended products.
If we/they fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. · Failure to successfully develop, manufacture, market, and sell our future products will have a material adverse effect on our business, financial condition, and results of operations. · 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. · 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. · If the third parties on which we increasingly rely to assist us with our current and anticipated pre-clinical development or clinical trials do not perform as expected, we may not be able to obtain regulatory clearance or approval or commercialize our products. · We expect to expand our product development, research and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. · We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage third party providers for such services, could have a material adverse effect on our business. · We rely on third parties to clinically validate, manufacture and supply our intended products.
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.
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 veterinary testing services in Japan.
Any product liability claim brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing insurance coverage in the future. 19 Table of Contents Risks Related to Governmental Regulation and Reimbursement Our failure to obtain necessary regulatory clearances or approvals on a timely basis would significantly impair our ability to distribute and market our future products on the clinical IVD market.
Any product liability claim brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing insurance coverage in the future. 20 Table of Contents Risks Related to Governmental Regulation and Reimbursement Our failure to obtain necessary regulatory clearances or approvals on a timely basis would significantly impair our ability to distribute and market our future products on the clinical IVD market.
We believe that 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. We rely on third parties to manufacture and supply our intended products.
We believe that 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. We rely on third parties to clinically validate manufacture and supply our intended products.
The delays associated with the verification of a new manufacturer could negatively affect our ability to develop products or receive approval of any products in a timely manner. 18 Table of Contents We depend on third-party distributors to market and sell our products, which will subject us to a number of risks.
The delays associated with the verification of a new manufacturer could negatively affect our ability to develop products or receive approval of any products in a timely manner. 19 Table of Contents We depend on third-party distributors to market and sell our products, which will subject us to a number of risks.
Our board of directors has the power, under our charter documents to: · issue additional shares of common stock without having to obtain stockholder approval for such action; · fill vacant directorships except for vacancies created by the removal of a director; · amend our bylaws without stockholder approval subject to certain exceptions; and · require compliance with an advance notice procedure with regard to business to be brought by a stockholder before an annual or special meeting of stockholders and with regard to the nomination by stockholders of candidates for election as directors.
Our board of directors has the power, under our corporate governance documents to: · issue additional shares of common stock without having to obtain stockholder approval for such action; · fill vacant directorships except for vacancies created by the removal of a director; · amend our bylaws without stockholder approval subject to certain exceptions; and · require compliance with an advance notice procedure with regard to business to be brought by a stockholder before an annual or special meeting of stockholders and with regard to the nomination by stockholders of candidates for election as directors.
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.
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 325,000,000 shares of common stock, par value $0.001 per share.
Before we are able to place our intended products in the clinical IVD markets in the United States, China and Europe, we will be required to obtain clearance or approval of our future products from the FDA and the CFDA with respect to the United States and China, respectively, and receive a CE mark with respect to Europe.
Before we are able to place our intended products in the clinical IVD markets in the United States, China and Europe, we will be required to obtain clearance or approval of our future products from the FDA and the NMPA with respect to the United States and China, respectively, and receive a CE mark with respect to Europe.
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.
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.
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.
Investors should consider our independent registered public accountant’s comments when deciding whether to invest in the Company. If we fail to regain compliance 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.
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.
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. It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
We are subject to regulation by the FDA in the United States, the CE in Europe, the CFDA in China, and other regulatory bodies in other countries where we intend to sell our future products.
We are subject to regulation by the FDA in the United States, the CE in Europe, the NMPA in China, and other regulatory bodies in other countries where we intend to sell our future products.
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. 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.
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. 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 regain compliance 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. · Lind has conversion rights under each of the Lind Notes, the exercise of which could result in the issuance of a substantial amount of our common stock at a significant discount to the trading price of our common stock. · 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.
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
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.
Additionally, for so long as we remain as a smaller reporting company, under current rules our accounting firm will not be required to provide an opinion regarding our internal controls over financial reporting. We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate.
Additionally, for so long as we remain as a smaller reporting company, under current rules our accounting firm will not be required to provide an opinion regarding our internal controls over financial reporting. 24 Table of Contents We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate.
Any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third-party providers for such services, could have a material adverse effect on our business. 17 Table of Contents Our products will require several dynamic and evolving sales models tailored to different worldwide markets, users and products.
Any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third-party providers for such services, could have a material adverse effect on our business. Our products will require several dynamic and evolving sales models tailored to different worldwide markets, users and products.
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.
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.
Performance or accuracy defects, incomplete or improper process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling of samples or test results (whether by us, patients, healthcare providers, courier delivery services, or others) can lead to adverse outcomes for patients and interruptions to our services.
We must maintain high service standards and other quality controls. Performance or accuracy defects, incomplete or improper process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling of samples or test results (whether by us, patients, healthcare providers, courier delivery services, or others) can lead to adverse outcomes for patients and interruptions to our services.
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.
Our patent portfolio includes 52 patent families (plus three in-licensed families) and a total 68 patents granted related to our diagnostic tests (including veterinary applications), with 13 patents granted in the United States, 17 patents granted in Europe and a further 38 patents granted worldwide. Additionally, we have 132 patent applications pending, worldwide.
However, our management has broad discretion to pursue other objectives. Our management might not apply our cash in ways that increase or permit any return 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.
Our management might not apply our cash in ways that increase or permit any return of your investment. 14 Table of Contents 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 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.
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 We have incurred significant losses, and we may never achieve profitability.
Our business is dependent on our ability to successfully develop and commercialize diagnostic products. If we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Our current business strategy focuses on discovering, developing and commercializing diagnostic products.
Our business is dependent not only on our ability to successfully develop and commercialize diagnostic products but also the ability of our licensing partners. If we/they fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Our current business strategy focuses on discovering, developing and commercializing diagnostic products.
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.
We are a clinical stage company and have incurred losses since our formation. As of December 31, 2025, we have an accumulated total deficit of approximately $252.9 million. As we continue the discovery and development of our future diagnostic products, we expect our expenses to increase significantly.
Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, unauthorized access, loss or disclosure could also disrupt our operations, including our ability to: · provide customer assistance services; · conduct research and development activities; · collect, process and prepare company financial information; · provide information about our tests and other patient and healthcare provider education and outreach efforts through our website; and · manage the administrative aspects of our business and damage to our reputation. 14 Table of Contents Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the U.S.
Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, unauthorized access, loss or disclosure could also disrupt our operations, including our ability to: · provide customer assistance services; · conduct research and development activities; · collect, process and prepare company financial information; · provide information about our tests and other patient and healthcare provider education and outreach efforts through our website; and · manage the administrative aspects of our business and damage to our reputation.
See Part II, Item 9A of this Report for a complete discussion of these material weaknesses in our internal control over financial reporting and remediation efforts.
We have determined that we have material weaknesses in our internal control over financial reporting as of December 31, 2025. See Part II, Item 9A of this Report for a complete discussion of these material weaknesses in our internal control over financial reporting and remediation efforts.
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.
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.
We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third party providers for such services, could have a material adverse effect on our business .
Any inability to manage growth could delay the execution of our business plan or disrupt our operations. 18 Table of Contents We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third party providers for such services, could have a material adverse effect on 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 potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition. 16 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.
Patients and healthcare providers rely on us to provide accurate clinical and diagnostic information that may be used to make critical healthcare decisions. Consequently, users of our tests may have a greater sensitivity to errors than users of some other types of products and services. We must maintain high service standards and other quality controls.
Inherent risks are involved in providing and marketing diagnostic and monitoring tests and related services. Patients and healthcare providers rely on us to provide accurate clinical and diagnostic information that may be used to make critical healthcare decisions. Consequently, users of our tests may have a greater sensitivity to errors than users of some other types of products and services.
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.
If any of these analysts ceases coverage of us, we could lose visibility in the market, which in turn could cause our common stock price or trading volume to decline and our common stock to be less liquid. 26 Table of Contents 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.
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.
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.
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.
In addition, due to technological changes that may affect our products or judicial interpretation of the scope of our patents, our products might not, now or in the future, be adequately covered by our patents. 22 Table of Contents 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 fail to obtain a required license and are unable to design around a patent, we may be unable to effectively market some or all of our products, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations. 21 Table of Contents 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.
If we fail to obtain a required license and are unable to design around a patent, we may be unable to effectively market some or all of our products, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.
For all the foregoing reasons, we may not be able to compete successfully against our competitors, which could jeopardize our ability to recoup research and development expenditures, hurt our reputation and harm our business, results of operations and financial condition. 13 Table of Contents 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 .
For all the foregoing reasons, we may not be able to compete successfully against our competitors, which could jeopardize our ability to recoup research and development expenditures, hurt our reputation and harm our business, results of operations and financial condition.
The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plan or disrupt our operations.
The expansion of our operations may lead to significant costs and may divert our management and business development resources.
Risks Related to Our Securities The market prices and trading volume of our stock may be volatile. The market price of our common stock is likely to be highly volatile and the trading volume may fluctuate and cause significant price variation to occur.
The market price of our common stock is likely to be highly volatile and the trading volume may fluctuate and cause significant price variation to occur. We cannot assure you that the market prices of our common stock will not fluctuate or decline significantly in the future.
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.
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. 17 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.
Moreover, others may independently develop equivalent proprietary information, and third parties may otherwise gain access to our trade secrets and proprietary knowledge. Any disclosure of confidential information into the public domain or to third parties could allow our competitors to learn our trade secrets and use the information in competition against us, which could adversely affect our competitive advantage.
Any disclosure of confidential information into the public domain or to third parties could allow our competitors to learn our trade secrets and use the information in competition against us, which could adversely affect our competitive advantage. 23 Table of Contents Risks Related to Our Securities The market prices and trading volume of our stock may be volatile.
Although we utilize a variety of measures to secure the data that we control, even compliant entities can experience security breaches or have inadvertent failures despite employing reasonable practices and safeguards. 20 Table of Contents We may also face new risks relating to data privacy and security as the United States, individual U.S. states or Canadian provinces, E.U. member states, and other international jurisdictions adopt or implement new data privacy and security laws and regulations as we continue to commercialize our products worldwide.
We may also face new risks relating to data privacy and security as the United States, individual U.S. states or Canadian provinces, E.U. member states, and other international jurisdictions adopt or implement new data privacy and security laws and regulations as we continue to commercialize our products worldwide.
If we are found to have violated laws concerning the privacy and security of patient health information or other personal information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business. There are a number of U.S. and international laws protecting the privacy and security of personal information.
If reimbursement is not available or is available only at limited amounts, we may not be able to successfully commercialize our future products. 21 Table of Contents If we are found to have violated laws concerning the privacy and security of patient health information or other personal information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
Failure to adequately protect and maintain the integrity of our information systems and data, including as a result of a security breach, may result in significant losses and have a material adverse effect on our financial position, results of operations and cash flows.
Failure to adequately protect and maintain the integrity of our information systems and data, including as a result of a security breach, may result in significant losses and have a material adverse effect on our financial position, results of operations and cash flows. 15 Table of Contents 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.
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.
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.
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. The diagnostics market is extremely competitive and characterized by rapidly evolving industry standards and new product enhancements.
Our failure to comply with these covenants could result in an event of default which, if not cured or waived, could result in the acceleration of our debt. 13 Table of Contents 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.
This limitation on liability may reduce the likelihood of derivative litigation against our officers and directors and may discourage or deter our stockholders from suing our officers and directors based upon breaches of their duties to our Company.
This limitation on liability may reduce the likelihood of derivative litigation against our officers and directors and may discourage or deter our stockholders from suing our officers and directors based upon breaches of their duties to our Company. 25 Table of Contents Our corporate governance documents, 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.
Our diagnostic tests are technologically innovative and require significant planning, design, development, and testing at the technological, product, and manufacturing process levels. These activities require significant capital commitments and investment. There can be no assurance that our intended products or proprietary technologies will remain competitive following the introduction of new products and technologies by competing companies within the industry.
The diagnostics market is extremely competitive and characterized by rapidly evolving industry standards and new product enhancements. Our diagnostic tests are technologically innovative and require significant planning, design, development, and testing at the technological, product, and manufacturing process levels. These activities require significant capital commitments and investment.
If we fall out of compliance with the NYSE American’s listing standards and fail to regain compliance within the applicable cure periods, our common stock may be delisted from the NYSE American.
If the NYSE American rejects the Plan, or accepts the Plan but we fail to regain compliance within the applicable cure periods, our common stock would be subject to delisting from the NYSE American.
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.
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. However, our management has broad discretion to pursue other objectives.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
If we experience an Event of Default under either of the Lind Notes, we may experience a material adverse effect on our liquidity, financial condition, and results of operations. Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
Reimbursement may impact the demand for, or the price of, our products. If reimbursement is not available or is available only at limited amounts, we may not be able to successfully commercialize our future products.
Reimbursement may impact the demand for, or the price of, our products.
Removed
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. Inherent risks are involved in providing and marketing diagnostic and monitoring tests and related services.
Added
Servicing our existing and future debt, including the Lind Notes, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness.
Removed
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition.
Added
On May 20, 2025, we issued a secured convertible note to Lind Global Asset Management XII LLC, a Delaware limited liability company (“Lind”), which has a principal amount of $7,500,000 (the “2025 Lind Note”) and an accompanying common stock purchase warrant.
Removed
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
On January 15, 2026, we issued an additional secured convertible note to Lind which has a principal amount of $2,400,000 (the “2026 Lind Note”) and an accompanying common stock purchase warrant. The 2025 Lind Note and the 2026 Lind Note are collectively referred to as the “Lind Notes”.
Removed
In addition, entities operating in the healthcare industry have increasingly become targets for hackers.
Added
Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, including the Lind Notes (which Notes permit us to elect to use shares of common stock for repayments in lieu of cash under certain circumstances), depends on our future performance, which is subject to economic, financial, competitive, and other factors beyond our control.
Removed
In addition, due to technological changes that may affect our products or judicial interpretation of the scope of our patents, our products might not, now or in the future, be adequately covered by our patents.
Added
We may not generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures.
Removed
We cannot assure you that the market prices of our common stock will not fluctuate or decline significantly in the future.
Added
If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt, or obtaining additional debt financing or equity capital on terms that may be onerous or highly dilutive.
Removed
Our corporate governance documents, 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.
Added
Our ability to refinance any future indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.
Removed
Future sales of our common stock could depress the market price of our common stock.
Added
In addition, the Amended and Restated Securities Purchase Agreement, dated January 7, 2026, by and between the Company and Lind (the “Lind Securities Purchase Agreement”), and the Lind Notes contain, and any of our future debt agreements may contain, restrictive covenants that may prohibit us from adopting any of these alternatives.
Removed
If any of these analysts ceases coverage of us, we could lose visibility in the market, which in turn could cause our common stock price or trading volume to decline and our common stock to be less liquid.
Added
There can be no assurance that our intended products or proprietary technologies will remain competitive following the introduction of new products and technologies by competing companies within the industry, including competitors’ use of artificial intelligence (“AI”). AI is increasingly being used across the diagnostics market, including by our competitors, which presents risks to our competitive position.
Added
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 . As of December 31, 2025, we had approximately $1.1 million in combined cash and cash equivalents compared to approximately $3.3 million as of December 31, 2024.
Added
Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the U.S.
Added
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
Failure to achieve any of the foregoing would have a material adverse effect on our business, financial condition, and results of operations.
Added
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
There are a number of U.S. and international laws protecting the privacy and security of personal information. These laws include the U.S.
Added
In addition, entities operating in the healthcare industry have increasingly become targets for hackers. Although we utilize a variety of measures to secure the data that we control, even compliant entities can experience security breaches or have inadvertent failures despite employing reasonable practices and safeguards.
Added
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
Moreover, others may independently develop equivalent proprietary information, and third parties may otherwise gain access to our trade secrets and proprietary knowledge.
Added
On February 6, 2026, we received a notice of non-compliance from the NYSE American stating that we are not in compliance with continued listing standards of Section 1003(a)(i), Section 1003(a)(ii), and Section 1003(a)(iii).
Added
To regain compliance, the Company submitted a plan (the “Plan”) advising of actions it has taken or will take to regain compliance with the continued listing standards by August 6, 2027.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWhile we do not believe that our business strategy, results of operations or financial condition have been materially adversely affected by any cybersecurity incidents, cybersecurity threats are pervasive and, similar to other global financial institutions, we, as well as our employees, customers, regulators, service providers, and other third parties have experienced a significant increase in information security and cybersecurity risk in recent years and will likely continue to be the target of cyber attacks.
Biggest changeWhile we do not believe that our business strategy, results of operations or financial condition have been materially adversely affected by any cybersecurity incidents, cybersecurity threats are pervasive and, similar to other international corporations, we, as well as our employees, customers, regulators, service providers, and other third parties have experienced a significant increase in information security and cybersecurity risk in recent years and will likely continue to be the target of cyber attacks.
Materials presented to our Audit Committee include updates on our data security posture, results from internal audit and third-party assessments, our incident response plan, and certain cybersecurity threat risks or incidents and developments, as well as the steps management has taken to respond to such risks. The committee also regularly engages with our Group IT Manager on technology risk-related topics.
Materials presented to our Audit Committee include updates on our data security posture, results from internal audit and third-party assessments, our incident response plan, and certain cybersecurity threat risks or incidents and developments, as well as the steps management has taken to respond to such risks. The committee also regularly engages with our Group IT Director on technology risk-related topics.
The Company’s policy is for the board and the Audit Committee to receive prompt and timely information regarding any cybersecurity risk (including any incident) that meets reporting thresholds, as well as ongoing updates regarding any such risk, in accordance with our data breach reporting procedure and GDPR. 25 Table of Contents
The Company’s policy is for the board and the Audit Committee to receive prompt and timely information regarding any cybersecurity risk (including any incident) that meets reporting thresholds, as well as ongoing updates regarding any such risk, in accordance with our data breach reporting procedure and GDPR. 28 Table of Contents

Item 2. Properties

Properties — owned and leased real estate

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Biggest change(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.
Biggest change(4) Volition America signed a new one-year lease for this property, commencing on April 1, 2026, located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014, at an annual rent of $20,925.
Square 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.
Square 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 2027 Henderson, Nevada (4) Administration 301 Leased, expiring 2027 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, 2024: Location Primary Function Approx.
ITEM 2. PROPERTIES Listed below are our current facilities as of December 31, 2025: Location Primary Function Approx.
(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.
(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, 2026 until January 31, 2027, at an annual rent of £71,400 GBP.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeHolders 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.
Biggest changeHolders As of March 26, 2026, there were 158,481,243 shares of our common stock outstanding held by 173 holders of record, based on information provided by our transfer agent.
Recent Sales of Unregistered Securities None. Repurchase of Equity Securities No equity securities were repurchased during the fourth quarter of 2024.
Recent Sales of Unregistered Securities None. Repurchase of Equity Securities No equity securities were repurchased during the fourth quarter of 2025.

Item 7. Management's Discussion & Analysis

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

28 edited+4 added−5 removed28 unchanged
Biggest changeIncrease 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.
Biggest changeIncrease Percentage Increase 2025 2024 (Decrease) (Decrease) $ $ $ % Service 450,805 228,138 222,667 98 % Product 1,276,579 1,005,373 271,206 27 % Total Revenues 1,727,384 1,233,511 493,873 40 % Research and development 10,081,299 14,406,486 (4,325,187 ) (30 %) General and administrative 9,463,581 8,487,562 976,019 11 % Sales and marketing 3,921,075 5,364,433 (1,443,358 ) (27 %) Total Operating Expenses 23,465,955 28,258,481 (4,792,526 ) (17 %) Grant income 516,515 103,368 413,147 >100 % Gain /(Loss) on disposal of fixed assets 1,829 (34,731 ) 36,560 %) Interest income 600 9,947 (9,347 ) (94 %) Interest expense (532,192 ) (340,362 ) (191,830 ) 56 % Amortization of debt discount (1,957,147 ) - (1,957,147 ) %) Gain on change in fair value of warrant liability 76,908 28,763 48,145 >100 % Gain on change in fair value of derivative liability 128,729 - 128,729 >100 % Total Other Income (Expenses) (1,764,758 ) (233,015 ) (1,531,743 ) %) Net Loss (23,503,329 ) (27,257,985 ) (3,754,656 ) (14 %) Revenues Our operations are transitioning from a research and development stage to a commercialization stage.
Management plans to address the above as needed by: (a) securing additional grant funds; (b) obtaining additional financing through debt or equity transactions; (c) granting licenses to third parties in exchange for specified up-front and/or back-end payments; and (d) developing and commercializing our products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.
Management plans to address the above as needed by: (a) obtaining additional financing through debt or equity transactions; (b) securing additional grant funding; (c) granting licenses to third parties in exchange for specified up-front and/or back-end payments; and (d) developing and commercializing our products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.
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.
This discussion includes an analysis of our financial condition and results of operations for the years ended December 31, 2025 and 2024 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 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.
We now have a team of over 75 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.
If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business. Critical Accounting Policies and Estimates Our consolidated financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), applied on a consistent basis.
If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business. 35 Table of Contents Critical Accounting Policies and Estimates Our consolidated financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), applied on a consistent basis.
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.
Net cash used in investing activities was $0.1 million and $0.6 million for the years ended December 31, 2025 and December 31, 2024, respectively. The decrease in cash used in investing activities during 2025 was primarily due to reduced purchases of laboratory equipment as compared to 2024.
We base our estimates and assumptions on current facts, historical experiences, information from third-party professionals and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources.
We base our estimates and assumptions on current facts, historical experiences, information from third-party professionals and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources.
We do not have any substantial source of revenues and expect to rely on additional future financing, through the sale of licensing or distribution rights, grant funding and the sale of equity or debt securities to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.
We do not currently have sufficient revenues and expect to rely on additional future financing, through the sale of licensing or distribution rights, grant funding and the sale of equity or debt securities to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.
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.
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 with a particular focus on lung cancer. · Capture-Seq™ / Capture-PCR™ - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.
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.
If we are unable to obtain adequate capital, we could be forced to cease operations. 31 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, 2025, we had cash and cash equivalents of approximately $1.1 million.
Net 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.
This compares with $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.
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.
Net Loss For the year ended December 31, 2025, the Company’s net loss was $23.5 million, a decrease of approximately $3.8 million, in comparison to a net loss of $27.3 million for the year ended December 31, 2024. The change was a result of the factors described above.
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.
Net cash provided by financing activities after associated costs was $17.1 million and $8.7 million for the years ended December 31, 2025 and December 31, 2024, 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.
Net cash used in operating activities was $19.7 million and $25.9 million for the years ended December 31, 2025 and December 31, 2024, respectively.
We have determined that for the periods reported in this Report the following accounting policies are critical in understanding our financial condition and results of operations: 32 Table of Contents Stock-Based Compensation The Company records stock-based compensation in accordance with ASC 718, “ Compensation – Stock Compensation”.
A complete summary of these policies is included in the Notes to our consolidated financial statements. We have determined that for the periods reported in this Report the following accounting policies are critical in understanding our financial condition and results of operations: Stock-Based Compensation The Company records stock-based compensation in accordance with ASC 718, “ Compensation – Stock 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 general and administrative expenditures during 2025 was primarily due to stock-based compensation, legal and professional fees and higher personnel expenses and partially offset by lower general and administrative expenses.
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.
Revenue for the year ended December 31, 2025 was $1.7 million compared with $1.2 million for the year ended December 31, 2024. The main source of revenues during the years ended December 31, 2025 and December 31, 2024, was product sales primarily of the Nu.Q® Vet Cancer Test and Nu.Q Discover kits.
These sales may include the sale of equity securities from time to time through our “at the market facility” with Jefferies LLC under an equity distribution agreement dated May 20, 2022 (see Note 7, Common Stock – Equity Distribution Agreements, of the Notes to consolidated financial statements).
These sales may include the sale of equity securities from time to time through our “at the market facility” with JonesTrading Institutional Services, LLC under a Capital On Demand™ Sales Agreement dated April 22, 2025 (see Note 7, Common Stock – “At the Market” Offerings of the Notes to consolidated financial statements).
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.
Services revenue related solely to Nu.Q ® Discover services. 33 Table of Contents Operating Expenses Total operating expenses decreased to $23.5 million from $28.3 million for the years ended December 31, 2025 and December 31, 2024, respectively, as a result of the factors described below.
The decrease in overall sales and marketing expenditures was primarily due to decreased personnel expenses and lower stock-based compensation.
The decrease in overall sales and marketing expenditures was primarily due to reduced personnel expenses and direct marketing and professional fees during the year.
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.
The FTE personnel number within this division decreased by three to eleven during 2025 compared to the prior year period. 2025 2024 Change $ $ $ Personnel expenses 2,859,964 4,104,101 (1,244,137 ) Stock-based compensation 312,617 289,069 23,548 Other Sales & Marketing expenses 717,972 922,602 (204,630 ) Depreciation and amortization 30,522 48,661 (18,139 ) Total sales and marketing expenses 3,921,075 5,364,433 (1,443,358 ) 34 Table of Contents Other Income (Expenses) For the year ended December 31, 2025, other expenses increased to approximately $1.8 million compared to other expenses of approximately $0.2 million for the year ended December 31, 2024.
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).
We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2025, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.
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.
The FTE personnel number within this division decreased by two to seventeen during 2025 compared to the prior year period. 2025 2024 Change $ $ $ Personnel expenses 4,509,900 4,220,539 289,361 Stock-based compensation 1,292,807 746,459 546,348 Legal and professional fees 2,398,904 1,909,076 489,828 Other general and administrative 1,109,447 1,447,719 (338,272 ) Depreciation and amortization 152,523 163,769 (11,246 ) Total general and administrative expenses 9,463,581 8,487,562 976,019 Sales and Marketing Expenses Sales and marketing expenses decreased to $3.9 million from $5.4 million for the years ended December 31, 2025 and December 31, 2024, respectively.
The decrease in overall research and development expenditures during 2024 was primarily related to decreased clinical research costs and lower personnel expenses.
The decrease in overall research and development expenditures during 2025 was primarily related to lower research expenses and a reduction in personnel expenses as a result of reduced clinical trial activity following completion of certain clinical studies.
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.
FTE personnel numbers within this division decreased by five to forty-seven during 2025 compared to the prior year period. 2025 2024 Change $ $ $ Personnel expenses 5,957,453 7,463,938 (1,506,485 ) Stock based compensation 134,286 233,014 (98,728 ) Direct research and development expenses 2,177,834 4,397,828 (2,219,994 ) Other research and development 777,263 1,221,903 (444,640 ) Depreciation and amortization 1,034,463 1,089,803 (55,340 ) Total research and development expenses 10,081,299 14,406,486 (4,325,187 ) General and Administrative Expenses General and administrative expenses increased to $9.5 million from $8.5 million for the years ended December 31, 2025 and December 31, 2024, respectively.
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.
This increase in other expenses was primarily due to amortization of debt discount of $2.0 million related to the Lind note and $0.5 million of interest expenses partially offset by increased grant income received of approximately $0.5 million during 2025 compared to $0.1 million in 2024, together with gains in the fair value of derivative and warrant liabilities, during 2025.
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.
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 following table summarizes our approximate contractual payments due by year as of December 31, 2025.
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.
The decrease in cash used in operating activities during 2025 when compared to 2024 was primarily due lower personnel costs of $2.4 million, lower research and development expenses of $2.7 million together with an increase in accounts payable of $1.1 million during the period.
Removed
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.
Added
Net cash provided by financing activities in 2025 consisted of (i) $6.3 million in cash, before deducting commitment and legal fees of $0.3 million, received in exchange for the issuance of a senior secured convertible note and warrants in May 2025, (ii) $2.3 million in cash, before deducting offering expenses of $0.1 million, received from the issuance and sale of common stock and warrants in a registered direct offering that closed in March 2025, (iii) $0.3 million in net proceeds received from the issuance and sale of 448,706 shares of common stock under our “at-the-market” facility with Jefferies LLC (“Jefferies”) acting as exclusive placement agent, which facility terminated effective April 20, 2025, (iv) $1.7 million in net proceeds received from the issuance and sale of 4,364,087 shares of common stock under our 2025 ATM Sales Agreement during the year ended December 31, 2025, (v) $1.2 million in cash, before deducting offering expenses of $0.1 million, received from the issuance and sale of common stock and warrants in a registered direct offering that closed in August 2025, (vi) $0.3 million in cash, received from the issuance and sale of common stock and warrants in a private placement that closed in September 2025 and (vii) $6.0 million in net proceeds received from the issuance and sale of common stock and warrants in an underwritten public offering with Newbridge.
Removed
The following table summarizes our approximate contractual payments due by year as of December 31, 2024.
Added
Approximate Payments (Including Interest) Due by Year Total 2026 2027 - 2030 Greater than 5 years Description $ $ $ $ Financing lease liabilities 402,344 63,116 252,460 86,768 Operating lease liabilities and short-term lease 561,012 274,159 286,853 - Grants repayable 590,745 117,093 339,402 134,250 Long-term debt 7,998,134 1,602,982 6,339,584 55,568 Collaborative agreements obligations 1,248,176 1,248,176 - - Convertible Note 6,666,666 5,000,000 1,666,666 - Total 17,467,077 8,305,526 8,884,965 276,586 32 Table of Contents We intend to use our cash reserves to predominantly fund product development, and commercialization activities.
Removed
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.
Added
Results of Operations Comparison of the Years Ended December 31, 2025 and December 31, 2024 The following table sets forth our results of operations for the years ended on December 31, 2025, and December 31, 2024, respectively (expressed in United Stated Dollars, except outstanding share numbers and percentages).
Removed
We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities.
Added
Research and Development Expenses Research and development expenses decreased to $10.1 million from $14.4 million for the years ended December 31, 2025 and December 31, 2024, respectively.
Removed
A complete summary of these policies is included in the Notes to our consolidated financial statements.

Other VNRX 10-K year-over-year comparisons