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Item 1. Business

2026-03-31 compared with 2025-03-31 · 77 added, 34 removed, 164 unchanged (40% of the section changed)

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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.

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.

The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built 17,000 square foot lab and 10,000 square foot production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London and Nevada.

We now have a team of over 80 dedicated employees, spanning a wide range of disciplines;

all united in our mission to improve outcomes for patients.

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.

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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 tests are platform agnostic and can be adapted to any workflow setting – manual, automated reference laboratory and point-of-care.

We believe that our focus on innovation and robust assay development, as well as our diverse intellectual property portfolio, positions us to become a signiﬁcant player in this cutting-edge ﬁeld of science.

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Modern genetics – the study of genes and heredity – is underpinned by the linear sequences of molecular “letters” present in the DNA double helix of each living cell, many of which encode the genes.

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.

However, there’s more to chromosomes than just the DNA sequence;

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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).

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).

Our test can be easily integrated into preventive care programs and used alongside other routine bloodwork during regular wellness visits.

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Our test is also available in Japan through Fujifilm Vet Systems Co.

Ltd, a leading provider of veterinary testing services in Japan and through other regional and national distributors such as Vita Genomics, DNA Tech, Nationwide Laboratories, The Veterinary Pathology Group etc.

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.

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.

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,

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.

Use of Capture-Seq ™ in canines.

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.

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.

Our Nu.Q ® NETs assay is a groundbreaking CE-marked diagnostic solution that clinicians can use to detect NETosis.

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Sepsis is the number one cause of death in hospitals worldwide.

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.

Just under half of all survivors are left with psychological and/or physical effects.

Sepsis, also known as ‘blood poisoning’, is hard to identify.

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.

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 7.6% for every hour of treatment delay.

Risk of death increases by approximately 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.

Our Nu.Q ® NETs assay is the only analytically validated assay to quantify the level of NETs.

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.

It is platform agnostic so it can be adapted to any workflow/clinical setting – including central lab and point of care.

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.

We are preparing to submit an IVDR application in 2026 for CE marking in Europe.

Nu.Q ® Discover

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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.

Our biomarkers support the entire drug discovery and development process from pre-clinical testing to market-readiness.

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.

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.

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.

Cancer is a devastating disease that touches many peoples’ lives, accounting for approximately 10 million deaths worldwide each year.

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.

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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”).

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”).

Either quantitative real-time PCR (“qPCR”) testing or Sequencing (“Seq”) is then undertaken to establish whether cancer is present.

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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.

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.

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.

Manufacturing Capabilities and Strategy

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Commercializing our products via global players and in fragmented markets through regional companies.

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.

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:

We are partnering with established diagnostic companies and liquid biopsy companies to market, sell, and process our tests, leveraging their networks and expertise.

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.

We 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.

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).

To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska, now an Antech Company.

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.

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.

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.

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.

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.

On March 28, 2022, Volition entered into a master license and product supply agreement with Heska, now an Antech Company.

In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q ® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing, received $13.0 million based upon the achievement of two milestones and is eligible to receive up to an additional $5.0 million based upon the achievement of a final milestone upon the earlier of the first commercial sale by or on behalf of Heska of a screening or monitoring test for lymphoma in felines, or the nine-month anniversary of the first peer reviewed paper evidencing clinical utility for the screening or monitoring of lymphoma in felines being published in any one of a number of periodicals identified by the parties.

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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.

In July 2024, we launched the Nu.Q® Vet Cancer Test in Japan with Fujifilm Vet Systems.

As of the 2025 fiscal year end the Nu.Q ® Vet Cancer Test is available in over twenty countries.

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.

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.

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.

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.

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.

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.

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.

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.

Our Market Opportunity

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Given the wide-ranging nature of our products in development we believe that our market opportunity is large.

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.

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.

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.

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.

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.

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.

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.

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.

There may also be other companies developing products competitive with ours of which we are unaware.

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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).

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 diagnostic products fall within the IVD medical device category and are subject to FDA clearance or approval in the United States.

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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.

A similar system operates in China through the NMPA.

In Europe, IVD medical devices are regulated by the European In Vitro Diagnostic Regulation 2017/746 (“EU IVDR”) which brings almost all IVDs under the direct review and control of designated assessment organizations (“Notified Bodies”), and the performance evaluation of IVDs, which requires extensive clinical and analytical performance studies in addition to a demonstration of scientific validity.

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We have used this position to build a growing, broad and strong patent portfolio covering the ability to profile the epigenetic environment surrounding circulating chromosome fragments from diseased cells, including the epigenetic signaling status of nucleosomes, DNA, and other epigenetic chromatin proteins.

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.

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.

We intend to continue our development of the Nucleosomics™ technologies and will continue to apply for patents for future product developments.

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.

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We continually assess employee turnover, recruitment initiatives, compensation and benefits programs, safety in performing critical laboratory work, diversity and other matters relevant to human capital management, and we review results with our board of directors on a periodic basis.

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 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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business