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Item 1. Business

2024-03-25 compared with 2023-03-15 · 115 added, 130 removed, 86 unchanged (74% of the section changed)

Volition is a multi-national epigenetics company powered by Nu.Q ® , its proprietary nucleosome quantification platform.

Through its subsidiaries, Volition is developing simple, easy to use, cost effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19.

Imagine a world where diseases like cancer and sepsis can be diagnosed early and monitored easily using routine blood tests.

That’s the world Volition is trying to build by developing its innovative family of simple, easy to use, cost-effective blood tests.

Volition is a multi-national epigenetics company.

It has patented technologies that use chromosomal structures, such as nucleosomes, and transcription factors as biomarkers in cancer and other diseases.

The tests in the Company’s product portfolio detect certain characteristic changes that occur from the earliest stages of disease, enabling early detection and offering a better way to monitor disease progression and a patient’s response to treatment.

The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis and COVID-19.

Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.

The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

We have five key pillars of focus, all of which use the same proprietary Nu.Q ® platform to commercialize in different areas:

Nu.Q ® Vet - cost-effective, easy-to-use cancer screening blood test for dogs and other animals.

We have several key pillars of focus:

Nu.Q ® Vet - cost-effective, easy-to-use blood tests for dogs and other companion animals.

The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs.

Nu.Q ® NETs - monitoring the immune system to save lives.

Nu.Q ® Cancer - detecting cancer early to save lives.

Nu.Q ® Capture - capturing and concentrating samples for more accurate diagnosis.

Nu.Q ® Discover - a complete solution to profiling nucleosomes.

Our product development and manufacturing activities are centered in Belgium, with innovation and U.S.

operations in California, and additional offices in Nevada, London, and Singapore, where we focus on bringing our diagnostic and disease monitoring products to market.

Nu.Q ® Cancer - monitoring disease progression, response to treatment and Minimal Residual Disease (“MRD”).

Capture-PCR TM - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.

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

In 2015, the Company’s common stock was listed on the New York Stock Exchange (VNRX).

We now have a team of over 100 dedicated employees, spanning a wide range of disciplines;

all united in our mission to improve outcomes for patients.

Cultivating successful, ongoing relationships with stakeholders worldwide has been fundamental to Volition’s development.

We have fostered ties with leading academic institutions, clinical centers of excellence, multi-national pharmaceutical companies and financial institutions across the globe.

Volition’s Solution and the Science Behind It

We are dedicated to revolutionizing the diagnosis and monitoring of life-altering diseases by advancing the science of epigenetics.

Imagine a world where diseases like cancer and sepsis can be diagnosed early and monitored easily using routine blood tests.

That’s the world we’re trying to build by developing our innovative family of simple, easy to use, cost-effective Nu.Q ® tests.

Our patented Nucleosomics™ technology uses chromosomal structures called nucleosomes as biomarkers in cancer and other diseases:

as explained below, chromosomes consist of the genetic material (DNA) wrapped in a coat of proteins and other molecules.

All the tests in our portfolio detect various characteristic changes in nucleosomes that occur from the earliest stages of disease, potentially enabling early detection and a better way to monitor disease progression and the patient’s response to treatment.

Our team has worked tirelessly for more than a decade to evolve and master our understanding of the rich, complex information encoded in circulating chromatin and in particular, in circulating nucleosomes and transcription factors.

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

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.

Unlocking Epigenetics

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The cells of most bodily organs are continuously replaced by new ones.

As they die, many old cells release their nucleosomes into the bloodstream.

Our patented Nucleosomics™ technology isolates these circulating nucleosomes from the blood for quantification and analysis.

Chromosome and nucleosome structure represent a major mechanism for epigenetic control.

Epigenetic changes can be detected before the diseased cells themselves become abnormal enough to show up in traditional biopsies, and oftentimes before the ﬁrst symptoms are felt.

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.

We have two technologies:

Nucleosome Quantification (“Nu.Q ® ”)

Capture-PCR TM

Chromosome, nucleosome and transcription factor structures represent a major mechanism for epigenetic control.

Each chromosome contains one long, single molecule of DNA that is coated by a complex array of proteins, mostly in the form of nucleosomes, giving the stretched-out, unwound DNA/protein core, or chromatin, the appearance of “beads on a string.” Unwound chromatin is accessible for reading (or transcribing) and unwound genes may be active.

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This regulation is achieved through reversible chemical changes to both the DNA and protein components, as well as through the binding of specific regulatory proteins to the DNA.

Volition’s Epigenetic Approach

Through our Nu.Q ® (short for nucleosome quantification) family of tests in our five key pillars of focus, we aim to offer a new, convenient and cost-effective approach to the detection, diagnosis and monitoring of diverse diseases from a simple blood test.

Highlighting abnormalities

Our technology seeks to detect characteristic epigenetic changes in nucleosomes that occur from the earliest stages of cancer and other diseases.

Epigenetic changes often occur before the diseased cells themselves become abnormal enough to show up in traditional biopsies, and oftentimes before the first symptoms are felt.

We aim to replace unpleasant, invasive, and often expensive screening and diagnostic tests such as colonoscopies and biopsies with Nu.Q ® blood tests, helping to save lives and to reduce overall healthcare costs.

We have five key pillars of focus:

Nu.Q ® Vet, Nu.Q ® NETs, Nu.Q ® Cancer, Nu.Q ® Capture and Nu.Q ® Discover, all of which use the same proprietary Nu.Q ® platform to commercialize in different areas.

Cancer is the most common cause of death in dogs over the age of two years in the United States.

Nearly 50% of all dogs over the age of 10 will develop cancer in their lifetime.

With approximately 84 million pet dogs in the United States, there are an estimated six million pet dogs diagnosed with cancer each year.

As with humans, earlier detection can save lives and can also improve the quality of life of the dog and its owner.

Our patented Nucleosomics™ technology isolates circulating nucleosomes from the blood for quantiﬁcation and analysis, to enable earlier diagnosis and monitoring of life-altering diseases.

Nu.Q ® Product Overview

Nu.Q ® Vet Cancer Test

Cancer is the most common cause of death in dogs over the age of 2 years in the US, and it is estimated that up to 50% of all dogs over the age of 10 will develop cancer in their lifetimes.

There are an estimated 6 million pet dogs diagnosed with cancer each year.

Earlier cancer detection can improve outcomes, including the quality of life of the dog and its owner.

Yet, as of today, there are few single assay cancer blood tests on the veterinary market.

Currently, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming, and painful for the animal.

Currently, dogs are usually diagnosed when they are unwell or there is a suspicion of cancer.

Even then, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming, and painful for the animal.

We hope to change this with the introduction of the Nu.Q ® Vet Cancer Test.

a simple, cost-effective, easy to use enzyme-linked immunosorbent assay (“ELISA”) based screening blood test which may help streamline the diagnostic process for older or “at-risk” dogs.

For example, findings from a clinical study conducted by Volition and Professor Wilson-Robles and the team at Texas A&M University, peer-reviewed and published in August 2022, reflect that Volition’s Nu.Q ® Vet Cancer Test detected 76% of systemic cancers ( including lymphoma, hemangiosarcoma, and histiocytic sarcoma) at 97% specificity versus control.

Data presented at the European Society of Veterinary Oncology Congress suggests that Nu.Q ® Vet may also serve as a more sensitive measurement of both minimal residual disease and remission and could be a useful monitoring test for dogs with cancer.

We are currently conducting ongoing research regarding Nu.Q ® Vet as follows:

Point of Care platform (in partnership with the Heska Corporation),

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).

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

The Nu.Q ® Vet Cancer Test is available to veterinarians in the United States, Europe, and Asia through our distributors, which include IDEXX Laboratories, Inc.

(“IDEXX”), a global leader in pet healthcare innovation, and Heska Corporation (“Heska”), a leading global provider of advanced veterinary diagnostics, and now part of Mars Petcare, one of the largest pet health companies in the world.

Transfer of the Nu.Q ® Vet Cancer Test onto Heska’s in-house diagnostic platform (the element i+) was completed in 2023.

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, and

Use of the Nu.Q ® platform in NETosis in canines.

Nu.Q ® NETs - Monitoring the immune system to save lives.

The immune system can be both friend and foe;

a potent protective force that sometimes overreacts, damaging the body’s own cells and tissues in the process.

We are working to develop tests that will identify people at high risk of poor outcomes/death caused by an immune system overreaction to sepsis, COVID-19 and other infections.

The immune system is comprised of many different types of white blood cells with different functions.

The most abundant of these white blood cells are neutrophils, which serve as a first line of defense.

When neutrophils detect bacteria, viruses, injuries, or other threats, these cells produce Neutrophil Extracellular Traps (“NETs”), which are sticky webs made of long strings of nucleosomes that work to inhibit a perceived threat from spreading through the body.

Although NETs are an important part of the body’s response to infection, the presence of too many of them in the blood can tip the immune system’s delicate balance between reaction and overreaction.

Elevated levels of NETs are a complicating factor associated with poor patient outcomes in a range of infectious and non-infectious diseases.

Sepsis—widespread tissue and organ damage triggered by an abnormal immune response to an infection—is an area of particular focus for our research on NETs.

A recent global study estimated that there were approximately 49 million cases and 11 million sepsis-related deaths worldwide in 2017, accounting for approximately 20% of all deaths from the same year.

Severe cases of COVID-19 can cause excessive production of NETs in the lungs, which can lead to severe lung impairment or death.

Because NETs contain nucleosomes, our proprietary Nu.Q ® nucleosome assays have been shown to detect NETs.

Using our Nu.Q ® nucleosome assays could enable the stratification of patients with a high level of NETs, allow physicians to rapidly triage these patients, and monitor their disease progression and response to treatment.

In May 2022, our Nu.Q ® NETs product was CE marked for the detection and evaluation of NETosis on two platforms (ELISA plates and i-10), enabling clinical use in more than 27 countries across Europe.

In August 2022, we appointed Diagnostic Oncology CRO, LLC (“DXOCRO”), a contract research organization specializing in the commercialization of diagnostic biomarker technologies, to spearhead our clinical product development and regulatory programs in the United States.

DXOCRO is undertaking large-scale finding studies across multiple sites using our Nu.Q® platform to determine clinical utility in sepsis and cancer.

We hope the study will support an application to the FDA’s Breakthrough Device program.

The first phase of the study focused on sepsis has been completed and an application to the FDA’s Breakthrough Device Program is expected to be submitted in the first half of 2023.

Nu.Q ® Cancer - Detecting cancer early to save lives.

We are developing a simple, cost-effective blood test for cancer.

Pre-analytics for the use of Nu.Q ® Vet in the feline population,

Use of the Nu.Q ® platform in NETosis in canines, and

Use of Capture-PCR TM in canines.

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.

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.

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.

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.

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.

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

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.

Nu.Q ® Discover is a valuable research tool for R&D professionals working within the field of Pharmacoepigenetics, and studying the epigenetic basis for variation in response to drugs and can help to answer clinical questions, such as measuring treatment eﬃcacy, or on-target and oﬀ-target eﬀects in drug development.

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.

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.

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

Early diagnosis is the best way to improve someone’s chances of surviving cancer;

however, current population-wide screening tests (such as mammograms and colonoscopies) are often invasive and unpleasant.

They can also be expensive, causing many people to miss routine screening.

There are no population screening tests at all for some types of cancer, including aggressive forms of the disease such as ovarian or pancreatic cancers.

Unfortunately, many patients are therefore diagnosed too late, when their cancer has already spread, and treatment is more difficult.

We believe that Nu.Q ® Cancer can become a cost-effective routine blood test for multiple types of cancer, allowing doctors to check off an extra box along with other routine blood tests like cholesterol during an annual wellness visit.

Nu.Q ® Cancer tests have further potential applications in clinical oncology beyond cancer detection.

Being able to use epigenetic information from tumor cells’ nucleosomes could also help physicians select the best treatment for each patient, monitor their response and the disease progression.

We are currently investigating the potential use of Nu.Q ® Cancer tests in a range of cancers and clinical settings.

Nu.Q ® Capture - Capturing and concentrating samples for more accurate diagnosis - Locating the needle in a haystack.

Human blood is a mixture of many different cell types floating in a complex soup of proteins and other molecules, including nucleosomes released by cells from all around the body.

Detecting a handful of cancerous or other abnormal cells in a patient’s blood sample has historically been like finding a proverbial needle in a haystack.

Volition’s Nu.Q ® Capture program has several strands of technology which either essentially removes background noise, thereby amplifying the signal or looks to identify the signal in a novel way.

This sample enrichment tool removes healthy nucleosomes, leaving an enriched sample of abnormal nucleosomes behind for further analysis.

These nucleosomes contain tumor-specific DNA “typos,” epigenetic changes, and other biomarkers that when analyzed could potentially be used to diagnose a specific type of cancer or other medical condition, guide treatment selection, and monitor disease and treatment progress.

Other strands of Nu.Q ® Capture technology involve isolating various chromatin fragments including nucleosomes and transcription factors from plasma for analysis by mass spectrometry and next-generation DNA sequencing.

Deploying Nu.Q ® Capture as the first blood sample processing step could potentially:

Enhance the sensitivity of subsequent Nu.Q ® immunoassays for diagnosing and monitoring different types of disease using our proprietary Nucleosomics™ platform,

Aid the development of improved diagnostic DNA sequencing methods,

Serve as a quality control tool to reduce the rate of clinical test failure, saving time that is especially valuable for people whose test results are being used to inform their treatment,

Aid the discovery of new biomarkers, and

Allow the complete profiling of nucleosomes.

The use of Nu.Q ® Capture technology in the field of transcription factors has led to the successful isolation of tumor derived transcription factor-DNA complexes from blood samples obtained from cancer patients.

As transcription factor binding to DNA is cancer and tissue specific, this technology may, in principle, provide the basis for blood tests for cancer in general as well as blood tests to identify the organ or tissue affected by cancer.

Development is ongoing.

Another novel method utilizing Nu.Q ® Capture and mass spectrometry was published in 2021 and demonstrated the detection and quantification of histone modifications present in the circulating nucleosomes in the blood of cancer patients.

We believe that our work has highlighted for the first time that histone H2A1R3 citrulline is, in plasma, upregulated in colorectal cancer patients and so could be a biomarker we target for future Nu.Q ® immunoassay development.

Furthermore, the use of Nu.Q ® Capture may open up the possibility of using mass spectrometry not only for biomarker discovery as demonstrated in this publication but also as a high throughput platform for screening and/or diagnostics when used in combination with either sequencing and/or our Nu.Q ® assays.

This technology sheds new light on epigenetic changes that cannot be effectively detected amid the noise left behind when using current testing methods, leading to better clinical tests and potentially improved outcomes in the future.

Volition is engaged in multiple research collaborations with academic laboratories working at the cutting edge of their respective fields, to ensure we take advantage of the latest findings and turn them into new clinical tools as quickly as possible.

Nu.Q ® Discover - A complete solution to profiling nucleosomes.

Nu.Q ® Discover empowers drug developers and scientists through access to a range of state-of-the-art assays for rapid epigenetic profiling in disease, model development, preclinical testing, and clinical studies - from discovery to market ready.

Identify potential drug targets by measuring levels of specific histone modifications

Screen and identify lead compounds that modulate the levels of specific histone modifications

Monitor changes in histone modification levels to assess the efficacy and Mechanism of Action (MoA) of compounds

Monitor target engagement to determine the pharmaco-dynamics (PD) of drugs in patients

Support regulatory submissions and help demonstrate drug safety and efficacy

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.

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.

Being able to use epigenetic information from the nucleosomes of tumor cells could help physicians:

Predict treatment response for each patient,

Monitor treatment response and disease progression, and

Promptly amend a patient’s cancer treatment regimen to achieve a better outcome.

Nu.Q ® Cancer could also play a pivotal role in MRD monitoring.

The concept of MRD refers to the proportion of remaining cancer cells among otherwise normal bone marrow or, more rarely, among circulating blood cells after any given treatment of blood cancer.

MRD monitoring has proven to be an independent prognostic factor and an important instrument for therapeutic decisions.

Capture-PCR TM

Based on over a decade of work on the chemistry of circulating chromatin fragments, we have also developed a transformational wet chemistry pathway that identifies and physically isolates chromatin fragments that we know are tumor-derived from background DNA of the same sequence, using Chromatin Immunoprecipitation (“ChIP”).

Quantitative real-time PCR (“qPCR”) testing is undertaken to establish whether cancer is present.

This breakthrough method obviates expensive, time-consuming DNA sequencing and bioinformatics - allowing for rapid, cost-effective detection in a routine blood test.

It may also be suitable for automation, enabling application in hospital laboratories.

In early-stage cancer, it is difficult to detect cancer-derived circulating tumor DNA (“ctDNA”) in the blood because it may comprise only 0.01% of the DNA present among a background of 99.99% normal DNA.

Moreover, most of the cancer DNA has exactly the same sequence as normal DNA.

Current ctDNA detection methods involve DNA extraction, sequencing of all (cancer and normal) circulating DNA and analysis of the sequencing data using sophisticated computer bioinformatics to tell them apart.

Our patented Capture-PCR TM is a novel method for liquid biopsy involving the first reported physical isolation of a class of tumor-derived ctDNA fragments from blood.

Cancer-derived ctDNA fragments are then extracted after removal of all normal background DNA of the same sequence for detection with a simple, low-cost PCR test.

Manufacturing Capabilities and Strategy

Our Silver One site in Belgium offers cutting edge, purpose-built manufacturing and processing facilities.

Our manufacturing facility in Belgium, known as Silver One, offers cutting edge, purpose-built manufacturing and processing facilities.

We are currently focusing on manufacturing our key components such as the antibodies and positive controls at Silver One, as well as ELISA kits.

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Are accessible worldwide.

We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, Nu.Q ® could potentially be used throughout the world.

We aim to remain an IP powerhouse in the Nucleosomics™ 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).

To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”), a leading global provider of advanced veterinary diagnostics.

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 and is eligible to receive up to an additional $18.0 million based upon the achievement of certain near and mid-term milestones.

The principles above inform our overall commercialization strategy for our products, which is driven by the following:

Conducting R&D in-house and through our research partners,

Monetizing our IP with upfront payments, milestone payments, royalties, and sales of kits and key components, and

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

We aim to partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise.

We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, they could potentially be used throughout the world.

We aim to 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.

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.

In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q ® Vet Cancer Test in kit format for companion animals through Heska’s network of central reference laboratories.

Subsequent to year end, in February 2023 Heska commenced pre-orders of the Nu.Q ® Canine Cancer Screen and Monitor Test to veterinarians at the point of care through Heska.

We also entered into a licensing and supply agreement with IDEXX Laboratories, Inc.

(“IDEXX”), a global leader in pet healthcare innovation, in October 2022.

We also entered into a licensing and supply agreement with IDEXX in October 2022.

This contract provides worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available.

Subsequent to year end, IDEXX launched the IDEXX Canine Cancer Test in January 2023.

Further, we engaged with DNAtech, Portugal, and, through our agreement with Heska, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe commencing in November 2022.

IDEXX launched the IDEXX Nu.Q® Canine Cancer Test in January 2023.

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 Market Opportunity

Volition applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases for both humans and animals including certain cancers and diseases associated with NETosis such as sepsis and COVID-19.

Volition applies its technologies through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases for both humans and animals including certain cancers and diseases associated with NETosis such as sepsis and COVID-19.

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

Based on our calculations, we believe that Volition’s annual total addressable market (“TAM”) is approximately $70 billion (including distributor and vet/clinician margins).

Key assumptions for this market forecast include:

opportunity is calculated based on canine and feline populations that are eligible for screening and monitoring.

Nu.Q ® Discover:

opportunity is calculated using drug pipeline data (registered clinical trial programs) for relevant epigenetic targets.

opportunity is calculated based on average length of stay and estimated hospital admissions and discharges for sepsis.

Nu.Q ® Cancer:

opportunity is calculated based on eligible population for annual screening, target participation rates and incidence/prevalence of specific cancers and risk stratification use cases.

We have assumed the following prices per test:

$120 for the U.S., €45 for Europe, $25 for the rest of the world.

$50 globally.

To the extent that one or more of our assumptions prove incorrect our calculation could be materially impacted.

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 Competition

We anticipate facing 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., Oncimmune Holdings Plc, Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Invitae, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, and Roche Diagnostics, and from companies such as PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on 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., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc., and Immunexpress Inc., and from companies such as PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.

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

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A similar system operates in China through the CFDA.

In Europe, since May 2022, IVD medical devices are regulated by the new European In Vitro Diagnostic Regulation 2017/746 (“EU IVDR”).

The most challenging changes compared to the previous Directive are those regarding the classification of products, 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.

Additional requirements are now applied to reinforce the safety of the products such as extended responsibilities of the economic actors of the supply chain, increased post marketing surveillance activities, unannounced audits from Notified Bodies, implementation of an improved traceability and transparency of the devices with the introduction of the Unique Device Identification system and an expanded European Database on Medical Devices.

Tailored transitional periods have been introduced for devices that must undergo a conformity assessment involving Notified Bodies for the first time under the EU IVDR.

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.

Additional requirements are applied to reinforce the safety of the products such as extended responsibilities of the economic actors of the supply chain, increased post marketing surveillance activities, unannounced audits from Notified Bodies, implementation of an improved traceability and transparency of the devices with the introduction of the Unique Device Identification system and an expanded European Database on Medical Devices.

Tailored transitional periods have been introduced for on-market IVD devices that must undergo a conformity assessment involving Notified Bodies for the first time under the EU IVDR.

The length of the transitional periods depends on the classification of device.

In practice, the conformity assessment procedure for our products requires a combination of Quality Management System (“QMS”) audits and Technical Documentation assessments.

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.

We have already begun discussions with the TÜV SÜD and are in the process to ensure compliance with the EU IVDR in 2023.

Any new devices introduced to the market will undergo EU IVDR assessment.

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 have completed inspections in 2023 with the TÜV SÜD and our QMS is in compliance with the EU IVDR.

Belgian Volition has maintained its ISO certification since 2015.

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Intellectual Property

Volition is developing clinical products based on the enrichment and analysis of epigenetically modified circulating nucleosomes using immunoassay, mass spectrometry, DNA sequencing and other methods.

Volition is developing clinical products based on the enrichment and analysis of circulating chromatin using immunoassay, mass spectrometry, DNA sequencing and other methods.

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 34 patent families (plus three in-licensed families) and a total 97 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 15 patents granted in Europe, and a further 70 patents granted worldwide.

Our patent portfolio includes 50 patent families (plus two in-licensed families) and a total 79 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 19 patents granted in Europe, and a further 48 patents granted worldwide.

Additionally, we have a total of 132 patent applications currently pending, worldwide.

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The patent filings on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2043.

As of December 31, 2022, we had 104 full-time equivalent (“FTE”) compared to 83 as of December 31, 2021, reflecting the growth in commercial and production activities.

As of December 31, 2023, we had 110 full-time equivalent (“FTE”) personnel compared to 104 as of December 31, 2022, reflecting the growth in our commercial and production activities.

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 in each of our locations and in each of our employee groups at each level around the globe as assessed with internal and external benchmarking data.

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.

Corporate History

VolitionRx Limited was originally incorporated on September 24, 1998 in the State of Delaware under the name “Standard Capital Corporation.” VolitionRx acquired its wholly owned operating subsidiary, Singapore Volition Pte.

VolitionRx Limited is a Delaware corporation that was incorporated on September 24, 1998 under the name “Standard Capital Corporation.” VolitionRx acquired its wholly owned operating subsidiary, Singapore Volition Pte.

Limited, a Singapore registered company (“Singapore Volition”) in October 2011.

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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