Volition Business Review 2022.
Cameron Reynolds, Group CEO of Volition, talks through the company’s highlights from 2022 and looks ahead to 2023.
2022 was a transformational year for Volition. After twelve years in operation, Volition has successfully transitioned from a company solely focused on research and development to a product-based organization as a result of the hard work, expertise, and commitment of our team. I am so proud of what we have achieved together.
Volition is powered by Nu.Q®, our cutting-edge Nucleosomics™ platform which has enabled the development of all our product pillars and is the foundation of our company. I could not be more positive about our work at the heart of epigenetics and am excited for the next phase of our journey. For now though, here are some of our highlights from 2022 and some expectations for 2023.
Expanded access to the Nu.Q® Vet Cancer Test on a worldwide basis
Our aim for 2022 was to make our Nu.Q® Vet Cancer Test accessible to veterinarians worldwide for canine cancer screening, and we were able to do just that. In March, we announced a global licensing and supply agreement with Heska Corporation ("Heska"), a leading global provider of advanced veterinary diagnostics.
Our licensing agreement with Heska granted exclusive rights to commercialize the Nu.Q® Vet Cancer Test for canine cancer screening and monitoring at the point of care. We also granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Test in kit format for companion animals through their network of central reference laboratories.
Our accurate, affordable, and non-invasive canine cancer screening test is an ideal fit within Heska's expanding portfolio and in November, after seven months of working closely together, Heska launched the Nu.Q® Vet Cancer Test in the U.S. and subsequently in Europe through their veterinary diagnostics laboratories.
Heska’s plan to launch their flagship point-of-care solution for canine cancer screening is targeted for the first half of 2023 and is a key milestone for us as we strive to ensure as many veterinarians as possible can access our Nu.Q® Vet Cancer Test for their patients.
Further, in October, we announced the signing of another global supply agreement with a market leader in pet healthcare to provide the Nu.Q® Vet Cancer Test worldwide through its extensive reference laboratory network.
This latest global supply agreement is hugely exciting for Volition as we seek to capitalize on what we believe to be significant mass market opportunities within the companion animals sector and we look forward to our counterparty’s launch of the Nu.Q® Vet Cancer Test and distribution across its reference laboratories.
There are approximately 84 million pet dogs in the United States alone and just under half of all dogs will have at least one veterinary care visit each year. We believe that this provides a significant opportunity for us to introduce the Nu.Q® Vet Cancer Test as an accessible and affordable screen for senior dogs and at-risk breeds, to aid early detection and improve outcomes.
Achieved a CE mark for Nu.Q® NETs
In May, we announced that our Nu.Q® NETs Test had been CE marked for the detection and evaluation of diseases associated with NETosis, enabling clinical use in more than 27 countries across Europe.
We believe that our Nu.Q® NETs test is a ground-breaking diagnostic aid that clinicians can use to detect NETosis.
NETosis is a unique form of cell death that is characterized by the release of neutrophil extracellular traps (“NETs”) that trap and kill bacteria and viral particles. Although NETs play an important role in our immune system, excessive production can lead to tissue damage and, in severe cases, sepsis, shock, and death.
The role of NETs in the progression of acute, chronic, and debilitating conditions is critical and cannot be understated. Our Nu.Q® NETs test can now be used to identify patients with clinically relevant elevated levels of circulating NETs and allow physicians to rapidly treat these patients.
We believe that there is significant potential for Nu.Q® NETs to support clinical decision-making, enabling physicians to act quickly, and crucially improve patient outcomes.
Achieving CE marking was a critical regulatory milestone for us. We believe that Nu.Q® NETs is the only analytically validated test for NETs in the world and it is now registered for use in Europe in both ELISA (enzyme-linked immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay) formats, which are widely used testing methods.
We are working with teams at several major hospitals across the UK and France, undertaking studies to test our technology as a diagnostic aid for sepsis and COVID-19, to monitor disease progression and treatment response. We are also collaborating with the University of Texas MD Anderson Cancer Center on a research study looking at the correlation of NETs in cancer patients with sepsis.
In addition, we are currently developing a network of key opinion leaders through our Market Access Program for Nu.Q® NETs and have started commercial discussions with potential licensing targets.
We anticipate that 2023 will be a pivotal year for Nu.Q® NETS as we strive to make substantial progress toward commercialization.
Launched our U.S. clinical product development and regulatory programs
In August, we announced the appointment of Diagnostic Oncology CRO LLC (“DXOCRO”) to spearhead our clinical product development and our regulatory programs in the United States and seek to establish clinical utility for our Nu.Q® products.
DXOCRO is a leading contract research organization specializing in the commercialization of diagnostic biomarker technologies and an ideal partner for us as we develop our FDA strategy in the United States.
DXOCRO is undertaking large-scale finding studies across multiple sites using Nu.Q® NETs and Nu.Q® Cancer tests to determine clinical utility in sepsis and cancer. We anticipate that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the FDA, and allow the tests to be marketed in the U.S.
These multi-site studies will help us demonstrate how our Nucleosomics™ technology can directly benefit patients and support our application to the FDA’s Breakthrough Devices Program, which is expected in the first half of 2023 with a pre-submission also anticipated this year.
Developed our Nu.Q® pipeline
Whilst our strategic focus last year was to ensure the successful commercialization of Nu.Q® Vet and Nu.Q® NETs, we also made excellent progress in developing our wider product portfolio, namely our Nu.Q® Cancer and Nu.Q® Capture product pillars.
In November, we announced that we are taking part in a government-backed prospective study to evaluate the performance of blood biomarkers in the early detection of lung cancer with Hospices Civils de Lyon (“HCL”), France’s second largest university hospital.
The Lyonnaise Initiative for the Initiation of Lung Cancer Screening (“ILYAD”) is a wide-ranging clinical study assessing the feasibility of a lung cancer screening program and the effectiveness of screening.
The ILYAD study will evaluate the performance of our Nu.Q® Cancer test as a blood biomarker for the early detection of lung cancer, when used alone and in conjunction with a CT scan, with the ultimate goal of developing a national screening program in France.
Lung cancer is the most common cause of cancer deaths worldwide, with 1.8 million cases each year. We know that screening saves lives and there is a real unmet need for lung cancer screening globally. Our colleagues at HCL have recognized that need and we are proud to be part of their pioneering study.
Our research and development team continues to develop Nu.Q® Capture, an enabling and enrichment technology to capture and concentrate nucleosomes containing particular epigenetic signals for further analysis, more accurate diagnosis, and to help guide treatment.
Our Nu.Q® Capture program now has several strands of technology that essentially: remove background noise, thereby amplifying the signal; look to identify the signal in a novel way including through mass spectrometry; or isolate various chromatin fragments, including nucleosomes and transcription factors.
We believe that Nu.Q® Capture, when used in combination with either sequencing, mass spectrometry, and/or our Nu.Q® assays offers significant potential. In addition to aiding biomarker discovery, Nu.Q® Capture could potentially aid diagnosis, treatment selection, and treatment and disease monitoring.
Scaled up our operations
To position Volition for commercial success, starting in 2022 through to the present time we have dedicated considerable time and resources to scaling up and strengthening our infrastructure.
We now have over 100 staff worldwide, based in Belgium, the UK, the U.S., and Singapore. During 2022 we sought to build out our HR, IT, Finance and Legal functions to support the growing needs of the company.
In April, we moved into a new state-of-the-art innovation laboratory in Carlsbad, California, which now provides a base for our U.S. research and development and Quality operations. Meanwhile in July, we were delighted that our Silver One production facility in Belgium was awarded ISO 13485:2016 certification. This means our Quality Management System meets the global standard of requirements for medical devices, which is fantastic news and a pre-requisite as we scale up with third-party manufacturers. A huge well done to the whole team for achieving such an important company milestone.
2022 was a phenomenal year for Volition. For over a decade we have sought to advance the science of epigenetics, develop and reﬁne our technology to be - what we believe to be - the best-in-class in the diagnostics industry.
Powered by Nu.Q®, our Nucleosomics™ technology has the potential to play an important role in the ﬁght to save lives and improve outcomes worldwide and we are thrilled that our Nu.Q® Vet Cancer Test is now commercially available, with plans to commercialize Nu.Q® NETs also well underway.
A huge thanks again to our team at Volition for ensuring we remain at the very cutting edge of epigenetics through your hard work, expertise, and commitment.
We expect that 2023 will be our best year yet and I very much look forward to sharing regular updates regarding our Nu.Q® product pillars with you including results from our clinical studies, publications, licensing agreements and other key milestones. Thank you for your continued interest and support.
Safe Harbor Statement
Statements in this Business Review may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, Volition's expectations related to the launch of product sales with Heska and other counterparties to agreements, the success of negotiations and the timing, completion and execution of term sheets and/or agreements with third parties regarding the licensing and distribution of Volition's products, the timing, completion, success and delivery of data from clinical studies, the potential uses, benefits and effectiveness of its Nucleosomics™ technology platform, including the Nu.Q® NETs test and the Nu.Q® Vet Cancer Test, and the timing and execution of Volition's strategy with the FDA. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests, a failure by the marketplace to accept Volition's Nu.Q® NETs test, Nu.Q® Vet Cancer Test or other products based on its Nucleosomics™ platform; Volition's failure to secure adequate intellectual property protection; Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products; Volition will face fierce competition and its intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring markets and their rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Forward-looking statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this Business Review, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
Nucleosomics™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this Business Review are the property of their respective owners.