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TIMELINE OF RECENT EVENTS
In April 2022, the Nu.Q Vet test was launched in Singapore through SAGE Healthcare, which expanded the Nu.Q Vet test's geographic footprint to Asia.
In late May 2022, Nu.Q NETs assay completed the European CE Mark (Conformitè Europëenne) certification process for detecting and monitoring diseases with a NETs component.
On May 26, 2022, Dr. Wilson-Robles advanced Nu.Q Vet by presenting "Monitoring treatment response and disease progression in canine lymphoma using serial plasma nucleosome concentrations" at the European Society of Veterinary Oncology (ESVONC).
On June 24, 2022, Dr. Heather Wilson-Robles presented "Evaluation of Plasma Nucleosome Concentrations in Healthy Dogs and Dogs with Various Common Cancers" at the American College of Veterinary Internal Medicine (ACVIM) Forum in Austin, Texas. A slide deck of the presentation is available on Volition's (NYSE:VNRX) website at https://veterinary.volition.com/vet-resources/scientific-resources.
In mid-July 2022, a poster concerning NETosis and utilizing Volition's Nu.Q NETs assay ("Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients") was presented at the International Society on Thrombosis and Haemostasis (ISTH).
VolitionRx announced that it is developing a 1000+s patient Nu.Q Capture study in lung cancer and colorectal cancer. Further announcements are expected later in 2022.
Volition sponsored an educational GenomeWeb webinar on NETs entitled "The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease." To view the webinar on demand, go to genomeweb.com.
Volition has a webinar available on its Nu.Q Vet cancer diagnostic test, including case studies and how veterinarians should interpret test results. To view on demand, go to https://us02web.zoom.us/webinar/register/WN_dxFl_IpCRHWXpZSCuVawOg.
OPERATIONAL HIGHLIGHTS - 1H 2022
Nu.Q NETs – CM Mark (Europe)
The CE Mark (Conformitè Europëenne) certification process in Europe for the company's Nu.Q NETs assay was completed in late May 2022. Volition registered the Nu.Q H3.1 NETs assay with a broad claim for detecting and monitoring diseases with a NETs component (e.g. sepsis, COVID-19, influenza, autoimmune diseases and cancer) and across multiple platforms (ELISA plate, automated beads etc.). The CE Mark enables the clinical use of the NETs assay test in more than 27 countries across Europe.
Data for published clinical studies have demonstrated that the level of circulating NETs correlates with the current disease's severity and also can be used to predict future disease severity, an important aspect in guiding treatment selection. With Neutrophil Extracellular Traps (NETs) having been discovered only in 2004, this nascent market has just begun to be fully understood and developed. Part of the body's response to infection (bacteria and viruses), certain white blood cells (neutrophils) produce and eject NETs to catch and kill the bacteria and viruses. The over-release of NETs are associated with poor patient outcomes in diseases, such as COVID-19 (excessive cytokine production that can result in acute respiratory distress) sepsis and cancer. The company's Nu.Q NETs assay enables medical professionals to monitor for elevated levels of NETs to help detect the immune system's status in terms of reaction and/or overreaction.
Recently, Sharon Ballesteros has joined Volition America as U.S Head of Quality and Development Process with the mandate to navigate the Nu.Q NETs effort through the U.S. regulatory process for the purpose of obtaining FDA approval. The plan to complete a U.S. clinical study includes an initial pilot study, which is expected to begin later in 2022.
Commercialization of Nu.Q Vet in U.S.
On March 29, 2022, VolitionRx announced the signing of an exclusive Global License and Supply Agreement with Heska Corporation (NASDAQ:HSKA) for the distribution of the Nu.Q Vet Cancer Screening Test at the point-of-care for companion animals. Heska is a growing veterinary health laboratory diagnostic systems company specializing in point-of-care tests, analyzers and specialty products for canines and felines in North America (62.6% of revenues) and 9 international markets.
VolitionRx received a $10 million upfront payment on March 30, 2022 and will receive up to an additional $18 million based upon the achievement of certain milestones with up to $13 million expected in the 2022-2023 timeframe and an additional $5 million milestone payment expected in 2024. Initially, the licensing agreement grants exclusive rights to commercialize Nu.Q Vet for canine cancer screening and monitoring at the point of care. Heska will offer the Nu.Q Vet test on its proprietary Element i+ Immunodiagnostic Analyzer point-of-care platform, which was launched in 2020. Element i+ is designed to deliver test results in minutes.
Also, Heska has been granted non-exclusive rights to sell the Nu.Q Vet test kits through its reference laboratory network. The payments for the kits and key components for both reference lab work and point-of-care services will be at pre-agreed prices, which should provide another revenue stream for VolitionRx.
VolitionRx estimates that the total addressable market (TAM) worldwide for cancer screening and monitoring in canines and felines to be about $11 billion. The managements of VolitionRx and Heska share the same vision of being able to provide affordable diagnostic tests that enable the early detection and treatment of health conditions in order to achieve better outcomes. Nu.Q Vet tests are expected to be offered at a price point of under $50 per kit (of which VolitionRx will receive around $10), which will position the test as a mass market product with the aim of supporting clinical decisions during annual check-ups, wellness exams and healthcare treatments. As a result, an ongoing revenue stream is expected to be generated by providing kits and key components to veterinarians around the world.
The commercialization process is anticipated to take at least six months as Nu.Q Vet test is adapted to Heska's Element i+ point-of-care platform, and potentially on Heska's multiplexed Heska panels. Revenues could be generated as early as late 2022.
On June 24, 2022, Volition presented at the American College of Veterinary Internal Medicine (ACVIM) Forum in Austin, Texas. The presentation is available on Volition's website at https://veterinary.volition.com/vet-resources/scientific-resources.
Commercialization of Nu.Q Vet in Asia
The launch of the Nu.Q Vet test in Singapore through SAGE Healthcare (as an appointed distributor) occurred in April 2022. The target point of sale remains the routine wellness check-up for older dogs and at risk breeds so that the early detection of cancer can be affordably and effectively treated. In mid-December 2021, VolitionRx entered into non-exclusive License and Supply Agreement with SAGE Healthcare Private Limited for the Nu.Q Vet Cancer Screening Test in Asia.
Nu.Q NETs – Poster Presentation at ISTH
In mid-July 2022, a poster concerning NETosis and utilizing Volition's Nu.Q NETs Nu.H3.1 assay was published and presented at the International Society on Thrombosis and Haemostasis (ISTH). Entitled "Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients," the key finding from this study was the correlation reported between the Nu.Q NETs assay level and the currently used SOFA and APCHE-II score in sepsis patients. In addition, the Nu.Q NETs assay appears to be a marker of NETosis in COVID-19 patients.
Volition has sponsored an educational GenomeWeb webinar on NETs entitled "The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease." To view the webinar on demand, go to genomeweb.com.
Nu.Q Capture
Volition has sponsored an educational GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes." To view the webinar on demand, go to genomeweb.com.
VolitionRx is now working on developing a large 1,000+ patient study in the areas of lung cancer and colorectal cancer. Further announcements about the study are expected later in 2022.
Nu.Q Discover (Silver One)
During 2021, a Service Lab was installed in Silver One. During the second quarter, Volition provided quotes to multiple pharmaceutical and biotechnology companies for processing samples under the Nu.Q Discover moniker. The first Nu.Q Discover Agreement was signed in the fourth quarter of 2021. An additional five contracts were signed in the first quarter of 2022. The aggregate annual value of these service contracts is slightly over $200,000. The customers include both pharmaceutical companies and academic research institutions which are using Volition's epigenetic platform to help profile disease models, preclinical testing and clinical trials.
First Quarter 2022 Financial Results
On May 11, 2022, VolitionRx reported financial results for the first quarter ending March 31, 2022. Total revenues were $144,211, which was driven by services revenue from Nu.Q Discover and product revenue from sales of the Nu.Q Vet cancer screening and H3.1 kits.
Operating expenses increased 27.5% from $6.11 million to $7.79 million. R&D expenses declined 7.3% to approximately $3.59 million. G&A expenses increased 43.8% to approximately $2.60 million, as the number of full-time employees (FTE) increased from 14 to 19. Sales and marketing expenses increased 274% due to higher personnel expenses, stock-based compensation and direct marketing & professional fees as FTE personnel increased by seven to 18.
For the first quarter, VolitionRx reported a net loss of $7.63 million (or $0.14 per diluted share) versus a net loss of approximately $6.12 million (or $0.12 per diluted share) in the comparable quarter last year.
As of March 31, 2022, working capital was approximately $844 million, declining from $15.5 million on December 31, 2021. Shares outstanding increased by 1.1% to 53,790,261 shares from 53,223,761 shares on December 31, 2021.
Milestones Expected During 2022 - 2023
• Nu.Q Vet Cancer
◦ Achievement of Heska Agreement milestones in order to receive $18 million in milestone payments.
◦ Additional announcements of licensing agreement(s) for the distribution of Nu.Q Vet Cancer Screening Test nationally and/or internationally. VolitionRx continues to be in negotiations with other companies.
• Silver One: Under the Nu.Q Discover program, six contracts for processing samples utilizing Nu.Q Discovery assays were signed in late-2021 and the first quarter of 2022. These contracts have an aggregate annual worth of slightly over $200,000, but are expected to ramp up slowly throughout 2022, but particularly in the second half.
• Nu.Q NET
◦ In an effort to obtain FDA approval of Nu.Q NETs, a pilot study is expected to begin later in 2022.
• Additional Papers, Posters and/or Abstracts
◦ Nu.Q Vet
▪ The results of a clinical study with over 100 canines is in progress with the results are expected to be submitted in a peer-reviewed publication in 2022. Preliminary data suggest that Nu.Q Vet may be able to detect that a dog is coming out of remission weeks prior to the current methodology of physical detection.
▪ The analysis of over 600 canines, 504 of which are cancer patients, has been accepted for publication by a veterinary journal and is currently under review.
◦ Large-scale Study of Lung Cancer Conducted in Asia - The findings have been submitted for presentation at two conferences later in 2022.
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