VolitionRx (NYSE:VNRX) is engaged in multiple epigenetic projects based on company’s proprietary Nu.QTM platform, which encompasses numerous blood-based clinical assays that have been developed internally within the company.
Commercialization of Nu.Q Vet
Since the beta launch of Nu.Q Vet Cancer Screening Test in late-November 2020, management has been in active discussions with a range of companies in the veterinarian products and services space in order to secure licensing arrangement(s) for the commercialization the test for cancer detection in canines. A major milestone is expected in the fourth quarter, since the company is now in advanced term sheet discussions with three major global veterinary companies.
Management anticipates the signing of an agreement with one of those parties before the end of 2021. Negotiations involve various factors including, but limited to, exclusive versus non-exclusive licenses, global versus regional agreements, product pricing, laboratory processing fees versus licensing of IP for processing samples, potential reagent sales, the potential of an up-front payment and/or commercial milestone payments etc.
The Nu.Q Vet Cancer Screening Test positioned as a part of an annual wellness test on dogs over seven years old and also on canine breeds predisposed to cancer at ages as early as four years old. All three companies desire to position the test as a mass market product with a price point below $75 to the pet owner. The signing of a licensing arrangement would lead to the launch of the first a low-cost canine cancer screening test.
The beta launch of Nu.Q Vet Cancer Screening Test continues to generate quarterly revenue around $25,000 per quarter. The signing of a distribution licensing arrangement in late 2021 could result in an upfront payment could be booked in 2021 and would portend a significant ramp up in Nu.Q Vet revenues in 2022, from licensing fees, point-of-care tests and laboratory processing fees. Management anticipates launching the Nu.Q Vet Cancer Screening Test in Europe in the first half of 2022.
Recent Nu.Q Vet Posters Presented at the Veterinary Cancer Society Annual Conference
Two posters were presented at the Veterinary Cancer Society Annual Conference in early November. The first was entitled Enrichment tools to better understand the different types of circulating nucleosomes and their associated genome patterns in the plasma of dogs with lymphoma, which was presented by Kira Bourne, a resident veterinary oncologist at the Texas A&M University College of Veterinary Medicine. H1 Nu.Q Capture was utilized to isolate and sequence cancer-specific nucleosomes in plasma from dogs with lymphoma. The study concluded that canines with lymphoma have circulating nucleosomes that lack linker DNA (i.e. have shorter nucleosomes), which is similar to the findings in Volition’s human studies. The enrichment process of Nu.Q® Capture helped identify certain genetic variants, namely a gain of chromosome 13, a loss of chromosome 14 and potential abnormalities on chromosome 31.
The second poster was Evaluation of plasma nucleosome concentrations as a tool for treatment and disease monitoring in cancer bearing dogs, which was presented Heather Wilson-Robles, Associate Professor at the College of Veterinary Medicine of Texas A&M University College of Veterinary Medicine and Chief Medical Officer, Volition Veterinary Diagnostics Development LLC.
A study on 21 dogs concluded that canines in remission often exhibit Nu.Q H3.1 assay elevations preceding physical detection by weeks and sometimes a month or two. Therefore, the H3.1 assay might be a useful tool to monitor dogs in remission in order to determine when a dog is coming out of remission. A follow-on study of over 100 canines is expected to be completed in the first half of 2022. A successful study most likely will lead to a second Nu.Q Vet product for monitoring the disease progression of dogs with cancer.
Volition Funded Nu.Q Vet Clinical Paper
On August 16th, a clinical paper entitled Characterizing circulating nucleosomes in the plasma of dogs with lymphoma was published online by BMC Veterinary Research on August 16, 2021. The paper expanded upon the Nu.Q Vet abstract published in mid-2020. Heather Wilson-Robles was significant contributor to the study.
This clinical study consisted of 260 dogs (126 diagnosed with lymphoma and 134 healthy controls) concluded that dogs with lymphoma (LSA) had significantly higher Nu.Q™ H3.1 assay nucleosome concentrations compared to control animals (AUC 87.8%). Furthermore, H3.1 assay levels increased with the stages of cancer and also dogs with B cell lymphomas had higher concentrations than dogs with T cell lymphomas.
Nu.Q Vet Clinical Study in Progress
In addition to being a cancer detection test, the data suggests that Nu.Q Vet may serve as a useful monitoring tool during the therapeutic regime and progression of the disease. Furthermore, Nu.Q Vet may be able to detect that a dog is coming out of remission, an unmet need in the market. A clinical study with over 100 canines is in progress; the results are anticipated to be published in early 2022.
3Q Nu.Q NETs Posters
At the ISTH (International Society on Thrombosis and Haemostasis) Virtual Congress (July 17-21, 2021), two posters that used the Nu.Q NETs assay in COVID 19 studies were presented by two collaborators at two British hospitals, King’s College Hospital and Hampshire Hospitals. The posters demonstrated that Nu.Q NETs assays administered at admission could predict future disease severity of COVID-19 and that serial assay results correlated with the progression of the disease, including 28-day mortality.
Poster: Circulating Nucleosome Immunoassay: Evaluating a Clinically-applicable Test to Risk Stratify COVID-19 and Target Anticoagulation, (Catherine Rea et al.)
Utilizing the Nu.Q NETs assay (H3.1-nucleosome ELISA), the level of circulating H3.1 nucleosomes was measured in plasma samples of two cohorts (20 COVID-19 patients that required hospitalization & organ support and 20 COVID-19 patients that required only hospitalization). Nucleosome levels were measured on the day of admission and on days three, seven and ten. The level of elevated nucleosomes correlated with disease severity, and serial results correlated with the progression of the disease. The study suggests that the Nu.Q NETs assay may be able to risk stratify COVID-19 patients upon admission to hospital.
Poster: Identifying Tools to Track Hypercoagulability in COVID-19 Patients. Exploring Global Haemostasis (ROTEM) and Neutrophil Extracellular Traps (NETs) Immunoassays, (Sophia Stanford et al.)
Utilizing the Nu.Q NETs assay (3.1-nucleosome ELISA), the level of circulating H3.1 nucleosomes was measured in plasma samples in three COVID-19 patients (one admitted directly to the ITU, one that was transferred to the ITU in due course and one that remained in the general ward. The level of nucleosomes closely tracked the clinical course of these three COVID-19 patients. This small exploratory study suggests that the Nu.Q NETs assay may be able to risk stratify COVID-19 patients upon admission to hospital and thereafter monitor the progression of the disease.
Nu.Q NETs Clinical Studies in Progress
Additional clinical studies on COVID-19 and sepsis have been completed. The data is being finalized with publication expected thereafter.
Nu.Q NETs CE Mark Registration
Management intends to complete the CE Mark certification process in Europe for the company’s Nu.Q NETs assay. Volition plans to register 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.). Management expects the CE Mark registration process to be completed by the summer of 2022.
After publishing the first two clinical papers concerning Nu.Q Capture in the first and second quarters (A Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes and Serial profiling of cell-free DNA and nucleosome histone modifications in cell cultures, respectively), the third quarter saw the continued recruitment of team members for Nu.Q Capture research at the innovation hub in San Diego. Multiple methods for enrichment have been identified, along with using Nu.Q Capture in combination with sequencing, other Nu.Q assays and mass spectrometry. Also, Nu.Q Capture technology was used in the poster (concerning canines with lymphoma) that was presented at the VCS Society Annual Conference (see details above).
A Service Lab has been 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. A handful of contracts are currently in the negotiation phase, and management expects at least one contract to be signed in 2021 with revenue potentially being generated this year.
Nu.Q Cancer – Updates on ongoing human studies in hematological, lung and colorectal cancers)
Updates on Large-Scale Blood, Lung and CRC Clinical Trials
On-going Large-scale “Marquee” Study for Lung Cancer in Asia
Volition has completed preliminary analysis of the lung cancer study and continues to look forward to reviewing the data with Professor Chen of the National University of Taiwan and his team.
On-going Large-scale Study of Colorectal Cancer (CRC) Clinical Trial in Asia
The clinical data of the 5,000-subject asymptomatic screening study and the 2,000-subject symptomatic study, along with the data logs, were analyzed during the third quarter of 2021. The findings have been have been submitted for a conference presentation in early 2022.
On-going Clinical Trial for Diagnosis of Non-Hodgkin’s Lymphoma (NHL) in the U.S.
Due to delays caused by the COVID-19 pandemic, the study protocol of the 1,500-subject NHL study was altered in order to upgrade to a high-throughput platform, which should assist in the FDA approval process. Recruitment for the altered study is expected to begin in the first quarter of 2022, and the study is expected to be completed in 2023.
On-going Large-scale “Marquee” Study for Colorectal Cancer (CRC) in the U.S.
In June, collections resumed for EDRN study; enrollments have been slow, but steady. Management anticipates that the study will be completed in the fourth quarter of 2022.
Colorectal Cancer Testing Product – China
The company continues to negotiate with Fosun for a licensing agreement in Asia, along with continuing to adapt and transfer Volition’s assays for use on Fosun’s open-access LUMIART-II assay platform.
Milestones Expected Over the Next Two Quarters
• The announcement of licensing agreement(s) for the distribution of Nu.Q Vet Cancer Screening Test nationally and/or internationally. It is possible that an upfront payment could be booked in 2021.
• Silver One: Under the Nu.Q Discover program, a handful of contracts (for processing samples utilizing Nu.Q Discovery assays) are currently in the negotiation phase. The signing of at least one of the contracts could potentially generate revenues in 2021.
• 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 expected to be published in early 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.
◦ Large-scale Study of Colorectal Cancer (CRC) Clinical Trial Conducted in Asia – The findings on the 5,000-subject asymptomatic screening study and on the 2,000-subject symptomatic study on CRC have been submitted for a conference presentation in early 2022.
As of September 30, 2021, VolitionRx has a strong balance sheet with slightly above $22.9 million in cash and cash equivalents.
Third Quarter 2021 Financial Results
On November 10, 2021, after the market close, VolitionRx reported financial results for the third quarter ending September 30, 2021. Total revenues were $25,483, which consisted of product revenue from direct sales of the Nu.Q Vet Cancer Screening Tests being processed by the GI (Gastrointestinal) laboratory at Texas A&M University.
Total operating expenses increased 68.4% from $4.50 million to $7.56 million. R&D expenses increased 38.9% to approximately $4.45 million, primarily due to higher personnel expenses and stock-based compensation. G&A expenses increased 125% to approximately $2.43 million, also driven by personnel expenses and stock-based compensation. Sales and marketing expenses increased 192%, driven by higher personnel and stock-based compensation expenses, along with higher direct marketing & professional fees. Full Time Equivalent personnel numbers over the operating expense base increased by 20, increasing from 37 to 57. Also, in order to attract and retain employees, management has increased the stock-based compensation component to a more competitive level.
For the third quarter, VolitionRx reported a net loss of $7.18 million (or $0.13 per diluted share) versus a net loss of approximately $4.33 million (or $0.09 per diluted share) in the comparable quarter last year.
During the third quarter, the company’s cash burn rate declined from approximately $2.0 million to 1.7 million per month. As of September 30, 2021, working capital was approximately $24.0 million, an improvement over the $14.1 million on December 31, 2020, but also an increase from the $18.6 million at the end of the second quarter. The company has a strong balance sheet with slightly above $22.9 million in cash & cash equivalents.
During the third quarter, Volition received net proceeds of $252,852 through the company’s aftermarket (or ATM) equity distribution program, and was awarded $419,271 in grant income from Walloon Region. Shares outstanding have increased by 9.5% to 53,223,761 shares from 48,607,017 shares on December 31, 2020.
VolitionRx is a multi-national epigenetics company with a focus on developing blood tests (assays) that can help detect a range of cancers and other diseases so that appropriate treatment may be prescribed. Blood tests are a diagnostic tool that is relatively simple to administer, convenient and cost-effective. Also, as a front line screening modality, blood tests would be the optimal approach for the diagnosis of life-threatening diseases (especially cancer), where early diagnosis is the key factor for survivability.
Management’s goal is to lead the foray and then dominate the epigenetics diagnostics space. The company has developed the Nu.Q platform, which is designed to accurately identify and measure the amount of nucleosomes (and chromatin) in the bloodstream. Each Nu.Q blood assay or panel is intended to detect epigenetically-altered, circulating nucleosomes, which are biomarkers for cancer and other diseases. The company is in the process of developing and clinically testing multiple blood assays, particularly for lung, colorectal and hematological cancers.
Management’s Conceptual Business Development Model
Management’s commercial strategy has been fine-tuned into four pillars composed of Nu.Q Vet, Nu.Q NETs, Nu.Q Capture and Nu.Q.
• Nu.Q Vet – pursue full commercialization of the current beta-launched Nu.Q Vet blood assay in the United States, Asia and Europe
• Nu.Q NETs – research program to bring the Nu.Q H3.1 assay to commercialization for monitoring the progression of diseases associated with NETosis, such as sepsis, COVID-19 and influenza
• Nu.Q Capture – advance sample enrichment platform that enhances samples using mass-spectrometry and/or sequencing in order to be able to better identify new biomarker targets for the purpose of detecting tumors and other mutations
• Nu.Q Cancer – ongoing human studies in hematological, lung and colorectal cancers
• Nu.Q Discover – helps determine levels of circulating nucleosomes and provides epigenetic profiling in disease models, pre-clinical testing and clinical trials
Management is also looking to quickly advance its market opportunities by expanding and dominating each specific market by driving aggressive volume growth through attractive pricing.
VolitionRx has a substantial IP portfolio with 82 granted patents, including 12 in the U.S., 14 in Europe and an additional 56 worldwide as of June 30, 2021. The company has 82 patent applications pending.
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