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VolitionRx VNRX is engaged in multiple epigenetic projects based on company's proprietary Nu.QTM platform that has developed numerous blood-based clinical assays. The beta launch of Nu.Q Vet Cancer Screening Test is currently generating revenue, and management is in active discussions with a ranger of smaller and several large companies in the veterinarian products and services space in order to secure licensing arrangement(s) for Nu.Q Vet Cancer Screening Test for cancer detection in canines. The beta launch has created a high level of interest for the licensing and distribution of the product. Management anticipates entering into a distribution licensing arrangement in the second half of 2021 with revenues being generated in 2022, which may come from up-front payments and/or the achievement of certain commercial milestones. There is a possibility that an upfront payment could be booked in 2021. 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.
A Service Lab has been installed in Silver One, and Volition has provided quotes to multiple pharmaceutical and biotechnology companies for processing samples under the Nu.Q Discover moniker. Management anticipates that revenue from this service will be generated later in 2021, most likely in the fourth quarter.
As of June 30, 2021, VolitionRx has a strong balance sheet with approximately $27.9 million in cash & cash equivalents.
Milestones Achieved During the First Half of 2021
Revenues
During the first half of 2021, approximately 1,100 Nu.Q Vet Cancer Screening Tests were processing generating over $50,000 in revenue.
Papers, Posters & Abstracts
On January 28, 2021, VolitionRx had a poster presented at the IASIC World Conference on Lung Cancer (WCLC) on a 220-subject subset of the on-going 1,200-subject, large-scale lung cancer study. The abstract entitled Circulating Nucleosomes in Lung Cancer Diagnosis following Low-Dose Computed Tomography was virtually presented by Dr. Tung-Ming Tsai of the National Taiwan University Hospital. The data suggests that Nu.Q™ assays could help identify non-cancerous nodules following a Low-Dose Computed tomography (LDCT) scan.
The company's first clinical paper concerning Nu.Q Capture was published in Nature's Scientific Reports on March 31st. Entitled A Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes, the paper details a pilot study of enriched plasma samples from colorectal cancer (CRC) patients (n = 9) and healthy donors (n = 9). Utilizing mass spectrometry in the analysis of the enriched plasma samples, certain elevated biomarkers were discovered in CRC tissues when compared to the control samples. The Nu.Q Capture protocol was utilized to isolate the circulating nucleosomes in human plasma to provide the enriched samples on which the analysis was conducted. Marielle Herzog, Volition's Research & Development Director, supervised the study.
On May 4, 2021, a clinical paper entitled Serial profiling of cell-free DNA and nucleosome histone modifications in cell cultures (Professor Stefan Holdenrieder et al.) was published in Nature's Scientific Reports. This paper on Nu.Q Capture detailed the company's novel approach to epigenetic profiling of select circulating nucleosomes in the blood of cancer patients in order to identify new biomarkers.
Near the end of the quarter, on June 29th, a clinical paper entitled Characterizing circulating nucleosomes in the plasma of dogs with hemangiosarcoma (Heather Wilson-Robles et al.) was published online by BMC Veterinary Research, an open access, peer-reviewed journal. The paper expanded upon the abstract published in mid-2020 and presented at the Veterinary Cancer Society Annual Conference in October 2020.
Events Subsequent to the end of the First Half of 2021
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.
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 (3.1-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.
On August 16th, a clinical paper entitled Characterizing circulating nucleosomes in the plasma of dogs with lymphoma was published online by BMC Veterinary Research. The paper expanded upon the Nu.Q Vet abstract published in mid-2020 and presented at the Veterinary Cancer Society Annual Conference in October 2020.
Milestones Expected During the Second Half of 2021
• The announcement of licensing agreement(s) for the distribution of Nu.Q Vet cancer screening nationally and potentially internationally. Possibly, an upfront payment could be booked in 2021.
• Silver One: Under the Nu.Q Discover program, quotes have been sent to multiple pharmaceutical and biotechnology companies. recombinant nucleosomes, antibodies, reagents and supply kits, along with laboratory services and/or contract research (branded as Nu.Q Discover) for external parties Processing samples at Silver One using its Nu.Q® Discovery assays, and
• Completion of 1,200-subject lung cancer study in Asia (National University of Taiwan)
• Additional Papers, Posters & Abstracts
◦ Nu.Q Vet - new clinical data may broaden the application of the Nu.Q Vet Cancer Screening Test to seven common canine cancers.
◦ Two Nu.Q Vet abstracts have been accepted for the Veterinary Cancer Society meeting scheduled for October. The topics are expected to be "the use of Nu.Q Vet in monitoring disease progression and treatment response" and "using the Nu.Q Vet assay to monitor both disease progression and treatment response in dogs with cancer."
◦ A multi-cancer study paper in under development, which potentially could be published in the fourth quarter of 2021.
Upcoming Conferences
Volition will be at the Western Veterinary Conference in Las Vegas (September 26-9, 2021), at the Veterinary Cancer Society Annual Conference in Boise (October 14-16), the Vet Show in NYC (November 4-5), the London Vet Show (November 11-12) and the VMX Conference in Orlando (January 15-19, 2022).
Volition will be hosting a booth at the Western Veterinary Conference. Two Nu.Q Vet abstracts have been accepted for the Veterinary Cancer Society meeting in October. The topics are expected to be "the use of Nu.Q Vet in monitoring disease progression and treatment response" and "using the Nu.Q Vet assay to monitor both disease progression and treatment response in dogs with cancer."
Second Quarter 2021 Financial Results
On August 11, 2021, after the market close, VolitionRx reported financial results for the second quarter ending June 30, 2021. Total revenues were $24,782, 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.
Operating expenses increased 13.6% from $5.22 million to $5.93 million. R&D expenses increased 4.5% to approximately $3.65 million as higher personnel expenses were somewhat offset by lower research and collaboration costs. G&A expenses increased 20.4% to approximately $1.82 million, also driven by personnel expenses. Sales and marketing expenses increased 113%, primarily driven by higher personnel expenses and higher direct marketing & professional fees.
For the second quarter, VolitionRx reported a net loss of $5.53 million (or $0.10 per diluted share) versus a net loss of approximately $5.04 million (or $0.12 per diluted share) in the comparable quarter last year.
As of June 30, 2021, working capital was approximately $24.0 million, still an improvement over the $14.1 million on December 31, 2020, but down sequentially from the $28.7 million at the end of the first quarter due to the company's cash burn rate of approximately $2 million per month. The company has a strong balance sheet with approximately $27.9 million in cash & cash equivalents. During the second quarter, Volition received net proceeds of $854,711 through the company's aftermarket or ATM equity distribution program, and was awarded $400,000 in grant income from Walloon Region.
Shares outstanding have increased by 9.3% to 53,144,082 shares from 48,607,017 shares on December 31, 2020.
Updates on Large-scale Blood, Lung and Colorectal Cancer Trials
On-going Large-scale "Marquee" Study for Lung Cancer in Asia
In May 2019, VolitionRx signed a formal contract with the National University of Taiwan to conduct a large-scale lung cancer study. The study includes 1,200 participants receiving Low-Dose CT (LDCT) scan, 1,000 of which have lung cancer. Collection commenced in the summer of 2019, but the COVID-19 pandemic impacted the sample gathering process. In May 2021, the target number of patient cohorts had been collected. The Nu.Q H3.1 assays were processed, and Volition has completed the preliminary analysis of the lung cancer study.
A review of the data with Professor Chen of the National University of Taiwan and his team is being planned. Management anticipates that this large lung cancer study should be completed in 2021 and that the findings will be presented at a conference in 2022. If the study's data continues to be positive, management plans to initiate a FDA 510(k) regulatory study in the U.S. for lung cancer.
As stated above, an abstract on Nu.Q performance in lung cancer detection was presented at the IASLC World Conference on Lung Cancer (WCLC) conference in January 2021. The presentation, which was based on an interim analysis of a subset of 220 subjects, indicated that the Nu.Q H3.1 assay could help identify non-cancerous nodules following a LDCT scan. As a result, up to 32% of the subjects that were LDCT positive could avoid unnecessary follow-up biopsies.
On-going Large-scale Study of Colorectal Cancer (CRC) Clinical Trial in Asia
In July 2018, VolitionRx signed an agreement with the National University of Taiwan to conduct two, large-scale, three-year colorectal cancer studies: a 5,000 subject asymptomatic screening study and a 2,000 subject symptomatic study. As of July 2020, more than 50% of the samples have been collected, but the COVID-19 pandemic impacted the sample gathering process. Nevertheless, the collections were completed in mid-2021, and now the National Taiwan University is in the process of collecting the clinical data, along with the data logs. Volition's management anticipates that the data will be analyzed in the second half of 2021, and the findings will be presented at a conference during 2022.
On-going Clinical Trial for Diagnosis of Non-Hodgkin's Lymphoma (NHL) in the U.S.
In November 2020, Volition engaged Diagnostic Oncology CRO LLC (a contract research organization) to conduct a program that will lead to multiple FDA 510(k) submissions for Nu.Q assay(s) that will assist physicians in distinguishing five of the most common forms of Non-Hodgkin's Lymphoma (NHL) from common conditions. At a cost of approximately $2.9 million, the effort includes a 1,500-subject clinical trial and data analysis, along with the preparation of regulatory and reimbursement submissions. The trial is planned to be conducted across 10 major U.S. healthcare institutions.
Despite delays due to the COVID-19 pandemic, the preliminary protocol development and study preparation has been completed. Management anticipates that the collection of samples will begin in late 2021 and that the first data should be submitted to the FDA in late 2022.
On-going Large-scale "Marquee" Study for Colorectal Cancer (CRC) in the U.S.
After a pause on collecting samples for the U.S. EDRN study for colorectal cancer (6,000 subjects) that began in May 2020 due the COVID-19 pandemic, enrollments were re-initiated in June 2021. Enrollments are expected to be at full capacity in September 2021. The collection period has been extended to the fourth quarter of 2022.
Colorectal Cancer Testing Product - China
As part of Volition's project with Shanghai Fosun Long March Medical Science Co., Ltd to adapt and transfer VolitionRx's assays for use on Fosun's open-access LUMIART-II Automated Chemiluminescence Immunoassay platform, Volition has been in continuing negotiations with Fosun for a licensing agreement, which could lead to a launch a human colorectal cancer testing product in China.
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.
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