Research that is free to access for all investors. Companies commission these providers to write research about them.
Brokers who write research on their corporate clients and make it available through our main bundle offering.
Research that is paid for directly by asset managers. Only accessible to institutional investors permissioned for access.
Event in Progress:
View the latest research on other companies in the sector.
VolitionRx is a clinical diagnostics company with a different perspective on immunoassay technology for the detection and monitoring of severe diseases in both humans and companion animals. Unlike sequential organ failure assessment (SOFA), which requires multiple physiological measurements, VolitionRx’s proprietary Nu.Q neutrophil extracellular traps (NETs) immunoassay technology takes a more direct route in a largely stale and fragmented market. This ability to rapidly diagnose and monitor patients supports numerous clinical use cases across specialties and most immediately addresses sepsis, which has a c 25% mortality rate. VolitionRx aims to leverage its CE marking and demonstrate further proof of concept (PoC) in both preclinical and clinical settings to increase commercial activities in Europe in H222 and generate further clinical evidence to help support the application for FDA breakthrough device designation (BDD).
VolitionRX Ltd
ValuEngine Rating and Forecast Report for VNRX
The last several months were eventful for VolitionRx. The publication of the first ever proof-of-concept data in haematological cancers was the R&D highlight in Q419. On the corporate front, the company has acquired Octamer, now an in-house manufacturer of a key assay component, and is rapidly developing its veterinary subsidiary in the US. From a platform perspective, VolitionRx is moving away from traditional ELISA plates to a new format immunoassay based on magnetic particles. This is expected to improve the analytical performance of VolitionRx’s Nu.Q assays in the clinical studies. Our valuation stays at $223m or $5.42/share.
According to the latest Q319 update, VolitionRx has made progress with proof-of-concept studies with its upgraded Nu.Q assays and expects to start publishing the data in the coming weeks. After that, it plans to continue working on its lead indications, including colorectal and lung cancers. VolitionRx also reported progress with its newer programmes. Its agreement with the Texas A&M University has been executed to develop cancer tests for animal health. The innovative Nu.Q Capture programme made a breakthrough this summer and could eventually speed up biomarker discovery or potentially bring in licensing revenues from liquid biopsy players. Our valuation is $223m or $5.42/share.
<a href="https://www.edisongroup.com/company/volitionrx/2128/"><strong>Volition</strong></a> is a multinational life sciences company developing simple, easy-to-use, cost-effective blood tests to help diagnose a range of cancers and other diseases in the human and animal health markets. The tests are based on the science of NucleosomicsTM, which is the practice of identifying and measuring certain nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present. In this <a href="https://www.edisongroup.com/edison-tv/executive-interview-volitionrx-discusses-q3-2019-results-and-provides-a-business-update/"><strong>video,</strong></a> Cameron Reynolds, President and Chief Executive Officer of VolitionRx, discusses the company’s third-quarter financial results and operating activities. During the quarter, the company made significant progress with its Nu.QTM Capture and Nu.QTM Vet platforms and with its colorectal cancer and lung cancer trials, particularly in Asia. The company began two studies in lung cancer this quarter, a large-scale study with the National Taiwan University and its first study in China with Shanghai Fosun Long March Medical Science. In addition, VolitionRx reported its first revenues from sales of research-use only kits and the provision of contract research services. Subsequent to the quarter, the Volition team executed a contract with Texas A&M University to collaborate on the research and development of Nu.QTM Vet products and help drive early revenue in the all-important veterinary market. Financially, Volition strengthened its balance sheet with an existing investor exercising $4.8m of outstanding warrants to purchase shares of common stock, making a total of $16.5m in warrants exercised during the first three quarters of 2019. It ended the quarter with cash and cash equivalents of $19.7m. During the third quarter, the company was awarded a further $1.4m in non-dilutive grant-funding from the Walloon Region and, after the quarter end, an additional $500,000 unsecured loan from SOFINEX was approved.
The main highlights of VolitionRx’s Q219 results were the establishment of a veterinary subsidiary in Texas, US and the initiation of two lung cancer trials; the first in collaboration with Fosun Long March in China and the second with National Taiwan University. This indicates that lung cancer is gaining traction in R&D and is now the second most advanced indication after colorectal cancer. In July 2019 VolitionRx exercised warrants to raise another $4.8m (ytd it has exercised $16.5m), extending the cash runway to 2021. Our valuation post the warrant exercise is $226m or $5.50/share.
VolitionRx released its Q119 financial results last week and provided an operational update at the capital markets day on 9 April at the NYSE. Among other areas, VolitionRx highlighted the assay upgrade progress, which was one of the main operational goals in 2018. Although this caused delays to original commercial product development timelines, VolitionRx emphasises the current product-grade Nu.QTM assays excel when it comes reliability and reproducibility. The first batch of proof-of-concept data with the new assays in detection of colorectal and lung cancers was released in March 2019 and larger trials should follow. The other CMD highlights include detailed presentations by the invited KOLs on the newer R&D areas Nu.QTM Capture and Nu.Q Vet. Our valuation is $215m or $5.46/share.
VolitionRx's latest Q318 results announcement provided an update on the progress across its established R&D projects and added more detail to several newer initiatives. Management explained that the delays in some of the ongoing trials were due to the identified need to upgrade the Nu.Q platform assays to clinical grade. As a result, readouts from the lead trials are now expected throughout 2019 (previously end-2018/early-2019). According to management, upgrade work is underway and a number of R&D milestones are reachable within the next 12 months. Our valuation post share issue is $233m or $6.60/share.
VolitionRx has broad R&D programme and expects to announce major milestones in the coming months, culminating with CE marking and launch of both colorectal cancer (CRC) triage and frontline screening tests in Europe, potentially in 2019. Other recent positive developments include a recommendation to reduce age to start CRC screening in the US and a new legislative initiative that could help increase reimbursement coverage in the US. Our valuation is $243m or $7.02 per share (vs $6.93 per share).
VolitionRx recently announced the initial results from a 680-sample study taken from asymptomatic colorectal cancer (CRC) patients. The study demonstrated 80% sensitivity against stage 1 CRC and 66% against high-risk adenomas (at 78% specificity). The company has stated that it is moving on to the 4,300-sample study to determine the final test panel for European launch (results in Q218). This will be followed by a 12,000+ sample blinded study which is expected to complete in H218.
In September 2017, VolitionRx announced its European development plan for the Nu.Q™ colorectal cancer (CRC) frontline screening test. It will run two clinical trials (of 4,300 and 10,000 samples), which are expected to initiate in Q118 and Q218, respectively, supporting an expected CE mark and launch in Q318. VolitionRx is also participating in a three-year, 13,500-person US clinical trial including Nu.Q™ assays to support a US launch.
VolitionRx recently announced the initiation of a two-phase logistical study for its Nu.Q™ Triage test for colorectal cancer (CRC) in Denmark, which may enable the inclusion of the test in the country’s national screening program in conjunction with the standard fecal immunochemical test (FIT). The study is expected to take six months to complete with the potential for a decision by the national screening committee by the end of the year. If included, the Nu.Q™ Triage test would be the first blood-based cancer diagnostic as part of a national screening program for CRC.
VolitionRx reported in January 2017 that it had received a CE mark for its Nu.Q™ triage test for colorectal cancer (CRC). The company is targeting commercialization of the test initially in EU member states that have established fecal immunochemical testing (FIT) programs (of which there are 14 in total), and the CE mark should enable launches in these territories as early as 2017.
VolitionRx is a developer of blood-based diagnostics for cancer that detect the quantity and composition of cell-free nucleosomes (a complex of protein and DNA) present in the blood. The company announced its first commercial product, the NuQ triage colorectal cancer test, will launch in select European countries in early 2017. The product is not a diagnostic test, but is designed to reduce the number of colonoscopies by screening false positives from fecal immunochemical tests (FIT).
VolitionRx announced a new commercialization strategy for the US with its FY15 results. The company will seek a 510(k) approval in the US as an intermediate step to eventual PMA approval. This will allow for a quicker commercial launch of the NuQ colorectal test in the US, but would limit its marketing to “informing” a physician’s diagnosis instead of being a definitive diagnostic tool. The nearest-term revenues are in Europe, where a CE-mark approval and commercial launch are slated for late 2016.
VolitionRx recently released data for NuQ in colorectal and lung cancer, which both exceeded results from previous trials. In colorectal cancer (CRC), the test when adjusted for age detected 91% of tumors with 90% specificity in its first completed prospective study, unlike previous retrospective studies. The company also released encouraging interim lung cancer data detecting 93% of tumors with 91% specificity using the NuQ test in combination with smoking history, which positions the test as one of the most accurate non-invasive lung cancer diagnostics.
VolitionRx recently had data published in the peer-reviewed journal Clinical Epigenetics, which confirmed the utility of the NuQ platform for detecting pancreatic cancer. Also, combining NuQ assays with the CA 19-9 biomarker, it was able to achieve 92% sensitivity and 90% specificity. Additionally, the company announced interim data from a 4,800-subject trial in colorectal cancer (CRC) and received its first CE mark in Europe for an assay for the detection of CRC.
VolitionRx develops low-cost blood-based cancer diagnostics based on its proprietary NuQ technology, which detects the level and structure of nucleosomes in the blood using one drop of blood serum. It is currently focused on colorectal cancer (CRC), a very large opportunity with around 225 million people aged 50-75 in the US and EU eligible for screening. Data so far have suggested 84% sensitivity and 78% specificity in detecting CRC. NuQ also has the potential to detect multiple cancers. We value the company at $11.64 per basic share.
