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VolitionRx reports several highlights in 2018 and eyes key milestones going into 2019

The company is bolstering its intellectual property rights by securing additional patents
cancer assay tests
VolitionRx is a life sciences company focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers

VolitionRx Limited (NYSEMKT:VNRX) said Wednesday it has achieved several highlights and is looking forward to a number of milestones going into 2019 for all its potential product lines.

"We have had numerous highlights this quarter, with good progress being made on many fronts demonstrating the diverse nature of our platform technology." said VolitionRx's president and CEO, Cameron Reynolds.

For the remainder of 2018 into 2019, VolitionRx is targeting several important clinical and commercial milestones.

They include receiving data on both the Triage and the frontline colorectal cancer screening products, securing an additional mid-size US colorectal cancer study to support the US regulatory strategy. Volition is also strengthening their intellectual property rights by obtaining additional key patents in several countries, including in the US.

The Belgium-based company is also securing large prostate trials and announcing a development pathway to commercialization of products for such indications. It is also developing a veterinary product strategy in conjunction with receiving data from trials involving the three most prevalent dog cancers.

BIG PICTURE: VolitionRx's revolutionary Nu.Q blood tests could change the future of cancer screening

Volition is increasing revenue from the sales of Research Use Only kits. Volition is receiving preliminary "proof of concept" data on the validity of its Nu.Q technology platform from trials including the Bonn27 study and the endometriosis study.

"The first Research Use Only kit was launched in August and we expect to add to the range of kits by the end of 2018," Reynolds said.

He said the research and development team in Belgium is "hard at work on the significant task of turning our assays into robust products that can be used worldwide. This development work will be key to our future success and is now very much bearing fruit." The company welcomed Professor Han-Mo Chiu of National Taiwan University, the principal investigator of the Pan-Asian colorectal cancer studies, to its Belgium facility.

Among the highlights in the third quarter, Volition released encouraging preliminary data from a prospective, multi-centered proof of concept study into the utility of Volition's Nu.Q assays to diagnose men with high-grade prostate cancers. At 88% specificity, the Volition assays identified 94% of high-grade prostate cancers that require treatment.

MAJOR CANCER STUDIES UNDERWAY IN ASIA-PACIFIC

The company signed agreements to conduct two large-scale colorectal cancer research studies across the Asia-Pacific region in collaboration with the National Taiwan University. The first study will comprise 5,000 asymptomatic colorectal cancer screening subjects, and the second trial will include up to 2,000 symptomatic colorectal cancer patients.

The studies are being conducted to test and validate Volition's proprietary Nu.Q platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes. The studies will cost approximately $2.55 million payable over three years and should assist product development in Asia in 2019.

Volition has also launched and achieved sales of the Nu.Q Total assay kit, the first of our range of Research Use Only kits through its exclusive global distributor, Active Motif.

"We expect to add further products for Research Use Only during the balance of 2018, building through next year and beyond," the company said in a statement.

Volition began work on the Bonn27 study, which is a 4,500-patient cohort that has been collected by the University of Bonn, Germany, and includes patients with 27 of the most prevalent cancers.

The company started proof of concept work in one of its non-cancer disease areas. This study is in collaboration with the University of Oxford, which has completed a collection of 350 patient samples over the last three years.

READ: VolitionRx moves into veterinary medicine after encouraging study results

Volition expanded its Nu.QTM trials into veterinary diagnostics following encouraging preliminary results from initial proof of concept studies in dogs and more recently horses. Volition announced a pilot study in collaboration with Texas A&M College of Veterinary Medicine & Biomedical Sciences as a first step toward developing a product commercialization strategy.

Reynolds said they have strengthened the company's balance sheet "with completion of a private placement (PIPE) of shares of common stock and a warrant with an existing accredited investor resulting in gross proceeds of $9 million, securing an additional $700,000 in non-dilutive funding from the Walloon Regional Government; and most recently, the exercise of outstanding warrants that provided approximately $717,000 in additional funds to the company."

VolitionRx is a life sciences company focused on developing simple, easy to use, cost-effective blood tests designed to help diagnose a range of cancers.

For the three months ended September 30, 2018, Volition reported a net loss of $4.48 million, or $0.14 per share. This compares to a net loss of $3.89 million, or $0.15 per share, in the third quarter of 2017.


Reporting by Rene Pastor, contactable on [email protected]

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