VolitionRx Limited Announces Third Quarter 2017 Financial Results and Business Update

 

ISNES, Belgium, November 9, 2017 /PRNewswire/ -- VolitionRx Limited (NYSE American: VNRX) today announced financial results and a business update for the third quarter ended September 30, 2017. Volition management will host a conference call tomorrow, November 10, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

 

Mr. Cameron Reynolds, President and Chief Executive Officer of Volition, said, “We have made fantastic progress this quarter, moving our clinical product development strongly forward in Asia, Europe and the U.S, and broadening our potential revenue base with our recently announced research kit sales. We have further expanded our talented scientific team, with four new hires to the R&D team, financially supported by the local government in Belgium.” Mr. Reynolds added, “We continue to announce large trials at very affordable costs in our efforts to gain worldwide adoption of our products. We look forward to achieving our upcoming clinical and commercial milestones, while continuing to keep close control on our cash burn, which has remained relatively stable.”

 

Third Quarter 2017 and Recent Company Highlights

 

Clinical

 

As the cornerstone of our frontline screening colorectal cancer test for the all-important U.S. market, we entered into an agreement to participate in a large, multi-center study with the Great Lakes New England Clinical Validation Center, funded by the U.S. National Cancer Institute’s Early Detection Research Network. 

 

oThe objective is to validate Volition’s Nu.Q™ Colorectal Cancer Screening Test in a large, asymptomatic population for U.S. regulatory purposes. 

oThe study provides approximately 13,500 asymptomatic screening samples of people aged 50 or over who have not previously undergone screening or a diagnostic colonoscopy. 

oThe study will come at a cost of no more than $3 million, paid in equal, quarterly installments. 

 

Intellectual Property

 

We secured four additional patents, in the U.S., Europe, Mexico and Australia, further solidifying Volition’s intellectual property portfolio worldwide.  

 

oThe patents are complementary to those previously granted. Volition now has 5 granted patents in the U.S. and 8 more patents in other territories. 

 

Operational

 

In line with our goals to best utilize our Nucleosomics® platform and to broaden our revenue base, we announced the initial order of a bespoke Nu.QTM clinical research use only kit from a large multi-national pharmaceutical company together with plans to launch a range of Nucleosomics® clinical research use only kits in the first half of 2018.  

 

oThe kits based on our proprietary Nucleosomics® technology are expected to:  

 

allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes across a broad range of clinical applications including cancers, inflammatory and infectious diseases. The kits can be used for many purposes, for example as an aid to drug development and treatment selection.  

represent the first revenue from the Nu.QTM platform and potentially provide an additional licensing revenue stream beyond the commercialization of our blood-based cancer tests on the same platform of assays. 

 

We commenced a project to investigate the use of Nucleosomics® to purify or enrich nucleosomes from cancer. This aims to provide purified circulating tumor DNA to help address the main technology barrier in this emergent field of cancer diagnostics. 

 

We were awarded $1.5 million in non-dilutive funding from SOFINEX and the Walloon Region of Belgium, bringing the total amount of non-dilutive funding from various agencies in the region to nearly $2.5 million. 


Third Quarter 2017 and Other Financial Results

 

For the three months ended September 30, 2017, Volition reported a net loss of $3.89 million, or $0.15 per share. This compares to a net loss of $3.48 million, or $0.15 per share in the third quarter of 2016.

 

Cash and cash equivalents as of September 30, 2017 totaled $13.84 million, compared with $12.53 million as of September 30, 2016.

 

Upcoming Milestones

 

Volition is targeting several important clinical and commercial milestones, including:

 

Selection of the panel for our frontline Nu.QTM Colorectal Cancer Screening Test by the end of 2017. This panel will be subject to validation in a 4,300-subject trial in the first quarter of 2018 followed by a more than 10,000 subject cohort in second quarter of 2018. It is expected that the product will have CE marking by the third quarter of 2018, which would allow the sale of the product in all 28 European Union countries (where there is a total screening market of over 150 million persons).  Regulatory approval will follow in Asia in early 2019. 

In line with our strategy to launch colorectal cancer products worldwide through working with world-class collaborators on large, cost effective trials, we hope to announce our clinical trial program in Asia. 

Completion of the Logistics and Pathway design study currently underway in Denmark.  

Launch of the Total Nucleosome Assay Research Use Only kit with an extended range in the first quarter of 2018, with increased revenue expected commencing in the second quarter of 2018. 

Update on our progress utilizing Nucleosomics® to purify or enrich nucleosomes of tumor origin. 

Obtaining additional non-dilutive funding. 

 

Conference Call

 

Volition will host a conference call tomorrow, November 10, at 8:30 a.m. U.S. Eastern Time, to discuss its financial and operating results for the third quarter of 2017, and to provide an update on recent developments. To participate in the call, please dial 1-877-407-9716 (toll-free) in the U.S., 0-800-756-3429 (toll-free) in the U.K., and 1-201-493-6779 (toll) internationally. A live audio webcast of the conference call will also be available via link from the investor relations page of Volition's corporate website at http://ir.volitionrx.com/. The conference ID is 13673016.

 

The call will be hosted by Cameron Reynolds, President and Chief Executive Officer, along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President.

 

About Volition

 

Volition is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

 

As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life.

 

Volition's research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.

 

For more information about Volition, visit Volition's website (http://www.volitionrx.com) or connect with us via:

 

Twitter: https://twitter.com/volitionrx

LinkedIn: https://www.linkedin.com/company/volitionrx

Facebook: https://www.facebook.com/VolitionRx/

YouTube: https://www.youtube.com/user/VolitionRx

 

The contents found at Volition's website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document.  The addresses for Volition's website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.


Media / Investor Contacts

 

Louise Day, Volition

L.day@volitionrx.com

+44 (0)7557 774620

Scott Powell, Volition

S.powell@volitionrx.com

+1 (646) 650 1351

Tirth Patel, Edison Advisors

tpatel@edisongroup.com

+1 (646) 653 7035

Rachel Carroll, Edison Advisors

rcarroll@edisongroup.com

+44 (0)20 3077 5711

 

Safe Harbor Statement

 

Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition’s bodily-fluid-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

 

Nucleosomics®, NuQ®, Nu.QTM and HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

 

View differences made from one to another to evaluate Volitionrx Ltd's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Volitionrx Ltd.

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account