NAMUR, Belgium, Aug. 11,
2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), a
life sciences company focused on developing diagnostic tests for
cancer and other conditions, today announced financial results for
the second quarter ended June 30,
2016.
Second Quarter 2016 and Recent Company Highlights:
Clinical:
- Presented highly-encouraging study results demonstrating NuQ®'s
ability to detect 71% of early stage I prostate cancer cases at 93%
specificity at the American Association of Cancer Research (AACR)
Annual Meeting;
- Initiated study with the German Cancer Research Center (DKFZ)
to evaluate NuQ®'s ability to detect pancreatic cancer following
encouraging data from two previous pancreatic cancer pilot
studies;
- Published study confirming stability of circulating cell-free
nucleosomes (cfnucleosomes) as biomarkers in cancer, highlighting
NuQ®'s low cost and ease of use. Importantly this study
demonstrates that no special blood draw requirements are needed;
and
- Presented data from three clinical trials demonstrating NuQ®'s
ability to detect colorectal cancer and adenomas at the World
Endoscopy Organization (WEO) Colorectal Cancer Screening
Meeting.
Regulatory:
- New CE marks for two NuQ® biomarker assays, NuQ®V001 and
NuQ®T003, to detect the presence of colorectal cancer signatures,
allowing their clinical use in 28 European countries; and
- Granted a 4th key U.S. patent for the Nucleosomics®
platform's ability to detect nucleosomes in blood circulation.
Operational:
- Appointed Louise Day as Chief
Marketing and Communications Officer in preparation for the
commercial launch of NuQ® in Europe and the U.S.;
- Appointed Dr. Edward Futcher,
Ph.D., to Board of Directors; and
- Engaged Edison Advisors to strengthen investor relations and
broaden global visibility.
Cameron Reynolds, President and
Chief Executive Officer of VolitionRx, said, "CE marking another
two of our biomarker assays, NuQ®V001 and NuQ®T003, which brings
the total to three CE marks, helps clear the regulatory path for
transition into a commercial-stage company. With the expected
launch of our first NuQ® blood test later this year in Europe, our efforts over this and the upcoming
quarter are focused not only on meeting these regulatory hurdles,
but also making the key management appointments to ensure a
successful launch."
"With respect to our first commercial product launch, the
Company expects to be making announcements during September and
October to discuss this in greater detail, including the specific
role it will play in the screening regimen for specific countries
and our market entry strategy. We have already begun our branding
and labeling processes for our initial commercial product and have
engaged a branding agency to assist us with the launch. We aim to
have this product CE marked by the end of this year, making it
potentially saleable in 2017 in all 28 EU countries."
Jake Micallef, Ph.D., MBA, Chief
Scientific Officer of VolitionRx, said, "We have had several
important clinical accomplishments for NuQ® in this second quarter
of 2016. The publication of our study in the Scandinavian
Journal of Clinical and Laboratory Investigation confirms that
results of our NuQ® test are the same regardless of when and how
blood samples are taken due to the discovered stability of
circulating cfnucleosomes, a key highlight of the viability and
ease-of-use of our platform. At the World Endoscopy
Organization (WEO) Colorectal Cancer Screening Meeting,
Jason Terrell, M.D., Volition's
Chief Medical Officer and Head of U.S. Operations, presented data
from our targeted clinical trial of 430 pre-cancerous colorectal
adenoma patients with Hvidovre Hospital and the University of Copenhagen that demonstrated a panel
of five NuQ® biomarker assays in an age-adjusted algorithm detected
75% of high-risk colorectal adenomas and 86% of stage I colorectal
cancers. These are our highest adenoma detection rates yet,
and they demonstrate the power of NuQ®, not only for the detection
colorectal cancer, but also for pre-cancerous polyps."
Second Quarter 2016 Financial Results
For the three months ended June 30,
2016, VolitionRx reported a net loss of $2.9 million, or $0.13 per share. This compares to a net loss of
$1.9 million, or $0.10 per share in the second quarter of
2015.
Cash and cash equivalents as of June 30,
2016 totaled $14.5 million,
compared with $17.0 million as of
March 31, 2016 and $5.9 million as of December 31, 2015.
Conference Call
As a reminder, Cameron Reynolds,
Chief Executive Officer, will host the Company's Q2 earnings
conference call today, Thursday, August
11th, 2016 at 8:30 am U.S.
Eastern Time. To participate in the call, please
dial 1-800-946-0706 (toll-free) in the U.S. and
Canada,
and 1-719-325-2352 (toll) internationally. The
conference ID number for both is 1996014. A
live audio webcast of the conference call will also
be available via link on the investor relations page
of VolitionRx's corporate website at http://ir.volitionrx.com.
About VolitionRx
VolitionRx is a life sciences company focused on developing
diagnostic tests for cancer and other conditions. 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.
VolitionRx's goal is to make the tests as common and simple to
use, for both patients and doctors, as existing diabetic and
cholesterol blood tests. VolitionRx's research and development
activities are currently centered in Belgium as the company focuses on bringing its
diagnostic products to market first in Europe, then in the U.S. and ultimately,
worldwide.
Visit VolitionRx's website (http://www.volitionrx.com) or
connect with us via Twitter, LinkedIn, Facebook or YouTube.
Media / Investor
Contacts
|
|
|
|
Louise Day,
VolitionRx
|
Scott Powell,
VolitionRx
|
L.Day@volitionrx.com
|
S.Powell@volitionrx.com
|
+44 (0)7557 774
620
|
+1 (646)
650-1351
|
|
|
Tirth Patel, Edison
Advisors
|
Katherine Fennell,
Edison Advisors
|
tpatel@edisongroup.com
|
kfennell@edisongroup.com
|
+1 (646) 653-7035
|
+44 (0) 20 7841
1556
|
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 the Company's bodily-fluid-based diagnostic
tests as well as the Company's ability to develop and successfully
commercialize such test platforms for early detection of cancer.
The Company's actual results may differ materially from those
indicated in these forward-looking statements due to numerous risks
and uncertainties. For instance, if we fail to develop and
commercialize diagnostic products, we may be unable to execute our
plan of operations. Other risks and uncertainties include the
Company'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
the Company's development pipeline or any other diagnostic products
the Company might develop; the Company will face fierce competition
and the Company'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 the Company's
most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, as well as other documents that the Company files with
the Securities and Exchange Commission. These statements are based
on current expectations, estimates and projections about the
Company'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, the
Company does not undertake an obligation to update its
forward-looking statements to reflect future events or
circumstances.
Nucleosomics®, NuQ® 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/volitionrx-announces-second-quarter-2016-financial-results-and-business-update-300312040.html
SOURCE VolitionRx Ltd