ISNES, Belgium, Aug. 9, 2017 /PRNewswire/ -- VolitionRx
Limited (NYSE AMERICAN: VNRX) ("Volition") today announced
financial results and a business update for the quarter ended
June 30, 2017. Volition management
will host a conference call to discuss these results and provide a
further business update tomorrow, August 10,
2017 at 8:30 AM U.S. Eastern
Time.
Cameron Reynolds, President and
Chief Executive Officer of Volition, said, "We have had numerous
highlights this quarter, with strong progress being made on many
fronts. I am delighted with the growing strength of new talent in
our team, especially the growth in our Research and Development
Team in Belgium. We are also
fortunate to be working with institutions and individuals who have
brilliant reputations." Mr. Reynolds continued, "We continue to
announce large trials, such as the recent signing of a 13,500
patient U.S. trial in colorectal cancer. We believe that this most
recently announced trial, with a cost to us of only $3 million, represents an exceptional value for
our money. We look forward to achieving additional milestones in
the upcoming quarters and sharing further exciting news."
Second Quarter 2017 and Recent Company Highlights
Clinical
- Signed 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 (NCI) Early
Detection Research Network (EDRN).
- The aim of this study is to validate
Volition's Nu.Q™ Colorectal Cancer Screening Test, in a large,
asymptomatic population for U.S. regulatory purposes.
- The study will provide
approximately 13,500 asymptomatic screening samples of people aged
50 or over who have not previously undergone screening or a
diagnostic colonoscopy.
- Volition America, Inc., a
subsidiary of Volition, will contribute up to $3 million towards the study which will last 2-3
years, and will be paid in equal installments over a 3-year
period.
- The publication of a research paper in Clinical
Epigenetics, entitled, "Circulating nucleosomes as new
blood-based biomarkers for detection of colorectal cancer," which
reported that our four Nu.Q™ assays demonstrated Colorectal
Cancer detection accuracy of 74% sensitivity at 90% specificity.
The study also showed that by including age as a variable, the
accuracy of CRC detection increased to 91% of cancers at 90%
specificity.
Regulatory
- Initiated the regulatory acceptance process in both
Taiwan and Singapore, with the latter, if approved,
granting Volition access to nine other South Asian markets.
Operational
- Opened a new R&D facility in Belgium's Walloon Region, increasing
Volition's capacity to both run large-scale clinical trials and
extend efforts into other cancers, notably pancreatic, lung and
prostate.
- Formed Volition America, Inc., an Austin, Texas-based wholly-owned subsidiary
whose main purpose is FDA trial development and the launching of a
range of products in the U.S. over the coming years.
- Appointed Mr. David Vanston as
Chief Financial Officer of Volition.
- Hired several key employees to the R&D team.
Second Quarter 2017 and Other Financial Results
For the three months ended June 30,
2017, Volition reported a net loss of $3.5 million, or $0.13 per share. This compares to a net loss of
$2.90 million, or $0.13 per share in the second quarter of
2016.
Cash and cash equivalents as of June 30,
2017 totaled $16.5 million,
compared to $18.5 million as of
March 31, 2017 and $14.5 million as of June
30, 2016.
Upcoming Milestones
In the second half of 2017, Volition is targeting several
important clinical and commercial milestones, including, among
others:
- Regarding studies which are currently in progress:
- Results of the Logistics and
Pathway design study currently underway in Denmark.
- Results of the clinical
evaluation currently underway in Taiwan.
- Updates on the frontline CRC screening product.
- Further clinical data on at least one of the other targeted
cancers.
- Additional key patents in several countries, including
the United States.
- Further non-dilutive grant funding anticipated from the Walloon
Region in Belgium.
Conference Call
Volition will host a conference call tomorrow, Thursday, August 10, 2017 at 8:30 AM Eastern Time, to discuss its financial
and operating results for the second 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
13668238.
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.Q™ 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.
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SOURCE VolitionRx Ltd