NAMUR, Belgium, May 11,
2017 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX)
("Volition") today announced financial results for the quarter
ended March 31, 2017 and provided a
business update.
Cameron Reynolds, President and
Chief Executive Officer of Volition, said, "I am delighted with the
progress we are making on many fronts. As I have always said, our
team is extremely important to us and we continue to grow
stronger." Mr. Reynolds continued, "We have kept very close
controls of costs despite the high level of research and
development and marketing activity in a broad range of areas, and
yet again we have completed many milestones on a relatively tight
budget to ensure we use our shareholders' equity carefully. 2017 is
off to a strong start and I am proud of the team's accomplishments
in the first quarter. We look forward to achieving additional
milestones in the second quarter as we ramp up into a commercial
stage company in 2017."
First Quarter 2017 and Recent Company Highlights:
Clinical:
- Successfully completed training and two large validation
studies of the CE Marked Nu.Q™ Colorectal Cancer (CRC) Triage
Test.
-
- Presented initial data at the European Society for Medical
Oncology (ESMO) in October 2016 and
the World Congress of GI Endoscopy (ENDO) in February 2017.
- Presented final data set at the Digestive Disorders Week (DDW)
conference in Chicago earlier this
week.
- Demonstrated that with the total combined data set of just
under 8,000 subjects, the Nu.Q™ CRC Triage Test identified a
reduced need for colonoscopies by 24.5% (as compared to the current
standard screening test, the faecal immunochemical test (FIT),
alone) with a sensitivity for CRC detection of approximately 95% of
the cancers.
- Expanded into Asia with the
first clinical evaluation of the Nu.Q™ CRC Triage Test underway in
Taiwan.
Regulatory:
- Initiated the regulatory acceptance process in both
Taiwan and Singapore, with the latter, once approved,
granting Volition access to nine other South Asian markets.
Operational:
- Launched the new research and development facility in the
Walloon Region of Belgium
increasing Volition's capacity to both run large-scale clinical
trials and extend Volition's efforts into other cancers, notably
pancreatic, lung, and prostate
- Formed Volition America, Inc., a U.S. subsidiary, to have a
dedicated team in the U.S. whose sole purpose will be FDA clinical
trial development and the launching of a range of products in the
U.S. over the coming years.
-
- Volition America, Inc. will be led by Volition's Chief Medical
Officer, Dr. Jason Terrell, and is
based in Austin, Texas.
- Named Dr. Jasmine Kway, Ph.D. as
Vice President of Volition Asia.
- Named David Vanston MBA FCCA as Chief Financial Officer.
- Additionally, added several key hires to the R&D and
marketing teams as Volition continues to develop and market new
products.
First Quarter 2017 and Other Financial Results
For the three months ended March 31,
2017, Volition reported a net loss of $3.35 million, or $0.13 per share. This compares to a net loss of
$2.49 million, or $0.13 per share for the quarter ended
March 31, 2016.
Cash and cash equivalents as of March 31,
2017 totaled $18.5 million,
compared to $21.7 million as of
December 31, 2016 and $17.0 million as of March
31, 2016.
Volition's Chairman as well as several Board Directors and
Officers have recently further extended their shareholdings by
exercising warrants for aggregate cash proceeds to Volition of
approximately $400,000 in cash,
providing additional support to our cash position.
Upcoming Milestones:
Looking ahead to the rest of 2017, Volition is targeting several
important clinical and commercial milestones, including, among
others:
- A step change in both discovery and R&D work, in CRC and
other cancers, due to significantly increased capacity in
Volition's new Walloon facility.
- With regards to the Nu.Q™ CRC Triage Test,
-
- Results of the Logistics and Pathway design study currently
underway in Denmark, which will
hopefully answer the questions required for a product launch in
Denmark.
- Results of the evaluation currently underway in Taiwan.
- Publication of validated product results in a well-regarded
journal.
- Additional key patents in several countries, including the
U.S., as Volition expands intellectual portfolio to strengthen
shareholder value.
- Further non-dilutive grant funding connected to the Walloon
Region in Belgium.
- Volition America to provide an update on a clear and affordable
pathway to FDA approval of a colorectal product.
Conference Call
Volition will host a conference call today, May 11, 2017 at 8:30 a.m.
Eastern time to discuss its financial and operating results
for the first 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
13661851.
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 and more widespread,
our 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,
New York, 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/volitionrx-limited-announces-first-quarter-2017-financial-results-and-business-update-300455882.html
SOURCE VolitionRx Limited