ISNES, Belgium, Nov. 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.
-
- The objective is to validate Volition's Nu.Q™ Colorectal Cancer
Screening Test in a large, asymptomatic population for U.S.
regulatory purposes.
- The study provides approximately 13,500 asymptomatic screening
samples of people aged 50 or over who have not previously undergone
screening or a diagnostic colonoscopy.
- The 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.
-
- The 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.
-
- The 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.
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SOURCE VolitionRx Ltd