AUSTIN, Texas, Nov 13, 2019 /PRNewswire/ -- VolitionRx Limited
(NYSE AMERICAN: VNRX) ("Volition") today announced financial
results and a business update for the third quarter ended
September 30, 2019. Volition
management will host a conference call tomorrow, November 13, at 8:30
a.m. U.S. Eastern Time to discuss these results. Conference
call details may be found below.
Cameron Reynolds, President and
Chief Executive Officer of Volition, upon releasing these results,
commented, "I could not be more proud of our dedicated team at
Volition, and the ground-breaking work we are doing. I'm
happy to say that we have made excellent progress this quarter on
our platform development, Nu.QTM Capture,
Nu.QTM Vet and our colorectal cancer and lung cancer
trials, particularly in Asia, and
we reported our first revenues from sales of Research Use Only kits
and the provision of contract research services.
We are an epigenetics company focused on advancing the science
of epigenetics and exploiting these advances in human and animal
health. This has been our mission since our founding, and it is
coming to fruition with our Nu.QTM platform at the very
heart of epigenetics. We believe the last decade of work and our
extensive intellectual property portfolio puts Volition in a strong
position to be a significant player in this field by launching
multiple products."
Click here to view an interview with Volition's Chief Executive
Officer.
Mr. Reynolds further commented "We aim to strengthen our product
pipeline beyond colorectal cancer to cover several cancers, most
notably in lung cancer, and so are especially delighted to have
commenced two studies in lung cancer this quarter, firstly our
large-scale study in lung cancer with the National Taiwan
University and secondly our first study in China with Shanghai Fosun Long March Medical
Science Co. Ltd. We have also expanded our colorectal cancer work
with a first trial in China
underway with Fosun.
I am also delighted to announce that subsequent to quarter end
we executed a contract with Texas A&M
University to collaborate on the research and development of
Nu.QTM Vet products and help drive early revenue in the
all-important veterinary market."
Additionally, Mr. Reynolds added "During the third quarter 2019,
we further strengthened our balance sheet with an existing investor
exercising $4.8 million in aggregate
amount of outstanding warrants to purchase shares of our common
stock making a total of $16.5 million
in warrants exercised during the first three quarters of 2019 and
ended the quarter with cash and cash equivalents of $19.7 million. During the third quarter we
were awarded a further $1.4 million
in non-dilutive grant-funding from the Walloon Region and,
subsequent to quarter end, an additional $500,000 unsecured loan from SOFINEX was
approved. We also recorded our first revenues this quarter
from sales of our Research Use Only kits and the provision of
services."
Company Highlights
Financial
- Cash and cash equivalents as of September 30, 2019 totaled $19.7 million compared to $13.4 million as of the end of 2018.
- Recorded first revenues from the sales of our Research Use Only
kits and from the provision of sample processing services to a
third party.
- Continued to manage cash carefully with an average quarterly
cash burn rate over the first three quarters of 2019 of
approximately $3.6 million.
Clinical Trials
- Commenced our first large-scale lung cancer study in
conjunction with the prestigious National Taiwan University
("NTU"). The study is being conducted under the supervision
of Professor Chen Jin-Shing in the
Department of Surgery of NTU and will include 1,200 subjects
receiving Low-Dose Computed Tomography scans. We expect the first
data from this trial in the first half of 2020.
- Commenced our first studies in China for both lung and colorectal cancer with
Shanghai Fosun Long March Medical Science Co. Ltd.
Organizational
- Completed the formation of a U.S.-based majority-owned
subsidiary, Volition Veterinary Diagnostics Development LLC, to
drive the development and commercialization of Nu.QTM
Vet products and appointed its Chief Executive Officer, Mr.
Nathan Dewsbury.
- Executed agreements with Texas A&M
University's College of Veterinary Medicine to collaborate
on the research and development of Nu.QTM Vet
products.
- Made strong progress in platform development, including the
appointment of a Clinical Validation Expert with more than 15 years
of experience in adapting assays to automated machines to greatly
broaden our product platform range.
Intellectual Property
- Achieved steady growth in our worldwide patent portfolio. We
believe that this is a key differentiator versus many other
technologies either under development or available on the market,
where the patent position may be poor and/or narrow.
20 patent families related to our
diagnostic tests (including both human and veterinary medicine
applications).
8 patents granted in the United States.
7 patents granted in the European
Union.
25 further patents granted
worldwide.
106 patents pending worldwide.
Upcoming Milestones
We expect to achieve the following milestones during 2019 and
through 2020:
- Announce the results of multiple proof of concept cancer
studies, starting in December 2019
and continuing throughout 2020.
- Complete the CE Marking of IVD kits for cancer triage
tests.
- Advance our previously announced large-scale colorectal and
lung cancer trials with a significant number of assays on the
highly analytically accurate automated platform(s).
- Announce preliminary results of Nu.QTM's performance
in other disease conditions.
- Advance the development of Nu.QTM Capture by
determining the level of discrimination of tumor associated
nucleosomes using immunoassays and sequencing.
- Through Volition Veterinary and the collaboration with
Texas A&M, complete the
pre-analytical and discovery studies to determine and announce the
route to revenue for Nu.QTM Vet products.
- Submit abstracts and clinical papers for publication from our
NucleosomicsTM work in a wide range of areas.
Mr. Reynolds concluded, "We are extremely proud of the
accomplishments we have achieved thus far. I thank the dedicated
Volition team for their tireless efforts. I, along with the rest of
the Board and indeed the whole company, look forward to sharing our
progress and the results of key studies over the remainder of 2019
and throughout 2020."
For further details please contact
mediarelations@volition.com.
VolitionRx Limited Third Quarter 2019
Earnings
and Business Update Conference Call
- Date: Wednesday, November 13,
2019
- Time: 8:30 a.m. U.S.
Eastern time
- U.S. & Canada Dial-in: 1-877 407 9716 (toll
free)
- U.K. Dial-in: 0 800 756 3429 (toll free)
- Toll/International: 1-201 493 6779
- Conference ID: 13696533
Cameron Reynolds, President and
Chief Executive Officer of Volition, will host the call along with
David Vanston, Chief Financial
Officer and Scott Powell, Executive
Vice President, Investor Relations. The call will provide an update
on recent developments and Volition's activities, including details
of new and ongoing clinical trials, important events which have
taken place in the third quarter of 2019, and milestones for 2019
and beyond.
About Volition
Volition is a multi-national life sciences company developing
simple, easy to use, cost effective blood tests to help diagnose a
range of cancers and other diseases. Early diagnosis has the
potential to not only prolong the life of patients, but also to
improve their quality of life. The tests are based on the science
of NucleosomicsTM, which is the practice of identifying
and measuring nucleosomes in the bloodstream or other bodily fluid
- an indication that disease is present. Volition is
primarily focused on human diagnostics but also has a
majority-owned subsidiary focused on animal diagnostics.
Volition's research and development activities are centered in
Belgium, with additional offices
in Texas, London and Singapore, as the company focuses on bringing
its diagnostic products to market.
For more information about Volition, visit Volition's website
(http://www.volition.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 Batchelor,
Volition
mediarelations@volition.com
+44 (0)7557
774620
|
Scott Powell,
Volition
investorrelations@volition.com
+1 (646) 650
1351
|
Joseph Green,
Edison Advisors
jgreen@edisongroup.com
+1 (646) 653
7030
|
|
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 timing and availability of clinical data, the completion of
CE marking for certain products, the effectiveness of Volition's
blood-based diagnostic tests as well as Volition's ability to
develop and successfully commercialize such test platforms for
early detection of cancer and other diseases. 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 or the
veterinary markets; a failure by the marketplace to accept the
products in Volition's development pipeline or any other diagnostic
products Volition might develop; Volition's failure to secure
adequate intellectual property protection; 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.
NucleosomicsTM and Nu.QTM 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