AUSTIN, Texas, May 8, 2019 /PRNewswire/ -- VolitionRx Limited
(NYSE AMERICAN: VNRX) ("Volition") today announced financial
results and a business update for the first quarter ended
March 31, 2019. Volition management
will host a conference call tomorrow, May
9, 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 they are doing. During
the first quarter, we, together with our collaborators, have made
significant progress, particularly with the work on the basics of
our Nu.QTM platform and its expansion into exciting new
areas."
Mr. Reynolds further commented "We were very happy to report the
initial data from the first of our product grade assays during this
first quarter. 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 executed an
agreement with the National Taiwan University to conduct our first
large-scale study in lung cancer. I am also delighted to announce
that we are in the process of forming a Texas-based subsidiary to focus on the
development and commercialization of our Nu.Q Vet products and help
drive early revenue."
Additionally, Mr. Reynolds added "During the first quarter 2019,
we further strengthened our balance sheet with existing investors
exercising $6.7 million in aggregate
amount of outstanding warrants to purchase shares of our common
stock and end the quarter with cash and cash equivalents of
$16.2 million. Subsequent to the
ending of the quarter, a further $5
million in warrants were exercised for cash, making a total
of $11.7 million in warrants
exercised this year."
Company Highlights
Financial
- Cash and cash equivalents as of March
31, 2019 totaled $16.2 million
compared to $13.4 million as of the
end of 2018.
- An additional $5 million in
aggregate exercise price of warrants (at $3 per share of common stock) were exercised
subsequent to the quarter-end, leaving approximately $4.9 million in aggregate exercise price of
warrants (at $3 per share of common
stock) outstanding with an expiration date of August 10, 2019.
- Continue to manage cash carefully with a cash burn of
$3.9 million in the first quarter of
2019.
Intellectual Property
- Achieved steady growth in worldwide patent portfolio. This is a
key differentiator versus many other technologies either under
development or available on the market, where the patent position
maybe poor and/or narrow.
- 20 patent families related to our diagnostic tests (including
both human and veterinary medicine applications).
- 7 patents granted in the United
States.
- 7 patents granted in the European Union.
- 25 further patents granted worldwide.
- 106 patents pending worldwide.
Proof of Concept Data
- Tested our optimized product grade assays in three separate
small-scale proof of concept cohorts and plan to move onto the
larger clinical trial cohorts that are either in our freezer or the
collection of which is underway. The preliminary results from our
initial optimized product grade assays are as follows:
- In a colorectal cancer cohort (123 subjects), a single Nu.Q assay
detected colorectal cancer with an Area Under the Curve (AUC) of
72% while a two-assay panel had an AUC of 84%, cancer versus
healthy.
- In a lung cancer cohort (76 subjects), a single Nu.Q assay
detected lung cancer, including stage I lung cancer. The AUC for
this single assay was 85%, cancer versus healthy.
- In a second confirmatory lung cancer cohort (152 subjects), the
same single Nu.Q assay also detected lung cancer with an AUC of
79%, cancer versus healthy.
The above proof of concept results give us confidence to move
onto potentially dozens of other assays that we have under
development and the large range of cohorts and trials we have
collected and planned.
- Presented encouraging preliminary results using our Nu.Q
platform in veterinary medicine. Executed a non-binding Memorandum
of Understanding with Texas A&M
University's College of Veterinary Medicine to conduct a
study of Nu.Q Vet. Volition is in the process of establishing a
Texas-based subsidiary to drive
the development and commercialization of Nu.Q Vet products and help
generate early revenue.
- Developed Nu.Q Capture, which investigates the use of
NucleosomicsTM to purify or enrich tumor associated
nucleosomes. Initial studies have demonstrated that Nu.Q Capture
has been able to deplete/enrich nucleosomes by 70-90% using
magnetic beads in serum and plasma. This is a still a work in
progress, but it is a great first step and one that excites our
scientific team.
Clinical Trials
- Added to our extensive clinical trial program with the
execution of a contract to conduct our first large-scale lung
cancer study in conjunction with the prestigious National Taiwan
University ("NTU"). The study will be 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, including 1,000 with lung cancer.
- Executed a non-binding Memorandum of Understanding with
Shanghai Fosun Long March Medical Science Co., Ltd. with the shared
intention to enter into a binding agreement and to conduct three
small-scale clinical trials in China. One of the trials is in lung cancer,
and the others are in colorectal cancer and ovarian cancer, with
preliminary data expected in 2019.
Upcoming Milestones
We expect to achieve the following milestones during 2019 and
beyond:
- Advance our previously announced large-scale colorectal cancer
trials in Europe, the U.S. and
Asia.
- Advance the clinical trial program for Lung Cancer, focusing
initially on the significant need in Asia, most notably in China.
- Through our to be formed Texas-based subsidiary, determine and announce
the route to revenue for Nu.Q Vet with the aim of having a
USDA-approved product in 2020.
- Announce the results of multiple proof of concept cancer
studies to include prostate, pancreatic and ovarian, in addition to
our 27-cancer study, and to initiate larger studies.
- Announce preliminary results of Nu.Q's performance in other
disease conditions, including endometriosis.
- Advance the development of Nu.Q Capture by determining the
level of discrimination of tumor associated nucleosomes using mass
spectrometry and sequencing.
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 the
results of key studies over the coming year."
For further details please contact
mediarelations@volitionrx.com.
VolitionRx Limited First Quarter 2019 Earnings and
Business Update Conference Call
- Date: Thursday, May 9,
2019
- Time: 8:30 a.m. U.S.
Eastern time
- U.S. & Canada Dial-in: 1-855-327-6837 (toll
free)
- U.K. Dial-in: 0 808-101-2791 (toll free)
- Toll/International: 1-631-891-4304
- Conference ID: 10006803
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 first 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's research and development activities are currently
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.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 Batchelor,
Volition
mediarelations@volitionrx.com
+44 (0)7557
774620
|
Scott Powell,
Volition
investorrelations@volitionrx.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 negotiation and execution of a binding agreement with Fosun
Long March Medical Science Co., Ltd. and the timing of availability
of preliminary data under such agreement, 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 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.
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.
View original
content:http://www.prnewswire.com/news-releases/volitionrx-limited-announces-first-quarter-2019-financial-results-and-business-update-300846195.html
SOURCE VolitionRx Ltd