AUSTIN, Texas, August 13, 2020 /PRNewswire/ -- VolitionRx
Limited (NYSE AMERICAN: VNRX) ("Volition") today announced
financial results and a business update for the second quarter
ended June 30, 2020. Volition
management will host a conference call tomorrow, August 14 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, "During the second quarter, given the persistence of the
COVID-19 pandemic, we focused on two key areas to try and mitigate
the effects of lockdowns and allow us to keep moving towards our
first commercial products utilizing our cutting edge Nu.Q™
platform. Firstly, we significantly strengthened our balance sheet
to ensure we have sufficient capital to work on our many programs
concurrently, and launch products where possible during the
pandemic. Secondly, we have increased the flexibility of our supply
chain of key components and are moving towards producing our key
components in house. Cancer remains our core disease focus,
however, we have discovered that our technology potentially has
applications beyond just cancer, for example with COVID-19."
https://youtu.be/EU0yrbMLgj4
An interview with Cameron Reynolds, President and Chief Executive
Officer.
Mr. Reynolds added, "I am proud of the way our team has adapted
to the different world we find ourselves in and kept on working at
full speed, their fantastic efforts have put us in an excellent
position as we move towards the launch of our first products
expected later this year and early next year."
Company Highlights
Financial
- Cash and cash equivalents as of June 30,
2020 totalled approximately $21.3
million compared with $12
million the previous quarter.
- Raised $13.8 million in gross
proceeds in an underwritten public offering.
- Periodically sold shares of our common stock pursuant to our
previously disclosed "At The Market" equity offering program, or
"ATM", under our existing registration statement along with our
Rule 10b5-1 plan. Through the end of the second quarter of
2020 we had raised approximately $1.7
million in gross proceeds under the ATM.
- During July and the first week of August we raised an
additional approximately $4.7 million
in gross proceeds through the ATM.
- Volition was added to both the Russell 3000® and Russell
Microcap® Indexes in June.
Product Production Facility
- Submitted an offer to purchase a neighboring facility in
Belgium known as "Silver One". We
expect this facility to be the production hub of all of our
products and components, to both secure our own supply at a lower
cost, and to drive reagent revenue building on our purchase of
Octamer GmbH (now called Volition Germany) earlier this year.
Clinical – COVID-19
- The preliminary study results reported in May demonstrated the
Area Under the Curve (AUC) for a single Nu.Q™ assay was 98.7% PCR
positive versus control subjects, with 100% sensitivity at 94%
specificity. A second Nu.Q™ assay also showed promising results
with an AUC of 86.2%.
- To date we have now tested two independent cohorts of COVID-19
positive patients with quantitative nucleosome immunoassays and
found that nucleosomes were highly elevated in plasma of severe
COVID-19 patients relative to healthy control subjects and
importantly, that both histone 3.1 variant and citrullinated
nucleosomes increased with disease severity.
- Given that the highest levels of nucleosomes were found in
patients requiring artificial ventilation or extracorporeal
oxygenation, we believe that nucleosomes could serve as a guiding
biomarker for disease severity in COVID-19 positive patients.
- These data imply that Nu.Q™ could have strong prognostic
potential, and so we are now focused on the completion of larger
longitudinal studies that would be needed to support a potential
COVID-19 product launch.
- Our collaborators have submitted this data for peer-review and
we look forward to its publication.
- We have filed a novel patent for this application and plan to
utilise results of these trials and other ongoing studies to
further our aim of developing a clinically useful product to help
in the battle against the COVID-19 global pandemic and potentially
other diseases such as influenza and pneumonia.
Clinical- Veterinary
- In a proof of concept study conducted by Texas A&M University, a single Nu.Q™ Vet assay
detected almost 70% of both Canine Hemangiosarcoma and Canine
Lymphoma with AUCs of 84.5% and 83.1% cancer versus healthy,
respectively, at a specificity of 90%. These two cancers alone
represent almost a third of all canine cancers.
- Based on the results of this study, we plan to move forward
with other Nu.Q™ Vet assays in our pipeline, and with the larger
range of cohorts and trials that we have collected and
planned.
- The first Nu.Q™ Vet products expected to be launched late
in 2020 are likely to be for blood and lymphoma remission
monitoring and we then aim to target additional uses (such as
remission monitoring for other cancers and for diagnosis itself) in
2021.
Assay Development and Clinical Studies (Cancer)
- We exceeded our target of 12 assays being finalized by the end
of the second quarter with respect to our fully-automated magnetic
bead-based chemiluminescent format. To date, 13 assays have been
developed and are being tested in our clinical research programs.
We plan to reach a total of 20 by the end of 2020.
- In various ways our "Marquee trials" have now been affected by
the continued pandemic either by slower or paused collection, or a
host of other supply chain or travel and communication issues. We
believe we have successfully managed those areas under our direct
control (such as assay development and running samples – both on
track with our milestones) but many issues are not within our
control.
- We have now successfully completed 8 assays on subsets of both
of our National Taiwan University studies – colorectal and lung
cancers - and are working on data analysis. We expect over this
coming quarter to run an additional number of assays and to submit
the data at upcoming conferences.
Epigenetic Toolbox
- We have developed and are seeking patents on our novel Nu.Q™
Capture-based epigenetic tools. We are using these tools to
expand diagnostic developments that focus on circulating DNA
fragment analysis, leading to a broader and potentially more
powerful investigation of the epigenetic status of a patient's
circulating chromosome fragments. We have made significant progress
with this work and will continue to publicise data as it is
completed in the coming quarters.
Publications
- The second quarter was the best quarter ever from a
publications point of view.
- We had three abstracts published at ASCO, the American Society
for Clinical Oncology, including data in both lung and blood
cancers.
- We have received acceptance for oral presentation of two
abstracts at the Veterinary Cancer Society Meeting in October this
year.
- A Nu.Q™ Vet paper regarding pre-analytics has been submitted
for peer review and accepted for publication.
- Three papers have been submitted by collaborators using our
Nu.Q™ technology, for lung disease, for complications during
pregnancy and for COVID-19, yet again showing the wide adaptability
of our platform.
- We have other papers in process, including a pre-analytics
paper for humans that we expect to submit over the next couple of
months, and two papers from the Nu.Q™ Capture program on mass
spectrometry and also sequencing.
Upcoming Milestones
Volition expects to achieve the following milestones during 2020
and beyond:
- We will focus on driving revenue in the coming quarters, where
possible during the pandemic, in 4 key areas:
-
- Our four potential triage tests (3 cancers and COVID-19);
- Nu.Q™ Vet products;
- Reagent sales; and
- Licensing of our technology for others to commercialize.
- Continue to advance our previously announced large-scale
colorectal and lung cancer trials in Europe, Asia
and the U.S.
- Commission and complete longitudinal studies for COVID-19.
- Publish several abstracts and peer reviewed scientific papers
with clinical results as well as showing the robustness and utility
of our Nu.Q™ platform.
- Advance the development of Nu.Q™ Capture
- Announce patient data demonstrating the wide utility of our
epigenetic toolbox.
- Complete the purchase and fit out of "Silver One", to serve as
our manufacturing hub and service lab in Belgium.
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 especially given the
challenging circumstances we all face during the COVID-19 pandemic.
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@volition.com
VolitionRx Limited
Second Quarter 2020 Earnings
|
and Business
Update Conference Call Date: Friday, August 14,
2020
|
|
Time: 8:30
a.m. 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:
13707978
|
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.
A live audio webcast of the conference call will also be
available on the investor relations page of Volition's corporate
website at http://ir.volition.com. In addition, a telephone replay
of the call will be available until August
28, 2020. The replay dial-in numbers are 1-844-512-2921
(toll-free) in the U.S. and Canada
and 1-412-317-6671 (toll) internationally. Please use replay pin
number 13707978.
About Volition
Volition is a multi-national epigenetics 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 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
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
|
Jen Lewis,
Pegasus
jen.lewis@thisispegasus.co.uk
+44 (0)7809
867943
|
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, completion and delivery of data from clinical
studies, the effectiveness of Volition's blood-based diagnostic and
prognostic tests, Volition's ability to develop and successfully
commercialize such test platforms for early detection of cancer and
other diseases as well as serving as a diagnostic or prognostic
tool for COVID-19, the timing of product launches and publications,
and the timing and completion of the acquisition of the additional
facility in Belgium. Volition's
actual results may differ materially from those indicated in these
forward-looking statements due to numerous risks and uncertainties,
including, without limitation, results of studies testing the
efficacy of its tests. For instance, if Volition fails to develop
and commercialize diagnostic or prognostic 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; a failure by the marketplace to accept the products in
Volition's development pipeline or any other diagnostic or
prognostic 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; downturns in domestic
and foreign economies; 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™ and Nu.Q™ 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