- Launch of first product, the Nu.Q™ Vet Cancer Screening Test
planned for November 30, 2020
- Engaged Diagnostic Oncology CRO LLC to conduct U.S. clinical
trial for Non-Hodgkin's Lymphoma
- Expanded research program for the use of Nu.Q™ technology in
NETosis
AUSTIN, Texas, Nov. 12, 2020 /PRNewswire/ -- VolitionRx Limited
(NYSE AMERICAN: VNRX) ("Volition") today announced financial
results and a business update for the third quarter ended
September 30, 2020. 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 commented: "During the third
quarter, despite the persistence of the COVID-19 pandemic, we have
made significant progress on many fronts and are on track to launch
our first product, the Nu.Q™ Vet Cancer Screening Test, on
November 30. This is a pivotal moment
for Volition, demonstrating that our platform has the reliability
and reproducibility to launch in an independent laboratory."
Mr. Reynolds added, "We have also made considerable progress in
our human cancer program and, in particular, in blood cancer where
we have obtained similar results in both humans and dogs using the
same assay. Based on these promising results, we have engaged
Diagnostic Oncology CRO LLC as a contract research organization to
conduct a U.S. clinical trial for Non-Hodgkin's Lymphoma. I am
proud of the way our team has adapted to the different world we
find ourselves in and has kept working at full speed. It is their
efforts and tenacity that have made possible these milestones and
the many others that we have achieved this quarter and year to
date."
Company Highlights
Financial
- Cash and cash equivalents as of September 30, 2020 totalled approximately
$21 million compared with
$17 million as of December 31, 2019.
- We continue to manage our expenditures carefully, and as we
approach launch and commercialization our burn rate is
approximately $1.6 – $1.7 million per month.
Nu.Q™ Vet Cancer Screening Test Commercial Launch
- Launch date of Nu.Q™ Vet Cancer Screening Test planned for
November 30, 2020.
- This test will initially be positioned for use in the annual
health check of older dogs (those that are seven years and older)
and for cases where there is a high suspicion of cancer.
- The test will be available from the GI Lab at Texas A&M University to potentially thousands
of veterinarians across Texas and
the rest of the U.S.
- Significant potential market opportunity into the millions of
tests per year as there are approximately 77 million dogs in the
U.S.
- Revenue to Volition is expected to be $45 per test and generate a greater than 85%
gross margin.
- Pre-launch marketing efforts are underway, including a report
entitled "A Look to the Future of Cancer Diagnostics" which
compiles contributions from some of the key opinion leaders in the
veterinary oncology space. A downloadable copy is available
here.
Nu.Q™ Vet Cancer Screening Test: Clinical Data
- The Nu.Q™ Vet Cancer Screening Test is a simple, low-cost, easy
to use ELISA based screening blood test which will help streamline
the screening process for up to 1/3 of cancers in dogs including
common malignancies such as lymphoma and hemangiosarcoma.
- Two abstracts were presented at the Veterinary Cancer Society
Virtual Annual Conference in October
2020.
- In a study of over 330 dogs conducted by Texas A&M University, the Nu.QTM Vet
Cancer Screening Test gave good clinical discrimination with an AUC
of 87.3% for lymphoma and 97.6% for hemangiosarcoma.
- At 100% Specificity the Nu.Q™ Vet Cancer Screening Test
demonstrated detection rates of 74% of lymphoma and 89% of
hemangiosarcoma.
Clinical – New US Regulatory Study
- Engaged Diagnostic Oncology CRO LLC, the largest U.S. Contract
Research Organization specializing in oncology purposed in-vitro
diagnostic device clinical trials, to conduct a U.S. clinical trial
for Non-Hodgkin's Lymphoma (NHL).
- The trial is designed to obtain multiple FDA-approved adjunct
tests to aid in the diagnosis of the five most common and
aggressive forms of NHL.
- The trial will enroll up to 1,500 subjects across 10 major U.S.
healthcare institutions over 22 months.
- This extensive program will cost approximately $2.9 million over two years assuming the
completion of numerous projects and includes not only the clinical
study but also data analysis and regulatory and reimbursement
submission preparation.
- Existing data suggests Nu.Q™ technology will greatly aid
physicians in distinguishing NHL from common conditions, fulfilling
what we feel is a critical unmet clinical need which represents a
major market opportunity.
- We expect our first FDA 510K
submission will be possible approximately 10-12 months into the
trial.
Clinical – NETosis including COVID-19
- We have made great progress on the research program for the use
of our Nu.Q™ technology in NETosis and in particular in monitoring
disease progression of COVID-19.
- Several studies have either been collected or are being
negotiated in Europe and we
anticipate the next results will be reported before the end of this
year.
- We are also negotiating a large FDA trial for use of our assays
in neutrophil extracellular traps (NETs) for COVID-19 and influenza
in the U.S. and will announce the full details once they have been
finalized.
- 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 pandemic and potentially other
diseases such as influenza and sepsis.
Expansion
- We are in the final paperwork stages for "Silver One" the
production hub for our products and components close to our Lab in
Belgium.
- Facility will 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.
- We plan to achieve full ISO certification next year.
- Our plan is to produce, at large scale, raw materials such as
recombinant nucleosomes, which act as the calibrant to our Nu.Q™
assays, in addition to antibodies that are key elements to our
branded products. We plan to manufacture our full diagnostic kits
once finalized.
- We expect to offer all elements, including a service lab
provision, for both commercial sale and for clinical trial purposes
and CE-marked products for Europe
and beyond.
- To drive revenue, we have appointed our first Sales Manager who
starts in December.
- We have also opened a small, shared laboratory at California State University in San Marcos,
California where we will focus on blue-sky innovation and discovery
research.
Assay Development and Clinical Studies (Cancer)
- 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 12 Nu.Q™ discovery grade
assays on subsets of both of our National Taiwan University studies
– colorectal and lung cancers - and are working on data
analysis.
- An abstract has been accepted regarding Nu.Q™ performance in
lung cancer detection for presentation at the upcoming IASLC
conference in January 2021. We expect
to submit the colorectal cancer data to upcoming conferences.
Upcoming Milestones
Volition expects to achieve the following milestones during 2020
and beyond:
- Launch of the Nu.Q™ Vet Cancer Screening Test in the U.S.
- Complete the purchase and fit out of "Silver One", to serve as
our manufacturing hub and service lab in Belgium.
- Focus on driving revenue in the coming quarters, where possible
during the pandemic, in four key areas:
- Nu.Q™ Vet products
- Disease monitoring tests (e.g. COVID-19)
- Reagent sales
- 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.
- 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.
- Continue to file patents to expand and extend our Intellectual
Patent portfolio.
VolitionRx Limited Third Quarter 2020 Earnings and Business
Update Conference Call
Date: Friday, November 13, 2020
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: 13713126
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 November 27, 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 13713126.
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 a small laboratory
in California and 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