Conference call to discuss financial and operational results
scheduled for Thursday, August
11, at 8:30 a.m. U.S. Eastern
Time
HENDERSON, Nevada, Aug. 10,
2022 /PRNewswire/ -- VolitionRx Limited (NYSE
AMERICAN: VNRX) ("Volition") today announced financial results and
a business update for the second quarter ended June 30, 2022. Volition management will host a
conference call tomorrow, August 11
at 8:30 a.m. U.S. Eastern Time to
discuss these results. Conference call details can be found
below.
"I am delighted with the progress we are making, and in
particular could not be prouder of the team's achievement in
securing a CE Mark for Nu.Q® NETs in Europe and in announcing new clinical studies
for NETosis, or NETs, in the U.S. with both MD Anderson and with
Diagnostic Oncology CRO LLC, or DXOCRO. As the only analytically
validated test for NETs currently available, we believe that there
is enormous potential for Nu.Q® NETs to support clinical
decision-making, enabling physicians to act quickly, and improve
patient outcomes," commented Cameron
Reynolds, President and Chief Executive Officer of
Volition.
"Following the execution of our global licensing and supply
agreement for the Nu.Q® Vet Cancer Screening Test with Heska
Corporation, the team has been hard at work with the technology
transfer program and launch preparation. We also continue to make
good progress with other potential licensing and supply partners.
Finally, we have recently executed a number of contracts for Nu.Q®
Discover."
Company Highlights
Financial
- Cash and cash equivalents as of June 30,
2022, totaled approximately $16.7
million compared with $20.6
million as of December 31,
2021.
- Subsequent to quarter end, Volition received approximately
$6.4 million net of underwriter's
fees and expenses in cash through an underwritten public offering
of its common stock that closed on August
2.
- Secured a further $1.5 million in
non-dilutive funding from Namur Invest Capital Risk in Belgium to fund an early access program for
Volition's Nu.Q® product portfolio at key sites across the EU, UK,
and U.S.
- Continued to manage expenditures carefully with net cash used
in operating activities averaging approximately $2.1 million per month in the quarter.
Personnel/ Operational
- Appointed Sharon Ballesteros as
U.S. Head of Quality and Development Process to spearhead
Volition's clinical product development program in the U.S. and
expanded her team and operations in California.
Nu.Q® NETs
- Nu.Q® NETs test has been CE marked for the detection and
evaluation of NETosis, enabling clinical use in Europe in both ELISA (enzyme-linked
immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay)
formats.
- Announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to
evaluate the role of NETS in cancer patients with sepsis.
- Appointed DXOCRO to undertake development and clinical
validation studies for Volition's Nu.Q® product portfolio in
the United States.
-
- DXOCRO will conduct large-scale finding studies across multiple
sites in the U.S. using Volition's Nu.Q® NETs and Nu.Q® Cancer
tests to determine clinical utility in sepsis and cancer.
- Volition anticipates that subsequent studies will investigate
the chosen intended use claims of the tests, with the objective to
gain clearance, authorization, or approval from the United States
Food and Drug Administration (the "FDA") and allow the tests to be
marketed in the U.S.
- These multi-site development studies will help demonstrate how
Volition's Nucleosomics™ technology can directly benefit patients
and support our application to the FDA's Breakthrough Devices
Program and a Pre-submission anticipated in 2023.
- In collaboration with researchers at the University of Namur
and QUALIblood in Belgium,
published:
-
- a clinical paper entitled "NETosis and Nucleosome Biomarkers
in Septic Shock and Critical COVID-19 Patients: An Observational
Study", and
- a poster presentation entitled "Evaluation and comparison of
NETosis biomarkers in sepsis and COVID-19 patients" at the
International Society on Thrombosis and Haemostasis (ISTH) Congress
in July.
- Subsequent to quarter end, sponsored a GenomeWeb webinar titled
'The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers
in Inflammatory Disease'. To watch on demand, visit the
GenomeWeb website.
- Commenced a Market Access Program with European Key Opinion
Leaders and early adopters.
Volition Veterinary
- Following the execution of a global licensing and supply
agreement with one of the industry's leading companies, Heska
Corporation, started the technology transfer and launch
preparations with Heska.
- SAGE Healthcare launched the Nu.Q® Vet Cancer Test in
Singapore.
- Advanced negotiations with other potential licensing and supply
partners in efforts to make Nu.Q® Vet products as accessible as
possible worldwide and anticipate further announcements in
2022.
- Expanded product claims with the presentation of new clinical
data at:
-
- the European Society of Veterinary Oncology Congress in May. To
view click here.
- the American College of Veterinary Internal Medicine (ACVIM) in
June. To view click here.
- Expanded access to a larger clinical research laboratory at
Texas A&M University and appointed
a veterinary emergency criticalist to commence work in non-cancer
indications in addition to developing our clinical research network
in Europe.
Nu.Q® Capture
- Nu.Q® Capture, when used in combination with either sequencing,
mass spectrometry and/or Volition's Nu.Q® assays could potentially
aid diagnosis, treatment selection, and both treatment and disease
monitoring in addition to aiding biomarker discovery.
- The Nu.Q® Capture program now has several strands of technology
which:
-
- essentially remove background noise, thereby amplifying the
signal,
- look to identify the signal in a novel way including through
mass spectrometry, or
- isolate various chromatin fragments, including nucleosomes and
transcription factors.
- Sponsored a GenomeWeb webinar entitled "Novel Proteomics
Approach to Epigenetic Profiling of Circulating Nucleosomes"
featuring Professor Axel Imhof. To
watch on demand, visit the GenomeWeb website.
Nu.Q® Discover
- Progressing projects with a range of customers.
- Recently signed contracts with three bio-pharmaceutical
companies who are accessing our assay portfolio for rapid
epigenetic profiling of their drugs in development.
Upcoming Priorities
- Drive near term revenue in the following key areas:
-
- Licensing of its technology, with a particular but not
exclusive focus on Nu.Q® Vet.
- Complete Heska Corporation agreement milestones in order to
receive further milestone payments.
- Sales of key components of Point of Care test with Heska.
- Sales of kits from non-exclusive agreements for the use of
Nu.Q® Vet via central reference labs.
- Ongoing and new Nu.Q® Discover agreements.
- Sales of its disease monitoring tests (e.g. COVID-19,
sepsis).
- Continue to progress the research program for the use of Nu.Q®
NETs, in monitoring disease progression of COVID-19, sepsis, and
potentially other diseases and as a possible companion diagnostic
for the treatment of sepsis.
- Continue to advance its previously announced large-scale blood,
lung, and colorectal cancer trials in Europe, Asia,
and the U.S.
- Publish several abstracts and peer-reviewed scientific papers
with clinical results showing the robustness and utility of its
Nu.Q® platform.
- Advance the development of Nu.Q® Capture.
- Continue to file patents to expand and extend its intellectual
property portfolio.
Event: VolitionRx Limited Second Quarter 2022
Earnings and Business Update Conference
Call
Date: Thursday, August 11,
2022
Time: 08:30 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: 13732149
Cameron Reynolds, President and
Chief Executive Officer of Volition, will host the call along with
Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition
Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor
Relations of Volition. The call will provide an update on important
events which have taken place in the second quarter of 2022 and
upcoming milestones.
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
25, 2022. 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 13732149.
About Volition
Volition is a multi-national
epigenetics company that applies its Nucleosomics™ platform through
its subsidiaries to develop simple, easy to use, cost effective
blood tests to help diagnose and monitor a range of life-altering
diseases including some cancers and diseases associated with
NETosis such as sepsis and COVID-19. Early diagnosis and monitoring
have 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 Nucleosomics™, 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 and monitoring but also has a subsidiary
focused on animal diagnostics and monitoring.
Volition's research and development activities are centered in
Belgium, with an innovation
laboratory and office in the U.S. and additional offices in
London and Singapore.
For more information about Volition, visit Volition's website
volition.com
The contents found at Volition's website address or any other
website link or address are not incorporated by reference into this
document and should not be considered part of this document.
Website addresses and links are included in this document as
inactive textual references only.
Media Enquiries:
Louise
Batchelor/Debra Daglish,
Volition, mediarelations@volition.com +44 (0)7557 774620
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, among other topics,
Volition's expectations related to the launch of product sales with
Heska, the success of negotiations and the timing, completion and
execution of term sheets and/or agreements with third parties
regarding the licensing and distribution of Volition's products,
the timing, completion and delivery of data from clinical studies,
the potential uses, benefits and effectiveness of its Nucleosomics™
technology platform, including the Nu.Q® NETs test, and the timing
and execution of Volition's strategy with the FDA. 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, a failure by the marketplace to accept
Volition's Nu.Q® NETs test or other products based on its
Nucleosomics™ platform; Volition's failure to secure adequate
intellectual property protection; Volition's failure to obtain
necessary regulatory clearances or approvals to distribute and
market future products; Volition will face fierce competition and
its intended products may become obsolete due to the highly
competitive nature of the diagnostics and disease monitoring
markets and their rapid technological change; downturns in domestic
and foreign economies; and other risks, including those 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. For instance, if
Volition fails to develop and commercialize diagnostic, prognostic
or disease monitoring products, it may be unable to execute its
plan of operations. Forward-looking 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 Limited