Conference call to discuss financial and operational results
scheduled for Thursday, March 31, at
8:00am U.S. Eastern Time
·
- Executed global licensing and supply agreement with Heska
Corporation to distribute Nu.Q® Vet Cancer Screening Test at the
Point of Care with a $10 million
upfront payment and up to $18 million
based upon the achievement of near/mid-term milestones.
- Under said agreement will receive ongoing additional revenue
for key components and kits.
- In advanced negotiations with other potential licensing
partners in efforts to make Nu.Q® Vet as accessible as possible
worldwide.
- Expanded its intellectual property portfolio.
- Made significant progress with its
Nu.Q® NETs development.
- Continued progress towards additional new product launches and
licensing in both the human and veterinary spaces worldwide.
- Approximately $20.6 million in
cash and cash equivalents on the balance sheet as of December 31, 2021.
AUSTIN, Texas, March 30, 2022 /PRNewswire/ -- VolitionRx
Limited (NYSE AMERICAN: VNRX) ("Volition") today announced
financial results and a business update for the full fiscal year
ended December 31, 2021.
Volition management will host a conference call tomorrow,
March 31 at 8:00 a.m. U.S. Eastern Time to discuss these
results. Conference call details may be found below.
"I could not be prouder of the team's achievement in securing a
global licensing and supply agreement for our Nu.Q® Vet Cancer
Screening Test with Heska Corporation, one of the industry's
leading companies," commented Cameron
Reynolds, President and Group Chief Executive Officer of
Volition. "Volition Veterinary is an exciting, fast-moving part of
our business with clear potential to generate significant revenue
for the company, initially under our agreements with Heska and SAGE
Healthcare, through both milestone payments and ongoing sales of
kits and key components. We have also made good progress in other
key areas including our Nu.Q® NETs and Nu.Q®
Capture programs as we shift gears towards our goal of becoming a
commercial company with products."
An interview with Cameron
Reynolds, President and Group Chief Executive Officer of
Volition, Dr. Tom Butera, Chief
Executive Officer of Volition Veterinary Diagnostics Development
LLC, and Terig Hughes, Group Chief Financial Officer of Volition:
https://youtu.be/QH2pMGufmWg
Company Highlights
Financial
- Cash and cash equivalents as of December
31, 2021, totaled approximately $20.6
million compared with $19.4
million as of December 31,
2020.
- Subsequent to year end, Volition is due to receive a
$10 million upfront payment as a
result of the execution of the agreement with Heska
Corporation.
- Cash burn rate averaged approximately $2
million per month.
- Net loss for the full year of 2021 was $27 million versus $20.4
million for 2020 with this increase primarily due to
non-cash items in addition to new hire staffing costs.
- Signed our first Nu.Q® Discover agreement in 2021 and
subsequent to year end have signed an additional five agreements
worth an aggregate of approximately $200,000 on a full-year basis.
- Made strong progress in improving internal controls and
processes and anticipate the remaining weakness regarding
segregation of duties in finance will be resolved in 2022.
Commercial Opportunity
- We estimate our annual total addressable market ("TAM") to be
approximately $70 billion worldwide
including Nu.Q® Vet, Nu.Q® Discover, Nu.Q® NETs and Nu.Q®
Cancer.
- All estimates are global and on an annualized basis using key
assumptions as follows:
-
- We estimate the Nu.Q® Vet TAM to be approximately $11 billion based on global canine and feline
populations that are eligible for screening and monitoring and a
price assumption of $50 per test to
the consumer.
- For Nu.Q® Discover we estimate the TAM to be over $200 million using drug pipeline data of
registered clinical trial programs for relevant epigenetic
targets.
- We estimate the Nu.Q® NETs TAM to be approximately $22 billion calculated using estimated hospital
admissions and discharges for sepsis and the associated average
length of stay.
- We estimate our Nu.Q® Cancer TAM to be approximately
$37 billion calculated based on
eligible populations for annual screening, target participation
rates and incidence/prevalence of specific cancers, and risk
stratification use cases.
- Price per test assumptions for Nu.Q® and Nu.Q® NETs range from
$120 for the U.S., $50 for Europe
and $25 for the rest of the
world.
Personnel/ Operational
- To support our commercial expansion, we welcomed Terig Hughes
as our Chief Financial Officer, Gael
Forterre as our Chief Commercial Officer, Dr. Tom Butera as the Chief Executive Officer of our
veterinary subsidiary, and Mr. Nick
Plummer as Group General Counsel.
- In addition, Gaetan Michel was
promoted to Chief Operating Officer and has relocated to the U.S.
to accelerate the development of Volition America.
- Dr. Terry Kelly was promoted to
Chief Innovation Officer and is building a team focused on
cutting-edge, discovery research at our new innovation hub which
opened in California in
March 2022.
Volition Veterinary
- Executed a global licensing and supply agreement with one of
the industry's leading companies, Heska Corporation.
- In exchange for granting Heska exclusive worldwide rights to
sell the Nu.Q® Vet Cancer Screening Test for companion animals at
the Point of Care, Volition will receive:
-
- a $10 million upfront payment on
signing,
- up to $18 million based upon the
achievement of near/mid-term milestones, and
- ongoing additional revenue for key components.
- In addition, Volition has granted Heska non-exclusive rights to
sell the Nu.Q® Vet Cancer Screening Test in kit format for
companion animals, through Heska's network of central reference
laboratories for which Volition will receive ongoing additional
revenue for such kit sales.
- Appointed SAGE Healthcare as a non-exclusive licensee and
distributor of our Nu.Q® Vet Cancer Screening Test for the Asian
market.
- We remain in advanced negotiations with other potential
licensing partners in our efforts to make Nu.Q® Vet as accessible
as possible worldwide and anticipate further announcements in
2022.
- Published two peer-reviewed clinical papers and two abstracts
at the Veterinary Cancer Society Annual Conference including the
first data demonstrating the use of Nu.Q® Vet as a disease
monitoring tool.
Clinical – NETosis including COVID-19
- Volition believes the Nu.Q® NETs assay will have wide
applicability for monitoring diseases with a NETs component (such
as COVID-19, influenza, sepsis, autoimmune diseases, and cancer)
and potentially to risk-stratify patients for treatment
selection.
- Volition expects to register CE marks on its first NETs
product, across multiple platforms including ELISA plate, automated
beads, and a proof of concept on a very high throughput platform by
the summer of 2022.
- Volition intends to register the Nu.Q® NETs product with a
broad almost C-reactive protein (CRP) style claim "for the
detection and evaluation of infection, tissue injury, inflammatory
disorders and diseases associated with NETosis."
- Posters published during 2021 (at the International Society on
Thrombosis and Haemostasis Congress) showed that results on
admission using the same Nu.Q® NETs assay could predict future
COVID-19 disease severity and that serial results correlate with
disease progression including 28-day mortality.
- Further larger studies have been completed in COVID-19 and
sepsis which are now awaiting publication, as well as studies in
other diseases in progress, with results expected in the coming
quarters.
Clinical – Cancer
- Published data at ASCO GI 2022 for two colorectal cancer
studies (asymptomatic and symptomatic populations) conducted with
the National Taiwan University.
- Results demonstrated that using Nu.Q® assays in conjunction
with FIT could potentially reduce unnecessary colonoscopies by up
to 28% in patients with gastrointestinal symptoms and that this
dual approach could also improve the effectiveness of FIT-based
screening programs for asymptomatic patients.
- The Lung Cancer team at the National Taiwan University has
completed collection and preliminary analysis and submitted
abstracts to upcoming conferences.
- Volition has also undertaken active and continuing
negotiations in Asia, in addition
to platform development on its first human cancer launch in
China.
- Collection for the U.S. Early Detection Research Network
("EDRN") study restarted in June 2021
and enrollment has been slow but steady. The EDRN has diverted some
efforts to drive recruitment and it still anticipates study
completion in the fourth quarter of 2022.
- With regards to Volition's U.S. blood cancer studies, the
timing of expected completion for each has been impacted by the
COVID-19 pandemic due to sample collection and protocol
issues.
-
- Given the pandemic, and resultant delays in the larger
Non-Hodgkin Lymphoma ("NHL") study (of 1500 subjects), the Company
has taken the opportunity to upgrade the platform to a
high-throughput platform which will help facilitate an FDA
compliant product. Consequently, Volition now expects this study to
initiate recruitment in the second quarter of 2022 with study
completion anticipated in 2023.
- A smaller, proof of concept NHL monitoring study is ongoing.
However, due to missing serial samples as a result of pandemic
collection issues, we are not in a position to publish yet.
Collection continues and we anticipate analyzing a more complete
data set in 2022.
Nu.Q® Capture
- 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.
- 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.
- Further to the publication in 2021 of a novel method utilizing
Nu.Q® Capture and mass spectrometry, Volition is developing a large
1000-plus patient study in lung cancer and colorectal cancer with
further announcements expected in 2022.
Intellectual Property
- 29 patent families (plus three in-licensed families) covering
both human and animal use of Volition's Nucleosomics™
platform.
- 84 granted patents (12 in the U.S., 14 in Europe, and 58 rest of world).
- 93 patents pending worldwide.
- Continued focus on filings and expect portfolio to grow in the
quarters and years ahead.
Publications
- In 2021, data for the Nu.Q® platform was presented at five
international conferences and Volition has collaborated on four
clinical papers.
- In 2022, to date, two posters were presented at the ASCO GI
2022 conference.
- These publications are another very important step forward for
the Company.
Upcoming Milestones
- 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®
in NETosis, in monitoring disease progression of COVID-19, sepsis,
and potentially other diseases and as a possible companion
diagnostic for a treatment for 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.
VolitionRx Limited Full Fiscal 2021 Financial Results and
Business Update
Date: Thursday, March 31,
2022
Time: 8:00a.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: 13728406
Cameron Reynolds, President and
Group Chief Executive Officer of Volition, will host the call along
with Terig Hughes, Group 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.
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 April 14, 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 13728406.
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 in California and
additional offices in Texas,
London, and Singapore, as the company focuses on bringing
its diagnostic and disease monitoring 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 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
potential benefits under the agreements with Heska and SAGE, the
size of Volition's addressable markets, 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, effectiveness of Volition's
blood-based diagnostic, prognostic and disease monitoring 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, prognostic or disease monitoring
tools for such diseases, the timing of product launches and
publications, and expectations regarding Volition's ability to
transition to a commercial products company, its future revenue and
financial performance. 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, prognostic or disease monitoring 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, prognostic
or disease monitoring 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 and disease monitoring markets and their 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.
Pursuant to the disclosure requirements of the NYSE American
Company Guide Section 610(b), Volition is reporting that its
audited consolidated financial statements for the fiscal year ended
December 31, 2021, included in
Volition's Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 30,
2021, contains an audit opinion from its independent
registered public accounting firm that includes an explanatory
paragraph related to Volition's ability to continue as a going
concern. This announcement does not represent any change or
amendment to Volition's financial statements or to its Annual
Report on Form 10-K for the fiscal year ended December 31, 2021.
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