LONDON and DUBAI, UAE ,
June 14,
2023 /PRNewswire/ -- Virax Biolabs Group Limited
("Virax" or the "Company") (Nasdaq: VRAX), an innovative
diagnostics company focused on the detection of immune responses
and diagnosis of viral diseases, announced that Mr. James
Foster, Chairman of the Board & Chief Executive Officer of
Virax, has issued a letter to shareholders.
Dear Fellow Shareholders
As we reach the mid-year mark of 2023, I am pleased to provide
you with an update on the exciting developments at Virax and
disclose for the first time, a comprehensive outline of the
upcoming milestones for ViraxImmune™, and ongoing progress of
ViraxClear™.
ViraxImmune™
We believe our ViraxImmune™ platform will shift the way
individuals are able to manage aspects of their immune health,
moving testing and diagnostics from event-driven to a proactive and
preventative approach. ViraxImmune™ will empower patients to take
control of their health and make informed decisions on how to
respond to current and future viral threats.
ViraxImmune™ assesses susceptibility to viral threats by
measuring individuals' specific T-Cell response to viruses. T-Cells
are responsible for long-term immunity and the level of T-Cell
response correlates with the level of immune protection an
individual may already have due to prior disease exposure.
Individuals will be able to order ViraxImmune™ kits and have
blood drawn at a convenient location that can then be sent to a
laboratory for analysis using our proprietary technology. Results
will then be delivered directly to an individual through our
ViraxImmune™ Mobile Application, providing them an immune
profile for a number of viruses.
We are using COVID-19 as our first target for the in vitro
diagnostic T-Cell tests to prove the effectiveness of our
technology. This will then allow us to adapt to additional
pathogens, whether variants of existing pathogens or new ones, as
they emerge. A subscription that can be purchased through our
mobile application will allow the community of ViraxImmune™
customers to test their immune responses to the most prevalent
viral threats each year before they come into contact with them.
This will allow customers to make informed decisions on their
immune risk and provide them actionable results with convenience,
high accuracy, and affordability.
In addition to gaining insights into one's own personal immune
health, we intend to pursue partnerships with academic labs engaged
in viral studies, as well as pharmaceutical companies and Clinical
Research Organisations who may need T-Cell tests as a pre-screening
tool for clinical trials. By leveraging both business-to-business
and direct-to-consumer, we plan to capitalize on the opportunities
for ViraxImmune™.
Our Anticipated Timeline for ViraxImmune™
For ViraxImmune™, we are focused on important milestones and
initiatives, including stability of clinical samples – as we expect
ViraxImmune™ technology to allow the use of a broad range of
samples – improving the accuracy and precision of our COVID-19
test, and the completion of our clinical performance
study.
The clinical protocol for the clinical performance study
will soon be reviewed during our FDA pre-submission to satisfy the
501(k) requirements. This clinical performance study is intended to
take place in multiple sites located in the United States, European Union, and
United Kingdom in order to
facilitate the access to United
States and European Union markets through the FDA and IVDR
pathways. Regular announcements will be made as the study
progresses and we expect to announce full results in the fourth
quarter of 2023.
Once the clinical performance study is complete and we are
satisfied with the results, we can immediately start applications
in the first quarter of 2024 to seek compliance with United States (FDA 501(k)), European Union
(IVDR), United Kingdom (MHRA) and
Canadian (HC) regulations. In parallel to our 510(k) application,
we are working toward the obtention of the FDA's Clinical
Laboratory Improvement Amendments (CLIA) approval for the first
quarter of 2024.
While commercialization entirely relies on regulatory bodies
approval, we are confident that we would be able to access most
markets in the second quarter of 2024. However, due to the lack of
European IVDR notified bodies, delays in the review of our
technical documentation can be expected. Therefore, we have adopted
a precautionary approach and aim to obtain European CE marking in
the fourth quarter of 2024.
We expect that ViraxImmune™ will be initially available for
research use only (RUO) in the fourth quarter of 2023 before the
launch as an in-vitro diagnostic (IVD) product next year. This
approach will allow us to market and commercialise our products
before they have gone through the regulatory approval process in
the different territories specified above.
ViraxImmune™ Mobile Application
We are not stopping at just preventative diagnostics. The
ViraxImmune™ Mobile Application is being designed to provide
tailored wellness advice and practical steps that can be taken to
improve an individual's immune profile and lower their risks of
infection. We have incorporated lifestyle questions within the
application to capture additional information.
Users will have the option to answer these questions and provide
details about any relevant tests they may have completed, such as
Vitamin C, Vitamin D, Iron, and Zinc as well as other lifestyle
questions that are relevant to an individual's immune profile. This
supplementary data will help paint a more holistic picture of their
immune profile at a specific point in time.
These lifestyle questions and additional tests are entirely
optional. Users can still generate a report using only the
ViraxImmune™ IVD results or any of our additional partner tests,
and they will receive limited general wellness recommendations
based on this information.
We believe that by offering users the choice to provide
additional data, we can provide a more well-rounded view of their
lifestyle and other important immunity markers. This will
ultimately empower individuals to make informed decisions about
their health and take appropriate next steps. We anticipate
launching our ViraxImmune™ mobile application in the fourth quarter
of 2023.
ViraxClear™
In the first half of 2023, we continued to expand the range of
ViraxClear™ tests and distribution partners. We signed a purchase
order with Cosmos Health to launch and market our ViraxClear™
COVID-19 and Influenza A+B Antigen Combo Rapid Detection Kits.
Cosmos has exclusive distribution rights for Greece and Cyprus, with the opportunity to distribute the
ViraxClear™-branded test kits across Europe on a non-exclusive basis.
We also announced an agreement for the distribution of an Avian
Influenza A Virus real-time PCR test kit to markets accepting the
CE mark, and an agreement for the distribution of Marburg Virus PCR
testing kits with plans to launch in areas accepting CE mark.
ViraxClear™ is intended to act as a supporting vertical and
additional revenue stream to assist in the funding and development
of our primary company focus: ViraxImmune™. The
ViraxClear™ vertical has been further augmented through the
addition of ViraxVet™, a veterinary diagnostics platform that is
focussed on multiplex test kits. By offering a disruptive
diagnostic portfolio through our soon to be implemented
direct-to-consumer Polymerase Chain Reaction (PCR) &
Antigen platform that is inclusive of new multiplex assays and
competitively priced, we intend to further disrupt the IVD
sector.
Build Out of Infrastructure and Global Reach
We are eager to bring world-class testing solutions for viral
threats to additional geographies and expand our reach globally. In
alignment with that mission, we have established a Regional
Headquarters at Dubai
Science Park.
The new headquarters will accommodate the company's expansion
into the Middle East and improve
global operations by attracting local partnerships and expanding
our distribution reach of high-quality in-vitro diagnostics,
innovative products and proprietary T-Cell test while creating
logistical efficiencies.
Looking forward, we have plans to augment our research and
development capabilities with a new facility to propel the
development of ViraxImmune™, and a laboratory to spearhead the
initial launch of the platform and optimize the test for smaller
volumes of blood, acting as an affordable laboratory for blood draw
and analysis.
Financial Results
For the year ended March 31, 2023,
consolidated cash was approximately $9.5
million. The Company has no debt obligations other than a
note payable with a remaining balance of $146,250, which is offset by an approximate
amount included in prepaid expenses and deposits on the balance
sheet. The remainder of the liabilities, which are all current,
represent mostly trade payables and accrued expenses. Our current
assets total approximately $9.6
million while our total current liabilities are less than
$1.0 million. During the fiscal year
ended 2023, the Company was able to extinguish a large portion of
payables that resulted in a gain on debt extinguishment of
approximately $290,000. Research and
development expense associated with the ViraxImmune™ platform
was approximately $400,000 and we
anticipate additional research and development expenditures to
bring ViraxImmune™ to the market to be approximately
$1.1 million. With the current cash
balance, we believe we have adequate capital to take us through
this important milestone.
Research and development expenses were approximately
$400,000 for both the years ended
March 31, 2023 and 2022. Research and
development expenses consisted entirely of clinical protocol and
performance studies from third party laboratory partners.
General and administrative expenses were approximately
$5.3 million and $1.3 million, for the years ended March 31, 2023 and 2022, respectively. The
significant increase in general and administrative costs was mainly
due to the increase in costs relating to the preparation for the
IPO and costs associated with ongoing operations. Much of the
increase was attributed to hiring for all levels of personnel.
Non-cash stock-based compensation for the year ended March 31, 2023 was approximately $1.7 million representing approximately 32% of
general and administrative expenses and which has been reversed
with the cancellation of certain stock options subsequent to the
fiscal year end.
Net cash used in operating activities was $4,329,194 and $811,991 for the years ended March 31, 2023 and 2022, respectively. The
increase in cash used for operations was mainly due to increased
losses as the Company increased general and administrative and
research and development costs.
Net cash used in investing activities was $178,403 and $0 for
the years ended March 31, 2023 and
2022, respectively. Investing activities for the year ended
March 31, 2023 consisted of
capitalization of certain intangible software costs associated with
the development of the ViraxImmune™ mobile application.
Net cash provided by financing activities was $13,838,379 and $813,205 for the years ended March 31, 2023 and 2022, respectively. The
increase in cash flows from financing activities was due to the IPO
and the two PIPE transactions that occurred in November 2022 and March 2023.
Closing statement
We continue to focus heavily on piecing together a comprehensive
preventative diagnostics platform. By combining cutting-edge
technology, strategic partnerships, and a strong infrastructure, we
strive to create a unified system that enables early detection and
proactive prevention of diseases worldwide.
We look forward to empowering a healthier world.
Sincerely,
James Foster
Chairman and CEO
Virax Biolabs Group Limited
About Virax Biolabs Group Limited.
Founded in 2013, Virax Biolabs Group Limited is an innovative
biotech company focused on the detection of immune responses to and
diagnosis of viral diseases.
In addition to distributing an array of in-vitro diagnostic test
kits, Virax Biolabs Group Limited is currently developing a
proprietary T-Cell Test technology with the intention of providing
an immunology profiling platform that assesses each individual's
immune risk profile against major global viral threats. T-Cell
testing can be particularly effective in the diagnosis and
therapeutics of COVID-19 as well as other threats including
Monkeypox, Hepatitis B, Malaria, Herpes and Human
Papillomavirus.
For more information, please visit www.viraxbiolabs.com.
Caution Concerning Forward Looking Statements:
This press release contains forward-looking statements. In
addition, from time to time, we or our representatives may make
forward-looking statements orally or in writing. We base these
forward-looking statements on our expectations and projections
about future events, which we derive from the information currently
available to us. Such forward-looking statements relate to future
events or our future performance, including: our financial
performance and projections; our growth in revenue and earnings;
and our business prospects and opportunities. You can identify
forward-looking statements by those that are not historical in
nature, particularly those that use terminology such as "may,"
"should," "expects," "anticipates," "contemplates," "estimates,"
"believes," "plans," "projected," "predicts," "potential," or
"hopes" or the negative of these or similar terms. In evaluating
these forward-looking statements, you should consider various
factors, including: our ability to change the direction of the
Company; our ability to keep pace with new technology and changing
market needs; and the competitive environment of our business.
These and other factors may cause our actual results to differ
materially from any forward-looking statement. Forward-looking
statements are only predictions. The forward-looking events
discussed in this press release and other statements made from time
to time by us or our representatives, may not occur, and actual
events and results may differ materially and are subject to risks,
uncertainties, and assumptions about us. These forward-looking
statements are based on information currently available to Virax
and its current plans or expectations and are subject to a number
of known and unknown uncertainties, risks and other important
factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These and other important factors are
described in detail in the "Risk Factors" section of Virax's Annual
Report on Form 20-F for the year ended March 31, 2023.
Although we believe the expectations reflected in such
forward-looking statements are reasonable, we can give no assurance
that such expectations will prove to be correct. We are not
obligated to publicly update or revise any forward-looking
statement, whether as a result of uncertainties and assumptions,
the forward-looking events discussed in this press release and
other statements made from time to time by us or our
representatives might not occur.
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SOURCE Virax Biolabs