LONDON, Dec. 17,
2024 /PRNewswire/ -- Virax Biolabs Group Limited
(NASDAQ: VRAX) ("Virax" or the "Company"), an innovative
biotechnology company focused on the detection of immune responses
to and diagnosis of viral diseases, today announced that
Mr. James Foster, Chief Executive Officer of Virax, has issued
a letter to shareholders outlining the Company's plans for 2025 and
highlights recent accomplishments.
Dear Fellow Shareholders,
As we wrap up 2024 and look forward to the year ahead, we are
excited to share an update on our achievements and outline our
strategic goals for 2025. Over the past year, we have enhanced our
capabilities, forging new and expanding existing distribution
partnerships, and deepened our commitment to addressing indications
associated with chronic inflammation and immune
dysfunction.
Our goal at Virax is to bring to the market a comprehensive set
of T-cell diagnostics and immune profiling solutions utilizing our
novel ViraxImmune™ in vitro diagnostic (IVD) platform. Our
broad strategic focus is to develop and commercialize immune
profiling in vitro diagnostics in post-acute infection syndromes
and protective immunity. This year we have launched
ImmuneSelect, our research-use-only version of ViraxImmune™,
which includes immune profiling assays targeting researchers,
clinicians and drug developers working in the areas of chronic
inflammation and immune dysfunction. Additionally, our
ViraxClear portfolio offers a diverse selection of PCR and
antigen-based test kits designed to target various pathogens to
support public health initiatives and disease control.
These distinct diagnostic solutions exemplify our commitment to
advancing global health through innovative testing platforms,
establishing a strong foundation for the significant strides we
anticipate in 2025.
Major Developments in 2024
We have spent the past year making improvements to our
laboratory facility which we believe to be fully staffed and
equipped for the next stage of our development process.
We are pleased to announce the initiation of a clinical study in
the United Kingdom (NCT06731179)
aimed at assessing the ViraxImmune™ platform's performance in
detecting T-cell dysfunction in post-acute infectious syndrome
patients, including those with long COVID, post-treatment Lyme
disease (PTLD), and Myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS). The study will enroll up to 160 participants,
with first patient dosed anticipated in early Q1 2025, followed by
initial data readout anticipated in Q1 2026.
Building on the progress of initiating our UK-based clinical
validation study, we are also focusing on advancing our U.S.
regulatory and clinical development. To facilitate this, we have
begun discussions with renowned U.S. based clinical institutions to
initiate studies to support our IVD development. Additionally,
activities have been initiated to submit a request for a formal
meeting with the FDA through its pre-submission program, also known
as Q-submission. This will allow us to receive formal written
feedback from the FDA regarding our ViraxImmune™ IVD clinical
development and regulatory plans in the U.S., including guidance on
our clinical validation and performance testing. We anticipate
receiving the FDA written feedback by Q2 of 2025, followed by the
initiation of our U.S. based clinical validation study.
In addition, as part of our launch and commercialization plans
for our ViraxImmune™ IVD platform, we aim to establish strategic
collaborations with CLIA laboratories in the U.S. to offer
laboratory development tests (LDTs) for clinical studies to support
the development of our ViraxImmune™ platform. We have initiated
consulting activities in the U.S. with external partners to assist
with market research and pricing activities needed for product
placement of this launch.
Alongside advancing the ViraxImmune™ IVD platform, we launched
our research-use-only (RUO) ImmuneSelect portfolio in Q2 of 2024.
ImmuneSelect is a commercially available suite of research-use-only
(RUO) immune profiling solutions, including peptide pools, ELISpot
kits, and recombinant antibodies. This enables researchers and drug
developers to study T-cell activation, immune profiling, and immune
status in infections and conditions linked to chronic inflammation
and adaptive immune dysfunction.
New Distribution Agreements
Building on the commercial launch of our ImmuneSelect portfolio,
we are expanding our global distribution infrastructure. This year,
we reached agreements with regional distributors Europa Biosite and
Tebubio to distribute ImmuneSelect products across the European
Union, as well as the UK, Norway,
and Switzerland; increasing access
for researchers and pharmaceutical entities in that region. In
addition, we have signed country specific distribution agreements
for ImmuneSelect in Spain and
Portugal with Abyntek Biopharma,
and in Italy with DBA Italia. To
expand access further, we aim to secure U.S. distribution partners
by Q1 of 2025.
These developments have been supplemented by the continued
expansion of our ViraxClear distribution channels. We entered into
a new agreement to supply Mpox Virus Real-Time PCR Detection Kits
to 13 European countries and the Middle
East. We also expanded our current agreement with Cosmos
Health to extend the distribution of the Mpox Virus Real-Time PCR
Detection Kits to countries in the Gulf Cooperation Council (GCC)
and India. In addition, ViraxClear
maintains the capability to distribute H5N1 testing kits, commonly
known as Avian Flu tests, and can ship them as needed.
Looking Ahead to 2025
In 2025, our key priorities include:
- Advancing ViraxImmune™ UK and U.S. Clinical Validation Studies:
We will be leveraging insights gained from ongoing data and
collaborations to fine-tune our offerings for broad-scale
deployment. We expect to present key data at major international
scientific conferences.
- U.S. regulatory Progress: We aim to initiate formal
interactions with regulatory authorities to define the approval
pathway for the ViraxImmune™ IVD platform. This step is critical to
transitioning our innovative assays into clinical use.
- Expansion of ImmuneSelect Distribution Channels: Building on
recent agreements, we will focus on growing our presence in
additional markets, with particular emphasis on the Americas, and
into U.S.-based markets.
- Initiation of Protective Immunity IVD clinical performance
study (Lyme Disease and Pre & Post Transplant Infection).
This multi-faceted approach underscores our commitment to
innovation, market growth, and scientific excellence as we position
Virax as a leader in immune diagnostic solutions.
Financial Highlights
Research and development activities have accelerated from the
prior year in both capital expenditures and research expenses. We
have tripled our laboratory area since signing our first lease in
BioCity, Glasgow in August 2023 and doubled our property, plant and
equipment for that lab to approximately $1.1
million as of September 30,
2024 from the prior period. Our ongoing research and
development expenses were approximately 33% higher year over year
as of September 30, 2024.
During 2024, we received approximately $0.8 million from a warrant exercise and
approximately $5.1 million from two
cash for stock transactions, each in increasing valuation per
raise. Our cash balance as of September
30, 2024 was approximately $7.3
million and working capital was approximately $6.6 million. In addition, we do not have
any long-term debt obligations. Regarding the stock valuation, as
of December 10, 2024, our shares
are trading at a price less than our current cash on hand
per share. We believe this valuation is not
representative of the overall value and future
potential of Virax. With the current cash balance and no debt
to service, we believe we have adequate capital to fund our
near-term priorities.
Commitment to Innovation and Impact
The challenges posed by post-acute infection syndromes such as
long COVID underscore the urgent need for new diagnostic tools, and
we are proud to be at the forefront of addressing this global
issue. In the next 12 months, we eagerly anticipate substantial
advancements in the development of our ViraxImmune™ platform and
expanding our distribution footprint to the U.S. and other
regions.
We are deeply grateful for your continued support as we work to
advance our mission and deliver value to our shareholders,
partners, and the broader medical community.
Sincerely,
James Foster
Chairman and CEO
Virax Biolabs Group Limited
About Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology
company focused on the detection of immune responses to and
diagnosis of viral diseases. Virax Biolabs Group Limited is
currently developing T-Cell-based test technologies with the
intention of providing an immunology profiling platform. T-Cell
testing can be particularly effective in the diagnosis and
therapeutics of post-viral syndromes such as Long COVID and other
chronic conditions linked to immune dysregulation.
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, 2024. 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.
Investor Relations Contact:
Russo Partners, LLC
Nic Johnson
12 West 27th Street
4th Floor
New York, NY 10001
M: 303-482-6405
nic.johnson@russopartnersllc.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/virax-biolabs-ceo-james-foster-issues-letter-to-shareholders-302333454.html
SOURCE Virax Biolabs