JERUSALEM, March 23, 2021 /PRNewswire/ --
Dear Shareholders,
After many years of pharmaceutical leadership positions in the
US and Europe, I jumped at the
opportunity to return to my roots in Israel to take over the reins as BiondVax's
CEO. Since my appointment was announced in January, I had been
wrapping up my role as Head of Global Vaccines Engineering, Core
Technologies, and Asset Management at GSK Vaccines headquarters in
Belgium. I started as BiondVax's
full time CEO on March 2nd
and intend to relocate to Israel
this coming summer. In the meantime, I will be traveling between
Belgium and Israel.
The first thing I have done as the new CEO, together with our
Board of Directors, was to define a new mission and vision for
BiondVax. Our new mission reflects an aspiration to focus on
infectious diseases, which leverages BiondVax's core competencies,
while ensuring diversification of our corporate risks through the
establishment of a new, broad product and platform pipeline.
BiondVax's mission is to help build a healthier and happier
world by developing, manufacturing and ultimately commercializing
products for the prevention and treatment of infectious diseases
and related illnesses.
In the past, BiondVax was a one product company, solely focused
on developing the M-001 universal influenza vaccine. Going forward,
my intent in rejuvenating BiondVax is to implement a strategy that
will diversify the risk along several axes:
- Build a pipeline of products not only for prevention (through
vaccines) but also for treatment of infectious diseases and related
illnesses
- Build a pipeline that would present various routes of drug
delivery (e.g., intra-muscular, nasal, oral, etc.)
- Build a pipeline that would rely on various platforms
(different types of molecules and manufacturing platforms)
- Build a pipeline of products at different stages of clinical
development
If successfully implemented, this strategy would provide
BiondVax with a robust and diverse multi-dimensional pipeline. Over
these past few months, we have been actively engaged in identifying
and evaluating many opportunities. These include in-licensing,
acquisitions, and joint ventures, with industry, academia, and
governments. Indeed, we are currently engaged in due diligence and
negotiations on a number of exciting potential opportunities.
I would like to share with you what attracted me to BiondVax. I
believe that BiondVax presents a unique set of strong capabilities
along the three most important pillars of business management:
People, Process and Technology. In my view,
these capabilities, if managed correctly, could prove to be a
serious competitive advantage versus other bio-pharma companies of
comparable size and value, and serve as a jumping board for a
revitalized and rebuilt company.
People: Our leadership
team has deep and highly relevant biotech and pharmaceutical
industry experience, including our Chairman Mark Germain (Alexion, Neurocrine, Pluristem and
others), Board director Samuel Moed (Bristol Myers Squibb), and COO
Elad Mark (Novartis). As CEO, I
bring a background of extensive vaccines R&D, supply chain,
manufacturing, and engineering at a global level from Novartis in
the USA and GSK in Europe. Furthermore, our Chief Science
Officer, Dr. Tamar Ben-Yedidia,
ushered a novel influenza vaccine candidate from R&D at the
Weizmann Institute through eight clinical trials culminating in a
12,400 participant, seven country, two season pivotal Phase 3
clinical trial. Dr. Ben-Yedidia conducted her preliminary research
in the 1990's under the guidance of Professor Ruth Arnon, co-inventor of Teva Pharmaceutical's
blockbuster Copaxone drug; Professor Arnon continues to serve as
head of BiondVax's Scientific Advisory Board.
Process: Thanks to 18 years
of experience, BiondVax has developed a mature set of business
processes including pre-clinical and clinical development,
regulatory, quality, GMP manufacturing processes and more. We are
still under a master services agreement with our CRO, with whom we
partnered for our recent Phase 3 clinical trial, and through which
we retain access to over 90 medical centers in their
investigational site network which can rapidly be re-activated
should we in-license a clinical stage asset. These processes can
help us accelerate time to market for future in-licensed assets and
hence provide us with a competitive value proposition versus other
companies our size.
Technology: Our existing
and highly advanced GMP vaccine manufacturing facility in
Jerusalem uses an agile and
modular 'Single Use' infrastructure that can be used for a wide
variety of applications and technologies, such as the production of
recombinant proteins, RNA, monoclonal antibodies, and other
vaccines and treatments. In addition, we have advanced automation,
data management and IT systems necessary for regulatory compliant
clinical development, clinical supplies and commercial supplies.
Looking back over 2020, the results of the Phase 3 clinical
trial of our M-001 universal influenza vaccine candidate were
deeply disappointing for our management, employees, shareholders,
and all our other stakeholders. While clinical effectiveness of
M-001 versus a placebo was not observed in the trial, there was
evidence of robust immune responses in the seven previous clinical
trials. Thus, we believe our vaccine still has potential and under
different trial settings it is possible that clinical effectiveness
would be observed. For this reason, we have not discarded M-001 but
rather placed it on the shelf for the time being, in the hope that
we may revisit it in the future.
While the Phase 3 trial of M-001 did not meet its clinical
endpoints, a common occurrence in the industry, the employees and
Board of Directors devoted a tremendous amount of time and effort
to ensure that the trial was properly managed, completed on time
and on budget despite the looming threat of the COVID-19 pandemic.
This by itself was a major achievement for any company in the
industry, much less a relatively small biotech firm.
On April 6, BiondVax will host an
extraordinary meeting of shareholders to approve my terms of office
as CEO of BiondVax, approve compensation packages, and expand our
authorized share capital to provide flexibility in raising
additional capital in the future. While we will seek to fund our
growth in a manner that enhances long-term shareholder value,
equity remains an important component in the financing strategy of
building the prospective diverse portfolio of products, drug
delivery technologies and platforms that I described earlier.
You, our shareholders, have an important say in these measures
which we believe are essential steps towards realizing BiondVax's
new mission and vision. On behalf of Management and the Board, we
would be grateful for your continued support by voting in line with
our recommendations on the proxy. Details are available on the SEC
website[1], and we urge you to contact your broker to
exercise your right to vote. You may also contact my investor
relations team at any time for any query you may have or
information you require.
Under my new leadership, I believe BiondVax is well positioned
to become a globally trusted and preferred bio-pharmaceutical
company known for fast and efficient product development of highly
innovative products, offering a reliable supply of high-quality and
effective prophylactic and therapeutic products targeting
infectious diseases and related illnesses.
I pledge to keep you updated as we progress towards our
important and exciting goals.
Sincerely,
Amir
Reichman
CEO
BiondVax Pharmaceutical Ltd.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ:
BVXV) is a biopharmaceutical company focused on developing,
manufacturing and ultimately commercializing products for the
prevention and treatment of infectious diseases and related
illnesses. The Company had been developing M–001, a novel influenza
vaccine candidate that was designed to provide multi-strain and
multi-season protection against current and future seasonal and
pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials
designed to test for immunogenicity, the Company was able to
demonstrate M-001 was effective in stimulating an immune response
to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3
clinical trial of M–001 which failed to meet the trial's primary
and secondary efficacy endpoints. The Company is now pursuing
opportunities in the infectious disease space towards development
of a pipeline of diversified products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 |
j.phillipson@biondvax.com
Investor Relations:
Megan
Paul (USA) | +1 646 653
7034 | mpaul@edisongroup.com
Kenny Green (Israel) | +1 646 201 9246 |
kgreen@edisongroup.com
Forward Looking Statements
This press release
contains forward-looking statements within the meaning of the
Private Litigation Reform Act of 1995. Words such as "expect,"
"believe," "intend," "plan," "continue," "may," "will,"
"anticipate," and similar expressions are intended to identify
forward-looking statements, including statements regarding future
business strategies that BiondVax may explore. These
forward-looking statements reflect management's current views with
respect to certain current and future events and are subject to
various risks, uncertainties and assumptions that could cause the
results to differ materially from those expected by the management
of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include,
but are not limited to, the risk that BiondVax may not be able to
secure additional capital on attractive terms, if at all; the risk
that the European Investment Bank may accelerate the loans under
its finance contract with BiondVax; the risk that BiondVax may not
execute a strategic alternative to M-001 or implement a strategy
that will diversify BiondVax's risk, and, if executed, may not be
successful; risks relating to the COVID-19 (coronavirus) pandemic;
BiondVax's ability to acquire rights to additional product
opportunities; BiondVax's ability to enter into collaborations on
terms acceptable to BiondVax or at all; timing of receipt of
regulatory approval of BiondVax's manufacturing facility in
Jerusalem, if at all or when
required; the risk that the manufacturing facility will not be able
to be used for a wide variety of applications and other vaccine and
treatment technologies, and the risk that drug development involves
a lengthy and expensive process with uncertain outcomes. More
detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk Factors" in our
prospectus supplement, which is available on the SEC's website,
www.sec.gov. BiondVax undertakes no obligation to revise or update
any forward-looking statement for any reason.
[1]
https://www.sec.gov/Archives/edgar/data/0001611747/000121390021013393/ea136999-6k_biondvax.htm
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SOURCE BiondVax Pharmaceuticals Ltd.