Full Press Release Details
Letter from BiondVax's New CEO
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
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
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.
BiondVax Pharmaceutical Ltd.
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.
Company: Joshua E. Phillipson | +972
8 930 2529 | j.phillipson@biondvax.com
Megan Paul (USA) | +1 646 653 7034 | mpaul@edisongroup.com
Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.com
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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.