JERUSALEM, Oct. 7, 2019 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (NASDAQ: BVXV), a phase 3 clinical stage
biopharmaceutical company focused on developing and commercializing
the M-001 clinical Phase 3 Universal Influenza Vaccine candidate,
announced today the receipt of €4 million from the European
Investment Bank (EIB). These funds are the final tranche of the
previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
Dr. Ron Babecoff, BiondVax's President and CEO,
commented, "This past June we were honored to welcome EIB
Vice-President Mr. Ambroise Fayolle
to our manufacturing facility in Jerusalem for a signature event celebrating
the extension of the EIB-BiondVax financing agreement to
€24 million. I am grateful to the EIB for their ongoing
support of our efforts to introduce an effective universal
influenza vaccine to the world."
The €24 million financing has been provided by the EIB in
support of construction of BiondVax's pilot manufacturing facility
in Israel and the ongoing pivotal,
clinical efficacy, Phase 3 trial of BiondVax's M-001 Universal Flu
Vaccine candidate in Europe.
Together with the $20m raised in the
July 2019 rights offering to
shareholders, BiondVax expects its existing cash resources will
enable funding of operational and capital expenditure requirements
to the end of the Phase 3 trial.
The pivotal, clinical efficacy, Phase 3 trial aims to assess
safety and effectiveness of the M-001 vaccine alone in reducing flu
illness and severity in approximately 12,000 adults aged 50 years
and older, with at least half aged 65 and older. An aggregate of
4,094 people was enrolled in the trial's first cohort prior to the
2018/19 flu season, and approximately 8,000 participants are being
enrolled in the trial's second cohort (2019/20 flu season) in 85
sites in seven countries in eastern Europe. Results are expected by the end of
2020.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage
biopharmaceutical company developing a universal flu vaccine. The
vaccine candidate, called M-001, is designed to provide
multi-strain and multi-season protection against current and
future, seasonal and pandemic influenza. BiondVax's proprietary
technology utilizes a unique combination of conserved and common
influenza virus peptides intended to stimulate both arms of the
immune system for a cross-protecting and long-lasting effect. In a
total of 6 completed Phase 1/2 and Phase 2 clinical trials covering
698 participants, the vaccine has been shown to be safe,
well-tolerated, and immunogenic. The ongoing pivotal Phase 3
clinical trial aims to assess safety and effectiveness of M-001 in
reducing flu illness and severity. For more information, please
visit www.biondvax.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. These forward-looking
statements reflect the 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 prosecution, timing and results of the ongoing
Phase 2 and Phase 3 trials and any subsequent trials; timing of
receipt of regulatory approval of our manufacturing facility in
Jerusalem; ability to demonstrate
the efficacy and safety of the vaccine; the timing of clinical
trials and marketing approvals; the risk that drug development
involves a lengthy and expensive process with uncertain outcome;
the ability of the Company to maintain, preserve and defend its
intellectual property and patents granted; whether our vaccine
candidate will successfully advance through the clinical trial
process on a timely basis, or at all, and receive approval from the
U.S. Food and Drug Administration or equivalent foreign regulatory
agencies; the adequacy of available cash resources and the ability
to raise additional capital when needed. More detailed information
about the risks and uncertainties affecting the Company is
contained under the heading "Risk Factors" in our Annual Report on
Form 20-F for the year ended December 31,
2018 filed with the U.S. Securities and Exchange Commission,
or SEC, which is available on the SEC's website, www.sec.gov. We
undertake no obligation to revise or update any forward-looking
statement for any reason.
Contact Details
Joshua E.
Phillipson
+972 8 930 2529
j.phillipson@biondvax.com
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SOURCE Biondvax Pharmaceuticals Ltd