NESS ZIONA, Israel, June 28,
2017 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV),
developer of the Universal Flu Vaccine candidate M-001, today
provided a general corporate update of its activities in the first
half of 2017.
Ron Babecoff, BiondVax CEO, commented, "The first half of
2017 was exciting and important for BiondVax. Three major events
occurred: (1) We welcomed a major strategic investor,
Marius Nacht and his aMoon Fund, who
currently hold approximately 20% of our company; (2) Israel's Ministry of Economy approved a grant
covering 20% of the construction costs of a commercial scale
manufacturing facility; and also significantly advancing our
goals, (3) the European Investment Bank (EIB) signed a
€20 million non-dilutive
funding agreement to support commercial production and Phase
3 trials. I am thrilled that we now have the resources to launch
our Phase 3 program towards commercialization."
Recent Updates
€20 million in non-dilutive
funding
- On June 19, BiondVax signed a
significant €20 million (approximately $US
22 million) non-dilutive funding agreement with the European
Investment Bank (EIB).
- The funding will be provided as a zero-percent fixed interest
long-term loan, with variable remuneration based on royalties of
net sales of BiondVax's Universal Flu vaccine.
- BiondVax retains the option to repay the loan and repurchase
the royalties at any time.
- Further details in the joint EIB-BiondVax press release:
http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/.
New Patent Allowed in
Canada
- On June 21, BiondVax received
notice that its main patent application on the Multimeric
Multi-Epitope Polypeptide Influenza Vaccines was allowed in
Canada.
- This allowed patent application is part of a family of over 30
granted patents around the world, covering the multimeric
multi-epitope influenza vaccine M-001 and its use for vaccination
against influenza in humans.
European Phase 2b Trial Progress and Results
Timetable
- BiondVax's Phase 2b trial is being conducted as part of the
European UNISEC[1] Consortium.
- This was M-001's first international trial. In preparation,
BiondVax's manufacturing facilities, processes, and practices
achieved European-audited GMP certification, BiondVax gained
approval from the EU to conduct clinical trials in Europe, and funds were granted through UNISEC
towards the costs of executing the trial.
- Positive preliminary safety results for the 219 participants
were announced in November
2016[2]. Blood sample analysis conducted
over the past few months by a member of the Consortium was recently
completed. Subsequently, the Consortium informed BiondVax that
statistical analysis of the results is expected to begin soon.
- While progressing, it is important to note that the pace of the
analysis is outside of BiondVax's control and while the results
from the trial are expected in the near term, it will be beyond the
end of the second quarter of 2017.
- While the process has taken longer than initially anticipated,
it is not unusual when so many partners are involved in a complex
project. BiondVax is privileged to be participating in the UNISEC
consortium, and pleased to be part of this collaboration.
Commercial Mid-Size
Manufacturing Facility
- We have identified a suitable existing location for our
manufacturing plant, and are working with an engineering company on
detailed planning.
- The mid-size factory is planned with annual production capacity
of up to 20 million single-doses in syringes, or 40 million doses
in bulk.
- For details, please see
http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/.
Strategic Investment by Leading Investor
- aMoon Fund, part of Angels High Tech Investments, a company
fully owned by Marius Nacht,
Co-founder and Chairman of Check Point (NASDAQ: CHKP), invested
NIS 10.9 million (close to
$3 million) in BiondVax, at the
then-prevailing market price. Following the transaction aMoon holds
approximately 20% of the outstanding shares of the Company.
- For details, please see
http://www.biondvax.com/2017/01/biondvax-receives-us-2-8-million-investment-from-angels-high-tech-investments-ltd/.
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company
developing a universal flu vaccine. The vaccine is designed to
provide multi-season protection against most seasonal and pandemic
human influenza virus strains. BiondVax's proprietary technology
utilizes a unique combination of conserved and common peptides from
influenza virus proteins, activating both arms of the immune system
for a cross-protecting and long-lasting effect. BiondVax is traded
on NASDAQ: BVXV and TASE: BVXV. Please visit
http://www.biondvax.com .
BiondVax 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 involve certain risks and uncertainties
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 risk that drug development involves a
lengthy and expensive process with uncertain outcome, the results
of the Phase 2 & 3 trials, delays or obstacles in
launching and/or successfully completing our clinical trials,
the receipt and timing of approved grant funds,
our ability to procure the funds and permits and other
governmental authorization for a commercial size manufacturing
plant, our ability to satisfy rigorous regulatory requirements,
the impact of the global economic environment on the Company
customer target base, the adequacy of available cash resource and
the ability to raise 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, 2016 filed
with the U.S. Securities and Exchange Commission, or SEC, which is
available on the SEC's website, http://www.sec.gov,
and in the Company's periodic filings with the SEC
and the Tel-Aviv Stock Exchange.
References
1. The research has received funding from the European Union
Seventh Framework Program (FP7/2007-2013) under grant agreement
n°602012.
2.
http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/
For further information, please contact:
BiondVax
Joshua Phillipson
Business Development Manager
+972-8-930-2529 ext.5105
j.phillipson@biondvax.com
SOURCE BiondVax Pharmaceuticals Ltd.