NESS ZIONA, Israel, Dec. 5,
2017 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd.
(NASDAQ: BVXV, TASE: BVXV) today released a Letter from the
CEO regarding recent activities and plans.
"BiondVax has enjoyed a remarkably encouraging 2017, with
promising Phase 2b clinical trial
results and a significantly strengthened financial
position. The combination of events has led us to proceed
towards a pivotal clinical efficacy Phase 3 trial. Indeed,
we anticipate enrolling the first participants by Q4 2018. I'm
happy to take this opportunity to answer some of your questions
about our plans. As well, I would like to thank my BiondVax team,
our partners at the Weizmann Institute, and our other stakeholders
for their contributions.
Together, we are accomplishing great things and I look forward to
continued success in the coming year."
Kind regards,
Dr. Ron Babecoff
President & CEO
2017 Highlights and 2018 Plans:
January 2017: Marius Nacht's aMoon Partners fund invests in
BiondVax, becoming our largest shareholder. Nacht is co-founder and
Chairman of Check Point Software Technologies Ltd. (Nasdaq: CHKP).
aMoon is a new Israeli healthcare fund.
March: Israel Ministry of Economy grant towards
construction of mid-size commercial manufacturing facility in
Jerusalem. Planned production of
batch for Phase 3 trial's second participant group. In July, we
secured a lease for an entire floor (approximately 20,000 square
feet or 1800m2) in the
Jerusalem Bio Park building.
June: The European Investment Bank (EIB) entered into a
€20m (approximately $23m)
non-dilutive funding agreement to support the Phase 3 trial and
complete the set up of our manufacturing facility.
July: Statistically significant results from our European
Union UNISEC consortium Phase2b clinical trial: M-001 is deemed
safe and induces significant cellular immunity. Our UNISEC
colleagues are in the process of submitting an article for
publication in a peer-reviewed science journal.
September: Raised $10m in
secondary offering. Following the placement, BiondVax has 3 large
strategic investors holding a total of over 30%, with Marius Nacht's aMoon Partners fund remaining our
largest current shareholder.
October: Began regulatory procedures with the European
EMA (akin to the American FDA) regarding Phase 3 trial plans.
November: Signed clinical trial agreement (CTA) for a
Phase 2 trial conducted by the U.S. NIH. The NIH-funded trial will
include 120 participants with sites in Texas, Ohio,
Missouri, and Iowa. This, our first trial in the US under an
FDA IND, is planned for Q2 2018, and is in addition to our planned
Phase 3 trial in Europe.
January 2018: Trading will
be consolidated on Nasdaq following our voluntary delisting from
the Tel Aviv Stock Exchange effective January 22. Final day of trading on TASE will be
January 18. Shareholder FAQ in Hebrew
at http://bit.ly/BVXV-TASE.
Keep in touch: Join our mailing list from
www.biondvax.com or email j.phillipson@biondvax.com
About BiondVax Pharmaceuticals Ltd
BiondVax is a
clinical phase biopharmaceutical company developing a universal flu
vaccine. The vaccine candidate 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 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 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 contemplated Phase 2 & 3
trials, delays or obstacles in launching and/or successfully
completing our clinical trials, 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, www.sec.gov, and in the Company's periodic filings with
the SEC and the Tel-Aviv Stock Exchange.
For further information, please contact:
BiondVax
Joshua
Phillipson
+972-8-930-2529 x5105
j.phillipson@biondvax.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/biondvaxs-ceo-issues-letter-to-shareholders-300566775.html
SOURCE Biondvax Pharmaceuticals Ltd