BiondVax is a 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. For more information, please visit www.biondvax.com.
1. One for all
THE UNIVERSAL FLU VACCINE
BIONDVAX OVERVIEW
BiondVax is an innovative biopharmaceutical company developing a Universal Flu
Vaccine, designed to provide multi-season and multi-strain protection against most
human influenza virus strains, including both seasonal and pandemic flu strains.
BiondVax has to-date successfully completed three Phase II and two Phase I/II clinical trials
of its lead Universal Flu Vaccine product. It is currently engaged in a Phase II trial in
Europe and another trial in the US is expected to start soon.
FLU—A MAJOR GLOBAL PROBLEM
Influenza is a fast mutating, fast spreading and unpredictable virus, with new strains
appearing constantly. Each year in the US there are an average of 23,000 deaths– mainly
the elderly and children, and 200,000 hospitalizations1
. Last year’s vaccine tends to be
ineffective against the next season’s strain as development of the specific vaccine takes 6
months, in which time the predominant flu strain can mutate. Thus existing solutions are
wholly ineffective: in the 2014/2015 flu season, vaccine effectiveness was only 19%2
.
Pandemics pose an even bigger problem— major ones tend to occur once per century,
killing hundreds of millions and economic costs up to 5% of global GDP3
. There were four
pandemics in the past century. The worst one was the Spanish flu starting in 1918, killing
more people than World War I which had just ended.
INVESTMENT HIGHLIGHTS
Huge market opportunity: Biondvax has the first mover advantage and best-in-class
solution. The company estimates that its immediate market potential for seasonal flu
vaccine strains is $1bn with significant further potential for the pandemic flu stockpile.
Strong IP Position: Several patent families covering compositions, uses and production
aspects, expiration to 2031 (extendable).
Experienced management team with many years of pharmaceutical experience is
additionally backed by world-leading scientific experts.
Proof of concept has been established: In trials, the vaccine was shown to be safe and
immunogenic, successfully stimulating both humoral and cellular immune responses. In
addition, the vaccine has been shown to provide protection against future strains which
did not exist at the time the vaccine was administered.
KEY STATISTICS:
US Ticker (NASDAQ) BVXV
Israel Ticker (TASE) BVXV
Market Cap $13 million
ADS Outstanding 3.3 million
(as of December 24, 2015)
MANAGEMENT TEAM
Ron Babecoff DMV, President & CEO
Tamar Ben-Yedidia, PhD, CSO
Uri Ben-Or, CPA, MBA, CFO
Shimon Hassin, PhD, COO
Limor Chen, PhD, Director of BD
DIRECTORS
Prof. Avner Rotman, PhD, Chairman
Jack Rosen
Dr. George Lowell, MD
Prof. Moshe Many, MD, PhD
Michal Brickman, CPA
Ron Babecoff, DVM
Prof. Liora Katzenstein
Irit Ben Ami
1 WHO Study
2 CDC Study, 2015
3 World Bank 2014
COMPANY CONTACT:
Ron Babecoff, CEO
Babecoff@biondvax.com
INVESTOR RELATIONS CONTACT:
Kenny Green
GK Investor Relations
kenny@biondvax.com
Tel. U.S. 1-646-201-9246
Infects up to 20%
of the population1
2. SCIENCE
TECHNOLOGY
BiondVax’s technology was developed by Prof. Ruth Arnon of the Weizmann
Institute. The technology utilizes a unique, proprietary combination of
conserved and common epitopes from influenza virus proteins to activate
both arms of the immune system for cross-
protecting and long-lasting effect. Nine
common regions of flu strains are
connected to make one
recombinant protein called M-
001 produced in E.coli.
BIONDVAX ADVANTAGES
Biondvax’s solution provide universal and
broad coverage. Biondvax provides a single formulation covering all flu strains
and year-round vaccination. Production takes only 6-8 weeks versus the
current 6 month production cycle.
In addition, in the event of a pandemic Biondvax’s solution could be
administered as a pandemic primer, to prepare the population
immunologically while the pandemic strain-specific vaccine is manufactured.
SUCCESFUL CLINICAL TRIALS
Certain statements contained in this material are forward-looking statements which
involve known and unknown risks, uncertainties, and other factors which may cause the
actual results, performance or achievements of the Company, or industry results, to be
materially different from any results performance or achievement expressed or implied
by such forward-looking statements. Please refer to the Company’s filing with the
Security and Exchange Commission for a comprehensive list of risk factors that could
cause actual results, performance or achievements of the Company to differ materially
from those expressed or implied in such forward-looking statements. The Company
undertakes no obligation to update or revise any forward-looking statements.
KEY FACTS & FIGURES
$87 BILLION1
Annual US economic flu burden
250-500 THOUSAND2
Annual global flu related deaths
5 PERCENT OF GDP3
Global cost of pandemic
$3.2 BILLION4
2013 seasonal flu vaccine market
1 Molinari et al, 2007
2 WHO Study
3 World Bank, 2014
4 Datamonitor Report, 2013
INFLUENZA
A SEASONAL PROBLEM…
A PANDEMIC THREAT TO
HUMANITY
FOR UPDATES:
www.biondvax.com
Phase II BVX-008
US Initiation
BVX-007 (European)
and BVX-008 (US)
trial results
CMO production
ready to provide
commercial phase
3 batches
End of phase 2
meeting with FDA
& phase 3 ready
Q1 2016 H2 2016 H2 2016 2017-2018
VACCINE EFFECTIVENESS
BY FLU SEASON
Source: CDC Data
Trial Year Population
(age)
Participants
(location)
Status Results
BVX-002 2009 18-49 63 (Israel) Complete M-001 was shown to
be safe, well tolerated
and a humoral and
cellular immune reac-
tion was revealed to
multiple influenza
strains
BVX-003 2010 55-75 60 (Israel) Complete
BVX-004 2011 18-49 200 (Israel) Complete
BVX-005 2012 65+ 120 (Israel) Complete
BVX-006 2015 50-65 36 (Israel) Complete
BVX-007 2015 18-60 222 (Europe) Ongoing Expected H2 2016
BVX-008 2016 50-65 150 (US) Starting Expected H2 2016