BiondVax's next generation flu vaccine is in late Phase 2 human clinical trials. Designed to offer multi-season protection against all seasonal and pandemic influenza, results from 5 completed trials have shown safety and immunogenicity. Learn More: www.biondvax.com.
2. Seasonal Problem
▸ Infects up to 20% of the population
▸ Kills up to 500,000 worldwide1
▸ 8th leading cause of death2 (US)
▸ $87B economic burden in the US
($56B in elderly)3
Pandemic Threat
▸ New unpredictable strains from other
species
▸ Over 100M deaths4 over last century
▸ 2009 swine flu killed up to 0.5M. 80%
younger than 65 years5
▸ Estimated6 pandemic burden up to $3T
1. www.who.int/mediacentre/factsheets/fs211/en/; 2. www.cdc.gov/nchs/fastats/deaths.htm; 3. Molinari et al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096; 4. 1918 Influenza: the Mother of All Pandemics, Volume 12, Number 1—
January 2006, CDC; 5. Dawood, FS et al., Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study The Lancet Infectious Diseases , Volume 12 , Issue 9 , 687 - 695;
“I rate the chances of a
widespread epidemic…in my
lifetime at well over 50%”
- Bill Gates
www.youtu.be/9AEMKudv5p0
Flu Viruses Mutate Frequently & Unpredictably
3. Challenge: Virus-Vaccine Mismatch
10%
21%
52%
37%
41%
56%
60%
47%
49%
52%
19%
47%
Why current solutions fall short:
▸ Past strains selection Mismatch phenomenon
▸ Previous season’s vaccine will not necessarily
protect against next season’s flu strains
▸ 4-6 month production lag
6. http://www.worldbank.org/en/topic/pandemics/overview 7. CDC: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
8. WHO: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
CDC: Seasonal Flu Vaccine Effectiveness7
Average 40% general population; As low as 9% in elderly8
2004-05
2005-06
2006-07
2007-08
2008-09
2009-10
2010-11
2011-12
2012-13
2013-14
2014-15
2015-16
4. Solution: Target Common Regions
Universal Flu Vaccine
A common denominator for seasonal & pandemic strains
9 regions common to most seasonal and
pandemic flu strains connected into one
recombinant protein, called M-001
BiondVax’s M-001 Current vaccines
Universal: Broad coverage Strain specific
Single formulation
enabling year-round
vaccination
New vaccine every year
Quick, robust year-round
production (6-8 weeks)
Long (4-6 month)
production cycle
Activates both arms of
the immune system,
enhances existing vaccines
Limited effect
Non-allergenic:
Manufactured in E. coli
Egg allergy
Key Advantages
ImageadaptedfromCDC
5. Sanofi
36%
Seqirus / CSL
(Novartis)
16%
GSK
10%
AZ 7%
Others
31%
Meeting Milestones & Catalysts
Current Vaccine Market: Large and Growing
BiondVax
operational
Mid 90’s
Technology
developed by
Prof. Ruth Arnon,
developer of
Copaxone (Teva)
2005
1st of
two
Phase
1/2 (IL)
2008
1st of
three
Phase 2
(IL)
2010
NASDAQ:
BVXV
2015
FDA accepts
IND
Begin EU
Phase 2b
2016/17
EOP2M1 Phase
3 ready
EU Phase 2b
results
USA NIH Phase 2
USA CMO Phase 3
Material
2018
1 End of Phase 2 meeting with the FDA prior to Phase 3
▸ Worldwide $4B in 20151
▸ Projected to grow to
$5.3B by 20212
▸ Forecast CAGR 5.7%
Seasonal Flu Vaccine Global Sales Pandemic Flu Vaccine
▸ 2009’s H1N1 ‘Swine’ Flu sales additional
~$6.4B worldwide
▸ “…part of the national strategy for pandemic
influenza, the United States’ plan is to stockpile
enough pre-pandemic influenza vaccines to
cover 20 million in the critical workforce.”3
▸ “The United States has spent approximately
$1 billion in these [H5N1 flu vaccine stockpile]
efforts to date.”3
1. http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html; 2. PharmaPoint: Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, Feb, 2014 3. WHO, Oct. 2013
Mid-size
manufacturing
plant construction
6. Plans: Regulatory & Go-to Market Strategy
Standalone VaccinePrimer Vaccine
Pandemic primer for
national stockpile
Seasonal primer
for the elderly
Independent universal vaccine
Replace existing vaccines
$ $▸ Leverage existing marker (HAI)
▸ Smaller clinical trials
▸ Shorter time-to-market
▸ Clinical efficacy: Reduction of illness
rate and severity
Pandemic National Stockpile
▸ National stockpile for critical workforce
▸ Vaccination starts immediately upon any pandemic declaration
Seasonal Primer for Elderly
▸ Prime Boost Regimen: M-001 primer before flu
season (Q3), then regular vaccine boost (Q4)
1 2 3 4 5 6 7 8
Pandemic
Declaration
Proactive Preparedness Ahead
of Any Pandemic Outbreak
monthsToday’s situation
BiondVax’s
National Stockpile
7. Advanced Clinical Stage
Looking Ahead
▸ Ongoing 219 participant Phase 2b in EU UNISEC partnership
▸ Ongoing NIH-sponsored Phase 2 in USA
▸ Phase 3 ready 2017/18
‣ In 2011 we administered M-001 to seniors 65+ (BVX005)
‣ 4 years later, 5 times more seniors were seroprotected from a new
epidemic strain (A/Swiss) that didn’t exist in 2011!
Broad Coverage to Existing & Future Strains
Lowell GH et al. Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12
enhanced protective immune responses against 2014/15 epidemic strain. Vaccine (2017)
Positive Results
▸ Five completed Phase 1/2 and Phase 2 clinical trials
▸ 479 adults (ages 18-91yrs) have participated
▸ M-001: Safe and immunogenic in all studies
8. Safe Harbour Statement
This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.
All statements in this communication, other than those relating to historical facts, are "forward-looking statements" within the meaning of the United States Private Litigation Reform Act of 1995.You can identify forward-looking statements by terms including
‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’ ‘‘expects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-looking statements. These forward-looking statements
relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not guarantees of
future performance and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different
from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, among others: the risk that drug development
involves a lengthy and expensive process with uncertain outcome; BiondVax's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of
any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize BiondVax's products; the difficulty in evaluating business prospects; lack of sufficient funding to finance
the clinical trials; termination of license agreement with Yeda which is the owner of certain patents, patent applications and other intellectual property, as a result of dispute that can arise with Yeda or the failure of BiondVax to comply with financial and other
terms of the license; the difficulty of predicting actions of the U.S.A FDA; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; changes in the global pharmaceutical industry; changes in customers’
budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters; labor disputes; rising interest rates; general market, political or economic conditions in the countries in which we operate; pension and health insurance
liabilities; volatility or crises In the financial market; arbitration, litigation and regulatory proceedings; and war or acts of terror; Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks
and uncertainties. You should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and
events and circumstances reflected in the forward-looking statements will be achieved or will occur. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our
Prospectus which was declared effective on May 11, 2015. Readers are urged to carefully review and consider the various disclosures made in the Company’s SEC reports, which are designed to advise interested parties of the risks and factors that may affect its
business, financial condition, results of operations and prospects. These forward-looking statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. whether as a
result of new information, future events or otherwise, except as required by law.
Analyst Coverage
Edison: Jonas Peciulis. Price Target: $21
Zacks: Dr. David Bautz, PhD. Price Target $17
Aegis: Robert LeBoyer. Price Target: $15
Highlights
4.2M outstanding ADS (7.0M fully diluted)
About $10M cash on hand, no debt
About $35M raised (including ~$6M government grants)
Monthly burn rate approximately $250K/month
Strong and Broad IP
Five patent families covering conserved peptides, preparation, and use against flu
Filed in major countries with tentative expiration dates until 2035 (extendable)
BVXV
American Depository Shares and Warrants
(representing 40 ordinary shares) ticker:
BVXV
Ordinary shares ticker:
BVXVW
A Promising Future
Contact: Joshua Phillipson, Business Development (j.phillipson@biondvax.com) ● www.biondvax.com ● Q2 2017