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www.biondvax.com Flu Eradication? Yes! The Universal Flu

BiondVax 8 page brochure

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Page 1: BiondVax 8 page brochure

www.biondvax.com

Flu Eradication?

Yes!The

UniversalFlu Vaccine

Page 2: BiondVax 8 page brochure

Seasonal Problem‣ 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 deaths3 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 Gateswww.youtu.be/9AEMKudv5p0

Flu: Infects up to 20% and kills…

Page 3: BiondVax 8 page brochure

Challenge: Virus-Vaccine Mismatch

2015-16

2014-15

2013-14

2012-13

2011-12

2010-11

2009-10

2007-08

2006-07

2005-06

2004-05

47%

23%

51%

49%

47%

60%

56%

37%

52%

21%

10%

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 lag6. http://www.worldbank.org/en/topic/pandemics/overview 7. CDC: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm8. 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 elderly

Page 4: BiondVax 8 page brochure

Solution: Target Common RegionsUniversal 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 Hen egg allergy

Key Advantages

Imag

e ad

apte

d fro

m C

DC

Page 5: BiondVax 8 page brochure

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 INDBegin EU Phase 2b

2016

EU Phase 2b results

USA NIH Phase 2

USA CMO Phase 3 Material

EOP2M1 Phase 3 ready

2017/18

1 End of Phase 2 meeting with the FDA prior to Phase 3

‣ Worldwide $3.2B in 20131

‣ 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

Sanofi33%

Seqirus / CSL (Novartis)19%

GSK18%

AZ11%

Others19%

1. Datamonitor report: DMKC0107117, 18/11/2013; 2. PharmaPoint: Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, Feb, 2014 3. WHO, Oct. 2013

Page 6: BiondVax 8 page brochure

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 Declaratio

n

1st Vaccination

Strain-specific Vaccination

2nd Vaccination

Proactive Preparedness Ahead of Any Pandemic

Outbreak

monthsToday’s situation

BiondVax’s National Stockpile

Page 7: BiondVax 8 page brochure

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

Advanced Clinical Stage

Looking Ahead‣ Ongoing Phase 2 in EU partnership with

UNISEC‣ Ongoing NIH-sponsored Phase 2 in USA‣ Phase 3 ready 2017/18

‣ In 2015 blood samples of 2011 elderly study participants were tested against the new ‘Swiss’ flu strain

‣ 5 times more participants primed with M-001 reached the level of protection (seroprotection) against this new strain compared to the control group

Broad Coverage to Vaccine & Non-Vaccine Strains

Page 8: BiondVax 8 page brochure

Safe Harbour StatementThis 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 Zacks Research: Dr. David Bautz, PhD. Rating: Buy. Price Target $17. Aegis: Robert LeBoyer. Rating: Buy. Price Target: $15. 

Highlights 3.3M outstanding ADS (6.28M fully diluted) About $8M cash on hand, no debt 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)

BVXVAmerican Depository Shares and Warrants(representing 40 ordinary shares) ticker:

BVXVOrdinary shares ticker:

BVXVW

A Promising Future

Kenny Green, Investor Relations - [email protected] Joshua Phillipson, Business Development – [email protected]

Q4 2016