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1. BiondVax – December 2011
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Universal Flu Vaccine One
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For All
BiondVax Pharmaceuticals Ltd.

2. BiondVax – December 2011
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Forward Looking Statements
This presentation includes “forward-loo king statements” within the meaning of
applicable securities laws. These forwar d-looking statements involve risks and
uncertainties, including those identified wi thin the “Risk Factors” section of the
Company's Prospectus dated 26 November 2009.

Although management of the Company believes the expectations reflected in
such forward-looking statements are based on reasonable assumptions, the
Company cannot assure investors that these expectations will prove correct, and the actual results that the Company achieves may differ materially from any forward-looking statements, due to such risks and uncertainties.

3. BiondVax – December 2011
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Introduction
Agenda
Introduction ►
Science
Market
Road Ahead

4. BiondVax – December 2011
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Flu the Most Common Infectious Disease
600 million - 1
billion cases of
influenza
globally
3-5 million
cases of
severe illness
300,000 -
500,000 deaths
Estimated annual influenza incidence:
5-15% of the overall population
Source: WHO, Acute Respiratory Infections (Update September 2009)
Agenda
Introduction ►
Science
Market
Road Ahead

5. BiondVax – December 2011
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BiondVax’s Road Map
BiondVax Pharmaceuticals Ltd.

→Established in 2003
→Exclusive, worldwide license
agreement with the
Weizmann Institute
→Publicly-traded on Tel Aviv
Stock Exchange since June
2007 (TASE:BNDX)
→Raised ~$17m since its
inception
BiondVax
today
Prof. Ruth Arnon &
Dr. Tamar Ben-Yedidia
Weizmann Institute

→More than 15 years of R&D
led by Prof. Arnon and her
team
→Established feasibility in
animals prior to founding of
BiondVax
→Registration of initial patents on universal influenza vaccine
Human Clinical Trials
Positive safety & immunogenicity
→FDA Pre-IND (July 2008)
→Two Phase I/II clinical trials:
≥63 younger adults (18-49)
≥60 older adults (55-75)
→Two Phase II clinical trials:
≥200 younger adults (18-49)
μ120 older adults (>65) on-
going, results by Q1-2012
Basic research
Weizmann Institute
►
Agenda
Introduction ►
Science
Market
Road Ahead

6. BiondVax – December 2011
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One Product – Two Indications
Proven Track
Record of Success in
Clinical Trials
•
Currently conducting second Phase II trial – in Elderly
≥120 participants aged over 65
•
First Phase II trial successfu lly concluded (June 2011)
≥200 participants aged 18 - 49
≥Positive safety and immunogenicity results
•
Completed two Phase I/II trials (Dec 2009 & April 2010)
≥60 adult participants aged 55 - 75
≥63 younger adult participants aged 18 - 49
≥Positive safety and immunogenicity results
Standalone Universal Flu Vaccine
Combination Flu Vaccine
ONE VACCINE
→
For seasonal & pandemic flu strains
→
Multi-year protection
ENHANCEMENT of TIV
→
Prime: M-001 & Boost: TIV
→
Elderly and Other at-risk populations
One Product ● Two Indications
►
Agenda
Introduction ►
Science
Market
Road Ahead

7. BiondVax – December 2011
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Advantages
Standalone Universal
Influenza Vaccine
Combination Influenza Vaccine

Positioning

“Next Generation”


▲Replacement of existing
vaccines

▲Game-changing product

Priming in elderly & other at-risk
populations Improves existing flu
vaccines

▲Combination vaccine – no longer a
commodity product
▲Potential for premium pricing

▲Potential for expansion into new
markets: M-001 can prime many TIV
brands
▲Early preparedness for seasonal &
pandemic vaccines
Regulatory
Pathway
Need to show protection
(that correlates with new
surrogate marker)

▲Clear regulatory pathway using
existing HAI surrogate marker :
•HAI seroconversion and GMT
Phase III
▲Large scale field trial ▲Smaller, quicker trial
►
Agenda
Introduction ►
Science
Market
Road Ahead

8. BiondVax – December 2011
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Scientific Rationale and Background
►
Agenda
Introduction
Science ►
Market
Road Ahead

9. BiondVax – December 2011
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The Multimeric-001 Vaccine
H
emagglutinin (HA) x 5
(B- & T-Cell)
M
1
Matrix Protein x 1
(T-Cell)
N
ucleo
P
rotein x 3
(T-Cell)
M-001 Concept: Common Denominator
The Multimeric-001 (M-001) is comprised of a
unique and proprietary combination of nine
selected linear B- and T-cell epitopes that are
conserved and common to most influenza
strains
The Multimeric-001 Vaccine
A single recombinant polypeptide containing
each of the nine linea r epitopes, taken in
triplicate, with proline as a spacer
Selected epitopes
from HA, NP and M
proteins
The Influenza Virus
►
Agenda
Introduction
Science ►
Market
Road Ahead

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B- & T-cell Epitopes for Improved Protection
The selected epitopes used: ≥
Conserved & Common
→Type A and B influenza (Victoria &
Yamagata)
≥
Activate both arms of the immune system: T-Cells & B-Cells
Major Advantages…
… resulting in:
→
One single formulation
Optimal Vaccination:
B-cell + T-helper + CTL epitopes
(●) Untreated control
(x) B-cell epitope
(■) B-cell epitope & CTL epitope
(
▲
) B-cell & CTL & T helper epitope
Vaccine, Vol. 14 (1) pp. 85-92, 1996 Early pre-clinical work at the Weizmann
Institute showed that a mixture of
adjuvanted B-cell + T-helper + CTL epitopes provides optimal protection against influenza infection:
►
BiondVax M-001 Protection
HLA A*0201 transgenic mice immunized IM x3 with adjuvanted
M-001vaccine and infected with highl y lethal (30LD50) dose of
H3N2
Agenda
Introduction
Science ►
Market
Road Ahead

11. BiondVax – December 2011
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Enhancement of TIV: Pre-Clinical
►
Agenda
Introduction
Science ►
Market
Road Ahead

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Combination Vaccine: Prime - Boost
0
10
20
30
40
50
60
70
% Mice with HAI ≥ 1:40
p ≤ 0.01
% Mice with HAI (A/New Caledonia/20/99) ≥ 1:40
In mice:

Priming with M-001
+
Boosting with TIV*

Resulted in:

5-fold increase in % of mice
achieving HAI ≥ 1:40
Prime (day 0): PBS PBS BiondVax M-001
Boost (day 21): PBS TIV TIV

~5x increase
►
* Suboptimal dose of Vaxigrip 2006 season
Agenda
Introduction
Science ►
Market
Road Ahead

13. BiondVax – December 2011
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Clinical Trials
►
Agenda
Introduction
Science ►
Market
Road Ahead

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Phase I/II & II Clinical Trials
Endpoints: →
Primary endpoint: Safety
→
Secondary (exploratory) endpoints:
Immunogenicity evaluation
BVX 002, 004 – Younger Adults
BVX 003 – Elderly
→
Phase I/II (BVX002): 63 participants,
♀ ♂, 18-49 years old) June – December
2009. Single blind, dose escalating
→
Phase II (BVX004): 200 participants, ♀
♂, 18-49 years old) Oct. 2010 – June
2011. Double blind, combined
vaccination, partial (15%, 50%) TIV
dose
→
Phase I/II (BVX 003): 60 participants, ♀ ♂, 55-75 years old). Sept 2009 –
April 2010. Single blind, dose
escalating, Prime-boost full TIV dose.
Younger Adults Elderly
Clinical Trial
BVX 002 BVX 004 BVX 003
Safety
→

→

→

Immunogenicity
Humoral (antibodies)
M-001
→

→

→

HAI
N/A
→
(partial TIV)
→
(full TIV)
Cellular
IFN-g
→

→

→

IL-2
→
N/D
→

FACS
N/D
→
N/D
►
Agenda
Introduction
Science ►
Market
Road Ahead

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Seroconversion to TIV Viruses (HAI)
Phase I/II in Elderly: Combination vaccine
1. Seroconversion: % of individuals with MFI≥4x from ≥1:10 at baseline or rise fr om <1:10 at baseline to ≥1:40 at 63 days
2. M-001: Adjuvanted Multimeric-001 250mcg; 3. Contro l: Adjuvanted PBS; 4. TIV used: Vaxigrip 2009/2010
0
10
20
30
40
50
60
70
80
90
100
% Seroconverted subjects
Minimum required for
regulatory approval
Priming with M-001 results in increase in HI seroconversion for all three strains
►
Prime: Adj PBS Adj M-001 Adj PBS Adj M- 001 Adj PBS Adj M-001
Boost: TIV TIV TIV TIV TIV TIV

A/Brisbane/59/07 H1N1 A/Brisb ane/10/07 H3N2 B/Brisbane/60/08
Agenda
Introduction
Science ►
Market
Road Ahead

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Second Phase II Study (BVX005) – Underway
Trial Design: •
Randomized, double-blind, placebo-contro lled study in 120 elderly volunteers
•
Various formulations and administration schedules –
Single and double prime before boost with TIV
–
With and without Aluminum Phosphate adjuvant
Timeline:
•
Initiation: September 2011 Projected study completion: Q1 2012






Endpoints:
•
Primary –
To assess the safety, tolerability, reactogenici ty and local tolerance of non-adjuvanted and
Alum-adjuvanted (Aluminum Phosphate) Multimeric-001 vaccine, when used as a primer
to TIV
•
Secondary (exploratory) – Immunogenicity endpoints –
To characterize the immune responses in all study groups, in cluding assessment of HI
antibody levels
•
Immunogenicity assessment will examine two concepts:
–
Administration schedule: single vs. double prime
–
Adjuvant: contribution of Alum inum Phosphate as an adjuvant
Group DAY 0 DAY 21 DAY 42 #
A M-001 (500μg) M-001 (500μg) TIV 30
B M-001 (500μg) TIV - 30
C M-001 (500μg) + Alum TIV - 30
D Saline TIV - 30
TOTAL 120
►
Agenda
Introduction
Science
Market ►
Road Ahead

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Third Phase II Study (BVX006) – 2012 in EU
Trial Design: •
Randomized, double-blind, placebo-contro lled study in 400 elderly volunteers
•
Will employ the best performing formulation (adjuvanted or non-adjuvanted) and administration schedule (single or double prime) from the second Phase II (now underway)

Timeline:
•
Initiation: Q2 2012 Projected study completion: Q1 2013






Endpoints:
•
Primary –
To assess safety, tolerability, reactogenicity and local tolerance of Multimeric-001 vaccine
–
Immunogenicity: Significant elevation in antibodies (IgG) to Multimeric-001

•
Secondary (exploratory) –
To describe the enhancement of TIV by priming with Multimeric-001 vaccine in elderly at
different prime-boost time intervals
–
Enhancement of TIV will be measured by HI GMT or seroconversion rates for any of the vaccine strains (2011-2012 influenza season) at 4 weeks post-TIV vaccination
Group Vaccination 1 Vaccination 2 Intervals #
A M-001 (500μg) TIV 12 weeks 100
B M-001 (500μg) TIV 8 weeks 100
C M-001 (500μg) TIV 3 weeks 100
D, E, F Saline TIV 3, 8, 12 weeks 100
TOTAL 400
►
Agenda
Introduction
Science ►
Market
Road Ahead

18. BiondVax – December 2011
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The Market
Agenda
Introduction
Science
Market ►
Road Ahead

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38%
14%
18%
7%

4%
3%
16% Flu Vaccines are a Major, Growing Market
Seasonal Flu Vaccine Market
Source: Datamonitor, BCC Research 1
BiondVax estimate. Actual Novartis 2008 Influenza Vaccine sales data
are not publicly available
$1,077m
$378m
(1)
$516m
$200m
$104m
$91m
Others $446m
Flu Vaccine Market

•Seasonal Flu:
→2010 sales: ~$3bn worldwide
2
→~500m doses supplied
2

→Predominantly for elderly and
toddlers
→Forecasted CAGR of ~10% over next 5
years
3

→Expected 2016 sales: ~$7 bn
3


•Pandemic Flu:
e.g. Swine Flu A/H1N1, Avian Flu etc.,
→2010 sales: ~ $3.6 bn worldwide
4
(in
addition to seasonal flu vaccine sales)
→Mainly for children and young adults
Agenda
Introduction
Science
Market ►
Road Ahead
2
http://www.sanofipasteur.com/sanofi-pasteur2/sp-
media/SP_CORP/EN/222/1758/EN_Factsheet%20SP%20world%20ma
nufacturer_2011.pdf
3
http://centerforvaccineethicsandpolicy.wordpress.com/2011/03/27/
world-vaccines-market-and-future-forecast/
4
http://www.gsk.com/investors/presentations/2011/2011-03-23-
martin-andrews-citi.pdf

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Significant M&A Activity
Vaccine Transactions
($m, log-scale)
$1.5bn
$888m
$1,5bn
$5.4bn
$480m
$380m
$15.6bn
$364m
$550m
$68bn
$781m
$6.6bn
$2.4
bn
1
10
100
1,000
10,000
100,000
2002
2003
2005
2006
2007
2008
2009
2010
Agenda
Introduction
Science
Market ►
Road Ahead

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Value Proposition: Combination Vaccine
►
Agenda
Introduction
Science
Market ►
Road Ahead

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Influenza & the Elderly: The Slippery Slope •
Adults ≥65 years of age c omprise ~15% of the US population, but account for 65% of hospitalizations and 90% of deaths attribu table to influenza and its complications
•
136,000 hospitalizations and 36,000 deaths per year in the US (elderly)
•
Aging population: proportion of popu lation ≥65 years expected to rise to ~ 25% by 2050
leading to almost one million hospitalizatio ns and quarter million deaths annually in
countries belonging to the OECD
Older Adults are More Prone to Influenza-Related Complications
►
OECD (US)
Current
Situation
Penetration of Combination Vaccine in
Elderly who get the TIV (%)
25% 50% 75%
Flu Illnesses among Elderly
(‘000) 12,433 (3,200)

9,087 (2,339) 5,741 (1,478) 2,395 (616)
Direct
Medical Costs ($m) 16,318 (4,200)

11,926 (3,070)

7,535 (1,939) 3,143 (809)
Flu
-Related Hospitalizations (‘000
)
528 (136) 386 (99) 244 (63) 102 (26)
Influenza
-Related Deaths (‘000) 140 (36) 102 (26) 65 (17) 27 (7)
Assumptions: •
Proportion of elderly that receive TIV : 70%
•
Combination vaccine results in in crease in average HAI sero protection rates of 10% (conservative)
•
4.3% of elderly sick with flu are admitted to hospital (3.2 million illnesses in US with 136,000 hospitalizations)
•
26.5% of hospitalized elderly flu patients die (136,000 hospitalizations and 36,000 deaths)
•
Note: Calculations based on above as sumptions applied to data from Sanofi Pasteur presentation to CDC at
www.cdc.gov/vaccines/recs/acip/downloads/ mtg-slides-feb10/05-6-flu-vac.pdf
The Combination Vaccine: Major Savings in Morbidity, Mortality and Costs
Agenda
Introduction
Science
Market ►
Road Ahead

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Value Proposition: Combination Vaccine
OECD Peak Sales Potential: $500 -
$1,500m
Peak Sales
($m)
Elderly Penetration Rates
25% 50% 75%
5.00

250 500 750
7.50

375 750 1,125
10.00
500 1,000 1,500
12.50
625 1,250 1,875
15.00
750 1,500 2,250
Price per Dose ($)
Assumptions for Peak Sales: •
200m elderly (>65) in OECD
•
Assumed prices per dose are ex-factory prices
•
Royalty to Weizmann Inst. of 3% of net sales
•
M-001 COGS of $1 per dose (incl. syringe)
►
Medicare Part B Payment Allowances
Source: US Dept of Health and Human Services, CMS (Centers for
Medicare and Medicaid Services) accessed at
https://www.cms.gov/mcrpartbdrugavgsalesprice/10_vaccinespricing.asp
Note: The Medicare Part B payment allowance limits for
seasonal influenza and pneu mococcal vaccines are 95% of
the Average Wholesale Price (AWP)
Assuming pricing of Combination Vaccine similar to Fluzone HD, and TIV price of $12,
the Multimeric-001 component could be priced up to $18
Agenda
Introduction
Science
Market ►
Road Ahead
Price per Dose ($)

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Value Proposition: Pandemic Preparedness
Potential Pre-Pandemic Sales
OECD Pre-
Pandemic Sales
($m)
OECD Population Penetration Rate
25% 50% 75%
5.00 1,500 3,000 4,500
7.50 2,250 4,500 6,750
10.00

3,000 6,000 9,000
12.50

3,750 7,500 11,250
15.00

4,500 9,000 13,500
Price per Dose ($)
Assumptions: •
Population in OECD: 1.2bn
•
Assumed prices per dose are ex-factory prices
BiondVax M-001 Priming Period
Pandemic Vaccine
WHO Global Influenza
Preparedness Plan
►
M-001
Release
from
Stockpile
Agenda
Introduction
Science
Market ►
Road Ahead

25. BiondVax – December 2011
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The Road Ahead
Agenda
Introduction
Science
Market
Road Ahead ►

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Combination Vaccine Regulatory Pathway
Second
Phase II

• 120 elderly (65+)

• In Israel – 2
centers

• Q4 ‘11 – Q1 ’12

• $ 0.6m
Third
Phase II
1
• 300 – 400
elderly (65+)
• In EU – multi-
center
• Q2 ‘12 – Q1 ’13
• $1.5 – 2.0m
Pivotal
Phase III
2

• 3,000 – 4,000
elderly (65+)
• EU + US


• Q3 ’13 – Q1 ’14

• $20 – 25m
Regulatory
Submissions

• Q3 ‘14

• US BLA

• EU MAA
►
Agenda
Introduction
Science
Market
Road Ahead ►
1
Additional Phase II may be required
2
Pivotal Phase III clinical tri als require strategic partner

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Key Milestones
d
b
≥
1
st
Phase I/II
Results – younger
adults (12/2009)
≥
2
nd
Phase I/II
Results – older
adults
(04/2010)
≥
1
st
Phase II
Results (06/2011)
LAUNCH
Agenda
Introduction
Science
Market
Road Ahead ►
1
Additional Phase II may be required
2
Pivotal Phase III clinical tri als require strategic partner

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A Game Changer for
Flu Vaccines

Thank You!
For further details:

Dr. Ron Babecoff, DVM President & CEO BiondVax Pharmaceuticals Ltd.
T: [phone]
E: [email protected]