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1 NASDAQ: VBIV | TSX: VBV NASDAQ: VBIV TSX: VBV MARCH 2017 CORPORATE PRESENTATION

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Page 1: CORPORATE PRESENTATION1o976r1jw2eculmeoxz46ig6-wpengine.netdna-ssl.com/wp...CORPORATE PRESENTATION NASDAQ: VBIV | TSX: VBV 2 Certain statements in this presentation contain forward-

1NASDAQ: VBIV | TSX: VBV

N A S D A Q : V B I VT S X : V B V M A R C H 2 0 1 7

CORPORATEPRESENTATION

Page 2: CORPORATE PRESENTATION1o976r1jw2eculmeoxz46ig6-wpengine.netdna-ssl.com/wp...CORPORATE PRESENTATION NASDAQ: VBIV | TSX: VBV 2 Certain statements in this presentation contain forward-

2NASDAQ: VBIV | TSX: VBV

Certain statements in this presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “goals” and similar expressions. All statements other than statements of historical fact included in this presentation are forward-looking statements.

Such forward-looking statements are based on a number of assumptions, including, without limitation, assumptions regarding the successful development and/or commercialization of the company’s products, such as the receipt of necessary regulatory approvals; general economic conditions; that the company’s business is able to operate as anticipated without interruptions; competitiveconditions; and changes in applicable laws, rules and regulations.

Although management believes that the assumptions made and expectations represented by such statements are reasonable, there canbe no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments maydiffer materially from those expressed or implied by the forward-looking statements contained herein, and, even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include, without limitation: the failure to successfully develop or commercialize the company’s products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company’s reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions.

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement and are made only as of the date of this presentation. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

Cautionary Statement Regarding Forward-Looking Information

Page 3: CORPORATE PRESENTATION1o976r1jw2eculmeoxz46ig6-wpengine.netdna-ssl.com/wp...CORPORATE PRESENTATION NASDAQ: VBIV | TSX: VBV 2 Certain statements in this presentation contain forward-

3NASDAQ: VBIV | TSX: VBV

• World-class leadership: Dr. Steve Gillis, Steve Rubin, Jeff Baxter, Dr. Michel De Wilde, and Dr. David Anderson

• Scientific Advisory Board: Dr. Florian Schödel and Dr. Stanley Plotkin

M A N A G E M E N T• Broad research collaborations to confer

thermostability and enhance stability of key vaccine programs with:

• Sanofi Pasteur

• GSK

L P V ™ C O L L A B O R AT I O N S

• Hepatitis B Vaccine: 3rd generation vaccine targeting non-responders to standard of care

• Congenital CMV Vaccine: Target young women to prevent birth defects

• Brain Cancer Therapeutics: Tx vaccines for most common adult and pediatric brain tumor types – GBM, Medulloblastoma

• Congenital Zika Vaccine

• Enveloped Virus-Like Particle (“eVLP”) platform closely mimics viruses and induces potent and durable immune responses

• Lipid Particle Vaccine (“LPV™”)platform enables thermostable delivery, and increased access, safety, and efficacy

T E C H N O L O G Y P L AT F O R M S P I P E L I N E

Leading Immunology Innovation in Significant Markets with High Unmet Need

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4NASDAQ: VBIV | TSX: VBV

Recent Key AchievementsM AY 2 0 1 6 – M A R C H 2 0 1 7

February 2017 Received positive response from Health Canada regarding Sci-B-Vac™ Phase III clinical program

February 2017 Received positive EMA Scientific Advice regarding Sci-B-Vac™ Phase III clinical program

December 2016 Closed $23.6MM financing from Perceptive Advisors

October 2016 Completed FDA pre-IND meeting for GBM candidate

September 2016 Completed enrollment of CMV Phase I clinical trial

July 2016 Announcement of Zika vaccine program

June 2016 Start of CMV Phase I clinical trial

June 2016 Closed $13.6MM PIPE

June 2016 Announcement of Medulloblastoma candidate

May 2016 Closed SciVac Therapeutics Transaction

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5NASDAQ: VBIV | TSX: VBV

O P P O R T U N I T I E S I N I N F E C T I O U S D I S E A S E & O N C O L O G Y

VBI Vaccines Pipeline

LEAD PRE-CLINICAL PHASE I PHASE II PHASE III APPROVED STATUS

I N F E C T I O U S D I S E A S E

Sci-B-Vac™ (Hepatitis B)(Licensed in 15 countries)

EU & N. America Regulatory feedback expected H1 2017

eVLP

Cytomegalovirus (CMV) Interim Ph I data expected mid 2017

Zika Candidate selection 2017

I M M U N O - O N C O L O G Y

eVLP

GlioblastomaMultiforme (GBM)

IND filing expectedmid 2017

Medulloblastoma IND filing expectedmid 2017

Undisclosed -

L P V ™ P L A T F O R M C O L L A B O R A T I O N S

Undisclosed Collaboration ongoing

Undisclosed Collaboration ongoing

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F I V E K E Y VA LU E D R I V E R S I N N E X T 1 2 M O N T H S

• Sci-B-Vac™: Meeting with regulatory bodies H1 2017 to determine clinical development path in Europe and North America

• CMV: Interim Phase I Clinical Trial results with immunologic human proof of concept data expected mid-year 2017

• GBM: Mid-year 2017 IND submission for approval to start a Phase I clinical trial

• Expanding Pipeline: Announcement of additional immuno-oncology programs during 2017+

• Business Development: Additional non-dilutive collaborations/partnerships H1 2017+

Value Proposition for VBI Vaccines

1

2

3

4

5

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VBI Vaccines Pipeline Programs

1

3

4

Sci-B-Vac™ : Hepatitis B

VBI-1901 : Glioblastoma Multiforme (GBM)

Lipid Particle Vaccine (LPV)™ platform collaborations

2 VBI-1501A : Congenital Cytomegalovirus (CMV)

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8NASDAQ: VBIV | TSX: VBV

Hepatitis B Unmet NeedReported U.S. Hepatitis B Vaccination Coverage (2014)

Otherwise Healthy

Adults aged ≥ 19 years 24.5%

Adults aged 19-49 years 32.2%

Adults aged ≥ 50 years 15.7%

High-Risk

Chronic Liver Conditions 29.8%

Diabetics – Aged 19-59 years 23.5%

Diabetics – Aged ≥ 60 years 13.5%

Healthcare Providers ≥ 19 years 60.7%

Source: 2014 CDC Surveillance of Vaccination Coverage Among Adult Populations

• Seroconversion rates with current 2nd generation hepatitis B vaccines significantly decline in both the elderly and in the high-risk subpopulations

• The need for a next-generation hepatitis B vaccine in specific patient groups represents an annual global market opportunity of $600M - $800M

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• Patients with chronic liver disease ~50%

• Chronic renal failure & dialysis 34-81%

• Pre-transplantation candidates 28-36%

• Post-transplantation patients ~10%

• “Otherwise Healthy” ~50-85%

• Obese

• Over age 40

• Smokers

Sources: Yang et al, Scientific Reports (2016) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4914839/; WHO -http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html; http://jama.jamanetwork.com/article.aspx?articleid=409965; http://jama.jamanetwork.com/article.aspx?articleid=409967

Existing High Unmet Need in Specific PopulationsSEROPROTECTION RATES WITH CURRENT VACCINES FALL DRAMATICALLY WITHIN THE ELDERLY AND HIGH-RISK PATIENT POPULATIONS

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Sci-B-Vac™ Overview

• Pre-S1 antigen induces key neutralizing antibodies that block virus receptor binding

• Sci-B-Vac™ is currently approved in Israel as the neonate standard of care, and is licensed in an additional 14 other countries as a prophylactic vaccine in pediatrics and adults

2ND GENERATION VACCINES SCI-B-VAC™

Viral antigens mimicked:

S Protein ✔ ✔Pre-S1 ✔Pre-S2 ✔

Adjuvant: Next-generation Adj. (e.g. TLRs) Alum

Derivation: rDNA yeast Mammalian cell

THE ONLY COMMERCIAL HEPATITIS B VACCINE TO MIMIC ALL THREE VIRAL SURFACE ANTIGENS – SAFELY USED IN 300,000+ PATIENTS

• Sci-B-Vac™ achieves rapid onset of protection, with high levels of anti-HBV antibodies (HBsAb), at a lower dosage than competing vaccines

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Sci-B-Vac™ Clinical Experience

• Product distribution data globally estimates that over 300,000 infants and adults have been vaccinated with Sci-B-Vac™

• In the last two decades, 22 clinical trials have been completed using the current and/or prior formulations of Sci-B-Vac™

• A total of seven Sci-B-Vac™ clinical trials have been conducted in healthy adults

• In head-to-head comparative trials, all formulations of Sci-B-Vac™ have consistently demonstrated earlier and higher rates of seroprotection in adult populations compared to currently licensed hepatitis B vaccines

EXTENSIVE CLINICAL DEVELOPMENT SUPPORTS EMA/HC/FDA FILINGS

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Excerpt of Publicly Available Sci-B-Vac™ DataSEVERAL PHASE II & III STUDIES HAVE BEEN CONDUCTED IN > 4,500 PATIENTS, RESULTS OF WHICH INCLUDE:

Size Population Sci-B-Vac™ 2nd-Generation HBV Vaccine

N=105 Young adults98% SPR - month 6, post 2nd

injection; 100% SPR - post 3rd injection

NA

N=29 ESRD86% SPR - post 3rd vaccination

(previous non-responders to double-dose of 1st generation vaccine)

56% SPR - post repeated 2x-dose immunizations

(comparison, retrospective evaluation in same study center over

3 years)

N=716

Previous low/non-

responders (mean age 50 yrs)

82% SPR - post 2nd vaccination 49% SPR - post 2nd vaccination

Sources: Shouval D, “Enhanced Immune Response to Hepatitis B Vaccination Through Immunization with a Pre-S1/Pre-S2/S Vaccine” 2015

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VBI Vaccines Pipeline Programs

1

3

4

Sci-B-Vac™ : Hepatitis B

VBI-1901 : Glioblastoma Multiforme (GBM)

Lipid Particle Vaccine (LPV)™ platform collaborations

2 VBI-1501A : Congenital Cytomegalovirus (CMV)

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eVLPs are a 3rd-Generation Class of Synthetic Vaccines

Electron Microscopy image of VBI’s CMV eVLPs captured at Scripps Institute.

• eVLPs are the same size and structure as enveloped viruses; present antigens in their natural state for an improved immune response

• The foundation of the eVLP Platform is a stable, protein-based core on which additional vaccine antigens of interest can be added

e V L P

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Presentation of gB antigen in an eVLP improves relevant functional CMV neutralizing responses relative to recombinant gB protein

P R E C L I N I C A L R E S U LT S

eVLP Presentation Improves CMV Vaccine Potency

• Neutralizing antibodies (nAb) are the desired functional immune response for prophylaxis

• gB in eVLP generates higher levels of CMV nAbs than recombinant (gB)

• eVLPs potency is not dependent on powerful adjuvants; FDA approved alum is sufficient

50%

Epi

thel

ial c

ell n

Ab T

iter (

1/x)

Neutralizing antibody titers for mice immunized with comparable doses of Recombinant gB of

optimized gB eVLPs (VBI-1501)

1

10

100

1,000

10,000

Recombinant gB gB-G eVLPs (VBI-1501)

VB

I-1

50

1

Source: VBI Studies: 15BC04, 15BC19, 15BC39

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Congenital CMV is a Leading Public Health Priority

U.S. CHILDREN BORN WITH OR DEVELOPING LONG-TERM MEDICAL CONDITIONS

Sources: Cannon, M.J., and K.F. Davis, 2005. Washing our hands of the congenital cytomegalovirus disease epidemic. BMC Public Health 5:70; CDC website; Stratton KR et al, Committee to Study Priorities for Vaccine Development, Inst. Of Med., Washington DC

• Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, some of them severe, including deafness, blindness, and developmental delays

• In the U.S., the direct economic costs of CMV infection exceeds $2.0B annually

CMV affects more live births than Down Syndrome or Fetal Alcohol Syndrome

Incidence per year

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NEUTRALIZING ANTIBODY TITERS OF RABBITS 28 DAYS AFTER A SECOND VACCINATION WITH VBI-1501A, COMPARED TO CMV+ DONORS IN TWO

CLINICALLY RELEVANT, CMV-SUSCEPTIBLE CELL LINES

Fibroblast Cells Epithelial Cells

1

10

100

1,000

10,000

HFF: CMV+ sera HFF: VBI-1501A sera ARPE: CMV+ sera ARPE: VBI-1501A sera

Endp

oint

nAb

Tite

r (1/

x)VBI-1501A Stimulates CMV Neutralizing Antibodies Comparable to Natural Levels of Immunity

Natural levels of CMV immunity provide 90%

protection

VB

I-15

01A

VB

I-15

01A

Source: VBI Studies: 15RA44

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Opportunity for immunologic human proof-of-concept with Phase I data

CMV Phase I Clinical Trial Overview

T R I A L D E S I G N

• Started: June 2016

• Population: ~125 CMV-Negative Healthy Adults (18-40 yrs)

• Design: Staggered Enrollment with Vaccinations at 0, 2, and 6 Months

• Expected Duration: 20 Months

• Interim Data Collected: 1 month after last-patient 2nd dose

• Primary Endpoint: Safety and Tolerability

• Secondary Endpoints:

• gB binding titers • nAb titers in fibroblast and epithelial cells • gB avidity measurement

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C O M P L E T E D M I L E S T O N E S - A C H I E V E D R I S K M I T I G AT I O N

Q1 2015: CMV vaccine candidate manufactured at 50L production-scale

Q2 2015: Verified stability of CMV vaccine candidate

Q2 2015: Demonstrated batch-to-batch consistency

Q2 2015: Confirmed potency of clinical formulations in 2nd animal model

Q3 2015: GMP clinical batch in final production

Q3 2015: Finalized clinical protocol and Investigators Brochure

Q4 2015: Completed formal toxicology studies for CMV vaccine candidate

Q2 2016: Submitted CTA for Phase I

Q2 2016: Initiated Phase I Clinical Trial

R E M A I N I N G M I L E S T O N E T O K E Y VA L U E I N F L E C T I O N P O I N T

Mid 2017: Expected interim data from Phase I Clinical Trial

VBI CMV Candidate Milestones

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VBI Vaccines Pipeline Programs

1

3

4

Sci-B-Vac™ : Hepatitis B

VBI-1901 : Glioblastoma Multiforme (GBM)

Lipid Particle Vaccine (LPV)™ platform collaborations

2 VBI-1501A : Congenital Cytomegalovirus (CMV)

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Therapeutic GBM Candidate Builds on Prophylactic CMV Candidate (VBI-1501A) by Adding an Internal pp65 Protein to Elicit a Th1 Response

Attributes Monovalent gB for Prophylaxis

Bivalent – pp65 for Therapeutic Immuno-

Oncology

Present antigen in natural conformation +++ +++Broadly Reactive Neutralizing Antibodies +++ +++Polyvalent Immune Response ++Potent Th1 Cellular Immunity for Therapeutic Applications

CD4+ ++ +++

CD8+ ++

gB Envelope‘NeoAntigen’

pp65 ‘NeoAntigen’

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Sources: 1Cobbs CS(2013) Curr Opin Oncol 25, 682; 2Baryawno N(2011) J Clin Invest 121, 4043-4055; 3Libard S(2014) PLoS ONE 9, e108861; 4Taher C(2013) J Clin Virol 54, 240; 5Harkins LE (2010) Herpesviridae 1, 8

Poor Immunogenicity of Traditional Tumor-Associated Antigens (TAAs) has Limited Past Therapeutic Cancer Vaccines

I M M U N O G E N I C I T Y

L O W H I G H

“Self” TAAsNeoantigens

“Foreign” Viral TAAs

V I R A L C M V A N T I G E N S A R E O V E R - E X P R E S S E D ( > 9 0 % ) I N M U LT I P L E S O L I D T U M O R S , I N C L U D I N G :

• Glioblastoma (GBM)1

• Medulloblastoma2,3

• Meningioma3

• Breast cancer4,5

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CMV as a “Foreign” Viral TAAC L I N I C A L E V I D E N C E S U G G E S T S C M V VA C C I N AT I O N C A N B E S U C C E S S F U L ( D U K E D ATA ) 1

• Dendritic cell priming combined with CMV vaccination significantly extended overall survival of GBM patients relative to the standard of care

• Three patients in investigational cohort (n=6) did not progress and were alive at the time of survival analysis (>36.6 months) vs. control cohort with median PFS of 10.8 months and median OS of 18.5 months

G B M U N M E T M E D I C A L N E E D

• Over 20,000 patients diagnosed each year

• Only 40% survive longer than 6 months2

• GBI Research predicts a market size of $600+ million by 2020

Sources: 4Mitchell DA(2015) Nature 519, 366-369; 2Ohgaki (2004) Cancer Research, 64:6892

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• Fresh PBMCs stimulated with VBI-1901 vsrecombinant antigens

• eVLPs rapidly restimulateboth CD4+ & CD8+ T-cell responses

• eVLP presentation enhances stimulation relative to matched recombinant antigen

24

Restimulation of CD4+ & CD8+ T-cells in Ex Vivo Human Samples

VBI-1901: Re-stimulated CD4+ and CD8+ T-cell Responses in CMV-positive Human Subject Ex Vivo

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• PBMCs from CMV+ healthy subjects or patients with GBM, medulloblastoma, or breast cancers were stimulated for 36 hours with gB/pp65 eVLPs+GM-CSF (VBI-1901) or empty eVLPs+GM-CSF, at which time CCL3 production was measured by ELISA

• VBI-1901-induced responses were compared to stimulation of all T cells (PHA stimulation) to estimate the strength of the vaccine-induced responses ex vivo

VBI-1901 Induction of CCL3 in Ex Vivo PBMCs from CMV-positive Healthy Subjects and Patients with Solid Tumors

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C O M P L E T E D M I L E S TO N E S

Q1 2016: Pre-clinical IND-enabling data

Q1 2016: Clinical Advisory Meeting

Q2 2016: Pre-IND meeting with FDA

R E M A I N I N G M I L E S TO N E S TO P H A S E I S TA R T

H1 2017: GMP clinical trial materials manufacturing

Mid 2017: IND submission for approval to start Ph I clinical trial

VBI GBM Candidate Expected Timeline

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VBI Vaccines Pipeline Programs

1

3

4

Sci-B-Vac™ : Hepatitis B

VBI-1901 : Glioblastoma Multiforme (GBM)

Lipid Particle Vaccine (LPV)™ platform collaborations

2 VBI-1501A : Congenital Cytomegalovirus (CMV)

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LPV™ Platform OverviewEnables thermostable vaccine delivery, which is expected to increase vaccine access and preserve safety and efficacy.

U N LO C KS VA LU E

90% of all vaccines require “cold chain”

shipment at 4°C

P R ES E RV ES P OT E N C Y

Improved stability enables delivery of an

effective dose, every time

I M P ROV ES AC C ES S

Enables safe storage and transfer outside of the refrigerator / freezer

“cold chain”

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LPV™ Platform Proof of ConceptProprietary formulation of lipids preserves stability and potency for multiple classes of vaccines and biologics

P R O O F O F C O N C E P T

• Protein subunit vaccine (Influenza)

• 12 Months at 40° C

• Live Biologic Vaccine (MMR)

• 8 Weeks at 37° C

• Monoclonal Antibody Therapeutics

• 8 Weeks at 40° C

• Complex Protein Vaccine (Rabies)

• 18 Months at 40° C

VBI’s Ottawa, Canada-based research facility.

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C O M M E R C I A L I Z AT I O N

LPV™ Development PlanThe LPV™ Platform has the potential to confer thermostability to vaccines and biologics under development

VBI’s Ottawa, Canada-based research facility.

• Entered into a broad research collaborations with Sanofi Pasteur and GSK to apply LPV™ technology to further the development of key vaccine candidates

• VBI’s formulation team has expertise working with multiple classes of vaccines and biologics

• Demonstrated clinical scale manufacture at a GMP compliant contract facility

• Technology is available for partnership and licensing, with several prospects in discussion

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F I V E K E Y VA LU E D R I V E R S I N N E X T 1 2 M O N T H S

• Sci-B-Vac™: Meeting with regulatory bodies H1 2017 to determine clinical development path in Europe and North America

• CMV: Interim Phase I Clinical Trial results with immunologic human proof of concept data expected mid-year 2017

• GBM: Mid-year 2017 IND submission for approval to start a Phase I clinical trial

• Expanding Pipeline: Announcement of additional immuno-oncology programs during 2017+

• Business Development: Additional non-dilutive collaborations/partnerships H1 2017+

Value Proposition for VBI Vaccines

1

2

3

4

5

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S A M P L E O F N A S D A Q / N Y S E VA C C I N E & I O C O M PA N I E S

Company Ticker Date Public Lead Programs Dev’t Stage Share Price ($U.S.)

Market Cap($U.S.)

Dynavax DVAX 2004HepB

Cancer Immunotherapy

BLA Rej.Ph I/II $6.00 $231.2M

Advaxis ADXS 2005HPV,PSA,HER2

Ph IIIPh I/IIPh I

$8.51 $342.9M

Agenus AGEN 1990's Malaria/ShinglesHSP GBM

Ph IIIPh II $4.10 $401.0M

CellDex CLDX 2004

GBM,TNBC,

Melanoma,Solid tumors,Lymphomas

Ph IIIPh IIPh IIPh IIPh I

$3.37 $412.1M

Inovio INO 1998Cervical Dysplasia

HPV cancersSeasonal Flu, HIV

Ph IIPh IPh I

$6.10 $451.8M

Peer Comparison

Source: Share Price Data as of close on March 20 2017 via Yahoo! Finance

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Experienced LeadershipVaccine development, commercialization, and financing expertise

Immunologist and investor with track record of blockbuster drugs and visionary corporate development success.

Founder of Immunex, the developer of Enbrel, a $7B/year landmark innovation. Managing director at Arch Venture Partners, a biotech VC with $1.9B under

management.

D R . S T E V E N G I L L I S , C H A I R M A N O F T H E B O A R D

A history of focused value creation, company building, and strategic management. Former Senior Vice President, R&D Finance and Operations at GlaxoSmithKline

(“GSK”) during a period of tremendous corporate growth and shareholder returns. Managing Partner at The Column Group, a VC fund, responsible for start-ups and

successful exits.

J E F F B A X T E R , P R E S I D E N T & C E O

Well-published immunologist with broad expertise in the areas of vaccine development, autoimmunity, and tumor immunology

Inventor of much of VBI’s intellectual property Dr. Anderson joined VBI full time in 2009 from Harvard Medical School

D R . D A V I D E . A N D E R S O N , P H . D . , C H I E F S C I E N T I F I C O F F I C E R

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VBI Vaccines Board of DirectorsDR. STEVEN GILLISCHAIRMAN OF THE BOARD

DR. MICHEL DE WILDE, PH.D.

SCOTT REQUADT, JD

SAM CHAWLA

JEFF BAXTERPRESIDENT & CEO

STEVEN RUBIN

ADAM LOGAL

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VBI Vaccines Global Footprint

H E A D Q U A R T E R S – C A M B R I D G E , M A CEO, CSO + 4 FTEs Central location in biotechnology hub

R E S E A R C H O P E R A T I O N S – O T T A W A , C A N A D A CMO, CFO + ~25 FTEs World-class R&D team and facility

M A N U F A C T U R I N G F A C I L I T Y – R E H O V O T, I S R A E L ~55 FTEs GMP manufacturing facility for the production of Sci-B-Vac™ and for contract services

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VBI Vaccines Inc.222 Third Street, Suite 2241

Cambridge, MA 02142(617) 830-3031

[email protected]