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Corporate Presentation
N A S D A Q : V B I V F E B R U A R Y 2 0 1 6
2NASDAQ: VBIV
This presentation contains forward-looking statements within the meaning of the provisions of Section 27A of theSecurities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect,""anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on thesewords or comparable terminology. The reader is cautioned not to put undue reliance on these forward-lookingstatements, as these statements are subject to numerous factors and uncertainties outside of our control that can makesuch statements untrue, including, but not limited to, inadequate capital, adverse economic conditions, intensecompetition, lack of meaningful research results, entry of new competitors and products, adverse federal, state andlocal government regulation, termination of contracts or agreements, technological obsolescence of our products,technical problems with our research and products, price increases for supplies and components, inability to carry outresearch, development and commercialization plans, loss or retirement of key executives and research scientists andother specific risks. We currently have no commercial products intended to diagnose, treat, prevent, or cure anydisease. The statements contained in this presentation regarding our ongoing research and development and the resultsattained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance thatfurther research and development, and/or whether clinical trial results, if any, will validate and support the results ofour preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will beobtained or that we will be able to develop new products on the basis of our technologies. In addition, other factorsthat could cause actual results to differ materially are discussed in our SEC periodic filings. Investors and security holdersare urged to read these documents free of charge on the SEC's web site at www.sec.gov. We undertake no obligation topublicly update or revise our forward-looking statements as a result of new information, future events, or otherwise. NOOFFER; NO RELIANCE. This presentation does not constitute an offer to sell, or a solicitation of an offer to buy, anysecurity and may not be relied upon in connection with the purchase or sale of any security. Any such offer would onlybe made by means of formal documents, the terms of which would govern in all respects. You should not rely on thispresentation as the basis upon which to make any investment decision.
Forward-Looking Statement Disclaimer
3NASDAQ: VBIV
Technology Platforms
Pipeline
Management
Leading Immunology Innovation in Significant Markets with High Unmet Need
• Enveloped Virus-Like Particle (“eVLP”) platform closely mimics viruses and induces potent and durable immune responses
• Lipid Particle Vaccine (“LPV”) platform enables thermostable delivery, expected to increases access, safety, and efficacy
Targeting high unmet needs in Infectious Disease and Immuno-Oncology Congenital CMV Vaccine: Target young women to prevent birth defects GBM Therapeutic: Therapeutic vaccine for most common brain tumor type RSV Vaccine: Target infants to prevent respiratory disease
World-class leadership: Dr. Steve Gillis, Jeff Baxter, Dr. Michel De Wilde, and Dr. David Anderson
Scientific Advisory Board: Dr. Florian Schödel and Dr. Stanley Plotkin
Collaborations• Sanofi Pasteur, GSK: Broad research collaborations to confer thermostability
and enhance stability of key vaccine programs
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Recent Key Achievements
Received NASDAQ listing via reverse merger with Paulsen Capital – completion of $16.25MM private placement
Entered into LPV Sanofi Pasteur collaboration
Closed $6.29MM PIPE
Announcement of RSV program and NRC-IRAP grant of $350,000 CAD
Announcement of GBM candidate
July 2014
April 2015
August 2015
August 2015
October 2015
July 2014 – February 2016Entered into LPV GSK
collaborationFebruary 2016
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Research Lead Preclinical Phase I Phase II Phase III
eVLP Platform
Infectious Disease
CMV (VBI-1501A)
HCV
RSV
Immuno-Oncology
GBM
Undisclosed
Thermostable LPV Platform
Undisclosed
Undisclosed
Expected Ph I Start H1 2016
Multiple Opportunities in Infectious Disease and OncologyVBI Vaccines Pipeline
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Near-Term Goals for Value Creation
1
2
3
4
Advancement of congenital CMV vaccine candidate, VBI-1501A, into Phase 1 clinical trials
Expansion of CMV eVLP program into therapeutic GBM Immuno-Oncology indication
Continued advancement of vaccine discovery programs
Engagement of additional collaborations around LPV Platform
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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
% E
pit
he
lial c
ell
nA
b T
ite
r (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
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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 mental retardation
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
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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
End
po
int
nA
bTi
ter
(1/x
)
VBI-1501A Stimulates CMV Neutralizing Antibodies Comparable to Natural Levels of Immunity
Natural levels of CMV immunity provide 90%
protection
VB
I-1
50
1A
VB
I-1
50
1A
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VBI-1501A CMV Candidate: Phase I Trial DesignBenchmarking against natural immunity may allow for human proof of concept in a sufficiently powered Phase I clinical trial.
A N T I C I PAT E D T R I A L D E S I G N
Estimated Start: H1 2016
Target Population: ~125 CMV-Negative Healthy Adults (18-40 yrs)
Design: Staggered Enrollment with Vaccinations at 0, 2, and 6 Months
Expected Duration: 20 Months
Primary Endpoint: Safety and Tolerability
Secondary Endpoint: Anti-CMV nAb Effective in Fibroblasts / Epithelial Cells
nAb are neutralizing antibodies that indicate acquired CMV immunity
Interim potency data available after second immunization H1 2017
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Near-Term Goals for Value Creation
1
2
3
4
Advancement of congenital CMV vaccine candidate, VBI-1501A, into Phase 1 clinical trials
Expansion of CMV eVLP program into therapeutic GBM Immuno-Oncology indication
Continued advancement of vaccine discovery programs
Engagement of additional collaborations around LPV Platform
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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
AttributesMonovalent 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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Complex Immuno-Oncology Landscape Likely to Require Rational Combinations for Success
“Steering” Agents
Directing Immunity to Target Antigens
“Gas” Agents
Stimulation of Potent Immunity
“No Brakes” Agents
Blocking Negative Feedback Loops
Examples:
Optimized “CAR-T” receptors
“Neoantigens”, viral tumor antigens
Examples:
Immunostimulatoryadjuvants
Co-stimulatory molecule induction
Examples:
Checkpoint inhibitors
Blockade of CTLA-4, PD-1/L1, TIM-3, LAG-3, BTLA
P R O D U C T I V E T h 1 T U M O R I M M U N I T Y
Potential Combination Target
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CMV as a NeoAntigenC 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 LU D I N G :
Glioblastoma (GBM)1
Breast cancer2,3
C 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 DATA ) 4
Dendritic cell priming combined with CMV vaccination significantly extended overall survival of GBM patients relative to SoC
G B M U N M E T M E D I C A L N E E D
Over 20,000 new patients diagnosed each year
Only 40% survive longer than 6 months5
GBI Research predicts a market size of $600+ million by 2020
Sources: 1Cobbs CS(2013) Curr Opin Oncol 25, 682; 2Taher C(2013) J Clin Virol 54, 240; 3Harkins LE (2010) Herpesviridae 1, 8; 4Mitchell DA(2015) Nature 519, 366-369; 5Ohgaki (2004) Cancer Research, 64:6892
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VBI Opportunity in Immuno-oncology
‘NeoAntigens’ provide opportunity for next generation cancer vaccines
CMV antigens are a ‘NeoAntigen’ in GBM and other cancers
Bivalent CMV eVLPs induce desired Th1 immunity in vivo & ex vivo
Opportunity for accelerated development given CMV lead program manufacturing achievements
Opportunity to evaluate eVLP vaccination for cancer alone and in combination with other therapies (e.g. checkpoint inhibitors)
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Near-Term Goals for Value Creation
1
2
3
4
Advancement of congenital CMV vaccine candidate, VBI-1501A, into Phase 1 clinical trials
Expansion of CMV eVLP program into therapeutic GBM Immuno-Oncology indication
Continued advancement of vaccine discovery programs
Engagement of additional collaborations around LPV Platform
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VBI RSV Discovery ProgramP R O G R A M H I G H L I G H T S
The eVLP platform may provide opportunity for improved conformation and potency relative to first-generation RSV candidates
Early data suggests RSV candidate may present certain RSV target proteins in a desires ‘pre-fusion’ conformation, potentially allowing for a potent and durable immune response
$350,000 CAD in grant funding by the National Research Council-Industrial Research Assistance Program (“NRC-IRAP”) received August 2015
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Overview of Respiratory Syncytial Virus (RSV) RSV is the leading cause of respiratory disease among newborn children and elderly adults; RSV accounts for 6.7% of deaths among infants under one year old, more than any other pathogen except malaria.
M A R K E T O P P O R T U N I T Y
Recognized as a significant unmet medical need and among highest priority vaccine targets; total market predicted to exceed $2B annually
VBI development targeted towards two primary patient segments:
Pregnant Women
Maternal antibodies cross placental to confer protection to infants < 3 months
Influenza and now DTaP vaccination in pregnancy establishes precedent
Infants
Well established disease burden (LTRI, hospitalization)
nAb titers and protection (versus Synagis®) and waning of maternal
20NASDAQ: VBIV
Near-Term Goals for Value Creation
1
2
3
4
Advancement of congenital CMV vaccine candidate, VBI-1501A, into Phase 1 clinical trials
Expansion of CMV eVLP program into therapeutic GBM Immuno-Oncology indication
Continued advancement of vaccine discovery programs
Engagement of additional collaborations around LPV Platform
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LPV Platform OverviewEnables thermostable vaccine delivery, which is expected to increase vaccine access and preserve safety and efficacy
UN LO C KS VALUE
90% of all vaccines require “cold chain”
shipment at 4°C
P R ES E RVES P OT E N C Y
Improved stability enables delivery of an
effective dose, every time
I M P ROVES 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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Upcoming Milestones
K E Y N E A R - T E R M A N T I C I PAT E D VA LU E D R I V E R S
H1 2016: Pre-IND meeting with FDA regarding therapeutic GBM vaccine candidate
H1 2016: Obtain IND/CTA approval for CMV vaccine candidate
H1 2016: Start Phase I clinical studies for CMV vaccine candidate
TBD: Engagement of additional LPV platform collaborations
TBD: Acquire or in-license new products or technologies identified and vetted by VBI leadership
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Investment HighlightsExperienced leadership, novel platforms technologies, and runway to achieve multiple near-term catalysts.
O P P O R T U N I T Y H I G H L I G H T S
eVLP platform gives rise to a CMV vaccine candidate with $1B annual market potential –additional ‘catch-up’ cohorts could increase initial market size significantly
CMV vaccine candidate on track to reach Ph I in H1 2016 – potential to provide human proof of concept in Phase I by benchmarking against naturally acquired immunity
Extension of eVLP platform into Immuno-Oncology – opportunity for accelerated development of GBM candidate given CMV lead program manufacturing achievements
Promising early-stage eVLP RSV program – early data suggests improved vaccine construct
LPV technology can preserve stability of vaccines and biologics – currently more than 90% of all vaccines require “cold chain” shipment at 4°C
Sanofi Pasteur and GSK collaborations provides significant platform validation
Exploring other eVLP vaccine and therapeutic candidates for internal development
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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
Clinical vaccinologist with extensive drug development experience. Former VP Vaccines Clinical Development at Merck. Led development of multiple complex global licensures for Measles, Mumps, and
Rubella (“MMR”) and Rotavirus, each billion dollar products.
D R . F L O R I A N S C H O D E L , S A B C H A I R & A C T I N G C M O
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Sam Chawla, Director, is a Portfolio Manager of Perceptive Advisors LLC, an investment
fund focused on the healthcare sector. Prior to joining Perceptive Advisors in 2013, Mr.
Chawla was a Managing Director at UBS Investment Bank in the Global Healthcare
Group.
Dr. David E. Anderson, Ph.D., Chief Scientific Officer, is a dynamic and well-published
immunologist with broad expertise in the areas of vaccine development, autoimmunity,
and tumor immunology. Dr. Anderson joined VBI full time in 2009 from Harvard Medical
School.
Scott Requadt, Director, is a Managing Director at Clarus Ventures with 15+ years of
operating and investment experience. Prior to joining Clarus in 2005, Scott was Director of
Business Development for TransForm Pharmaceuticals (acquired by J&J) and practiced as a
mergers and acquisitions attorney for Davis Polk & Wardwell.
Dr. Michel De Wilde, Ph.D., Director was Senior Vice President, R&D, at Sanofi Pasteur,
the human vaccines division of Sanofi from 2001 until June 2013. In this position, he was
responsible for managing approximately 1,500 employees and a broad portfolio of
development projects.
Experienced Leadership Cont.Diverse and complementary knowledge of vaccine development.
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VBI Vaccines North America Footprint
R E S E A R C H O P E R AT I O N S – O T TA W A , C A N A D A• CFO + ~20 FTEs• World-class research facility for programs from conception through to technology
transfer to GMP manufacturing and/or out-licensing
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