Corporate Presentationcontent.stockpr.com/vbivaccines/media/fd5ddd3baa9... · This presentation contains forward-looking statements within the meaning of the provisions of Section

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

4NASDAQ: VBIV

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

5NASDAQ: VBIV

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

6NASDAQ: 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

7NASDAQ: VBIV

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

8NASDAQ: VBIV

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

9NASDAQ: VBIV

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

10NASDAQ: VBIV

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

11NASDAQ: VBIV

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

12NASDAQ: VBIV


1

2

3

4





13NASDAQ: VBIV

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’

14

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

15NASDAQ: VBIV

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

1616

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)

17NASDAQ: VBIV


1

2

3

4





18NASDAQ: VBIV

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

19NASDAQ: VBIV

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


1

2

3

4





21NASDAQ: VBIV

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”

22NASDAQ: VBIV

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.

23NASDAQ: VBIV

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

24NASDAQ: VBIV

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

25NASDAQ: VBIV

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

26NASDAQ: VBIV

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

27NASDAQ: VBIV

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.

28NASDAQ: VBIV

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

VBI Vaccines Inc.222 Third Street, Suite 2241

Cambridge, MA 02142(617) 830-3031

[email protected]

Corporate Presentationcontent.stockpr.com/vbivaccines/media/fd5ddd3baa9... · This presentation contains forward-looking statements within the meaning of the provisions of Section

Documents