CORPORATE OVERVIEW N E W YO R K, N Y N A S D A Q : V B I V T S X : V B V J U N E NASDAQ: VBIV TSX: VBV
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1 CORPORATE OVERVIEW 2017 JEFFERIES HEALTHCARE CONFERENCE N E W YO R K, N Y N A S D A Q : V B I V T S X : V B V J U N E
2 Cautionary Statement Regarding Forward-Looking Information 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; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ 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. 2
3 Agenda 1. INTRODUCTION TO VBI VACCINES 2. SCI-B-VAC : HEPATITIS B 3. evlp PORTFOLIO PROGRAMS a. CYTOMEGALOVIRUS (CMV) b. GLIOBLASTOMA MULTIFORME (GBM) 4. SUMMARY 3
4 1. Introduction to VBI Vaccines 4
5 About VBI Vaccines VBI Vaccines Inc. (NASDAQ: VBIV) is developing novel technologies that seek to expand vaccine protection in significant markets of unmet medical need. V B I OV E R V I E W NASDAQ: VBIV (as at close on 6/8/2017) o Common Stock Currently Outstanding: 40MM Shares o Share Price: $4.56 o Market Cap: $183MM o 3-Month Average Volume: 112,500 Closed a $23.6MM financing with Perceptive Advisors on Dec Domiciled in Vancouver, British Columbia Headquartered in Cambridge, MA with its main research site in Ottawa, Canada, and a manufacturing and research facility in Rehovot, Israel 5
6 VBI Vaccines Leadership M A N A G E M E N T Jeff Baxter President & CEO Dr. David Anderson, Ph.D. Chief Scientific Officer Dr. Francisco Diaz-Mitoma, M.D., Ph.D. Chief Medical Officer B O A R D O F D I R E C T O R S Dr. Steven Gillis Chairman of the Board Steven Rubin Dr. Michel De Wilde, Ph.D. Adam Logal Sam Chawla Scott Requadt, JD 6
7 Leading Immunology Innovation in Significant Markets with High Unmet Need TECHNOLOGY PLATFORMS 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 PIPELINE Hepatitis B Vaccine: 3 rd 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 Broad research collaborations to confer thermostability and enhance stability of key vaccine programs with: Sanofi Pasteur GSK LPV COLLABORATIONS MANAGEMENT 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 7
8 evlp evlp VBI Vaccines Pipeline Multiple Opportunities in Infectious Disease and Oncology INFECTIOUS DISEASE LEAD PRE-CLINICAL PHASE I PHASE II PHASE III APPROVED STATUS Sci-B-Vac (Hepatitis B) (Licensed in 15 countries) Cytomegalovirus (CMV) Zika EU & N. America Regulatory feedback expected H Interim Ph I data expected mid 2017 Candidate selection 2017 IMMUNO-ONCOLOGY Glioblastoma Multiforme (GBM) Medulloblastoma Undisclosed IND filing expected mid 2017 IND filing expected mid LPV PLATFORM COLLABORATIONS Undisclosed Undisclosed Collaboration ongoing Collaboration ongoing 8
9 2. Sci-B-Vac : Hepatitis B 9
10 Hepatitis B Unmet Need Reported US Hepatitis B Vaccination Coverage Otherwise Healthy Adults aged 19 years 24.5% Adults aged years 32.2% Adults age 50 years 15.7% High-Risk Chronic Liver Conditions 29.8% Diabetics Age years 23.5% Diabetics Age 60 years 13.5% Healthcare Providers 19 years 60.7% Seroconversion rates with current 2 nd 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 Source: 2014 CDC Surveillance of Vaccination Coverage Among Adult Populations 10
11 Sci-B-Vac Overview ONLY COMMERCIAL HBV VACCINE TO MIMIC ALL 3 VIRAL SURFACE ANTIGENS ALREADY 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 Viral antigens mimicked: 2 ND GENERATION VACCINES SCI-B-VAC S Protein Pre-S1 Pre-S2 Adjuvant: Next-generation Adj. (e.g. TLRs) Alum Derivation: rdna yeast Mammalian cell 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 11
12 Sci-B-Vac Clinical Experience EXTENSIVE CLINICAL DEVELOPMENT SUPPORTS EMA/HC/FDA FILINGS 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 12
13 Excerpt of Publicly Available Sci-B-Vac Data Trial Size Population Sci-B-Vac 1 st Generation HBV Vaccine N=88 Adults Age % SPR 60-days post 2 nd vaccination NA N=716 Previous low/ non-responders (mean age 50 yrs) 82% SPR Post 2 nd vaccination 49% SPR Post 2 nd vaccination Sources: SciVac-sponsored ongoing Phase IV clinical study in Israel; Shouval D, Enhanced Immune Response to Hepatitis B Vaccination Through Immunization with a Pre-S1/Pre-S2/S Vaccine
14 Recent Feedback from Regulatory Agencies Positive discussions have been held with the EMA and Health Canada regarding the proposed Phase III clinical trial design Both regulatory agencies have given their general support of the proposed development path for Sci-B-Vac and confirmed that the product is Phase III-ready A pre-ind meeting was held with the FDA in April formal feedback is expected over the next few weeks Based on the outcomes of these discussions, VBI expects to file Phase III IND/CTAs with the FDA, EMA, and Health Canada mid-year
15 3. evlp Portfolio Programs 15
16 evlps are a 3 rd -Generation Class of Synthetic Vaccines 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 Electron Microscopy image of VBI s CMV evlps captured at Scripps Institute. 16
17 Congenital CMV is a Leading Public Health Priority Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV including deafness, blindness, and developmental delays In the U.S., the direct economic costs of CMV infection exceeds $2.0B annually The vaccination regimen would be: For all adolescent girls: 3-dose course of vaccine When planning a family: If adolescent course of vaccine received 1 booster shot If adolescent course of vaccine not received 2 booster shots This correlates to a $1B U.S. annual market with a $5B catch-up market 17
18 CMV Phase I Clinical Trial Overview Opportunity for Immunologic Human Proof of Concept with Ph I Data T R I A L D E S I G N Target Population: 125 CMV-Negative Healthy Adults (18-40 yrs) Design: Staggered Enrollment with Vaccinations at 0, 2, and 6 Months Expected Duration: 20 Months Interim Data Read-Out: 1 month after last-patient 2 nd dose, expected midyear 2017 Primary Endpoint: Safety and Tolerability Secondary Endpoints: o gb binding titers o nab titers in fibroblast and epithelial cells o gb avidity measurement 18
19 Therapeutic GBM Candidate Builds on Prophylactic CMV Candidate (VBI-1501A) by Adding an Internal pp65 Protein to Elicit a Th1 Response gb Envelope NeoAntigen pp65 NeoAntigen Attributes Monovalent gb for Prophylaxis Bivalent pp65 for Therapeutic Immuno- Oncology Present antigen in natural conformation Broadly Reactive Neutralizing Antibodies Polyvalent Immune Response ++ Potent Th1 Cellular Immunity for Therapeutic Applications CD CD
20 VBI GBM Candidate Expected Timeline C O M P L E T E D M I L E S T O N E S Q1 2016: Pre-clinical IND-enabling data Q1 2016: Clinical Advisory Meeting Q2 2016: Pre-IND meeting with FDA Q1 2017: GMP clinical trial materials manufactured R E M A I N I N G M I L E S T O N E S T O P H I S TA R T Mid 2017: IND submission expected for approval to start Ph I/IIa clinical trial 20
21 4. Summary 21
22 Peer Comparison S A M P L E O F N A S DA Q / N Y S E VA C C I N E & I O C O M PA N I E S Company Ticker Date Public Lead Programs Dynavax DVAX 2004 Advaxis ADXS 2005 Agenus AGEN 1990's CellDex CLDX 2004 Inovio INO 1998 HepB Cancer Immunotherapy HPV, PSA, HER2 Malaria/Shingles HSP GBM GBM, TNBC, Melanoma, Solid tumors, Lymphomas Cervical Dysplasia HPV cancers Seasonal Flu, HIV Dev t Stage BLA CRL Ph I/II Ph III Ph I/II Ph I Ph III Ph II Ph III Ph II Ph II Ph II Ph I Ph II Ph I Ph I Share Price ($U.S.) Market Cap ($U.S.) $7.00 $346.4M $8.16 $330.8M $3.33 $330.1M $2.34 $292.8M $7.39 $611.2M Source: Share Price Data as of close on June via Yahoo! Finance 22
23 Value Proposition for VBI Vaccines 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 : 1 Sci-B-Vac : Meeting with regulatory bodies H to determine clinical development path in Europe and North America 2 CMV: Interim Phase I Clinical Trial results with immunologic human proof of concept data expected mid-year GBM: Expected mid-year 2017 IND submission for approval to start a Phase I/IIa clinical trial 4 Expanding Pipeline: Announcement of additional programs throughout Business Development: Additional non-dilutive collaborations/partnerships H
24 VBI Vaccines Inc. 222 Third Street, Suite 2241 Cambridge, MA (617)
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