CORPORATE PRESENTATION

Transcription

1 CORPORATE PRESENTATION NASDAQ: VBIV TSX: VBV MARCH

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 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 LPV COLLABORATIONS Broad research collaborations to confer thermostability and enhance stability of key vaccine programs with: Sanofi Pasteur GSK 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 3

4 Recent Key Achievements MAY 2016 MARCH 2017 February 2017 February 2017 December 2016 October 2016 September 2016 July 2016 June 2016 June 2016 June 2016 May 2016 Received positive response from Health Canada regarding Sci-B-Vac Phase III clinical program Received positive EMA Scientific Advice regarding Sci-B-Vac Phase III clinical program Closed $23.6MM financing from Perceptive Advisors Completed FDA pre-ind meeting for GBM candidate Completed enrollment of CMV Phase I clinical trial Announcement of Zika vaccine program Start of CMV Phase I clinical trial Closed $13.6MM PIPE Announcement of Medulloblastoma candidate Closed SciVac Therapeutics Transaction 4

5 VBI Vaccines Pipeline OPPORTUNITIES IN INFECTIOUS DISEASE & ONCOLOGY INFECTIOUS DISEASE LEAD PRE-CLINICAL PHASE I PHASE II PHASE III APPROVED STATUS evlp 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 evlp Glioblastoma Multiforme (GBM) Medulloblastoma IND filing expected mid 2017 IND filing expected mid 2017 Undisclosed - LPV PLATFORM COLLABORATIONS Undisclosed Undisclosed Collaboration ongoing Collaboration ongoing 5

6 Value Proposition for VBI Vaccines FIVE KEY VALUE DRIVERS IN NEXT 12 MONTHS Sci-B-Vac : Meeting with regulatory bodies H to determine clinical development path in Europe and North America 1 CMV: Interim Phase I Clinical Trial results with immunologic human proof of concept data expected mid-year GBM: Mid-year 2017 IND submission for approval to start a Phase I clinical trial 3 Expanding Pipeline: Announcement of additional immunooncology programs during Business Development: Additional non-dilutive collaborations/partnerships H

7 VBI Vaccines Pipeline Programs 1 Sci-B-Vac : Hepatitis B 2 VBI-1501A : Congenital Cytomegalovirus (CMV) 3 VBI-1901 : Glioblastoma Multiforme (GBM) 4 Lipid Particle Vaccine (LPV) platform collaborations 7

8 Hepatitis B Unmet Need Reported U.S. Hepatitis B Vaccination Coverage (2014) Otherwise Healthy Adults aged 19 years 24.5% Adults aged years 32.2% Adults aged 50 years 15.7% High-Risk Chronic Liver Conditions 29.8% Diabetics Aged years 23.5% Diabetics Aged 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 8

9 Existing High Unmet Need in Specific Populations SEROPROTECTION RATES WITH CURRENT VACCINES FALL DRAMATICALLY WITHIN THE ELDERLY AND HIGH-RISK PATIENT POPULATIONS 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) WHO

10 Sci-B-Vac Overview 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 2 ND 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 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 10

11 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 11

12 Excerpt of Publicly Available Sci-B-Vac Data SEVERAL PHASE II & III STUDIES HAVE BEEN CONDUCTED IN > 4,500 PATIENTS, RESULTS OF WHICH INCLUDE: Size Population Sci-B-Vac 2 nd -Generation HBV Vaccine N=105 Young adults 98% SPR - month 6, post 2 nd injection; 100% SPR - post 3 rd injection NA N=29 ESRD N=716 Previous low/nonresponders (mean age 50 yrs) 86% SPR - post 3 rd vaccination (previous non-responders to double-dose of 1 st generation vaccine) 56% SPR - post repeated 2x-dose immunizations (comparison, retrospective evaluation in same study center over 3 years) 82% SPR - post 2 nd vaccination 49% SPR - post 2 nd vaccination Sources: Shouval D, Enhanced Immune Response to Hepatitis B Vaccination Through Immunization with a Pre-S1/Pre-S2/S Vaccine

13 VBI Vaccines Pipeline Programs 1 Sci-B-Vac : Hepatitis B 2 VBI-1501A : Congenital Cytomegalovirus (CMV) 3 VBI-1901 : Glioblastoma Multiforme (GBM) 4 Lipid Particle Vaccine (LPV) platform collaborations 13

14 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 evlp Electron Microscopy image of VBI s CMV evlps captured at Scripps Institute. 14

15 evlp Presentation Improves CMV Vaccine Potency Presentation of gb antigen in an evlp improves relevant functional CMV neutralizing responses relative to recombinant gb protein PRECLINICAL RESULTS 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 Neutralizing antibody titers for mice immunized with comparable doses of Recombinant gb of optimized gb evlps (VBI-1501) 50% Epithelial cell nab Titer (1/x) 10,000 1, Recombinant gb VBI gb-g evlps (VBI- 1501) Source: VBI Studies: 15BC04, 15BC19, 15BC39 15

16 Congenital CMV is a Leading Public Health Priority 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 U.S. CHILDREN BORN WITH OR DEVELOPING LONG-TERM MEDICAL CONDITIONS CMV affects more live births than Down Syndrome or Fetal Alcohol Syndrome Incidence per year Sources: Cannon, M.J., and K.F. Davis, 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 16

17 VBI-1501A Stimulates CMV Neutralizing Antibodies Comparable to Natural Levels of Immunity 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 10,000 Natural levels of CMV immunity provide 90% protection Endpoint nab Titer (1/x) 1, VBI- 1501A VBI- 1501A 1 HFF: CMV+ sera HFF: VBI-1501A sera ARPE: CMV+ sera ARPE: VBI-1501A sera Fibroblast Cells Epithelial Cells Source: VBI Studies: 15RA44 17

18 CMV Phase I Clinical Trial Overview Opportunity for immunologic human proof-of-concept with Phase I data TRIAL DESIGN 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 2 nd dose Primary Endpoint: Safety and Tolerability Secondary Endpoints: gb binding titers nab titers in fibroblast and epithelial cells gb avidity measurement 18

19 VBI CMV Candidate Milestones COMPLETED MILESTONES - ACHIEVED RISK MITIGATION 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 2 nd 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 REMAINING MILESTONE TO KEY VALUE INFLECTION POINT Mid 2017: Expected interim data from Phase I Clinical Trial 19

20 VBI Vaccines Pipeline Programs 1 Sci-B-Vac : Hepatitis B 2 VBI-1501A : Congenital Cytomegalovirus (CMV) 3 VBI-1901 : Glioblastoma Multiforme (GBM) 4 Lipid Particle Vaccine (LPV) platform collaborations 20

21 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

22 Poor Immunogenicity of Traditional Tumor-Associated Antigens (TAAs) has Limited Past Therapeutic Cancer Vaccines IMMUNOGENICITY Self TAAs Neoantigens Foreign Viral TAAs LOW HIGH VIRAL CMV ANTIGENS ARE OVER- EXPRESSED (>90%) IN MULTIPLE SOLID TUMORS, INCLUDING: Glioblastoma (GBM) 1 Medulloblastoma 2,3 Meningioma 3 Breast cancer 4,5 Sources: 1 Cobbs CS(2013) Curr Opin Oncol 25, 682; 2 Baryawno N(2011) J Clin Invest 121, ; 3 Libard S(2014) PLoS ONE 9, e108861; 4 Taher C(2013) J Clin Virol 54, 240; 5 Harkins LE (2010) Herpesviridae 1, 8 22

23 CMV as a Foreign Viral TAA CLINICAL EVIDENCE SUGGESTS CMV VACCINATION CAN BE SUCCESSFUL (DUKE DATA) 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 GBM UNMET MEDICAL NEED Over 20,000 patients diagnosed each year Only 40% survive longer than 6 months 2 GBI Research predicts a market size of $600+ million by 2020 Sources: 4 Mitchell DA(2015) Nature 519, ; 2 Ohgaki (2004) Cancer Research, 64:

24 VBI-1901: Re-stimulated CD4+ and CD8+ T-cell Responses in CMV-positive Human Subject Ex Vivo Fresh PBMCs stimulated with VBI-1901 vs recombinant antigens Restimulation of CD4+ & CD8+ T-cells in Ex Vivo Human Samples evlps rapidly restimulate both CD4+ & CD8+ T-cell responses evlp presentation enhances stimulation relative to matched recombinant antigen 24

25 VBI-1901 Induction of CCL3 in Ex Vivo PBMCs from CMVpositive Healthy Subjects and Patients with Solid Tumors 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 25

26 VBI GBM Candidate Expected Timeline COMPLETED MILESTONES Q1 2016: Pre-clinical IND-enabling data Q1 2016: Clinical Advisory Meeting Q2 2016: Pre-IND meeting with FDA REMAINING MILESTONES TO PHASE I START H1 2017: GMP clinical trial materials manufacturing Mid 2017: IND submission for approval to start Ph I clinical trial 26

27 VBI Vaccines Pipeline Programs 1 Sci-B-Vac : Hepatitis B 2 VBI-1501A : Congenital Cytomegalovirus (CMV) 3 VBI-1901 : Glioblastoma Multiforme (GBM) 4 Lipid Particle Vaccine (LPV) platform collaborations 27

28 LPV Platform Overview Enables thermostable vaccine delivery, which is expected to increase vaccine access and preserve safety and efficacy. IMPROVES ACCESS Enables safe storage and transfer outside of the refrigerator / freezer cold chain PRESERVES POTENCY Improved stability enables delivery of an effective dose, every time UNLOCKS VALUE 90% of all vaccines require cold chain shipment at 4 C 28

29 LPV Platform Proof of Concept Proprietary formulation of lipids preserves stability and potency for multiple classes of vaccines and biologics PROOF OF CONCEPT 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. 29

30 LPV Development Plan The LPV Platform has the potential to confer thermostability to vaccines and biologics under development COMMERCIALIZATION 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 VBI s Ottawa, Canada-based research facility. 30

31 Value Proposition for VBI Vaccines FIVE KEY VALUE DRIVERS IN NEXT 12 MONTHS Sci-B-Vac : Meeting with regulatory bodies H to determine clinical development path in Europe and North America 1 CMV: Interim Phase I Clinical Trial results with immunologic human proof of concept data expected mid-year GBM: Mid-year 2017 IND submission for approval to start a Phase I clinical trial 3 Expanding Pipeline: Announcement of additional immunooncology programs during Business Development: Additional non-dilutive collaborations/partnerships H

32 Peer Comparison SAMPLE OF NASDAQ/NYSE VACCINE & IO COMPANIES Company Ticker Date Public Lead Programs Dev t Stage Dynavax DVAX 2004 Advaxis ADXS 2005 HepB Cancer Immunotherapy HPV, PSA, HER2 BLA Rej. Ph I/II Ph III Ph I/II Ph I Share Price ($U.S.) Market Cap ($U.S.) $6.00 $231.2M $8.51 $342.9M Agenus AGEN 1990's Malaria/Shingles HSP GBM Ph III Ph II $4.10 $401.0M CellDex CLDX 2004 GBM, TNBC, Melanoma, Solid tumors, Lymphomas Ph III Ph II Ph II Ph II Ph I $3.37 $412.1M Inovio INO 1998 Cervical Dysplasia HPV cancers Seasonal Flu, HIV Ph II Ph I Ph I $6.10 $451.8M Source: Share Price Data as of close on March via Yahoo! Finance 32

33 Experienced Leadership Vaccine development, commercialization, and financing expertise DR. STEVEN GILLIS, CHAIRMAN OF THE BOARD 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. JEFF BAXTER, PRESIDENT & CEO 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. DR. DAVID E. ANDERSON, PH.D., CHIEF SCIENTIFIC OFFICER 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 33

34 VBI Vaccines Board of Directors DR. STEVEN GILLIS CHAIRMAN OF THE BOARD JEFF BAXTER PRESIDENT & CEO DR. MICHEL DE WILDE, PH.D. STEVEN RUBIN SCOTT REQUADT, JD ADAM LOGAL SAM CHAWLA 34

35 VBI Vaccines Global Footprint HEADQUARTERS CAMBRIDGE, MA CEO, CSO + 4 FTEs Central location in biotechnology hub RESEARCH OPERATIONS OTTAWA, CANADA CMO, CFO + ~25 FTEs World-class R&D team and facility MANUFACTURING FACILITY REHOVOT, ISRAEL ~55 FTEs GMP manufacturing facility for the production of Sci-B-Vac and for contract services 35

36 VBI Vaccines Inc. 222 Third Street, Suite 2241 Cambridge, MA (617)