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CORPORATE PRESENTATION NASDAQ: VBIV APRIL 2019

VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

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Page 1: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

1N A S D A Q : V B I V

CORPORATE PRESENTATION

N A S D A Q : V B I V A P R I L 2 0 1 9

Page 2: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

2N A S D A Q : V B I V

Certain statements in this presentation that are forward-looking and not statements of historical fact are forward-looking statements

within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking

information within the meaning of Canadian securities laws (collectively “forward-looking statements”). The company cautions that

such statements involve risks and uncertainties that may materially affect the company's results of operations. Such forward-looking

statements are based on the beliefs of management as well as assumptions made by and information currently available to

management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain

factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;

the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or

necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and

working capital and to obtain such funding on commercially reasonable terms; the company's ability to manufacture product candidates

on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key

executives and scientists; and the ability to secure and enforce legal rights related to the company's products, including patent

protection. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the

Company's filings with the Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on

Form 10-K filed with the Securities and Exchange Commission on February 25, 2019, and filed with the Canadian security authorities at

sedar.com on February 25, 2019, and may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The

company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future

events or otherwise, except as required by law.

Cautionary Statement Regarding Forward-Looking Statements

Page 3: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

3N A S D A Q : V B I V

Overview• Leveraging significant immunology expertise to address unmet medical needs in both

INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

• Advancing prevention and treatment of HEPATITIS B:

• Sci-B-Vac® : Only commercially-approved trivalent Hepatitis B vaccine – approved in 11 countries worldwide and currently in Phase III clinical studies in the U.S., Europe, and Canada (data expected mid-2019)

• VBI-2601 : Immuno-therapeutic in development in a collaboration with BriiBiosciences for a functional cure for chronic Hepatitis B

• Integrating CYTOMEGALOVIRUS (CMV) EXPERTISE with a proprietary enveloped virus-like particle (eVLP) platform technology to develop next-generation vaccines:

• VBI-1501 : Prophylactic CMV vaccine candidate (positive topline Phase I data announced in May 2018)

• VBI-1901 : Therapeutic GLIOBLASTOMA (GBM) vaccine candidate (currently in Phase I/IIa study)

• Most recent financing in December 2018 of $43M, led by Perceptive Advisors

Page 4: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

4N A S D A Q : V B I V

VBI Vaccines PipelinePRE-

CLINICAL PHASE I PHASE II PHASE III APPROVED STATUS

INFECTIOUS DISEASE

Hepatitis B –Prophylaxis

Sci-B-Vac®VLP

• Approved in Israel + 10 countries worldwide

• US, EU, CAN in ongoing Phase III• Topline data from PROTECT Phase

III study expected mid-year 2019

Hepatitis B –Therapeutic

VBI-2601VLP

• License & collaboration agreement with Brii Biosciences

• VBI retains ex-China/Taiwan rights

Cytomegalovirus(CMV)

VBI-1501eVLP

• Positive Phase I data announced May 2018

Zika VBI-2501eVLP • Candidate selected

IMMUNO-ONCOLOGY

GlioblastomaMultiforme (GBM)

VBI-1901eVLP

• Ongoing Phase I/IIa• 6 mo. OS/PFS from Part A of

study expected H1 2019

Medulloblastoma VBI-1901eVLP • Preclinical work ongoing

Page 5: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

5N A S D A Q : V B I V

Recent Key AchievementsA P R I L 2 0 1 8 – M A R C H 2 0 1 9

February 2019 3rd

Positive DSMB review in Phase I/IIa study of VBI-1901 (GBM)

January 2019 Appointment of Blaine McKee to Board of Directors

December 2018 Announcement of planned Phase II clinical study design for VBI-1501 (CMV)

December 2018 Closed Public Offering for gross proceeds of $42.9M

December 2018Announcement of Brii Biosciences License and Collaboration Agreement for the

development of a functional cure for Hepatitis B

November 2018 Announcement of early data from Phase I/IIa study of VBI-1901 in recurrent GBM patients

October 2018 Completion of vaccination in PROTECT Phase III study for Sci-B-Vac® (Hepatitis B)

September 2018 Announcement of formation of new Scientific and Clinical Advisory Boards

September 20182

ndPositive DSMB review in Phase I/IIa study of VBI-1901 (GBM) and initiation of

enrollment in high-dose cohort

May 2018 Announcement of positive topline results from CMV Phase I study

April 2018 Completion of enrollment in PROTECT Phase III study for Sci-B-Vac®

April 2018Positive DSMB review in Phase I/IIa study of VBI-1901 (GBM) and initiation of enrollment in

intermediate-dose cohort

Page 6: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

6N A S D A Q : V B I V

Hepatitis B - Prophylaxisa. SCI-B-VAC®Only commercially-available trivalent vaccine containing pre-S1, pre-S2, and S antigens of Hepatitis B virus

Page 7: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

7N A S D A Q : V B I V

2ND GENERATION VACCINES SCI-B-VAC®Viral antigens mimicked:

S Protein ✓ ✓Pre-S1 ✓Pre-S2 ✓

Adjuvant: Next-generation Adj. (e.g. TLRs) AlumDerivation: rDNA yeast Mammalian cell

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

• Published data demonstrates that T cell response to pre-S1 and pre-S2 antigens can further boost responses to the S antigens, resulting in a more immunogenic response

Sci-B-Vac® : Importance of Trivalent Conformation

Page 8: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

8N A S D A Q : V B I V

Reported US Hepatitis B Vaccination Coverage – 2015(≥ 3 doses)Otherwise Healthy

Adults aged ≥ 19 years 24.6%

Adults aged 19-49 years 32.0%

Adults age ≥ 50 years 16.5%

High-Risk

Chronic Liver Conditions 27.4%

Diabetics – Age 19-59 years 24.4%

Diabetics – Age ≥ 60 years 12.6%

Healthcare Providers ≥ 19 years 64.7%

Source: 2015 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 represents an annual global market opportunity of approximately $600M - $800M

Hepatitis B Unmet Need : Low Vaccination Rates

Page 9: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

9N A S D A Q : V B I V

Sources: WHO - http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html

SEROCONVERSION RATES WITH CURRENT VACCINES FALL DRAMATICALLY WITHIN THE ELDERLY AND HIGH-RISK PATIENT POPULATIONS

Anti-HBs Seroconversion Rates After Hepatitis B Vaccination Neonates > 95%

Age 2 - 19 ~99%

Age 20 - 29 ~95%

Age 30 - 39 ~90%

Age 40 - 49 ~85%

Age 50 - 59 ~70%

Age 59+ ~50%

Renal failure, HIV infection, other immunosuppression 50-70%

Liver Disease 60-70%

Hepatitis B Unmet Need : High-Risk Populations

Page 10: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

10N A S D A Q : V B I V

• Currently approved in 11 countries worldwide, most notably used in Israel

• Commercial product distribution data estimates that over 500,000 infants and adults have been safely vaccinated with the current formulation of 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®

• Approximately 2,000 subjects have received the current formulation of Sci-B-Vac® in clinical trials

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

• In head-to-head comparative trials, Sci-B-Vac® consistently achieved higher rates of seroprotection earlier in adult populations compared to the vaccines in the control arms, which were licensed hepatitis B vaccines

• The safety profile of Sci-B-Vac® has been shown to be clean and comparable to vaccines in the control arms

Extensive Existing Efficacy and Safety Data Package

Page 11: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

11N A S D A Q : V B I V

86.0%

78.3%

96.6% 96.0%

50.0%

55.0%

60.0%

65.0%

70.0%

75.0%

80.0%

85.0%

90.0%

95.0%

100.0%

Engerix B <= 45 (n = 136) Engerix B > 45 (n = 115) Sci-B-Vac <= 45 (n = 118) Sci-B-Vac > 45 (n = 126)

Perc

ent

HB

sAg

Sero

prot

ecti

on

Seroprotection Stratified by Age

Engerix B <= 45 (n = 136) Engerix B > 45 (n = 115)Sci-B-Vac <= 45 (n = 118) Sci-B-Vac > 45 (n = 126)

Study Reference: Phase III 38-96-040

Stratification by Age Demonstrated Significantly Improved Potency in Older Adults

Sci-B-Vac® Demonstrated Superior Seroprotection Rate in Older Adults

Page 12: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

12N A S D A Q : V B I V

Sci-B-Vac®: High & Rapid SPR in AdultsSci-B-Vac® Phase IV Study in Israeli Adults (Age 18-40, N=88)Seroprotection defined as > 10 IU/mL

0

56.8

91.998.8 98.8 98.7 98.1 100

0

20

40

60

80

100

0 1 2 3 4 5 6 7

SPR

(%)

Study MonthImmunizations:

Study Reference: Phase IV – SciB018

Page 13: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

13N A S D A Q : V B I V

• Target Population: ~4,500 adults age 18 years and older

• Clinical Trial Sites: 42 sites across the US, Europe, and Canada

• Design: Two concurrent Phase III studies:

1. PROTECT : Safety and immunogenicity study (n=1,600)

2. CONSTANT : Lot-to-lot consistency study (n=2,900)

• Control Vaccine: Engerix-B® (GSK)

• Start Date: Enrollment initiated in Q4 2017

• Expected Headline Data Readout:

• PROTECT : Mid-year 2019

• CONSTANT : Around 2019 year-end

Ongoing Phase III Clinical Program to Support Licensure in U.S., Europe, and Canada

Page 14: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

14N A S D A Q : V B I V

Target Market SegmentationAging cohorts of unvaccinated adults define a key market segment for Sci-B-Vac®Key markets require superior potency and earlier seroprotection

Adult Population(Age 18+)

Immuno-Compromised“Otherwise Healthy”Market Segment:

Unvaccinated,At-Risk Populations:

• Public service workers (incl. HCW)

• Age 45+

• Pre-diabetics

• Diabetics

• CKD/ESRD

• Other high-risk populations (e.g. HIV, HCV, etc.)

Key Product Attributes Driving Use:

• Earlier seroprotection

• Superior potencySuperior potency

Page 15: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

15N A S D A Q : V B I V

Hepatitis B - Therapeuticb. VBI-2601Potential to contribute to a functional cure by inducing and sustaining broad and effective immunity against chronic Hepatitis B infection

Page 16: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

16N A S D A Q : V B I V

Functional Cure Combination for Hepatitis B

Scientific consensus is that a functional cure is within reach(AASLD 2017):

1. Drive down HBV DNA à achieved by Nucleoside Inhibitors (NUCs)

2. Drive down immuno-suppressive HBV S-antigen à multiple next-generation approaches

3. Achieve long-term immunologic control à In clinical trials, Px Sci-B-Vac® has demonstrated restoration of HBV immunity in some chronic HBV patients

• VBI-2601 is a novel formulation designed to further enhance T-cell immunity

Page 17: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

17N A S D A Q : V B I V

1. Attachmento Pre-S1 immunity blocks binding

2. Entryo Pre-S1/NTCP inhibitors

3. cccDNA Formationo cccDNA Inhibitors

4. Transcriptiono siRNAo Antisense

5. Translation o NUCs

6. Assemblyo Core Inhibitorso Assembly inhibitors

7. Secretion8. Circulation

o Anti-HBsAg antibodies9. Elimination of Infected Cells

o CD8+ T-cell vaccine responses

Current NUCs & next-gen therapies impacts intracellular steps downstream of transcription (steps 4 – 7)VBI-2601 is formulated to impact circulating virus (via anti-S immunity), viral entry (via pre-S1 immunity) & infected hepatocytes (via T-cell immunity)

Hepatocyte

HBV Life Cycle

1

8

2

3

4

5

6

79

VBI-2601 Offers an Opportunity to Influence Key Extra-Cellular Steps in HBV Life Cycle (1/2)

Page 18: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

18N A S D A Q : V B I V

Brii Biosciences License & Collaboration AgreementIn December 2018, VBI announced a license and collaboration agreement with Brii Biosciences (“Brii Bio”) to develop a functional cure for Hepatitis B

• Under the agreement, VBI and Brii Bio will collaborate in the development of the product candidate through to completion of a proof-of-concept clinical trial, following which, Brii Bio will be responsible for funding all development in the licensed territory – China, Hong Kong, Macau, and Taiwan

• VBI received gross proceeds of $11 million, consisting of a $4M upfront payment and a $7M equity investment at $3.05 per share

• VBI is eligible to receive an additional $117.5 million in potential milestone payments and potential low double-digit royalties on commercial sales in the licensed territory

• VBI will retain all rights outside of the licensed territory with respect to the treatment of hepatitis B

Page 19: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

19N A S D A Q : V B I V

Enveloped Virus-Like Particle (“eVLP”) Vaccine Technology

Page 20: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

20N A S D A Q : V B I V

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, presenting antigens in their natural state for an improved immune response

§ The foundation of the eVLP Platform is a stable, protein-based core which has the flexibility to express additional vaccine antigens of interest

e V L P

Page 21: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

21N A S D A Q : V B I V

Two Candidates from eVLP Platform Technology Target CMV-Associated Indications

Attributes Monovalent gB-G for Prevention of Infectious Disease Indications

Bivalent – pp65 + gB 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 Antigen pp65 Antigen

VBI-1501 VBI-1901

Modified gB-G Unmodified gB

Page 22: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

22N A S D A Q : V B I V

CMV eVLP Vaccine – VBI-1501eVLP vaccine candidate potently expresses a modified-form of the gB antigen, which is functionally differentiated from other gB approaches

Page 23: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

23N A S D A Q : V B I V

Impact and Risks of Cytomegalovirus (CMV)INFECTIOUS DISEASE

Birth Defects (Congenital Infection):• Congenital CMV is a leading cause of birth defects worldwide

• A first exposure during pregnancy can lead to death, blindness, deafness, and developmental delays of the newborn

• ~30,000 infants are born in U.S. with CMV annually

• 5,000+ will develop permanent impairments (more impacted births than Downs Syndrome)

• Direct economic costs of CMV infection exceeds $3.0B per year in U.S.

• No approved treatment or prevention

• ~$1B U.S. annual market with a $5B catch-up market opportunity

Transplant Rejection/Mortality:• CMV is also a leading cause of transplant rejection in both the solid organ transplant and the stem-cell

transplant settings

• Over 100,000 individuals in the U.S. are on the waiting list to receive a solid-organ transplant

• Matching based on CMV sero-status is not practical given other constraints (e.g. timely organ supply)

• Despite anti-viral pretreatment, CMV status of both recipient and donor still has a major impact on organ and recipient survival

Page 24: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

24N A S D A Q : V B I V

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)

VBI-15

01

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

Page 25: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

25N A S D A Q : V B I V

VBI-1501 : Congenital CMV Phase I Study OverviewS T U D Y D E S I G N

• Target Population: 128 CMV-Negative Healthy Adults (18-40 yrs)

• Design: 5-arm study, staggered Enrollment with Vaccinations at 0, 2, and 6 Monthso Placebo : Empty eVLPo 0.5μg VBI-1501A : 0.5μg of gB-G w/ adjuvant alumo 1.0μg VBI-1501 : 1.0μg of gB-G o 1.0μg VBI-1501A : 1.0μg of gB-G w/ adjuvant alumo 2.0μg VBI-1501A : 2.0μg of gB-G w/ adjuvant alum

• Duration: 20 Months

• Topline Data Read-Out: Announced May 2018, based on samples collected 1 month after 3rd dose, with 6-month follow-up for safety

• Primary Endpoint: Safety and Tolerability

• Secondary Endpoints:o gB binding titers

o nAb titers in fibroblast and epithelial cells

o gB antibody avidity measurement

Page 26: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

26N A S D A Q : V B I V

0 28 56 84 112 140 168 196 224 252 280 308 336

103

104

105

Days

Ant

i-gB

End

poin

t Tite

r (1

/X) VBI-1501A (0.5µg gB)

VBI-1501A (1µg gB)VBI-1501A (2µg gB)

VBI-1501 (1µg)

Vaccine immunizations

VBI-1501 Phase I Results : gB Antibody Binding Titers

Page 27: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

27N A S D A Q : V B I V

Neutralizing Antibody Seroconversion Rates

FIBROBLAST CELLS:• 2.0μg VBI-1501A induced an 85%

fibroblast cell nAb response after the 2nd

dose and a 100% nAb response after the 3rd dose

• The GMT for CMV+ sera was 237 (CI: 140,400) and for the 2µg dose of VBI-1501A was 174 (CI: 109, 276)

93% 100%92%

83%

30%

EPITHELIAL CELLS:• 2.0μg VBI-1501A also demonstrated a 31% epithelial cell neutralizing antibody

seroconversion rate after three vaccinations, up from 17% after two vaccinations

• The epithelial cell neutralizing activity was correlated with both higher binding titers and with fibroblast neutralizing activity

Page 28: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

28N A S D A Q : V B I V

• VBI-1501 is safe and well tolerated at all doses tested, with and without the adjuvant alum, with no concern about evaluating VBI-1501A at higher doses

• VBI-1501A is immunogenic, even at a low dose

o gB antibody binding titers induced at all dose levels, with clear evidence of dose-dependent boosting after each vaccination

o Neutralizing antibodies against fibroblast cell infection were comparable to those from CMV-positive controls in 100% of subjects receiving the highest dose

o Neutralizing antibodies against epithelial cell infection had a correlation with higher gB binding titers and fibroblast cell neutralizing activity, suggesting the modified form of the gB-G used in VBI-1501A qualitatively enriches for functional nAb activity

o Highest dose tested (2.0μg) is 1/10th that of several other licensed VLP-based vaccines and past non-VBI CMV candidates

• There is strong scientific rationale to support that higher doses of VBI-1501A could improve the immunogenicity and efficacy

• Discussions with regulatory bodies ongoing to determine the design of the next stage of development

Summary of Final Phase I Study Results

Page 29: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

29N A S D A Q : V B I V

Proposed Phase II Study DesignS T U DY D E S I G N

• Target Population: ~110 CMV-negative healthy adults (18-40 yrs)

• Design: 4-arm study with vaccinations at 0, 2, and 6 Months

o Placebo : Salineo 5μg VBI-1501A : 5μg of gB-G w/ adjuvant alumo 10μg VBI-1501A : 10μg of gB-G w/ adjuvant alumo 20μg VBI-1501A : 20μg of gB-G w/ adjuvant alum

• Following discussions with Health Canada, toxicology studies are underway, the results of which are required prior to the start of the clinical study

• The Phase II is expected to initiate enrollment around the end of 2019

Page 30: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

30N A S D A Q : V B I V

Glioblastoma - VBI-1901Targeting CMV as a foreign viral antigen approach to Immuno-Oncology (GBM) with a bivalent eVLP expressing two potent CMV antigens – pp65 and gB

Page 31: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

31N A S D A Q : V B I V

Impact and Risks of Cytomegalovirus (CMV)ONCOLOGY

Solid Tumors:

• 90%+ of some solid tumors, incl. glioblastomas, breast cancers, and medulloblastomas are

CMV+

• CMV is not causative, but does influence disease progression of CMV+ tumors

• In multiple clinical studies, CMV-targeting vaccines have increased overall survival in GBM

patients

• Because CMV is so broadly (and differentially) expressed on tumor cells, but not on healthy

cells, a potent CMV vaccine has potential to make “cold tumors hot”

• GBM is one of the most aggressive cancers with few therapeutic options and no standard of

care in the recurrent setting

Page 32: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

32N A S D A Q : V B I V

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

VBI-1901 (GBM) : CMV as a Foreign Viral Antigen Approach to Immuno-Oncology

Page 33: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

33N A S D A Q : V B I V

VBI-1901 : Rationally-Designed Immuno-Therapeutic Vaccine for CMV+ Solid Tumors

SchematicVirus-like structure stimulated innate immunity & promotes uptake by Antigen Presenting Cells (APCs)

Antibody Target gB

T Cell Targets gB (CD4+), pp65 (CD8+)

Target Indication Treatment of CMV+ glioblastoma, breast cancer, and other CMV+ solid tumors

RationaleTargets multiple antigens, each with multiple epitopes, to promote broad immunity & delay

avoid tumor selection/escape

Adjuvant Co-administered with GM-CSF via intradermal route

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GBM Phase I/IIa Clinical Study DesignTWO-PART, MULTI-CENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF VBI-1901 IN PATIENTS WITH RECURRENT GBM (RGBM)

Part A: Dosing and safety• Recurrent GBM (any # of times)• N = up to 18 patients (6/cohort)

Part B: Extension Study• Best dose selected from Part A• 1st recurrent GBM• N = up to 10 additional patients

Rolling Immunogenicity Data

Optimal Dose Level

Immunogenicity/biomarker measures for Low, Med & High Dose Cohorts 6 mo & 12mo survival

Low : 0.4µg of pp65 Med. :

2.0µg of pp65 High : 10.0µg of pp65

Patient Treatment:• Vaccinations every 4 weeks until tumor progression

• Safety visit/immunogenicity measure: 2 weeks post each vaccination

• MRI: at screening and every 6 weeks

Primary outcomes:• Safety and tolerability

Secondary outcomes:• Immunogenicity: (1) T-cell immunity (CD8 & CD4); (2) Serum anti-gB antibody titers; (3) Other immune correlates & biomarkers

• Change in quality of life compared to baseline, including reduction in steroid use

• 6&12 month PFS, OS

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0 28 56 84 112 140168196103

104

105

106

DaysCM

V g

B A

b B

indi

ng T

iter

(1/x

)

GBM Phase I/IIa Clinical Study : Early Data (1)

LOW-DOSE COHORT (0.4µg) : • January – April 2018 : 6 patients enrolled

• 6-month data : Overall Survival (OS) 83%, Progression-Free Survival (PFS) 17%, with one subject who was on therapy for 9 months

• Historical rGBM 6-month OS and PFS rates are approximately 60% and 20%, respectively [Brada M, 2001; Desjardins A, 2012; Stupp R, 2012]

Impact of vaccination on CMV-specific immunity - Patient-specific data of responders :

Early immunologic data from the low- and intermediate-dose cohorts illustrate robust boosting of CMV-specific immunity directed against multiple antigens in some subjects

Subject 01-0032 recurrences

Subject 01-0073 recurrences

CMV gB Antibody Binding Titers

0 28 56 84 112 140168196103

104

105

106

Days

8.6X ↑ 1.5X ↑

CMV

gB

Ab

Bind

ing

Tite

r (1

/x)

T cell Responses

0 28 56 84 112 1401681960

500

1000

1500

2000

2500

Days

SFC/

106

PBM

Cs

TMTC

0 28 56 84 112 1401681960

500

1000

1500

2000

2500

Days

TMTC

TMTC = too many to count

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GBM Phase I/IIa Clinical Study : Early Data (2)INTERMEDIATE-DOSE COHORT (2.0µg) : • June – August 2018 : 6 patients enrolled

• Study sites expanded to include Dana Farber Cancer Institute and Massachusetts General Hospital

• September 14 2018 : DSMB review of all safety data and recommended continuation of study with no modification

Impact of vaccination on CMV-specific immunity - Patient-specific data of responders :

Subject 01-0122 recurrences

CMV gB Antibody Binding Titers

CMV

gB A

b Bi

ndin

g Ti

ter (

1/x)

T cell Responses

Subject 03-0021 recurrence

HIGH-DOSE COHORT (10.0µg) : Completed enrollment in December 2018

3.8X ↑ 18.3X ↑

Data in progress

TMTC = too many to count

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Summary

Page 38: VBIV Corporate Overview Apr 2019 · NASDAQ: VBIV 3 Overview • Leveraging significant immunology expertiseto address unmet medical needs in both INFECTIOUS DISEASE and IMMUNO-ONCOLOGY

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VBI Vaccines LeadershipM A N A G E M E N T

B O A R D O F D I R E C T O R S

Dr. Steven Gillis (Chairman)

Dr. Michel De Wilde, Ph.D.

Jeff BaxterPresident & CEO

Dr. David Anderson, Ph.D.Chief Scientific Officer

Dr. Francisco Diaz-Mitoma, M.D., Ph.D.Chief Medical Officer

Tomer Kariv

Nell BeattieChief Business Officer

Chris McNultyChief Financial Officer

Blaine H. McKee, Ph.D.

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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, CFO, CBO + 3 FTEs§ Central location in biotechnology hub

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§ CMO, Finance + ~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§ ~70 FTEs§ GMP manufacturing facility for the production of Sci-B-Vac®

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N OTA B L E C ATA LYS T S T H R O U G H 2 0 1 9 Y E A R - E N D :

• Sci-B-Vac®: Hepatitis B Prophylaxis

• Mid-Year 2019 – Topline results expected from PROTECT Phase III study

• Around Year-End 2019 – Topline results expected from CONSTANT Phase III study

• VBI-1901: GBM (Immuno-Oncology)

• H1 2019 – Expanded immunologic data and 6-month overall survival (OS) and progression-free

survival (PFS) expected in all dose cohorts in Part A of the ongoing Phase I/IIa study

• H2 2019 – Immunologic data expected from Part B of the ongoing Phase I/IIa study

• VBI-1501: CMV

• Around Year-End 2019 – Expected start of Phase II dose-ranging study

• VBI-2601: Hepatitis B Therapeutic

• Around Year-End 2019 – Expected start of clinical proof of concept study

1

2

3

Summary

4

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VBI Vaccines Inc.222 Third Street, Suite 2241

Cambridge, MA 02142(617) 830-3031

[email protected]