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NASDAQ: VBIV | TSX: VBV 1 VBI Vaccines, Inc. 222 Third Street, Suite 2241 Cambridge, MA 02142 (617) 830-3031 Adam Buckley [email protected] NASDAQ: VBIV TSX: VBV APRIL 2017 SCI - B - VAC: THIRD GENERATION HBV VACCINE WORLD VACCINE CONGRESS 2017

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Page 1: SCI-B-VAC: THIRD GENERATION HBV VACCINE WORLD ...1o976r1jw2eculmeoxz46ig6-wpengine.netdna-ssl.com/wp...NASDAQ: VBIV | TSX: VBV 1 VBI Vaccines, Inc. 222 Third Street, Suite 2241 Cambridge,

NASDAQ:VBIV|TSX:VBV 1

VBIVaccines,Inc.222ThirdStreet,Suite2241

Cambridge,MA02142(617)830-3031

[email protected]

NASDAQ : VB I VTSX : V BV APR I L 2 0 1 7

SCI -B-VAC: THIRDGENERATIONHBVVACCINEWORLDVACCINECONGRESS 2017

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NASDAQ:VBIV|TSX:VBV 2

Certainstatementsinthispresentationcontainforward-lookingstatementswithinthemeaningofthePrivateSecuritiesLitigationReformActof1995orforward-lookinginformationunderapplicableCanadiansecuritieslegislation(collectively,“forward-lookingstatements”)thatmaynotbebasedonhistoricalfact,butinsteadrelatetofutureevents,including,withoutlimitation,statementscontainingthewords“believe”,“may”,“plan”,“will”,“estimate”,“continue”,“anticipate”,“intend”,“expect”,“goals”andsimilarexpressions.Allstatementsotherthanstatementsofhistoricalfactincludedinthispresentationareforward-lookingstatements.

Suchforward-lookingstatementsarebasedonanumberofassumptions,including,withoutlimitation,assumptionsregardingthesuccessfuldevelopmentand/orcommercializationofthecompany’sproducts,suchasthereceiptofnecessaryregulatoryapprovals;generaleconomicconditions;thatthecompany’sbusinessisabletooperateasanticipatedwithoutinterruptions;competitiveconditions;andchangesinapplicablelaws,rulesandregulations.

Althoughmanagementbelievesthattheassumptionsmadeandexpectationsrepresentedbysuchstatementsarereasonable,therecanbenoassurancethataforward-lookingstatementcontainedhereinwillprovetobeaccurate.Actualresultsanddevelopmentsmaydiffermateriallyfromthoseexpressedorimpliedbytheforward-lookingstatementscontainedherein,and,evenifsuchactualresultsanddevelopmentsarerealizedorsubstantiallyrealized,therecanbenoassurancethattheywillhavetheexpectedconsequences oreffects.Factorswhichcouldcauseactualresultstodiffermateriallyfromcurrentexpectationsinclude,withoutlimitation: thefailuretosuccessfullydeveloporcommercializethecompany’sproducts;adversechangesingeneraleconomicconditionsorapplicablelaws, rulesandregulations;andotherfactorsdetailedfromtimetotimeinthecompany’sreportsfiledwiththeU.SSecuritiesandExchangeCommissionandtheCanadianSecuritiesCommissions.

Giventheserisks,uncertaintiesandfactors,youarecautionednottoplaceunduerelianceonsuchforward-lookingstatementsandinformation,whicharequalifiedintheirentiretybythiscautionarystatementandaremadeonlyasofthedateofthispresentation.Allforward-lookingstatementsandinformationmadehereinarebasedonthecompany’scurrentexpectations,andthecompanyundertakesnoobligationtoreviseorupdatesuchforward-lookingstatementsandinformationtoreflectsubsequenteventsorcircumstances,exceptasrequiredbylaw.

CautionaryStatementRegardingForward-LookingInformation

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NASDAQ:VBIV|TSX:VBV 3

IntroductiontoSci-B-Vac™Sci-B-Vac™isa3rd GenerationHBVVaccineExpressingAllMajorSurfaceAntigensofHBV– ABetterViralMimic,LeadstoImprovedPotency

1st GenerationHBVVaccines

• InactivatedHBVparticlesderivedfromserumofinfectedindividuals

• Nativehumanglycosylation• IncludeHBsAg,Pre-S1,Pre-S2• HighlyPotent

2nd GenerationHBVVaccines

• RecombinantHBVVLPsproducedinyeast• IncludesonlyHBsAg withyeastglycosylation• HighlyPotentinchildren• Lesspotentinadults&immunocompromised

Sci-B-Vac™

• RecombinantHBVVLPsproducedin(CHO)cells• Naturallymammalianglycosylated• IncludeHBsAg,Pre-S1,Pre-S2• HighlyPotentinallstudiedpopulations

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NASDAQ:VBIV|TSX:VBV 4

AgingCohortsofUnvaccinatedAdultsDefineKeyMarketSegmentsforanImprovedHBVVaccine

UniversalPediatricVaccinationin1990’sStillLeaveMajorityofAdultsExposed(AdultVaccinationRatesinUS&EU=20– 24%)

Immuno-Compromised

“OtherwiseHealthy”

Diabetics&ChronicRenalFailure

>20MinUSA1

>40MinEU2

>50MinChina3

Obese,Over-40,Smokers&HCW

>94MinUSA4

>200MinEU5

>375MinChina

SuperiorPotency

SuperiorPotency&

EarlierSeroconversion

1)http://www.diabetes.org/diabetes-basics/statistics/ 2)http://www.euro.who.int/en/health-topics/noncommunicable-diseases/diabetes3)Yang,etal(2010),NEngl JMed,362:1090-11014)https://www.cdc.gov/mmwr/volumes/65/ss/ss6501a1.htm 5)http://www.biomedcentral.com/1471-2458/8/1326)GlobalHealthObservatoryDatahttp://apps.who.int/gho/data/view.main.80300?lang=en

KeyProductAttributesUnvaccinatedAt-RiskPopulations

MarketSegment

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NASDAQ:VBIV|TSX:VBV 5

• Immuno-compromised

o Patientswithchronicliverdisease ~50%

o Chronicrenalfailure,dialysis&diabetes 34-81%

o Pre-transplantationcandidates 28-36%

o Post-transplantationpatients ~10%

• “OtherwiseHealthy” ~50-85%

o Obese

o Overage40

o Smokers

o Travellers&HCW

TheUnmetNeed:High-RiskPopulationsofNon-Responders&LowResponderstoYeast-derived,AlumAdjuvanted,HBsAg Vaccination

EXEMPLAR S EROPROTEC T ION RATES :

Sources:Yangetal,ScientificReports(2016)http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4914839/WHO- http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.htmlhttp://jama.jamanetwork.com/article.aspx?articleid=409965http://jama.jamanetwork.com/article.aspx?articleid=409967

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NASDAQ:VBIV|TSX:VBV 6

• ImprovedPotencyvs 2nd GenerationVaccines

• RapidOnsetofImmunity

• Potentinhigh-risk,non-responsive&immuno-compromisedpopulations

• Safe,well-knownadjuvant:AlumHydroxide

• ExceptionalSafetyo Administeredtoover300,000(approx 50%neonates)

KeyAttributesofSci-B-Vac

OpportunityforanImprovedHBVVaccineinAdultPopulations

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NASDAQ:VBIV|TSX:VBV 7

Sci-B-Vac EvokesRapidImmunity– RecentPh IVStudyShowedOver90%Sero-ProtectionAfter2-DosesinAdults18- 40

56.8%

91.9% 98.8%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

1 (P1Vd30) 2 (P2Vd30) 3 (P2Vd60)

Month

Sci-B-Vac PhaseIVStudyinIsraeliAdults(age18-40,N=88)Seroprotection (>10mIU/mL)

ClinicalStudy:SciB018

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NASDAQ:VBIV|TSX:VBV 8

AdditionalClinicalDevelopmenttoDefineBenefitsinKeyAdultPopulations

9.5

1876421

16.8

92112203

5.4%

92.4% 85.1%

34.7%

99.2% 98.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1

10

100

1,000

10,000

100,000

1month(P1Vd30) 7month(P3Vd30) 12month(P3Vd180)

Percen

tSerop

rotection(>10

mIU/m

l)

ReciprocalGMT

Study38-96-040:Sci-B-VacSeroprotectionandGMTvsEngerix-B(n=524)inAdultsAge18-60(meanage=43)

Engerix-BGMT(20ugdose) Sci-B-VacGMT(10ugdose)Engerix-BSeroprotection(20ugdose) Sci-B-VacSeroprotection(10ugdose)

(6.6– 13.7) (13.2– 21.4)

(1367– 2574)(7093- 11962)

(306- 579)

(1698- 2858)

OpportunityforImprovedPotencyvs2nd GenerationVaccinesinAdultPopulations

ClinicalStudy:38-96-040

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NASDAQ:VBIV|TSX:VBV 9

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%

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

Percen

tHBsAg

Seroprotectio

n

Seroprotection StratifiedbyAge

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

p<0.001p = 0.003

StudyReference:PhaseIII38-96-040

StratificationbyAgeofStudy38-96-040DemonstratesSignificantlyImprovedPotencyinOlderAdults

OlderAdultsareonePopulationthatmayBenefitfromSci-B-Vac™:SuperiorSeroprotection Rates

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NASDAQ:VBIV|TSX:VBV 10

Sci-B-Vac OffersPotentialforImprovedPotencyinHigh-RiskGroups,IncludingDiabetics&CKDSci-B-Vac StimulatesSeroproective anti-HBsAg ImmunityinCKDPopulationsThatHadNotRespondedtoDouble-DoseofEngerix-B

StudyReference:Post-launchV01

0

10

20

30

40

50

60

70

80

90

100

0

50

100

150

200

250

300

350

4Doses40ugEngerixB(schedule0,1,2&6months)

TwoDoses20ugSci-B-Vac(atday90,8wkspost2ndvaccination)

ThreeDoses20ugSci-B-Vac(atday210,30dayspost3rdvaccination)

Percen

tSerop

rotected

(>10m

IU/m

l)

ReciprocalGMT

EfficacyofSci-B-Vac inNon-Responders:Studyof16ChronicKidneyDiseasePatientswhohadnotresponded(<10intl.units)to

4x40ugdosesofEngerix-B

GMT Seroconversion

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NASDAQ:VBIV|TSX:VBV 11

Datasupportsfurtherwell-controlledstudyinImmunocompromised/ESRDpopulations

DatainImmuno-compromised:End-StageRenalDiseaseInvestigatorLed(T.Weinstein,2004)StudyatRabinMedicalCenter,IsraelEvaluatedSeroprotection RateofSci-B-Vac™in29ESRDSubjects– NotionalComparisonMadetoHistoricEngerix-B®ResponsesinSameDepartment

0%

20%

40%

60%

80%

100%

Engerix-B@3x20ug(n=36) Sci-B-Vac@3x10ug(n=29)

%Serop

rotection(>10

mIU/m

l)

Sci-B-VacSeroprotection(>10mIU/ml)inIsraeliESRDPatientsvsHistoricControls

StudyPublication:T.Weinstein,NephronClin Pract 2004;97:c67-c72

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NASDAQ:VBIV|TSX:VBV 12

• 22clinicaltrialsconductedtodate

• 14openlabelclinicalstudies+extensionstudies

• 5observerblindclinicalstudies

• 9oftheabovestudiesconductedinadults,7ofwhichwillbeusedtosupportaphase3ClinicalTrialApplication

• Morethan95%ofpatientsareprotectedwithin2monthsafterfirstvaccination

• Safeandwelltolerated

SynopsesofExistingClinicalStudiesforSci-B-Vac™

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NASDAQ:VBIV|TSX:VBV 13

• Feb2017:ReceivedpositiveresponsefromHealthCanadaregardingSci-B-Vac™PhaseIIIclinicalprogram

VBIisDiscussingItsClinicalDevelopmentPrioritieswithRegulatorsinNorthAmerica&Europe

EMA

HealthCanada

FDA

• Feb2017:ReceivedpositiveEMAScientificAdviceregardingSci-B-Vac™PhaseIIIclinicalprogram

• ExpectingfeedbackonproposedclinicaldevelopmentplansinH12017

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NASDAQ:VBIV|TSX:VBV 14

ProphylacticSci-B-Vac™Summary

• Potent&RapidHBVImmunityo Improvedpotencyvs 2nd generationHBVvaccineso Rapidonsetofimmunityo Stimulationofimmunityinnon-responders

• VBIiscurrentlydevelopingSci-B-Vac forprophylacticadultIndicationinUS/EUo Historyofsafetywithover300,000dosesadministered(allpopulations)o EstablishedmanufacturingprotocolsatGMPcommercialscale

• IntegratedregulatoryfeedbackonVBI’sproposedclinicaldevelopmentplanisexpectedfromNorthAmerican&EuropeanregulatorsinH12017

OPPORTUNITYFORIMPROVEDPOTENCYINADULT&AT-RISKPOPULATIONS

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NASDAQ:VBIV|TSX:VBV 15

VBIVaccines,Inc.222ThirdStreet,Suite2241

Cambridge,MA02142(617)830-3031

[email protected]