NASDAQ:VBIV|TSX:VBV 1
VBIVaccines,Inc.222ThirdStreet,Suite2241
Cambridge,MA02142(617)830-3031
NASDAQ : VB I VTSX : V BV APR I L 2 0 1 7
SCI -B-VAC: THIRDGENERATIONHBVVACCINEWORLDVACCINECONGRESS 2017
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
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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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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• 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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• 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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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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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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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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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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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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• 22clinicaltrialsconductedtodate
• 14openlabelclinicalstudies+extensionstudies
• 5observerblindclinicalstudies
• 9oftheabovestudiesconductedinadults,7ofwhichwillbeusedtosupportaphase3ClinicalTrialApplication
• Morethan95%ofpatientsareprotectedwithin2monthsafterfirstvaccination
• Safeandwelltolerated
SynopsesofExistingClinicalStudiesforSci-B-Vac™
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• Feb2017:ReceivedpositiveresponsefromHealthCanadaregardingSci-B-Vac™PhaseIIIclinicalprogram
VBIisDiscussingItsClinicalDevelopmentPrioritieswithRegulatorsinNorthAmerica&Europe
EMA
HealthCanada
FDA
• Feb2017:ReceivedpositiveEMAScientificAdviceregardingSci-B-Vac™PhaseIIIclinicalprogram
• ExpectingfeedbackonproposedclinicaldevelopmentplansinH12017
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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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VBIVaccines,Inc.222ThirdStreet,Suite2241
Cambridge,MA02142(617)830-3031