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REPORT ANNUAL

BIOTRON

41

AnnualGeneralMee+ng22November,2016

ForwardLookingStatements

This presenta,on may contain forward-looking statements with respect to the financialcondi,on,resultsandbusinessachievements/performanceofBiotronLimited(ACN086399144) and certain of the plans and objec,ves of its management. These statements arestatements that are not historical facts.Words such as “should”, “expects”, “an,cipates”,“es,mates”,“believes”orsimilarexpressions,astheyrelatetoBiotronLimited,areintendedtoiden,fyforward-lookingstatements.Bytheirnature,forward-lookingstatementsinvolve

riskanduncertaintybecausetheyreflectBiotron’scurrentexpecta,onsandassump,onsastofutureeventsandcircumstancesthatmaynotproveaccurate.Thereisnoguaranteethattheexpectedevents,trendsorresultswillactuallyoccur.Anychangesinsuchassump,onsorexpecta,onscouldcauseactualresultstodiffermateriallyfromcurrentexpecta,ons.

BiotronSnapShot

•  Biotron’scoreexper,seisdesignanddevelopmentofnewan,viraldrugstarge,ngviralionchannelproteins(viroporins)

•  Viroporinsarepresentinbroadrangeofviruses:

•  Influenza(M2),HIV-1(Vpu),HepC(p7),DengueandWestNile(Mprotein),SARS(Eprotein)andothers

•  Broadplaborm:

•  Rapid,proprietaryprimarybacterialcell-basedscreeningassaysfortargetproteins

•  Focusedlibraryofcompoundsthattargettheseviralproteins

•  Pipelineoffirst-in-classsmallmoleculeviroporininhibitorsforkeymarkets

BIT225clinicalprogramcon%nuestodemonstratethatBiotron’sviroporin-targe+ngapproachtodrugdevelopmentworks

StrategyUpdate

•  Con,nuetoposi,onBiotronasClinicalStageAn,-viralDevelopmentCompanywith:

o  ClinicalprogramsforHIV-1andHepa,,sCvirus(HCV)

o  Aleadprogram,BIT225,as“FirstinClass”therapyforHIV-1eradica,on

o  ValuableHCVclinicalprogram,withanewclassofdirect-ac,ngan,viralagent

o  Earlystagecollabora,onopportuni,esforpreclinicaltargetssuchas:

§  Dengue

§  Zika

§  Hepa,,sBvirus

o  Addi,onaldevelopmentcollabora,onpoten,alfor“other”Pharmatarget(s)

•  DemonstratesrobustnessofBiotron’sapproach

•  BIT225isavaluablePhase2assetwithtwoindica,ons–HIV-1andHCV

•  Botharemul,-billiondollarmarkets

•  Over200individualsdosed(healthy,HCV,HIV-1andHIV-1/HCVco-infected)intrials

•  7clinicaltrialscompleted-posi+vedatarecordedinalltrials

•  Demonstratedclinicalac,vityagainstHCVGT1andGT3

•  Posi,vedatareadoutfromBIT225-008GT1dataearlierinyear

•  ComprehensivedatapackageonBIT225completed(manufacturing,safetyprofile,PK,efficacy,dosage,etc)

•  Forregulatoryfilings

•  Tosupportcombina,onstudieswithpoten,alpartners”HCVdrugs

DatageneratedinHCVtrialsisalsoapplicabletoHIV-1program

BIT225–Phase2AssetforTwoIndica+ons

HIV-1 Eradica+on – Towards a “Cure”

•  Keymarketopportunity–significantunmetmedicalneed

•  E.g.BIT225@US$100,000perdosewith25%marketpenetra,on:

•  Poten,alUS$60billioncurrentinfectedmarket

•  Poten,alUS$2.25billionnewinfec,ons•  Long-termhealthimplica,onseveninpa,entson

an,retroviraldrugse.g.HAND,immuneac,va,on,etc

•  Newmodeofac,onsdrugsareneeded:

•  Toimprovehealthoutcomesinpa,ents

•  ToeradicateorcureHIV-1infec,on

•  Areaofrealinteresttointerna,onalpharmaceu,calindustry

HIV-1Reservoirs

MarioStevenson-Scien/ficAmerican299,78-83(2008)

•  HIV-1remainshiddeninreservoirs,leadingtochronic,life-longinfec,on

•  Invisibletobody’simmunedefenses

•  Notsensi,vetoan,-HIV-1drugs

•  Eradica,onwillrequiremul,pleapproaches;approachesinclude:

•  An,-latencyagentsforlatently-infectedTcells

•  Drugstomodifyimmuneresponse

•  Drugstarge,ngHIV-1inmacrophagelineagecells

BIT225haspoten+altoimpactimmuneresponseANDreduceHIV-1inmacrophage

reservoircells

BIT225–ProvenClinicalAc+vityAgainstHIV-1

•  BIT225-004:Phase1b/2arandomised,placebocontrolled,double-blindtrial

•  21pa,ents,HIV-1posi,ve,treatment-naïve;10daysdosingwithBIT225(monotherapy)

Resultsdemonstratedthat:

1.   BIT225significantlyreducedHIV-1levelsinthemacrophage(reservoir)cells;BIT225crossedblood-brainbarrier,possibilityoftreatmentofAIDS-relateddemen+a

2.   BIT225reducedmyeloid-specificimmuneac+va+onmarkersduringtrial

-  Resultssupportapoten+alroleforBIT225incure/eradica+onstrategies

-  Finalstepistoshowefficacyincombina+onwithcurrentHIV-1treatment

TimeinCo-culture(days)

4 6 8

10 12 14 16

5 10 15 20 25

HIV-1Re

plica,

on(p

g/20

0uL) BIT225Placebo

BIT225HIV-1TrialsDesignedtoShowClinicalBenefitinCombina+onwithART

1-BIT225-009 2-TreatmentInterrup+on

Slide13

•  BIT225-009Overview

•  Phase2humanclinicaltrial

•  12weeksBIT225incombina,onwithcurrentan,retroviraltreatment(ART)

•  Pa,entpopula,oniscommencingARTtreatmentforfirst,me

•  Doubleblind,placebocontrolledstudy

•  MeasuringBIT225impacton:

•  HIV-1secondphaseofdecay

•  Immuneac,va,on

•  IntracellularHIV-1inreservoirlineagecells

•  SpecificallydesignedtoshowaclinicalbenefitwithBIT225overandaboveART

HIV-1ProgramTrials-I

•  TreatmentInterrup%onStudy(ATI)

•  Tolookatimpactonviralreservoir:

•  TreatwithcurrentARTdrugs,withandwithoutBIT225

•  Takeawaydrugs

•  Measureimpactonviralrebound

•  Delay,changeindynamics,etc

•  Difficulttodoinpa,entsastheywouldneedtogoofftreatment

•  BUTRecentadvancesinmodelsofHIV-1infec,onallowustodothisinanewanimalmodel:

•  Significantlyfasterandmorecost-effec,vethanahumantrial

•  DirectlymimicshumanATI

•  Validatedindiscussionswithpoten,alpartners

HIV-1ProgramTrials-II

HumanTreatmentInterrup+onModel

•  Micewithhumanimmunesystem•  CanbeinfectedwithHIV-1andtreatedwithhumandrugs•  MimicTreatmentInterrup,ontrialinhumans

ADVANTAGES:•  Lesscost,risk,%me•  Providedatato:

•  Guideforpoten%alclinicaluse•  Supportoutcomeof009trial•  Handleon%metorebound•  Dataiskeytobeddingdownpartnership

POTENTIALEffectofaddi+onofBIT225

Crea+ngClearValueInflec+onPointsinHIV-1Program

•  Studiesverycarefullydesignedinconjunc,onwithKeyOpinionLeaderswithindustryfeedback•  Specificallydesignedtoshowpoten,alpartnershowBIT225canbeusedincombina,onwithcurrentART

•  Phase2HIV-1Trial(BIT225-009)-

•  Expecttrialcommencementshortly–Headlinedataexpectedin3Q17

•  Expectedoutcome(s)–changeofviralloadinbloodindica%ngimpactonunderlyingviralreservoir,alsoimpactonimmuneac%va%on

•  Analy,calTreatmentInterrup,on(ATI)Study–

•  Trialisunderwayevalua,ngBIT225inHIV-1InfectedHumanisedMice-DataexpectedQ1/17•  Expectedoutcome(s)–impactonviralreboundonceARTisstopped

Bothstudyapproachesvalidatedindiscussionswithpoten+alpartners

HCVProgramUpdate

•  DatapackagepreparedforregulatoryfilingsinUSorelsewhere•  Partner-readyforcombina,onstudieswithotherHCVdrugs

•  BIT225ispan-genotypic,newclassofHCVdrug•  ChinaremainsasignificantopportunityforHCVtherapy

•  30–50millionpeopleinfected(comparedto3–5millioninUSA)

•  Iden,fiedandini,ateddiscussionswithanumberofChinabasedcompanieswithinterestinlicensingBIT225(forHCV)

•  PricingoflatestHCVdrugsfromtheUSAisstrongincen,veforChinatocommercialisetherapiesforitsdomes,cmarket

•  Licenseewouldundertakedevelopment,regulatory,manufacturing&marke,nginChinaforitsdomes,cmarket

•  Renewedindustryinterestintarge,ngviraldiseasesincluding

•  Respiratorysyncy,alvirus(RSV)

•  Hepa,,sBvirus

•  TropicaldiseasesincludingDengue

•  Influenza(inpar,culardrugresistantstrains)

•  Ebola,MERS-CoVandZikaoutbreakshavecausedpublichealthissuesworldwide

•  BIT225hasdemonstratedtherobustnessofBiotron’sapproachwithtarge+ngviroporinproteins

•  Compoundswithac,vityagainstotherkeyviruseshavebeeniden,fied

•  MainfocusremainsoncommercialisingtheCompany’sHIV-1andHCVprograms,butessen,althatotheropportuni,esaredeveloped

UnlockingValueinCompoundLibrary

CompoundLibraryisRichSourceofHits

X-axis:BITcompoundIDY-axis:VirusclassZ-axis:Strengthofhit

LibraryisvaluabletoBiotronandpoten+alpartnersasitisanewchemicalspacethathasnotbeenexploitedindrugdevelopmenttodate

Preclinical–EarlyStageOpportuni+es

•  Technologycoreisanan,viralplabormwithnewclassofsmallmoleculeswithbroadrangeofac,vityagainstdifferentviruses

•  Extendingearlierstageprogramsforotherkeyviruses:

•  Iden,fyinghitsforothervirusesincludingRSV,Zika,BK,andothers

•  DevelopingleadsforprogramsincludingDengueandHBV

•  Denguevirus–Applyingfornon-equityfundingfromUSorganisa,ons

•  Hepa,,sBVirus(HBV)-Earlystage,butkeytargetofinteresttopoten,alpartners

•  Screeningac+vi+esareKEYtodemonstra+ngvalueofourpladorm

•  Seekingcollabora,onsforindividualprogramsoren,replaborm

SummaryBiotronwellposi,onedforvaluegrowthin2017:

•  StrongclinicalprograminHIV-1

•  Definedvalueinfec,onpointsbasedonpoten,allyposi,vedatafromBIT225-009trialandATIStudymakingBiotron“PartnerReady”

•  RegionalHCVlicensingstrategyenablingaddi,onalvalueop,misa,on

•  Extensivesafety,etcdatapackageforBIT225suppor,ngbothHIV-1andHCVprograms

•  Mul,plepreclinicalcollabora,onopportuni,esincludinghighvalueHBVapproach

•  Commercialisa,onofdrugsandplabormremainsthekeyfocusandaimofthecompany,andbasisofallac,vi,es

Contact

DrMichelleMillerCEO&ManagingDirector+61412313329mmiller@biotron.com.auwww.biotron.com.au