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BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018

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Page 1: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

BIOTRONLIMITED(ASX:BIT)BiotechShowcase2018

Page 2: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

Forward Looking Statements

This presenta,onmay contain forward-looking statementswith respect to the financial condi,on, results andbusinessachievements/performanceofBiotronLimited(ACN086399144)andcertainoftheplansandobjec,vesof its management. These statements are statements that are not historical facts. Words such as “should”,“expects”, “an,cipates”, “es,mates”, “believes” or similar expressions, as they relate to Biotron Limited, areintended to iden,fy forward-looking statements. By their nature, forward-looking statements involve risk anduncertainty because they reflect Biotron’s current expecta,ons and assump,ons as to future events andcircumstancesthatmaynotproveaccurate.Thereisnoguaranteethattheexpectedevents,trendsorresultswillactuallyoccur.Any changes in suchassump,onsorexpecta,ons could causeactual results todiffermateriallyfromcurrentexpecta,ons.

Page 3: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

BiotronLimited

•  Biotron is designing, developing and commercialising a plaUorm ofan,viraldrugswithanovelmodeofac,on–abletotargetawidevarietyofviralinfec,ons

•  Pipelineofprogramsinhighvalue,highneedmarkets•  Progress in clinical leadprogram (BIT225) provides strong valida,on foren,replaUorm

Page 4: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

BiotronLimited–SnapShot

BROADPLATFORMWITHNEWCLASSOFANTIVIRALDRUGS

HIV-1ERADICATION HBV&EARLYSTAGEPROGRAMSHEPATITISCVIRUS(HCV)

-  Targe,ngHIV-1inlong-livedreservoirs

-  Phase2trialinprogressduring2017;dosingcomplete

-  NewclassofHCVdrug

-  Phase2completed

-  SeekingpartnershipsinChina

-  Pipelineofearlystageprograms,including:

-  Hepa,,sBvirus

-  Respiratoryviruses

-  Flaviviruses(Dengue)

ROBUSTCLINICALVALIDATION–COMPLETED8CLINICALTRIALSWITHSTRONGSAFETY&EFFICACYOUTCOMES

Page 5: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

KeyAchievements2017

•  CommencedPhase2HIV-1clinicaltrialofBIT225andCombina,onAn,retroviralTherapy(cART)inFeb’17

•  DosingwithBIT225/placebocompleted;datapending(an,cipated1Q18)

•  Demonstratedsignificantandacceleratedreduc,oninHIV-1viralloadfollowingaddi,onofBIT225inhumanisedmousemodelofHIV-1infec,oninFeb‘17

•  IndependentNaturepublica,onvalidatedBiotron’sapproachoftarge,ngHIV-1inmacrophagesasakeystepinHIV-1eradica,oninMay’17

•  AppointedaCorporateAdvisorforChina–assis,ngwithexecu,ngHCVregionalpartneringstrategyinJune‘17

•  Raised$1.56millionviarightsissueinJune‘17

•  Received$1.6millionR&DtaxrefundinNov‘17

Page 6: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

HIV-1EradicaTonCurrentdrugsdonoteradicateHIV-1virus

WhyisHIV-1eradicaTonnecessary?•  Long-termhealthimplica,onse.g.HAND,immuneac,va,on,drug-drug

interac,ons•  Costoftreatment

•  ~$20billionp.a.worldwide•  Majorburdenonhealthcaresystems

BIT225haspotenTaltobeusedincombinaTonwithotherdrugsto

eradicateHIV-1reservoirs

•  HIV-1remainshiddeninreservoirs,leadingtochronic,life-longinfec,on•  Invisibletobody’simmunedefenses•  Notsensi,vetoan,-HIV-1drugs

•  Newmodeofac,onsdrugsareneededtoeradicateorcureHIV-1infec,on

MarioStevensonScien.ficAmerican299,78-83(2008)

Page 7: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

CurrentDrugsDoNotEradicateHIV-1

Page 8: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

MacrophagesareKeyHIV-1Reservoirs

StudypublishedinNatureMedicineinApril2017confirmedthatmacrophagesarekeyviralreservoirs

Page 9: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

•  BIT225inhibitsassemblyandbuddingofnewvirusinmacrophagereservoirs

•  Phase1b/2atrial(004)demonstratedthatBIT225canreduceHIV-1levelsinmacrophagecellsinvivo,parallelinginvitrostudies(Wilkinsonetal,JAn,microbChemother.2015)

•  Phase2trial(009)inprogress(BIT225incombina,onwithART)during2017

BIT225TargetsHIV-1inReservoirCells

A B

(A)UntreatedControls (B)BIT225treatedcells

Page 10: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

BIT225–ProvenClinicalAcTvityAgainstHIV-1•  BIT225-004:Phase1b/2arandomised,placebocontrolled,double-

blindtrial–  21pa,ents,HIV-1posi,ve,treatment-naïve;10daysdosing

withBIT225(monotherapy)•  ResultsdemonstratedthatBIT225:

1.  TargetsHIV-1inbloodreservoircells,andsignificantlyreducesvirusinthesecells

2.  Crossestheblood-brainbarrier,openingupthepossibilityoftreatmentofAIDS-relateddemenTa

2.  Reducedmyeloid-specificimmuneacTvaTonmarkersduringtrial

2 4 6 8

10 12 14 16

5 10 15 20 25

HIV-1Re

plica,

on(p

g/20

0uL)

TimeinCo-culture(days)

BIT225Placebo

PotenTalroleforBIT225:-  AddiTontocurrentARTtoeradicatekeyreservoirs,impacTngimmuneacTvaTon-  Keycomponentofcure/eradicaTonstrategies

Page 11: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

HIV-1EradicaTon:BIT225-009Trial

•  36HIV-1+ve,treatment-naïvesubjectscommencingART•  Randomised2:1(drug:placebo)

BIT225orplaceboaddedtoART

•  BIT225orplaceboaddedtoARTforfirst12weeksoftreatment•  Read-out

•  Impactonviruslevels;reduc,onofimmuneac,va,onmarkers•  Fullyrecruited;completeddosingwithBIT225/placebo.AnTcipatedatain1Q18

Page 12: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

Biotron–NewApproachtoAnT-ViralDrugDevelopment

•  Coreexper,seisdesignanddevelopmentofanewclassofan,viraldrugstarge,ngviral-encodedviroporinproteins

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

•  BroadplaUorm:

•  Rapid,proprietaryprimarybacterialcell-basedscreeningassaysfortargetproteins

•  Focusedlibraryofcompoundsthattargettheseviralproteins

•  Pipelineofinternally-generated,first-in-classsmallmoleculeviroporininhibitorsforkeymarkets

Page 13: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

Viroporins

•  Smallhydrophobicproteinswithionchannelac,vity

•  Formhydrophilicporesinhostcellmembranes

•  Keystagesoftheviralcyclesuchasvirusuncoa,ng,transportandmatura,onareion-influencedprocessesinmanyviralspecies

•  Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles

•  IdealtherapeuTctargets;exemplifiedbyBiotron’sHIV-1program(BIT225)

NatureReviewsMicrobiology10,563-574

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UnlockingValueforOtherVirusTargets

Libraryofcompoundsdesignedtotargetviroporinsfoundinsomeviruses:Ini,ally>250compoundsdesignedandsynthesised;librarynow~350OTHER“HITS”INLIBRARYinclude:•  InfluenzaAandB•  Hepa,,sBvirus(HBV)•  Coronaviruses(IncludingSARS)•  Epstein-Barrvirus(EBV)•  Zikavirus•  Denguevirus•  Herpesviruses•  BKvirus

X-axis:compoundIDY-axis:virusZ-axis:strengthofhit

Page 15: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

UnlockingValueforOtherVirusTargets

Biotron’sViroporinapproachenablesthetarge,ngofawiderangeofviraldiseases;examplesinclude:•  RespiratoryVirusessuchasRespiratorySyncy,alVirus(RSV),Influenza,&Coronaviruses(leading

causeof“commoncold”)•  FlavivirusessuchasZikaVirusandDengue•  TransplantvirusessuchasBKvirus•  EpsteinBarrvirus(EBV)-par,cularinterestinAsiawhereitiscausa,veagentofNasopharyngeal

Carcinoma Biotron’sViroporin-targeTngplahormhasthepotenTaltobecomeanimportanttoolin

thedevelopmentofanTviraltherapies

Page 16: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

HepaTTsBVirusProgram•  Hepa,,sBvirus(HBV)therapeu,cspacehassignificantinterestfrompharma&biotechcompanies

•  ScreeningofBiotron’scompoundlibraryhasiden,fiedseveralcompoundswithac,vityagainstHBV

•  ScreeninginHepG2andAD38celllines,aswellasstudiesinprimaryhumanhepatocytes(PHH)

•  InvitrodataincludesevidenceofreducTonofindustryrecognisedmarkers,includingcccDNA

•  Biotroncompoundsappeartohaveanovelmechanismofac,on•  Poten,alforuseincombina,onapproachestotreatmentofHBV

•  ExpandsBiotron’spartneringopportuni,es–poten,alforearlystageco-development/collabora,onagreement

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DengueVirusProgram

•  2.5billionpeople(40%worldpopula,on)liveinareasatriskofDengue

•  ~100millionpeopleinfectedyearly

•  Aleadingcauseofillnessanddeathintropicsandsubtropics

•  Transmissionisbymosquito;mostpreven,onprogramstargetthevector

•  NoapprovedDengue-specifictherapeu,cdrug

•  Vaccinetrialshavehaddisappoin,ngresults

•  Biotronistarge,ngDengueMprotein–SimilartargettoHIV-1/VpuandHCV/p7

•  Severalcompoundswithpromisingac,vityhavebeengenerated;testsareon-going

•  Poten,alforpan-Flavivirustherapeu,c

www.sciencenews.org

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HCV–RemainsanOpportunity

•  ThenewHCVdrugsmaycausereac,va,onofHBVinHCV/HBVcoinfectedpa,ents

•  ResultedinUSFDA“BlackBox”WarningonnewHCVdrugs

•  30millionHCV-infectedpeopleinChina,comparedto3-5millioninUSA

•  93millionchronicallyinfectedwithHBVinChina,comparedto2.2millioninUSA

•  HighHCV/HBVco-infec,onrateinChina(es,matedtobe10million)

•  Reac,va,onofHBVhaspoten,altobeamajorhealth&economicissueinChina

•  BIT225hasbeenshowninclinicaltrialstosignificantlyimproveclinicaloutcomeinHCVGT1-infectedpa,entsincombina,onwithInterferon&Ribavirin(IFN/RBV)

•  IFN/RBVhaveseveralpoten,aladvantagesovernewHCVdrugsinsomeseyngs

•  IFN/RBVissignificantlycheaperthanthenewHCVdrugs

•  HBVreac,va,onislesscommonandlesssevereinHCV/HBVco-infectedpa,entswithIFN/RBV

•  SeekingpartnershipsforBiotron’sHCVprograminChina

Page 19: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

CommercialisaTonandPartnering

•  HIV-1Program-Significantvalueinflec,onpointsaroundHIV-1programdataexpectedin2018

•  HCVProgram-BIT225par,cularlywellsuitedtoAsia,withhighnumbersofHCV-infectedpa,entsincludingahighpropor,onofHCV/HBVco-infectedpa,ents

•  Earlystagecollabora,onopportuni,esforpre-clinicaltargets,suchas:

•  Hepa,,sB

•  Dengue

•  Addi,onaldevelopmentcollabora,onpoten,alfor“other”pharmatargets

•  Seekingpartnersforindividualtargetsoren,replaUorm

Page 20: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018...viral-encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue

BoardMichaelHoy Non-execu,veChairman

MichelleMiller ManagingDirector

SusanPond Non-execu,veDirector

RobThomas Non-execu,veDirector

CorporateSnapshot

KeyFinancialMetricsTickerCode ASX:BIT

SharePrice(09Jan18) A$0.03

Marketcapitalisa,on A$11.4million

12MonthTradingRange A$0.016–0.046

SharesOutstanding 392million

CashPosi,on(09/2017) A$0.83million*

*ExcludesA$1.6mR&DtaxrebatereceivedinNov‘17

•  SpunoutfromJohnCur,nSchoolofMedicalResearchattheAustralianNa,onalUniversityin1999

•  ListedonASXinJan2001(ASX:BIT)

•  HeadquarteredinSydney,Australia

BriefBiotronOverview

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InvestmentHighlights

PorholioofpatentsandpatentapplicaTonsdirected to theCompany’s anT-viraldrugporholio

STRONGINTELLECTUALPROPERTYPOSITION

TargeTngviroporinproteinswitharapidscreeningproprietaryprimarybacterialcell-basedplahorm-alibraryofover350compoundswithacTvityagainstarangeofviruses.

NOVELANTIVIRALPLATFORM

ClinicalandPreclinicalprogramsinindicaTonswithhighunmetclinicalneedorlargepaTentpopulaTonssuchasHIV-1,HCV&Dengue,HBV,Zika&Influenza

BROADANTIVIRALPIPELINE

Completed7humanClinicalTrialswithpromisingsafetyandefficacyoutcomes

ROBUSTCLINICALVALIDATION

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15 20

REPORT ANNUAL

BIOTRON

41

DrMichelleMillerManagingDirector+61412313329mmiller@biotron.com.auwww.biotron.com.au