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BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017

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Page 1: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

BIOTRONLIMITED(ASX:BIT)BiotechShowcase2017

Page 2: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

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 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

InvestmentHighlights

•  Developingnewclassofan,viraldrugs

•  Leadprograms:BIT225targe,ngHIV-1eradica,onandHepa,,sCvirus(HCV)–mul,-billiondollarmarkets

•  Phase1/2atrialscompletedinover200subjects–safetyandefficacyvalidated

•  Severalnearterm,value-addingmilestonesdrivenbytwokeyHIV-1studiesin2017:

•  BIT225treatmentinterrup,onstudyandBIT225Phase2HIV-1humantrial

Page 4: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

BoardMichaelHoy Non-execu,veChairman

MichelleMiller ManagingDirector

SusanPond Non-execu,veDirector

RobThomas Non-execu,veDirector

DenisWade Non-execu,veDirector

CorporateSnapshot

KeyFinancialMetricsTickerCode ASX:BIT

SharePrice(09Jan17) A$0.04

Marketcapitalisa,on A$12.24million

12MonthTradingRange A$0.040–0.105

SharesOutstanding 313million

CashPosi,on(09/2016) A$2.29million

•  SpunoutfromJohnCur,nSchoolofMedicalResearchattheAustralianNa,onalUniversityin1999

•  ListedonASXinJan2001(ASX:BIT)

•  HeadquarteredinSydney,Australia

BriefBiotronOverview

Page 5: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

Biotron–LeaderinViroporin-TargePngDrugDevelopment

•  Coreexper,seisdesignanddevelopmentofanewclassofan,viraldrugstarge,ngviral-encodedviroporinproteins

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

•  Broadplalorm:

•  Rapid,proprietaryprimarybacterialcell-basedscreeningassaysfortargetproteins

•  Focusedlibraryofcompoundsthattargettheseviralproteins

•  Pipelineofinternally-generated,first-in-classsmallmoleculeviroporininhibitorsforkeymarkets

Page 6: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

Viroporins

•  Smallhydrophobicproteinswithion

channelac,vity•  Formhydrophilicporesinhostcell

membranes•  Keystagesoftheviralcyclesuchasvirus

uncoa,ng,transportandmatura,onareion-influencedprocessesinmanyviralspecies

•  Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles

•  IdealtherapeuPctargetsNatureReviewsMicrobiology10,563-574

Page 7: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

Compound Discovery Process

Designofcompoundstoexplore3DspaceanddetermineSARoftargetproteins;expansionofcompoundlibrarytoincreaseac,vityagainsttarget

Compoundsscreenedinproprietaryassaysetupforeachvirustargete.g.HIV-1Vpu;HCVp7;InfluenzaM2;DengueM;CoronavirusE.

Hitstestedagainstvirusincellcultures;Secondaryscreeningofhitsagainstotherkeyvirusese.g.HepB,influenza,Zika

Leadop,misa,onandselec,on.Currentlead:BIT225(HIV-1andHCV).BIT314(HCV)isnextgeneraPon

1

2

3

4

Addi,onalchemistrytorefinehits

Page 8: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

Core Technology Drives Rich Compound Library

Libraryofcompoundsdesignedtotargetviroporins:Ini,ally>250compoundsdesignedandsynthesised;librarynow~350OTHER“HITS”INLIBRARYinclude:•  InfluenzaAandB•  Coronaviruses(Including

SARS)•  Epstein-Barrvirus(EBV)•  Hepa,,sBvirus(HBV)•  Zikavirus•  others

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

Page 9: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

Biotron-AdvancedPipeline

INDICATION

COMPOUND

DISCOVERY PRECLINICAL PHASE1 PHASE2 PHASE3

HCV BIT225

HIV-1 BIT225

NextgeneraPon-HCV

BIT314

Dengue Leads

Page 10: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HIV-1Reservoirs

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

–  Invisibletobody’simmunedefenses

–  Notsensi,vetoan,-HIV-1drugs

•  Eradica,onwillrequiremul,pleapproaches;approachesinclude:

–  An,-latencyagentsforlatently-infectedTcells

–  Drugstomodifyimmuneresponse

–  Drugstarge,ngHIV-1inmacrophagelineagecells

MarioStevensonScien6ficAmerican299,78-83(2008)

Page 11: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HIV-1:TowardsaCure

•  Over1.1millionpeoplelivingwithHIV-1intheUSA,with1in6unawareofdiagnosis

•  US$11.9bnsalesinUS,EuropeandJapanin2013;expectedtogrowtoUS$16.8bnby2020

•  HIV-1pa,entsneedtostayonan,retroviraldrugs(ART)tokeepviruslevelsundercontrol

•  Long-termhealthimplica,onseveninpa,entsonan,retroviraldrugse.g.HAND,immuneac,va,on,etc

•  Newmodeofac,onsdrugsareneededtoeradicateorcureHIV-1infec,on

Page 12: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

•  BIT225inhibitsassemblyandbuddingofnewvirusinmacrophages•  Phase2atrial(004)demonstratedthatBIT225canreduceHIV-1levelsinmacrophagecellsinvivo,

parallelinginvitrostudies(Wilkinsonetal,JAn,microbChemother.2015Nov29.pii:dkv389.[Epubaheadofprint])

•  Poten,albenefitsonimmuneagingandHIV-associateddemen,a•  Poten,alforuseinfutureviruseradica,ontreatment

BIT225TargetsHIV-1inReservoirCells

Time(days)+HIV-1

50100150200

16 17 19 21 22 23 24 25 26 27 28

+BIT225

BIT225StopsHIV-1Replica7oninHumanMacrophageCells

A B

(A)UntreatedControls (B)BIT225treatedcells

Page 13: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

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

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

withBIT225(monotherapy)•  ResultsdemonstratedthatBIT225:

1.   SignificantlyreducesHIV-1levelsinthemacrophage(reservoir)cells

2.   Crossestheblood-brainbarrier,openingupthepossibilityoftreatmentofAIDS-relateddemenPa

2.   Reducedmyeloid-specificimmuneacPvaPonmarkersduringtrial

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

PotenPalroleforBIT225:-  AddiPontocurrentARTtoeradicatekeyreservoirs,impacPngimmuneacPvaPon-  Keycomponentofcure/eradicaPonstrategies

Page 14: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HIV-1ViralDynamics

BIT225-009 Hu-MouseATI

Page 15: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

BIT225 HIV-1 Eradication – Next Steps

Crea,ngvalueinflec,onpointswithposi,vetrialdata•  Ini,atePhase2HIV-1ClinicalTrial-3monthtrialincombina,onwithART(BIT225-009);Expecttrial

commencementearly2017–Dataexpectedin3Q17•  Expectedoutcome(s)–Impactonkine7csofviralloaddecayincombina7onwithARTindica7ng

impactonunderlyingviralreservoir,alsoimpactonimmuneac7va7on

•  Analy,calTreatmentInterrup,on(ATI)Study–Currentlyunderwayevalua,ngBIT225inHIV-1InfectedHumanisedMice-DataexpectedQ12017

•  Expectedoutcome(s)–impactonviralkine7csincombina7onwithART,pluspoten7alimpactonreboundonceARTisstopped

•  Accumulatedsignificantquan,tyofclinicaldataforBIT225fromhealthyvolunteer,HCV&HIV-1pa,enttrials.

Page 16: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

BIT225–FirstofaNewClassofHCVDAADrugs

•  Novel,oral,smallmoleculecompound

•  Onlyoneofitsclass(p7inhibitor)inclinicaltrials

•  Inhibitsviralassemblyandinfec,vity

•  Pan-genotypeac,vity:

•  Ac,veinvitroagainstallmaingenotypes

•  Clinicallyac,veagainstHCVGT1(1aand1b)andGT3

•  Seekingpartnershipsforfurtherdevelopment,inpar,cular,inAsia

POLYMERASE/PROTEASEINHIBITORSe.g.Sofosbuvir/Simeprevir

BIT225-ASSEMBLY/BUDDINGINHIBITOR

Page 17: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HCVBIT225ProgramSnapshot

-  PreparedbasedonaboveazertheAugustBoardmee,ng

-  Guidedthewordingoftheprospectusdrazandtheuseofproceeds

-  Whilecapitalrequirementsaredeterminedbasedonproposedplan,thefinalschedule

ofworkwillbelargelydictatedbyavailablecapital

-  FourclinicaltrialsIHCV-infectedsubjectscompleted(includingoneHIV-1/HCVcoinfectedtrial)

-  PromisingclinicalefficacyagainstHCV

-  HCVGT1(BIT225-005)–100%receiving400mgBIDfor28daysincombina,onwith48weeksIFN/RBV(perprotocol)werevirus-freeat48weeks

-  HIV-1/HCVGT3(BIT225-006)–100%receiving300mgBIDfor28daysincombina,onwith48weeksIFN/RBV(perprotocol)achievedSVR12i.e.curedofHCVinfecPon

-  BIT225increasestherateatwhichHCVisclearedincombinaPonwithotherdrugs

Page 18: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HCV–RemainsanOpportunity

•  EmergingevidencethatInterferonsparingtherapiesmaycausereac,va,onofHepa,,sB(HBV)

•  Evidenceofreac,va,onofhepa,,sBinco-infectedpa,ents(HBV&HCV)presentedatAASLD

•  30–50millionHCV-infectedsubjectsinChina

•  HighHCV/HBVco-infec,onrateinChina

•  Poten,alforanotherclassofDAAsuchasBIT225toshortentreatmentandreducecosts,inpar,cularinmarketsex-USA/Europe

Page 19: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

UnlockingValueinCompoundLibrary

•  Renewedindustryinterestintarge,ngviraldiseasesincluding

•  Respiratorydiseasese.g.Respiratorysyncy,alvirus(RSV)&Influenza

•  Hepa,,sBvirus

•  TropicaldiseasesincludingDengue

•  Ebola,ZikaandMERS-CoVoutbreakshavecausedpublichealthissuesworldwide

•  BIT225hasdemonstratedtherobustnessofBiotron’sapproachwithtargePngviroporinproteins

•  Compoundswithac,vityagainstotherkeyviruseshavebeeniden,fied;secondaryscreeningisinprogress,withtheaimofiden,fyingpoten,alcandidatestoprogressintoIND-enablingstudies

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

Page 20: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

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

Page 21: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

HepaPPsBVirus

•  LimitedscreeningofBiotroncompoundlibraryhasgeneratedinteres,ngdata

•  Hitsiden,fied

•  Veryexperiencedscien,ficadvisoryandopera,onalteaminplaceforHBV

•  Seekingcollabora,ontoexplorehitsanddevelopprogram

•  Hepa,,sBremainsasignificantunmetneedwithamul,-billiondollarmarket

Page 22: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

CommercialisaPonandPartnering

•  HIV-1Program-Significantvalueinflec,onpointsaroundHIV-1programdataexpectedin2017

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

•  Earlystagecollabora,onopportuni,esforpre-clinicaltargets,suchas:

•  Dengue

•  Hepa,,sB

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

•  Seekingpartnersforindividualtargetsoren,replalorm

Page 23: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

KeyMilestonesfor2017

•  CompleteAnaly,calTreatmentInterrup,on(ATI)StudyinHIV-1InfectedHumanisedMice-DataexpectedQ22017

•  Expectedoutcome(s)–Impactonkine7csofviralloaddecayincombina7onwithARTindica7ngimpactonunderlyingviralreservoir

•  CompletePhase2HIV-1Trial-Dataexpectedin3Q17

•  Expectedoutcome(s)–impactonviralkine7csincombina7onwithART,pluspoten7alimpactonreboundonceARTisstopped

•  FinalisearegionalpartneringagreementforBIT225forHCV

Page 24: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

InvestmentHighlights

PorfolioofpatentsandpatentapplicaPonsdirected to theCompany’s anP-viraldrugporfolio

STRONGINTELLECTUALPROPERTYPOSITION

TargePngviroporinproteinswitharapidscreeningproprietaryprimarybacterialcell-basedplaform-alibraryofover350compoundswithacPvityagainstarangeofviruses.

NOVELANTIVIRALPLATFORM

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

BROADANTIVIRALPIPELINE

Completed7humanClinicalTrialswithpromisingsafetyandefficacyoutcomes

ROBUSTCLINICALVALIDATION

Page 25: BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017...Biotron – Leader in Viroporin-Targeng Drug Development • Core exper,se is design and development of a new class of an,viral drugs

15 20

REPORT ANNUAL

BIOTRON

41

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