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Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: [email protected] Website: www.biotron.com.au 13 January 2017 The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000 (26 pages by email) Dear Madam BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE TM 2017 CORRECTED PRESENTATION Biotron Limited advises that Dr Michelle Miller, Managing Director, will be giving the attached presentation to the Biotech Showcase TM 2017 Conference being held this week in San Francisco, California, USA. In addition, Dr Miller will give briefings to USA institutional investors and pharmaceutical company representatives as part of activities surrounding the annual JP Morgan Healthcare Conference. This is one of the most important annual healthcare investor conferences, attracting thousands of healthcare and life science business executives, as well as investors and analysts, to San Francisco. The Biotech Showcase TM features corporate presentations by innovative life science companies to an audience of public and private investors, business development executives and professional advisors who are interested in investment opportunities and collaborations. Now in its ninth year, it expects to attract upwards of 2,800 attendees. Yours sincerely Peter J. Nightingale Company Secretary pjn8740 For personal use only

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Page 1: Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 ...2017/01/13  · Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au

 

Level 2, 66 Hunter Street Sydney NSW 2000

Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333

E-mail: [email protected] Website: www.biotron.com.au

13 January 2017 The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000 (26 pages by email) Dear Madam

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASETM 2017

CORRECTED PRESENTATION Biotron Limited advises that Dr Michelle Miller, Managing Director, will be giving the attached presentation to the Biotech ShowcaseTM 2017 Conference being held this week in San Francisco, California, USA. In addition, Dr Miller will give briefings to USA institutional investors and pharmaceutical company representatives as part of activities surrounding the annual JP Morgan Healthcare Conference. This is one of the most important annual healthcare investor conferences, attracting thousands of healthcare and life science business executives, as well as investors and analysts, to San Francisco. The Biotech ShowcaseTM features corporate presentations by innovative life science companies to an audience of public and private investors, business development executives and professional advisors who are interested in investment opportunities and collaborations. Now in its ninth year, it expects to attract upwards of 2,800 attendees. Yours sincerely

Peter J. Nightingale Company Secretary pjn8740 

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BIOTRONLIMITED(ASX:BIT)BiotechShowcase2017

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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.

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InvestmentHighlights

•  Developingnewclassofan,viraldrugs

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

•  Phase1/2atrialscompletedinover200subjects–safetyandefficacyvalidated

•  Severalnearterm,value-addingmilestonesdrivenbytwokeyHIV-1studiesin2017:

•  BIT225treatmentinterrup,onstudyandBIT225Phase2HIV-1humantrialFor

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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

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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

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Viroporins

•  Smallhydrophobicproteinswithion

channelac,vity•  Formhydrophilicporesinhostcell

membranes•  Keystagesoftheviralcyclesuchasvirus

uncoa,ng,transportandmatura,onareion-influencedprocessesinmanyviralspecies

•  Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles

•  IdealtherapeuPctargetsNatureReviewsMicrobiology10,563-574

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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

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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:strengthofhitF

or p

erso

nal u

se o

nly

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Biotron-AdvancedPipeline

INDICATION

COMPOUND

DISCOVERY PRECLINICAL PHASE1 PHASE2 PHASE3

HCV BIT225

HIV-1 BIT225

NextgeneraPon-HCV

BIT314

Dengue Leads

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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)

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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

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•  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

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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

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HIV-1ViralDynamics

BIT225-009 Hu-MouseATI

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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.

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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

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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

-  BIT225increasestherateatwhichHCVisclearedincombinaPonwithotherdrugsFor

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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

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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

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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

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HepaPPsBVirus

•  LimitedscreeningofBiotroncompoundlibraryhasgeneratedinteres,ngdata

•  Hitsiden,fied

•  Veryexperiencedscien,ficadvisoryandopera,onalteaminplaceforHBV

•  Seekingcollabora,ontoexplorehitsanddevelopprogram

•  Hepa,,sBremainsasignificantunmetneedwithamul,-billiondollarmarket

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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

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KeyMilestonesfor2017

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

•  Expectedoutcome(s)–Impactonkine7csofviralloaddecayincombina7onwithARTindica7ngimpactonunderlyingviralreservoir

•  CompletePhase2HIV-1Trial-Dataexpectedin3Q17

•  Expectedoutcome(s)–impactonviralkine7csincombina7onwithART,pluspoten7alimpactonreboundonceARTisstopped

•  FinalisearegionalpartneringagreementforBIT225forHCV

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InvestmentHighlights

PorfolioofpatentsandpatentapplicaPonsdirected to theCompany’s anP-viraldrugporfolio

STRONGINTELLECTUALPROPERTYPOSITION

TargePngviroporinproteinswitharapidscreeningproprietaryprimarybacterialcell-basedplaform-alibraryofover350compoundswithacPvityagainstarangeofviruses.

NOVELANTIVIRALPLATFORM

ClinicalandPreclinicalprogramsinindicaPonswithhighunmetclinicalneedorlargepaPentpopulaPonssuchasHIV-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

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