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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 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
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se o
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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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