present ation to annual genera ng - biotron limited · add crede e the comm linical trial ed in the...
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20 Novemb The ManagASX Limit20 Bridge SSYDNEY Dear Mada
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In particular, I should single out Denis Wade for his enduring contribution and dedication to the Company since he joined the Board in 2010. For personal reasons, Denis steps down from the Board today. Denis' advice and insight have been of enormous value to me personally and to the entire Board. He departs with a mix of our regret and gratitude. I am relieved to report he won't be going far. Denis will retain an ongoing advisory role with the Company. I would now like to invite our CEO, Michelle Miller, to address the meeting.
Michael J. Hoy Chairman
ForwardLookingStatements
Thispresenta'onmaycontainforward lookingstatementswithrespecttothefinancialcondi'on, resultsandbusinessachievements/performanceofBiotronLimited (ACN086399144)andcertainof theplansandobjec'vesofitsmanagement.Thesestatementsarestatementsthatarenot historicalfacts.Wordssuchas“should”,“expects”,“an'cipates”,“es'mates”,“believes”orsimilar expressions,astheyrelateto Biotron Limited, are intended to iden'fy forward lookingstatements. By their nature, forward lookingstatements involve risk and uncertainty because they reflect Biotron’s current expecta'ons andassump'onsastofutureeventsandcircumstancesthatmaynot proveaccurate.Thereisnoguaranteethat the expected events, trends or results will actually occur. Any changes in such assump'ons orexpecta'onscouldcauseactualresultstodiffermateriallyfromcurrentexpecta'ons.
InvestmentHighlights
• Biotronisdesigning,developingandcommercialisingaplaUormofan'viraldrugswithanovelmodeofac'on–abletotargetawidevarietyofviralinfec'ons
• Pipelineofprogramsinhighvalue,highneedmarkets• Progressinclinicalleadprogram(BIT225)providesstrongvalida'onforen'replaUorm
BiotronLimited–SnapShot
BROADPLATFORMWITHNEWCLASSOFANTIVIRALDRUGS
HIV-1ERADICATION HBV&EARLYSTAGEPROGRAMSHEPATITISCVIRUS(HCV)
- Targe'ngHIV-1inlong-livedreservoirs
- Phase2trialinprogressduring2017;dosingcomplete
- NewclassofHCVdrug
- Phase2completed
- SeekingpartnershipsinChina
- Pipelineofearlystageprograms,including:
- Hepa''sBvirus
- Respiratoryviruses
- Flaviviruses(e.g.Dengue)
ROBUSTCLINICALVALIDATION–COMPLETED8CLINICALTRIALSWITH
STRONGSAFETY&EFFICACYOUTCOMES
KeyAchievementsFY2017
• CommencedPhase2clinicaltrialofBIT225andCombina'onAn'retroviralTherapy(cART)inFeb’17
• FullyrecruitedinJuly‘17;DosingwithBIT225/placebocompleted;datapending
• Demonstratedsignificantandacceleratedreduc'oninHIV-1viralloadfollowingaddi'onofBIT225inhumanisedmousestudyinFeb‘17
• IndependentNaturepublica'onvalidatedBiotron’sapproachoftarge'ngHIV-1inmacrophagesasakeystepinHIV-1eradica'oninMay’17
• AppointedLynxFinancialasCorporateAdvisorforChina–assis'ngwithexecu'ngHCVregionalpartneringstrategyinJune‘17
• Raised$1.56millionviarightsissueinJune‘17
• Received$1.6millionR&DtaxrefundinNov‘17(post-endofFY)
CommercialisaUon–KeyFocus
• Threetac'calpriori'es:• Partneringleadclinicalprogram-BIT225forHIV-1eradica'on
• Partneringoneormorepreclinicalprograms–e.g.HBV
• ExecutearegionallicensingdealinChina-HCVprogramremainsagreatopportunity
HIV-1EradicaUon
MarioStevensonScien.ficAmerican299,78-83(2008)
CurrentdrugsdonoteradicateHIV-1virus
WhyisHIV-1eradicaUonnecessary?• Long-termhealthimplica'onse.g.HAND,immuneac'va'on,etc• Costoftreatment
• ~$20billionp.a.worldwide• Majorburdenonhealthcaresystems
BIT225haspotenUaltobeusedincombinaUonwithotherdrugsto
eradicateHIV-1reservoirs
• HIV-1remainshiddeninreservoirs,leadingtochronic,life-longinfec'on• Invisibletobody’simmunedefenses• Notsensi'vetoan'-HIV-1drugs
• Newmodeofac'onsdrugsareneededtoeradicateorcureHIV-1infec'on
HIV-1EradicaUon:BIT225-009Trial
• 36HIV-1+ve,treatment-naïvesubjectscommencingART• Randomised2:1(drug:placebo)
BIT225orplaceboaddedtoART
• BIT225orplaceboaddedtoARTforfirst12weeksoftreatment• Read-out
• Impactonviruslevels;reduc'onofimmuneac'va'onmarkers• Fullyrecruited;completeddosingwithBIT225/placebo;infollow-upperiod(ARTalone)
HIV-1EradicaUon:BIT225-009Trial
• FullyrecruitedJuly;lastpa'ent,lastdoseinmid-October
• Threemonthfollow-upperiodpost-dosingwithBIT225/placebo
• Addi'onalsamplescollectedfrompa'entsthroughoutthisnext3monthperiod
• Post-triallaboratoryanalysesonsamplesfromtreatmentperiodareinprogress:
• VirologicalOutcomes
• ImmunologicalOutcomes
• Post-dosingsampledataalsorequiredtocompletetheanalyses
• E.g.Anyreboundorchangeinparametersoncedrugceased?
• Alldataisnecessarytodetermineoutcomeofthetrial
CommercialisaUon:BIT225HIV-1EradicaUon
• Severalpharmaceu'calcompanieshaveac'veHIV-1“Cure”Programs• Iden'fiedandqualifiedpoten'alpartners
• Posi'veoutcomes–BIT225clinicaltrial-keytoprogressingcommercialisa'ondiscussions
• Poten'alpartnershavedefinedtheirsuccesscriteria–wearealigned!
• Communica'ngtrialdataassoonasavailable
• Followupmee'ngswithpoten'alpartnerscon'nue
CommercialisaUon:PreclinicalPrograms–HBV
• Hepa''sBvirus(HBV)therapeu'cspacehassignificantinterestfrompharma&biotechcompanies
• Biotron’sHBVprogramiselici'ngearlyinterestfrompoten'alpartners
• Invitrodataonseveralcandidatecompoundsincludesevidenceofreduc'onofindustryrecognisedmarkers
• Novelmechanismisveryasrac'veincombina'onapproachestotreatmentofHBV
• ExpandsBiotron’spartneringopportuni'es–poten'alforearlystageco-development/collabora'onagreement
CommercialisaUon:RegionalLicensing–China,HCVProgram
• ThenewHCVdrugs(e.g.Solvadi)maycausereac'va'onofHBVinHCV/HBVcoinfectedpa'ents
• ResultedinUSFDA“BlackBox”WarningonnewHCVdrugs
• 30millionHCV-infectedpeopleinChina,comparedto3-5millioninUSA
• 93millionchronicallyinfectedwithHBVinChina,comparedto2.2millioninUSA
• HighHCV/HBVco-infec'onrateinChina(es'matedtobe10million)
• Reac'va'onofHBVinpeopleundergoingHCVtreatmentwiththesenewHCVdrugshaspoten'altobeamajorhealth&economicissueinChina
• BIT225hasbeenshowninclinicaltrialstosignificantlyimproveclinicaloutcomeinHCVGT1-infectedpa'entsincombina'onwithInterferon&Ribavirin(IFN/RBV)
• IFN/RBVhaveseveralpoten'aladvantagesovernewHCVdrugsinsomesevngs
• IFN/RBVissignificantlycheaperthanthenewHCVdrugs
• HBVreac'va'onislesscommonandlesssevereinHCV/HBVco-infectedpa'entswithIFN/RBV
• Seekingpartnershipsforcommercialisa'onofBIT225forthetreatmentofHCVinChina
• AppointedaShanghai-basedcorporateadvisorwithextensiveexperienceincross-border
transac'onsinthehealthcarespace
• Developedawellqualifiedprospectlist
• Presentedtopoten'allicensees–allwithcapacitytofinalisecommercialdevelopmentand
launchofBIT225inChina
• Discussionsareon-going
CommercialisaUon:RegionalLicensing–China,HCVProgram
UnlockingValueforOtherVirusTargets
Libraryofcompoundsdesignedtotargetviroporinsfoundinsomeviruses:Ini'ally>250compoundsdesignedandsynthesised;librarynow~350OTHER“HITS”INLIBRARYinclude:• InfluenzaAandB• Hepa''sBvirus(HBV)• Coronaviruses(IncludingSARS)• Epstein-Barrvirus(EBV)• Zikavirus• others
X-axis:compoundIDY-axis:virusZ-axis:strengthofhit
UnlockingValueforOtherVirusTargetsBiotron’sViroporinapproachenablesthetarge'ngofawiderangeofviraldiseases;examplesinclude:• RespiratoryVirusessuchasRespiratorySyncy'alVirus(RSV),Influenza,&Coronaviruses(leadingcauseof
“commoncold”)• FlavivirusessuchasZikaVirusandDengue• TransplantvirusessuchasBKvirus• EpsteinBarrvirus(EBV)-par'cularinterestinAsiawhereitiscausa'veagentofNasopharyngeal
Carcinoma
Biotron’sViroporinplacormhasthepotenUaltobecomeanimportanttoolinthe
developmentofanUviraltherapies
PotenUalforestablishingearlystagecollaboraUonswithpharmaceuUcalcompaniesuUlisingBiotron’sapproach
Summary
• HIVEradicaUon• Engagedwiththerightpoten'alpartners• Wai'ngfordatafromtrialbutcon'nuetoengagewithpharma
• PreclinicalPrograms• HBVhaspromiseasapreclinicalcandidateforjointdevelopment.HBVtherapeu'cspaceisveryhot.• BIT225resultsvalidatetheplaUorm;poten'altofacilitatefundeddevelopmentsbypartnersfor
“other”viraldiseases• RegionalLicensing
• HCVinChinaremainsasignificantdevelopmentopportunity–“cost-conscious”marketcombinedwiththehighrateofco-infec'onHCV&HBVrequiresdifferentapproachthanusedintheUSA
Successinanyorallofthesestrategieswillbea“companymaker”increasingthevaluefor
Biotronstakeholders