For personal use only - Australian Securities Exchange · Populations (2016)1 Vet Care Expenditure...

InvestorPresentation(August2017)

ASX:PAAACN094006023

PharmAustInvestorPresentation(Aug2017) 1

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DisclaimerDISCLAIMERThis presentation has been prepared by PharmAust Limited (ASX: PAA) (ACN: 094 006 023) (the “Company”). It does not purport to contain all the information that a prospectiveinvestor may require in connection with any potential investment in the Company. You should not treat the contents of this presentation, or any information provided in connectionwith it, as financial advice, financial product advice or advice relating to legal, taxation or investment matters.No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness orreasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection withit, or any omission from this presentation, nor as to the attainability of any estimates, forecasts or projections set out in this presentation.This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your ownindependent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at anytime in its absolute discretion (without incurring any obligation to do so).Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entityarising out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and InvestmentsCommission Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding provision of any Australian state or territory legislation (or the law of anysimilar legislation in any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expresslydisclaimed and excluded.Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should notbe used in isolation as a basis to invest in the Company.FUTURE MATTERSThis presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company. Those intentions, expectations, future plans, strategyand prospects may or may not be achieved. They are based on certain assumptions, which may not be met or on which views may differ and may be affected by known and unknownrisks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside the control of the Company. No representation orwarranty, express or implied, is made by the Company, or any of its directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved eithertotally or partially or that any particular rate of return will be achieved.Given the risks and uncertainties that may cause the Company’s actual future results, performance or achievements to be materially different from those expected, planned orintended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that theactual results, performance or achievements will be as expected, planned or intended.US DISCLOSUREThis document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of any “USperson” as defined in Regulation S under the US Securities Act of 1993 (“Securities Act”). The Company’s shares have not been, and will not be, registered under the Securities Act orthe securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States or to any US person without being so registered orpursuant to an exemption from registration including an exemption for qualified institutional buyers.


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CorporateStructure

PharmAustInvestorPresentation(Aug2017)

PitneyPharmaceuticalsEpichem

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CorporateOverview

• PharmAust:Clinical-stageoncology company

• LeadproductisMonepantel (MPL)– arepurposeddrugalreadyapprovedforVeterinaryuse

• PharmAust patentedMPL asanovelanticancerdrug

• UniqueclinicalstrategytargetingMPL forbothhumanandvetapplications

• OptionAgreementwithNovartisAnimalHealth/Elancoforveterinarycancerapplications

• Epichem:profitablebusiness,forecastrevenuesof$4min2018FY


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CorporateSnapshot

1.Asof30June,20172.EFICloantoEpichem:Mar31,2017

ASX Code: PAA

MarketCap $10M

Cash1 $2.59M

Debt2 $0.5

Epichem Revenue $3.05M(FY17)

Total Shares onIssue 146,694,903

Options (Unlisted) 42,547,078

Top 20Own 35%

Board/ExecOwn 13%


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ExperiencedBoard&ManagementTeamDr.RogerAston,ExecutiveChairman

• >20yearsexperienceinthepharmaceuticalandhealthcareindustries.

• Directororchairmanonanumberofboardscarryingoutlatestagedrugdevelopment

• LargestShareholder

RobertBishop,ExecutiveDirector• >30yearsexperienceincorporatefinanceandequitycapitalmarkets

• Lawyerandaninvestmentbanker• Secondlargestshareholder


DrRichardHopkins,CEO• >15yrs biotechexperienceinDrugDiscoveryand

Development• ExecutiveexperienceinASXcompanies

Dr.WayneBest,Director• 30yearsexperienceinsyntheticandmedicinalchemistryinacademiaandindustry.•MDofPharmAust’ssubsidiaryEpichem.

SamWright,Director&CompanySecretary• 20yearsexperienceinthebiotechandhealthcare.• Experiencedinlistedcompanies,corporate

governanceandcorporatefinance.

DrRichardMollard,CSO• >15yrsbiotechexperienceinseniorscientificroles• Broadrangeofbiotechexpertiseinexecutive &

consultingrolesinc.regulationanddevelopment

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RepurposingMPLforacceleratedpathtocommercialreturns


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DrugRepurposing=Capitalefficientpathtomarket

Discovery Preclinical PhaseI Phase2 Phase3 FDA Market

3-6yrs 6-7yrs 0.5-2yrs

TypicalDrugDevelopmentPhases

10+yrs.~$1-2billion

Drugrepurposing/repositioning

3-5yrs.~$2-5million

Drugrepurposing/repositioning

6yrs.~$300million


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ValuecanbeunlockedearlyindevelopmentcycleDiscovery Phase1 MarketPreclinical Phase2 Phase3

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Preclinical Phase1 Phase2 Phase3

Averageupfronthumanoncologylicensingdealvaluesatdifferentdevelopmentstages(US$millions)

AvUpfrontsPayments- 2014($m)


(2016).TheDeloitteRecapOncologyDealMakingandDevelopmentTrendsReport2008-2012(pp.1–51).

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MonepantelOncologyProgramme:

Progressingtowardskeyclinicalandcommercialcatalysts


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MPLtargetsthemTOR pathway:commontomanycancersTwocomplexesofmTOR

(mammaliantargetofrapamycin)

Saxton,R.A.,&Sabatini,D.M.(2017).mTOR SignalinginGrowth,Metabolism,andDisease.Cell,168(6),960–976.

mTORC1 mTORC2

s6K 4EBP Akt

eIF4E

CellGrowth CellProliferationCellSurvival

CANCER!Increased

Expression


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>$2BillionmarketforapprovedmTOR DrugsDrug Approved Indications Company 2016Sales

(US$m)1

Sirolimus Transplantation Pfizer 170

Rapalogues(Affintor/Torisel)

TransplantationRenal CellCarcinomaBreastCancerPancreaticNeuroendocrineTumoursMantleCellLymphoma

Novartis/Pfizer >2,000

1.GlobalData


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PharmAust’sstrongMPLpatentposition

• >47patentsandpatentapplications

• 5patent families

• Granted patents inUS,Aus,China,NZand Europe

• Broad 'method ofuse’forMPLacross cancer andnon-cancer applications

• JointportfolioofMPLanalogues (composition of matter)with Nihon Nohyaku


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WhyMPLforCancer

MPLApprovedforAnimalHealth

ComprehensivePreclinicalData-pack(potentandsafe)

Invitro:MPLkillswiderangeofcancercelllines

Invivo:MPLmonotherapyinhibitstumours inmicexenografts(pancreatic,ovarian,colorectal)

Invivo:MPLcombinedwithfront-linedrugsimprovespotencyinmousexenografts(ovarian)

Toxicology:4species(mice,rats,sheep,dogs)

Pharmacology:(mice,sheep,dogs)

PhaseI/IIclinicaldataindogsshowingsafety,suppressionofcancerbiomarkersandefficacy

PhaseIclinicaldatainhumansshowingsafety,suppressionofcancerbiomarkers


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Recentclinicaloutcomespromotecommercialopportunities

PhaseIIpilotlymphomatrialindogsMPLusedasfront-linetherapy

• 1st reportofMPLclinicaltumourinhibition

• 1st reportmTOR druginhibitingLymphomaindogs

PreliminaryResults:¾(75%)treateddogsshowedstablediseaseandtumourreduction

PharmaOptionagreement


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1. Safety: Excellentsafetyprofileindogs&manaspredictedbypre-clinicalmodels

2. Efficacy: Observedreductionofkeycancerbiomarkers(p70s6Kandp4E-BP-1)andreductionintumours indogs(3/4)diagnosedwithlymphoma

3. Activedose:IdentifiedactivedoseofMPLinmanusingbiomarkers

4. Synergy: Demonstratedsynergyinpreclinicalmousemodelwithcurrentstandardofcarecytotoxicdrugs

MPLAchievedKeyPreclinicalandPhaseIClinicalEndpoints


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StrategytodevelopMPLasaCancerTherapeuticfor:

- VeterinaryHealth- Humans


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Rationalefordualclinicaldevelopmentstrategy


70%oncologydrugsfailinclinicaltrialdueto:• PoorEfficacy• PoorSafety

TraditionalDevelopmentPath

MouseCancerModel HumanClinicalTrial

MouseCancerModel DogCancerModel HumanClinicalTrial

DogcancerverysimilartohumancancerCancer5Xmorecommonindogs

Dogmodelmorepredictivethanmouse

Mousecancermodelsoftenpoorpredictorsofdrugactivityinhumans

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RationalefordualclinicaldevelopmentstrategyVetOncologyDevelopment

EfficacyPharmacologyBiomarkersCombinationtherapy

HumanOncologyDevelopment

ClinicalDevelopment

EstablishedMarket:RepurposedDrugs

Early-MidCommercialisationOpportunities

ClinicalDevelopment

PreclinicalModels

Later-stageHigher-ValueCommercialisation Opportunities

Generateshighqualitypreclinicaldata-pack

CanineOutcomesInformsHumanClinicalDevelopment


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TrendsinCompanionAnimalHealthMarket(US:2016)

1.http://www.americanpetproducts.org/press_industrytrends.asp

USDog/CatPopulations(2016)1

VetCareExpenditure$17b1

2.CompetitioninthePetMedicationsIndustry(2015)

Petdrugmarket$10.2bby20182(8%CAGR)

TotalPetExpenditure:$70b1

Willingnesstopaymorefortreatment3($2K-$5K/treatment)

$

90m94m

3.AP-Petside.com Poll,conductedbyGfK RoperPublicAffairsandMedia:April7-12,2010


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PetsandCancer● 1in4dogsdieofcancer

● Petsarelivinglonger(50%dogs>10yrsdieofcancer)

● 6milliondogsdiagnosedwithcancerinUS/yr

● Significant unmetneedfor new oncologydrugs($500m-$1bmarket)

● Vet therapeuticmarketdominated by repurposeddrugsalreadyapprovedforuseinhumansand/oranimals(eg.MPL)


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MultipleoptionsforMPLindogLymphomamarket


Diagnosis($2K)

Maintenance/PFS

MPL

Relapse

Remission/PFS(80%)

MaintenancePFSMPL

Maintenance/PFS

MPL

MPL

200K/YrLymphomainUS

PFS:ProgressionFreeSurvival

GeneralVetPractitionerMarket

NicheVetOncology

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AnimalHealthCommercialisation Strategy:TargetGeneralVetPractitionerMarket

● Monepantel:MeetsrequirementstotargetVetGeneralPractisemarket

● Monepantelcanbedeliveredorally,isnon-toxic(safe)andamenabletodailydosing

● Targetvetsinmajormarkets:US(90K+)andEurope(243K).

● NeedtoestablishclinicalefficacyforMPL(ProgressionFreeSurvival,TumourReductionetc)!!

● CompetingOncologyDrugs:

● Oftenrequirespecialhandling,storageandexpertiseduetotoxicity

● VeterinaryOncologistsoftenrequiredformorecomplicatedtherapies/treatmentregimens

● Only400VeterinaryOncologistsinUS=nichemarket.


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Epichem


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AboutEpichem

● SpecialistSynthetic&MedicinalChemistryServices

● HighlyawardedWest.Aust.Company(Founded2003)

● Staffof23(15PhD's)

Revenues

DrugDiscovery&TechnicalServices

- FeeforServiceConsultancy- CustomSynthesis- HittoLeadValidation/Optimisation- Trackrecordinclinicaldrugdevelopment

FineChemicalsCatalogue

- Highmarginsupplyofreferencestandards- ISO9001:2015Certification

ProprietaryDrugDiscoveryPlatform

- Enginetoreplenishdevelopmentpipeline


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Epichem Revenues

$0

$1,000,000

$2,000,000

$3,000,000

$4,000,000

$5,000,000

2008-09 2010-11 2012-13 2014-15 2015-16 2016-17 2018-19 2020-21

Revenues

Revenues

Phase1LabExpansion

Phase2LabExpansion

$6.2m

$4.3m

Record$3.05mrevenuesachievedin2017FY


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KeyDriversforEpichemGrowth

• Planned Phase2LabExpansionincreasescapacitytomeetdemand

• Pursuing ISO17025/34 accreditation – highest ‘calibration and testing’stds.

• Facilitatesexpansionofhighmargincatalogue business

• LowerAustralianDollarmaintains globalcompetitiveness

• Epichem:profitablebusiness,forecastsalesof$4min2018(>25%CAGR)


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NextStepsandRoadmap


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Q4

Q3/Q4

Q2-Q4

Q4

KeyDriversfor2017

CompleteMPLReformulation

CompletePhaseIILymphomaTrialinDogs

GrowthofEpichemBusiness

ProgressNovartis/ELANCOOption

InitiatePhaseIIClinicalTrialinDogsusingreformulatedproduct Q4


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ReformulationtoresolveMPLpalability

Reformulationachieves3strategicoutcomes:

• OvercomefoultasteofZolvix whichhasresultedinsignificantcomplianceissues.

• IncreasedoseofMPL/capsuleupto10-fold(ie.250mg/capsule)

• Establishoptimalformulation/manufactureprotocolsforallclinicaldevelopmentphases. Requiredtomaximisecommercialvalue.

Scaledproductionforclinicaltrial

GMP-grademanufacture

Reformulate

Pills/Capsules

MPL25mg/ml

Gelatinencapsulation

MPL250mg/tabletTaste⇧

2017


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Discovery

PharmAust’s TherapeuticPipeline


Compound Preclinical Phase1 Phase2 Phase3Screening

SolidTumours

Non-Cancer

SolidTumours (Dogs)

Lymphoma(Dogs)

NovelPAA1analogues

PAA1

PAA1

PAA1

PAA1

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Petmarketvaluecomparators(2017)


Nexvet:AcquiredbyZoetis(Pfizer)forUS$85m@66%premiumtoclosingshareprice

Oasmia Pharma:Spunout2Vetassetstowholly-ownedsubsidiaryvaluedatUS$75-80mAssetsincludeDoxphos (reformulateddoxorubicin)andPaccal Vet(reformulatedPaclitaxel)forcompanionanimals

Aratana Therapuetics :LicensedGalliprant toElancoforUS$45mupfront/$83mmilestones

Galliprant:Registeredforpainincompanionanimals

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AustralianPeerCompaniesCompany Description MarketCap($Aus)1

AntaraLifesciences(ASX:ANR)

Animal/HumanHealth Antimicrobial(Detach)Revenues 2017FY$1m,EBITDA-3.4m $47m

NationalVetCare(ASX: NVL) Consolidated VetPractices $127m

Apiam AnimalHeath(ASX:AHX) Consolidated VetPractices $63m

MaynePharma(MYX:PTX) Reformulated/repositioned approveddrugs $1,002m

PrescientTherapeutics(ASX:PTX)

Phase 1/IInoveltargetedtherapeuticforhumancancers $11m


1:21st August2017

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GlobalPeerAnimalHealthCompaniesCompany Description MarketCap($US)1

Zoetis(NASDAQ)

Worldslargestdiversifiedanimalhealthcompany $29b

AB-Science(Euronext)

Masitinib forhuman(Ph3)andpetcancers(Registered).ValidatesPAAmodelofdevelopingonedrugformultiplemarketsinhumanandanimalhealth.

$483m

KindredBio(NASDAQ)

Repurposedbiologics/smallmoleculesforanimalhealth $196m

AntaraTherapeutics(NASDAQ)

Diversifiedanimalhealth $274m

Oasmia Pharmceuticals(NASDAQ)

Diversified/ Repurposedhumanandanimalhealth $40m

VetDC Companion animalcancers Private


1:21st August2017

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PharmAust’s ValueProposition• $10mMarketCap=EnterpriseValue(revenue+cash+phaseIIreadyasset)

• Developingasingleproduct formultiplemarketsinhuman&animalhealth.

• Validatedmodel:Lowercosts/developmentrisks,acceleratespathtomultiple valueaccretioncatalysts

• NovartisAnimalHealth/ELANCO Option - strategicaccesstovethealthmarketwithglobalheavyweight.

• Granted patentsforcancer andnon-cancer – createslicenseopportunitiesinmultiple markets

• Epichem:profitablebusiness,forecastsalesof$4min2018(>25%CAGR)


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[email protected]:+61(0)405656868

Dr [email protected]:+61(0)402762204

ASX:PAAACN094006023

PitneyPharmaceuticalsEpichem


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