drugset / Press release

Investor Presentation

2017-09-13 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗

1 Investor presentation Broker Meets Biotech September 2017 Disclaimer 2 SomeoftheinformationinthispresentationmayrefertoDimerixLimited(“Dimerix”orthe“Company”)basedoninformationavailabletoitasatthedateofthispresentation.The informationinthispresentationisprovidedinsummaryformanddoesnotcontainallinformationnecessarytomakeaninvestmentdecisionregardingDimerix. Thispresentationdoesnotconstituteanoffer,invitation,solicitationorrecommendationwithrespecttothepurchaseorsaleofanysecurityinDimerix,nordoesitconstitutefinancial productadviceortakeintoaccountanyindividual’sinvestmentobjectives,taxationsituation,financialsituationorneeds.Aninvestormustnotactonthebasisofanymattercontained inthispresentationbutmustmakeitsownassessmentofDimerixandconductitsowninvestigations.Beforemakinganinvestmentdecision,investorsshouldconsiderthe appropriatenessoftheinformationhavingregardtotheirownobjectives,financialsituationandneeds,andseeklegal,taxationandfinancialadviceappropriatetotheirjurisdiction andcircumstances.Dimerixisnotlicensedtoprovidefinancialproductadviceinrespectofitssecuritiesoranyotherfinancialproducts.Coolingoffrightsdonotapplytothe acquisitionofDimerixsecurities. Althoughreasonablecarehasbeentakentoensurethatthefactsstatedinthispresentationareaccurateandthattheopinionsexpressedarefairandreasonable,norepresentation orwarranty,expressorimplied,ismadeastothefairness,accuracy,completenessorcorrectnessoftheinformation,opinionsandconclusionscontainedinthispresentation.Tothe maximumextentpermittedbylaw,noneofDimerix,itsofficers,directors,employeesandagents,noranyotherperson,acceptsanyresponsibilityandliabilityforthecontentofthis presentationincluding,withoutlimitation,anyliabilityarisingfromfaultornegligence,foranylossarisingfromtheuseoforrelianceonanyoftheinformationcontainedinthis presentationorotherwisearisinginconnectionwithit. TheinformationpresentedinthispresentationissubjecttochangewithoutnoticeandDimerixdoesnothaveanyresponsibilityorobligationtoinformyouofanymatterarisingor comingtotheirnotice,afterthedateofthispresentation,whichmayaffectanymatterreferredtointhispresentation. Thedistributionofthispresentationmayberestrictedbylawandyoushouldobserveanysuchrestrictions. Forwardlookingstatements ThispresentationcontainscertainforwardlookingstatementsthatarebasedontheCompany’smanagement’sbeliefs,assumptionsandexpectationsandoninformationcurrently availabletomanagement.Suchforwardlookingstatementsinvolveknownandunknownrisks,uncertainties,andotherfactorswhichmaycausetheactualresultsorperformanceof Dimerixtobemateriallydifferentfromtheresultsorperformanceexpressedorimpliedbysuchforwardlookingstatements.Suchforwardlookingstatementsarebasedonnumerous assumptionsregardingtheCompany’spresentandfuturebusinessstrategiesandthepoliticalandeconomicenvironmentinwhichDimerixwilloperateinthefuture,whichare subjecttochangewithoutnotice.Pastperformanceisnotnecessarilyaguidetofutureperformanceandnorepresentationorwarrantyismadeastothelikelihoodofachievementor reasonablenessofanyforwardlookingstatementsorotherforecast.Tothefullextentpermittedbylaw,Dimerixanditsdirectors,officers,employees,advisers,agentsand intermediariesdisclaimanyobligationorundertakingtoreleaseanyupdatesorrevisionstoinformationtoreflectanychangeinanyoftheinformationcontainedinthispresentation (including,butnotlimitedto,anyassumptionsorexpectationssetoutinthepresentation). Investment highlights Dimerix Limited (ASX:DXB) 3 1.Using proprietary “Receptor HIT”drug discovery platform to identify multiple development programs 2.Lead program is DMX-200 in Phase 2 human trials for Chronic Kidney Disease •Using compounds that are already known 3.Positive Phase 2a results –safety met and efficacy encouraging 4.Orphan Drug development path for DMX-200, targeting Focal Segmental Glomerulosclerosis (FSGS) enables a faster path to market 5.Strong near term news flow –presentation of DMX-200 Phase 2a detailed data on 2ndNovember 2017 at American Society of Nephrology (ASN) annual meeting Corporate overview Corporate Snapshot Major Shareholders 4 ASX Code: DXB Share Price (01 Sep 17): $.010 Market cap: $18.3m Cash (30 Jun 2017): $2.2m (R&D Tax incentive approx$540K during 2017) Shares on issue*: 1,829.9m Mr Peter Meurs 17.33 Yodambao Pty Ltd 5.11 Mrs Wishney Sritharan Krishnarajah 2.47 White Family 2.21 SRV Custodians Pty Ltd 2.07 Pfleger Family 1.70 Jampaso Pty Ltd (Williams Family) 1.51 * Unlisted Performance Shares: 75.0m; Options (expire 31 Dec 2017): 17.9m; Options (ESOP): 56.6m Share price history 0.01 0.02 0.00 Corporate history 5 2004 -2014 -Dimerix spun out of UWA 2004 2004 -2014 -Pre-clinical and proof of concept laboratory work -March 2014 COO appointed 2015 -2017 2015 -Listed on ASX -First patient enrolled DMX-200 Phase 2a -Orphan drug designation -AU and US patents granted 2016 -Kathy Harrison appointed CEO -Positive FDA meeting -Interim Phase 2a data announced -Enrolment in Phase 2a complete -Start commercial reformulation 2017 -Head of Drug Development appointed -Japanese patent granted -Engaged international clinicians -Phase 2a data announced -Phase 2b trial to commence Hugh Alsop –Director •Accomplished and commercially-focused pharmaceutical and biotechnology executive •Responsible for successful global commercialisation programs and NDA registrations David Franklyn –Director •Experienced Director of ASX-listed companies in a variety of sectors •Extensive experience in financial analysis, corporate advice, business management and IR Dr Sonia Poli–Director •Former Senior Management at Hoffman la Roche and Executive at Addex Therapeutics •20 years international experience in small molecule drug development Experienced board and management 6 Dr James Williams –Chairman •Co-founder of Dimerixand iCeutica (acquired in 2011 and now with 3FDA drug approvals) •Co-founder and Investment Director of Yuuwa Capital ($40M venture fund) Kathy Harrison –Chief Executive Officer •20 years operational and strategic experience in drug development including at AMRAD, Cytopia Research Pty Ltd, Phosphagenics Ltd •Registered Patent Attorney Dr Robert Shepherd –Head of Drug Development •Drug developer with experience in a wide range of projects / therapeutic areas •PhD in biomedical research, and background in finance and project management Chronic kidney disease (CKD) -market opportunity •CKD is a global health problem affecting over 10% of the population with 26 million patients in the US alone •Growing in incidence due to large number of people living with obesity and diabetes •CKD gets progressively worse, with patients whose kidneys fail requiring dialysis or kidney transplant •Hemodialysis treatment costs an average of $89,000 per patient annually in the United States •Independent analysts estimate FSGS* drug sales to be worth USD $1 billion per annum in the US alone 7 * Focal Segmental Glomerulosclerosis Source: U.S.Renal Data System,USRDS2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States,NIH, NIDDK Source: Global Burden of Disease Study 2013 Current treatments for CKD •Damaged kidneys “leak”proteins into the urine. This is called proteinuria and is the most common symptom of kidney disease –relevant measure of treatment efficacy (a prognostic indicator of future kidney damage). •First line therapy is reducing blood pressure using angiotensin receptor blockers (such as irbesartan) or ACE inhibitors. •In some types of kidney disease, including FSGS, patients are given a cocktail of drugs including immunosuppressantsand steroids such as Prednisone, which have serious and unpleasant side effects •There is a huge unmet medical need for a safe treatment which can significantly reduce proteinuria and prolong the life of the kidney 8 Will in remission Relapse from nephrotic syndrome DMX-200 –Dimerix lead program for CKD 9 •DMX-200 is a tablet which is taken in conjunction with existing medications. •DMX-200 is being developed as an ‘adjunct’ therapy, avoiding complications of combination therapy development. •Patients continue taking their standard of care medication (irbesartan) and add a second drug to this (propagermanium), a CCR2 antagonist. •Both drugs have been in use for many years, and their safety profile is well understood. Trial design •27 patients in open label dose escalation study across 4 sites in Australia •Patients were on stable irbesartan prior to and throughout the study. •Patients additionally received an oral dose of propagermanium •Propagermanium dose escalated at four week intervals, unless proteinuria was within normal limits. DMX-200 phase 2a trial outcomes 10 •Primary end point met –no serious safety or tolerability concerns observed when DMX-200 used as an adjunct to standard of care drug, irbesartan“ •Secondary end point –showed encouraging efficacy 6 of 24 patients achieved >50% reduction in proteinuria levels and were classified as “responders” using pre defined criteria (patients who completed the study) •Physicians consider result clinically meaningful •T op line data released in July 2017, detailed bottom line data to be presented on 2ndNovember in the American Society of Nephrology (ASN) •Phase 2b trial design to start later this year to use a placebo controlled (narrower patient population and dose selection) Post-hoc: 11 of 24 patients completing the study requested and were granted access to continue using DMX-200, under TGA’s Special Access Scheme. After dosing ceased, three patients saw a return to higher proteinuria levels (increase of 50% or greater), suggesting that DMX-200 may have had a possible benefit in slowing the disease progression in these patients. * N Engl J Med (2001) 345:870-878 September 20, 2001 DOI: 10.1056/NEJMoa011489 Nephrol Dial Transplant (2012) 27: 2255–2263 December 15, 2011 DOI: 10.1093/ndt/gfr696 DMX-200 Trial 100% 0% Irbesartan: 24 –38% reduction* (current standard of care) DMX-200: further 50% reduction Next steps and newsflow 11 •Human pharmacokinetics study with extended release formulation on track to complete 2H CY2017. •Detailed Phase 2a data to be released on 2ndNovember 2017 in the Annual meeting of the American Society of Nephrology (ASN). •Phase 2b –to explore efficacy in refined patient population using optimal doses identified in Phase 2a study, compared with placebo. •Ongoing discussions with big pharma and key opinion leaders. •Filing Orphan Drug designation in Europe (2018) •Meetings with European Regulatory Advisors (2018) Investment highlights Dimerix Limited (ASX:DXB) 12 1.Using proprietary “Receptor HIT”drug discovery platform to identify multiple development programs 2.Lead program is DMX-200 in Phase 2 human trials for Chronic Kidney Disease •Using compounds that are already known 3.Positive Phase 2a results –safety met and efficacy encouraging 4.Orphan Drug development path for DMX-200, targeting Focal Segmental Glomerulosclerosis(FSGS) enables a faster path to market 5.Strong near term news flow –presentation of DMX-200 Phase 2a detailed data on 2ndNovember 2017 at American Society of Nephrology (ASN) annual meeting Contact Kathy Harrison Chief Executive Officer +61 419 359 149 [email protected] Dimerix Limited ACN 001 285 230 www.dimerix.com

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