Slide 1: A clinical-stage drug development company: Corporate Update
For personal use only A clinical-stage drug development company Corporate Update Kathy Harrison General Manager July 2016
Slide 2: Disclaimer
Disclaimer For personal use only This presentation has been prepared by Dimerix Limited (“Dimerix” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessa
Slide 3: Quick overview
Quick overview For personal use only Key Assets Corporate Snapshot Who we are: A clinical-stage drug development ASX Code: DXB company focused on commercialising new Share Price (29 Jul): $.011 therapeutic treatments identified using our Market cap: $16.20m proprietary drug discovery platform. Cash
Slide 4: DMX-200 Orphan Development Pathway – FDA Pre-IND Highlights
DMX-200 Orphan Development Pathway – FDA Pre-IND Highlights For personal use only DMX-200: Phase 2 and IND • Pathway to IND for one comparative PK (Extended release formulation) • Recognition of potential value Australian Phase 2 trials for safety and suggestions to optimise the value of the data to
Slide 5: The Dimerix drug paradigm
The Dimerix drug paradigm For personal use only G Protein Coupled Receptors (GPCRs) •≈ 50% of all approved drugs act through GPCRs • Act as single units (monomers) or in complexes (heterodimers) New GRCR A Drug B pharmacological GPCR A GPCR B target Signal A Signal B Signal C •Dimerix owns Receptor-
Slide 6: Dimerix lead program – Why kidneys?
Dimerix lead program – Why kidneys? Chronic Kidney Disease (CKD) – the big opportunity For personal use only • A global unmet medical need leading to kidney failure, cardiovascular disease and premature death. • Currently affects an estimated 26 million people in the US • Est. $2.6 billion spent in
Slide 7: DMX-200 – Why kidneys?
DMX-200 – Why kidneys? For personal use only Dimerix identified DMX-200 using Receptor-HIT: Irbesartan Propagermanium (Irb) (PPG) AT1R CCR2 Off-patent blockbuster Available for use as an anti- treatment of high blood pressure inflammatory agent – CCR2 mediated Significant reduction in proteinurea •
Slide 8: Market interest in CKD treatments
Market interest in CKD treatments For personal use only • Acthar gel (injection only, steroid) • Phase I asset for treating kidney • Completed Phase II for CCX140 fibrosis in diabetic nephropathy – a • Approved in 2011 for treating CCR2 antagonist proteinuria in Nephrotic • Acquired by Shire Syndrom
Slide 9: DMX-200 – Current Status Snapshot
DMX-200 – Current Status Snapshot For personal use only Current Phase 2 POC – Part A • Treatment of proteinuria in chronic kidney disease (CKD) patients taking irbesartan • Dose escalation to find best dose of propagermanium • Recruitment on target • Initial safety and efficacy data to be reported Q
Slide 10: The Broader Opportunity
The Broader Opportunity For personal use only DMX-200 Product • Development path to registration as an orphan drug, broader CKD licensing opportunities Licensing Opportunity “DMX-200” • US patent covers use of any CCR2 antagonist with any angiotensin receptor blocker (ARB) • Standard Of Care in rena
Slide 11: Progress over past months
Progress over past 12 months For personal use only Dimerix key value drivers • Ethics approval for additional clinical sites • Australian patent for lead candidate granted • Fast-track for US patent under Pathway Prosecution Highway • First patient in Phase 2 Part A study treated • Patients
Slide 12: Outlook for next months
Outlook for next 12 - 18 months For personal use only DMX-200 Program • Interim analysis for DMX-200 Phase 2 dose escalation trial • Complete extended release formulation for propagermanium • Complete DMX-200 Phase 2 dose escalation trial • Open IND for PK study • Commence Phase 2 Part B Multiple ca
Slide 13: Experienced board and management
Experienced board and management For personal use only Executive Chairman: Dr James Williams • 15 years experience starting, funding, running and exiting biotechnology companies BSc(Hons), PhD, MBA, • Co-founder of Dimerix and iCeutica (acquired in 2011 and now with 3 FDA drug approvals) GAICD • Co-
Slide 14: Further Information
For personal use only Further Information Kathy Harrison, General Manager +61 419 359 149 kathy.harrison@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com