Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (November 2017)
24 slides from Dimerix's investor presentation, Nov 22, 2017
Slide 1: Dimerix Corporate Presentation
For personal use only Dimerix Corporate Presentation 22nd November 2017 1
Slide 2: Disclaimer
Disclaimer For personal use only Some of the information in this presentation may refer to 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
Slide 3: Company strategy
Company strategy Dimerix Limited (ASX:DXB) For personal use only 1. Using proprietary “Receptor HIT” drug discovery platform to identify multiple programs 2. Lead program DMX-200 in Phase 2 human trials for Chronic Kidney Diseases (CKD) • Reduced risk – compounds with known safety profiles • Faster
Slide 4: Corporate overview
Corporate overview For personal use only Corporate snapshot ASX Code DXB# Share price history Share Price (17 Nov 17) $0.175 Market cap $16.1m Cash (30 Sep 2017) $1.6m (R&D tax incentive, $545,771 received 17th October 2017) Shares on issue* 92m Major shareholders (%) Mr Peter Meurs 17.22 Yodambao P
Slide 5: Experienced board and management
Experienced board and management For personal use only Dr James Williams – Chairman Hugh Alsop – Director • Co-founder of Dimerix and iCeutica (acquired • Accomplished and commercially-focused in 2011 and now with 3 FDA drug approvals) pharmaceutical and biotechnology executive • Co-founder and Inve
Slide 6: Medical advisory board (MAB)
Medical advisory board (MAB) For personal use only David Packham – Chair David Power • Director of the Melbourne Renal Research Group. • Director of Nephrology at Austin Health and Professorial • More than 30-years experience participating in over Associate at the University of Melbourne. 40 interna
Slide 7: Chronic kidney disease (CKD) - market opportunity
Chronic kidney disease (CKD) - market opportunity For personal use only • CKD is a growing global health problem affecting over 10% of the population, including 26 million patients in the US alone • CKD can be caused by a number of different diseases, or be of unknown origin • CKD gets progressively
Slide 8: Important sub-group indications of CKD – FSGS and diabetic nephropathy
Important sub-group indications of CKD – FSGS and diabetic nephropathy For personal use only Focal segmental glomerulosclerosis (FSGS) Diabetic nephropathy (DN) • FSGS is characterized by proteinuria, • Diabetic nephropathy is the single most nephrotic syndrome and rapid progression common cause of
Slide 9: Current treatments for CKD
Current treatments for CKD For personal use only • Damaged kidneys ‘leak’ proteins into the urine. This is called proteinuria and is the most common symptom of kidney disease and is a measure of treatment efficacy. • First line therapy involves reducing blood pressure using angiotensin receptor Will
Slide 10: Comparator programs
Comparator programs For personal use only • NASDAQ: CCXI • NASDAQ: RTRX • Market Cap: ~US$329 million • Market cap : ~US$ 917 million • Completed Phase 2 for CCX140 in diabetic • Phase 2 asset, sparsentan, for treating nephropathy (a CKD sub-group indication)– FSGS (a CKD sub-group indication) – a d
Slide 11: DMX-200 – Dimerix lead program for CKD
DMX-200 – Dimerix lead program for CKD For personal use only • DMX-200 is a tablet which is taken in conjunction with existing medications for CKD. • Patients continue taking their standard of care medication (irbesartan) and add a second drug to this (propagermanium), a CCR2 antagonist. • The US FD
Slide 12: Study design Phase 2a
Study design Phase 2a For personal use only Primary Endpoints Secondary Endpoints • Incidence and severity of Adverse Events • The proportion of responders, defined as those participants • Clinically significant changes in the safety profile of achieving normalization of proteinuria or a 50% reducti
Slide 13: DMX-200 Phase 2a study summary
DMX-200 Phase 2a study summary For personal use only The graph shows individual patient PCR** values as % change from baseline value during treatment, ranked by PCR reduction level. 100 Positive PCR movements highlight possible disease progression during the study 50 ** Δ% PCR from baseline Responde
Slide 14: Primary and secondary end points
Primary and secondary end points For personal use only Primary Endpoint Met: DMX-200 was safe and well tolerated • Adverse Events consistent with underlying patient population • No changes in the rate or severity of Adverse Events with propagermanium • No clinically significant trends in safety sign
Slide 15: Phase 2a primary end point - safety
Phase 2a primary end point - safety For personal use only • Combined therapy with propagermanium and irbesartan was well tolerated. • Adverse events were consistent with underlying patient and population co-morbidities. • There was no change in the rate of AEs or severity of AEs with dose of propage
Slide 16: Why a post hoc analysis?
Why a post hoc analysis? For personal use only • 50% (5/10) of diabetic nephropathy patients showed a greater than 50% reduction from baseline in PCR (24-hr) during treatment. • This compelling data in the diabetic nephropathy group justified additional statistical analysis for that group, based on
Slide 17: Post hoc analysis – average PCR and ACR in diabetic nephropathy subgroup
Post hoc analysis – average Protein Creatinine Ratio (PCR) and Albumin Creatinine Ratio (ACR) in diabetic nephropathy subgroup For personal use only Reduction in PCR (24-hr) of diabetic nephropathy patient cohort (n=10) during Reduction in ACR (24-hr) of diabetic nephropathy patient cohort (n=10) du
Slide 18: DMX-200 – a pipeline in a program
DMX-200 – a pipeline in a program For personal use only Development by CKD groups/ Pre clinical Observational Phase 1 Phase 2a Phase 2b Phase 3 indications Orphan path/ out license FSGS Out license Diabetic Nephropathy *Follow on Orphan path / out IgA Nephropathy* orphan license opportunity Out Lice
Slide 19: DMX-200 Phase 2b FSGS study design
DMX-200 Phase 2b FSGS study design For personal use only • Patient group: FSGS (n=10+) FSGS study outline • 3-month run-in to ensure stable disease Primary endpoint prior to randomisation Baseline • Patients randomised to 3-month of continuous treatment with low dose of 0 1 2 3 4 5 6 7 8 9 propagerm
Slide 20: DMX-200 Phase 2b diabetic nephropathy (DN) study design
DMX-200 Phase 2b diabetic nephropathy (DN) study design DN study outline For personal use only Primary endpoint • Double blind, placebo controlled Baseline • Patient group: DN(n=60) 0 1 2 3 4 5 6 7 8 9 12 • 3-month run-in to ensure stable Screening Run-in R On-treatment Follow-up disease prior to ra
Slide 21: DMX-200 Phase 2b key inclusion and exclusion criteria
DMX-200 Phase 2b key inclusion and exclusion criteria For personal use only General Inclusion General Exclusion • Adults > 18 to 75 years • Use of an ACE or symptomatic use of • BMI 20-40 kg/m2 immunomodulatory agents including steroids • Proteinuric disease > 6 months duration • Previous renal tran
Slide 22: DMX-200 Intellectual Property
DMX-200 Intellectual Property For personal use only • Dimerix has granted patents in the USA, Australia and Japan covering the lead program DMX-200 (US patent no 9,314,450); and pending applications in Europe and other major jurisdictions including • The ‘450 patent covers the use of CCR2 antagonist
Slide 23: Significant next steps
Significant next steps For personal use only ü Human pharmacokinetics (PK) study to optimise dose of DMX-200 for extended release formulation on track to complete 2H CY2017 (3 tablets daily reduced down to 1-2 tablets daily) ü Commencement of Phase 2b powered diabetic nephropathy sub group trial (re
Slide 24: Contact
For personal use only Contact Kathy Harrison Chief Executive Officer +61 419 359 149 kathy.harrison@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com