Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (February 2017)
19 slides from Dimerix's investor presentation, Feb 14, 2017
Slide 1: A Phase 2 Company Treating Kidney Disease
A Phase 2 Company Treating Kidney Disease Corporate update 14 February 2017
Slide 2: Disclaimer
Disclaimer 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 information necessary
Slide 3: Dimerix overview
Dimerix overview Who A clinical-stage drug development company focused on discovering we are and developing new therapeutic treatments targeting G-Protein Coupled Receptors (GPCRs) Lead DMX-200 in a Phase 2 clinical study for Chronic Kidney Disease (CKD) program • US FDA Orphan Drug Designation for
Slide 4: Dimerix drug development paradigm
Dimerix drug development paradigm Why G Protein Coupled Receptors (GPCRs) are important • More than 30 per cent of all approved drugs act through GPCRs • They act as single units (monomers) or in complexes (heterodimers) GRCR GPCRAA Drug B GPCR B New pharmacological target Signal A Signal B Signal C
Slide 5: DMX-200 Intellectual Property
DMX-200 Intellectual Property • Dimerix has granted patents in the USA covering both its platform technology (8,283,127 and 8,568,997) and the lead program DMX-200 (9,314,450); and granted and pending applications in other major jurisdictions • The ‘450 patent covers the use of CCR2 antagonists in c
Slide 6: Chronic Kidney Disease - Opportunity
Chronic Kidney Disease - Opportunity • A global unmet medical need leading to kidney failure, cardiovascular disease and premature death – Estimated 26 million people in the US – Estimated US$ 2.6 billion spent in the US each year, mainly on late stage therapies due to lack of early stage treatment
Slide 7: DMX-200 – lead compound
DMX-200 – lead compound • DMX-200 is an adjunct therapy that uses two approved drugs: 1. Irbesartan = an off patent angiotensin II receptor type 1 (AT1) antagonist blockbuster drug primarily used for the treatment of hypertension 2. Propagermanium = a CCR2 antagonist and an organometallic compound o
Slide 8: The Orphan Pathway through the FDA
The Orphan Pathway through the FDA Orphan drug designation secured for DMX-200 • Orphan Drug Designation received in Dec 2015 for DMX-200 for the treatment of FSGS, a cause of chronic kidney disease with an unmet medical need • Disease is characterized by scarring of the kidney and leakage of blood
Slide 9: FSGS Renal Survival Rates
FSGS Renal Survival Rates Complete or partial remission of proteinuria has a profound effect on prognosis 1.0 Complete Remission 0.9 (CR) = proteinuria 0.8 CR reduced to < 0.3 0.7 PR g/day Renal survival 0.6 0.5 Partial Remission 0.4 (PR) = > 50% 0.3 reduction in peak 0.2 proteinuria and to P<0.001
Slide 10: What does Clinical Success look like?
What does Clinical Success look like? • No approved treatments for FSGS. The disease is debilitating and, if not treated, leads to kidney failure and ultimately the requirement for transplant or dialysis • Patients with unresolved high levels of proteinuria have a very poor prognosis for renal survi
Slide 11: CKD/ FSGS comparables
CKD/ FSGS comparables • NASDAQ: RTRX • NASDAQ: CCXI • Market cap : ~US$ 817 million • Market Cap: ~US$ 380 million • Phase 2 asset, sparsentan, for treating FSGS – a • Completed Phase 2 for CCX140 in diabetic dual angiotensin endothelin receptor blocker nephropathy – a CCR2 antagonist • Patients rem
Slide 12: DMX-200: path to registration for FSGS
DMX-200: path to registration for FSGS Phase 2 study Part A: Interim: confirmed safety and signs of efficacy: Reporting July 2017 Part B: Efficacy of optimal dose(s): Commencing 2017 US Investigation New Drug (IND) application • Initial pharmacokinetic (PK) study • Comparison of current three times
Slide 13: Value proposition of discovery platforms
Value proposition of discovery platforms • GPCR – G Protein-Coupled Receptor: A large and important family of drug targets • Dimerix’s proprietary Receptor-HIT discovery platform enables new discovery around GPCRs • Used under contract by pharma and biotech in their internal discovery programs – Mul
Slide 14: Outlook for next 12-18 months
Outlook for next 12-18 months DMX-200 Program • Complete extended release formulation for propagermanium - 1H 2017 • Report Phase 2 dose escalation (Part A) – July 2017 • Open IND for PK study – mid 2017 • PK Study for extended release tablet - 2H 2017 • Commence Phase 2 Part B – 2H 2017 DMX-250 Pro
Slide 15: Financial position
Financial position Top shareholders % ASX code DXB Mr Peter Meurs 17.33 Share price (6 Feb 17) AUD$0.008 Yodambao Pty Ltd 5.11 Market cap AUD$14.6m Mrs Wishney Sritharan Krishnarajah 2.68 Cash (Feb 17) ~AUD$2.9m White Family 2.21 Pending R&D Rebate AUD$0.42m SRV Custodians Pty Ltd 2.07 Shares on iss
Slide 16: Experienced board and management
Experienced board and management 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-founder and Investment
Slide 17: Investment summary
Investment summary ü A clinical-stage drug development company focused on discovering and developing new therapeutic treatments identified using its proprietary drug discovery platform ü DXB-200 in Phase 2 clinical development • Orphan drug designation received from the FDA, with seven years exclusi
Slide 18: Contact
Contact Kathy Harrison Chief Executive Officer +61 419 359 149 kathy.harrison@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com
Slide 19: DMX-200 Phase 2 CKD Study Design
DMX-200 Phase 2 CKD Study Design Part A: dose escalation study In Progress Part B: dose expansion study • 27 participants on stable irbesartan dose • Up to 30 participants on stable irbesartan dose • Propagermanium dose commencing at 30mg per prior to treatment day • “Best dose” of propagermanium se