DIMERIX LIMITED — Interim / Quarterly Report 2016

Oct 10, 2016

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A clinical-stage drug development company Corporate Update – Interim study update Wednesday 12 October 2016

Quick overview

Key Assets

Who we are: A clinical-stage drug development company focused on discovering and developing new therapeutic treatments identified using our proprietary drug discovery platform.

Lead Program: DMX-200 currently in Phase II clinical trial for Chronic Kidney Disease (CKD) and US Orphan Drug Designation for Focal Segmental Glomerulosclerosis (FSGS).

• Pre IND meeting with FDA held 29[th] June 2016

• Therapeutic use patent granted in USA 19[th] April 2016

• Positive interim Phase 2 safety data announced Oct 2016

Discovery Platform: Receptor-HIT technology to identify clinical opportunities from drug-receptor interactions, and potential revenue generation.

Leadership: Commercially focused and experienced board and management with a record of hitting milestones and creating significant shareholder value.

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Corporate Snapshot

ASX Code:	DXB
Share Price (10 Oct):	$.011
Market cap:	$16.5m
Cash (30 Jun 16):	$2.0m
Shares on issue:	1,497m
Performance Shares:	75m
Options:	98.7m

Top Shareholders	%
Mr. Peter Meurs	21.19
Yodambao Pty Ltd	4.71
Mrs Wishney Sritharan Krishnarajah	3.41
J&L Peterson	2.87
White Family	2.70
SRV Custodians Pty Ltd	2.53
Pfleger Family	2.08
Jampaso Pty Ltd (Williams Family)	1.85
Yodambao Investment	1.54
JGC Super Pty Ltd	1.43

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DMX-200 – Why kidneys?

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Dimerix identified DMX-200 using Receptor-HIT

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Irbesartan Propagermaniu
(Irb) m (PPG)
AT1R CCR2
Off-patent Available for use
blockbuster as an anti-
treatment of high inflammatory agent
blood pressure – CCR2 mediated
Both receptors expressed in the kidney
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• Published pre-clinical data show significant reduction in proteinuria when both receptors are targeted

• Standard of care treatment for CKD is angiotensin receptor blocker (ARB) or ACE inhibitor (ACEi)

• DMX-200 is adjunct (NOT combination) therapy comprising Irbesartan + Propagermanium

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Dimerix lead program – Why kidneys?

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Chronic Kidney Disease (CKD) – the big 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 options

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The Orphan Pathway

• Enables shorter trials with fewer patients and cost benefits

• Registration brings seven years of exclusivity in the US market

DMX-200 secured orphan drug designation for Focal Segmental Glomerulosclerosis (FSGS)

• Scarring of kidney (glomerulus)

• Leakage of blood and protein

• Serious and chronic disease leading to kidney failure

• Current therapy:

• Steroids – serious side effects, resistance and non-response is common

• Followed by a cocktail of off-label treatments

Source: kidneyfailurewe.com

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FSGS renal survival rates

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Cumulative percentage renal survival in primary FSGS Percent survival; From: Nephrol Dial Transplant (1999) 14 [Suppl. 3]: 68-73

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Non Nephrotic Proteinuria: 0.3–3 g protein/day (PCR – 30-300 mg/mmol) Nephrotic proteinuria: >[3-3.5] g protein/day (PCR > 300-350 mg/mmol) Massive proteinuria: >14 g protein/day (PCR >1,400 mg/mmol)

i.e. a reduction in proteinuria has a profound effect on renal survival

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DMX-200 Phase II (Part A) Interim Data

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• Study is on schedule and recruiting across four sites

• A total 21 of 30 participants dosed at end of Q3 2016

• Interim data shows DMX-200 well tolerated with encouraging safety profile

• All participants on stable irbesartan dose prior to start of treatment

• Participants dose of propagermanium escalated from 30 mg per day to a maximum of 240 mg per day

• Proteinuria measurement used was protein creatinine ratio (PCR) in mg/mol

• Three out of 11 participants (27%) who reached mid point (90 mg) show a ~ 50% reduction or greater in proteinuria over and above standard of care

• One participant achieved a 66% reduction in proteinuria at 90 mg dose

• Total participant exposure at end Q3 2016 was 67 months (5.5 years)

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CKD/FSGS treatment comparables

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• Phase II asset, sparsentan, for treating FSGS – a dual angiotensin endothelin receptor blocker

• Completed Phase II for CCX140 in diabetic nephropathy – a CCR2 antagonist

• Patients removed from Standard of Care treatment 2 weeks prior to dosing

• Top line positive data showing improved proteinuria compared with standard of care (irbesartan) at 8 weeks

• Standard of Care (irbesartan) reduced total protein urine excretion per day by 19% and sparsentan by 47.4%

• Significant improvement in proteinuria on background of standard of care (ACE Inhibitor or ARB)

• Measured urine albumin creatinine ratio (ACR) change from baseline by 16% over “placebo” (standard of care) at best dose (geometric mean reduction at 12 weeks of 24%)

• NASDAQ Listed: CCXI, Market Cap: ~US$215 million

• NASDAQ Listed: RTRX, Market cap : ~US$817 million

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DMX-200: Path to Registration for FSGS

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Australian Phase II study

• Part A: Interim: confirmed safety and signs of efficacy: Reporting mid 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 daily version with extended release formulation

Phase 3 Development for FSGS – FDA Pre-IND meeting outcomes

• Agreed development as an adjunct (not combination) therapy

• Primary endpoint discussions positive:

• “A substantial change in proteinuria in patients with marked proteinuria at

• baseline may be an acceptable endpoint for traditional or accelerated approval…”

Potential for a single Phase 3 pivotal study

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Outlook for next 12–18 months

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DMX-200 Program

• Complete recruitment for Phase 2 Part A – Q4 2016

• Complete extended release formulation for propagermanium - 1H 2017

• Report Phase 2 dose escalation trial - mid 2017

• Open IND for PK study – mid 2017

• Commence Phase 2 Part B – 2H 2017

DMX-250 Program

• Further pre-clinical studies for NASH program

Platform Technology

• Potential indications include diabetic retinopathy, cancer fatigue and multiple sclerosis

• Research collaborations and assay licensing opportunities

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Further Information

Kathy Harrison, General Manager +61 419 359 149 kathy.harrison@dimerix.com

James Williams, Executive Chairman +61 409 050 519 james@dimerix.com

Dimerix Limited ACN 001 285 230 www.dimerix.com

Experienced board and management

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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 Director of Yuuwa Capital ($40M venture capital fund)
General Manager:
Ms Kathy Harrison	• 20 years experience in Biotech: AMRAD, Cytopia Research Pty Ltd, Phosphagenics Limited
MSc, Cert.Gov.(Prac), FIPTA	• Registered Patent and Trademark Attorney
Director:
Dr Sonia Poli	• Former Senior Management at Hoffman la Roche and Executive at Addex Therapeutics (Switzerland)
MSc, PhD	• 20 years international experience in small molecule drug design, optimization and clinical development
	• Expertise encompassing multiple therapeutic areas

Director:

• Dr Liz Jazwinska • 25 years experience in R&D management and drug portfolio business development PhD, MBA, GAICD • Led Asia Pacific Partnering Group at Johnson and Johnson Research • Director Industry Engagement at Institute of Medical Biology, A*STAR, Singapore

Director:

• Mr David Franklyn • Experienced Director of ASX-listed companies in a variety of sectors BEcon • Extensive experience in financial analysis, corporate advice, business management and IR • Managing Director of Village National Holdings Limited

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