For personal use only A clinical-stage drug development business Investor Update Dr James Williams February 2016
Agenda today 1. Who we are 2. Snapshot and financials 3. Market and long-term growth strategy 4. Summary and outlook 2
Quick overview Key Assets Who we are: A clinical-stage drug development company focused on commercialising new therapeutic treatments identified using our proprietary drug discovery platform. Discovery Platform: Receptor-HIT technology to identify clinical opportunities from drug-receptor interactions, and potential revenue generation. Lead Program: A combination therapy (DMX-200) currently in Phase II clinical trials for Chronic Kidney Disease (CKD) and US Orphan Drug Designation for Focal Segmental Glomerulosclerosis (FSGS). Preparing to expedite US study through pre-ind and IND process Therapeutic use patent allowed in USA Leadership: Commercially focused and experienced board and management with a record of creating significant shareholder value. Corporate Snapshot ASX Code: DXB (formerly SBN) Share Price: $.006 Market cap: $8.4m Cash (31 Dec 15): $2.5m Shares on issue: 1,398.6m Performance Shares: 150.0m Options: 111.7m Top Shareholders % Mr. Peter Meurs 20.78 SRV Custodians Pty Ltd 6.42 Yodambao Pty Ltd 4.32 J& L Peterson 3.49 White Family 2.65 Nullaki Services Pty Ltd 2.16 Pfleger Family 2.04 Jampaso Pty Ltd (Williams Family) 1.91 Yodambao Investment 1.81 JQC Family Super Fund 1.53 3
The Dimerix drug paradigm G Protein Coupled Receptors (GPCRs) the most relevant molecules in drug development today 50% of all successful drugs currently in human medicine target GPCRs Act as single units (monomers) or in pairs (heterodimers) GRCR A GPCR A Drug B GPCR B New pharmacological target Signal A Signal B Signal C Dimerix owns Receptor-HIT: detection method for GPCR heterodimers - identified as one of the most exciting untapped opportunity in new therapeutic development Dimerix is unlocking new knowledge & opening a pipeline for new drugs 4
Dimerix lead drug program Chronic Kidney Disease (CKD) A global health problem leading to kidney failure, cardiovascular disease and premature death. Currently affects an estimated 26 million people in the US Focal Segmental Glomerulosclerosis (FSGS) Scarring of kidney (glomerulus) Leakage of blood and protein Source: Mayo Foundation Serious & chronic disease leading to kidney failure Current therapy: Steroids not suitable for long term use, resistance & non-response is common Source: kidneyfailurewe.com 5
DMX-200 Lead therapy Dimerix identified DMX-200 using Receptor-HIT: A new therapeutic approach to Chronic Kidney Disease Combination therapy comprising Irbesartan + Propagermanium Targets GPCR heterodimer: Angiotensin type 1 receptor (AT1) & Chemokine receptor 2 (CCR2) Pre-clinical data support significant reduction in proteinuria when both receptors are targeted Irbesartan (Irb) Off-patent blockbuster treatment of high blood pressure AT1 CCR2 Propagermanium (PPG) Available for use as an antiinflammatory agent Significant reduction in proteinurea DMX-200 secured orphan drug designation for FSGS: Enables shorter trials with fewer patients Ultimate registration entitles the owner to seven years of exclusivity in the US market 6
DMX-200 Clinical study progress Study Aim Treatment of proteinuria in chronic kidney disease (CKD) patients Study design Fixed dose combination of Irbesartan + Propagermanium Enrolment: Up to 60 patients in two parts: Part A: Dose escalation up to five doses x one month, then two months maximal dose Part B: Best dose combination - three months Endpoint: Safety and complete or partial remission of proteinuria @ 24 weeks of treatment Part A duration: ~12 18 months with interim data at six to nine months Current status Ethics approval and site initiation completed at four (4) Melbourne sites Three (3) patients dosed, screening continuing Initial safety and efficacy set to be reported Q3 2016 Commencing FDA pre-ind / IND processes for US extension of the trial 7
Market interest in CKD treatments Acthar gel (injection only, steroid) Approved in 2011 for treating proteinuria in Nephrotic Syndrome Headline pricing of $100,000 per treatment for the orphan indication 2013 sales: $761 million Acquired by Mallinckrodt in August 2014 for US$5.6B Phase I asset for treating kidney fibrosis Acquired by Shire Pharmaceuticals in 2014 US$75 million upfront, US $482.5 million in milestones Shire pursuing FSGS as initial indication Completed Phase II for CCX140 in diabetic nephropathy a CCR2 antagonist Significant improvement in proteinuria on background of standard of care (ACE Inhibitor or ARB) NASDAQ Listed: CCXI Market Cap: US$157 million 8
Market interest in discovery platforms Phase 1b plus multiple preclinical leads GPCR discovery platform Acquired by Sosei Feb 2015 for US$400 million Early phase III and two phase II assets GPCR discovery platform Nasdaq Listed (TRVN): Market Cap: US$375 million Phase III and phase II assets GPCR discovery platform Acquired by Celgene Jul 2015 for US$6 billion GPCR G Protein-Coupled Receptor: A large & important family of drug targets Dimerix proprietary Receptor-HIT discovery platform enables discovery of new drug approaches for GPCR mediated diseases 9
Pipeline of other therapeutic assets DMX-200 Potential utility in several other therapeutic indications Pre-clinical animal studies underway for liver disease Results expected Q3 2016 Positive data will support initiation of a second human clinical trial Receptor-HIT: A powerful discovery engine Proprietary technology that enables deep understanding of drug target pharmacology Enables identification of new therapeutic approaches using existing drugs Used under contract by pharma and other biotech in their internal discovery programs Multiple contracts completed for global pharmaceutical companies Partnering opportunities with global reagent suppliers 10
Summary and outlook Dimerix: A Clinical stage (Phase II) biotechnology business commercialising new therapies for under-served and unmet medical needs globally Business Model Experienced management and board Outsourcing to reduce costs Focus on US market approvals Mitigated Risks / High Potential New combinations of existing drugs Patent protected Clear medical and market needs Multiple catalysts ahead Top line data from current DMX-200 phase II study due 2016 Multiple other applications and therapies Global licensing agreements and partnering opportunities 11
Further Information James Williams, Executive Chairman +61 409 050 519 james@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com
Experienced board and management Executive Chairman: Dr James Williams BSc(Hons), PhD, MBA 15 years experience starting, funding, running and exiting biotechnology companies Co-founder of Dimerix and iceutica (acquired in 2011 and now with 3 FDA drug approvals) Co-founder and Investment Director of Yuuwa Capital ($40M venture capital fund) Director: Dr Sonia Poli MSc, PhD Former Senior Executive with Hoffman la Roche and Addex Therapeutics (Switzerland) 20 years international experience in small molecule drug design, optimization and clinical development Expertise encompassing multiple therapeutic areas. Director: Dr Liz Jazwinska PhD, MBA, GAICD 25 years experience in R&D management and drug portfolio business development Led Asia Pacific Partnering Group at Johnson and Johnson Research Director Strategic Alliances at Institute of Medical Biology, A*STAR, Singapore Director: Mr David Franklyn BEcon Experienced Director of ASX-listed companies in a variety of sectors Extensive experience in financial analysis, corporate advice, business management and IR Managing Director of Village National Holdings Limited General Manager: Ms Kathy Harrison MSc, Cert.Gov.(Prac), FIPTA Experienced Biotech Executive: AMRAD, Cytopia Research Pty Ltd, Phosphagenics Limited Registered Patent and Trademark Attorney 13
Leading scientific advisors Scientific Advisors: Assoc. Prof Kevin Pfleger MA, PhD Dr Brian Richardson PhD Inventor of Dimerix technology Head of Molecular Endocrinology and Pharmacology at the Harry Perkins Institute of Medical Research Leading National Health and Medical Research Council RD Wright Biomedical Research Fellow in Australia Multiple Prestigious National and International awards 42 year veteran of the pharmaceutical industry Leadership Team and Global Head of The Musculoskeletal Disease Therapeutic Area at The Novartis Institutes for Biomedical Research Prior roles: Deputy Head of Drug Safety, Head of Pathology and Experimental Toxicology, Head of Immunology, Inflammation and Respiratory Research as well as Senior Project Manager for the worldwide development of new therapies for Metabolic, Cardiovascular and Respiratory Diseases for Sandoz Pharma. 14
Core Intellectual Property Combination Therapy: PCT Number: International Filing Date: Status: Applicant: Inventors: Applications: AU2012/000014 11 January 2012 Detection System and Uses Therefor: PCT Number: International Filing Date: Status: Applicant: Inventors: Granted in Australia, Allowed in the US, examination progressing in EU and Japan Dimerix Bioscience Pty Ltd PFLEGER, Kevin Donald George; MCCALL, Elizabeth; WILLIAMS, James Combinations of drugs targeting Angiotensin and Chemokine Receptors; Multiple indications AU2007/001722 9 November 2007 Granted US, EU, Australia, China, Japan, South Africa Dimerix Bioscience Pty Ltd PFLEGER, Kevin Donald George; SEEBER, Ruth Marie; SEE, Heng Boon; EIDNE, Karin Ann 15