Disclaimer 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 necessary to make an investment decision. This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Dimerix, nor does it constitute financial product advice or take into account any individual s investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of Dimerix and conduct its own investigations. Before making an investment decision, investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to their jurisdiction and circumstances. Dimerix is not licensed to provide financial product advice in respect of its securities or any other financial products. Cooling off rights do not apply to the acquisition of Dimerix securities. Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of Sun Biomedical, its officers, directors, employees and agents, nor any other person, accepts any responsibility and liability for the content of this presentation including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of or reliance on any of the information contained in this presentation or otherwise arising in connection with it. The information presented in this presentation is subject to change without notice and Dimerix does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this presentation, which may affect any matter referred to in this presentation. The distribution of this presentation may be restricted by law and you should observe any such restrictions. Forward looking statements This presentation contains certain forward looking statements that are based on the Company s management s beliefs, assumptions and expectations and on information currently available to management. Such forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results or performance of Dimerix to be materially different from the results or performance expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding the Company s present and future business strategies and the political and economic environment in which Dimerix will operate in the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward looking statements or other forecast. To the full extent permitted by law, Dimerix and its directors, officers, employees, advisers, agents and intermediaries disclaim any obligation or undertaking to release any updates or revisions to information to reflect any change in any of the information contained in this presentation (including, but not limited to, any assumptions or expectations set out in the presentation). 1
Dimerix Overview Company Assets (Dimerix) A globally focused drug development company with a portfolio of new therapies for unmet medical needs Lead Program: DMX-200 in Phase II clinical trials for Chronic Kidney Disease (CKD) and US Orphan Drug Designation for Focal Segmental Glomerulosclerosis (FSGS) IP: Granted and Pending applications for lead product and discovery engine Discovery Platform: Innovative technology enabling identification of clinical opportunities from drug receptor interactions Leadership: Commercially focused and experienced board and management with record of creating shareholder value Value Inflection Points: (i) Initial PII data: Q2 / Q3 2016 (ii) US FDA Pre IND and IND Submission: H2 2016 / Q1 2017 (iii) US Patent Allowance (iv) Indication expansion: Q3 2016 Corporate Snapshot ASX Code: Share Price: $.005 Market cap: Cash (31 Dec 15): Shares on issue: DXB (formerly SBN) $6.6m $2.5m 1,323.6m Performance Shares: 225.0m Options: 111.7m Major Shareholders MR PETER MEURS 19.96% SRV CUSTODIANS PTY LTD 6.16% YODAMBAO PTY LTD 5.88% MR JASON PETERSON & MRS LISA PETERSON <J & L PETERSON S/F A/C> 3.68% NULLAKI SERVICES PTY LTD <ANVIL BAY A/C> 3.18% MR PAUL WHITE & MS ELIZABETH MCCALL <WHITE FAMILY A/C> 2.54% MRS GWEN MURRAY PFLEGER <PFLEGER FAMILY A/C> 1.96% JAMPASO PTY LTD <WILLIAMS FAMILY A/C> 1.75% JGC SUPER PTY LTD <JGC FAMILY SUPER FUND A/C> 1.62% 2
Board 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 early 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 Currently 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 funds management, financial analysis, corporate advice, business management and investor relations 3
Management and Advisors 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 Scientific Advisors: Assoc. Prof Kevin Pfleger MA, PhD Dr Brian Richardson PhD Inventor Dimerix technology Head Molecular Endocrinology and Pharmacology at the Harry Perkins Institute of Medical Research National Health and Medical Research Council RD Wright Biomedical Research Fellow Multiple National and International awards as early career scientist 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. 4
Chronic Kidney Disease and FSGS A major unmet clinical need with limited treatment options Chronic Kidney Disease (CKD): a large and complex group of disease ultimately leading to kidney failure, dialysis and transplant. ~26 million people in the US alone Focal Segmental Glomerulosclerosis (FSGS): An orphan subgroup of CKD characterised by leakage of protein to the urine Source: Mayo Foundation 5
DMX200 A new treatment for CKD DMX-200: A combination of Irbesartan (Irb, angiotensin II receptor type 1 (AT1) antagonist) and propagermanium (PPG, Chemokine Receptor 2 (CCR2) antagonist). Irb: Off-patent blockbuster drug used primarily for treatment of high blood pressure PPG: Approved in Japan for hepatitis B, available in US (controlled) as dietary supplement recommended for various ailments Strong pre-clinical data pack/ip position: Mechanistic interaction identified between target receptors Confirmed in vivo using gold standard model of nephrotic syndrome Secured orphan drug designation Shorter trials, fewer patients Registration brings 7 years of exclusivity in the USA 6
DMX200 Clinical trial progress Treatment of Proteinuria in CKD patients Study design: Fixed dose combination of Irbesartan + Propagermanium Enrolment: Up to 60 patients in two Parts Part A: Dose escalation Up to 5 doses x 1 month, then 2 further months at maximal dose Part B: Best dose combination - 3 months Endpoint: Safety and complete or partial remission of proteinuria @24 weeks of treatment Part A duration: ~12 18 months with interim data at 6 9 months Status Ethics approval and site initiation completed four (4) Melbourne sites Three (3) patients on trial, screening continuing. First patient approaching five months Initial efficacy read out Q3 2016 Commencing FDA pre-ind / IND processes for US extension of the trial. 7
Companies in CKD space o Acthar gel (injection only, steroid) o Approved in 2011 for treating proteinuria in Nephrotic Syndrome o 2013 sales: $761 million o Acquired by Mallinckrodt in August 2014 for US$5.6B o Phase I asset for treating kidney fibrosis o Pursuing FSGS as initial indication o Acquired by Shire Pharmaceuticals in 2014: US$75 million upfront, US$482.5 million in milestones o Completed Phase II for CCX140 in diabetic nephropathy a CCR2 antagonist o Significant improvement in proteinuria on background of standard of care (ACE Inhibitor or ARB) o NASDAQ Listed: CCXI o Market Cap: US$157 million 8
Dimerix Not a single asset play DMX-200 Potential utility in other indications Pre-clinical animal studies underway for liver disease a major global health problem Results expected Q3 2016 Receptor-HIT: A powerful discovery engine Enables identification of new therapeutic approaches for new and existing drugs (per DMX-200) Used under contract by pharma and biotech in their internal discovery programs Multiple contracts completed for global pharma companies Partnering opportunities with global reagent suppliers 9
Value proposition of GPCR discovery platforms o o Phase 1b plus multiple preclinical leads Acquired by Sosei Feb 2015 for US$400 o o Early phase III and two phase II assets Nasdaq Listed (TRVN): Market Cap: US$375 million o Phase III and phase II assets o Acquired by Celgene Jul 2015 for US$6 billion GPCR G Protein-Coupled Receptor: A family of drug targets representing ~40% of all approved drugs. Dimerix proprietary Receptor-HIT discovery platform enables new discovery around GPCRs. 10
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, examination progressing EU, accelerating in US through Patent Prosecution Highway 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 11
Summary Clinical stage (phase II) biotechnology company focused in an area of high unmet clinical need Orphan Drug Designation secured in the US On-track to report initial safety and efficacy data from DMX-200 in Q2/Q3 2016 Preparing to accelerate US trials through pre-ind and IND process Consolidating IP position around lead formulation US Patent in late stage prosecution A powerful discovery platform producing additional therapeutic opportunities and pharmaceutical company partnerships Experienced board and management with track record of delivering significant value in a timely and capital efficient manner. 12
Further Information James Williams, Executive Chairman +61 409 050 519 james@dimerix.com Dimerix Bioscience Limited ACN 112 223 417 www.dimerix.com