Positive Additional Data to Support DMX-200 Development

For Immediate Release DIMERIX ANNOUNCES POSITIVE ADDITIONAL DATA TO SUPPORT DMX-200 DEVELOPMENT IN KIDNEY DISEASE • DMX-200 demonstrated a reduction in proteinuria across both Phase 2 studies and a clear benefit to patients with both FSGS and diabetic kidney disease • DMX-200 reduced inflammatory biomarker by 39% versus placebo : translates to reduced inflammation and subsequent fibrosis • Inflammatory biomarker data supports previously announced positive data for both studies • Following detailed review of the FSGS data, the Medical Advisory Board unanimously agrees with progression of DMX-200 to a pivotal study in FSGS patients • DMX-200 safe and well-tolerated across all studies to date; benefits outweigh any potential risk to patients • Preparation of pivotal FSGS clinical study underway with pathway to accelerated approval MELBOURNE, Australia, 27 October 2020: Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company, is pleased to announce new positive data from both the Phase 2a clinical study in Focal Segmental Glomerulosclerosis (FSGS) patients and the Phase 2 clinical study in diabetic kidney disease patients that supports the continued development of DMX-200 in kidney diseases . The additional data can be seen in the updated Investor Presentation attached, and is also available on the Dimerix website, www.dimerix.com. DMX-200 treatment resulted in a decline in proteinuria in FSGS patients and in diabetic kidney disease patients in all treatment groups across both Phase 2 clinical studies (slides 9, 12, 17 and 19 in the attached presentation ). Additionally, for diabetic kidney disease patients with a marginally higher starting baseline, treatment with DMX-200 versus placebo showed statistically significant reduction in proteinuria versus placebo . The Medical Advisory Board unanimously agrees that the encouraging data supports the ongoing development of DMX-200, and that it should be confirmed by a larger pivotal randomised controlled trial for patients with FSGS as was discussed between Dimerix and the FDA in November 2019. A high correlation was observed between the severity of patient proteinuria and the molecular target of DMX -200 – an inflammatory molecule called Monocyte Chemoattractant Protein -1 (MCP-1) – across both studies (slides 11 and 18 in the attached presentation). In addition to the reduction in proteinuria, DMX-200 reduced the inflammatory biomarker MCP-1 by 39% versus placebo in the FSGS study and this translates to reduced inflammation and subsequent fibrosis (scarring) in the kidney. T he d ata further supports the proposed mechanism of action of DMX-200 being effective in diseases where active inflammatory processes are driving disease progression. An order of treatment effect was noted in both FSGS and diabetic kidney disease studies, where the treatment group receiving DMX -200 first did not return to baseline during the wash -out period, resulting in a significantly lower starting baseline proteinuria in the second period (slides 12 and 19 in the attached presentation). A potential disease modifying effect has not been ruled out, where the patient may have continued DMX-200 benefit through the washout period, after they had stopped taking DMX-200. This can be an indicator that the drug may be having a lasting positive effect on the function of the kidney . No concomitant medications effect trends were noted in either study. “I believe that the results of this Phase 2a FSGS study further validates Dimerix’ lead candidate, DMX-200, in sclerotic kidney diseases. The positive signals suggest that treatment with DMX-200 may indeed result in clinically meaningful improvements in kidne y function when added to the standard of care in patients with FSGS ,” commented Dr Hiddo Heerspink, Chair of the Dimerix Medical Advisory Board. “I am very excited at what this may mean for future studies in patients with FSGS.” Dr Nina Webster, CEO and M anaging Director of Dim erix, also commented “The positive correlation of reduced inflammatory biomarkers with a reduction in proteinuria following treatment with DMX-200 further strengthens our understanding of how DMX -200 is deliver ing clinically meaningful outcomes for these kidney patients. The significant body of clinical evidence Dimerix has established with DMX-200 supports progressing into a larger, randomised, controlled pivotal clinical trial in FSGS, with a pathway to accelerated approval.” Further analysis of the remaining data and planning of next steps for diabetic kidney disease are underway with the Medical Advisory Board. For further information, please visit our website at www.dimerix.com or contact: Dr Nina Webster, Dimerix Limited Chief Executive Officer & Managing Director Tel: +61 1300 813 321 E: [email protected] Rudi Michelson Monsoon Communications Tel: +61 3 9620 3333 Mob: +61 (0)411 402 737 E: [email protected] Authorised for lodgement by the Board of the Company —END— About Dimerix Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company developing innovative new therapies in areas with unmet medical needs for global markets. Dimerix is currently developing its proprietary product DMX -200 for Diabetic Kidney Disease , Focal Segmental Glomerulosclerosis (FSGS) and Acute Respiratory Distress Syndrome (ARDS), as well as DMX-700 for Chronic Obstructive Pulmonary Disease (COPD). DMX-200 and DMX-700 were both identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities. Receptor-HIT is licensed non-exclusively to Excellerate Bioscience, a UK- based pharmacological assay service provider with a worldwide reputation for excellence in the field of molecular and cellular pharmacology. About DMX-200 DMX-200 is the ad junct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving irbesartan, an angiotensin II type I (AT1) receptor blocker and the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032. In 2017, Dimerix completed its first Phase 2a study in patients with a range of chronic kidney diseases. No significant adverse safety events were reported, and all study endpoints were achieved. In a subse quent sub-group analysis, significant clinical efficacy signals were seen in the diabetic group. DMX-200 administered to patients already taking stable irbesartan reduced proteinuria levels by a further 36%. This reduction in proteinuria is highly correlated with improved renal function and delay in kidney failure and dialysis. The compelling results from this study prompted the decision to initiate two different clinical studies in 2018: one for patients with Diabetic Kidney Disease; and the second for patients with another form of kidney disease, Focal Segmental Glomerulosclerosis (FSGS). DMX-200 is also under investigation as a potential treatment for acute respiratory distress syndrome (ARDS) in patients with COVID-19. It is estimated that 40% of people with diabetes have kidney disease and many may not know it yet. With the incidence of diabetes growing so rapidly globally, so too will the incidence of kidney disease. This is a rapidly growing market, with few treatment options at this time. Dimerix reported statistically and clinically significant outcomes in a Phase 2 study in diabetic kidney disease patients in September 2020. FSGS is a serious and rare disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and kidney failure and for which there is a recognised medical need for a new or improved treatment. FSGS affects both children and adults. Dimerix reported positive Phase 2a data in FSGS patients in July 2020. DMX-200 for FSGS has been granted Orphan Drug Designation by the FDA and EMA. Orphan Drug Designation is granted to support the development of products for rare diseases and qualifies Dimerix for various development incentives including: seven years (FDA) and ten years (EMA) of market exclusivity if regulatory approval is received, exemption from certain application fees, and an abbreviated regulatory pathway to approval. 2 3 4 Dr Muh Geot Wong MBBS, PhD, FRCP Member Associate Professor Lesley Inker MD, MS, FRCPC Member Professor Alessia Fornoni MD, PhD, FASN Member Professor Jonathan Barratt MD, PhD, FRCP Member Professor Hiddo Heerspink PhD Chairman 5 6 Phase 1 study (DMX-200-101) • Healthy volunteers ➢ Pharmacokinetic, metabolism & safety clinical study Phase 2a study (DMX-200-201) • Chronic Kidney Disease ➢ Safety and tolerability study, with efficacy endpoints included Phase 2a study (DMX-200-202) • Focal Segmental Glomerulosclerosis ➢ Safety and efficacy endpoints • • • • • Phase 2 study (DMX-200-203) • Diabetic kidney disease ➢ Efficacy and safety endpoints 8 Phase 2a DMX-200-202 (ACTION for FSGS): Phase 2a, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of DMX-200 in Patients with Primary Focal Segmental Glomerulosclerosis who are Receiving Irbesartan • 10 patients enrolled, 7 patients qualified for the evaluable population and final analysis • Primary endpoint: safety. Secondary endpoint: proteinuria and biomarker analysis. • Patient population: Patients with primary FSGS who are receiving irbesartan Study period 1 16 weeks Washout 6 weeks Study Period 2 16 weeks Results Group 1 (n=5) DMX-200 Placebo Group 2 (n=5) Placebo DMX-200 Irbesartan 300mg 10 patients enrolled in study: 7 qualified for the final analysis Analysis population criteria defined in Statistical Analysis Plan (SAP) 9 • o o o • • 10 • PCR reduction (relates to effective kidney survival) 11 • o o • • 0 5 10 15 0.0 0.5 1.0 1.5 Time uMCR normalised uMCR normalised to baseline v time N=7, GeoMean On active On placebo (weeks) 50% 0% -50% 12 • o Baseline * 50% 0% -50% 13 14 2020 2021 2022 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 16 • • Study period 1 12 weeks Washout 6 weeks Study Period 2 12 weeks Results Group 1 (n=20) DMX-200 Placebo Group 2 (n=20) Placebo DMX-200 Irbesartan 300mg 17 • o • 18 0 200 400 600 0 10 20 30 40 50 Baseline ACR v baseline uMCR > 500 Baseline uACR (mg/mmol) Baseline uMCR (ng/mmol) 19 • o o 50% 0% -50% 21 22 Assets 100% owned by Dimerix $ 23 Generate strong investor returns Ongoing partnering activities and discussions DMX-700 in vivo proof of concept DMX-200 FSGS IND submission DMX-700 pre-IND submission Prepare for commercial scale manufacturing DMX-200 in COVID study outcomes Initiate pivotal Ph3 study in FSGS FSGS phase 2 data Jul20 $1million grant awarded for ARDS in COVID-19 Sep20 Diabetic Kidney Disease Phase 2 data

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