Clinical Study in Patients with COVID-19 Progresses

For Immediate Release CLINICAL STUDY IN PATIENTS WITH COVID-19 PNEUMONIA PROGRESSES THROUGHOUT EUROPE • Successful study completed to confirm nasogastric delivery of DMX -200 for patients with COVID-19 pneumonia admitted to intensive care units • Pan-Europe contract for DMX-200 in REMAP-CAP study executed, including UK • Study funding is supported by European Union’s H2020 programme through the RECOVER project (No 101003589) • Regulatory dossiers submitted in key European countries and UK MELBOURNE, Australia, 25 March 2021: Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company, is pleased to provide an update on the collaboration with the REMAP-CAP study into pneumonia in hospitalised patients with COVID-19. Dimerix has completed studies to confirm nasogastric delivery (delivery via feeding tube) of a DMX-200 formulation is acceptable and appropriate for patients in ICU unable to swallow a capsule. DMX -200 finished product to support the study is available and ready for recruitment throughout Europe, where cases of COVID -19 continue to climb and where contagious new variants account for the majority of new cases. Dimerix has now contracted with REMAP-CAP European clinical sites, including the UK, through the University Medical Center Utrecht (UMCU) in Utrecht, The Netherlands . The overarching REMAP-CAP study, incorporating DMX-200, is funded by the European Union through the H2020 Project called “Rapid European COVID -19 Emergency Research response ,” which uses the acronym “RECOVER”. The RECOVER project is among the first 18 projects that the European Union has funded in response to the COVID-19 pandemic. In addition to identifying treatments for COVID -19, t he research from RECOVER will also help improve the EU’s response to future epidemics and pandemics (https://www.recover-europe.eu/). DMX-200 delivery via nasogastric tube confirmed REMAP-CAP European study funded by European Union REMAP-CAP DMX-200 is included in a n investigator -led feasibility/Phase 3 s tudy in patients with COVID -19 pneumonia, driven by a consortium of global trialists, clinicians and experts through the study sponsor, REMAP-CAP. The study , endorsed by the World Health Organi zation (WHO), has initiated a master protocol across over 2 90 clinical sites across eight global regions. REMAP -CAP currently investigates over 20 active treatments for C OVID-19, mostly repurposed and novel medicines, including for registration purposes. The study has now recruited almost 6 ,000 patients with suspected or proven COVID-19 overall and is currently recruiting approximately 100 patients per week across Europe. DMX-200 is a new investigational drug included in the study as part of the “ACE2-RAS domain”, studying interventions aimed at the renin-angiotensin system to improve outcomes for patients with COVID-19. The protocol for this new REMAP-CAP domain was written and published in 2020 and the study co-ordinators have submitted the protocol and dossier to key European regulators, including the UK. Dimerix continues to support the study investigators in their regulatory submissions, as well as contract with each site/country co-ordinator for supply of DMX-200. Two Phase 3 Clinical Studies in Respiratory Complications Associated with COVID-19 Dimerix lead drug candidate, DMX-200, is part of two different investigator-led Phase 3 studies in COVID-19 patients with respiratory complications. For one of these studies, Dimerix was awarded $1 million from MTPConnect’s Biomedical Translation Bridge (BTB) program prov ided by the Australian Government’s Medical Research Future Fund, with support from UniQuest. Despite the introduction of vaccines that aim to reduce the symptoms caused by COVID -19, improving treatments for hospitalised patients with COVID-19 remains crucial. “Being able to incorporate DMX -200 in an actively recruiting international adaptive platform trial is very exciting. We use innovative trial design to test a novel drug for the treatment of patients with COVID-19. Our collaboration with Dimerix gives us the best of both worlds.” Dr Lennie Derde, MD PhD, REMAP-CAP EU, coordinating investigator and intensive care specialist “REMAP-CAP is an international adaptive platform trial investigating the best treatments for patients with community acquired pneumonia, including COVID-19. We are delighted to be working with such a high calibre team towards helping reduce the burden of COVID-19 in patients globally, as well as address respiratory complications commonly associated with pneumonia more broadly.” Dr Nina Webster, CEO & Managing Director of Dimerix REMAP-CAP currently recruiting ~100 patients per week across EU Dimerix proactively supports both studies driven by the REMAP-CAP and CLARITY teams in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites. Dimerix looks forward to reporting on progress and as key milestones are met. Importantly, if DMX-200 does show benefit in patients with COVID-19, it may also show benefit in respiratory complications associated with other infections too, such as pneumonia and influenza. Thus, this provides an opportunity that could extend well beyond the impact of COVID-19. Dimerix continues to undertake planning for the proposed Phase 3 pivotal program in FSGS, a rare kidney disorder without an approved pharmacologic treatment that often leads to end -stage kidney failure, as well as assess the next study design in diabetic kidney di sease patients and finally advance the COPD program towards the clinical stage of development. 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), and is developing 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 Ex cellerate 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 adjunct 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. 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 p otential treatment for acute respiratory distress syndrome (ARDS) in patients with COVID-19. FSGS FSGS is a very rare disease; and a particularly heart -breaking one. FSGS attacks the kidney’s filtering units, where blood is cleaned (called the ‘glomeruli’), causing irreversible scarring, which leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation. For those diagnosed with FSGS the prognosis is not good. The average time from a diagnosis of FSGS to the onset of complete kidney failure is only five years: sadly, it affects both adults and children as young as two years old. For those who are lucky enough to receive a kidney transplant, approximately 40% will get re-occurring FSGS in the transplanted kidney. At this time, there are no drugs approved for FSGS anywhere in the world, so the treatment options and prognosis are poor. FSGS is a billion-dollar plus market: the number of people with FSGS in the US alone is just over 80,000, and worldwide about 210,000. The illness has a global compound annual growth rate of 8%, with over 5,400 new cases diagnosed in the US alone each year. Because there is no effective treatment, Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Eu rope for FSGS. This is a special status granted to a drug to treat a rare disease or condition; the designation means that DMX -200 can potentially be fast -tracked, and receive tax and other concessions to help it get to market. DMX-200 for FSGS has been gr anted 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. Dimerix reported positive Phase 2a data in FSGS patients in July 2020. Diabetic Kidney Disease (DKD) There were 23 million diagnosed diabetics in the US alone in 2017, and the incidence of diabetes is estimated to grow by 54% by the year 2040. Approximately 40% of all diabetics suffer from kidney disease, which is a progressive disease leading to kidney f ailure and dialysis – and many of them do not know it yet. So sadly, diabetes has a large – and growing – population. With the incidence of diabetes growing so rapidly globally, so too will the incidence of kidney disease. This is a rapidly growing market, for which there is no cure for DKD, and current treatment options are ineffective as the kidneys deteriorate towards failure. The diabetic kidney disease market is reported to be a US$5.8 billion per annum (AU$8 billion) market and is estimated to grow at 5.1% a year by 2022. We believe our addressable market is at least US$1.1 billion (AU$1.5 billion), a market that is growing as diabetes incidence rises. Dimerix reported statistically and clinically significant outcomes in a Phase 2 study in diabetic kidney disease patients in September 2020. Respiratory Complications associated with COVID-19 Patients hospitalised with COVID-19 typically have acute lung dysfunction due to the human immune response to the virus. However, while the long-term effects on the lung from COVID-19 remain largely unknown, it is widely accepted that COVID-19 will result in acute injury in the same way as previous coronavirus infections such as SARS and MERS. As such, it is likely to result in chronic lung fibro sis in many patients, leading to poor quality of life, high ongoing hospitalisation requirements and ultimately a poor prognosis. Globally, and prior to COVID-19, ARDS affected more than 3 million people a year in 2019 accounting for 10-15% of intensive care unit admissions, and approximately 200 000 patients each year in the United States. The market size of Acute Respiratory Distress Syndrome (ARDS) in the seven major markets was US$917.81 million in 2017. This has grown significantly because of the 2020 pandemic. The death rate associated with ARDS is high, with overall mortality between 30 and 40%. The estimated average costs of treatment in an ICU unit with artificial ventilation total approximately US$100,000 per patient, with the average length of stay in ICU as a result of ARDS being 25 days, and the average length of hospitalisation being approximately 47 days. However, there are also significant costs associated with additional post-discharge treatment. There is no known prevention of ARDS currently available, nor is there any known cure. Chronic Obstructive Pulmonary Disease COPD is a progressive and life -threatening lung disease. The most common cause of COPD is exposure to tobacco smoke (either active smoking or secondary smoke) however, COPD is also caused by exposure to indoor and outdoor air pollution, occupational dusts and fumes and long-term asthma. COPD is the fourth-leading cause of death in the world and although treatments exist to improve the symptoms of COPD, there is currently no way to slow progression of the condition or cure it. Moreover, among the top five causes of death globally, this disease is the only one with increasing mortality rates. In 2016, the Global Burden of Disease Study reported a prevalence of 251 million cases of COPD globally, and it was estimated that 3.17 million deaths were caused by the disease in 2015, which equates to 5% of all deaths globally in that year (WHO Factsheet – Chronic Obstructive Pulmonary Disease). The global COPD treatment market was valued at US$14 billion in 2017 and is projected to increase at a compound annual growth rate of 4.9% to 2026.

The release as fetched from its publisher. dimerix.com ↗