Dimerix : Quarterly Appendix 4C and Activities Report

For Immediate Release

DIMERIX QUARTERLY ACTIVITIES REPORT

Quarter highlights and operational activities

• • Dimerix received A$3.7M R&D tax incentive rebate1

• • FSGS phase 3 kidney study actively recruiting2

• • 75 sites contracted across 12 countries to conduct FSGS Phase 3 study

• • 11 of the 12 countries received ethics and/or regulatory approval to conduct FSGS study3

• • A further new DMX-200 patent application submitted globally, bolstering patent protection to 2041 if granted

• • Australian Government's BTB program $1 million grant awarded to Dimerix4 completed during the quarter, with all milestones met and the full funds received

• • Data Safety Monitoring Board (DSMB) make change to REMAP-CAP COVID-19 study5

• • Dimerix appoints Chief Medical Officer6

• • First regulatory approval in Europe for DMX-200 FSGS study7

• • Patients dosed in DMX-200 COVID-19 phase 3 study in India8

• • Cash position of $16.8 million at 31 March 2022

• • Net operating cash flow for the March quarter was $0.5 million

MELBOURNE, Australia, 27 April 2022: Dimerix Limited (ASX: DXB) ("Dimerix" or the "Company"), a clinical-stage biopharmaceutical company with multiple late-stage clinical assets, today announced its Appendix 4C and Quarterly Activities Report for the period ended 31 March 2022. Dimerix made significant progress during the quarter across the Phase 3 FSGS global clinical study, towards opening all 75 sites in 12 different countries with the goal of bringing much needed treatments to patients around the world, with first interim data anticipated in the first half of 2023.

Dimerix ended the quarter with cash of $16.8 million ($16.3 million at 31 December 2021), with net operating cash inflows for the period of $0.5 million ($2.3 million net operating cash outflows in the prior quarter). The increase in total operating cash inflows for the quarter relative to the prior period is due to the receipt of $3.7 million relating to the FY21 R&D Tax Incentive Refund1 in conjunction with the receipt of $0.3 million relating to the Biomedical Translation Bridge (BTB) grant.

In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors' fees, salaries and superannuation.

The Dimerix growth strategy remains focussed by advancing clinical trials to provide treatments globally for patients with serious and life-threatening inflammatory diseases. Dimerix is well positioned to deliver on its commitment towards bringing the potential benefits of DMX-200 to these patients globally, while building value for our stakeholders.

A further new patent application for DMX-200, titled 'Treatment of Inflammatory Diseases', was filed globally just after quarter end (with a priority date of 25 March 2021). If granted, the patent application, PCT number PCT/AU2022/050249, will extend and broaden the protection for DMX-200 until at least March 2041 (DMX-200 granted patents currently provide protection until at least 2032).

FSGS Phase 3 study - ACTION3

The ACTION3 Phase 3 study is planned to recruit across 12 different countries globally, with ethics and regulatory submissions having been made in all 12 countries. During the quarter, 11 of the 12 countries received ethics and/or regulatory approval to conduct the study in preparation for patient recruitment. Ethics approvals have also been received in other territories, and recruitment has commenced in those territories that have received the required ethics and regulatory approvals. IQVIA, the appointed lead Contract Research Organisation (CRO), is coordinating study start-up activities on behalf of Dimerix. IQVIA is the largest global CRO and has extensive and recent experience in running late-stage global FSGS clinical studies.

About the study

The Phase 3 study, which is titled "Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis" - or ACTION3 for short, is a pivotal (Phase 3), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients, aged 18 to 80 years, will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo. The first interim analysis is anticipated in the first half of 2023.

Two COVID-19 Feasibility/Phase 3 studies

Dimerix' lead drug candidate, DMX-200, is being studied as part of two different investigator-led feasibility/Phase 3 studies in COVID-19 patients with respiratory complications. The inclusion of DMX-200 in these investigator-led studies is based on a clear scientific rationale, is unique and potentially complementary to others being investigated globally, and importantly if effective in this study, would likely be effective against any strain as well as potentially other pneumonias with a common mechanism of action.9

1 REMAP-CAP Feasibility/Phase 3 study

The REMAP-CAP study is an investigator-led study in patients hospitalised with moderate to severe COVID-19 pneumonia (in Intensive Care Units (ICU) or on ward), driven by a consortium of global trialists, clinicians and experts through the study sponsor, REMAP-CAP. Participants in the ACE2 RAS study domain are randomised to receive one of three different RAS blockade treatment arms, including the DMX-200 arm, or a control.

On 24 February 2022 (European time), the Independent Data Safety Monitoring Board (DSMB) conducted an assessment to determine if the treatment arms in the RAS study domain were safe and/or effective. The DSMB noted a concerning safety signal in critically ill patients in the study arms where patients were receiving an ACE inhibitor or an angiotensin receptor blocker (ARB). Importantly, no concerns were communicated with regards to DMX-200. Recruitment of patientsin study has been paused pending full analysis of all study outcomes for all randomized patients. The data analysis, conducted by REMAP-CAP, is underway and be released as soon as data are available.

Dr Nina Webster	Rudi Michelson
Dimerix Limited	Monsoon Communications
Chief Executive Officer & Managing Director	Tel: [phone]
Tel: [phone]	Mob: [phone]
E:[e-mail]	E:[e-mail]
Follow us onLinkedIn andTwitter
Authorised for lodgement by the Board of the Company
-END-

As announced on 03 September 2020 to the ASX, Dimerix was awarded $1 million from MTPConnect's Biomedical Translation Bridge (BTB) program provided by the Australian Government's Medical Research Future Fund, with support from UniQuest, to support DMX-200 inclusion in this study. The BTB program completed during the quarter, with the full $1 million having been received by Dimerix over the course of the program. On 22 December 2021, Dimerix announced the award of a further $100,000 to support commercialisation activities for Dimerix lead candidate, DMX-200, in patients with COVID-19.

2 CLARITY 2.0 Feasibility/Phase 3 study

The CLARITY 2.0 study is an investigator initiated, prospective, multi-centre, randomised, double blind, placebo-controlled study, which aims to enrol 600 patients diagnosed with COVID-19. The study is open for recruitment in India following approval by the regulatory agency DCGI11 and received ethics approval in Australia December 2021.10 An interim safety analysis will be conducted after the first 80 patients have been recruited in sites in India.11

The first patients were dosed in India in January 2022,8 with multiple sites now having been initiated in India following regulatory approval from the Indian regulatory agency, the Central Drugs Standard Control Organization (DCGI),11 and shipment of DMX-200 drug supply to India from Dimerix' US based manufacturer. Recruitment of the first 80 patients has been slower than anticipated, and the CLARITY 2.0 investigators now anticipate conclusion in Q2 2022.

Dimerix supports both studies driven by the REMAP-CAP and CLARITY 2.0 teams including supply of DMX-200. Dimerix looks forward to reporting on progress and as key milestones are met.

Dimerix has multiple assets in commercially attractive and growing markets that have a high unmet need, no current marketed competition, and with a potential fast pathway to market. Dimerix continues to drive the FSGS Phase 3 program, further progress the diabetic kidney disease and COPD programs, as well as support the investigator-led COVID-19 programs.

For further information, please visit our website atwww.dimerix.comor contact:

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 Focal Segmental Glomerulosclerosis (FSGS), respiratory complications associated with COVID-19 and Diabetic Kidney Disease, 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 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 adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker - the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042.

In 2020, Dimerix completed two Phase 2 studies: one in FSGS and one in diabetic kidney disease, following a successful Phase 2a study in patients with a range of chronic kidney diseases in 2017. No significant adverse safety events were reported in any study, and all studies resulted in encouraging data that could provide meaningful clinical outcomes for patients with kidney disease. DMX-200 is also under investigation as a potential treatment for acute respiratory distress syndrome (ARDS) in patients with COVID-19.

FSGS

FSGS is a rare disease that attacks the kidney's filtering units, where blood is cleaned (called the 'glomeruli'), causing irreversible scarring. This 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 and it affects both adults and children as young as two years old.12 For those who are fortunate enough to receive a kidney transplant, approximately 40% will get re-occurring FSGS in the transplanted kidney.13 At this time, there are no drugs specifically 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 80,000,14 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 year14. Because there is no effective treatment, Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe 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 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.

Dimerix reported positive Phase 2a data in FSGS patients in July 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 results 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 fibrosis 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.15 The global ARDS market is expected to grow at 10.1% (CAGR) between 2022 and 2029 and is expected to reach over US$18 billion by 2029. 16 Increasing prevalence and incidence of acute lung injury, wide range of risk factors for ARDS and acceleration in patient pool of COVID-19 with ARDS acts as driver for the ARDS market. The death rate associated with ARDS is high, with overall mortality between 30 and 40%.15 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.17 However, there arealso significant costs associated with additional post-discharge treatment. There is no known prevention of ARDS currently available, nor is there any known cure.

References

1 ASX 29Mar2022

• 2 ClinicalTrials.gov Study Identifier: NCT05183646

• 3 ASX investor presentation 29Mar2022

• 4 ASX 03 September 2020

• 5 ASX 28Feb22

• 6 ASX 07Feb22

• 7 ASX 01Feb2022

• 8 ASX 11Jan2022

• 9 Based on Szabo, et al., 2020; Merad, et al., 2020; Xiong, et al, 2020; Wu, et al., 2021; Chen, et al., 2009; Yong, et

• al., 2016

• 10 ASX 23Dec2021

• 11 ASX 24Sep2021

• 12 Guruswamy Sangameswaran KD, Baradhi KM. Focal Segmental Glomerulosclerosis (July 2021), online:https://www.ncbi.nlm.nih.gov/books/NBK532272/

• 13 DelveInsight Market Research Report (2020); Focal Segmental Glomerulosclerosis (FSGS)- Market Insight,

  Epidemiology and Market Forecast -2030

• 14 Nephcure Kidney International (2020); Focal Segmental Glomerulosclerosis, onlinehttps://nephcure.org/livingwithkidneydisease/understanding-glomerular-disease/understanding-fsgs/

• 15 REMAP-CAP background:https://www.remapcap.org/background

• 16 DataBridge Market Research 2022,https://www.databridgemarketresearch.com/reports/global-acute-respiratory-distress-syndrome-ards-market

• 17 Bice, T et al, (2013) Cost and Healthcare Utilization in ARDS - Different from Other Critical Illness?, Semin Respir

  Crit Care Med. 2013; 34(4): 529-536.