Dimerix : Quarterly Appendix 4C and Activities Report

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For Immediate Release

DIMERIX QUARTERLY ACTIVITIES REPORT

Quarter highlights and operational activities

• Phase 3 FSGS ACTION3 clinical trial now recruited 11 patients (15%) across multiple territories
• 60% of global ACTION3 sites open and actively recruiting; remaining sites anticipated to come online in the next 4-6 weeks
• DMX-700Study Shows Significant 80% Reduction in Lung Injury1
• REMAP-CAPCOVID-19 Study Analysis Underway2
• New Clinical Trial announced for DMX-200 in Diabetic Kidney Disease3
• Dimerix Presented at BIO International Partnering Convention4
• Phase 3 FSGS Kidney Trial Recruited First Patient5
• Dimerix presented at Bioshares Biotech Summit6
• FDA IND Approved for Phase 3 Study of DMX-200 in FSGS7
• Cash position of $9.6 million at 30 June 2022
• Net operating cash flow for the June quarter was -$7.2 million

MELBOURNE, Australia, 27 July 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 30 June 2022. During the quarter Dimerix made significant progress with its lead program, ACTION3 Phase 3 clinical study in focal segmental glomerulosclerosis (FSGS), with a number of the ~75 clinical sites actively recruiting globally. This has been a key quarter to the program, as an effective study start-up process is fundamental to the overall operational success of a clinical trial. It is also the largest cost component of the overall study that is reflected in the larger cash outflow for this quarter.

Dimerix ended the quarter with cash of $9.6 million ($16.8 million at 31 March 2022), with net operating cash outflows for the period of $7.2 million ($0.5 million net operating cash inflows in the prior quarter). The increase in total operating cash outflows for the quarter relative to the prior period is due to clinical trial start-up costs incurred in the current period in relation to the Phase 3 FSGS Study. Additionally, in the prior period $3.7 million was received relating to the FY21 R&D Tax Incentive Refund 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.

Dimerix remains on track to deliver on its growth strategy, 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.

Dimerix is a biopharmaceutical	Dimerix HQ
425 Smith St, Fitzroy 3065
company developing innovative new	Victoria, Australia
therapies in areas with unmet	T. 1300 813 321
medical needs.	E. [e-mail]

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FSGS Phase 3 study - ACTION3

The ACTION3 Phase 3 study is actively recruiting across clinical sites globally, with 11 patients (15%) having now been recruited to its DMX-200 phase 3 trial in patients with Focal Segmental Glomerulosclerosis (FSGS) kidney disease. The ACTION3 Phase 3 trial will recruit across 75 sites in 12 different countries, with ethics and regulatory submissions having been made in all 12 countries. Of those sites, 60% are now open and actively recruiting patients to the study, with the remaining sites anticipated to complete protocol training and activation in the next 4-6 weeks

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.

Diabetic kidney disease study

On 7 June 2022, Dimerix announced that it has entered into an agreement with The Australian Centre for Accelerating Diabetes Innovations (ACADI) to progress DMX-200 into a new clinical trial in patients with diabetic kidney disease. This new trial provides another potential market opportunity for Dimerix in addition to its other Phase 3 trials underway. The clinical trial protocol is currently being finalised and is expected to be a 12-24 month study of proteinuria and eGFR (kidney function) in patients with diabetic kidney disease, with an interim analysis. The study plans to recruit across Australia and is expected to commence late 2022.

Two COVID-19 Feasibility/Phase 3 studies

Dimerix' lead drug candidate, DMX-200, was 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.8

As investigator-led trials, both studies have been a relatively low-cost source of potential clinical data for Dimerix, with the REMAP-CAP and CLARITY teams being responsible for initiation, resourcing, project management and budgeting the clinical study. Dimerix proactively supported the study driven by the studies in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites.

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1 REMAP-CAP Feasibility/Phase 3 study

The REMAP-CAP study was 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.

On 27 June 2022 Dimerix announced that REMAP-CAP had formally close all recruitment of COVID-19 patients to the ACE2 RAS Domain clinical study (including DMX-200) to allow for the full results of this domain to be analysed and reported. The results of this study will be analysed by the REMAP-CAP team and prepared for publication. Dimerix will report the outcome as soon as it has been received from REMAP-CAP.2

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 patients diagnosed with COVID-19.

Dimerix is currently working with the CLARITY team on the study plans and expected timing, and anticipates updating the market on that outcome in the next 2-3 weeks.

Chronic obstructive pulmonary disease study

On 04 June 2022, Dimerix announced that its pipeline candidate, DMX-700, resulted in a statistically significant 80% (p<0.01, n=6) reduction in the PPE-induced lung injury in mice. The very encouraging and statistically significant pre-clinical data strongly supports further development of DMX-700. The clinical trial is now being designed, along with any further required nonclinical safety studies, with the initial clinical study expected to commence first half 2023

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-ledCOVID-19 programs.

For further information, please visit our website at www.dimerix.com or contact:

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]

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Authorised for lodgement by the Board of the Company

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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.9 For those who are fortunate enough to receive a kidney transplant, approximately 40% will get re-occurring FSGS in the transplanted kidney.10 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 80,000,11 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 year11. 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.12 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 2029.13 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%.12 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.14 However, there are

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also 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 release 04Jul2022
2. ASX release 27Jun2022
3. ASX release 07Jun2022
4. ASX release 06Jun2022
5. ASX release 31May2022
6. ASX release 12May2022
7. ASX release 09May2022
8. 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
9. Guruswamy Sangameswaran KD, Baradhi KM. Focal Segmental Glomerulosclerosis (July 2021), online: https://www.ncbi.nlm.nih.gov/books/NBK532272/
10. DelveInsight Market Research Report (2020); Focal Segmental Glomerulosclerosis (FSGS)- Market Insight, Epidemiology and Market Forecast -2030
11. Nephcure Kidney International (2020); Focal Segmental Glomerulosclerosis, online https://nephcure.org/livingwithkidneydisease/understanding-glomerular-disease/understanding-fsgs/
12. REMAP-CAPbackground: https://www.remapcap.org/background
13. DataBridge Market Research 2022, https://www.databridgemarketresearch.com/reports/global-acute-respiratory-distress-syndrome-ards-market
14. 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.