Additional US Patent Covering DMX-200

Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] For Immediate Release DIMERIX ANNOUNCES ADDITIONAL US PATENT COVERING DMX-200 MELBOURNE, Australia, 17 September 2019: Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company , today announced receipt of a Notice of Allowance from the US Patent and Trademark Office (USPTO) of a further US patent covering the use of Dimerix’ clinical stage can didate, DMX 200. Dimerix has also received notification that the patent covering DMX-200 will now proceed to grant in Israel. The new US patent, application number 15/704,713, claims the use of any CCR2 antagonist (e.g. DMX-200) in patients receiving any angiotensin receptor blocker (e.g. irbesartan) for kidney disease, wherein the CCR2 antagonist and the angiotensin receptor blocker may be administered either together or separately. As such, the patent titled “Combination Therapy” clearly articulates that the CCR2 antagonist and the angiotensin receptor blocker are not necessarily combined and may be administered independently of each other, as in the case of DMX-200. “The latest patent acceptance continues to demonstrate that global regulatory bodies recognise the novelty in Dimerix pharmaceutical products. These patents will join other granted patents in numerous key territories including in the United States of America (US) and Europe , with additional patent applications underway” Dimerix CEO & Managing Director, Dr Nina Webster, commented, “ With our expanding patent portfolio , our granted patents cover more than just DMX-200 and thus may strengthen the company's competitive position against some competitor products in development , in addition to any exclusivity period granted as a result of the new chemical entity status of DMX-200”. The new US patent, which is a divisional patent of US patent number 9,314,450, will be allocated a patent number upon issuance. These granted therapeutic use patents have a priority date of January 2011 and are set to expire post 2032 (2033 in the US). Additional patent applications that further extend this date are expected to be filed in due course. The current intellectual property strategy is very much aligned with the Dimerix business strategy and objectives. Dimerix continuously monitors the competitive landscape to identify, assess and minimise any IP risks, and to strengthen the Dimerix IP position. 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] —END— Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] 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 both Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis (FSGS). DMX -200 was identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor -HIT), which is a scalable and globally applicable technology platform enabling the understanding of re ceptor 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 mole cular 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 treatme nt for kidney disease. DMX-200 has 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 subsequent sub -group analysis, significant clinical efficacy signals were seen in the diabetic group. DMX-200 administered to patients already taking 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 Di sease; and the second for patients with another form of kidney disease, Focal Segmental Glomerulosclerosis (FSGS). 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. 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.

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