• Dimerix acquires Phase 2-ready asset, DMX-652 - with potential for rapid advancement into a Phase 2 clinical study under an open US Investigational New Drug (IND) application, with initial focus on acute kidney injury (AKI)
• DMX-652 offers potential to address a significant unmet need in AKI - with a global market opportunity estimated to be US$3.5 billion in 2026,^[1] and no currently approved therapies for the disease which is associated with rapid decline in kidney function and high mortality rate
• Strong safety data package - a large Phase 1 clinical trial in 85 healthy participants demonstrated DMX-652 was well tolerated at both a single dose and multiple doses over 14 days, with no serious adverse events related to drug reported
• Promising pre-clinical efficacy data demonstrated to date, with strong scientific reasoning validating DMX-652's mechanism of action
• DMX-652 is first and best-in class drug candidate, with no known clinical stage competitors and a mechanism of action which has the potential to extend across multiple other indications
• Strong strategic alignment with ongoing ACTION3 Phase 3 FSGS rare kidney disease program and Dimerix's broader existing renal-focused pipeline, leveraging Dimerix's existing infrastructure and expertise
• Completion of ACTION3 trial for Dimerix's lead asset, DMX-200 in FSGS; up front acquisition payment for DMX-652 and initiation of Phase 2 clinical trial all funded (see ASX announcement 17 July 2026) with further non-dilutive funding discussions underway

Dimerix Limited (ASX: DXB, "Dimerix") a clinical-stage biopharmaceutical company developing kidney disease treatments, is pleased to announce that it has acquired DMX-652 for all indications from Mission Therapeutics Limited ("Mission"). The new asset, which expands Dimerix's pipeline in rare kidney disease, is a novel first and best-in-class therapeutic candidate, initially targeting the prevention of acute kidney injury (AKI).

DMX-652 – expanding Dimerix's leadership in kidney disease

DMX-652 is a selective inhibitor of USP30 - a mitochondrial enzyme that slows the removal of damaged mitochondria. DMX-652, which is a small molecule delivered as an oral once daily capsule, is designed to support mitochondrial quality control in injured kidney cells, a mechanism indicated in the progression of AKI caused by ischaemia (lack of blood flow resulting in oxygen starvation), toxins or sepsis related causes, as well as in other renal and non-renal indications.

The DMX-652 acquisition includes assignment of the composition of matter patent, an open IND in the US with a Phase 2 clinical trial protocol which has received approval to proceed by the US Food and Drug Administration (FDA), as well as sufficient pharmaceutical grade (GMP) drug product for the Phase 2 trial and all manufacturing methodology. The Phase 2 trial is designed to investigate DMX-652's potential to prevent kidney injury and preserve renal function, however it's unique mechanism of action may allow it to be progressed into other indications.  

The opening of the US IND and the approval of the Phase 2 trial protocol follows successful completion of a Phase 1 clinical trial of DMX-652, in which 85 healthy volunteers received the drug candidate. The trial successfully demonstrated DMX-652 was safe and well tolerated in single doses of up to 200mg a day and multiple doses of up to 100mg a day for 14 days, with a promising pharmacokinetic profile.

Building a focused, rare kidney disease portfolio

The acquisition of DMX-652 aligns with Dimerix's strategy to build a focused pipeline of effective treatments for rare kidney diseases with high unmet medical needs. The DMX-652 program is a complementary addition to the Company's lead asset, DMX-200, which is currently in a fully recruited Phase 3 pivotal trial in focal segmental glomerulosclerosis (FSGS), a rare type of kidney disease. Bringing a complementary asset into the portfolio enables Dimerix to further leverage its core expertise and existing global network of relationships in kidney disease.

The acquisition of DMX-652 broadens Dimerix's renal franchise beyond glomerular disease and FSGS, into acute kidney injury. Dimerix's renal pipeline now includes drug candidates in two high-value indications with differentiated mechanisms and the potential to deliver meaningful value to patients and shareholders.

"Acute kidney injury (AKI) remains one of the most common and serious complications following cardiac surgery, affecting a substantial proportion of patients and contributing to increased morbidity, mortality, prolonged hospitalisation, and a heightened risk of long-term kidney and cardiovascular complications. Despite advances in perioperative care, there are currently no approved therapies specifically indicated to prevent cardiac surgery-associated AKI, representing an area of significant unmet medical need.  I believe DMX-652 represents a promising and innovative approach to addressing a major clinical challenge for patients undergoing cardiac surgery."
Univ.-Prof. Dr. med. Alexander Zarbock, Chair and Director of the Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at the University Hospital Münster, Germany

"DMX-652 has demonstrated a compelling clinical profile in Phase 1 development completed by Mission Therapeutics to date. There is a substantial unmet need for novel efficacious therapies for acute kidney disease and DMX-652 represents a unique step forward for these patients. Dimerix's deep domain focus in renal disease and their proven operational expertise make them an excellent partner to further the development and commercialisation of this important drug."
Dr Anker Lundemose, Executive Director, Mission Therapeutics

"DMX-652 represents an exciting and differentiated novel compound, and the acquisition of a Phase 2-ready program in acute kidney disease represents an important step in executing our strategy to expand our renal pipeline. This asset is highly complementary to our Phase 3 FSGS program and broadens our development footprint across the kidney disease continuum, from acute injury through to chronic disease."
Dr Nina Webster, CEO & Managing Director, Dimerix