Dimerix expands renal pipeline with acquisition of Phase 2-ready acute kidney injury asset
Dimerix Limited (ASX: DXB) has acquired DMX-652 for all indications from UK-based Mission Therapeutics Limited, adding a Phase 2-ready candidate targeting acute kidney injury to its renal pipeline. The clinical-stage biopharmaceutical company announced the deal on 17 July 2026.
The strategic appeal centres on the target indication. Acute kidney injury (AKI) has no currently approved therapies, with a global market estimated at US$3.5 billion in 2026 and forecast to grow to around US$7.5 billion over the next decade, according to internal market analysis cited by the company.
Dimerix describes DMX-652 as a “first and best-in-class” drug candidate with “no known clinical stage competitors.” The asset supports a two-pillar renal story, complementing lead Phase 3 candidate DMX-200 in focal segmental glomerulosclerosis (FSGS).
The acquisition diversifies the clinical pipeline and adds near and medium-term catalysts for ASX investors.
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Inside the DMX-652 acquisition
The transaction delivers a package designed for rapid clinical advancement. It includes assignment of the composition of matter patent, an open US Investigational New Drug (IND) application with a Phase 2 trial protocol that has received FDA approval to proceed, sufficient pharmaceutical grade (GMP) drug product for the Phase 2 trial, and all manufacturing methodology.
Under the terms, Dimerix will have sole ownership and control of development of DMX-652.
Deal terms at a glance
The consideration structure combines an upfront payment with a series of success-based milestones. All contracted financial terms are denominated in US dollars.
| Payment type | Trigger | Amount |
|---|---|---|
| Upfront payment | Within 30 days of signing | US$5 million |
| Deferred acquisition | Predefined clinical development milestones | Up to US$47 million |
| Marketing approval | Product marketing approval | US$40 million |
| Second indication | Approval in a second indication | US$25 million |
| Sales milestones | Success-based sales milestones | Up to US$175 million |
In addition to the milestone payments, Dimerix will pay royalties on global net sales:
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8–10% on global net sales if made by Dimerix
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2.5–5% on net sales if made by a third-party sub-licensee
Should Dimerix elect not to proceed with development, Mission holds the first right to negotiate for return of the acquired assets.
Understanding acute kidney injury — the unmet need DMX-652 targets
Acute kidney injury is a severe clinical syndrome defined by a rapid decline in kidney function, often within hours. It can arise from several high-risk clinical settings, most notably cardiac surgery and sepsis, and is associated with high morbidity and mortality.
The clinical burden is substantial and the commercial opportunity is meaningful for investors. There are no approved therapies for AKI, and the current addressable patient population is estimated at approximately 100,000–133,000 patients annually in the United States, making the indication a potential candidate for orphan designation.
How DMX-652 works
DMX-652 is a selective inhibitor of USP30, a mitochondrial enzyme that slows the removal of damaged mitochondria. Delivered as an oral once-daily capsule, the small molecule is designed to support mitochondrial quality control in injured kidney cells.
This mechanism is indicated in the progression of AKI caused by ischaemia (lack of blood flow resulting in oxygen starvation), toxins or sepsis-related causes. The company notes the mechanism may also extend across multiple other renal and non-renal indications, supporting differentiated positioning against a field with no known clinical-stage competitors.
A validated safety profile and a clear path to Phase 2
The opening of the US IND followed successful completion of a Phase 1 clinical trial in which 85 healthy volunteers received DMX-652. The trial demonstrated the candidate was well tolerated at single doses of up to 200mg a day and multiple doses of up to 100mg a day over 14 days, with no serious adverse events related to the drug reported and a promising pharmacokinetic profile.
The Phase 2 trial in cardiac surgery-associated AKI
The initial target indication is cardiac surgery-associated AKI, a predictable complication linked to cardiopulmonary bypass and valve surgeries. The proposed Phase 2 clinical trial is a multicentre, double-blind, randomised, placebo-controlled study evaluating the safety and efficacy of DMX-652 in approximately 160 patients at high risk of AKI following cardiac surgery. The primary endpoint is AKI incidence at 7 days post-surgery.
The anticipated development timeline is as follows:
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Ethics approval and clinical site initiation anticipated in H2 CY2026
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First patient dosing anticipated in H1 CY2027
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Interim data readout anticipated during 2027 (subject to recruitment)
Patent protection
The transaction transfers a substantial intellectual property position to Dimerix:
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The composition of matter patent family (PCT/EP2021/064897) will be assigned to Dimerix, with anticipated expiry in 2041
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An exclusive licence to further background patents and applications required for freedom to operate (PCT/GB2016/050851, PCT/GB2019/050608)
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Potential eligibility for a minimum of 5 years post-marketing approval exclusivity, extendable to 7 years in the US and 10 years in Europe upon any successful orphan drug designation
How DMX-652 fits Dimerix’s renal strategy
The acquisition broadens the renal franchise beyond glomerular disease and FSGS into acute kidney injury. Dimerix’s renal pipeline now spans two high-value indications with differentiated mechanisms.
The deal is designed to leverage the company’s existing infrastructure, expertise and global network of relationships in kidney disease. The asset complements lead candidate DMX-200, which is currently in a fully recruited Phase 3 pivotal trial in FSGS.
The ACTION3 Phase 3 trial completed dosing of its final adult patient in March 2026 with 333 patients randomised, exceeding the original target of 286 and strengthening the statistical power of the primary endpoints ahead of a March 2028 data readout.
Dr Nina Webster, CEO & Managing Director, Dimerix
“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.”
The unmet clinical need was reinforced by an external specialist. According to Univ.-Prof. Dr. med. Alexander Zarbock of the University Hospital Münster, there are currently no approved therapies specifically indicated to prevent cardiac surgery-associated AKI, representing an area of significant unmet medical need.
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Funding and potential catalysts ahead
Dimerix confirms it is funded through to completion of the ACTION3 Phase 3 trial in DMX-200, as well as the upfront acquisition payment and initiation of the DMX-652 Phase 2 clinical trial. The company identified the following funding sources:
- Existing cash reserves
The ~AU$14 million upfront inflow referenced here originates from the Everest Medicines licensing deal announced in June 2026, which granted Everest commercial rights across Greater China, South Korea and Southeast Asia and brought total potential milestone payments across all five DMX-200 regional agreements to AU$1.9 billion.
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~AU$14 million upfront payment to be received from Everest Medicines for commercial rights to Greater China, South Korea and Southeast Asia
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AU$10 million through a binding Loan Agreement, with any drawdown to take place at the company’s discretion
Negotiations to access up to a further AU$40 million in non-dilutive funding, anticipated to be on substantially similar terms to the loan facility, are progressing. This funding remains subject to a definitive agreement being executed and should not be regarded as secured.
For shareholders, the appeal lies in a dual-catalyst profile funded through non-dilutive sources. The pivotal ACTION3 Phase 3 readout for DMX-200 sits alongside progression of DMX-652 into Phase 2, delivering multiple near and medium-term catalysts while the company works towards building a sustainable development pipeline of assets in rare and renal disease.
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