DIMERIX EXCLUSIVELY LICENSES DMX-200 IN GREATER CHINA, SOUTH KOREA AND SOUTHEAST ASIA TO EVEREST MEDICINES

• Everest Medicines licenses exclusive rights to commercialise DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS) in Greater China, South Korea and Southeast Asia
• 500,000-1 million people are estimated to be living with FSGS in the territories^[1]
• Dimerix eligible to receive upfront and potential success-based milestone payments of up to ~AU$481^[2] million, plus royalties
  • US$10 million (~AU$14.1 million²) upfront payment
  • Up to US$330 million (~AU$467 million²) in potential milestone payments
  • Tiered royalties on net sales
• Everest is the fifth license deal executed for DMX-200 following the license deals with Advanz Pharma (announced October 2023)^[3], Taiba Rare (announced May 2024)^[4], Fuso Pharmaceutical Industries (announced 7 January 2025)^[5], and Amicus Therapeutics (announced 1 May 2025, now BioMarin)^[6]; with over AU$65 million having been received prior to the Everest transaction
• Collectively across the 5 transactions, Dimerix may be eligible to receive up to ~AU$1.9 billion^[7] in aggregate total upfront and potential milestone payments, plus additional royalties on net sales
• DMX-200 is in a pivotal Phase 3 trial for FSGS, a rare and serious kidney disease with no approved therapies across these regions
• The ACTION3 Phase 3 clinical trial is fully recruited, with patients enrolled across 21 countries, including Chinese mainland, Hong Kong SAR, Taiwan region, Thailand and Malaysia
• Everest will leverage its specialty kidney disease expertise and commercial platform to register and commercialise DMX-200, offering greater patient access to the growing Asian markets
• Dimerix retains all rights to DMX-200 in all other unlicensed territories

MELBOURNE, Australia, June 16, 2026 /PRNewswire/ -- Dimerix Limited (ASX: DXB, "Dimerix") today announced that it has entered into an exclusive license agreement with Everest Medicines for the commercialisation of Dimerix's Phase 3 drug candidate DMX-200 for all indications including FSGS, in Greater China (Chinese mainland, Hong Kong SAR, Macao SAR and Taiwan region), South Korea and certain Southeast Asian countries (Singapore, Malaysia, Thailand, Indonesia, Vietnam and Philippines). Dimerix retains all rights to commercialise DMX-200 in all territories other than those already exclusively licensed.

DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2) under development in a pivotal, Phase 3 study, ACTION3, for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare and serious kidney disease. The ACTION3 Phase 3 clinical trial adult cohort is fully recruited, with 333 patients, including patients in the licensed territories.

In early 2024, Dimerix reported positive interim results from the ACTION3 trial in FSGS, showing DMX-200 was performing better than placebo in reducing proteinuria at that time.^[8] There have been no safety concerns to date following 8 reviews by the independent data monitoring committee, the most recent in June 2026. In April 2026, an external statistical blinded review of ACTION3 data achieved its objective by confirming that the study remains appropriately statistically powered (>90%) to demonstrate a treatment effect for the primary study endpoint of proteinuria; meaning that if DMX-200 continues to reduce proteinuria in trial patients as anticipated, then there is a >90% chance that the study will successfully show a statistically significant proteinuria treatment effect at the trial's conclusion.^[9]

Dimerix will continue to fund and execute the ACTION3 study, and Everest will be responsible for supporting submission and maintenance of the regulatory dossier in the licensed territories, as well as all costs of commercialisation activities. Everest and Dimerix will form a Joint Steering Committee to align the development and commercialisation of DMX-200 in FSGS in the licensed territories. The agreement otherwise contains terms common for an arrangement of this kind.

In exchange for these rights, Dimerix is to receive a US$10 million (~AU$14.1 million²) upfront payment within 45 business days of execution. In total, Dimerix is eligible to receive potential success-based development and regulatory milestones payments of up to US$30 million (~AU$42.4 million²) and commercial milestone payments of up to US$300 million (~AU$424.4 million²), with tiered royalties on DMX-200 net sales of between 10-15% in Greater China, South Korea, and certain Southeast Asian countries. Note that milestone payments are not broken down further, as that can negatively influence negotiations of contracts in other territories currently under discussion, and thus remains commercial in confidence. All contracted financial terms are denominated in U.S. dollars.

Authorised for lodgement with ASX by the Board of Dimerix.

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About ACTION3 Phase 3 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, randomized, 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 will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.

The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval. Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785).

About DMX-200

DMX-200 is 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 addition to Orphan Drug Designation granted in the United States, Europe, UK and Japan^[10].

About FSGS

FSGS is a serious kidney disorder characterised by progressive scarring (sclerosis) in parts of the glomeruli—the kidney's filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. The pathogenesis of FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In China, 500,000 to 1 million people¹ are estimated to be living with FSGS, including both adults and children. Management relies on non-specific immunosuppressive and supportive therapies in most countries around the world. In patients with progressive or treatment-resistant FSGS, the time from diagnosis to end-stage kidney disease can be as short as five years. Even among those with FSGS who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases,^[11] underscoring the urgent need for new disease-modifying treatments.

About Dimerix Limited

Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glomerulosclerosis (FSGS) kidney disease. 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 receptor interactions to rapidly screen and identify new drug opportunities. For more information, please visit the company's website at www.dimerix.com and follow on X and LinkedIn.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercialising innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.

The Company's therapeutic areas of focus include CKM (cardiovascular, kidney, and metabolic), autoimmune, ophthalmology and critical care. Everest Medicines has developed a fully integrated commercialisation platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website at www.everestmedicines.com.

Dimerix Forward Looking Statement

This release includes forward-looking statements that are subject to risks and uncertainties. Although management believes that the expectations reflected in the forward-looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, results of clinical trials, contractual risks, risks associated with patent protection, future capital needs or other general risks or factors, including but not limited to those factors outlined in the most recent Dimerix Limited Annual Report.

References

SOURCE Dimerix Limited