• Significant milestone with 144 patients recruited, randomized, and dosed in DMX-200 ACTION3 Phase 3 trial
• Full study recruitment of 286 adult patients expected in Q3/2025
• Blinded interim data collection and analysis planned for August 2025

Dimerix Limited has achieved a significant milestone in its DMX-200 ACTION3 Phase 3 clinical trial for FSGS kidney disease, with the recruitment, randomization, and dosing of the first 144 patients. The company expects to complete the full recruitment of 286 adult patients by Q3/2025. The planned blinded interim data collection is scheduled for August 2025, following 35 weeks of dosing for the first 144 patients. The Part 2 interim analysis outcome is expected to be announced shortly after the data analysis is complete. The potential for accelerated or conditional approval submissions will be assessed based on the outcome of this analysis and discussions with regulatory authorities such as the FDA. The Phase 3 trial has undergone 5 separate Independent Data Monitoring Committee reviews, including a formal futility assessment, with no safety concerns identified. To date, 14 patients have completed the full 2-year ACTION3 clinical trial and have elected to continue into the additional 2-year Open Label Extension study. DMX-200 is the most advanced FSGS asset in a Phase 3 clinical trial globally and is attracting strong interest from potential commercial partners. Dimerix has received Orphan Drug Designation for DMX-200 in the US, Europe, and the UK, which provides regulatory and financial benefits to help bring the drug to market faster.

Subject to ongoing guidance and correspondence with the appropriate authorities, the Company may be able to apply for accelerated (or conditional) approval of DMX-200 in some key territories which could, if approved, enable commercial launch of DMX-200 prior to the completion of the 2 year double blind ACTION3 Phase 3 clinical trial.