• FDA confirmed proteinuria as acceptable primary endpoint for full marketing approval in US
• Dimerix announced a development and license agreement for Japan worth up to ¥10.5 billion
• Dimerix admitted into S&P ASX All Ordinaries

Dimerix Limited, a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, announced its Appendix 4C and Quarterly Activities Report for the period ended 31 March 2025. During the quarter, Dimerix continued to make significant progress with its lead program, ACTION3 Phase 3 clinical trial in focal segmental glomerulosclerosis (FSGS), including holding a positive Type C meeting with the US Food and Drug Administration (FDA) in March 2025 which confirmed the acceptability of proteinuria as an appropriate endpoint for full marketing approval in the United States (US) for DMX-200 in FSGS. Furthermore, Dimerix advised during the quarter that it had entered into a development and license agreement with Fuso Pharmaceutical Industries Limited, for the commercialisation of Dimerix' Phase 3 drug candidate, DMX-200, in FSGS kidney disease in Japan. This was the third licensing agreement that Dimerix had successfully executed for DMX-200 in FSGS, following the Advanz Pharma deal in October 2023 and Taiba deal in May 2024. Dimerix ended the quarter with cash of $17.0 million, with net operating cash outflows for the period of $4.3 million. Dimerix also announced that it was admitted into the S&P ASX All Ordinaries during the quarter.

Dimerix announced a development and license agreement with Fuso Pharmaceutical Industries Limited for the commercialisation of DMX-200 in FSGS kidney disease in Japan, which includes up to ¥10.5 billion (approximately AU$107 million) in upfront, development and sales milestone payments, plus royalties on net sales.