Dimerix (DXB) Earnings Call Presentation

Dimerix Overview - Dimerix is developing DMX-200, a lead drug candidate in Phase 3 clinical trial for focal segmental glomerulosclerosis (FSGS)[14] - FSGS is a rare kidney disease with no approved treatments, leading to irreversible kidney damage, dialysis, transplant, or death[14] - Dimerix has secured orphan drug designation for DMX-200, providing regulatory, marketing exclusivity, and pricing benefits in key territories[14] - Dimerix has licensing partners across key territories for DMX-200[14] Financial Achievements and Partnerships - Dimerix has received over AU$65 million in total payments to date[14,54] - Licensing deals are collectively valued up to approximately AU$1.4 billion in total upfront and potential milestone fees plus royalties[14,53] - A 3rd development and license agreement for DMX-200 in Japan is valued up to ¥10.5 billion (~AU$107 million) in upfront/milestones, plus royalties[17] - A 4th license agreement for DMX-200 in the United States is valued up to US$590 million (~AU$940 million) in upfront/milestones, plus royalties[17] Clinical Trial and Regulatory Progress - The FDA confirmed proteinuria as an acceptable endpoint for full marketing approval in the US[17] - The ACTION3 study has enrolled 225 patients, with 52 patients enrolled in the Open Label Extension Study as of August 5, 2025[33] - The Phase 3 trial aims to recruit a total of approximately 286 patients[33] - Dimerix held a positive Type C meeting with the FDA in March 2025 regarding proteinuria trial endpoints for full approval and potential accelerated approval for DMX-200[41] Market Opportunity - The estimated global incidence of FSGS is over 200,000 per year[61] - The estimated incidence of FSGS per year across all Dimerix licensed territories is approximately 50,071[61]