Dimerix (DXB) Bioshares Biotech Summit Presentation summary

Strategic focus and clinical development

• Advancing DMX-200, a lead drug candidate, in a Phase 3 global trial for FSGS, a rare kidney disease with no approved treatments and significant unmet clinical need.

• Achieved orphan drug designation, providing regulatory, marketing exclusivity, and pricing benefits in key territories.

• Initiated first pediatric clinical trial sites and confirmed adolescent dosing for the ACTION3 study.

• Over 50 patients have completed the 2-year ACTION3 study, with eligible patients rolling into an open-label extension.

• FDA alignment achieved on proteinuria as an acceptable endpoint for full marketing approval in the US.

Regulatory and clinical milestones

• Project PARASOL, an FDA-led working group, validated eGFR slope and proteinuria as surrogate endpoints for FSGS progression.

• Positive Type C meeting with FDA on trial endpoints and potential for accelerated approval for DMX-200.

• Interim analysis process established, with strict unblinding protocols to maintain trial integrity.

• Global regulatory pathways aligned for expedited approval in the US, EU, and Japan, leveraging conditional and accelerated programs.

Commercial partnerships and financials

• Secured four major licensing deals for DMX-200 across the US, Europe, Japan, and Middle East, valued up to AU$1.4 billion in upfront and milestone payments plus royalties.

• Over AU$65 million in total payments received to date from partners.

• Partners selected for their infrastructure, strategic alignment, and collaborative approach to maximize DMX-200's reach and impact.