Dimerix (DXB) Update / Briefing Transcript

Summary of Dimerix (DXB) Update / Briefing August 18, 2025 Company Overview - Dimerix is an ASX listed company (Code: DXB) focused on inflammatory diseases, particularly kidney and respiratory diseases [1] Key Asset and Clinical Study - The primary asset is DMX200 (also known as KYTOVRA), which is undergoing a phase three clinical study for focal segmental glomerulosclerosis (FSGS), a rare kidney disease with no current treatments available globally [2][3] - Dimerix has received orphan drug designation for FSGS, providing advantages such as expedited market access, pricing incentives, and market exclusivity [2] Clinical Trial Details - The phase three clinical trial aims to assess the efficacy of DMX200 in reducing inflammation and preventing kidney scarring [8] - Key surrogate endpoints include estimated glomerular filtration rate (eGFR) and proteinuria, which are critical for evaluating kidney function and disease progression [9][13] - The trial is designed to include approximately 286 patients, with 225 already recruited [15][16] - Interim analyses have shown positive outcomes, indicating that patients on DMX200 are performing better than those on placebo [17] Regulatory Engagement - Dimerix is collaborating with the FDA and a working group called Parasol to define appropriate clinical endpoints for FSGS [4][19] - The potential for accelerated approval is being explored based on the correlation between early and later endpoints [21][22] Market Opportunity - FSGS is classified as a rare disease, but increasing biopsy rates are expected to raise its prevalence and incidence, making it a commercially attractive opportunity [25][26] - There are currently no approved treatments for FSGS, but similar rare kidney diseases have products priced between $100,000 and $500,000 per patient per year [27][28] Commercial Partnerships - Dimerix has established partnerships with four commercial marketing partners across various regions, including the US, Europe, Canada, Australia, New Zealand, the Middle East, and Japan [29] - The total deal value with these partners is up to $1.4 billion, with over $65 million already received [30] Financial Position - As of June, Dimerix had nearly $70 million in cash, sufficient to support the phase three clinical trial and explore additional pipeline opportunities [31] Future Catalysts - Key upcoming milestones include FDA feedback from the Parasol group, completion of the blinded interim analysis, and full recruitment by the end of the year [32] - There are also opportunities for further licensing deals in regions such as China and Latin America [32][33]