Dimerix (DXB) Investor Update summary

Clinical trial progress and regulatory engagement

• DMX-200 (QYTOVRA) is in a global Phase 3 trial for FSGS, nearing full recruitment with 225 out of 286 patients enrolled and full recruitment expected by year-end or H2 2025.

• Orphan drug designation in key territories provides faster market pathway, pricing incentives, and exclusivity.

• Interim analyses showed DMX-200 outperformed placebo in reducing proteinuria, with regulatory alignment on proteinuria and eGFR as primary endpoints.

• Collaboration with FDA, Project PARASOL, and Parasol working group may enable accelerated approval based on surrogate endpoints, with a positive Type C meeting confirming proteinuria-based approval in the US.

• Regulatory discussions are ongoing in the US, Europe, and Japan for potential faster pathways, with conditional approval submission possible.

Disease context and treatment approach

• FSGS is a rare, aggressive kidney disease with no approved treatments, leading to rapid kidney failure and affecting over 200,000 patients globally.

• DMX-200 targets inflammation by acting as a CCR2 inhibitor, disrupting inflammatory pathways, preserving podocytes, and complementing standard blood pressure therapy.

• Proprietary pharmacology involves dual antagonism of AT1R and CCR2, reducing macrophage infiltration and proteinuria.

• Surrogate endpoints eGFR and proteinuria are used to measure kidney function and disease progression, with reducing proteinuria and stabilizing eGFR delaying dialysis and improving quality of life.

• DMX-200 demonstrated a 17% average reduction in proteinuria and a 39% reduction in inflammatory biomarkers in Phase 2, with no safety concerns and consistent tolerability in over 200 patients.

Commercial and financial outlook

• Four global commercial partners are in place, covering major territories and supporting regulatory, pricing, and sales, with four major licensing deals executed across US, EU, Japan, and Middle East.

• Total deal value with partners is up to $1.4 billion (AU$1.4 billion), with over $65 million (AU$65 million) already received.

• Cash reserves of nearly $70 million ($68.3 million as of June 2025) support ongoing trials and potential pipeline expansion, with a market capitalization of $282 million.

• Rare kidney disease drugs command high prices, with US retail prices up to $600,000 per annum; DMX-200 benefits from orphan exclusivity and established manufacturing.

• Additional licensing opportunities remain in regions like China and Latin America, with ongoing pursuit of new pipeline opportunities.