Dimerix (DXB) investor relations material

Clinical development highlights

• Phase 3 global trial of DMX-200 for FSGS is fully recruited, with interim analysis showing strong statistical power to demonstrate efficacy on proteinuria endpoints and a high rate of open-label extension enrollment.

• DMX-200 targets FSGS, a rare kidney disease with no approved therapies, and benefits from orphan drug designations and patent protection potentially extending to 2042.

• DMX-652, a first-in-class oral USP30 inhibitor, is phase 2 ready for acute kidney injury (AKI) in high-risk cardiac surgery patients, with strong preclinical and phase 1 safety data.

• Phase 2 trial for DMX-652 will enroll 160 patients, focusing on AKI incidence post-surgery, with secondary endpoints including safety and major adverse kidney events.

• Key value inflection points include phase 3 readout for DMX-200, NDA submission, and phase 2 milestones for DMX-652, supporting a cadence of value-creating events.

Commercial and financial overview

• DMX-200 is licensed to five commercial partners across major global markets, with deals valued up to AU$1.9 billion in milestones and royalties.

• Over AU$80 million in payments received to date, with royalties ranging from low teens to 30% depending on territory.

• Cash balance as of March 2026 is AU$26.6 million, excluding an additional AU$24 million expected from upfront payments and loan facilities.

• Market capitalization stands at AU$144 million, with substantial shareholders holding over 40% of issued shares.

Scientific and clinical rationale

• FSGS is characterized by progressive kidney scarring, proteinuria, and rapid progression to end-stage renal disease; DMX-200 acts as a CCR2 antagonist on top of standard care.

• Proteinuria is a validated surrogate endpoint for kidney disease progression and is less variable than eGFR.

• DMX-652 targets mitochondrial dysfunction in AKI, with preclinical models showing reduced kidney damage and fibrosis.

• Phase 1 data for DMX-652 demonstrated no serious adverse events, good tolerability, and a favorable pharmacokinetic profile.