Dimerix (DXB) Investor Presentation summary
Event summary combining transcript, slides, and related documents.
Investor Presentation summary
20 Oct, 2025Clinical development and trial progress
Lead candidate DMX-200 is in a Phase 3 global clinical trial for FSGS, a rare kidney disease with no approved treatments.
The ACTION3 study is a randomized, double-blind, placebo-controlled trial with 286 patients, including adults and pediatric cases.
Interim and final analyses will assess endpoints such as proteinuria and eGFR, with potential for accelerated approval based on FDA feedback.
Blinded analysis and regulatory alignment are ongoing, with PARASOL registry data supporting proteinuria as a key endpoint.
Full study recruitment is anticipated in H2 2025, with potential for conditional marketing approval submission.
Market opportunity and disease background
FSGS has a global incidence of 7 per 1,000,000 and is the leading primary glomerular disease causing end-stage renal failure in the US.
No approved therapies exist for FSGS, leading to high unmet clinical need and significant market potential.
Example pricing for rare kidney disease drugs in the US ranges up to $9,900 per month, with similar reference pricing in Europe and other regions.
Commercial manufacturing for DMX-200 is established in the USA.
Licensing, financials, and corporate overview
DMX-200 is licensed in key territories, with deals 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 licensing partners.
Cash balance as of June 2025 is $68.3 million, with a market capitalization of $312 million and 600 million shares on issue.
Substantial shareholders hold over 23% of issued capital.
Latest events from Dimerix
- Net loss widened to $15.97 million as R&D spending surged for the Phase 3 FSGS trial.DXB
H1 20265 Mar 2026 - ACTION3 Phase 3 trial reached full recruitment; cash reserves support ongoing operations.DXB
Q2 2026 TU29 Jan 2026 - Phase 3 trial nears full recruitment, with strong interim data, regulatory alignment, and global deals.DXB
Investor Update23 Nov 2025 - Cash reserves remain robust as clinical and regulatory milestones advance DMX-200 for FSGS.DXB
Q1 2026 TU28 Oct 2025 - DMX-200 advances in Phase 3 for FSGS, with major licensing deals and regulatory momentum.DXB
Investor Presentation2 Sep 2025 - Major licensing deals, strong cash, and clinical progress drive improved financial results.DXB
H2 202527 Aug 2025 - DMX-200 advances in global Phase 3 trials for FSGS, backed by major partnerships and regulatory progress.DXB
Bioshares Biotech Summit Presentation6 Aug 2025 - US licensing deal and strong cash inflows support ongoing Phase 3 FSGS trial and global expansion.DXB
Q4 2025 TU24 Jul 2025 - DMX-200 advances as a leading FSGS therapy with strong clinical and commercial momentum.DXB
Investor Presentation18 Jun 2025