Dimerix’s Licensing Agreements Could Unlock Over AU$458M in Milestones

Strategic Licensing Deal Expands DMX-200’s Reach

Dimerix Limited (ASX: DXB) has taken a significant step forward in commercialising its lead kidney disease drug candidate, DMX-200, by entering into a development and license agreement with Japan’s Fuso Pharmaceutical Industries Limited. The deal, announced in early January 2025, could deliver up to ¥10.5 billion (approximately AU$107 million) in upfront, development, and sales milestone payments, plus royalties estimated between 15-20% on net sales.

This agreement marks Dimerix’s third major licensing deal for DMX-200 in focal segmental glomerulosclerosis (FSGS), following previous deals with Advanz Pharma and Taiba covering Europe, Canada, Australia, New Zealand, and the Middle East. Collectively, these agreements represent potential milestone payments exceeding AU$458 million, underscoring the growing commercial interest in DMX-200’s potential to address an unmet medical need in FSGS.

Clinical Progress: ACTION3 Phase 3 Trial Recruitment Complete

On the clinical front, Dimerix has successfully completed recruitment for Part 2 of its pivotal ACTION3 Phase 3 trial, randomizing 154 patients with FSGS. This milestone triggers the next blinded interim analysis scheduled for Q3 2025, a critical data point that could validate DMX-200’s efficacy in reducing proteinuria, a key surrogate marker for kidney disease progression.

The ACTION3 trial is a global, multi-centre, double-blind, placebo-controlled study evaluating DMX-200 as an adjunct therapy to standard angiotensin II receptor blocker treatment. The trial’s design and ongoing recruitment across over 170 clinical sites, including specialist paediatric clinics, reflect Dimerix’s commitment to robust clinical evidence generation.

Financial Health and Operational Efficiency

Dimerix ended the December 2024 quarter with a strong cash position of AU$21.11 million, bolstered by a $7.9 million R&D tax incentive rebate and net operating cash inflows of AU$1.83 million. Importantly, this cash balance excludes the imminent AU$3.1 million upfront payment and AU$4.1 million first milestone payment from the Fuso agreement, expected in Q1 2025, as well as potential proceeds from outstanding options exercisable by mid-2025.

Operational expenditures during the quarter were primarily directed towards clinical and chemistry, manufacturing, and controls (CMC) costs associated with the Phase 3 study. The company’s ability to maintain positive net operating cash flow amidst significant trial activity signals prudent financial management.

Looking Ahead: Partnering and Regulatory Engagement

Beyond Japan, Dimerix continues to attract strong partnering interest for DMX-200 in territories yet to be licensed, suggesting further deals could materialize. The company is also actively engaging with regulatory authorities, including the FDA, to align on appropriate proteinuria endpoints for the ACTION3 trial, a move that could streamline the path to approval.

Additionally, the open-label extension study following the ACTION3 trial offers patients continued access to DMX-200 and provides valuable long-term safety and efficacy data, further de-risking the program.