Quarterly Appendix 4C and Activities Report

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Stock Dimerix Ltd (DXB.ASX)
Release Time 25 Jul 2025, 8:35 a.m.
Price Sensitive Yes
 Dimerix Announces Quarterly Activities and $1.4B in Potential Deals
Key Points
  • Signed $590M license deal with Amicus Therapeutics for DMX-200 in US
  • Received $48M upfront payment and up to $1.4B in potential milestone payments across 4 deals
  • Positive FDA meeting confirms proteinuria as acceptable endpoint for US approval
Full Summary

Dimerix Limited, a biopharmaceutical company developing innovative therapies, announced its Appendix 4C and Quarterly Activities Report for the period ended 30 June 2025. Key highlights include:- Dimerix signed an exclusive licensing agreement with Amicus Therapeutics for DMX-200 in the United States, worth up to $590M in upfront, milestone and royalty payments.- This was the fourth licensing deal for DMX-200, with the collective deals potentially worth up to ~$1.4B in total upfront and milestone payments, plus royalties.- Dimerix received a $48M upfront payment from the Amicus deal and a $4.2M milestone payment from its Japanese partner Fuso.- The company had a strong cash position of $68.3M at the end of the quarter, with net operating cash inflows of $45.6M.- Dimerix confirmed with the FDA that proteinuria is an acceptable primary endpoint for US approval of DMX-200 in Focal Segmental Glomerulosclerosis (FSGS).- The ACTION3 Phase 3 clinical trial of DMX-200 in FSGS continues to progress, with over 219 patients randomized to date across 190 activated sites globally.- Dimerix is well-funded to continue the ACTION3 trial and is also assessing potential new R&D pipeline opportunities.

Guidance

Dimerix may become eligible for up to ~AU$1.4 billion in total upfront payments and potential milestone payments, plus royalties on net sales, across its four licensing deals for DMX-200.

Outlook

Dimerix remains focused on patient recruitment into the ACTION3 Phase 3 clinical trial for DMX-200 in FSGS, as well as pursuing additional licensing opportunities in territories not already covered by existing deals.