Over the past few years Dimerix (ASX:DXB) has established all the building blocks in place to commercialise DMX-200 (known in some markets as Qytovra). DXB has gathered extensive clinical data, signed 4 commercial arrangements which provide not just paths to market but also validation and sources of non-dilutive funding in signature and milestone payments (up to $1.4bn).

Dimerix has all patients enrolled in ACTION3, and crucial FDA guidance

Dimerix’s Phase 3 trial (ACTION3), if successful, will likely be the final trial prior to commercialisation against FSGS. In mid-March 2026, the last adult patient recruited into the study was dosed, bringing the final enrolment to 333 patients and setting the 2 year clock ticking for the full study. The company also announced plans to conduct blinded statistical powering analysis of the primary endpoint of the study in March, with outcomes expected in April 2026. This review is important, as it looks to confirm the statistical powering assumptions made
at the start of the study, and if appropriate, could lead the company towards a potential early regulatory approval submission prior to the study’s completion.

A big market opportunity with FSGS

Dimerix has a significant opportunity with FSGS – a rare kidney disorder that is characterised by progressive scarring (sclerosis) in the kidney’s filtering units. There are no therapies specifically approved for FSGS in the US, any treatments on the market only attack symptoms rather than root causes and the disease can progress rapidly to the point where a kidney transplant is the only solution, and even then, recurrence is highly probable (it occurs in up to 60%) of cases. In our model, we believe there is a market of over 200,000 people in all of Dimerix’s approved markets and even a small market penetration (we assumed an average of 6%) could lead to a significant market opportunity.

Valuation of A$1.63-2.16 per share

Our valuation per share is $1.63 in a base case and $2.16 in a bull case, representing market capitalisations of $980-1,294m respectively. Our valuation was previously A$1.65-A$2.17 per share and has been adjusted to account for Dimerix’s changed cash balance since our last note, which has reduced but is still a healthy $38.5m. As before, this assumes successful commercialisation of DMX-200 and all that all promised milestones consequently eventuate. Please refer to pages 12-14 for more details on our valuation and the key risks to our thesis.