Some edited extracts below from the interview transcript.
-------------------------- Nina Webster: 17:24
The key thing for us in any rare disease is recruitment. So one of the things that we're very much focused on, we're opening clinical sites in additional countries and including in we're already in. So we'll be in 16 countries, opening another 100 clinical sites, and that is to really make sure that we mitigate that risk in recruiting those patients.
Rachel Williamson: 17:43
Will you need to raise again, um, before commercialization activities start? Nina Webster: 17:48
No. So we've got no plans for any capital raise now, we are, uh, we completed the capital raise in March of this year for A$20 million, and at the end of that March quarter we had A$35 million in cash. So those funds will not only support that Phase 3 program right the way through, but puts us in a great negotiating position with potential partners.
Rachel Williamson: 18:08
Let's talk about those two licensing deals that Dimerix has done for its FSGS drug. For our listeners, these are the cliff notes: one licensing deal is with the UK's Advanced Pharma and it covers most of Europe, Canada, Australia, and New Zealand. It's worth A$230 million, plus royalties. The other is with Middle East pharmaceuticals distributor Taiba, and it's worth A$120 million, plus royalties. But I understand Nina, you have other deals waiting, particularly for the important us market. What are they waiting for? Nina Webster: 18:50
One of the key things for us is that because we're the only candidate in Phase 3, we really have a lot of interest and potential partners around the world in all those other territories. We have made it public we do have term sheets on the table. We're in negotiation with other parties. The key priority for us is going to be US and China, given that those are the largest markets and collectively they could be worth 70% of the global opportunity. So a lot of potential upside to come.
Rachel Williamson: 19:15
What data are they waiting on in order to sign. Are they waiting on data or is it purely just negotiations that you have to undergo to get these across the line? Nina Webster: 19:26
No, so not waiting for any data. We deliberately have not pushed the US deal component, given that we felt that was the largest opportunity until after we got that interim analysis, which happened in March. That was something that we felt having that data put us in the best negotiating position, because not only do we have a magnitude larger cohort, but to confirm what we saw in the Phase 2 is what we expect in the Phase 3, but also that funding position that we put ourselves into in March as well meant that we're in a very strong negotiating position. So that was a strategic decision.
Rachel Williamson: 19:57
The US is nearly every biotech's target market because of the sheer size of the health market there. But also in your case, FSGS is much more common amongst people with African ancestry, so it's easy to see why you're aiming for the US. But in China, FSGS rates are much lower. What is it about that country that's appealing for licensing and commercialisation? Is it just the size of the market or is it something else as well? Nina Webster: 20:29
Yeah so I think two things. There is the incident rates for FSGS around the world are actually pretty uniform across territory to territory. Um, so it's actually a global issue affects children down to two years old as well as adults. You're right, there is a marginal increase in the black men population, but overall country by country is actually the same incidence rate.
So in China, they have the largest kidney disease issue in the world, and a large component of that is the glomerular nephritis, which FSGS falls into. So it's a very interesting target market, particularly given citizens in China do get free access to healthcare and then the treatments that come with that as well. And typically in orphan disease, which you can get exclusivity periods for in China of up to six years as well, uh, they typically follow European pricing. So it could be a very attractive opportunity.
DXB Price at posting:
44.5¢ Sentiment: Hold Disclosure: Held
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