Radiopharm Theranostics (ASX:RAD) receives FDA designations for DUNP19

Radiopharm Theranostics (ASX:RAD) receives FDA designations for DUNP19


Radiopharm Theranostics Limited (ASX:RAD) CEO and Managing Director Riccardo Canevari discusses the FDA's award of orphan status and rare paediatric disease designation for the company's DUNP19 technology.

Tim McGowen: We're talking today with Radiopharm Theranostics (ASX:RAD). The company has the ambition to become a recognised leader in the development of radiopharmaceutical products for both diagnostic and therapeutic areas in areas of high unmet medical needs. If you don't know the company, it's ASX code RAD, market cap around $47 million. We have with us Riccardo Canevari, who is both the Managing Director and Chief Executive Officer. Riccardo, welcome to the network. Thanks for your time.

Riccardo Canevari: Thank you, Tim, for having me.

Tim McGowen: Now, Riccardo, Radiopharm has had a number of price-sensitive announcements over the last couple of weeks in September, and these are all in relation to the treatment of osteosarcoma, which is one of the most common types of bone cancer. Can you talk through the significance of these announcements?

Riccardo Canevari: Absolutely, Tim. So, there's been two very important announcements, because coming from FDA is a recognition of our request to be recognised as a high-potential therapy in this area. So, we received first the FDA designation as orphan status. That, of course, is very important. It's coming with multiple financial benefits for the companies. It's coming also for seven-year market exclusivity when you launch.

But it is also important because now that we are planning to submit requests for starting clinical trials, FDA will be, of course, in a very positive position, of course, to assess our product, DUNP19. And after a few days, we received the Rare Pediatric Disease Designation. Price-sensitive announcement because, of course, it's a big unmet medical need for the younger population. Also, sarcoma is a very tough type of cancer. Unfortunately, today you only have surgery and chemotherapy, and these patients and their families are in desperate need for something new. So, the recognition from FDA is, of course, very important. Equally, we would be supported by FDA when we present our trial design and our approach to bringing this therapy to accelerated approval process. So, very important.

Tim McGowen: Riccardo, the FDA has granted this kind of Rare Pediatric Disease Designation for your DUNP19 technology. This can be incredibly valuable for the company as well, can't it?

Riccardo Canevari: Yes. In addition to multiple benefits that I mentioned before, there is also potential very high financial benefit, because every company that has this so-called voucher can decide to use it to further accelerate the marketing approval, or can be transferred or sold to other companies. We do have recent examples in the last three, four years and on average the voucher was sold from $100 million to $130 million. So, it's still a long way to go there, but, of course, is a very potential high value for the company.

Tim McGowen: And with your therapy, what's the size of the addressable market we're talking about?

Riccardo Canevari: So, osteosarcoma is a rare disease, so the prevalence is not extremely high, but at the same time, there are no therapies. So, we are talking about the potential to be either the first to market or the best-in-class targeted therapy, because there are no targeted therapies today. So, really, the first that can have the opportunity to launch in this market can have a significant premium as recognition.

Tim McGowen: Riccardo, what are the next steps? I mean, this can have a long time frame. Can you talk through what the next steps are for Radiopharm over the next 6 to 12 months?

Riccardo Canevari: We have multiple programs. So, we have nine molecules that we are working on, and we want to take them to clinical tryout. In very few months from now, we plan to start four clinical trials, two in Australia, and two, we are waiting approval from FDA to start in US. So, four trials to start Phase 1 in the next few months. But, also, we have an important readout. We have an imaging trial that is a Phase 2 that is going to readout in the next few weeks. So, really, we have a lot that is happening and ongoing. And, Tim, of course, I cannot avoid to mention our announcement of last week where Radiopharm Theranostics, together with MD Anderson, the number one cancer centre in US, decided to form together a joint venture. In this joint venture, the objective is really to bring at least four new extremely innovative radiopharmaceutical products to the market. We are very excited, first of all, that we have been selected by MD Anderson and secondly, to work with such a great team of scientists to bring innovation to patients.

Tim McGowen: Riccardo, always nice to talk to you. Thanks for your time.

Riccardo Canevari: Thanks a lot, Tim.

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