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Radiopharm Theranostics Limited (ASX:RAD) CEO and Managing Director Riccardo Canevari discusses the company's upcoming plans to list on the NASDAQ and provides an update on its clinical trials.
Tim McGowen: We're talking today with Radiopharm Theranostics (ASX:RAD). If you don't know the company, it's got an ASX code of RAD and a market cap around $45 million. The company has the ambition to become a recognised leader in the development of radiopharmaceutical products for both diagnostic and therapeutic uses in areas of high unmet medical needs. We have with us the CEO and Managing Director — we welcome him back — Riccardo Canevari. Riccardo, nice to see you back in Sydney again. Not a bad day outside, hey?
Riccardo Canevari: Thank you. It is fantastic to be here.
Tim McGowen: You've just recently announced the intention to have a secondary listing on the NASDAQ market. Is that to help you get access to US investors and capital?
Riccardo Canevari: Well, we are very excited. Now, we have a number of loyal Australian investors that we really want to take care of, and our place will always be Australia. But we do believe that having access to US biotech funds is important. And, speaking with some of them, they tend to say that they don't always have the possibility to invest in stock on the ASX or abroad. They don't like their trader to wake up in the middle of the night to follow other markets. So they always told us, "Okay, come back when you are listed here and we will have more to discuss." So, I believe it's an opportunity for Radiopharm Theranostics to have more exposure, both to analysts for the stock coverage as well for our future needs for US investment funds. So, we are excited.
Tim McGowen: It certainly makes sense. Now, right at the end of last year, you announced you'd received USFDA approval or Investigational New Drug Approval as they call it, IND, which is allowing the company to start an imaging trial or start a phase trial for patients with pancreatic cancer. Can you talk us through the next stages and the significance of that announcement?
Riccardo Canevari: Yes. It was the last week of December. We got FDA IND approval for our imaging Phase 1 trial in pancreatic cancer. And this is very important. When we speak to a physician, they always tell us, "Too long time without innovation in the field. We really need to have better tools for early diagnosis of patients with pancreatic cancer because if we do have early diagnosis we can really treat them and we can do more and have better outcomes." So, this is the space where we want to be with our imaging agent. Now that we have FDA approval to start, we have already set up our clinical centre. It will be in New York City. We do have a radiopharmacy that is delivering the products next to that clinical centre. We are finalising the supply chain logistics. We do believe this trial is going to be fast. Enrolling is only nine patients. That's what FDA asked us to do. So, we believe that we can start around April and the trial possibly will be completed about July or August of this current year. So this is going to be very fast to report back the results of our Phase 1 trial.
Tim McGowen: And when we last spoke, when you were last in Australia, we spoke about your Australian trials in lung cancer. Can you talk us through the next stages with that?
Riccardo Canevari: So, lung cancer, as you know, is a large disease area. Unfortunately, many patients are suffering from non-small cell lung cancer. There are good therapies outside the checkpoint inhibitor, but some patient do not respond to those therapies. So, there is a space for having new mechanisms of action, new approaches to therapies. And this is going to be our first therapeutic trial. We already have an agreement with GenesisCare as a CRO to conduct the trial. We have identified the centre. So, the last step we need to have is to conclude our preclinical biodistribution study, and we plan to submit a request to the ethics committee to start the trial around April or May this year. Again, we are going to have a very busy summer — I mean American summer — with the trial to start. But it is exciting to be with a therapeutic option for patients in non-small cell lung cancer here in Australia.
Tim McGowen: And it's obviously extremely important work the company's undertaking in pancreatic cancer and lung cancer. What's 2023 look like in terms of the sort of milestones you want to achieve?
Riccardo Canevari: I would say that, in addition to the opportunity to start the trial in pancreatic cancer and the trial in non-small cell lung cancer, we are also discussing with the FDA our next step for our imaging agent in brain metastases. We reported at the end of October 2022 a positive Phase 2a trial. So now we are discussing with the FDA what is the next step. Can we go directly to Phase 3 and start an imaging Phase 3 trial in patients with brain metastases? It is an important area. Usually patients are using MRI to detect the metastasis, their problem, but MRI has some limitations. So, having an innovative imaging agent that can help oncologists to better follow up on the brain metastasis is very important. So, in 2023, we are going to have two Phase 1 and potentially one Phase 3. And these represent important milestones for the company, but also an inflection point. So, we are very committed to execute on our plan on these three projects.
Tim McGowen: And do you think for investors who are potentially looking at the company for the first time, it's almost like you've got a portfolio approach? Is that the best way to look at it from a risk perspective, there are a number of opportunities with your drugs and therapies?
Riccardo Canevari: When we created the company, we always thought that we'd like to have a broad pipeline. We didn't like the idea of having one molecule that can bring to a binary result, positive or negative. And that's why we build a strong pipeline. We have six different technologies. As we are a small company, we want to go step by step. We want to be cautious of our cash expenditure, so we go in waves. The first three waves is what we just described. But, the future, we have other molecules in our pipeline for our wave two that I would say, probably at the end of 2023 or beginning of 2024, is going to start.
Tim McGowen: Riccardo, thanks for your time. Always nice to see you in Sydney.
Riccardo Canevari: Thank you. It's amazing to be here. Thank you very much.
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