RADIOPHARM THERANOSTICS LTD (RAD) - When Earlier Detection Becomes Better Survival

A scan that finds brain metastases earlier could change the whole treatment timeline, and that is exactly what we dig into with Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. We walk through how a clinical-stage ASX biopharmaceutical company designs radiopharmaceuticals for oncology, and why “theranostics” is more than a buzzword when patients need faster, clearer answers. 

Riccardo breaks down the company’s two-platform approach: small molecules for imaging that can penetrate tissue and light up tiny tumours, and larger antibody-based therapies that stay in the body long enough to deliver a targeted radioactive payload. We talk about RAD 101 and its interim Phase 2B results in recurrent brain metastases, including strong concordance with MRI and the bigger goal of proving clinical value by detecting more disease earlier. Earlier detection can mean earlier treatment, which can ultimately mean better outcomes. 

We also cover the first patient dosed in the Phase 1 RAD 404 study for advanced prostate cancer, using a Terbium‑161 radio labelled antibody designed to damage cancer cell DNA. From there, we zoom out to the broader pipeline, including ongoing Australian studies such as RAD 202 and RAD 204 across lung and breast cancers, and how the team thinks about prioritisation when multiple trials are running at once. Finally, we look at next steps towards a pivotal Phase 3 program, FDA alignment, and what fast track designations could mean as the company moves towards late-stage registrational pathways. 

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Transcript

Andrew Musgrave

Welcome back to ASX Briefs, where we explore the companies’ making waves on the ASX. And today we're joined by Riccardo Canevari, the CEO and Managing Director of Radiopharm Theranostics, a clinical stage biopharmaceutical leader developing oncology radiopharmaceuticals to address high unmet medical needs. Riccardo, great to have you with me today and welcome to the ASX Briefs Podcast.

Riccardo Canevari

Thank you very much for having me.

Andrew Musgrave

Now, Riccardo, for those new to the Radiopharm story, could you provide an overview of your platform technologies which span peptides, small molecules, and monoclonal antibodies and how they differentiate you in the global oncology market?

Riccardo Canevari

Sure, happy to simplify this story. So, we have two platforms. We have an imaging platform, and for this imaging platform, we use small molecules. Because the objective is that this small molecule really needs to find even the smaller tumour and highlight where they are. So, you need something small able to penetrate and go with the tumour is. For our therapeutic platform, on the opposite, we use monoclonal antibody or nanobodies. And the reason is that you need a molecule that goes to the tumour as the time to create uptake to kill the tumour cells and then to be released. So, you need something that stays longer in your body. For this reason, having two platforms, we use different molecules.

Andrew Musgrave

Now you've just released your second interim analysis for the phase 2b trial of RAD 101 in brain metastases, showing a 90% concordance with MRI imaging. So how does this result validate RAD 101's potential as a primary diagnostic tool for the 300,000 patients diagnosed annually in the US?

Riccardo Canevari

Look, we are excited. We have seen the first interim analysis, then the second interim analysis, and now we are close to present the final data read out. And these data are giving us the confidence to go and start a phase 3 registrational trial. The objective is to show that today's standard of care is MRI for diagnosis of recurrent brain metastases. But what our process is showing and needs to confirm in phase three that if, in addition to MRI, you use RAD 101, you can find earlier and more metastases in your brain. This is very important because it gives the opportunity to the patient to be treated earlier, and if you are treated earlier, you improve your probability of having a better and longer life. So, I'm really excited there.

Andrew Musgrave

Now, beyond RAD 101, you've just announced the dosing of the first patient in the phase one study of RAD 404 for advanced prostate cancer. So, what makes this Terbium-161 radio labelled antibody for potential first-in-class treatment compared to current standards of care?

Riccardo Canevari

Look, we are very proud to conduct this trial in Australia where we know there is limited availability of radiopharmaceutical molecule. RAD 402 is for patients with advanced prostate cancer, and we are using an isotope called Terbium-161 that is doing something important, is at the same time safe at the right dose and very potent in killing the cancer cell by destroying the cancer cell DNA. So, we are excited about this trial that just started in Australia, and we are looking forward to treating an important number of patients.

Andrew Musgrave
 
 Now with multiple trials running concurrently, including the RAD 202 ‘HEAT’ trial and the RAD 204 study for lung and breast cancers, how are you prioritizing your pipeline to ensure meaningful data readouts throughout the remainder of 2026?

Riccardo Canevari

Well, I'm pleased to say that also RAD 202 and RAD 204 are ongoing in Australia. So, we have the opportunity to treat patients in our clinical trial. I have to say that the team did a great job in allocating the trial to clinical centre that has patients in high need. And so, the recruitment is going extremely well. So, we feel very confident that we conduct this trial in parallel and to have the phase one data to really decide which of these molecules is the one with the highest value. But for the time being, we are very keen to do the three trials together.

Andrew Musgrave

And looking ahead to the final data readout for RAD 101 expected by June, what are the next steps for transitioning into a pivotal phase three trial?

Riccardo Canevari

We are already working on it. So, first of all, is to have the molecule ready from a late-stage development trial, and we have done it. Probably the most important next step is to have a meeting with FDA to align on how many patients the phase three trial should be: 150, 200, something around that number, and to agree on the trial design. So, this is already planned. So, we think that with releasing the primary endpoint of the study in June this year, we can work to ensure that we are ready to start the phase # by the end of 2026.

Andrew Musgrave

Now, finally, Riccardo, with FDA fast track designations already in hand for several assets, how do you envision Radiopharm evolving over the next 12 months as you move from early-stage clinical data to late stage registrational pathways?

Riccardo Canevari

Yeah, look, it's a great moment for the company. We had the opportunity to finish all the pre-clinical work and to move to no clinical stage and late clinical stage development. So, in the next three, six, and nine months, we really expect a lot of clinical data that we are willing to communicate to the market. So, we think that the rest of 2026 will be very exciting.

Andrew Musgrave: 06:48

Okay, Riccardo. Well, it's been great to chat today to get an update on where the company is at. So, thanks for your time, and we look forward to further updates from Radiopharm Theranostics in the upcoming months.

Riccardo Canevari

Thanks a lot, Andrew, for having me.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.