Spago Nanomedical AB (publ) (STO:SPAGO)
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Life Science Summit 2025

Nov 17, 2025

Mats Hansen
CEO, Spago Nanomedical

Really nice being here in Lund, in our home turf, presenting. I do not promise a cinematic experience, but at least I'm going to present Spago Nanomedical and our technology to expand the use of effective radiopharmaceutical cancer treatment. Very briefly about us, we are operating based on a platform technology that can be used to deliver medical ions to tumors. I will dwell into that a little bit more later, but our focus is on radiopharmaceutical treatment of cancer. We operate out of Sweden here in Lund, but also increasingly in Australia, where we are conducting our clinical development program at this very point, and we're listed at Nasdaq First Growth . I'm going to spend this presentation mainly on our development program, Tumorad, which is a clinical stage radiopharma program that we believe offers potential to treat several different types of tumors.

First of all, let's take a step back and have a look at radioactivity and the use of radioisotopes for treatment of cancer. As you probably know, all of you, radioactivity has been established for a long time as a very effective means of treating cancer, and it's one of the main pillars of basically all cancer treatments, even to this day. In the past decade, what has happened is that we've really seen a surge when it comes to bringing radioisotopes into the body and into the tumor tissue within the body. In that way, we've seen very effective new treatments coming out, being able to treat also metastatic disease and disease that is present in areas where it may be difficult to treat with other means, like external beam radiation. This field is really growing now.

What we've also seen in the past few decades is that nanomedicine has proven itself as a way of delivering already known effective therapeutic in a better or safer way to tumor tissue. With that in mind, we believe that with the growing numbers of cancer patients, there will be an increased need to combine these technologies in a way so that we maximize the potential seen with radioisotopes and being able to treat many different kinds of tumors. Looking at the radiopharma field as a whole, it's a very active field. There's a lot of M&A going on over the past years. We've seen an increasing number of the big companies stepping into this area, obviously driven by the fact that everybody knows that if you can get a radioisotope to the tumor, there will be effect.

The trick is to do it in a safe way. This technology is usually complementary to other types of treatment, so it can be added on or included in treatment regimes. We've also seen with the agents coming out that there is blockbuster potential even in single indications. There is a but, what we see now is that these agents are being used in very few indications. Basically, it's prostate cancer and neuroendocrine tumors, as you can see from the table here. What we'd like to achieve, and the challenge we face or the field faces, is the lack of molecular targets, really, and the kind of incapacity to develop stable radiopharmaceutical constructs that are able to be delivered to the tumors. Our solution to this is called Tumorad.

This is where we use our platform technology to combine nanomedicine with radioisotopes and deliver effective radioactivity to tumors through a well-proven mechanism and a medically proven isotope. Our platform technology provides for a new type of unique radioisotope therapy. It's independent of molecular targeting. Our particles are designed to optimally accumulate and be retained in tumor tissue within the body. In this way, we maximize the use of the clinically effective radiation that is being emitted by the therapeutic isotope that we use, namely lutetium-177, which is already on the market in other agents. On top of that, we have the potential to visualize the distribution of this agent in the body through imaging of the radioactivity. I think what we have here is something that may provide for expanded use of something that we already know is clinically effective. Where are we?

The clinical program is ongoing. As I said, we are mainly focusing on Australia right now. We are running the clinical trial Tumorad-01 at two clinical sites in Australia. I can talk a lot about that, but I can say very briefly that it's been a very good place to be in to run these types of studies. Recently, we announced that we had significant tumor uptake of our particles in a certain type of tumor. This is really a first proof of concept for us, and we are really, really happy about this. This is kind of a breakthrough for the program and for Tumorad. We have also shown that we have an acceptable safety profile over 10 different tumor types and three different dose levels so far. We are now progressing the trial with dose escalation in even further patients.

Obviously, we have a solid preclinical package from before, and we also importantly have an established manufacturing process, which is very important with radiopharmaceuticals, not the least that you have a stable product that does not kind of let go of the isotope in the body. This all works very well, including the logistics to patients. What we are facing now is we are continuing the clinical trial towards MTD and obviously want to identify clearly a dose for the coming phase two studies. Also, based on the findings that we recently have, and I will come back to that, we are exploring opportunities for accelerated development in the coming steps, including orphan drug track. For that, we are obviously seeking scientific advice. I should say also that the phase IIa part of the study is already included in the clinical protocol that we have.

What we see is we have probably significant market opportunities across multiple tumor types. This is just three examples where we have preclinical or clinical evidence already. I would like to draw your attention to the very last one here, adenoid cystic carcinoma, which is a rare type of cancer, mainly affecting women. It is lethal, at least in the recurring stage, and there is basically no treatment today. There is no gold standard. The options for these patients are very poor, and they ultimately die quite soon. We think this offers a true medical need and a great opportunity to accelerate the Tumorad development program.

For that, we are now raising capital to take us to the next step, mainly progressing the phase I trial and by dose escalation, but also to prepare for phase IIa, especially looking at this potential for accelerated development tracks. I should say we are very, very happy to have strong backing of our current owners, and the subscription period is ongoing now. With that, I think maybe not cinematic, but at least I think we stand out in this field. We know that radiopharma is effective. We have Tumorad that provides for a new type of delivery, which could expand the whole field. We also have the ongoing clinical trial that already provided good results and supportive results to proceed. We have some really interesting near-term milestones coming up. Thank you very much for your attention.

Operator

We'll get straight into some questions about the clinical results that you were just talking about. The safety profile was acceptable, as you said. How can you translate that into a commercial advantage in this space?

Mats Hansen
CEO, Spago Nanomedical

I think with Tumorad, we're coming from a different angle compared to the agents that are on the market, which are mainly based on small molecules. This is a large article. The safety profile we see so far is clean, relatively. We see some effects on the blood platelets, but other than that, we do not see the effects or adverse effects that are seen with other agents on the market.

Operator

You prolonged the phase one program. Someone here is giving you the opportunity, I will say, to address investors who may not have been pleased by that decision. What would you say to them?

Mats Hansen
CEO, Spago Nanomedical

I would say we're building a lot of value now. We are definitely at the stage where we could progress the trial to a higher dose level, which in itself is actually a very good thing because that means that we so far, at least, have a safe product or with acceptable safety. I wouldn't be too unhappy. We rather build value, and we continue to build value as we progress.

Operator

Thank you so much, Mats.

Mats Hansen
CEO, Spago Nanomedical

Thank you very much.

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