Modus Therapeutics Holding AB (publ)

Welcome to today's live interview with Modus Therapeutics. I'm joined by the company's CEO, John Öde, as usual. John, you have published your Q1 report here this morning. I thought you would briefly give your view on the work during the first quarter and what you see as the highlights during the period.

Thank you, Martin. I think it has been very intensive. We have made very clear progress that makes us say that we are on track with the study that we are conducting in malignant patients. Our track consists of completing the recruitment in the first part of the study. In addition, we saw during the March month that the recruitment in phase 1b, the study in severe malaria, which then has a room in Kenya and Zambia, is completed. And that opens up opportunities for us to work further with that strategy and see how we move forward with our collaboration partners towards the next step in that development. And also, I think we have seen that our portfolio renders interest outside of the typical spheres where we have, for example, participated. I got the opportunity to participate in a global roundtable. There is a number of important diseases, tuberculosis, malaria and HIV, and technical innovation in this area, which the world was divided by Global Fund and Swedish UD. These are some highlights, but as I said, it was a very successful quarter in a very good way.

Upplever du att intresset kring er forskning också ökar- om man ser mot bakgrund av det som sker nu i USA- med att man drar tillbaks finansiering för olika projekt? Jag tänker framförallt malaria då kanske. Och HIV finns ju där också. Men ser du att det ger ringar på vatten för er del- att det är större intresse för er forskning inom området?

Allt som visar ökat intresse för global hälsa- och sätter... Spotlight on that issue makes us look at what there is for future, more effective treatments and better ways to take care of patients in this area. And then it becomes such an issue that we come more in the broadest light. And it is very important for everyone who operates innovation in areas that otherwise may go under the radar. If we start with... We have to prefer a world where... important contributors that the United States could maintain. At the same time, I am convinced that this situation will be rebalanced. This will continue to be an important problem for the whole world. Among other things, climate change, climate change means that This type of problem, especially for malaria, is at risk of not stopping where the problem is the largest in the world. This is a global problem.

Could you give us a brief overview? The CKD study is the one that you are most focused on right now. Where are you? What is the next step? This is part one of a two-part study, so to speak. And what is required to get further in this study?

Yes, exactly. As I said, the central part in part one is that we follow the recruitment. The goal with the first part is basically two things. Firstly, that we should be able to see the effects of the drug in the blood and how it is affected by different levels of kidney failure. For us, it is simple. So when we have done that, then we can say that we have the trigger to move on to part two. What we do with the data is that we send them to the authorities and say, now we suggest these three dose levels, depending on what light weight the patients have in the longer treatment part, which is part two. So recruiting is central in this part of the study, you could say. And there, as we have been able to say in the Q3 report, we are on track. And we are very happy about that. And how does that look? We estimate that within this half year, we have been able to complete the recruitment. This means that we can update part two of the study and be able to start it as we have agreed at the end of Q3 and Q4. We are on with part two. And here it is important to say that we have been very clear that in the meantime it is required that we increase the funding to be able to start part two of the study.

And a short comment on how you see the financing part, that is, will it happen in partnership with someone or will it be done through an emission or how do you think?

The advantage with our model is that we have a portfolio where we have our our access, but who work in three different areas and in this way have a wider range of interests. So while we are conducting studies in chronic liver disease, we have a data package that we can discuss partnering with when it comes to sepsis, for example, where we use the data we have from the previous study that we did. sepsis. Det gäller förstås också att vi kan ha den typen av diskretationer inom alla tre områden, malaria, njursjukdom, anemi och sepsis. Det här gör att en möjlighet till finansiering för oss är ju förstås att få ett partnerskap och en co-development runt det och som då hjälper oss att driva ut without having to finance the market. At the same time, up to now, we have had the opportunity to get bridge financing loans from our large and long-term owners, Karolinska Development. This is also a very important part of this balance. Yeah.

Just your comment on the malaria study, SEWU-SMART, how does the development look ahead? You can't control everything in the project, I know, but you have completed patient recruitment and what will be the next step from your point of view?

Nästa steg är ju att man rapporterar av den här studien och parallellt med det försöker i konsortiet, i samarbetskonsortiet identifiera stöd för nästa steg i utvecklingen som ju då är en fas 2-studie, en kontrollerad fas 2-studie. Och fördelen med det här upplägget är ju förstås att We want to keep the development costs minimal. Trade-off means that we control the project a little less. But since we support the project and the consortium with access to the system, we can also share the benefits of data and so on. And since we have the first data on severe malaria, we can start looking at what types of regulatory steps we can take to start set in place, how much will this take malaria further. Among other things, one can say that severe malaria is an orphan designation or a rare disease in our part of the world, USA, Europe. And those who have malaria preparations on the market also have that type of special treatment. status i de här länderna det är en väldigt bra inkörsport och en väldigt intressant situation där de data vi delar med vårt konsortium hjälper oss att kunna driva den typen av regulatorisk verksamhet så att utöver så att säga en framtida i det fall vi har en framtida framgångsrik utveckling But on the other hand, there is also the possibility to go to European and American markets.

And the work in sepsis, you haven't commented that much at the end, but it's a planning phase before 2026, as I understand it, for phase 2a, possibly.

And there you can say that we have a portfolio where we focus on one thing at a time, or at least our own efforts with malaria, which is So it's about that other business research in collaboration with us. And when it comes to sepsis, we already have clinical data from our previous study. And there we develop business at the same time as we develop the next study. So right now the focus is on... to carry out partnership work on the SEPC side, and at the same time see how the next study is going to look like. So that's planning. Of course, this is time-consuming work, but this is how we distribute our resources in order to maintain maximum benefit of our portfolio.

You are going to present data here at the Bioiron Congress. What is important with this presentation? What are you looking for in that context?

Before we start, we have the feeling that we will continue on the same track and present data at the European Hematology Association Conference in Milan. And both of these presentations are about the same project. The focus is on animal violence and anemia. And what we want to achieve with that is that the clinical data we generate goes hand in hand with the mechanistic data. So that those who look at regulatory authorities, those interested in possibly taking over a project, they always look at these two together, so to speak. Kliniska data ger den ena delen att förstå varför det blir så, är den andra delen, och ger en väldigt viktig tilltro till att det vi ser i kliniken är riktigt. Så de här två går väldigt mycket hand i hand. Därför skulle jag säga att mekanistiska data i bra djurmodeller, som vi har i det här fallet, de adderar på ett tydligt sätt värde till projekt. And in this case, we have an update on BioIron, on the model of animal protection in mosquitoes and anemones. And in addition, at the EHA meeting, we plan to explain more about what we see and how we believe that the mechanism works when animal repellents are protected. And we think that's very exciting. It's a clear step. Earlier, we looked at the mechanisms for how anemia is addressed, but we have seen the preclinical observations that the neurons also seem to be better, they filtrate better, the tissue looks better. Now we have started to see the mechanisms behind it, and that's what we're going to talk about at EWA in June.

Related to that, can you explain to me a little bit about the CKD anemia market and the competitors there? I understand that they are quite significant. I had a question regarding how you differentiate yourself with CWP in this context and what you add to what already exists, so to speak.

Yes, there is a type of help that does not exist, so to speak. Our effects that we look at come first and foremost to their right. when you look at the standard treatments that exist today, where these giants that we are talking about are active, what they can and cannot do. And these mechanisms that we are looking at are primarily very important resistance mechanisms against standard treatments. So we continue where the limitations exist in the area today. And the advantage of that is that this area That's why the giants are there. It's a large and important commercially mature and large commercial area. You can also look at these segments, that they are really clear and important. Then you can also see that some parts of the standard treatments do not work so well in all animal conditions. Neither those that stimulate the bone marrow, which is called ESA or erythropoietin, And then also advanced brain preparations that boost the brain tissue. Both of them are affected by these resistance mechanisms that we look at. For example, we usually talk about the molecule hepcidin. It is very involved there and therefore it is important that we can reduce hepcidin in these cases. So we place ourselves where the others are not or where their limitations exist. And they are well-defined because the market is like that. And the patient segment is so well understood.

But can you say that it is an advantage that the landscape looks like this? Because you still have a strategy that goes out on eventual licensing or purchase of the company. It should be an advantage that there is actually a big competition and that there are perhaps parts missing.

Yes, because the competitors understand what these needs that need to be met are. Precisely. There is a good understanding of the needs that remain.

If you look at the way forward, what is the big value driver for you in the near future? Then maybe I don't think specifically about the share price, but the derivatives of the value for the company is also the share price. What will drive your development forward in the near future?

For us, in terms of development, it is of course to get started with part 2 of the study. But then it is mainly the reading of part 2, which we then see somewhere at the end of 2026. And that's where the really exciting parts happen. And here we have the advantages. If you think about your previous question, and the other areas where the risk is greater, we have advantages in this area. And that is also one of the reasons why many are bred in the animal and animal safety area. Endpoints and reading is very well-defined. We measure blood value, we measure the iron value that goes into the blood cells. We can measure all this very well-defined. And there we balance this area, our irrigation, which for example sepsis does, where you break new ground, where the conceptual risk is much greater. But maybe the presence and the upside are less well-defined, but much larger. So you take a higher risk with higher returns. Here you have a very well-defined risk that is described and addressed by the measured value that is very well-defined. And at the same time, a market that is so large that it is still a fairly important part of this market. So therefore, we see that the measured values that we hope to be able to generate in this clinical study should be able to be converted in a more direct way in understanding what the value is compared to areas that have a higher conceptual risk.

Very good, John. I don't have many more questions. I thought you could give a short, final reflection. You have been part of a number of round table talks, partnering congresses. A lot has happened in the short term. Could you give some reflections on what you have been part of and experienced during these presentations?

Yes, and what we can bring to the table is, of course, that we get the credit for the fact that these areas that we have chosen to research in have very high needs and get a lot of attention in those contexts. So when we run this study, one of the reasons is that we are on the track with the study in the new hospital is that there is a great need here. Patients want to participate in the studies. The doctors who run the studies together with us, what we call investigators, they are available. that we should be there and work with them. In the same way, we see the attention where we are invited to discussions when we talk about what, from a global perspective, is still a big problem that we don't see a bigger solution to. The question is then, what technical advancements are there in these areas that could help us to address this in the future? Yes, then we are on the radar there. And that applies to both malaria and sepsis areas. where the needs are very big and where the innovations that are going forward will also define the area. So we make sure that we get signals that we are in the right place and that the successes that we have been able to look at now during the quarter comes from that. And we are grateful for all the support we get. We are grateful for our long-term investors, especially the Karolinska Development, who show support for us and for patients and doctors who work with our studies. So that's a good conclusion. Thank you very much. I wish you good luck with your work in the future. Tack så mycket, Jonathan. Tack till alla som tittade in på det här.