Modus Therapeutics Holding AB (publ)

Välkommen till dagens livesända intervju från Modus Therapeutics. Vi har haft lite ljudbekymmer här inför sändningen så jag hoppas att det ska funka men jag kan inte garantera det. Vi får utgå från det vi har och hoppas på det bästa helt enkelt. Med mig i valigåring idag har jag med mig John Öd, VD. Han ska kommentera bokslutet för 2025 som presenterades i förra veckan. Välkommen John.

Thank you, Martin. Thank you to everyone who listened in and who will be here later.

If we go to the report, you describe the year as a year when Modus went from planning to implementation. What milestones would you like to lift up here in 2025?

Ja, man kan ju faktiskt summera det som att det har handlat om klinisk leverans och finansiell stabilisering. Vi tittar tillbaka. In 2025, it will be about preparing our proof-of-concept study in patients with anemia. During 2025, we will be able to activate the multiple dose proof-of-concept part. of the study in patients. And there are a lot of milestones. One of which was that we were approved within a predetermined time to start dosing the patients already in 2025 and that we also actually managed to dose the first patient before the start of 2025. In terms of delivery, we have kept the plan exactly according to the preparations that we did during 2024 and 2021. And at the same time, between part 1 and part 2, we secured an overdraft for the trial selection, which gave us the opportunity to take this to the final result, the proof concept.

If we look at the most important goals and values for the CKD Anemi study here in 2026, what data do you want to have on the table at the next year's shift, so to speak?

If you look at a proof of concept, it is just a way to distinguish from more verifying clinical evidence, that is, we do not need registration-based evidence, but we need Vi behöver ha data som indikerar att det koncept som vi tar framåt i den patientgruppen som man studerar indikerar att det är rätt. And for our part, since we can dose for a longer period of time, we can also get answers to previous markers that are primarily related to hemoglobin and iron. And then we have what is the actual reading of our mechanism, the most important mechanistic reading, and that is the signal on the levels of the hormone hepcidin, which regulates the brain. The most important thing when entering a new patient population is to ensure safety and durability. This is also an important part of the proof of concept. You should also remember that Kronisk Njursjuka, vi tittar ju på de som har måttlig njursjukdom- till terminal njursjukdom i den här delen av studien. De har redan ganska många andra sjukdomar. Så det är en sjukvårdspatientgrupp på det sättet. Det är också det som styr hur stora behov den patientgruppen faktiskt har. Om man tar det här till nästa steg... I studien tittar vi också på njurens effekter. In our animal models, we have also seen effects on the animal tissue that could indicate something that goes beyond the effects on the blood world. We also see this as a more exploratory measure in this study.

One step further, if you look at which signal in this ProfoConcept study that you are looking for to take this on to the next study, Phase 3 or Phase 2b, what would you look at then?

What you look at then in the registration is of course the effects on the blood value. It is something that is a prerequisite for longer and larger studies. But at the same time, you can look at hemoglobin, but there are also a lot of precursor results, the measurement that is very clear precursors to a greater effect on hemoglobin. So that's something we're looking at in this kind of proof of concept studies. where we have a limited population.

You also highlight the results that you have obtained through cooperation with the research group in Brescia, the preclinical data there. How specifically does that affect your clinical strategy in the CKD program? How do you take these results in the clinical strategy for the CKD program?

That's a good question. It's very important. This is an animal model where the mouse gets chronic nausea and develops a very difficult anemia. So it's a model that is very similar to the patients we recruited in the study. i den modellen vi följer precis de parametrar som vi sedan mäter i The parameters that we see in the mouse, they translate into the effects of the measurement that we also look at in the patients, including the more exploratory measurements of the effects on the cell's neural network. It also allows us to follow the mechanical connection, that is, the type of mechanical network that we have built through the understanding of these animal models. We can also use that to see that these mechanisms are relevant for the patient population that we study. And that, together with standard treatment that these mice get, just like the patients have, or at least a part of the patients who enter the study have made sure that they also have stable treatment with erythropoietin. And that is something that we have also tested in this model to make sure that we can act together with standard treatment in patients who need it, who do not have sufficient response to the treatment. So, if you're going to boil it down to something, it has made it possible for us to design a more definitive and more high-quality concept study. And that, in turn, in our opinion, increases the relevance of the partnership perspective. Because if you can contribute with a greater understanding of what it means, it contributes with a greater confidence that it is also something that can be verified in larger studies in the future.

I'm going to come back to financing. You did a financing last year, as I said, and it will take you to the reading at the end of this year, as I understand it. And it suggests somewhere that technical options are used during the year. My question is this, if they are not going to do that for some reason, what is the alternative financing strategy then?

I'd like to point out that this is in front of us. We don't have time for these technical options. At the same time, it's our job to constantly evaluate alternatives to make sure that we can do what we need to do by the end of the year. There are different alternatives for structured financing solutions that we can consider. If we look back, If we look at Modus's history, we have had a lot of solutions before, and we have been able to solve that. Of course, we have the great advantage of having a large institutional owner who believes in what we do. When we move forward, we are very careful that we can solve it with or without technology. Our main focus is that we can deliver these proof-of-concept data, which then contributes to our big value step, which is in the near future.

Om vi lämnar CKT och tittar lite på de andra indikationerna, svår malaria och sepsis, vilken nyckeldata och dialoger är viktiga där framåt för att avgöra om ni går vidare eller hur ni går vidare med de här programmen?

Programmet är någonting som har fördelarna att vi mest utvecklar det med hjälp av samarbeten som gör det möjligt för oss att ha icke-utspädande finansiering till de programmen. Och där vi har möjligheterna samtidigt att... to develop malaria based on the data, the malaria indication, based on the data that we generate in this collaboration with Imperial College. The study that was fully recruited in 2025, which was very important, We also see commercial opportunities where severe malaria is an infectious disease. in both the US and Europe, and where there are regulatory benefits to those who have large values in themselves. At the same time as the process to search for that type of approval based on data that we get from studies in the future also makes it possible distribution of a future malaria treatment to the parts of the world where it is most needed. So this is a synergistic collaboration between us and the Möbliai consortium. Of course, when we work with this on such cooperation conditions, it also makes Våra partners, det är de som sköter studien, de driver den. Vi har inte kontroll över hur fort det går och så vidare. The disadvantage is that we can do this with a very limited cost-effectiveness. If we look at sepsis, it is an indication that we have very good data that indicates that there is a broad effect in sepsis indication. ... ... ... ... ... which has had an artificial step-by-step interaction. We are business developers at the moment. We are working with a company that has an interest in this innovation. And here it is also very much about how the environment is developed. We are very interested in how relevant it would be for partner companies to have the risks that it entails to develop their sepsis program. And the way it becomes in the world, of course, is an increasingly increasing occurrence of severe bacterial resistance to antibiotics. And it is also and anxiety that exists in the world. Conflicts and wars contribute to very large problems, including infections, sepsis, and similar intensive care conditions. Det är bara för att ta ett antal exempel på att omvärlden också har betydelse för vilka risker en viss typ av utveckling, läkemedelsutveckling, innebär. I det läget så ser jag att vi har väldigt relevanta data att diskutera med partners i den här indikationen. Själva kommer vi inte att ta det vidare in i en fas 2b-studie. Det skulle i sådana fall vara ett sådant här partnerskap.

Om jag avslutningsvis ber dig att blicka framåt ett par år eller tre, hur ser du att ett lyckat scenario förmodet skulle se ut om vi står här 2029 så att säga?

Om man tittar på patienternas perspektiv så skulle jag säga att vi By 2029, we have reached a point where we have validated a new mechanism for the treatment of information-driven anonymity at CQD. And from a partner and business model perspective, we are at a point where we have a clinically verified program with a type of differentiation profile, which is the one we have. that we work with, from this concept study and forward. And I think that's what makes us the most attractive from our partner model. If you look at the ownership perspective, if we come to 2029, we have taken concept data that we now have, and built a structured partnership with a commercial path forward. Based on, and actually it takes from the beginning, also in the project concept that we are now doing. And that, we see here, is an ideal, it would be an ideal value development for the shareholders today, investors today. This is our business model. To build clinical product values ​​with smart and relevant studies in relevant patient populations. And to develop it further with a partner. Not just to be a broad and capital-intensive development company. The differentiation is also that we can work and a model where we are very capital-efficient. And we have been talking about this in several ways here today, including how we work with Malaria, but also how we work with close collaboration with academia, close innovation, and also with small, as we call it, boutique CROs, where we are very involved ourselves in the work and create a close link between the important work we do with our research projects and to pass them on to the patient studies we do. We can maintain a high innovation profile and at the same time focus on our clinical programs.

Yes, thank you very much, John, for today. I hope that those who are listening have heard this better than I have, because I heard really badly here. But we can't do much more for today, so we'll have to come back and see if we can find another format, maybe an inspired format, next time. But I apologize if the sound has been bad. It has been that for me, at least. But we'll have to hear each other again in the next quarter report.

Jonathan, we keep our thumbs up.