Modus Therapeutics Holding AB (publ)

Then I say welcome to today's live report comment from Modus Therapeutics, where we will talk to CEO John Öd om utvecklingen under det första kvartalet 2024. I vanlig ordning går att ställa frågor till John direkt i kommentarsfältet här så tar vi upp de frågorna under intervjunsgång där jag anser det lämpligt. Då säger jag välkommen till John.

Tack så mycket Jonathan och tack till alla som tittar in på det här nu och senare.

Om vi börjar med din övergripande bild av kvartalet. Ni kanske inte har rapporterat så mycket ut mot marknaden, men det har uppenbarligen hänt väldigt mycket i bolaget under perioden.

Ja, alltså det är ju så här med vår typ av bolag, forskande biotechbolag, att när man förbereder och arbetar så mest intensivt, då är det väldigt mycket präglat av inre tjänst. När man förbereder, till exempel som vi gör nu, en submission av en a larger study activity, a new study activity, then you have to work a lot with all the steps that are in that process. And then it becomes natural that, since we work sequentially with our projects, that it also becomes a calmer phase in external reporting.

How is your general feeling? How has the work gone, so to speak, from where you were at the beginning of the year?

Arbetet har gått väldigt bra. Vi har ju en väldigt kostnadseffektiv men samtidigt effektiv organisation med mycket erfarenhet i. En virtuell organisation med erfarna konsulter som arbetat i bolaget i många fall sedan 2011 och däromkring. Vi har kunnat arbeta så snabbt som vi är vana. Vi har nästan kommit till den punkten att vi står i begrepp och skickar in studien för godkännande. Själva initieringen har vi nu lagt under Q2 eller in i Q3. Men som sagt, den stora bulken av förberedsarbetet är redan gjort.

I note that the results are improving, halving the losses from last quarter, the same period last year. Can you say anything about that or purely educational technical things?

No, it's very much again about the type of activity a research company has, that is, when the activities start, when Klinikerna aktiveras när patienter strömmar in i studien. Det är då kostnaderna kommer för de planerade stegen i en studie som ingår i en studie. Vi hade pågående aktiviteter under samma tid förra året. Det som det återspeglar nu massive planning and preparations that we have devoted ourselves to. As soon as the study starts, you will get to know the cost picture again in that way. So it goes in the cycles that the activities de facto go, quite simply.

If we focus a little on the progress made in the phase 2a study for chronic kidney disease with anemia, can you comment a little more on what has been done and what progress has been made?

The progress, if you look at the study itself, is that we have a design, we have a finished study, where the preparatory work itself is about allocating to a CRO and getting approval from the authority to open the site. We have also identified a site that will be able to do the study. So we are really in the final phase here.

If you were to draw up the timeline and the expected results in the future, what should investors focus on in this study?

Partly the proposed initiation of the study and the milestones that come around it. That is, you get a approved study and so on. And then there is the first subject patient in. and that you can have top-line data on this study, which we see will be available at hand at the beginning of Q1 2025.

If we were to say something about the phase 2 study for sepsis, where you have initiated preparatory work, what should you expect here in the future?

There you can say that, again, We can see the benefits of having a company with a portfolio of projects or a pipeline. What we want to achieve is that on the SEPC side, we have quite good data, a finished study that we can continue to communicate with potential partners, under tiden som vi gör förberedsarbetet och startar studien i det nya området, för oss nya området, anemi och djursjukdom. In this work, where we discuss with partners, it is important for us to plan out what the program will look like in the future. What will the next study look like? How do we aim it? What alternatives are there based on the data we have? And there you can also link to what is happening. We experience that a lot is happening now in the field of awareness and the clinical care of sepsis. In several places in Sweden, for example from Skåne, a sepsis alarm has been introduced, just like we have a stroke alarm and a trauma alarm, where focus is focused on getting a quick recovery from a miscarriage of sepsis. And everything is moved earlier in recovery, so that valuable time is not lost for such a critically ill patient. And we are looking at how we can fit in there. We have said that a very clear way forward for us is to come in early. There we focus on the existing processes where the focus lies on the clinical way of finding patients where early medicines can come in when they are approved. And we see ourselves as such a product. One of our strong alternatives. We also evaluate other tracks that have high availability and build programs. At the same time, they help us in discussions with potential partners. i funktion av de data vi har. Så det här är en väldigt viktig del och vi kan ändå gå åt dem samtidigt som vi gör det praktiska jobbet i det nya projektet.

Du nämner ju ökad medvetenhet om sepsis där och ni nämner också i vd-ordet den här WSC Spotlight-konferensen som ni har följt med intresse och som också tar upp sepsis. Vad var de viktigaste takeaways från den konferensen?

Ja, vi försöker följa de här konferenserna. Det här är World Sepsis Organization som organiserar World Sepsis Day och World Sepsis Conferences. Den stora konferensen och den här spotlight som då är viktiga för att samla fältet av experter och alla som want to participate in these conferences can log in, register and log in. And for us it is a very important tool to understand where the field is on the way on a much larger scale than actually paying consultants as sole consultants who help us, because you do that too. For my part, it is important to focus on early identification. There are different routes, biomarkers, symptomatological indexes, which are often based on machine learning and AI, where everything is digitalized today in healthcare. When you take care of a patient, there are many parameters in real time. breathing, pulse and so on, oxygen saturation, the lab world goes in digitally. And here you can learn systems to quickly identify and flag patients earlier than we have expected to do. This is an interesting development, for it helps us to drive a development in something that could come in early in sepsis development. This is a good example. The rest is about optimized therapies. can you give too much liquid, can you give too little liquid, how early should you come in with standard and care to increase blood pressure or counteract blood pressure drops and so on. Even here we get important guidelines when we design our program on how we should think to function in a care environment. And the last one is also a lot about ecology. It is still a difficult Problem är hur man sätter in antibiotika och att man ofta hamnar fel och hur man integrerar besluten om när man ska byta antibiotika baserat på det första empiriska valet och sen de nya valen som kommer efter odlingsvar och efter vilken ekologi av bakterier som finns i den här regionen där fallet är. And then we can see that the focus there signals to us that there is still need for treatment that allows that in this process you lose time to be able to support patients from an early stage until you find the right one. So this is an example of what the focus is and how we can benefit from it to be able to give back to the field and suggest a medicine that works in the environment that the providers today would like to have.

It sounds like most of it is in your hands, but is it something that you don't do when you turn the coin?

That has always existed in the sepsis environment. How do you identify patients? It is still in time, for example. And do you introduce new treatments in that situation? And that is something that is handled in the development of drugs. For example, and then also that it is a very demanding environment. Det går inte riktigt att ändra på än. Det är intensivvårdsmässiga miljöer där man kanske inte har tid. Det kan vara problematiskt att driva studier. Man har inte tid att starta studieprotokoll och ta in patienter i studier i tid. De upptäcks för sent och så vidare. Sådana problem kvarstår ju förstås. Det har ju med området att göra. Men det är sådant som man också måste hantera. Där ser vi att den här nya utvecklingen hjälper oss. Where there used to be a bit more imbalance against the disadvantages, which is reflected in the entire sepsis field, these new focuses help us to balance it.

I also wanted to deal with severe malaria. You describe in the VD word that the spread of malaria has increased again for various reasons. Climate change is one of them. Maybe you don't think about it as much as Here in Sweden, but it's a big problem out there. You have important research there. Can you touch on the interest around this area?

There's an important nuance there. I think... The spread does not decrease, at least not in the same way as one could expect. There have been these large floods that have caused very large outbreaks, larger than in the region where there may not have been such large outbreaks before. But then also climate change in combination with large migrations and travel in the world makes new species move in places där de finner en ny grogrund. Till exempel, som vi tog upp som exempel här, den här myggan från Sydostasien som trivs i städer, där det kanske inte är lika lätt att bekämpa myggbestånd om de verkligen trivs i städer. Traditionellt så kan man torrlägga våtmarker och man kan spraya vegetation och så vidare. Men det ställer nya problem i stadsmiljö. Och där ställer vi oss frågor, aha, How does that relate to the potential for it to start to show up in places where we have previously been used to it being gone for a long time? The content in our message is that the problem with malaria is far from solved. It continues to be a big problem. nästan 300 miljoner fall, 289 miljoner fall, i senaste kartläggningen 600 000 döda barn, där många förstås har drabbats av den här tidiga svåra malaria.

Ja, och ni lägger till en ny sajt där i Zambia då, vad betyder det i sammanhanget?

Ja, den här studien är ett samarbetsprojekt där vi inte, så att säga, lägger oss i utvecklingen. Det här är sponsorskap som hålls av Imperial College. Utan vi kan väl se då att det är en annan region än den sajten som fanns i Kenya, där det finns möjligheter att balansera rekryteringen. Vi hoppas ju att rekryteringen kommer att ta fart tack vare den inklusionen. Vi drar vårt strå till stacken när man ser till att de har drog- eller studiemediciner på plats när det behövs, så att säga.

Hur upplever du annars?

Jag ser verkligen fram emot att kunna se, jag menar det finns ju stora fördelar i det här projektet där det åtnjuter ett anslag från Wellcome till Imperial College. För vår del så innebär ju det en väldigt låg utvecklingskostnad men samtidigt då fördelar i form av en utveckling som vi kan dra nytta av.

Hur upplever du annars intresset kring just malaria om man tänker i partnerdiskussioner och dylikt? Är det stort intresse eller är det inte så stort?

Alltså det har egentligen ökat på det sättet att man börjar förstå mer vad vacciner kommer att kunna erbjuda framöver och att det ökande resandet ändå bidrar till att Svår malaria medicinering har godkänts i USA på grund av de fall som kommer hem och utvecklar svår malaria av turisttypen. I och med att man ser vilka brister som fortfarande finns och att svår malaria förmodligen kommer att vara ett kvarstående problem framöver, så har vi fått fler frågor. När jag har varit ute och pratat om modus på olika affärsmöten och så vidare så har det kommit stadigt fler frågor och positiva undringar om malaria-delen av projektet. Sen tror jag många också ser likheterna. Jag menar, sepsis å ena sidan är en våldsam systeminflammation, akut systeminflammation, och där underfaller ju även severe malaria, so it is, so to speak, collected for a certain type of effect that our type of substance can have.

If you could give a comment on ongoing business development work, partnership discussions and so on, is there anything to add there?

Actually, I think I said one of the most important aspects, and that is that we have now reached the point that with the broader portfolio we can work in tandem with not only development but also business development, so that I can have more conversations and I can bring in people who may not have an intensive care focus or a difficult disease focus, but a more chronic disease focus. There are many people with chronic kidney disease and the problems chronic kidney patients have. Precisely as we have widened the base for investors and the risk spread that this means, we have also widened the base for those we can have discussions with.

I know that I have asked this before, but if you look at your product portfolio and the widening that you are talking about, can you expect further widening of it? Or is it in the focus areas now, what you are doing at the moment?

We focus on the activities that we... that costs, that is, what we finance for the most part, is exactly what we have done in the latest financing. That is what we see now in the portfolio. And we have said that sepsis is also a question of financing in the future. We have set a target for it in 2025. But at the same time, our collaboration is still ongoing, and especially the collaboration with Brescia, where we have a long-term collaboration and has very good channels. So we are good at operating that type of more discovery-like business. So that process is ongoing. At the same time, if it were something more specific, it's not something I can talk about, because Enlio is also sure that we can protect it and really believe in it. The research is still ongoing, but the focus is definitely on what we see and have ahead of us.

You often emphasize how important it is to publish various scientific journals. Is there anything new to report on that front?

Yes, in the activities that we have had so far during Q1 and part of Q2, it is also necessary to prepare publications, which can be guaranteed. These are peer-reviewed processes, but we have a great drive to try to get the scientific basis for what we do. There are very important anchors in the discussions we have, whether it is in future research collaborations or future business discussions. It plays a big role for us that what we have done has been reviewed by the PR system and valued, quite simply. We are not alone in believing in what we do, quite simply. That is one of the important functions. So there we work with that and hopefully we will be able to see that in the future, even if it is difficult to say. Based on how the system works, it is difficult to say when that happens.

John, as a last question, I thought, or question, but a message to investors and other interested parties in the company, what would you send with as a last word? What is the focus forward? What is it that you should focus on? What do you think that you should, what is the focus in the company right now?

Fokuset är uppbyggnaden av det här nya området, anemi vid kronisk djursjukdom, och som man ska komma ihåg har förlängningar in i andra kroniska sjukdomar som också har anemiproblem. Andelen till det är att vi har väldigt spännande data från sjukdomsmodeller som indikerar att vi påverkar anemin men också själva sjukdomen i den We see that there is a lot of focus on following the development here. We have a schedule in part 1 of the study that we have designed, where we prepare for dosing for longer periods in breast patients and at the same time have a first look into this biomarkers, hepsidine, which we have a very good track record with so far from cells via healthy sick mice to healthy voluntary people to have a very potent effect already at single doses. So yes, part 1 prepares, looks at dosing and safety in this new patient gruppen, men det finns också en chans att vi kan se i en relevant patientgrupp hur det här hepsidinhormonet svarar på endosemparin. Samtidigt då också den stora proof of concept delen som vi då efter finansiering kommer kunna starta i 2025 för att då behandla under längre tid i patienter.

It will be exciting to follow your reports in the future and see what happens. I haven't received any further questions from the audience today. If you don't have anything else to say at the end, I think we will end today's broadcast.

I think we had a very good discussion and I am grateful for your time and for the time that those who are listening have given us.

Yes, we will be back with a new report next quarter.

Yes, we will. Thank you very much. Goodbye.