Modus Therapeutics Holding AB (publ)

So there, then I say welcome to today's report comment from Modus Therapeutics, where I usually have with me VD John Öd. And you who are watching this live can, as usual, anytime in the comments, ask questions to John during the interview, so I try to get them in where it fits or towards the end of our discussion here. John, bra rapport. Ni får fortsätta framgångar här under Q3 och ni skriver i rapporten att tredje kvartalet plagades av stark leverans av kliniska planer, framgångsrik finansiering och växande förutsättningar för partnerskap. Jag tänker att vi kan diskutera utifrån de tre punkterna egentligen. Om vi börjar med... what you have delivered in studies, so to speak, the clinical plans, what do you have to say there? What are the major highlights in the context?

Well, you can really say that we have... The speed we have, it started already in December last year, actually, with the recruitment of part one and part one of the study. And it was delivered in a single plan, that is, we had the results in June, and then send it in, and then be able to draw the conclusions we needed to put the doses in part two and then send it in in August as planned to be able to keep our clinical plans. So actually, we can say that we have gone on a rampage. We have kept our clinical plan and it is actually always a challenge when you recruit patients into a clinical study, chronically ill patients who have a lot of complications, where it creates, so to speak, unpredictability for us who are trying to plan a clinical study. And then it is, so to speak, a good signal that we still manage to keep our plans just as we have thought. So to keep the deliveries in clinical research is really something to maintain as an advantage, actually.

We might also remind the viewers what this is for the study and the timeline for it, so to speak.

Yes, the timeline is that when we look forward now, we expect to start it now. We have received our approval and we have activated Our sites in the study and it will simply roll on now with recruitment in the patient group. Lung patients with degrees 3 to 5, that is, from medial to terminal lung disease. And we are looking forward to recruiting about 30 patients in these categories during the coming year with top-line data in Q4 next year. And so far, as I said, and what we signal in our Q3 report is that we are on the way to be able to deliver it. I might also mention that there is a You can clarify that the study as such, when it was sent in for approval and was approved in November last year, it contains these two parts. And when you talk about an amendment in this case, what we sent in between July and August, it is an amendment that is planned, that is, pre-determined. The study is approved with that amendment, that is to say, Hela studien är godkänd men det finns en förväntan om att man ska inkomma med slutsatser från del 1 för att starta del 2. Ibland måste man göra amendment och till och med stänga ner studierekrytering och så vidare för att komma in med uppgifter och det inte är planerat. Så var ju inte fallet i den här studien utan allt har följt planen och det här amendment var ett så kallat planerat amendment för att då kunna starta del 2.

And in parallel with the study, you have presented preclinical data, which is also positive. You see improved anemia and kidney function in a CKD model, where you presented September 20, I think it was. What do these preclinical data mean for the study itself?

Yes, actually, we can say that we have built these complete preclinical data during this year with several presentations, partly on BioIron, both at the big European hematological conference, EHA, in June, and now at this carbohydrate-based meeting in Italy. In this chain of presentations, we have added the findings we have made in our ongoing collaboration with Brescia University, where we are looking at a mouse model And if we have focused on the blood in the first part of this model, we have also looked at what happens in the kidney in the second part. We saw earlier in our data that there was a beneficial effect on the kidney's tissue. Less fibrosis and less inflammation. And we also saw that the urine seemed to work better and longer in the animals that were treated. And this was then beyond the effects on the blood picture, the blood clot. Now we have looked down at what the mechanisms can be for this. And we see some markers for urinary disease damage that are positively regulated by Cevaparin. And these are the data we have rolled out gradually here. I mean, to better understand the mechanisms for both what we then felt better about earlier, the blood loss, but also how it affects the animal.

Is there anything in these preclinical data that has surprised you, if you say so?

I think that from the beginning, we were talking about using this animal model to look at just the anemia or blood loss component. So I think that we were all a bit surprised to see that there was also a useful link to how the tumor worked. But at the same time, it made us even more aware that the tumor was the main indication we wanted to explore when it came to patient studies. And that's really why we are where we are today, with the ongoing study of the patient population.

I'll move on to point 2, successful financing. You carried out an investment in August and it was overshadowed and you received a net budget of 4.4 million. If you could briefly explain what you are going to use this money for in the future.

Exactly, if we look at it then. Nettolikviden som blev drygt 20 miljoner efter emissionskostnader och även kvittningen av det brygglån vi hade från KD som gjorde oss skuldfria i nuläget. Då har vi då den nettolikviden tillsammans med de planerade första serien optioner. som då ligger på vår kanten nästa år, så med det så bedömer vi att rörelsekapitalet räcker för oss för att kunna uppfylla och leverera det kliniska program vi planerar och komma till data i den här studien, helt enkelt. Och det är vi ju väldigt glada och tacksamma för det förtroende som vi fick i samband med att vi genomförde den här företagsemissionen. And we see it as a very clear buy-in to what we do. And with that, we continue to work very disciplined to continue to deliver on that journey.

Växande förutsättningar för partnerskap då? Ni har ju varit aktiva på en hel del event, ni har presenterat också projektlinjeska data och studierna fortgår ju som planerat. Hur ser du på möjligheterna för partnerskap och har de här, kanske retorisk fråga, men har de stärkts i och med de här framgångarna?

Jag tror framförallt, när man tittar på partnerskap, så spelar det väldigt stor roll hur mogen man är i utveckling. Och Det är en väldig skillnad att vara ute och prata om att vi tänker gå in i fas 2 mot att faktiskt vara i fas 2. Så jag tror att där ser vi den skillnaden, det vill säga att man får fler lyssnande öron, fler intresserade samtal när man verkligen då är på väg på en fas 2-resa jämfört med innan man startar. Så där kan man säga att That makes a significant difference now compared to earlier when it comes to the interest signals we get. The second thing is that there are opportunities to get back to the interest centers with data that are very relevant. For example, Pharma interest centers are phase two data, something that is highly interesting to be able to judge if a project has reached the right risk address or not.

And how do you look at your dream partner or partnership? What are you looking for, so to speak, in the context?

We have a fairly open view, but one type of dream partner that we would like to see is a a specialist pharmaceutical company that has a connection both on the hematology and renal side. And there are a number of such companies where you have an organization and knowledge to maximize and understand the maximum advantage with what Cevaparin offers in these patient groups. Then you can say that Vi har alltid också örat mot marken och försöker samtala med andra potentiella senfasinvesterare, stora investerare, som skulle kunna se möjligheter att komma in i det här mogna skedet och att öka den mer substantiella ägarbilden tillsammans med de stora ägar som vi har redan idag. It contributes to both competence and it contributes to momentum in the owner group. And we always see it as beneficial. So that's actually the two main groups we're looking at.

I just thought otherwise, when you think about risk management, you see on the market today that it is difficult for many smaller life science companies to take in capital. There are big geopolitical challenges, there is a lot of uncertainty all over the place. How do you see that dynamic and how do you work around this risk management part, so to speak?

Yes, and you can also add that being in the clinical phase, as I mentioned, the recruitment part, there are many things that are constantly exposed to risk even in the operational work when you get into chronically ill patient studies. And it's something, all this risk management is something that we continuously do. Myke kan man göra genom att preemptivt arbeta med väldigt disciplinerat operationellt finansiellt tänkande. Det tycker jag att vi har visat väldigt väl sedan vår IPO. Vi vet ju alla att det här har varit ganska utmanande tider, men genom att arbeta smart med väldigt högt kompetenta samarbetspartners på and by also finding development models where we can offer a diversified portfolio, but with very limited cost pressure, depending on that we actually have a project that we in-house invest in, while we have software-financed collaboration to drive our malaria project, and that we already have data inom sepsisområdet som vi kan använda i, vi har kliniska data i sepsisområdet som vi kan använda i affärsutvecklingssammanhang, så bygger vår modell egentligen kan vi säga på riskhantering av den här verkligheten du tar upp. Samtidigt så har vi ju, och det tycker jag också vi har visat under de här åren sedan vi gjorde vår börsintroduktion, vi har en långsiktig owners in Karolinska Development, who believe in what we do, and who have made sure to support us when we needed to do so. Partly to save the shareholders in times when you don't need to do unnecessary financing in the market, but also as an important signal that we are still on the right track. So with those parts, we continue to navigate this risk scenario that all small biotechs in Sweden face today. And so far, that model has worked for us.

If we could come back to the long-term commercial goals for Cebu and Paris and how you plan to maximize the value for the shareholders here in the long term, how would your summary of that sound?

I think one of our most important value maximization for shareholders is that we have a clinical asset that has several parallel development tracks in Klinik, where we can manage the different requirements and costs that exist, in order to simultaneously maintain several shots at the target. And in the long run, we are now focusing on chronic cancer and anemia. And here there are actually two tracks, or two different paths. Partly the anemia part, but also an even larger group of diseases, the animal ones. And since we are now working with Cevparin, which shows an effect both on Den hematologiska komponenten, som är utveckling på medellång sikt, men in i ett väldigt högvärderat och kommersiellt moget område. Och dessutom att den utvecklingen sedan också adresserar riskerna med det ännu längre, men också ännu större kliniska området. which is the animal weight per se. What can you do there? And while studying the hematological blood defect effects, you can also observe how well you can address the risk on the animals as well in those patients. Because these patient populations have both problems. And there I think there is a very good value maximization route for us. Och de grundar sig egentligen att Sedparin har de egenskaper som de har och att vi nu är i klinikutveckling.

Vill du säga någonting om övriga indikationer? Vi har pratat mycket CKD här idag, men övriga indikationer och hur arbetet går framåt där?

Ja, det är ju naturligt att fokus har legat på just CKD, för där har vi vårt fokus för ögonblicket, att få igång och driva del två, proof of concept-delen. At the same time, we know that Imperial College, our collaboration partner on the malaria side, is working on what the next step is. And as soon as we find out what it is and their progress in reporting the study that was completed in March, it is a new wave that we expect to have in our channels during the coming year. There we expect development, but as I usually say, in these types of collaborations, when the sponsorship is with our development partners, then we are also not in the front row in the same way, but we have to receive the developments that come from our partners in that sense. And when it comes to Sepsis, then we can say that We can see that there is a very high focus on antibiotic resistance right now. This is due to the increase in antibiotic resistance. The position we see for Ceviparin, if we were to develop it further, we would use the data we have to try to find a partner. And if we were to find a partner in the sepsis area, then we see ahead of us that it would be a trigger to start phase 2 in sepsis together with that partner. And what could drive that is the ever-increasing antibiotic resistance that we see in the world. Why is that good for sepsis? Well, the position we see for sepsis is just that So that, in that way, I think that an increasing antibiotic resistance could actually increase the relevance for how we see that Cevaparin could be used in sepsis. So in that way we have, now that we are talking, also managed to figure out where we are in the other two areas in our portfolio.

Great, thank you for your time, John. I have not received any questions in the chat. Is there any question you usually get, as you would like to address here at the end, before we leave for today?

I was talking about the design of the study. It can be confusing if you send in an amendment to a study that has already been approved. Then it often concerns the fact that the design has been predefined. So the study is still approved. And that is to trigger a second part or a following sequence in a study where you come in with data to show, now we have a good rationale to dose in this way and for this long in these patients. And then it is already in the study protocol from the beginning, the expectation, i.e. a predetermined use.

John, thank you very much and good luck in the future with the study, so we will have reason to return to it.

Tack så mycket, Jonathan, och tack till alla som har lyssnat in. Det går alltid att rista