Modus Therapeutics Holding AB (publ)

So there, then I welcome to today's presentation from Modest Reputix, who has presented his shareholding report for the third quarter of 2024. And with me to comment on it, I have in regular order, the CEO of the company, John Öd. John, we both have a little bit of a hard time today, you hear my voice and it may disappear. So I get a reservation for me to get through this, but otherwise you take over, simply.

Yes, in that sense, my voice holds. As I said, we both, we have to lead each other, simply.

Yes, but comment briefly on the quarter, there are several milestones that are reached. I thought the most interesting milestone is the CKD study, which is now approved in Italy. I thought we could start there.

Yes, so this is for those who may not be familiar with how it works, but we discussed last quarter how our application had gone in, and what happens then is that you work with a team, I am privileged to work with a team of experts who have very long experience within their areas, the chemistry and substance area, the clinical operations area, or the operational clinical area, and so on, regulatory, strategic areas. And there you go together and work to answer the questions that the authorities work to have. And all authorities have a little different angles, a little different working traditions, and as we also tried to explain in the next, in the last quarter report, there is also a new system called CETIS, which is completely computerized, where things are a little more four-sided, and which also gives greater freedom of expression in time. So we have worked very intensively in this system, and the success that you can see in that work is precisely to get the approval that we have now. And of course we are very happy about that, it opens up for us to focus on beginning to deliver the study, to start taking in the subject of trial, and to start the way towards our next milestone.

What is the timeline for the future? You start next year, or what does it look like?

Yes, well, it is probably the basic plan to be able to get started at least after the year shift. But we are of course starting, the work has already started, from the day we got the approval, the operational work began to prepare the clinics, what we call sites in Swedish, to start recruiting, screen in the first part of the process, to look at the suitability of those who then go into the study, and if they manage that, then you can include patients. And this takes a while, sometimes it works very quickly and well, and sometimes it is not, or more slow, and that is why we are somewhere there, that after the year shift, we aim to start recruiting.

I have always been out fishing a little after the malaria study too, and I have had some answers to that now actually, with some updated recruitment data, but you seem to have doses of 10 patients so far and you are in the middle of November 15th at least.

Can you tell us more about

what is happening?

Yes, I think one of the important parts we have talked about in earlier reports, and that was that our collaboration team, or those who run the study, and who update us, we do not have operational insight into this study, we deliver the sepulchre to this study. And what we talked about, as we had understood from our collaboration partners, is that this site that has been established in Zambia should be very important. And given where in the world this is, and under what circumstances you work, it takes a little while to get start activity in sites, so it has taken a while to activate this site, but from the moment this site was activated, they have started to recruit, just the way we understood that our collaboration partners had hoped. So that for a fairly short time, and that is probably the reason we have received this recruitment update, is that we have included a total of 10 patients in the study and triggered the next dose level. And how many

will be recruited?

This study, with reservation for that it is not our study, but I have an insight into the protocol, so if we have understood it, around 20 patients will be recruited, but we have a so-called adaptive safety assessment model, and this is due to the fact that this is children who are often under 12 months, who are affected by this condition, so therefore you need to have extra eyes on safety when running, and this adaptive safety model, as I understand it, can make it variable, so you say approximately 20 patients. So approximately we have something half now.

Another thing that you mention in the CEO's word, and that is also secured funding from your long-term owner, Carolin development, and you have secured a bridge funding there for 5 million, which you can use, can you comment on that and why it is important forward?

It is important to give us a boost in the way to start the patient study, simply, the psychotherapy study now. So it is a very important part, which our most reliable and our largest investor is handling here, and for our part it is also a very important signal of the value of what we are doing, this is a specialized life science investor who really believes in what we do.

And that should be enough for part one of the CKD study? Yes,

as we see it now. Part one, as I mentioned, is a part that primarily supports the start of part two. And part one is patients with a weight of different degrees, who get one single dose of sebum parin, and then you measure how the concentration of the medicine develops in the blood, and we use one of those data to be able to write down three specific dose levels, depending on which Christmas function the patients will have in part two, where they will be treated for longer, what daily dose they will have. So given that it is a single dose that we talk about per patient, it is a little faster, at least our hope. But that is the way it is, in our learning with the years, to become humble about how clinical research can be difficult to predict, so this is best based on our experience and our assessments.

And if you look at resource allocation here, is the CKD study the big priority?

Yes, of course. The CKD study and activities that are around it. And in the medium-term perspective, it is part one. And when we start part two of the study, there is a prerequisite that we have financed for part two, which is dosage up to a month, and will take more than a year to implement. So we need to refinance that.

I saw that you have also received further distribution of your scientific material. Can you comment a little on how that looks and how the interest looks forward?

The interest is great for our material. In this case, what went out in October in Holland, and will also be presented at the British Pharmacological Society in December, is our finished, reported data in the CEPSY area, that is, the LPS study that was completed in early 2023. And it was presented by our partners, CHDR, which will be our proxies in these meetings, but we see that it is met with great interest. They are accepted to be published at the meetings and presented data. We are very happy about that. We have several publications that we are waiting to publish, and as soon as they are published, we will talk about it.

I was going to leave the question open last, because you can comment on your view on the way forward, and if it is something we have missed here today that you think is important for the company's development.

I think we have covered what our priority activities are for now. We have filed, as I said earlier, two patents, one that concerns cancer and anemia, and one that concerns the LPS and CEPSY area. And the data that we have generated, we will continue to follow up on, even during the next year. They will continue to be an important part of our IP portfolio. We had not mentioned that during this report, but I think that what we have not touched is what needs to be mentioned.

You have recently signed a contract with

the US Department of Defense. That's right. We have also received Johan Diget from Karolinska Development. We lost Torsten Gursch very sadly earlier this year, very suddenly. We had to find someone who could replace him very quickly. And then the possibility arose that Johan could join the board. We are very happy about that. He has a long experience from the banking world, and is also one of those who participates in the leadership group in Karolinska Development and has a background as a lawyer and loan expert. He has many strengths in his line, and we look forward to working with him.

Thank you very much, Johan, for your time. Now I feel that my voice is starting to break, so it's probably good that we end and finish. We will take a new take next quarter. Yes, we will.

Thank you very much, Johan Tant. Thank you to everyone who has listened.