Modus Therapeutics Holding AB (publ)

Then I say welcome to today's presentation from Modus Therapeutics, which has presented its part-time report for the third quarter of 2024. And with me to comment on it I have, as usual, the company's CEO, John Öd. John, we are both a bit crass today. You can hear my voice here and it may disappear, so I have a reservation to get through this, but otherwise you take over, quite simply.

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

But please comment briefly on the quarter. There are several milestones that have been achieved. I thought the most interesting milestone is the CKD study that is now approved in Italy. I thought we could start there.

Yes, this is for those who may not be familiar with how it works, but we discussed last quarter how our applications had gone in and what happens then is that you work with I am privileged to work with a team of experts who have a very long experience in their areas. The chemistry and substance area, the clinical operations area or the operative clinical area and so on, regulatory, strategic area. And there you go together and work to answer the questions that it is the work of the authority to have. And all authorities have a little different angles, a little different work tradition. And as we also tried to explain at the last quarter's report, there is also a new system called CETIS, which is completely, one could say, datorized, where things are a little more square and that also gives greater degrees of freedom in terms of time. So we have worked very intensively in this system and the success that can be achieved in this work is just to get approved as we have now. And what we are very happy about is that it opens up for us to focus on starting to deliver the study, to start to take in trial subjects and start the way towards our next milestone.

What is the timeline forward here? Are you starting next year or how does it look?

Det är väl i grundplan att kunna komma igång åtminstone efter årsskiftet. Arbetet har redan startat. Från den dagen vi fick godkännandet så började operativarbetet att förbereda klinikerna, det vi kallar för sajter på svengelska, att börja rekrytera, screena i den första delen av processen, att man tittar på lämpligheten på dem som And if they manage to do that, then you can include patients. And this takes a while. Sometimes it works very quickly and well, and sometimes it is more time-consuming. And that's why we put ourselves somewhere where we aim to start recruiting after the change of year.

I'm always out fishing after the malaria study, and I've got some answers to that now, actually, with some updated recruitment data. But you seem to have dosed 10 patients so far since November 15th, at least.

Can you tell us more about what's going on? Yes, I think one of the important parts is that we have talked about in previous reports, and that was that our collaboration team, or those who run the study and are the ones who update us, that is, we do not have operational insight in this study, but we deliver Sevparin 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 would be very important. With regard to where in the world this is and under what circumstances you work, it takes a little longer to get start activity in sites. It has taken a while to activate this site, but since you have activated this site, they have begun to recruit Precisely in the way that we understood that our partners had hoped for. So that during a fairly short time here, and that is probably the reason that we have received this recruitment update, 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 a reservation that it is not our study, but I have an insight into the protocol, As far as I understand, around 20 patients will be included, but you have a so-called adaptive safety assessment model. This is due to the fact that these are children who are often under 12 months old who are affected by this condition. Therefore, you need to have extra eyes on safety. This adaptive safety model, as far as I understand, can make it possible So we have approximately 20 patients. Approximately, we have reached half now.

Another thing you bring up is the secured financing from your long-term owner Karolinska Development. You have secured a bridge financing for 5 million that you can use. Can you comment on that and why it is important in the future?

It's important because it gives us a boost in the way towards starting the patient study, the CKD study. It's a very important part that our most trusted and largest investors are handling. For our part, it is also a very important signal about the value of what we are doing. This is a specialized life science investor who really believes in what we do.

And that should then be enough for part one of CKD's study?

Yes, as we see it now. Part one, to remind you, is a part that primarily supports the start of part two. And part one is... Patients with different levels of diabetes get one single dose of Sevparin and then they measure how the concentration of the medicine develops in the blood. We use those data to be able to write down three specific dose levels, depending on what animal function the patients will have in part two, where they will be treated for a longer period of time. What daily dose should they have? Since it is a single dose that we are talking about per patient, it is a slightly faster part, at least in our expectation. But it is still the case that You learn with the years to be humble about how clinical research can be difficult to predict. This is based on our experience and our appreciation.

If you look at resource allocation in the future, is it the CKD study that is the big priority?

Yes, of course. The CKD study and the activities around it. In the medium-long perspective, it is part one. When we start part two of the study, There is a condition that we have financed the second part, which is the dosage, up to a month. It will take more than a year to carry out. So we need to refinance that.

I saw that you have received further dissemination of your scientific material. Can you comment on what that looks like and what the interest looks like in the future?

The interest for our material is large. In this case, what was published in October in the Netherlands and will also be presented at the British Pharmacological Society in December is our finished, reported data in the sepsis area, that is, the LPS study that we completed in the beginning of 2023. It was presented by our partners, CODR, who became 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 to be able to present data. We are very happy about that. We have several publications that we are waiting for news about. As soon as they are published, we will of course talk about it.

I was going to leave the question open for the last one. You can comment on your view on the way forward and if there is something we have missed today that you think is of importance for company development in the future.

No, I think we have covered what our prior activities are for now. We have filed, as I mentioned earlier, two patents, one that concerns breast cancer and anemia, and one that concerns... LPS and the sepsis area and the data that we have generated, we will continue to follow up on them even next year and they will continue to be an important part of our IP portfolio. We hadn't mentioned that in this report, but I think that, from what we haven't touched on, that's probably what needed to be mentioned.

You have a new board member as well.

That's right. We've also got in Johan Dighet from Karolinska Development. We lost, in a very sad way, Torsten Görs earlier this year, very suddenly, and needed to get someone who could replace him quite quickly. And then the opportunity arose for Johan to join the board and we are very happy for that. He has long experience from the banking world and is also one of those who participates in the management group in Karolinska Development. and has a background as a lawyer and loan expert. So he has many strings on his back and we look forward to working with him.

Thank you very much, John, for your time. Now I feel that my voice is starting to crack, so it's good that we end and round off. We'll take new steps next quarter. Yes, we will.

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