Lipum AB (publ)

Good morning, you will be listening to the presentation of the first quarter of the year. Welcome Ola Sandborg.

Thank you very much and welcome to all of you who are listening. I am Ola Sandborg, the CEO of Lipum. I am pleased to present the report for the first quarter of the year 2025. We will talk about that in January to March this year. Looking at the report we have published this morning, I have put the headline on the overview that Lipum is in a very difficult situation. I will explain and tell you about the time we have been together. So you can see what is behind this. In a quarter report there are some financial information. For us as a company that is researching and has no commercial activity, there may be limited interest in the actual expenses. But it can be good for you to know that we had moving revenues for the quarter of the year at 492,000 SEK. Which is higher than the same period last year. But what it is about here is that we have received contributions from different parties for some projects that we are running. Contributions among other things from Vinnova, Swelife and Eurostars. Our result after the financial posts is at minus 19 million SEK. Which is what you should expect from a research and development company. As you can see, the sum is much higher than last year. The reason for this is simple. We have started production of study drugs for the next phase. And we did not have the costs a year ago. And to produce biological drugs comes with a total cost. From start to finish it is about 52 million SEK. But it is costs that we have already taken for this. But it can be good to know the difference compared to the previous year. In the plan book we have at the end of the quarter, about 4.3 million SEK. And the number of employees at the end of the period is 6 compared to 5. And that is what we have reported since before. That Peter Hofstadius is appointed as chief medical officer during the autumn. But it is about the numbers. I want to take you further into the fact that we say that the leap is in a very good position. And what it is about is that we have been able to close the gap. We are going to carry out the first clinical study on humans. And we have done that with our Läckmennenskandidat Sol 116. And the result has been so good that we clearly see that we have been on the way to a further clinical development. I will give you a little more detail. But in summary we can say that we have a very light safety profile. We have a very light safety profile where Sol 116 has been tolerated well in all doses without serious side effects. We also have a predictable pharmacogenetic. And it is very important to see how our product is taken up in the body and how it is distributed and exported over time. We can also see that we have a average of half a year on about 16 to 21 days. Which is also a support to be able to treat patients once a month, which is a plus. We can also see that for low immune and immunity. We know that with these types of drugs antibodies can be developed against the drug. Often abbreviated as ADA, anti-drug antibodies. And that was not necessarily a problem. We found one participant. But at a later stage, the patient was negative. So really nothing that has been a question mark. And finally, an explorative effect we have looked at the target effect. And then we talk about the target protein that our antibodies are directed at. And we often talk about it as BSSL or Bile Salt Stimulated Light Pace. And there we see that we have a clear indication that we have a direct target effect. So there is no doubt that the result we have got is just as good as you can hope to have to continue to have the support to be able to continue. And what can also be said about this is that we have been concerned about the cost of the drug for the first two studies. But that goes to the highest degree and supports the timeline we have before the start of this study in the first half of next year, 2026. We have also looked at how this phase two study can look. We have a design, we have a synopsis presentation that we have also agreed on with global key panel leaders. So we have their support because this looks to be a very well designed and structured study for that product and that phase. So we have a good direction forward. And what is currently around this is that for me and the board, it is a lot right now a job to look at how we can finance our business to be able to carry out this study that is estimated to have a result available by the end of 2027. We are working to finance the business forward to and with 2027 and we need to do that to be able to carry out a study. It is not ethical to start a study without security and security, but we have drugs to use throughout the study as well as we have the funding in place. But what I mean is that we have a product that comes to the market and we look first hand at Rematid Arthritis or RA, which is often abbreviated as leading Rematism in Swedish. There are a lot of treatments available already and especially during the last 15 years, a lot of biological drugs have been added, especially when the phalpha-hemmas have been well received. But despite that, I see that a large number of patients still do not receive the help they need for their illness and symptoms. We can see that -40% do not respond to the first line of treatment. We also know that -40% lose effect over time, so they get a good treatment from the beginning, but it does not last over time. In total, about 75% do not have a B-container remission and there is also a restriction, both with the use of a phalpha-hemma or infection sensitivity, as well as a JAK-hemma from cardiovascular diseases, which has then ended up in what is called a black box warning, so that the patients should avoid that type of treatment. It is obvious that there is a great need for additional drugs that work in a different way to help these patients. And that is precisely where our treatment is at, since we have a whole new protein that we are working on, with the hope that we will be able to have good support for these patients. If you want to look at the final study report, I would like to share the results in more detail so that you can feel how good and reassuring it is. It is something that is a great and safe support for us to move forward. But as I said, the first study is human, which we look at healthy volunteers, individuals who participate and also a number of patients who have had time to leave. The study was in three different groups. One, as you can see on the top, in blue, is the first step we took, looking at healthy volunteers. They get the soliates of 16 in increasing doses. The first group got a dose of 0.075 mg per kilogram, almost a homeopathic dose. Then they have tripled the dose for each group that comes after that, so that the maximum is 6 mg per kilogram. And eight individuals in each group, six got sol 116 and two got placebo. Then we have the same situation, looking at six plus two patients. Now we are talking about the RA, the orange box is down there. Those eight who participated there, those six who got sol 16, got the same dose as they got in chart number four on the SAD part. The last part of the study was that they gave a multiple dose on healthy volunteers, in this case three milligrams per kilogram. Each dose was given with 28 days in between, that is, once a month. The study design is a classic setup for a phase one study, with the primary goal we look at is to evaluate safety and tolerability. That is what the phase one study has as its primary goal, so that is what it is designed for. Of course, we look at their secondary result goal and talk about the pharmacogenetics as one of them, and you will see a slide there soon. And explore how sol 116 interacts with the goal protein BSSL. But to get to the result, perhaps not the image I am most proud of, because there are a lot of details, but what it is about is safety and tolerability. You can see the three groups in the columns next to each other, different colors and lines. The SAD part, in total 40 individuals, distributed 10 placebo and 30 on sol 116. Those who were in the RA got a dose, two and six. The patients were distributed on placebo and sol 116, and the same on the multiple-billion part. This is very, very safe and attractive data around the safety perspective. To start with, the distribution of what is called treatment emergent adverse events, evenly distributed between all groups, nothing sticking out. The only serious side effect is that the individual who got placebo, which is what you see on the other row, is 50%. In that case, the individual was taken out of the study, but he wanted to continue despite the increase in the number of people who had been given the heart attack. In total, very well distributed, evenly between the groups and nothing alarming for sol 116, but gives us that security and support we need to continue. I mentioned the antibody antibodies earlier. There was one individual out of 56, which we could have shown in one case. There was one test out of 336 tests taken. It was on a close patient on day 49, but the individual tested negative on the next case, on day 90. So it's not a result that you take anything more than a note out of. What might feel better is that you could not see any positive ADA tests among those who got multiple doses. This risk can increase with the number of doses given. But in this case, out of those who went with the multiple dose cohort, they got four doses. Out of the 16 or placebo, but no evidence of development of ADA. The second secondary goal is to look at pharmacogenetics. To the left you see how the concentration of sol 116 in blood is increasing over time. The concentration is increasing from the day 0 to the day 90. The concentration is in the y-axis. It's a fantastic, clear, clean data, almost taken from a schoolbook. If you increase the dose, you get a higher peak concentration, but at the same time the destruction is happening equally over time, even to day 90. We also see that the orange line almost at the top is mostly the spot on on the black line behind. In this case, the patients who got sol in the 2.025 mg dose and the healthy volunteers who got the same dose, they are acting just as well over time. It's very nice to see that. It's important for us, when we involve patients in this study, to be able to take part in the distribution of the vaccine. In the diagram to the right, you see those who have got four doses on each other, day 1, day 29, day 57 and day 85. They have then been transferred to day 167. There is no doubt that you reach a steady state at the end of the time after you have found the third dose, just before you give the fourth. That is what is expected at that time, if you have reached a steady state. So even in this case, very clearly, very good, very convincing results in pharmacogenetics and as I said earlier, this supports that we can give our product once a month. And finally, the explorative effect measure that I have looked at, and it was then BSSL levels, at the health volunteers as well as at patients. It can be worth noting that the patients who entered this study were very well treated in their current treatment, so that there should not have been any higher levels of BSSL. Which we can see when you compare these three diagrams with each other, that it is about the same level of BSSL as you can expect to achieve if you have an active disease. But also what is clearly coming out, and that is what you see, the black lines against the blue ones, that we have a very effective secretion of BSSL when you have given the sun 116, both for healthy volunteers and for the volunteers. So even here, very convincing to see that the antibody simply does what it should do. If there is BSSL, then BSSL activities are blocked. So the conclusion is that we have received the results that confirm safety, tolerance and a predictable pharmacogenetics, which also supports it once a month. We can see that we have an effective secretion of BSSL both in healthy volunteers and in patients. As I mentioned earlier, anti-drug antibodies have not been anything that sticks out at all, and we get a strong support to be able to move on to phase two, which we then also do a -of-concept study on patients with active BSSL-hard rheumatoid arthritis, and that is what we plan for the future. If you look at what this timeline looks like, we have divided it into three blocks. One is the clinical program, which you see at the top in purple. We look at the pre-clinical or non-clinical program, which is blue in the middle, and also CMC or product production, which is at the bottom in gray. So what we are doing now is that we have come in and completed the first quarter of 2025. As you can see at the top, we are at the lowest level in the study planning for phase two, as I mentioned earlier, but it is now that we are able to really put the caps on the ground for how it should look. The goal is to be able to start this study in the first half of the year, 2026. This requires that you have a confirmation from the registration authority, which is what stands as CTIS approval, in the beginning of 2026, and that is how the timeline looks. You can also see that this is hoping well for the study medical staff to be ready to go into the study, which will also happen in the end of the year, together with sending in the application to the registration authority. But also, the work is going on in parallel with the pre-clinical work, and it is mainly three larger projects that have been and are going on. The first is a collaboration with the Carolinian Institute, where we look at the operating mechanism for sols 16 and how it affects BSSL. This project has been going on since late autumn 2023, so it is now reaching its end in autumn 2025. We have also started a project together with Carolinian and Linköping, which has received support from SWILive, where we look at different subgroups of patients with rheumatoid arthritis and their expression of BSSL. It is very exciting to understand the variations that can occur between different subgroups. And finally, at the bottom of the blue, we have the project that we received positive feedback from EuroStars in December, that they want to support our project together with a Norwegian company, AgeLab. We are looking at the development of a companion diagnostic. I will go a little closer to what this is about, because I'm not sure if it is fully implemented, but it is something that can have a great impact on us in the future. At the highest level, a lot of activity is underway, and as you can see, our goal, our scope, is mainly to reach the end of 2027, which is a real trigger point for the future, when we have the results of phase two study. I will go a little closer to the project that is supported by EuroStars. They work through Vinnova in Sweden and the research council in Norway. It is we together with AgeLab who take joint responsibility for this project. EuroStars finances the project with 50 percent, and it is 50 percent of the total project costs of 1.9 million euros. It is a fantastic support and recognition that they go in and support us. The goal of this project is to develop a technique, or what we call the companion diagnostic tool, a diagnostic tool that can predict which patients with rheumatoid arthritis are expected to have the greatest value in dealing with our medical services, the O-16. When it comes to companion diagnostics, it is something that has started to emerge during the year. I think the biggest amount at the moment is in the USA. We know that there are about 190, almost 200 companion diagnostics approved by the FDA, the American Medical Association. Most of them are in the cancer area, where this has been a question that has been developed many tests, but it is also beginning to come to other areas, not least where we are. But a companion diagnostic has the possibility, as you can see in these three points below, and it is what the FDA has published in the information, that it can identify which patients are most likely to respond to a treatment, to benefit from the treatment. It can also identify patients who could have a risk of side effects, and it can be as important to find them as well as those who could have benefited from the treatment. But also, finally, to be able to follow the treatment results over time, which can also bring value to this. For our part, we consider it a success project, that it can be beneficial for us without hesitation, the way to registration, but also the implementation, commercialization of the O-16, and to have a device that the doctor can use when they see if the O-16 is the right treatment for the patient. This type of product comes as an add-on to the actual medicine, and it is also paid for. This is how the situation looks today in the US, and if you look at 2024, the market is up by almost 2.8 billion dollars, and you can predict not a double, but another, until 2032, when you have an estimate of 4.8 billion dollars in value in the market. Of course, this will not be the biggest source of income for us, or for Eriksleps, but still a very important support for the introduction of the O-16 on the market, the day we get there. Finally, I would like to summarize by bringing together, or probably connect, where we work mainly to create value around our company and the projects we have. The clinical program, as you have understood, the safety side, the safety study, phase 1 study is completed, and the next step is a phase 2 study, a proof of concept in the material treatment. At the same time, given the P-clinical program, I mentioned the effectiveness mechanism of the project together with Karolinska. This companion diagnostic was something that we have already talked a little more about, as well as that this type of medicine, anti-inflammatory medicine, where the O-16 is included, they will most likely be able to have value on other diseases. So for us to look at other indications, something that we also put time and effort into, to understand where it can do something new, and also to clarify what it is that should not have a value. And the last third leg on this, yes, it is really something that has to do with the future, to do, but which is also a part of my everyday life, and that is to look at the possibility of finding the perfect partner, either to be able to get a company to keep up with the development that is required. We know that when you go into a phase 3 program, which is then there, in the horizon, there is something that means a lot more higher costs than where we are today with our development program. But it could also be that we look at licensing and different ways to take the product to the market. So to the highest degree, great activity, good progress, and as you saw on the timeline, we deliver according to what we have said earlier. So I am very proud and pleased with where we are. And of course, a big thank you should be directed to the whole group who work around me. And here you see incredibly beautiful individuals who are with me and work with me on a daily basis in a different direction. So a big thank you to all of them, but also to the co-workers that we have out there in the form of the production of Notex Biologics and QPS, who have been in clinical studies. And don't forget, a big thank you to all of you who support our business through our active shareholder. So there, I'm actually going to end and open up for questions, if there is anything that has come in, we'll see.

Yes, thank you for this, Ola. We will try to get you in the picture here too. And yes, we have some questions here that have come in, and they touch on different types of areas. I thought we would start with the financial issues. You had of course with this that the costs have increased now when you have started to produce the study medicine and so on. But how does the company's cash position look in relation to the planned development 12 months in advance? Is there any additional funding needed?

Yes, absolutely. There was no doubt about that. And it's actually the case that, yes, I touched on it earlier. When we now take the step into phase two, there are a number of different parts that require a high cost. The first one you think of is the production of study medicine, but it has actually already been secured, and that was through the emission we carried out last year. The main purpose was to be able to start the medicine production in a long time, and also have such a large cost. So it is already safe. But what comes is the cost for phase two study. And phase two study, we don't really have the actual price on it, but here we are talking about 70-80 million crowns, as it conditions, and we must have the cost secured to be able to start a study. We will not be approved by the registration authority if we do not have that. But the fact is that the same applies to our own part. We would never go into starting a study if we do not know with confidence that we can complete it. And as I was in the study, the expected start was during the first half of the year. So we have to have the funding in place. This is to cover the costs until 2027. But it has affected a little. We are working very intensively to have done during this period to secure the funding, but we are not there so that we have released that information.

Thank you very much. If we look at, now you have with good results cleared off phase one results here. Have you changed anything in the strategy from these results, would you say, or is it a plan in its entirety?

Well, phase one study is very significant from the point of view of security and tolerability in the primary, but also pharmacogenetics. So it has really only given us support to be able to continue with what has been our hypothesis. So now we have the capacity we need to be able to design phase two studies with another security. Then of course we have discussed different views on how a phase two study can look. There are different variants, but the one I think is absolutely the most important and the most common question I get in relation to investors and other partner companies that I meet today is that it is about the impact on patients with rheumatoid arthritis and therefore we have been able to make much more clear that we are doing a clean test and concept study as the first step. So there it has been crystallized more clearly what we want to go on, but no major variants compared to what we had in our thoughts earlier.

Thank you very much. What markets will be the most prioritized for the future commercialization of SOL 116?

It is an interesting question today in terms of what is happening in our environment. But I had without hesitation in December said that the USA is the most important market then followed by Europe. And in Europe we may talk about the five major markets with England, Germany, France, Spain and Italy, but not to mention all the other member states in the EU which is also very important. So it is probably the primary North America with Canada across the US and Europe. But it is actually very interesting markets. They also have a need in Asia, and I think above all in Japan and China. And also there we have had some contacts with partners for a while. So they come a little bit as not just a Not just a little bit as a not just a little bit as a but still as a more outer part that I see as interesting.

Thank you very much. You talked here at the end about this with coming potential license holders or pharmaceutical companies as partners. Can you give a little more meat on the bones about this?

What I think is the most important thing to know is that this is a long-term relationship that you work with, which is that the team that was in place before I came to Lipum in December 23, and that was under the leadership of Einar Fonten, has done a very good job in building up a relationship, a network, and that we keep these possible partners continuously updated with the results we achieve. It is also very clear that they have an interest in our product, our research, and a lot is built on that when you come with a product with a completely new attack method, it gives new possibilities. At the same time, it also gives new challenges. For example, you have to be able to show that this product is expected to be so effective on the disease, and that's what makes the phase two study that we are going into so important. Phase one result, as I said, I could not have expected or hoped that we would have better results than this, but that's exactly what we need to be able to move forward with security. For example, recently when the Bayer Europe Congress was in Stockholm in November, we met a number of the R companies that we have fast-growing communication with, and it is very clear that when you meet them, and this is a 30-minute meeting where you have a small box and you change the box every 30 minutes, when they meet us, they are prepared, they are interested, they want to know, and that signals, as I think, that they are not interested in anything else, stimulating and exciting, but it is equally important that we play up with the same attitude in return to them, and that's what we do. So continuous work, very interesting, very good, in total we are talking about 20 companies on the list, but we actually have eight of them that we also have CDA signed with so we can share more sensitive information if needed.

Thank you very much, and that ends today's presentation. Thank you very much Lipum and Ola Sandborg.

Thank you very much, have a good day.