Lipum AB (publ)

Good morning. You will be listening to Lipum's quarterly presentation for the first quarter. Welcome, Ola Sandborg.

Thank you very much and welcome to all of you who are listening. As I said, I am Ola Sandborg, CEO of Lipum. I am pleased to be able to present the report for the first quarter 2025. That will of course be in January to March this year. Tittar man litegrann på den rapport som vi har publicerat nu på morgonen så har jag satt rubriken på den övergripande att LIPEN befinner sig just nu i ett mycket gynnsamt läge. Det är litegrann det jag tänker förklara och berätta för er om under den här stunden med jag tillsammans så att ni får se vad det är som ligger bakom det här. But if we start, there is always a quarterly report, of course, a lot of information about the financial and for our part, as a company that is research and has no commercial business, then maybe there will be limited interest in the actual expenses. But still, it can be good for you to know that we had turnover for the quarter of 492,000 kronor. which is higher than the same period last year. But what it's about here is simply that we have received contributions from different directions for some of the projects that we run. Contributions, among other things, from Vinnovans, WeLife and Eurostars. Our result, according to the financial reports, is minus 19 million kronor, which is what you would expect from a research and development company. As you can see, the sum has been higher than last year, and the reason for that is very simple. We have started production of study drugs for the next phase, and we did not have those costs a year ago. And to produce biological drugs comes with a cost. In total, from start to finish, it is about 52 million kronor, but these are costs that we have already taken for this. But it can be good to know the difference compared to previous years in relation to this. In the plan we have at the start of the quarter, approximately 4 million kronor, 4.3 and the number of employees at the end of the period is 6 compared to 5 and what has happened is that we have announced earlier that Peter Hofstad was employed as Chief Medical Officer during the autumn. But it's about the numbers. I want to take you directly to the fact that we say that LiPen is in a very favorable position right now and what it's really about, yes. is that we have been able to complete the first clinical study on humans. We have done it with our lactic acid candidate SOL116 and the results have been so good that we clearly see that we have been able to continue clinical development. I'm going to give you a little more detail, but in summary, we can say that we see that we have a very favorable safety profile where Sol under 16 has tolerated well in all dose levels without serious side effects. We also have a predictable pharmacokinetics. It is very important to see how our product is taken up in the body and how it is distributed and distributed over time. We have an average half-life of about 16 to 21 days, which is also a support for being able to treat patients once a month, which is of course a advantage. We have also seen a low level of immunogenicity. We know that with this type of medication, antibodies can be developed against the medication. Often we shorten it to ADA, anti-drug antibodies. And that has not been a problem either. We found it with one participant, but in a later trial, that patient was negative. So it's really nothing that has stood out as a question mark. And finally, an exploratory effect model where we have looked at the target effect. And then we talk about the target protein that our antibody is focused on. And it's the one we often talk about as BSF-celled. or bile salt-stimulated lipase, as it is actually called. And there we see that we have a clear indication that we have a direct goal effect. So there is no doubt that the result we have got is just as good as you can hope that you will get in order to have the support to continue. And what can also be said about this is that we have production of drugs for phase 2 studies. This is in the highest degree and supports the timeline that we have before the start of this study during the first half of next year, 2026. We also have Tittat på hur kan den här fas 2-studien se ut? Vi har en design, vi har ett synopsisframtaget som vi också har stämt av med globala key opinion leaders och vi har deras stöd för att det här ser ut att vara en väldigt väl designad och inriktad studie för den produkten och den fas vi befinner oss i. Så att vi har en bra riktning framåt. Och det som ju givetvis ligger runt omkring det här är att för mig och för styrelsen så är det mycket just nu ett arbete med att titta på hur kan vi finansiera vår verksamhet för att då kunna genomföra den här studien som beräknas ha resultat tillgängligt i slutet av 2027. Och vi arbetar alltså för att finansiera verksamheten fram till och med 2027. Och det behöver vi göra för att då kunna genomföra en studie. Det är inte etiskt förfarbart att starta en studie och inte ha security and security, because we have drugs to use throughout the whole study as well as we have funding in place. But with the fact that we have a product that comes to the market and we look in the first hand at rheumatoid arthritis or RA, which is often shortened to lead rheumatism in Swedish. There are a lot of treatments available already and especially in the last 15 years or so, there have been a lot of biological drugs, not least in the case of the hemorrhoids, which has been a good addition. Men trots det så ser vi att det är en stor andel av patienterna som fortfarande inte får hjälp. Den hjälp som de behöver för sin sjukdom och sina symptom. Vi kan se att 30-40% inte svarar på första linjens behandling. Vi vet även att 35-40% tappar effekt över tid. De får en bra behandling från början men den består inte över tid. In total, about 75% do not have a postpartum remission, and there is also a limitation, both with TNF-alpha inhibitors and infection sensitivity, as well as JAK inhibitors from cardiovascular diseases, which have then rendered in what is called black box warning, i.e. clear warnings that these patients should avoid that type of treatment. So it is quite obvious that there is a great need for additional drugs that work in a different way in order to be able to help these patients. And it is precisely there that our treatment, which was introduced in 2016, because we have a completely new target protein that we are working on, and with that, we hope that we will be able to have a good support, a good help for these patients. But if you look at the phase 1 study that came with its final study report just a few weeks ago, I would like to share the results a little more in detail so that you get a sense of how good and reassuring this is. This is something that is a great and safe support for us to move forward. But as I said, the first study in humans, we looked at healthy volunteers, individuals who participate and also a number of patients who have rheumatoid arthritis. Upplägget var i tre olika grupperingar. En del som ni ser på den högra sidan här i blått är det första steget vi gjorde, att titta på friska frivilliga. De får soligheten av 16 i stigande doser. Den första grupperingen fick en dos på 0,075 mg per kg, närmast homeopatisk dos. Sedan har man tripplat dosen för varje kort som kommer därefter. to a maximum of approximately 6 mg per kg. And 8 individuals in each group, 6 got sun, 116, and 2 got placebo. Then we have had the same survey to look at 6 plus 2 patients, now we are talking RA, that is the orange box down there, the 8 who participated there, the 6 who got the sun and 16 got the same dose as they got in chart number 4. And then the last part of the study was that they gave a multiple dosage of free will and in that case 3mg per kg. And each dose was given with 28 days in between, that is, once a month. And the study design, the classic approach for a phase 1 study with the primary goal that we look at, is to evaluate safety and tolerability. And that is what the phase 1 study has as its main goal. So that's what it's designed for. Of course, we look at a number of secondary results, goals, and we talk, for example, about pharmacokinetics as one of them, and you will see a slide for that in a moment. And exploratively, a little about how Sol 116 interacts with the target protein, the BSS cell. But to get to the results. Maybe not the picture I'm most proud of, because there are a lot of details, but what matters here is safety and durability. And you can see the three groups in the columns next to each other, separated by different colors and lines. But the SAD part, that is a total of 40 individuals, divided 10 placebos and 30 on doses 16. Those who were in RA received one dose, 2 and 6. Patients were divided on placebo and doses 16 and also the same on the multiple dose part. So this is very, very reassuring and encouraging data around the safety perspective. To start with, the distribution of what is called treatment emergent. Adverse events, evenly distributed between all groups, nothing that stands out. And the only serious side effect that actually appeared in the multiple dose part to one of the individuals who had received placebo. And that's what you see in the second row as a one and in parentheses 50%. In that case, the individual was taken out of the study, but he actually wanted to continue. trots att det här hade dykt upp och det var ju då en icke-SD förhöjd hjärtinfarkt som den hade drabbats av. Men på ett sätt väldigt väl fördelat, jämt mellan grupperingen och ingenting som alarmerande på något sätt för soligheten av sexton utan ger oss den trygghet och det stöd vi behöver för att gå vidare. I mentioned earlier that there was one individual out of these 56 patients who had been able to show such antibodies in one case. That is, one test out of a total of 336 tests that have been taken. And that was, as I said, on a close patient on day 49. But that individual tested negative for the next case on day 90. So it's probably not a result that you take any more notice of. What might feel better is to see that you could not see any positive ADA tests among those who got multiple doses. This risk can increase with the number of doses you give. But in this case, among those who entered the multiple dose cohort, they got four doses. of SOL116 or placebo, but no indicated development of ADA. The second secondary goal is to look at pharmacokinetics and to the left you can see how the intake and the concentration of SOL116 in blood occurs over time from the dose given on day 0. And then you follow along for 90 days afterwards. And the concentration is on the y-axis. And it's fantastic, clear, clear, clean data, almost like taken from a school book. But when it increases, you get a higher peak concentration. But at the same time, the exhalation occurs at the same rate over time, up to and with day 90. And we also see that the orange line, almost at the top, is largely spot-on on the black line at the back. In this case, the patients who had received sol in the dose of 2.025 mg plus 3 g and the healthy volunteers. who had received the same dose, they behave exactly the same over time. So it's very nice to see that too, because it's one of those things that was important for us when we involved patients in this study, to be able to take part in whether they differ from the flu or not. In the diagram to the right you can see those who have received four of each other's repeated doses, day 1, day 29, day 57 and day 85. Och de har sedan följts ända upp till dag 167. Och det är ingen tvekan om att man når en steady state i slutet av tiden efter att man hittar den tredje dosen, precis innan man ger den fjärde. Och det är väl lite grann det man förväntar sig också, att vid det tillfället har man nått ett steady state. So even in this case, very clear, very good, very reassuring results in pharmacokinetics. And as I said before, this supports us to be able to give our product once a month. And finally, the exploratory effect measure that I had looked at, and that was then BSSL levels in healthy volunteers as well as in patients. It is worth noting that the patients who entered this study were very, very well treated in their current treatment, so it has not been expected that there would be any higher levels of BSSL, which we also see when comparing these three diagrams with each other, that it is about the same level as BSSL compared to what one can expect to achieve if one has an active disease. Men även det som tydligt framkommer, och det är det som ni ser, de svarta linjerna kontra de blå, att vi har då en väldigt effektiv hämning av BSSL när man har givit sol-116. Nu gäller det både för friska frivilliga och för aerobaterna. Så även här är jag väldigt betryggad att se att antikroppen helt enkelt gör det den ska göra. Finns det BSSL så blockerar man BSSLs aktivitet. Så konklusionen. är att vi har fått resultat som konfirmerar säkerhetsoperabilitet och en förutsägbar farmakokinetik som även stödjer en dosering en gång i månaden. Vi kan se att vi har en effektiv hämning av BSS både hos friska frivilliga och ära patienter And as I mentioned earlier, anti-drug antibodies have not been anything that sticks out at all. And we get a strong support to then be able to move on to phase 2, which we then also do a proof-of-concept study on patients with active medical care for severe rheumatoid arthritis. And that's what we plan for the future. Tittar man litegrann på hur den här tidsplanen ser ut så har vi delat in det i tre block. Det ena är det kliniska programmet som ni ser längst upp i lila. Vi tittar på det prekliniska eller icke-kliniska programmet som ligger i blått i mitten och även då CMC eller produkttillverkningen som ligger längst ner i grått. Så där vi befinner oss i dagsläget är att vi har kommit in och klarat av det första kvartalet av 2025. Så som ni ser på toppen We are currently working on the study planning for phase 2, as I mentioned earlier, but it is now that we will be able to really put our feet on the ground for how it will look. The intention is to be able to have a start on this study during the first half of the year 2026. This requires that you have a approval from the Registration Authority, which stands as CTIS approval, In the beginning of the year, and this is how the time frames look like. You can also see that this is good for us to have the study medicine ready to go into the study, which will also take place at the end of the year, together with the application to the Registration Authority. But also work is going on in parallel with preclinical work. There are three major projects that have taken place and are taking place. The first is a collaboration with the Karolinska Institutet, where we look at the mechanism of operation for solar panel 16 and how it affects BSSL. This project has taken place since late autumn 2023, so it is starting to come to an end now in the autumn of 2025. Vi har även påbörjat ett arbete tillsammans med Karolinska och Linköping utifrån ett projekt som vi har fått stöd från SweLife, där vi tittar på olika subgrupper av patienter med reumatoid artrit och deras uttryck av DSSL. Oerhört spännande för att förstå variationer som kan ske mellan olika subtyper av grupper. And finally, at the bottom in the blue, we have the project that we received a positive message in December from Eurostars, that they want to support our project together with the Norwegian company AgeLab. We are looking at the development of a companion diagnostic. I was going to go in a little closer to what it is about, because I'm not sure that you may be fully engaged. But it is something that can have a very big meaning for us in the future. In the second highest degree, a lot of activity is underway and as you can see, our scope now is primarily to reach 2027, which is a real trigger point for the future when we have the results of the phase 2 study. So a little short about this project supported by Eurostars. They operate via Vinnova in Sweden and the Norwegian Research Council. And it is we, together with Agelabs, who take the joint responsibility for this project. Eurostars finances the project with 50% and it is 50% of the total project cost of 1.9 million euros. So a fantastic support and recognition to get from their side that they go in and support. And the goal with this project is to develop a technique or then what we call a companion diagnostic tool, a diagnostic tool that can predict which patients with rheumatoid arthritis are expected to have the greatest value of being treated with our drug SOL-1916. And when it comes to companion diagnostics, there are some things that have started to emerge over the years. I think the biggest measure at the moment is in the USA, and we know that there are about 190, almost 200 companion diagnostics approved by FDA, the American Medical Association. Most of them are in the cancer area, where this has been questioned and many tests have been developed, but it also starts to come to other areas, and not least where we are. Companion Diagnostics has the possibility, as you can see in the three dots below, as the FDA has printed out the information, to 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 at least as important to find them as well as those that you think can be useful to take the treatment. But also ultimately to be able to follow the results of the treatment over time, which can also be valuable in this. So for our part, we assess it with a successful project here that it can without doubt be beneficial for us, the way forward to registration, but also implementation, commercialization of SOD 116, to have such a tool that the doctor can use when they are to see if SOD 116 is a suitable treatment for your patient. And it is also the case that this type of product comes as an add-on to the actual drug and it is also paid for. So this is what the situation looks like in the current situation in the USA. And if you look at 2024, the market is up to almost 2.8 billion dollars. And you predict, not a doubling, but almost until 2032, when you have an estimate of 4.8 billion dollars in value in the market. Of course, this will not be the largest source of income for us or Elkslabs, but still a very important support. till introduktionen av Sol 116 på marknaden den dagen vi kommer dit. Slutligen så tänkte jag bara summera med att på något sätt dra ihop eller knyta ihop säcken var är det vi arbetar i huvudsak för att skapa värde runt omkring vårt företag och de projekt vi har. Ja, det kliniska programmet har ni förstått, säkerhetssidan, säkerhetsstudien, passivhetsstudien är avklarad och nästa steg är ju då A phase 2 study, a proof of concept in rheumatoid arthritis. In parallel, of course, the preclinical program. I mentioned the mechanism of operation, the project together with Karolinska. This companion diagnostic was something that we have already talked a little more about. Just as this type of anti-inflammatory medication, where SOLD-106 is included, they will most likely be able to have value on other diseases. Så för oss att titta på andra indikationer är någonting som vi också lägger tid och kraft på för att förstå var kan det göra nytta och även förklarligt i vad det inte skulle ha ett värde. Och den sista tredje benet på det här, ja, det är verkligen någonting som har med framtiden att göra men som i allra högsta grad också är en del av min vardag och det är ju att titta på möjligheten till att hitta den perfekta partnern. Antingen för att kunna då få ett företag att hålla i hand under den utvecklingen som krävs We know that when you go into a phase 3 program, which is over there in the horizon, it is something that means much higher costs than where we are today with our development program. But it can also be that we look at outsourcing and different ways to take the product to the market. Så i allra högsta grad, stor aktivitet, bra progress och som ni såg på tidslinan vi levererar enligt vad vi har sagt sedan tidigare så att jag är oerhört stolt och nöjd över där vi befinner oss och det var självklart att ett stort tack ska riktas till hela gruppen som jobbar runt omkring mig och här ser ni oerhört vackra individer som är med och jobbar tillsammans med mig på daglig basis i en eller annan utsträckning. So a big thank you to all of them, but of course also to the collaboration partners that we have out there in the form of the production of Notex, Biologics and QPS over the clinical study. And not to forget also a big thank you to all of you who support our business by being active shareholders. So there, I actually think I'll stop and open up for questions if there is anything like that that has come in. We'll see.

Yes, thanks 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 concern different types of areas. I thought we'd start with The financial issues, you mentioned that the costs have increased now that you have started to produce the study drug. How does the company's cash position look in relation to the planned development 12 months ahead? Do you need more funding?

Yes, absolutely. There is no doubt about that. I touched on this before. When we now take the step into phase 2, there are a number of different parts that require a high cost. The first one is the production of study drugs, but we have actually already secured it, and that was through the emission we carried out last spring. The main purpose was to be able to start the drug production, since it takes a long time and also has such a high cost, so it is already safe. But what will come is the cost of the phase 2 study. The actual price of the phase 2 study is about SEK 70-80 million. We must have the cost secured in order to start a study. We will not be approved by the Registration Authority if we do not have it. But the fact is that the same applies to our own part. We would never go into starting a study if we did not know with certainty that we can complete it. As I mentioned, the study is expected to be started in the first half of the year 2026. For that, we must have funding in place. This is to cover costs in the future, even in 2027. Men det berörde litegrann. Vi arbetar väldigt intensivt och har gjort nu under en period för att trygga den finansieringen. Men vi är inte där så att vi har släppt ut den informationen.

Tack så mycket. Om vi tittar på, nu har ni ju med gott resultat klarat av fas 1 resultaten här. Har ni... Have you changed your strategy in any way based on these results, or is it completely according to plan?

The phase 1 study is very important from the point of view of safety and tolerability in primary care, but also in pharmacokinetics. So it has really only given us support for us to be able to move forward with what has been our hypothesis. So now we have the facet we need to be able to design phase 2 studies with another security. Then it is clear that we have discussed different approaches to what a phase 2 study can look like. And there are different variants, but what I think is absolutely the most important and the most common question I get in connection with investors and other partner companies that I meet in the current situation is It is about the impact of the disease symptoms on patients with rheumatoid arthritis and therefore we have been able to be much more clear about making a pure proof-of-concept study as the first step. So it has been crystalized more clearly what we want to do, but no major variants compared to what we had in our thoughts before.

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

This is an interesting question given what is happening in our environment. In December I said that the US is the most important market, followed by Europe. And in Europe, we might be talking about the five major markets with England, Germany, France, Spain and Italy. But not to mention all the other member countries in the EU, which are also very important. So it's the primary North America with Canada across the US and Europe. But it's actually very interesting markets and they also have a need in Asia. And then I think above all about Japan and China. Even there, we have had a lot of contacts with partner companies. They come as an integral part of the process, but also as an additional part that I find interesting. Thank you very much.

You talked here at the end about this with upcoming potential licensors or pharmaceutical companies as partners. Can you give a little more meat on the bone about this?

I think the most important thing to know is that this is a long-term relationship that we work with. The team that was in place before I came to LIPEM in December 2023, under the leadership of Einar Fontén, has done a very good job of building up a relationship, a network, and that we keep these possible partners continuously updated with the results that we achieve. It is also very clear that they have an interest in our product, our research. And a lot of it is based on that when you come up with a product with a completely new approach, it gives you new opportunities. At the same time, it also gives new challenges. For example, you have to be able to show that the product is expected to be effective on the disease. And that is what makes this phase 2 study that we are entering into so important. As I said, I could not expect or hope that we will have better results than this, but it is exactly what we need to be able to move forward with confidence. For example, recently, when the BioEurope congress was in Stockholm in November, så träffar vi ett antal av de här företagen som vi har fortträffande kommunikation med. Det är väldigt tydligt att när man träffar dem, och det här är ju då 30 minuters möten i ett litet bås, man byter bås var trettionde minut, When they meet us, they are prepared, they are interested, they want to know. And that signals, as I think, a genuine interest, extremely stimulating and exciting. But just as important is that we play along with the same attitude in return to them. And that's what we do. Så kontinuerligt arbete, väldigt intressant, väldigt bra. Totalt sett pratar vi om ett 20-tal företag på listan, men vi har faktiskt åtta av dem som vi även har CDA skrivna med, så vi kan dela mer känslig information om så behövs.

Tack så mycket, och det får summera och avsluta dagens presentation. Tack så mycket Lipum och Ola Sandborg.

Tack så mycket, ha en bra dag.