Lipum AB (publ)

Hej och välkomna till dagens webcast med Lipum där vd Ola Sandborg kommer presentera rapporten för det andra kvartalet 2024. Efter presentationen så kommer vi hålla en Q&A och så om ni har några frågor till Ola så är ni varmt välkomna att skicka in dem i formuläret till höger. Och med det sagt så lämnar jag över ordet till dig.

Thank you so much, Ludvig, and welcome to all viewers, listeners, whatever you want to call it when it's a webcast, but it's probably the same thing really. Ola Sandborg and I have been the CEO of Liipum since December 1st last year, so it's been eight successful months, and I have to say that it's been eight fantastic months. This is also my second quarterly report that I'm going to publish. It's the first day after Q1 and now it's a part-year report in connection with Q2. So a warm welcome and I will take you through a number of slides with, as I see it, useful and relatively good information for you. But the report that we released, which came out this morning, What I put the heading on, and a bit of an overarching message, is that the clinical phase 1 study that we are working on is nearing completion and the planning of phase 2 has started. I have to say that after this half year, everything that we have achieved, I am very happy and very proud of my organization, my team and those who have contributed. And it's not just my own organization, but many partners who are involved as well. So it's been a very, very successful and good first half year, which I hope to be able to show in the upcoming pictures. As always, in connection with the report, there is a lot of hard data. And for our part, since we are not a commercial organization at the moment, it may be a limited interest. But if you look at the overall financial composition for the first half of the year, we have turnover, overall turnover, which goes up to 315,000 kronor. This is mainly about contributions to the business. Otherwise, the result after financial reports is that we have a minus of SEK 28,109,000 compared to minus SEK 21,000,000 last year. This is completely natural given the type of business we operate, which needs to be covered. In our budget, we have liquid funds on June 13 at approximately SEK 20,000,000 compared to SEK 12,000,000 from last year, so we have a good basis for our continued work in the future. But something else that can be interesting from this first half of the year, some highlights, I have already prepared, together with the Q1 report, things that have happened, so a part has been covered up there, but some of the things I want to raise right now is that, to begin with, in April, we could go out with the information that we strengthen the protection for our medical candidate, Sol 116, even more, by doing a patent application that has become public, and it is about information-caused cancer. Under the recent period, we have also received funding from Swelife for 2.8 million kronor for a project. I will mention it later in the presentation. And for those of you who have been with us, of course, we have carried out the pre-emission during the spring, which then gave us a contribution of almost 80 million kronor gross. And beyond that, we also have a loan agreement of 20 million kronor, which gives us a good security for the time that comes forward to be able to work without having to have small breaks along the way. Vi har även ingått ett strategiskt samarbete med Northex Biologics för produktion av vårt läkemedel, studierekemedel för fas 2. Och även ytterligare en sak som har hänt under perioden är att vi har haft ett stämma som sig bör en gång om året. Och i samband med det så har Ulf Björklund, vår tidigare ordförande, slutat. Men han har ersatts av Ingmar Kihlström som har varit en ledamot i styrelsen under en tid. So a very natural and good change and a big thank you to Ulf for the incredibly valuable work he has done over many years and has been involved in creating this company. When Ringman then took the step up to the chairman's post, we also got in Åsa Magnusson as the new board member. A very inspiring and positive contribution. And finally, before Sillen came to midsummer, we could actually report the interim results for the multi-dose part of the phase 1 study that is now completed. I will also show you the results. Before we get into the details, I would like to mention something about the company. For those of you who don't know, Lipum is a biopharmaceutical company in the clinical phase with a focus on chronic inflammatory diseases. The main project is based on an antibody called SOL-116, which is then targeted at the target, which is often referred to as bile salt stimulated lipase, or BSSL in short. If translated into Swedish, it would be gall salt stimulated lipase. But this is based on research that has been carried out in Umeå, which started 50 years ago by Olle Hernell and colleagues. The company was founded in 2010. And since April 2021, we are listed on the Nasdaq First North Growth Market. And as I said, everything is about BSSL, Bile Stool Stimulated Lipase, which is the target protein that we aim for. And this was actually something that primarily had to do with breast milk for breastfeeding women. For BSSL, it is extremely important to be able to breastfeed the breast milk to the breastfeeding child and then be able to get the nutrition out. But as always, when you do research, things come up along the way. And one area that we have seen is that it is actually also connected to inflammatory diseases. And that's where we have come in and work as a company at Lipum. And it is also because of this that our antibody SOL116 has been developed. It has been developed in Sweden together with Lifesize Lab in Uppsala and Stockholm. It is designed to be an optimal antibody to work on the protein BSSL. Our activity today, I would say, It is primarily linked to three strategic areas. The first is that we are a biopharmaceutical company in the clinical phase. We have a phase 1 program that is ongoing. It is primarily to study the safety profile of our product. You will get a little more detail in the coming slides, but that is the main focus. What we also focus on is to be able to show that the product is effective in treating symptoms and diseases. Based on that, we have a proof-of-concept application in planning, where we focus on RA, rheumatoid arthritis, or rheumatism in Swedish. Parallel to that, a lot of preclinical work, because this type of medication, DITSOL 116 MÖR, can often be used in many other diseases as well. So for our part, it is very important to understand which indications we could possibly have. In addition, we also work to clarify the action mechanism or mode of action that SOL 116 works through. And last but not least, the third leg is something that is very important from a larger and longer perspective, and that is to have good partners. And for our part, as a Swedish company in the size we are, it may not be reasonable to see that it is we who will take the product all the way to a commercial series on a global market. So that's why we need to have Good partners to be able to continue the development together. And it can also be about a new licensing in the end. So all three of these are the main areas that I work with more or less daily. And it's been incredibly fun and exciting to step into Lipumak and be a part of this. Men om vi då tar oss till de resultat som vi har sett och som jag blir oerhört glad för och som samtidigt då verkligen stödjer där vi är och vart vi är på väg. Så att under våren har vi då släppt två stycken pressmeddelanden. Den ena i slutet av januari så var när vi kunde då redovisa de interimsresultaten från den första delen av fas 1-studien där vi tittade då på hur Sol 116 kunde då tas upp och mottas hos friska frivilliga personer. The second part, which we came up with in June in a press release, deals with the multiple dose part of the clinical phase 1 study that has been carried out. And to give a little more detail on what this is about, we have three parts in this phase 1 study, the first in human, the first time we inject the drug into humans. So the first part, the one that came in January, actually studied 40 healthy volunteers who got one dose Huvudspåret givetvis tittar på säkerhet. Den rapporten kom i januari. Den andra delen, som berör en flerdos på friska frivilliga, startades i oktober 2023. Där fick vi interimsrapporten tillägnad i andra kvartalet 2024. Den tredje och sista delen pågår fortfarande. Den startade i februari i år. I det här fallet tittar vi på en singeldos This is the first time we have treated patients, and the recruitment is still ongoing. We are actually waiting for the last, the eighth patient, so I will soon be able to close that study as well. But if we also look at the layout, the first part, the blue boxes to the left, are the 40 fresh patients. Frivilliga, som har fått en dos av Sol 116, och som ni ser, det är fem kohorter som har fått det i stigande dos. Den absolut första karten fick en knappt märkbar dosering på 0,075 mg per kilogramm, och den sista karten fick faktiskt så mycket som 6 mg per kilogramm. That part was a guide for how we could look at the dosage before we went to multiple doses or multiple doses of fish free will. And those individuals got four doses on each other, given one dose per month. So under four dosage cases with one month in between, they got sol 116, which is a dose of 3 million per kilogramme. And as I said, the last part is the part that is going on, where there are eight patients who get, in this case, two milligrams per kilogram, which matches the same dose they got in CART4. And the primary effect you look at, as it always is in a phase 1 study, is safety and how well the product is tolerated. But at the same time, we take the opportunity to look at other effect variables. And for example, as a secondary endpoint, we look at pharmacokinetics and anti-drug antibodies, or ADA, which is often shortened. It is actually a fairly important part to be able to see if this product that you give to an individual, if it develops antibodies itself in the body. And this is something that can limit the effect of a product over time. Finally, we also look at some exploratory effects, especially the BSSL concentrations in individuals, but also the number of inflammatory biomarkers that are very important. I can also finally mention that in each cohort there are eight individuals that are included, of which six get the active drug, i.e. sol-116, and two get placebo. This is a blind randomization as always. If you look at the results, here we see the serum concentration, how it looks from the normal given dose to peak and how it is released from the body over time. In this case, it is shown in hours on the x-axis versus the concentration on the y-axis. What I can say is that this is exactly what you want to see with the increased dose, increased top concentration, that we have a linear release over time and that these relate to each other in exactly the way you see. And the fact is that in this case we have a halving time of our product for about 20 days, which is very impressive and viktigt för den framtida utvecklingen av produkten och hur den kommer att designas. Jag nämnde även att vi tittar på nivåer av BSS, alltså det målproteinet som vi går på, och som antikroppen ska blockera effekten av. In this case, it is actually healthy volunteers, because this is the result from the five cohorts in the first single dose section. And these healthy volunteers are actually expected not to have any BSSL levels, but they have a number of them. 23 of the 40, that is 58%, have been able to show BSSL levels at some point during this study period. And what is interesting to see, and it is actually so that the grey bars are those who have had solar 116 and the blue-purple are those who have had placebo. So it is very obvious that when they have had solar 116, they have been able to take it down to non-measurable levels. Very, very soon, a few individuals, maybe on day two or three, but from day four and onward, så är det icke-mätbara nivåer för de som fått SOL 116, kontra de som har fått placerbara, där ni ser att staplarna finns kvar över hela studieperioden. Det finns fyra individer där det dyker upp resultat på BSS-nivåer i slutet av studieperioden, från dag 49 och framåt, men det är alltså för det väldigt fåtal And above all, it is important to see that we have a good excretion of BSSL over time. So it is obvious that SOL116 does what it should do. It eliminates the free circulating BSSL in the blood in individuals. And for most of them, it is up to 90 days after a given dose. Very, very strengthening and important result for us. And very encouraging too, I have to say. Because it shows that the antigrapher does exactly what it should do. So in summary, in the phase 1 study where we are in the current state, we have received very positive interim results. We know that SOL116 is well tolerated with few and above all no serious side effects at the different dose levels. At the same time, we have also seen that no individual has been able to show anti-drug antibodies, which I mentioned earlier, which is a measure of immunogenicity. This applies both to those who have received a part of the first dose, the single dose, but also the multiple dose. And we may not have gotten a better result this early. This really strengthens the fact that this product will continue to have an effect over time in a good way, even if it has to be studied further in studies. We have also, as we can say, received an expected and desirable pharmacogenetic profile. So you saw the discharge, the top concentrations, and that this is also associated with a half-life of about 20 days, as well as very clearly that we have a potent BSS-binding antibody that we maintain. So with this, we have interim reports from SAD and MD-cards that have been added now during the spring and as already mentioned, the Singedol study on the number of patients that occur and will be able to close relatively soon. As I said, the last patient is what we are waiting for. So very positive and good results. This is very important for us when we look forward and see what the next step is. Looking forward, it was a bit of a message together with the launch of our previous emission earlier this spring. We hoped to get support and have received support for is to get a financial base to be able to start advancing SOL 116 into phase 2. And then the preceding emissions were extremely important for that, and I must really once again thank everyone who has a support in connection with it, because this has given us a platform to then be able to take the climate further. One of the important parts and a, let's say, a basal starting point for going into phase 2 is that we should have study drugs available in connection with that we start the phase 2 study. And for that we have actually looked around and tried to do it in the best possible way. And here we entered a strategic collaboration agreement with NoteX Biologics. And we have been able to start that from April with a start-up. NoteX Biologics has operations both in Matfors outside of Sundsvall and in Solna. And they will be the companies that will help us with the production of Sol 116, as the pruritus medication we will use in the clinical phase 2 studies. I think it is worth mentioning that this is, as I said, a very important starting point, but also a relatively expensive part of the development program we have. In total, it costs about 52 million kronor. att ta fram studieläkemedlet i tillräcklig volym för att kunna genomföra fas 2-studierna, samt att det tar i stort sett ett och ett halvt år. Det här kanske för en oinvid, det kan tyckas vara dyrt och ta lång tid, varför är det så, men faktum är att här hanterar vi biologica läkemedel och de har ju en helt annan tillverkningsprocess jämfört med de kanske mer vanliga medicinerna som vi köper eller får utskrivna på recept som benämns som små molekyler eller syntetiska läkemedel för det kan man producera mycket snabbare och mycket enklare. But in our case, it is based on cell growth that should occur over time and there are many analysis and quality controls that should be done along the way. Plus that from a small initial volume from a cell bank where you start, you should then scale this up to volumes of over 200 liters in bioreactors. Så det tar tid, det kostar pengar att göra det, men det är väldigt, väldigt viktigt att det sker på ett kvalitativt och bra sätt. Vi är oerhört nöjda med att ha just Notex Biologics som vår samarbetspartner i det här. Och jag kan bara säga att arbetet kom igång med rivstart och allting löper på precis som det ska göra, vilket gör att vi ser fram emot att till hösten nästa år, hösten 2025, kunna då få det läkemedlet which will be for the test to enter the stability study and then be ready for an initiation of phase 2 study from the year shift 2025-2026 approximately. I also mentioned in the summary at the beginning that we have received support from SweLife for 2.8 million kronor. This is for a collaboration project we have together with the Carolinian Institute and the University of Linköping focused on looking at precision medical biomarkers to be able to optimize a person in treatment with RA, rheumatoid arthritis. This is a real project that looks into the future, but everyone wants to be in the present, to be able to find some kind of signals that show what is the best treatment for this individual. And this is very, very important for us to have with us in the package on the day we will be able to commercialize the product. Because then you can really tell which individuals would benefit the most from the product. Then you can really get a good assessment of the right individual and a very good assessment of the product's suitability for that individual. So very, very cool. This has come into effect now and will generera resultat inom den kommande framtiden, dock inte i år, utan vi får vänta in i nästa. Slutligen, innan jag öppnar upp för frågor så tänkte jag ändå nämna att vi gick ut med en pressmeddelande igår. Det här var faktiskt lite oväntat för oss att göra det, men som alltid, den information man har vid handen tycker jag är viktigt att dela, oavsett om den är positiv eller negativ. Viktigt med öppenhet och transparens. And the fact is that we have received a negative preliminary report. It is important to say that a preliminary report regarding the revision of the Horizon 2020 project. And some of the information I shared in the press release I think is important to take into account. Because what it all really is about is that we received a contribution from the European Commission or the Horizon 2020 project in 2018. And that was about 23 million kronor. and it is through the innovation program that Horizon 2020 is mentioned. A very successful project that will be finalized in February 2021. For our part, it is very much about getting the manufacturing process and the antibody SOR-116 in place so that we could get into the phase that we are in today with clinical studies. After the project has been finalized, a revision will be introduced in 2022 that can appear And this time we were chosen to be part of a revision, where they had to look at the project, how we had carried it out and its costs. And roughly two years after this, very recently, we received a preliminary report regarding the revision, where the reviewers raised that we risked repaying 400,000 euros, generally a claim of 25% for indirect costs, which is a generous suggestion. This surprises us a lot. Nothing that we see that it can be right, but the revisions have done their job and they do it based on the conditions they have. But I also think it is worth mentioning that this project is something that the European Commission has also mentioned during the year's run as a very successful one. They talk about this being a game changer for chronic inflammatory disorders. And this is communicated, for example, via its information channel, Cordis. Just then, as a very successful example of how their contribution comes to well-being and helps companies move forward with development. But what I would perhaps summarize entirely with, and a slightly different view from later, is that this is a complicated issue with EU-contracts. You get a lot of formal, a lot of agreements and But at the same time, it is also extremely valuable to be able to take part in these contribution funds. We can not only be safe with support from shareholders, but it is good if we get from the other side, and we have really gotten what was an important contribution in 2018. At the same time, we have also been chosen as a unique European technology company that really stands out. Sammanfattningsvis kan jag också säga att vi känner oss trygga med att samtidigt har de projektmedel som beviljas LIPUN för det projektet använts till de avsedda och berättigade ändamålen. För vår del kommer YTSA att gå in med svaromål på det här. What it basically is about is the classification of these costs that we have reported to the Commission, that we have classified them wrong. And it is about consulting costs. A part of our organization, the staff we have, has been equipped with consultants, which is very common in Sweden today. Det har vi rapporterat som personalkostnad, inte som en subcontracting kost som de då hade velat att det skulle gå. Så det handlar alltså om en teknisk miss när det gäller hur vi har klassificerat och rapporterat de här kostnaderna tillbaka, ingenting annat. Så vi känner oss trygga med att det här kommer inte att hända. Men oavsett det, det är en risk och det var det vi flaggade för i samband med pressmeddelandet gick ut med. Men återigen, det här med Horizon 2020 är inte den enda kontakten vi har haft med den europeiska kommunikationen. Vi har även varit del av ansökan om medel från det som idag heter EIC Accelerator. Horizon 2020 bytte namn under vägen och i oktober förra året så var vi på utvalda på en intervju och det är en väldigt liten del av de som ansöker som kommer på intervjun. Very good presentation and performance from each side, but unfortunately the competition was too hard and we were short and did not get the contribution we had asked for at that time. But at the same time we got such an input from EIC, which they call the seal of excellence, which further strengthens their very positive understanding of our work and project. So, a few personal words about this. We will deal with it in the future, so I don't see the need for the risk to be so obvious, but we still have to flag it because it is part of it all. And as you can see, over the years, we have had a number of cases where we have received funds into the company. If you look back towards 2018, you see the EU flag with the 23 million kronor that we have received in this case. Over the years, there has been an increase. We had a big one in connection with the IPO we went into on the Nasdaq Stock Exchange with 85 million kronor in 2021. And now you can also see the contribution this year from the forecast emissions of 79 million kronor. But above this timeline, you can see all the projects and initiatives that have been carried out. And above all, that we are currently working on the clinical phase 1 study, where all three parts are underway and have been reported with interim results. Verkligen, som jag ser på som ny på företaget, men ändå med några månader nu, en väldigt imponerande progress över åren och en bra utveckling som jag ser fram emot att vara en fortsatt del av nu när vi även börjar rikta in oss på fas 2. Men givetvis ska vi slutföra fas 1-programmet först i sin helhet, men det kommer jag kunna ha klart innan året är slut. Och lite grann som sista bild och sista budskap är väl kanske bra för er att se var vi befinner oss och vad som är framför oss. Men som sagt, 2024 så har vi kunnat rapportera data på singeldos och multipedos hos friska frivilliga de första två kvartalen. RA-patienterna förväntar vi oss i tredje kvartalet, eller som det ser ut just nu, att vi kan ha interimsresultat i oktober. Men även att vi då med det här kommer att ha en slutförd och helhetsbild från fas 1-studien tillgänglig vid årsskiftet. Parallel, we work with biobank data to study BSSL and its connection to inflammatory diseases. We have some preclinical data on NOC-INMUS studies that we have started now. And for 2025, 2026, 2027, there is a lot to be able to take part in these biobank data. The implementation mechanism, the projects we have run together with Karolinska, we expect to have Resultat att dela under det andra kvartalet nästa år plus att vi då är redo för att kunna starta fas 2-programmet som fas 2-programmet proof of concept delen ser vi har sin huvudsakliga tyngdpunkt under 20, 26 och 27. Så det, mina vänner, mina lyssnare, är den sammanfattningen som jag skulle vilja ge från den här delårsrapporten från första halvåret 2024. Och så sagt var, hoppas ni håller med mig, men jag är oerhört glad, oerhört stolt över det som har hänt under det här och ser fram emot fortsatt. action from and with the end of the semester, as it is there for most of us in the current situation. So I say thank you and leave it to you, Ludvig. We'll see if you have any questions.

Yes, but thank you so much for the presentation here. And I thought we'd get started right away. And you mention at the end this with Horizon 2020 and so on. I thought you might give us a little short summary. What happens next here, if you put it that way, in that aspect?

This is a preliminary report we have received. Deloitte, the company that has done this work, shares it with us for our opinion. We also have the opportunity to contribute with information that the European Commission should take into account when they look at the final report. So part of the final report that goes to the European Commission, we have it. möjlighet att lyfta vår syn på revisionen. Och det kommer vi givetvis att göra. Och som jag sa förut, vi känner oss trygga i att de här medlen som vi har fått, de har använts, det där var avsett för, men vi har tyvärr gjort en miss när det gäller klassificeringen av de här kostnaderna som vi har rapporterat tillbaka till kommissionen. Det är bara att vara ärlig. Men vi har inte använt medlen fel. Och vi har på oss fram till den sista augusti att komma in med vårt That is our contribution to the report and that is primarily what we will do now during August. Formulate and present our view on the whole in a convincing and credible way.

Thank you very much. You mentioned that planning work for phase 2 has begun. When do you expect to be able to start phase 2?

As far as the timetable is concerned, we are in that position that in the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter of the first quarter pratar lite grann om när det gäller Norrvägs biologiska tycker de gör ett fantastiskt arbete och de har verkligen bra fart i det så det är inga problem men det tar tid att producera biologiska läkemedel och det är ju det som framför allt styr att vi inte skulle kunna starta en fas 2-studie innan den här tidsperioden heller så att det skifter 25-26 det tycker jag är en bra tidpunkt att titta på i dagsläget.

Thank you. Let's take a look at some more questions. Do you have any dialogue with potential partners for commercialization? Let's take a look. The easy answer is yes.

As I showed in one of the first pictures, we have three key pillars in our business. Eina Pontén, my representative, and the team have worked on this before I joined, so I've really managed it. and try to take over all these contact areas in the best possible way. And we have a number of possible partner companies that we discuss with, and they are updated on where we are. They are extremely excited to see the results of the phase 1 program, so I will have a great autumn with these companies to meet them, inform them and also again see how their interest and vision for the future looks like. But I can say that the interest is great and above all when you come with a unique drug that works on a completely new mechanism, on a completely new target protein, then the interest is great. But at the same time, they have to feel safe in that there is data that supports that this could succeed all the way and Yes, we are a good bit on the way, but the companies that are there we work with. It is medium-sized and large global pharmaceutical companies we are talking about in this case.

Is it that you go out and meet companies or is it that you will go out to some fairs and conferences?

It's both. The trade fairs and conferences. For example, BioEurope is a classic meeting. It's in Stockholm now, the first week of November this year. It's a given occasion that you are at. There you meet and there is professional communication. You can almost call it a connection business, but you report your interest in meeting companies. They accept it and then there is a meeting room on site at the fair where you meet and share information. So there I exist. But the companies where we have a slightly more clear interest from, we meet separately outside as well. It happens all the time. I've had some of these meetings here during the summer actually.

A final question, Ola. We have looked a bit forward, but are there any hard estimates of how big the potential could be for SOL 116?

Yes, you do this kind of assessment based on best ability. I have been working on this kind of estimations for a number of years now. So you do it as much as you can. If you look at our part, on the RA-indications, which we have as the main track right now, and appreciate what it could bring in terms of a measurable increase in the market when I look at the seven major markets, which are the US, Europe and Japan. It is about peak sales, which may come after about four or five years after launch. att vi har intäkter på i storleksgraden 3,5 miljarder USD. Alltså upp någonstans uppemot 35-40 miljarder svenska. Så att om produkten levererar där den ska, och då man kan få den att användas på rätt patienter som är uppskattade, ja, då finns det bra möjligheter till rejäla intäkter. Och som jag sa, det här har varit måttfulla estimat vi har gjort, så det är inte överdriftet på något sätt, men det är ändå tydligt att produkter måste leverera ett resultat. In that sense, it is an incredibly interesting product.

Thank you very much, Ola, for presenting today and answering questions. And thank you to everyone who watched. We hope you have a nice weekend when it comes here.

Yes, the same to all of you. There are a few hours left if I have to quit the job earlier, but then I do not have the opportunity to do it. There are a number of things I have to do, but a big thank you to everyone who has been a part of this.