Lipum AB (publ)

Hello and welcome to today's webcast with LIPUM, where the CEO Ola Sandborg will present the report for Q1 2024. After the presentation, there will be a Q&A. If you have any questions, you can send them in the form to the right. With that said, I hand over the floor to you, Ola.

Thank you very much, Ludvig, and welcome to all listeners who are here to take part in our report for Q1 2024. We have chosen to publish it today and it will not be a surprise that it is about our business, our product and our intention to have a unique treatment of chronic inflammatory diseases. My name is Ola Sandborg and I am the CEO of Lipum. I don't know if it's news now, but the fact was that on December 1st, when I applied for my job, my position at Lipum as CEO, And this was a strategic step for me. It was really a job that I wanted to have. And I have to say that the first few months have really freed up what I thought it was about and what it was supposed to be. I have a background in the pharmaceutical industry. I started about 30 years ago and have been at a number of companies. Last at Swedish Orphan Biovitrum, or SOBI, as it is called. I was Vice President for Immunology and Specialty Care and worked with the development of the business. So I have worked on a global level, have led multi-functional teams and worked with a number of partnerships and development projects. Development projects, both in the early and late stages. And beyond that, with regard to the journey that Swobo has made, I have been part of their company evaluation, acquisition and even sales. So that's a bit of the history and background, but it's fantastic to be at a company like Lipum and to be able to be involved and develop a completely new drug for chronic inflammatory diseases. The quarterly report is a bit of a striking first, I say that it has been a very intense first quarter where we have been able to launch a number of important initiatives and there is no doubt that 2024 has started at full speed for Lipum Det är det jag tänkte att jag skulle kunna dela med er i ett antal slides under den här presentationen. För min egen del så kan jag med stolthet se tillbaka på en fantastisk början av det här året. Jag kan säga att vi fortsätter helt och hållet enligt plan. Under 2024, we will be able to complete and report the phase 1 study that is really in its final stages. We will then have a summary that we will be able to share before the end of the year. At the same time, we will also start preparations for the next part, the phase 2 program. We see this as extremely exciting and potentially valuable for our business. So the first quarter, without a doubt, a lot has happened and full speed forward. And with that, maybe you can look to see what it is about, what I mean. Yes, there are a number of important initiatives and results that put their emphasis in this case. The first, which we did already in January, was that we could share interim results from the first part of the phase 1 study. You will see them very soon. Vi har genomfört en företrädelseemission som har stärkt vår kassa med drygt 73 miljoner kronor. Miljoner hade i och för sig varit fantastiskt men det är det inte utan 73 miljoner kronor. Vi har även kunnat inkludera första patienterna med reumatidartrit eller ledgångsreumatism som vi kanske säger på vanligt svenska som då fått en dos av Sol 116 vårt läkemedel. Vi har även skrivit ett avtal och inlett samarbete med en ny tillverkare och vårt läkemedel är något som är oerhört viktigt för den fas vi förbereder oss för, för fas 2. Och vi har även kunnat utöka patentskyddet för Solina 116 till att även omfatta cancer. Och slutligen så har vi även fått ett bidrag från Sweet Life om 2,8 miljoner kronor för att kunna genomföra ett viktigt prekliniskt projekt. Och det här är vad jag tänkte att jag skulle presentera för er under den här lilla stunden vi har tillsammans. But we can start with the basics in a quarterly report and what we actually share. This is the financial outcome for the first quarter from January to March 2024. And our net income of 0 kronor is no surprise. We have no productive sales, but the business we have is purely research and development, which means that for our part, the financial side is very much around the cost side. So the result for financial positions is that we have a cost of minus 9.3 million kronor. To be able to compare with the same period last year, which was at 7.2 million kronor. En liten ökning, men det är helt och hållet kopplat till den verksamhet och den organisation vi har för där vi befinner oss i utvecklingsfas just nu. Våra likvida medel per den 31 mars var på nästan en och en halv miljon kronor att jämföra med 26,8 då för ett år sedan. Att vi var så pass lågt var ju ingen konstigt heller, för vi genomför en företeelseemission och det var ju ett måste att det skulle hända i den här perioden. So yes, the financial results are in balance and under control, but as I said, it was important for us to be able to add more funds to be able to continue our business forward, and the understanding that we have received help with that. A little short about the company for those who have not been with us and seen us before, but what it is about is that Lipum is a A biopharmaceutical company that is in a clinical phase and our focus is on chronic inflammatory diseases. Our product, a humanized antibody that has been developed in collaboration with SciLife Lab in Uppsala and Stockholm, We call it Sol-116 and it is directed towards a completely new target protein called bile salt stimulated lipase, or BSSL is often the abbreviation we use. Gal-salt stimulated lipase would be the name in Swedish if you translate this directly. But this is something that has its roots in academic research at Umeå University, which started about 50 years ago. And have then mentioned that we are a company that was created in 2010 and since 2021 we are listed on Nasdaq's First North Growth Market. Så nästan på dagen, tre år, har vi då varit på Nasdaq-börsen. Som ni ser på kartan, vi har huvuddelen av vår organisation knippad till Umeå. Nio individer som jobbar utifrån där. Och så har vi då i Uppsala-Stockholm-delen ytterligare 14. Och sen har vi lite mer spridning i Sverige med Skåne, Göteborg och Småland. Och icke att förglömma vår kollega i Finland. Och vi har även en kollega i USA på östkusten. Så det är en liten spridning på olika plats men huvuddelen då i Umeå och i Stockholmsregionen. And as I said, everything is about BSSL, the target protein that we focus on. And as I said, it came from the research that started in Umeå many, many years ago. And Olle Hernell, who is now the managing director, was one of the people who was behind this. And you had never found BSSL in breast milk for breastfeeding women. And this was then intended to help to dilute the breast milk so that the children would get the full nutritional content. But as always, you learn more along the way and what you have seen later during the research has been that you have increased BSSL levels in individuals with chronic inflammation. You have seen both in those with rheumatoid arthritis and in children's rheumatism and also in psoriasis arthritis that you have increased BSSL levels. So it is obvious that this is a way to help patients with a new and unique functional mechanism. And that is where our humanised antibody Sol 116 works towards BSS cells as the target protein. Vår verksamhet idag har tre huvudområden som vi riktar in oss på. Dels, som jag sa förut, vi är inne i klinisk fas och för vår del då är det oerhört viktigt att se att vi har en säker och väl tolererad produkt. Så fas 1-studien som pågår just nu har ju ett huvudfokus på säkerhet. But what we are also preparing for is to be able to show effects, and we have chosen the model indication to respond to rheumatoid arthritis, where we expect to be able to establish a proof of concept within the coming years, and that is the next step. Parallel to this, we have a preclinical business. We know that this type of medication can be used for various different indications, And it is very important for us to know which ones it can be, but also which ones that could not be expected to respond to treatment with Sol-116. In addition, it is also important to have a clear implementation mechanism or mode of action, MOA, so that it is a parallel work that occurs at the same time as we run the clinical program. And not to forget that we also look at the possibility of entering partnerships. Because it is so that even if we have a very, very strong and good organization like that and where we are today, but to develop this product ready for the global market requires that we get help and support. And for our part, it is extremely important to find the right partner to work with. So that work continues. So these are the three main areas that we focus on with our business in the current situation. But if we look at the different results and the progress we have achieved during the first quarter, and the result of all the work that has been done so far, we can start with the failure of the phase 1 study. The interim results that I could share in January. And it was very positive results, because it shows that Sol 116 reduces BSS levels in plasma in healthy people. And that was exactly what the product was supposed to do, but we don't know if it really succeeded in carrying out that type of research. So if you look at the phase 1 study, it consists of three different parts, and what we then provide in the RIMS report in January, it was part of the first group, the one we call SAD-HV, or it stands for Single Ascending Dose in Healthy Volunteers, En eskalerande dos i friska frivilliga. Så här är det 40 individer som har fått möjligheten att prova SOL-116. Men som alltid så är det då ett antal som får det och ett antal som får placebo. Ni kommer se på nästa sliden fördelningen. Det som har startats under hösten 2023 men som fortfarande är i utvärderingsfas är de individer som har fått multipedos, alltså fyra på varandra följande doseringstillfällen årsskilda med en månad. Det är åtta friska frivilliga individer som då har fått vara med i den delen och här förväntar vi oss att de har en rapport klar inom kort för det är nu i andra kvartalet som vi kommer att få det resultatet. And finally, the third part, which started here in March, and that was that we have eight RA patients, rheumatoid arthritis patients, who get the opportunity to try one dose of Sol 116. And by today's date, there are four who have already started and four who are on their way in. And the last autodom should have gotten its dose here by midsummer, as it looks at the moment. Studiedesignen har tre olika grupperingar. Till vänster ser ni de fem kohorterna som har haft en ökande dos per grupp. Jag nämnde att det var 40 individer och i det här fallet var det sex som har fått aktiv suktans, alltså soligheten av 16, och två som har fått placebo i varje grupp. And the same applies to the single dose arm, where RA patients get it as well as in the multiple dosage, that it is six who get active and two who get placebo. And the main effect we are looking at here is just the safety and tolerance of the product. But the secondary endpoint that we follow is of course pharmacokinetics. It is important to understand how the product is taken up in the body and how it is decomposed. And also in this case, we have chosen to follow ADA or anti-drug antibodies, i.e. antibodies that can then be developed against the product. And it is devastating if that happens, because then you lose effect. And then finally, we have exploratory endpoints where we look at BSL levels and also inflammatory biomarkers. So when we have a complete report, all these details will be available. Unfortunately, we don't have that yet. But if you look at the interim results from the first part, So handlar det här om hur sol-116 tas upp i kroppen och hur den utsundras över tid. Och här ser ni de fem kohorterna. Stigande dos per kohort och den armen som är längst upp, de gröna, är de som har fått den högsta dosen. Och det här ser vi precis det vi vill se. En väldigt tydlig och fin farmakokinetik med en halveringstid på ungefär 20 dagar. Och en ökande upptag per ökande dos. Så väldigt tydlig, klar och fin farmakokinetik. And the other thing we could also take part in and look at is the plasma levels of ABS-SL, and in this case before and after the manivit dose. And the three groups that have been looked at here are groups 1, 3 and 5. We also have preliminary results for groups 2 and 4 today, but 1, 3 and 5 are the ones that are displayed in the graph. Den gråa stapeln är de som har fått sol 116 och den blålila är de som har fått placebo. Det man kan se här är att de som har fått sol 116 så finns det möjlighet att kunna mäta BSL-nivåer upp till dag tre som mest hos en individ. Men därefter så är det inte mätbart att man har slagit ut BSL-aktiviteten hos samtliga de individer som fick sol 116 när det håller i sig över de 90 dagarna. att jämföra med de som fick placebo, där vi ser att de lila staplarna finns kvar där över hela testperioden, om andra ord, In that case, you have a remaining BSL that is not affected. So for our part, it is extremely nice to see that we have a potent BSL binding antibody that effectively eliminates the free-circulating BSL in plasma, and it does so up to 90 days after you have given it a dose. So a fantastic and very, very good result that gives us support for further development. Summarizing the phase 1 study, So, the first and primary thing is to look at it with certainty, and there is no doubt that Sol-116 has been well tolerated, with few and above all no serious side effects at the different dosage levels. There was also no individual who had anti-drug antibodies after dosage, and that is also very nice to see. And as you can see, we have an expected and desirable pharmacokinetic profile. So it is clear that SOL116 is a potent BCSL binding antibody. As I mentioned, the multiple dose study is under final evaluation. We will have the results within a short time and be able to share. And when it comes to the single dose study on RA patients, it has started and we expect to be able to take part in the results during the third quarter and a complete report in the fourth quarter this year for the whole study. So fantastic, good result from the phase 1 study. What I mentioned earlier was that we work in parallel with a whole preclinical activity and one of them was just to be able to clarify our functioning mechanism. And here we actually have a collaboration with the Karolinska Institute. And it started during the fall, but I can say that from this year it has really taken off. And what we are looking for here is partly to be able to Where is BSSL in the immune system, the immune defense? We also want to see where BSSL goes and works, and from there, when it binds to a receptor or something like that, what effects does it have? This is extremely important for us to be able to clarify and understand how our product works, but also where it could be a good support for patients in need. So this, together with the work we do with the phase 1 study, is the basis we need to be able to take the step forward towards phase 2. And with that mentioned, the fact that the pre-emission that we went out with at the end of February and that we have carried out since then during March and April is something that had the purpose of being able to take us to a phase 2 situation for our development program. So what we were looking for here was to have a pre-emission where we focused on getting the highest 187 million kronor. till en täckningskurs om 76 per aktie. Den här summan 187 skulle tas en bra bit in i fas 2-programmet nästan så vi var klara så vi hade täckning för alla kostnader fram till och med 2026 års slut. Resultatet är att vi har kunnat stärka vår kassa med, som jag nämnde förut, drygt 73 miljoner netto. Det här var precis vad vi behövde för att få den basen att kunna tas in i förberedelserna inför fas 2. At the same time, our market cap increased to about 135 million kronor. It was previously at 65, and of course this is very much in line with the share price that we are on. But for our part, with the share price that is currently moving around 6.50 kronor, it is somewhat up, somewhat down from day to day. This means that we have a market cap of 135 million kronor with the 21 million shares that exist in the company today. So we got a very increase in the number of shares in the company in connection with the emission, where we then came up to approximately 21 million shares compared to approximately nine that we had earlier. But this gives us the opportunity to be able to complete the phase 1 study where we are for the time being and to start planning the work of a phase 2 program. And that this is then a means that then helps us to get to 2025 when we then in the end of the year decide to be able to start the phase 2 program. And perhaps the most important part of the planning work that is underway now is to be able to manufacture study drugs, because it takes time and it costs money. And that is where we have a new collaboration with Notex Biologics here in Sweden. But before I talk more about that, I really have to say thank you for the strong support that we get from all of you, our shareholders. Without you, we do not have the opportunity to do this, given that we do not have any own revenue. Så fantastiskt att kunna få ha er med oss, att ni tror och stödjer vår verksamhet framåt. Vi gör det utan tvekan, men vi behöver hjälpen från er för den här delen. Men ända att gå in litegrann på vårt samarbete med Northex Biologics. It is a company that has its foundations in Matfors, just outside Sundsvall, but they also have a business in Solna, here in Stockholm, so they are located in two places. And we have entered into a cooperation agreement with them to manufacture our product Sol 116 as a test drug with the intention of using it in the clinical phase 2 studies that are being prepared. On the other hand, we transfer the production from the current production that we have on the west coast in the USA. And we do this so that we see that we get a better result of that investment. In addition, it will share both costs and time savings. Vi får möjligheten att göra det samarbete med närheten att kunna vara delaktigare tillsammans med dem och vi gör det med en bibehållen hög kvalitet. Så jag är oerhört nöjd med det här samarbetsavtalet vi har fått till och de tjänster och den support som Notex Parallelogix tillhandahåller är precis det vi behöver där vi är idag för att då kunna fortsätta vår utveckling. Vi får hela produktionen av the liquid substance to ready-made ampoules to be used in the study environment at one and the same place from the North X-BioLogix company. Something that has also happened during this quarter has been that we have been able to increase our patent protection. In this case, we have been able to get with treatment of various types of cancer, inflammation-caused cancer. We have seen that in recent years, some articles have been published about patients with breast cancer, who at the same time have increased levels of BSS or tumor tissue, have a worse prognosis, shorter survival. So for our part, it was interesting to see if our antibodies can help this. In preclinical models, we have been able to show that a blockade of BSS cells with sol-116 also causes home growth of cancer cells with certain types of cancer. This is undoubtedly a very good support for the understanding that BSS cells can be involved in several inflammatory conditions, including RA, which we looked at in the first place, and also that our antibodies would be good. Så oerhört spännande att vara inne på det här och skönt även att se att vi har en bredare användningsområde än bara RA som vi initialt har tittat på. Finally, I would also like to mention that we have received support from Swelife. This is a support we have received of 2.8 million kronor and it has been approved as a contribution to a project that we call precision medical biomarkers to optimize personal treatment at RA. This is a project that we are doing in collaboration with Lipum, the Carolinian Institute and Linköping University. And in this case, it is something that is very, very important, both for healthcare, but above all when it comes to the clinical care out there, to be able to see where you can use SOL 116 with the best results. In this case, get a number of trained biomarkers to be able to predict and assess the condition of the patient with increased risk for RA, for example. It is often the case that you have this as a companion diagnostic, so that you can already from the beginning see if it is a patient who is expected to be able to respond to the treatment. So it can be extremely important for us that day when SOL 116 will be introduced on the market. Very grateful, we are extremely happy about this and we are about to start this project right now together with vännerna på Karolinska och Linköpings universitet så att projektet kom igång. Men fantastiskt att få det stödet. Återigen ett väldigt, väldigt gott betyg för den verksamhet vi har. Så sammanfattningsvis, det här är väl litegrann där vi befinner oss och litegrann vad jag ser som de milstolpar vi har framför oss och lite triggers för när saker och ting kan hända. Men 2024 är ju ett år av väldigt mycket slutföljande av FACET-studien. Att vi får den with all three groups completed, and that we have a complete report ready for publication before the end of the year. Parallel to this, we work with a whole range of biobank analyses, patient data to look at BCS and various inflammatory diseases, and we also have a preclinical data model that we are currently testing with a NOC-INMUSE study. So we are really on the move to get more and more results as support for the future. And this is something that will be able to help us even more when we enter 2025, where we expect a publication on the implementation mechanism sometime in the second quarter next year. And also, as I mentioned earlier, to be able to start the phase 2 program before The year is over, but it is above all 2026 and 2027 that then the study itself, phase 2 study on rheumatism where time patients go and where we will then get the proof of concept answer that we are looking for. So that was what I was going to share with you today from the quarter one report. So I stop here and open up for questions, comments, opinions. I suspect Ludvig that you have something.

Ja men precis, tack så mycket för presentationen här och jag tänker vi kör några frågor här på en gång. Du berättade här att under kvartalet har ni inlett ett samarbete med NorthX. Kan du berätta lite mer om vad det här samarbetet betyder för Lipum?

We had a good collaboration with a former producer in California, but there is no doubt that where we are today, we would like to have the production closer to us. We would like to have it under full control under one roof. So we actually did a review during a period to see what exists. We got a number of offers and made an evaluation. And the one that came out best was Notex Biologics in Sweden, which was incredibly exciting because Om vi tyckte att det var långt till Kalifornien, vad kunde det vara närmare att ha dem i Sverige? Både då i Matfors och i Sonheim, att vi har så mycket utöver vår verksamhet i den här delen av landet. Det som också är bra, de kan producera på ett snabbare tidsschema. De gör det till en lägre kostnad och det här utan att på något sätt tulla på kvaliteten. För vår del så var det ett väldigt enkelt beslut att ta när vi hade de här olika the alternatives in front of us. We are very grateful that they felt the same. We have started this collaboration now in April and the whole idea is that we can have a finished product at the beginning of autumn 2025. So it takes so long from the start of production until it really comes into place.

I understand. You also said that you have applied for a patent to strengthen the protection of Sol 116. How come you have chosen to apply for this patent?

For all areas where we see that we have a unique position and can really contribute something, it is very important to ensure that part of our business as well, so that no one else comes in and complains about it. So for every part where we come up with this type of result, we try to broaden it. This is the result of the preclinical studies we have done on the cancer area, we have received the support to be able to submit a patent application. The work is ongoing now, country by country, to get it done and approved, but without a doubt something that strengthens our product and our focus on work in the future.

Thank you. You mentioned that there has been a lot of initiative and a bit of a final spurt for some of the Q1 results, or Q1 Phase 1 results and so on. Could you tell us a little bit about this calculation to be able to get started with Phase 2?

The most important thing is that the timing part has been to get started with the production of the study drug as soon as possible. Therefore, it is incredibly good that we have done this together with Northex Biologics already in April, very, very quickly after the agreement was written. Product from them we expect to have in hand sometime after the summer, autumn 2025. And in parallel with this, the planning work for how this phase 2 program will look. So the hope is to be able to start the phase 2 program before 2025 ends or in the beginning of 2026. That's what we see in the current situation and what we focus on.

You have just concluded a new investment of SEK 73 million. You also signed a loan agreement with several investors of SEK 20 million. Will this amount of capital be sufficient to implement your plans?

We were looking for a way to cover our costs until the start of phase 2, when the study would start. And for that, we needed somewhere between 90 and 100 million kronor. And that is exactly where we are now with the 73 we received and the loan agreement from Fleri Invest, which we got at least 20 million. So this gives us the flexibility and the opportunity to act as we should. Then we have a number of other initiatives that involve being able to receive more capital from investors and the like. So hopefully we won't be using the loan part, but it's good to have it so that we don't have to worry about it if something goes out in time, which can sometimes be completely natural.

So you can say that it's an extra safety factor to have in the back pocket if you need it?

Yes, a safety factor, a shock absorber, to be able to have this flexibility so that we don't have to brake and accelerate everywhere else, but to be able to roll on exactly according to the plan. That's the purpose of it. And it's very, very good to be able to get that help.

I understand. But that was all the questions we had, so I thank you for the presentation today and I thank you for answering the questions. I thank everyone who has watched. You can continue all week here in Werben.

I say the same. Thank you all for being here.