Lipum AB (publ)

Hej och välkomna till dagens sändning med Lipum, där vd Ola Sandborg kommer att presentera rapporten för det tredje kvartalet 2024. Efter presentationen kommer det hållas en Q&A, så om ni har några frågor till Ola så kan ni skicka in dem i formuläret till höger. Och med det sagt så lämnar jag ordet till dig Ola.

Tack så mycket Ludvig och välkommen till alla där ute i Eten som lyssnar in på denna stund. Ola Sandborg heter jag, vd på Lipum. För er som inte har träffat på oss tidigare så är Lipum ett svenskt biofarmaceutiskt Läkemedelsföretag. Vi befinner oss i klinisk fas. Vi har en antikropp, en humaniserad antikropp som heter Sol 116 som är vår lead candidate och det projekt vi jobbar med. Och vår inriktning är på kroniska inflammatoriska sjukdomar. Den tidiga artig mitt förfogande här idag med er är ju utifrån Q3-rapporten och den släppte vi idag på morgonen. Jag har satt lite grann som rubrik på den i mitt eget vd-ord att resan fortsätter med framgångsrika resultat. And there is no doubt that this year has been good for us. This is my first full year with Lipum. And what has been the basis of everything that we have been able to communicate with each other, it came from the clinical phase 1 study that is ongoing. And I can say that it has been a very fun year. We have fun, it is full speed forward and a lot to do all the time. All of a sudden, we are here and autumn is ahead of us. We had a nice picture of it to get this fantastic feeling of autumn with its colors. To be able to share the feeling that we have. But what feels most stimulating and exciting is that we have come so far in the clinical phase 1 study after almost two years of work with it. So we will be able to take part in the results at the end of this or especially at the beginning of next year. That is the main message with the Q3 report that we have. But to go a little more in detail around the report, it is of course that I will touch on the financial situation and the report is due in the period from July to September. And as you know, we have no commercial business in the company where we sell and get real income, if you say so, but the income that can occur is often in the form of contributions And that is also what you see today, that we have the rest of the turnover at 109,000 SEK during the period. And here comes directly with support contributions we have from Vinnova for a project that we have been able to fund there. The result after financial posts is roughly at minus 1.7 million SEK compared to minus 6.6 last year, same period. And in the cash register we have at the beginning of September 12.873 SEK. miljoner kronor att jämföra med 17,5 samma period förra året. Så vi har kontroll på finanserna, det rullar på framåt och vi kan då bedriva det arbetet som vi har planerat att göra. Men det kortom det finansiella, om vi tittar lite mer på vad jag väger in i det här med att resan fortsätter med framgångsrika resultat, för det är faktiskt så att jag är väldigt nöjd med det vi befinner oss idag, även om det är också så att jag sitter och längtar till jultomten kommer och även i januari. The phase 1 study is approaching a final report and as we have reported earlier this year, single dose and multiple dose doses on healthy people in the phase 1 study have been able to be completed and we have shared interim results from that. In addition to this, the last RA patient included and it is said that in the third part it was actually possible to take part and include patients with rheumatoid arthritis or rheumatism, one might say in Swedish. It includes and doses all eight patients. And right now we are in a period of 90 days, which means that what in our language is called database clock, it happens in the Christmas week, and that is the starting point to be able to do the complete evaluation and with that then get a clinical study report that we submit to us during the first quarter of 2025. Det är ju någonting som är oerhört centralt och viktigt, och det här sätter ju även grunden för den fortsatta verksamheten för oss under 2025 och framåt. Och jag kommer att beröra det lite mer sen i kommande slides. En sak till som har hänt under perioden är att jag har anställt Peter H. Stadius som ny Chief Medical Officer, CMO. Och det här har jag gjort trots att jag hade Karin Frank-Larsson som hade rollen sedan tidigare. Men tyvärr var det så att Karin meddelade mig vid halvårsskiftet att hon var tvungen att sluta av personliga skäl. So it can be, we have been pleased to work together with Karin both at Sobi earlier, but also now at Lipum and we have had the best collaboration and really been pleased to be able to share her knowledge. But all the less, Peter is a very, very nice start in the company and in a short time he has really been able to get involved in our business and be able to start contributing. So Peter is here and is working, I can promise you that. It is also the case that the planning of the coming phase 2 study is beginning to take shape. Of course, the results from the phase 1 study are very, very important for our planning and development of the phase 2 study. Men vi har med hjälp av de interimresultat vi tidigare kunnat titta på känt oss trygga att kunna starta planeringen för den kommande fas 2-studien. En del i det här är ITS att tillverka studieläkemedel och det tillverkningssamarbetet som vi har med NorthX Biologics och som vi startade i april har utvecklats mycket positivt. Vi helt håller på tidslinan. And the results have been just as good as expected. So it's going on in order. And I can say that the same goes for the research collaboration. We have the Karolinska Institute, which also proceeds according to a plan. And that collaboration, for those who may not remember, but for me it is of course, is that we together with them study and learn more about the action mechanism, mode of action, for our antibody soli 116 and this is very important to understand how it works but also additional possibilities that can be found from it. And finally, in connection with the Q2 report, I would also like to inform you that we have received a preliminary revision report of the Horizon 2020 project from Deloitte Spain. We would come in with views on it and what we have done so far is not only left views but also interventions på den rapporten vi gjorde den 13 september. Vi hade en månad på oss att göra detta och självklart har vi gjort det. Det råder ingen tvekan om att vi har lite delade meningar jämfört med dem men jag tror att med vårt svar så har de fått det de behöver för att kunna uppjustera den och vi känner oss trygga med hur vi har nyttjat dessa medel. Men det är ändå lite kort om hur jag ser på det här kvartalet i vissa punkter. Vi går in lite mer på detaljer. För er som kanske inte känner till oss till följd, vår verksamhet är ju väldigt mycket runt omkring vår lead candidate, vår humaniserade monoklonala antikropp som heter Sol 116. Den är utvecklad tillsammans med SciLife Lab i framförallt Uppsala men även till viss del i Stockholm. And this antibody is then directed at a target protein that we often abbreviate as BSSL. It stands for bile salt stimulated lipase. And this target protein was first discovered in breast milk in breastfeeding women. And the effect for BSSL was to be able to help dilute the breast milk to free up the nutrients and fats that are needed for the breastfeeding child. But as always, when you do research, it happens that you find others along the way, and one of them has been that you have seen increased BSS levels in connection with inflammation, and that is what has become the basis for Lipum and the business that we run, and also the antibody that we have developed. So there is the project, and if you look a little at the cornerstones that we are working from today, there are three main strategic focus areas we have. The first is the clinical program, and that is where we are with the phase 1 study. The main direction of a phase 1 program is of course to look at safety and tolerability. But what we are already looking at today is also the next step, phase 2, and then we have the intention of delivering proof of concept in RA, rheumatoid arthritis, or leading rheumatism. That is what our direction is today, that we have RA as a model indication. Parallel to this, the work is preclinical, where we want to clarify and better understand our mechanism, mode of action. At the same time, we also look at other possible indications where our antibodies could have a value and importance. The fact is that this type of anti-inflammatory medication has very often a wider use area than just one single indication. We know since earlier that we have expected effects even on psoriatic arthritis and juvenile idiopathic arthritis or child rheumatism. We have a few things to say, but we also look at other indications of this. Finally, something that is very important, and I think it is also worth being considerate of the situation, is that if we can take this product to the market, så krävs det så att vi har någon form av partnerskap. Jag är väldigt stolt och imponerad över mitt team, men att ta ett läkemedel till den globala marknaden på ett område som till exempel dermatism, ingenting som man gör lekande lätt, utan här är det viktigt att ha ett bra samarbete med en kvalitativ partner. Så att den här typen av arbete med att hitta lämplig partner, det pågår hela tiden. Dels för att de kan vara med och hjälpa oss att utveckla produkten färdig till marknaden, men också att kunna ta den till marknaden. Sen utöver det vet man ju inte hur Framtiden ser ut som utlicenseringar eller försäljning av produkter och liknande. Men oavsett det, i dagsläget är huvudfokuset att titta på vad som är lämpliga partners för oss. Och lite om det som har hänt under året och som man är väldigt stolt som vd och ansvarig för verksamheten är ju de här tre pressmeddelanden. Vi kunde släppa den första i slutet på januari, den andra i maj och den tredje nu i september som delrapporteringar på fas 1-studiens progress. The first two have been interim reports where we have been able to share the results. And the last one is that we have been able to include the last patient in the ongoing phase 1 study. And in some way, it sets the point for recruiting trial people and patients. If you look at the study, it consists of three parts. The first part is what we call a single descending dose, that is, five cohorts with eight fresh volunteers in each cohort. Six get active medication and two get placebo. In this case, they have had an increasing dose for each cohort that has been included, and this is done by increasing the dose based on safety control. The first dose at 0.075 milligrams per kilogram is not something that we expected and could have any greater effect on the individual, while when we come up to the fifth cohort, the dose is actually as high as 6 milligrams per kilogram. The second dose The part in the study is a multiple dose part, where the eight individuals have received four of the following doses, 28 days in between each dose, and here they have given 3 mg per kg. And finally, the third part is a number of eight patients with rheumatoid arthritis who have received a dose of 2.025 mg per kg or placebo. It is six who have received active, as I said, and two who have received placebo in each case. The main focus is to look at safety and tolerance. Of course, if we want to get more results and as a secondary endpoint, we look at pharmacokinetics, that is, how the drug is taken up in the body and how it is extracted, for example. Very important knowledge to take part in and to be able to use in the future. We also look at such a thing as ADA, or anti-drug antibodies, that is antibodies against the drug, or in this case antibodies against antibodies, something that can develop when you have drugs that affect the immune system. In this case, if there were to be such, of course it would limit the use of the product over time, because you may not risk getting the effect you are looking for. Of course, we look at other things, and one of the central things is to be able to follow how the BSS cell concentrations relate to the male individuals and how the impact happens if you give the antibody. In the same way as we have a number of inflammatory biomarkers that we follow in the cytokine panel, so that we get more results than just looking at CCD and total vulnerability, even though that is the main focus with the phase 1 study. But if you quickly look at it, there are three groups, i.e. the Single Ascending Dose, 40 healthy volunteers who have received one dose in increasing doses. We have the Multiple Dose, as I mentioned, the eight healthy volunteers, and here we have today's interim reports available that have come during the year. Den sista delen, den tredje delen med singeldos för RA-patienter så är vi just nu i den här 90-dagars uppföljningsperioden och de resultat som vi kan se så här långt är ju väldigt positiva och har gett oss då en trygghet och stöd för att redan nu börja titta på FAS-programmet och utveckla det. Sammantaget för de två första delarna, singeldos och multipeldos på friska frivilliga, är att vi kan se att Sol 116 är vältolererad med få och framförallt inga allvarliga biverkningar som man har kunnat observera vid de olika dosintervallen. Heller ingen individ som har visat sig utveckla antidröj-antibodies. Kanske kan vara något tidigt med tanke på att vi har begränsade data, men ändå, de som har fått multipeldos har ofta följt under i stort sett sju månader så att det är en avsevärd tid. Farmakokinetiska profilen har då kommit som förväntat och som önskat där vi har en tydlig ökning i plasmanivåer av läkemedlet vid ökad dos. Utsöndringen linjär över tid och vi ser att vi har en halveringstid på cirka 20 dagar vilket då skulle kunna stödja att vi har en dosering en gång i månaden och slutligen så vet vi även då utifrån the results we can take part in, that we also have a good connection to BSL with our antibodies. That is, it does what it should do, that it inhibits the effect of BSL. Because as soon as it has been bound, we see that from day three after you have given the dose, you have non-measurable levels of BSL in the blood in the individuals who have shown it. So now it's just a matter of waiting until we can take the whole study into consideration and take part in the result. So for my part, it's a matter of waiting. I think it's for the others in the team as well, but this is part of the standard. So a little bit of what's happening around the company overall. I'm going to connect a little bit to this with partnerships. Because it is extremely important to have good collaboration partners that you work with both now and in the future. And we have two good ones in the current situation. I have already mentioned them by name. The first is the manufacturing collaboration we have with Northex Biologics and the work around the operation mechanism together with the team at KI. In both of these two collaborations there are actually interesting articles you can read in BioStock. that they have come up with over the past few weeks. So at biostock.se you can see that, read a little more about how a manufacturing process, production process looks like, for example, and the opportunities and challenges you see, but also how good it is to do it between the two companies that exist in Sweden. And the same is also how the team at KI looks around the operating mechanism It is too early to give you the final result, but it is still a very interesting article to see what Benzer, Reti and his colleagues think. Speaking of cooperation, the fact is that in about a week, the 4th to 6th of November, the big BioEurope congress will take place here in Stockholm, at the Älvsjö fair in the south of Stockholm. And this is a real meeting point for many of us in this part of the industry, where you can have the opportunity to make contacts with co-operative partners. In that case, first and foremost, it could be pharmaceutical companies that could help us develop the product and bring it to the market. But also make contacts with central and important investors. So there I will be, and the man behind me is Peter Hofstadius, as I mentioned earlier. Both me and Peter will be there. Tre viktiga dagar för oss med oerhört bra möjligheter att förknyta de här kontakterna som då har betydelse för nu och framtiden. Och det här är väl ett möte som kanske är centralt för oss men faktum är att det kommer två liknande möten fast det betyder ett mindre grad senare under november och det är dels Red Dice som har ett möte här i Stockholm med inriktning på autoimmuna och inflammatoriska sjukdomar. Likaväl som just Stockholms årliga summit nere i Skåne. Det här är den 18, 19, 20 november som är våra stapeln. Så att intressanta tider, viktiga tider. Väldigt bra att få vara ute och få ta del av vår omvärld och kunna dela var vi står, vad vi behöver, men även få intryck och support från omvärlden. Det ser vi fram emot. Så avslutningsvis tänkte jag bara lägga på den här bilden. Jag har använt den tidigare som några kan ha sett den, men det är lite grann var vi befinner oss i dagsläget. För det här året har fokuset varit väldigt mycket på att ta fram och slutföra fas 1-studien och det är där vi är. Så att interimstata We will also be able to see some of the patients during the end of this year, but above all, we will be able to see the SAD and MD data on the healthy volunteers that we have previously shared. But as already mentioned, the clinical study report in Q1 2025 on the phase 1 study is very important. We also expect to be able to have publications and share results on the mode of action during the first half of the year. Just as we have a lot of biobank data that we work with around inflammatory diseases and RA that we are able to share with us. And not least then really being able to come to a program start of the phase 2 program where 2026 and 2077 are the main years when a proof of concept study would be able to be carried out on RA patients. Väldigt spännande, väldigt kul framtid vi har framför oss och vi har en väldigt bra plattform att stå på. Och som alltid när man presenterar en rapport så är det väldigt viktigt att skicka med ett tack till de som är involverade. Det är ingen tvekan om att det teamet jag har på LIPE är ett gäng som jag är väldigt nöjd och stolt över att ha vid min sida. De jobbar hårt och med glädje varje dag och verkligen gör det i linje med våra värderingar som vi har på företaget. Det är väl det som gör att vi mynnar ut i den här typen av progress och resultat. Men inte heller får vi glömma bort de partners som vi har. Jag nämnde ju två av dem idag i form av NAPEX Biologics och teamet kring Benzereti på Karolinska. Det är ju samarbetspartners vi har. Oerhört viktigt. Stort tack även till dem. So with that Ludvig, I'll stop there. We'll see if there have been any questions or thoughts.

Yes, but thank you very much for the presentation here. And as you mentioned, we jump right into the questions here. Given this ongoing review of the Horizon 2020 project, what measures are you planning to take with the European Commission? Would you like a refund? Can it affect future financing alternatives?

There was a risk that we could have a refund of up to 5 million kronor. It is a reasonable amount considering the study we received from the beginning. I would like to mention that I see the likelihood that it will happen as very low. But if it happens, we will have to take the cost. Om vi inte kan få en relativ snabb återfinansiering så får man väl kanske då skjuta något av våra delarbeten på framtiden. Jag ser inte att det ska direkt inverka på det här kliniska programmet vi har men en del andra kanske vi då får lägga lite grann i vänteläge tills att vi känner att vi har finansiering på plats för det. Men om ni tittar i Q3-rapporten så ser ni även att vi har en förväntad behov av att inhämta nytt kapital under våren 2025.

Thank you. I have a follow-up question. Have you received any indication of when you can make a decision about this?

No. I can say that it has been difficult to get a proof that they have received the answer we sent in on September 13. We had to chase them to get it, but they have confirmed that they have. Det svaret vi gav, det är ju som jag ser det väldigt mycket hjälp för dem också att kunna då uppgradera, uppjustera den här rapporten till slut, så att den bättre återspeglar hur vi har använt med den. För det har ju verkligen gått till projektet, även om du sa att vi hade som sagt var då en fel klassificering av kostnaderna i återrapporteringen till kommissionen. But there is no specific date for that and it can take some time. At best it ends at the end of this year, but equally likely at the beginning of next year. It is actually the case that the revision itself has been going on for about two years since they started. Incredibly long time and long term.

I understand, thank you. And you might have mentioned a little earlier here about traveling capital again. When do you need to do the next emission and can you get an indication of how big it can be in that case if you have any plans?

We see that it will have to be carried out during the spring, because right now we have costs up to the half-year shift next year. And this is not strange, that's what it looks like, and that's what we've communicated since earlier. We look at the size of the capital recovery, so I'll save that. What we focus on is to have a cost coverage for the coming Phase 2 program, i.e. the implementation of the Phase 2 study, the proof-of-concept study. For the preparation part, the study of the drug production, we already have coverage for that, so it is ongoing. It is to be able to drive the implementation of the clinical study itself.

Thank you. As you mentioned in the presentation, you have employed Peter Hostadius, who is the CMO here. What do you hope he will contribute and maybe you can tell us a little bit about where he comes from before?

Peter has had a few years on his neck and he has shifted to work in healthcare and in the pharmaceutical industry. Basically, he has a specialist doctor's degree in clinical pharmacology, but he also has a doctor's degree in pharmaceutical development. And most recently, he came to us from XMK Therapeutics, where he was Chief Medical Officer. He has previously worked with both Novartis and MSD. So he has considerable experience in pharmaceutical development, and above all in conducting clinical studies. So for our part, it was a very, very good contribution to him when we unfortunately lost Karin Frank Larsson. But I have not seen that we have lost him because of that, but rather been able to take over directly and Peter has a solid background. As a person, he is very driven and initiative-rich, so there is a speed forward when Peter comes in. Sometimes it's almost difficult to keep up with him.

How lovely. Thank you. Let's look forward to the new BioEurope event. What is the goal of participating in the event? Is it some kind of special collaboration? Maybe the first one? I'm not interested in talking about that.

There are two parts to it. The first one is more short-term, but also long-term. It is to find good and interested financiers for our business. We have a very good and safe that have helped us during this time, which I am very pleased with. But of course, they need to get some relief, so to get some significant investors who would like to help the company in the future, that is one aspect of BioEurope that I see. The other is perhaps the more long-term, and that is to find a suitable partner who would be able to develop this product, take it to the market. with the conclusion of the clinical program that includes phase 3 studies, but also registration activities. And then it may well be that the partner is also the one who will help to commercialize the product the day it becomes relevant. So that's something, and of course this is a work that has been going on for a while now and that we continue to do. A collaboration, a partnership, it is built over time and it should be built on mutual interests and trust for each other.

Thank you. Let's move on to the next question. How do you think about the future commercialization phase? Do you have an idea of what it will look like?

Not when it comes to the commercialization part, but of course, with my background and Peter's background, we may have changed the company a bit to adapt to it. So we see commercialization somewhere in the background of the collaboration, but it is not what is mainly driving it today, but to be able to complete the development of the product in order to be able to take it to the market.

Thank you. Finally, you have started planning phase 2 of the study. When do you consider that the planning goes over to the study?

To start with, it is very dependent on a number of things that can be done along the way, and one of them The time-limiting factor is the production of the study drug. This was something we really looked at in detail earlier this year. How should we be able to make it more effective? The result follows the impression that we chose to switch from the previous manufacturer from the USA to Northex Biologics. We started this work in April, directly in April this year. Vi förväntar oss att i tredje kvartalet nästa år så kommer studieläkemedlet vara klar för att gå in i de sista stabilitetsstudierna och vi kan med det också gå in med en ansökan till EMA om att få bedriva den kliniska studien. Så att i början av 2026, det är först då som den här proof-of-concept-studien kan starta och det är beroende på de här olika delstegen som måste klaras av under vägens gång. Men som jag nämnde tidigare, vi är helt och hållet på tidslinan för det. Allting framskrider precis så bra som vi hade kunnat tro och hoppas att det ska göras. Så här långt ser det helt rätt och riktigt ut som det ska.

Tack så mycket Ola för att du presenterade dig idag och svarade på frågor. Tack till alla som har tittat och skickat in frågor. Vi får önska en trevlig helg när den startar här.

Jag tar väl förmånen att göra detsamma, både till dig Ludvig och till alla som har lyssnat in. Så stort tack.

Tack.