Lipum AB (publ)

Hi, welcome to today's broadcast. It was me, Lipum, and Ola Sandborg who will present the Q2 report for 2025. If you have any questions, please use the form on the right and we will answer them after the presentation. And with that, Ola, please go ahead.

Thank you very much, Martin, and welcome to all of you who have connected to this broadcast. As Martin mentioned, we will present our Q2 report from January to June 2025. If you look at this, we have chosen to call it a time for planning and preparation. Om vi går vidare innan det gäller att titta på, vad är det egentligen vi har presenterat i vår rapport denna gång? Ja, låt oss börja med det basala och det är lite grann den finansiella sammanfattningen för perioden. And yes, for all of you who know us from before, we know that we have no revenue in the company, as the word usually says, but we are a research-based company that builds for the future. And the revenue we have in the future is in the form of contributions. So what you see here is the overall turnover of 760,000 kronor during the period. It is therefore contributions that we get from, among other things, Eurostars and Swelife. Vårt resultat efter finansiella poster ligger på minus 36,6 miljoner kronor, att jämföra med 28 miljoner från förra året. Vad de här kostnaderna i huvudsak handlar om, för vår del den här perioden, har dels varit kostnader för att slutföra en fas 1-studie, And it is a CRO that we have a fee to pay for. But at the same time, we also have investments in the future, and above all, the production of study drugs, study drugs for the upcoming study. So that means that we have that cost base and to that extent. So it resulted in that our liquid media at the end of the period was 1.7 million kronor compared to 20 million last year. And the number of employees at the end of the period was six. jämfört med fem för ett år tillbaka. Så vad är mångt och mycket som har hänt under den här perioden? Framförallt för sämre händelser under perioden. Jag tänkte väl nämna lite mer om det alldeles strax. Dels är det att vi har kunnat slutföra den första fas 1-studien och publicerat den kliniska studierapporten, en CSR för sol 116. Det här är en riktig milstolpe för vår del. Vi vet att resultaten var en väg för fortsatt klinisk utveckling, vilket är oerhört stimulerande och kul. Some of the events that occurred after the period started. Yes, in part, I made public the emergence of a technical option program. Something that was decided by a vote in spring. And that technical option program exists both for employees, for key consultants and board members. And I am extremely happy to see the interest and support that we get from this group, because 89% of the options that have been taken have been signed. And it's really cool to see De här personerna verkligen lägger ner allt under vardagen där ute och levererar. Men även att de har den tilltron till företaget så tillvida att de också vill investera i företaget. Utöver det så har vi en ny CFO på ingång, Tobias Helgersson. Jag kommer nämna något ord om det i slutet. And also that we have an additional bridge loan that will secure the company's running costs by 2025. So a little more about this at work. But we can start with this with time for planning and time for preparation. And this comes from the fact that we have a successful final phase 1 study with SOL 116. And this creates opportunities to take the next steps. The study itself In short, we have been able to see that we have a favorable safety profile for the Solin 716. It has tolerated well in all dose levels without any reported serious side effects. Also, what we have seen is that it is predictable pharmacokinetics, that is, that the drug is taken up in the body in such a way that you get a proportional dose exposure for the patients. And we also know that the half-life period is about 20 days, which then supports that you should be able to give one injection per month when you are going to treat. Also low immunogenicity. It is about that some drugs can develop antibodies against the drug. And that is what you only saw with one participant at one measurement during the entire study. And at the next measurement afterwards, what it is. The patient in that case had Aden negative. Very good results even in that case. Finally, what everyone is interested in, how is it with the target effect? We have a target protein that we use called BSS or gall-salt-stimulated lipase. The exploratory analyses show that the participants who got Solv1016 and showed BSS levels, which was about half, material from the study, then you have been able to indicate a direct goal effect. So just as good a result as you can hope and wish that you will get and that really lays the foundation for being able to take the next step. So what happens then? Yes, 2025 will be a year when we end a significant project, which I just mentioned, and at the same time take the next step. And we have a whole lot of important milestones that have been achieved, which then shows that our medical development is moving forward and that we then step by step can successfully strengthen our scientific position. We know what we are doing. We can, of course, take the step into phase two, which is what we want to do. And in this case, we will study the effect of treatment with patients with mild to severe rheumatism or rheumatoid arthritis. And what we saw in phase 1 studies, they are always designed to look at safety and tolerance as the main goal. In phase 2, yes, that's where you have the opportunity to look at the treatment effects. So a very, very important and exciting step to go into. And then in parallel with this, we have a whole preclinical project that is beginning to approach results. And there we have cooperated both with the Karolinska Institute here in Stockholm and the University in Linköping, Uppsala, Lund and Örebro. So, what is important now when we take the step towards the planned phase 2 study is to be able to secure the financing for that. And I can say that here we are in a very active phase. It means a very large part of my working time, but also of colleagues from the board and some other involved. And it is also with joy that I can say that we have strong support from our three largest owners. It is Fleri Invest, Christian von Königsegg with a company and also the Kraftforska Stiftelsen. The support has made it possible for us to get a mortgage loan that guarantees our ongoing costs during 2025, so that we can work with capital investment in a calm and good way. This gives us stability to implement an emission and with that focus on the next big step in development. It is also worth mentioning that the financing of pharmaceutical production for fossil fuels has already been secured. And we have actually come so far in our collaboration with Natex, Bagogex, that we are just now producing the solar energy sector according to GMP, that is the substance that will be used in the clinical study. So we are completely on the timeline to be able to get started with the project with the phase 2 study and it is there that we first of all need to add resources, i.e. the monetary resources, in order to then get a collaboration with a CRO for the planning of a series to be carried out with the phase 2 study. We expect a study start in the first half of 2026 and a final one in 2027. This is where the medical treatment is already underway, and we have ensured that. But to go back to our company, what is it we want? What is our vision? What is our mission? The company's vision is to be able to help patients who live with chronic inflammatory diseases to get a better life and better quality of life. And our mission is to develop and deliver a safer and more effective treatment that really meets the critical needs that are not met today. with chronic inflammatory diseases. And for our help there, we also have medicines. And that is needed on the market. Because if we look at the treatments that are available today, and I should say that it is actually the case that there are very good treatments, especially the biological medicines that have been on the market for 15, maybe soon 20 years, have brought a lot of benefits to these patients. But despite that, we see that there are patients who still do not get the help they need. We know that somewhere between 30-40% of the patients do not respond to the first-line treatment, which we often consider a treatment with methotrexate. An additional 35-40% lose effect over time on the treatment they have, which means that up to three-quarters of the patients, 75%, do not get an existing treatment effect. And there is also a part of these products that have what is called It was not so black box warning, so the area where you are advised directly not to use it. So half of the patients can neither use any products. So there is no doubt that there is a need to take more alternatives. And it is there that we see that we have the opportunity to contribute. And to this, we have developed our product Sol 116, which is a monoclonal antibody. A humanized monoclonal antibody that is directed towards a target protein that is often abbreviated as BSSL. And this is a completely new target protein that no one has previously gone into. And for our part, we see the possibility of being able to help more patients with this modern antibody, which also, in addition to the fact that it binds to BSSL, also has a clearly lower impact on the immune system, which is what the questions are about. Where we are today with our product is perhaps in the middle of this development plan you see in front of you. If you look at three different parts of it, the clinical program that we have at the top, it is a preclinical or non-clinical in the middle and the manufacture of drugs. Where we are today, in the middle of 2025, we have completed the phase 1 study that I mentioned, which is to the left in the upper right corner, and we are in the middle of the planning of a phase 2 study that is then intended to be able to be started during the first half of the year 2026. Parallel to this, a number of preclinical programs are taking place, and not least a number of collaboration projects that we have, partly with the Karolinska Institute, to then clarify the operating mechanism for SORD 116, but also a number of other interesting projects that I was going to mention briefly. All of this goes hand in hand with the production of study drugs, and the hope is to be able to start this phase 2 study during the first half of next year, in order to then get an outstanding result at the end of 2027. So extremely exciting, extremely stimulating where we are, and fun to be able to take the step into the future where we work so hard for. But if you look at some of the projects that we have that actually support the business that we have with developing our own products. So we have a project that has received support from Swilla, Vinnova. And that project is primarily to look at different biomarkers that could predict the outcome of treatment. And above all, to look at patients with early RA. Det här projektet utförs tillsammans med Linköpings universitetet, professor Alf Kastbo med, men även vi har en viss inkoppling av Karolinska institutet. Som Alf säger, målet är att kunna personalisera behandlingen och göra den specifik för den individuella patientens behov. Det här är någonting som allt fler vill, att man verkligen vet att när det går in med en behandling så ger du det på rätt sätt till rätt patient. Det här projektet har gått förhållandevis långt. Vi tror att vi i slutet av det här året borde kunna visa på resultat. Det vi har sett är att det har verkligen gått i rätt riktning. När man har då i det här fallet analyserat biobankdata hos ungefär 260 patienter med RA. Alltså vi har ju prover som har tagits sedan tidigare som nu återanvänds återigen. För att kunna se dels kopplingen av VSSL till sjukdomen. But also look at other biomarkers that can be one of these. Very exciting, very good project and a nice collaboration. Another project that we are carrying out that is a bit in the same direction. It is a project that we have received support from Eurostar. So it is European support for the whole. Together with Vinnova in Sweden and the Research Council in Norway. Because here is a collaboration together with the Norwegian company Age Labs. They finance 50% of the project budget, which is a total of 1.9 million euros. And here is the goal to develop a technique or a tool, a companion diagnostic tool, which can predict which patients would be able to have the best treatment on our medical condition in 2016. Jättespännande, jätteviktigt. Faktum är att det här med companion diagnostika som har kommit mer och mer under de senaste åren, kanske framförallt i USA, men det växer även i Europa. För er som kanske inte är så insatta i det, det är inte bara att hitta patienter som skulle svara på SOL116, utan tittar man generellt på det, så är det tre olika områden man kan se att den här typen av verktyg har betydelse. Dels är det att kunna identifiera de patienter som then it probably takes the value of being treated. But it can also be that you can identify patients who have an increased risk of side effects, for example, that you do not expose them to unnecessary burden. And it can also be that you follow the treatment effects over time with a specific drug. So a companion diagnosis can have several different areas of use. And of course, this is something that we also think is good for Soledad 116, even though it's been on the market for a few years. But we expect that this can actually be a requirement for the future. So our business builds a lot around creating value, creating value for the company, creating value for those who have chosen to invest in our company. And there are three main areas Som ni förstår så har vi ett kliniskt fokus där vi har ett utvecklingsprogram. Fas 1-studien var i huvudsak att titta på säkerhet och tolerabilitet. Men även att nu gå in i en fas 2-studie där vårt mål är att kunna visa på effekt vid reumatid artrit. Det är en proof of concept-studie där vi riktar in oss på. Givetvis när man genomför den tittar man också på säkerhet effekt. Parallel, as you have understood, the pre-clinical program involves looking at the mechanism of action with the collaboration project we have with the Karolinska Institute. This is one of the objectives. What you saw together with Aged Labs is a companion diagnostic, but also to look at other disease systems where SOL116 can be valuable. We know that this type of drug not only can help patients with one diagnosis, but it is most often flera olika inflammatoriska tillstånd där man kan tillföra ett värde och hjälpa till. Och givetvis måste vi även då utröna var Sol 116 har sin plats. Och sist men inte minst, det som är jätteviktigt för att kunna ta den här produkten, projektet till marknaden, är ju att kanske göra det tillsammans med någon annan, att hitta en partner att ha med längs med vägen när det gäller utvecklingen. Men det kan också handla om utlicensering och att kunna kommersialisera produkten Jag är väl oerhört stolt och nöjd över det, den grupp jag har, men att gå på en global marknad för vårt lilla företag är ju givetvis en utmaning utöver det vanliga. Så att det är någon form av partnerskap är det man verkligen hoppas och tror att vi ska ha längs med vägen. Och den typen av interaktioner pågår sedan de ser tillbaka och fortsätter. Jag kan bara säga att deras intresse i vår verksamhet är stort. Våra aktiviteter bygger väldigt mycket runt omkring de här tre huvudområdena, men självklart så är det så att det är mycket detaljer under det. Och de som gör det här, ja, det här är mitt Dream Team, det är ledningsgruppen med Susanne, Marina, Pernilla och Peter som jobbar tajt med. Vi har också hela projektteamet som finns där och har varit med under lång tid och som brinner för vår verksamhet. Som jag nämnde förut när det gällde teknisk auktionsprogrammen, That they really want to invest in the company. So it's a team that I really like and am happy with. So where we are is also going to be a small change. So Marina, who has been our CFO for quite a few years and who I have had the opportunity to work with for the last two years, will leave the company during the autumn. Tobias Helgesson is the person who will replace Marina. He has his first day on Monday next week. Tobias has more than 20 years of career behind him in a number of different companies and 11 of these more than 20 years he has been in the pharmaceutical industry and worked for companies like Pfizer, Sanofi and Otsuka Pharmaceuticals. So he has a very good background profile and has played various different roles, everything from controller to CFO within different companies. So he is well equipped to get into this CFO role at LeapDome. And I have actually had the privilege of working together with Tobias. It was almost 20 years ago when he was at Pfizer, but now I have time together with him. So I look forward to where he will come and of course also a big and genuine thank you till Marina för allting hon gjort. Men som sagt, hon lämnar oss inte på dagen utan är en överlämningsperiod och ska vi kunna tacka av henne på bästa sätt. Så med det sagt tänkte jag egentligen avsluta och jag tror att ni alla som lyssnar in här förstår att jag har stor inspiration och plöd att se fram emot det fortsatta arbetet med Sol 116 och att kunna ta det hela vägen till patienterna. Att kunna göra det här tillsammans med mitt team, våra medarbetare, samarbetspartners som vi har där ute, gör att vi gör skillnad och levererar hela tiden. Jag vill även rikta ett genuint tack. Just den här betryggande delen är att vi har våra aktieägare som står bakom oss, dels när det gäller att dela vår vision, men även då att fortsätta stödja vår verksamhet. Aktieägarna, partners och investerare, de är oerhört I'm so happy about the support we get. So I'll stop there and open up for questions.

Thank you so much, Olof, for this presentation. And then we open up the question time. I'll take the first question that sounds like this. You have had positive phase 1 results with low immunogenicity and clearly target effect. How do the regulatory plans look forward to phase 2? And when do you expect to start this study?

Jag tar det nästan bakifrån där kan man säga. Vi börjar med studien. Hoppas vi att vi ska kunna starta under första halvåret nästa år. And there is a lot of preparation for that, not least contact with regulatory authorities. And now we have all the results from phase 1. We have a lot of preclinical data, but also a good picture of how this phase 2 study is expected to look. So with that, we are building a package to be able to make contact with the registration authority, and in this case primarily with Växjö Medicinal Health in Sweden. So that contact will take place now during the autumn. so that we can get the final advice before we can go in with the actual application for approval of the study, which we see happens with the change of year.

Thank you. You have secured a bridge financing. How long do you think it will last? What alternatives are you looking at for more long-term financing?

The funding we have now helps us throughout the year, so it gives us a very good security and stability for what is to come. When it comes to the acquisition of land and capital to be able to run phase 2 studies, it is a work that I can say right now is a very intense phase and we hope to be able to complete it in a relatively short time. All in order to be able to have the basis to be able to start phase 2 studies. It is actually the case that Registraringsmyndigheten godkänner inte om inte vi har finansieringen säkra för en sådan studie så det är viktigt att vi får den på plats. Men vi är helt övertygade om att vi kommer att kunna lyckas med det och någon form av emission är det som ligger framför oss på det.

Tack Ola för det svaret. Vilka förberedande steg är det som återstår innan fas 2-studien är redo att initieras?

Till att börja med så är det ju att vi måste då ta ett finalt beslut på vilket CRO, alltså kontraktsforskningsorganisation, ett företag som hjälper oss att driva studien så att vi får det på plats. Den processen pågår, vi startade den redan för sommaren och vi var nere på en handfull alternativ som vi diskuterar med i dagsläget. Det tillsammans med att få ett clinical study protocol in place, that we have the interactions with the registration authorities so that we get the final recommendations on what to do, is what we are fixing. And of course, in parallel with the study medicine, as I mentioned during the presentation earlier, that it is in progress and there we are right now in that we are running the second batch, the second GMP batch, the second and last one, before we can finally finish the product that will be used in clinical studies.

And you mentioned that an eventual demission is ahead of you, but how much do you think your capital book commission has been for financing this coming phase 2 study?

The demission is ahead of us, and the fact is that we are currently calculating exactly what it is about. So I choose not to answer that question, but it is, one could say, normal amounts for a en klinisk fas 2-studie utav det upplägget som vi har, så det är ingenting som revolutionerar på något sätt, men jag vill återkomma med detaljerna så snart vi är klara med det.

Tack. Och hur bedömer ni sannolikheten att EIS-MEA står fast vid beslutet om återbetalning för Horizon 2020-projektet?

Ja, oj, det är What did you say earlier? 10,000 kronor question? That's a million-kronor question. It's really hard to know. If you look at what we received with the consent of En gång i tiden, and now back to 2018, it was to be able to develop and bring forward Antikroppen Sol 116. That's what the project was for, and we got a total support of about 23 million kronor. In that case, there is no doubt that it has been very successful. The fact is that Horizon Europe published an article where they wanted to show how successful the project was, that they had given the money, that it completed the project on time and that they reached the end result. So the project itself is something that they thought was very, very good and wanted to tell their friends, and we were just as proud. What has happened is that we came up with a revision, which it can be, and in that we have had an extremely large number of subjects that we have delivered to the revision bureau, in the case of Deloitte in Spain. som de har tagit del av. Och då har vi haft en oklarhet vad gäller klassificeringen av vissa kostnadslag, hur de har rapporterats. Och det är ju det som de har slagit ner på, som det finns en risk att vi då skulle kunna få en återbetalning. Men faktum är att på den tiden vi hade ingen annan verksamhet än just det här projektet, så alla kostnader som har tagits och som vi har haft det här stödet har gått rakt in i projektet. So we see that this can't be a problem that they would, when they look at it in detail from the Commission, to then be aware of this misclassification. But I also understand the reviewers' challenge to be able to handle it from the point of view that for them it is either black or white and they have to read from the rulebook as it is. So it's hard to say where it will fall out, but we still see very high hopes of not having to pay anything back.

Ni lyfter att LIPUM gradvis stärker sin vetenskapliga position. Kan du konkretisera vad det faktiskt innebär? Är det samarbete, publikationer, konferenser eller regulatoriska dialoger?

Den första är utan tvekan resultatet från fas 1-studien. Men annars är det väldigt mycket utifrån samarbeten. Nu lyfter jag två sådana idag. Dels tillsammans med Linköping och Karolinska, likaväl som samarbetet med HLABS, men vi har ju fler samarbeten, till exempel med universitetet i Lund, i Örebro, i Uppsala. Och alla de här bygger på vår kunskapsbas för hur BSSL är inkopplat vid olika typer av kroniska inflammationer. Så dels så får vi kunskap om hur det ser ut hos barn med levnadsneumatism eller juvenil idiopathiska blid som det ofta heter. Vi vet även kopplingen över till patients who have SLE and arthritis, and a number of other indications, so that we build on more and more knowledge, more and more volume, which gives us a safer and safer base to stand on. And then in parallel with this, there are also a whole lot of analytical methods and processes that we learn more and more about, and also can be secured so that we can use them for the future. But perhaps not least then, what we looked at with this, together with HLABS, a companion diagnosis, is incredibly exciting.

Och hur bedömer du, Ola, att konkurrensläget inom behandling av Moderat till Svår RA? Och vad skulle också du säga är den strategiska positionen för Sol 116?

Ja, men alltså konkurrenssituationen är ju öppenbar. Den finns där utifrån att det är ett antal etablerade produkter på marknaden, inte minst då TNF, Alfa och JAK-hämmarna, som har tillfört ett stort värde, som jag var inne på förut, de senaste 15-20 åren. But despite that, there are patients who do not get a treatment result that they are satisfied with. It can also be that you get side effects, which you have to change. So there is room for more. So that is perhaps the most obvious position that most people think about. Help those who are not helped. So that's one position we see. But another, and it is perhaps a little more challenging as a completely new product to come to the market, is that maybe could step into the stage before the Alpha or Jag-chamber. And the reason why we do that is primarily from a side effect perspective, where we have indications that our product would be nicer and better in that area. And that is primarily because we do not interact with the immune system in the same way as the other products do. So there are a few different positions, but I can think that the most obvious is when the other products have not responded.

Vi tar en avslutande fråga här, Ola, innan vi avrundar dagens frågestund. Du nämner att 2025 är året för planering och förberedelse. Vilka skulle du säga blir de viktigaste milstolparna man som investerare bör hålla ögonen på under de kommande 12 månaderna?

To begin with, there is no doubt about the fact that the funding will come into place, because it is the basis for everything. But then we have to submit an application for the study before the change of year. Then there is the study approval and the start, which will probably happen during the first half of the year, 2026. After that, in 2026, we will have to roll on a lot before we start taking part in the results during 2027. However, what happens in parallel with this is that the collaboration projects, we see that they will get results delivered during the coming half year. So there is a parallel with the whole thing as well. A fairly important and interesting part that will be able to be delivered. And that is step by step during the coming half year.

Tack så mycket, Ola. Och med det så avslutar vi dagens frågestund här. Och stort tack för att du kom och presenterade er Q2-rapport hos oss på Finwire. Och så önskar jag alla en fortsatt trevlig dag. Tack så mycket.

Toppen. Tack så mycket, Martin. Och tack till alla där ute.