Diamyd Medical AB (publ)

Hejsan hejsan allesammans. Välkommen till den rapportpresentationen som handlas av oss här på GV Pondkommission. Linus Svensson heter jag och med oss idag så har vi D&I Medical tillsammans med bolagets vd Ulf Hanelius som ska få presentera rapporten här för det första kvartalet för perioden 2024-2025 som kom ut imorse. Hoppas alla haft en chans att gå igenom den. Kvartalet i sig och även de senaste veckorna har bjudit på en hel del spännande nyheter, både kopplat till studierna som bolaget har på gång och även den kommersiella potentialen. Jag kan säga redan nu att det går bra att börja skicka in frågor via chatten om man skulle vilja göra det. Och så tar vi upp dem efter att Ulf egentligen har gått igenom kvartalet och sin presentation. Jag tänker att vi hoppar direkt in. Så varsågod Ulf!

Tusen tack. Det är roligt att det är så många som loggar in på den här presentationen. Som sagt, jag kommer att dra, jag har inte många slides, men jag kommer att ha två slides som är lite mera ingående och framförallt tala om kanske de två största nyheterna under kvartalet, vilket är både vår alignment med FDA, alltså vad vi kring det här möjligheterna, accelererat godkännande and commercial potential. These two images will be more relevant when we discuss them. We will also be able to ask questions after the presentation. To sum up briefly, the big thing is that we now have the opportunity to move towards an accelerated approval in the USA. Our launch indication is type 1 diabetes, but mainly stage 3, where we are now clinically diagnosed with type 1 diabetes. We focus on the genetic subgroup that we have seen in previous studies, linked to the effect of our treatment. And as I said, in 2024, we got fast track designation, that is, one of their fast track programs for all stages of type 1 diabetes. And as part of that, there was the opportunity to open up discussions with FDA about the accelerated approval, where we had a first meeting in the summer of 2024, where we got the thumbs up for accelerated approval. And then we have a follow-up meeting now in December, where we could still more clearly agree on all of the most important key components before a previous review and an accelerated approval. And then we also have a previous sales status, which is important, especially when you go to the market due to pricing and the like, which we can also discuss. And we now have almost only one year left until the den tidigare avläsningen i pågående fas 3, det vill säga vi förväntar resultatet runt mars 2026, så det är inte långt bort. Om det är positiva, starka resultat, så har vi då möjlighet att börja skicka in en marknadsansökan i USA, vilket är jättestort. Då är vi potentiellt sett först ute i hela världen på den marknaden. Vi är först ute som har möjlighet också i borgerliga taxerier att godkänna en antipettiabetes. Most of you know what we do, our main treatment is scandinavian thiamine, but just briefly to lift up perhaps the three most important points here. It is a simple treatment, which is important. That is to say, it is about three injections, one month in between. It is done in an out-of-the-box way, but you don't go to the hospital or anything like that. There are other treatments of what you do. And then after the three injections, we re-program the immune system, and then we maintain our own insulin production. So we actually change the slope of this curve, the disease progression, so we make it less steep. And one of the most important things we have is our safety profile. We have so far treated with the active drug more than 1,000 people with the different studies of type 1 diabetes without any serious side effects. And it is extremely important, above all also for a potentially accelerated approval, because when you do not have a complete effect data from the whole study, it is absolutely important that you can show that you had a lot of safe treatment, which makes it easier also for authorities to be able to approve something like that compared to if you would have a safety profile that looks different and that they have to make a decision. Do we dare to approve or not approve this? This is very important. And here you have to say that there is no other treatment that has a special status in the United States that has such a large safety database as we have. And that is also important. And precision medicine, we are talking about a genetic subgroup of type 1 diabetes. About 40% of type 1 diabetics have the right genetic profile to get an effect of our drug. And precision medicine is really the way forward now within several different indications. And we have, as the slide shows, the first the first precision medical fast-trace study ever conducted before type 1 diabetes, which is currently being conducted in Europe and the USA. A total of about 60 clinics. In the summer of 2024, we did a so-called futility analysis, that is, a futility analysis that was blind, 70 patients who had been born in six months, and it could then show that green light from the DSMB Security Committee to continue the study without any modifications, which in practice means that there is some kind of effect there yet. It was a blind analysis, so you don't know exactly what the result looks like, but in any case it is not active and possible to be equivalent at that time, but there is some kind of effect, the safety is good, so it reduces the risk further in the study. And now, as it also says in the report, we have randomized more than 200 patients in phase 3, and in November 2024, we would have received more than the 170 patients that are needed to make this earlier assessment with a 15-month review, which can lead to an accelerated approval. So the study is in full swing and very good as well. Then a little more detail about this FDA meeting we had in December. When we had our meeting in July with FDA in Washington D.C., we were given the thumbs up for being taxed and approved, and to use C-peptide as the primary effect parameter. C-peptide is the biomarker for the production of its own insulin. It's the first time FDA has given a thumbs up for that. So this really breaks new ground for type 1 diabetes and immunotherapies. And then the FDA asked for more details about the statistical analysis protocol, how it should look like to be able to do this accelerated reading, and also the clinical protocol, which changes should be made to it. And then we had sent in an updated analysis protocol to the FDA, an updated clinical protocol, and other things to really agree on those points. And here, Again, at this meeting, the FDA said that it is reasonable that we can go for an actual approval based on our FAST-3 study and a previous review. We agreed on these protocol updates on the clinical protocol, the statistical analysis and how the blindness should look. And here it is important to note that when you do a previous review of the ongoing FAST-3 study, you can't break the blindness for patients or doctors, or for the majority of the company. If the blindness is to be broken, it can create some difficulties, which can affect the final result in the complete study. So it is extremely important how you do the blindness, who becomes blind and who does not become blind, whether you should have a clear protocol and procedure for that. So that's what we agreed on, and they approved it too. to ensure that the integrity of the entire study remains the same, even though one has measured the results in a previous chain. Also in agreement with how the security database in the accelerated approval looks like, and then it is the earlier studies we have done with the Interinfantil administration and the earlier placebo-controlled studies with the Sukutan administration, samt den säkerhetsstatus som finns från den pågående fastigheten vid tillfället man gör den här tillgängliga avläsningen. Samma sak, vad är då den bekräftande effekt- evidensen, från vilka studier ska det komma? Det viktigaste här kanske take-home message är att vi behöver inte göra några ytterligare We do not need to fill in the database or the effect database, but what we already have, plus what comes with the earlier reading, it is enough for FDA to be able to give a approval. FDA also confirmed during the meeting our special request status for Diamyd in our launch indication, i.e. STAGE. 3 type 1 diabetes, which is important given that we got this particular study quite a long time ago, many, many years ago, but it was confirmed. And the FDA does not need any further interactions when it comes to this process for a possible accelerated approval, but the next discussion takes place at a so-called pre-BLA meeting, and at a pre-BLA meeting, then you have the results. That is, you go to a pre-BLA meeting DSNB-committee has given a thumbs up that they think the results look good enough to be able to take the discussion with FDI on a marknadsgodkännande, och då har man ett pre-BLA-möte var några, mycket få, från bolaget är med, och sen är det ju från CRO-bolag och från FDI med på det. Men egentligen det är då man diskuterar resultaten, och ingenting behöver egentligen diskuteras innan det, om inte vi vill som bolag stämma av någonting ännu. Sen, om vi går in på den kommersiella potential here, we have done further market analysis in the USA. We have followed up on what we did a year ago, we have done further interviews with both doctors and payers in the USA to understand even more about how exactly the launch would look, where to launch it so that the launch is done in the best possible way. And the most important thing here is that you can see that there is a sales potential over 2 billion dollars for our advanced indication in the USA. And then it's about patients who have stadium 3 type 1 diabetes, are 12 years old or older, have the right type of HLA and who have enough of their own insulin production left to preserve. So it's not just some newly diagnosed, it's about maybe up to 80% of the patients keep quite a lot, including two years after the diagnosis, so you can now count them on, shall we say, the annual available market. And when it comes to pricing, we expect at least a gross price of around $160,000. It can go up to $20,000 or more, it depends in the end on the final three results. Vi förväntar oss ganska små rabatter på priset. Det är ganska vanligt i USA att man ger rabatter. Det finns olika mellanhänder som tar sin del. Bolaget har ett listpris. Sen finns det mellanhänder som tar en del av den kakan. Det slutliga priset är oftast något annat än listpriset. Det är inte alltid helt tydligt vad det slutliga priset är. because there are different intermediaries that take different amounts. Here it is expected that it is a maximum of 20% discount. Some may not take any discount at all, mainly because it is a special drug and there are no other drugs today approved for this disease. Therefore, no large discounts are expected either. It is expected quite large so-called market access because most in the US have have type 1 diabetes, that is, in their insurance for type 1 diabetes, and that most insurance companies will also approve or pay for such a drug. So over 80% of those who have the disease will also be able to get access to this treatment. And then in a base case scenario, we expect at least a 30% market penetration, which is quite standard. It can absolutely go up to almost 50-60% as well. So it depends a little on, with more than 30% market penetration, that is to say that you achieve up to 30% of the target population. And with this pricing, then you achieve an expected sales of around 2 billion dollars. Then there is the possibility of broadening the treatment quite significant. So outside of the USA, if you take an example from the type 2 diabetes market, you can expect that the rest of the world is about 40% of the total. So then the USA would stand for 60% and the rest of the world for 40%. Some sometimes say that the USA can stand for 80% of everything, but in type 2 it is quite normal that it is about 40% of the rest of the world. And then we can also expand to the two earlier stages of type 1 diabetes, stage 1 and stage 2. It is stage 2 where Sanofi has been approved for T-sealed, that is, just before the clinical diagnosis, you have autoantibodies and a delayed blood sugar control, but no symptoms yet. So far, it is also clear in our market analyses that this market is not really mature yet, because there are no screening programs available, so it is extremely difficult to find these stage 2 individuals today, but hopefully the day we get approved there, then this screening will be available. And that's also why it's good to start with stage 3, because there is a market there. And then we have LADA, which is the 10% up to 2 diabetes, which has an autoimmune form of diabetes, and that is a market that exists. These are then diagnosed patients, They are often not insulin-dependent during diagnosis, so they become a bit similar to those treated in stage 2 type 1. And then the concept is to treat them before they become insulin-dependent. There are no disease-modifying treatments approved today, so potentially we should be the first to go out there too. And it is a market that is at least as big as stage 3 type 1, if not bigger. So there is also expected peak sales in the USA of over $2 billion. Then if we look a little at management and board and advisory board, so here, above all, there has been a change, an increase in advisory board, what we have announced, we have added both Emily Sims and Alice Long, who are two young people with a lot of, shall we say, strong and upcoming researchers in the USA who are very clinical. Emily Sims is a child doctor, very well known in the USA and in the world, and Alice Long is a transnational immunologist. Transnational here means how to translate something that comes from pre-clinical study to human. Both are very well known and this is especially important for us to both think about increasing our presence in the USA, and we also increase our presence in something that is very close to the clinic in the USA, because now it's about creating awareness about what is going on, so that on that day, if we get approved, then doctors, nurses, patients should also know what is going on, that the launches should be able to go as well as possible. So this is a lead in that process. And then the last slide. Kort här då om finanserna, market gap just nu runt 1,8 miljarder. Cash hade vi sista november då som ju då vårt Q1an med ungefär 150 miljoner kronor och nu den närliggande nästa finansiella hållpunkten är våra täckningsoptioner i mars som skulle kunna generera efterkostnader runt 100 miljoner kronor innan kostnader blir en affär. 111-112 million kronor, if it were to be 100% calculated. So, that's the next coming financial milestone. Of course, it is important to be able to extend our runway here, and make sure that we can prepare all of them, so that we can now enter the previous reading in March 2026. And with that, I thought we could leave it to questions.

Yes, thank you very much Ulf for a very nice introduction and just as we mentioned earlier, it is excellent to ask any questions that have arisen already now or that appear during the Q&A here in the chat, we will raise them. I think we can jump in directly here and it is when can patients under 12 years be estimated to have access to BMI?

That's a good question. It will probably be in the USA, and then hopefully approved in Europe as well, when we have the final study. There is what is called so-called off-label use. It's when you give the drug outside the drug label itself. And there is the possibility of being able to give it to younger ages, and then it usually i diskussion med Medical Advisors på bolaget, liksom att man husar säkerheten mot att ge läkemedel till yngre åldrar och sådant. Sedan får godkänt, alltså officiellt godkänt till yngre åldrar, då krävs det ju någon typ av mindre studie i de yngre åldrarna, och där har vi ju så kallade pediatriska planer. Framförallt i Europa ska man ha en pediatrisk plan, i USA behöver vi inte ha det på grund av vår särläkemedelsstatus, men vi vill ju kunna gå ner i ålder. to be able to show the safety of the effect and then get it officially approved as well. So those plans exist after you have been approved first in the placement and then be able to continue with studies to broaden even in terms of age. I can't say exactly when it is expected. Now there is full focus on the third and that placement, but it will then start to be done when you are on the market, also to be able to go down into age.

And a follow-up question in the same field. In addition to the launch indication that you are working on now, you mentioned a little during the presentation, also in the CEO report, that it feels very exciting to see your bladar. What is the need for you to be able to direct a marketing approach to that particular patient group? And when do you see the possibility of addressing that market in the future?

Exactly. It is interesting to note that we can say that it is type 1 diabetes, otherwise it is type 2 diabetes, but it is an autoimmune form. And exactly what is required, as I said earlier, the best case scenario would be that they have been approved for type 1 diabetes from 12 years and up, and then we have shown earlier the safety of all patients up to 70 years of age. om det skulle kunna räcka då att även kunna få godkänt att behandla äldre varupatienter? Eller krävs det en studie och exakt hur ska den studien se ut? Det är då den diskussionen ska man ju ta med myndigheterna. Vi vill ju inte starta en stor pivotal studie innan vi exakt vet egentligen vad förväntningarna är så att vi inte i onödan gör någonting som vi inte skulle behöva göra. Men det där är ju också dels en resursfråga för oss att verkligen kunna ta de diskussionerna samtidigt med att fokusera på lanseringen i stage 3. Men det finns ju absolut möjligheterna för oss att ta den diskussionen och se till att vi kan gå så snabbt som möjligt mot den marknaden också. Och den är ju som sagt en mycket stor marknad som vi absolut inte vill gå vidare med. Det har vi gjort ganska inuti, det gjorde vi i den här Gardiner-Lade studien. Ganska liten studie men som också bekräftade att med rätthåll, även i Lade, så verkar det finnas en riktigt god effekt och inga problem alls med säkerheten.

When we talk about other markets, there is a lot of focus on the US, and of course for obvious reasons, but even if we start to look at Europe, do you see the possibility that EMA can accept a similar approach as FDA for diabetes market in Europe?

It could be so. So far, they have said clearly that we want to have one phase 3, so we don't need two phase 3 as many other indications need, En enda fast reja räcker med goda resultat att få godkänt. Vi hade en diskussion för länge sedan med EMA, men då var det ju innan vi hade startat fast rejan, skulle vi kunna gå mot ett conditional approval i Europa baserat på faststårresultatet och sen bekräftet med fast reja. Men då var det tydligt att om vi ser fast rejan nu, om vi då får kan gå för att taxa reda godkännande i USA, det vill säga om mars 2026 avlösningen blir positiv och vi kan gå vidare där, finns det ju möjlighet att ta den diskussionen med EMA, skulle även då de vilja syna resultaten och se om det här skulle kunna räcka. Det är ju också faktiskt en, just för oss för tillfället, lite av en resursfråga, för det blir extremt mycket att göra, att både kunna starta en lansering i USA och ha en diskussion med den europeiska myndigheten om potentiell But of course, with a partner on board, there will be a financial opportunity to do that as well. But if you are going to choose, it is the US that is the most important. Then the end result from the entire Fast 3 is not that many years away after a potential launch, an accelerated launch, so it's not that many years to lose on that. But there are opportunities, but you have to make sure that you are not take on everything at once, because then it can just be wrong as well.

And from this whole timeline and from a purely planning perspective, you have come to a question here, when you see that it would have been optimal to have a partner to take place, just with regard to the time required for preparations before the introduction and approval of the Ministry of Health.

Optimally, one is to have it before the exam comes. If we go back to last year, when J&J entered the pyramid, it was about one year before the final results from the third grade. And then they could be involved in some of the planning that was done with everything on the manufacturing side and everything else. So that's one way, it's both optimal for us and optimal for a partner to be able to be involved, if the partner wants to be involved in the last FDI interactions when you're going to discuss Exatom. how the results should look and what is enough for approval and how to set up a strategy. So there is absolutely in our interest also to be able to have a partner on site as early as possible, but of course it is then that it should be according to the right conditions as well. But then there is absolutely from a partner perspective also a rationale to wait for the result, it is an even less risk you take when you first see the results and then see if it's a thumbs up for an accelerated or should you continue the study all the way to the end and then go for a full approval. So it depends a lot on the partner's own internal strategy and how they look at their development. But we have both opportunities and we are absolutely interested in being able to make an agreement before the resolution to make sure that the partner is part of the preparations for the BLA and then the financing.

Do you see yourself primarily that this is what many partners are asking for, that they want to see the results first?

Yes, it depends. We have discussions, of course, as we have said, a lot under confidentiality, of course, but it depends entirely on who you are talking to. De flesta bolag som är på något sätt relevanta, och då talar vi om diabetesbolag, bolag inom immunologi, kan vara riktigt stora bolag eller så kan det vara bolag som är mer särläkemedelsinriktade, men som har ett intresse inom inflammation och immunologi. Alla är såklart intresserade av fast trädresultaten. Det finns inte jättemånga fast trädprojekt i världen som är på gång och som är så nära avläsning. Everyone is interested in seeing the results. Then it depends a little more on the partners themselves, what internal strategy and approach they have. Is it important for them to be able to fill the pipeline early and also, of course, not to risk any other thread? In this case, then, they are more in favor of them or are they willing to take the risk of waiting for the result? And in the latter case, it means that it is not yet the highest priority for them, that is, the internal strategy is not yet in place for them to invest, to go all in, for example, in type 1 diabetes in this type of treatment. But then you would rather wait for the results and see if they are good, because then you have a lower risk. At the same time, there is a higher price gap for them and greater competition for licensing. So it depends completely on, there are both types of discussions.

If we go on a little, you didn't mention it so much during the presentation, but you have been out a part of the quarter and talked a bit about the factory in Umeå. And I have come to the question of how it goes with it, and when you think it will be ready, GMP certified, I assume. And we also talked a little bit in the previous report about that you had hired a business developer to investigate contract manufacturing. And actually, how does that track go on and so on?

Precisely. We have hired Sofia Majansson, who is our Business Development Director at URMEA. She is also involved in the business development of the entire company and a lot of the preparations that are made at URMEA. There is a lot going on there. Hon har varit ute på olika event, framförallt för att presentera Diabyd, men då lite mer från ett Umeå och tillverkningsperspektiv för att presentera den plattform som vi, den teknologi som vi använder, den plattform vi använder och vad vi för tillfälle där tillverkar. Framförallt är det för oss att kunna sondera dels att vi ska synas, att vi ska finnas på radaren, för att sådana här försäljningscyklerna inom tillverkning är ganska långa, det är inte så att du du hittar kunder direkt, utan du måste se till att du vet vad kunderna finns, vad är behoven hos kunderna, det vill säga, och vad skulle passa just vår facilitet, vår teknologiplatform, och sen också att kunderna vet att det finns till. Och där vet vi, som vi har sagt, det finns ju många, de här ska vi se, akademiska inkubatorer eller liknande, det finns akademiska startups eller akademiska projekt som And then it's up to them to find out what the next step is. And what are the actors in Sweden, for example, who could be a potential partner? So there we see a future opportunity to be a partner to different types of incubators, so that they can continue to fund a project for, for example, Umeå, to be able to take the next step in their production, when they start to go to the clinic and scale up the production. But it is important to understand the needs and what could fit our facility and what investments we should make in the future to make sure that we can also meet the existing needs. But now there is a 100% focus on GAD production and there is a lot going on. GMP certification in one part can be seen to be finished before a market survey. It should be in place and then the manufacturing should be in place. We have already manufactured it in large scale and continue, but then there is everything to be able to process validation and qualification, that is, before a e-market survey you should be able to show when you have manufactured GMP, you should be able to do it in the same way several times in a row and you should be able to There are a lot of different parameters. So there is a lot of work going on there. Everything is done in parallel. The most important thing for us is that we prioritize right. We have limited resources, like most biotech companies. The most important thing now is that we will be able to be BLA-complete as soon as possible. This applies to both Umeå, the formulation of the drug, and of course the whole clinic side, the preclinic side, everything that should be included in a market application. Där har vi en enhetlig tidslinje i bolaget som vi jobbar med för att se hur ska vi på bästa möjliga sätt vara så snabbt som möjligt klara om vi får positiva resultat från mars 2026. Så man kan inte se att det finns en enda grej att nu är allting klart utan det All in the company now works towards the same thing, to be VLA ready as soon as possible. But it's a lot of work, and it's of course a big component of it all. And GMP certification is of course an important thing too. It's like a milestone, and we're working on that. But exactly when it's done, we can't even say, but we want to be ready as soon as possible. But it's a big project.

Yes. When we are talking about the organization and the company as a whole, a question has come in here about a change of market space for stocks. Could it be relevant now that you are approaching a market with the pharmaceuticals?

Exactly, that question has often been asked, and this is something that is discussed internally as well. The most important thing with the change of market space is to link it with some kind of... You should not just change... marknad bara för sakens skull och tro att det händer någonting, då är det viktigt att man förknippar det till någonting, att det kommer in nya investerare som en del av ett byte, för det innebär ju också mera kostnader för bolaget, vissa förändringar kanske i styrelse och annat, bokföring och allt möjligt sådant, så det är ju en förändring i vad det innebär, vad högre kostnader, och då är det ju sett till att man ska också då kunna ta in mycket kapital om man gör någonting sådant. Den möjligheten finns ju A possibility is to list up in Sweden, for example, go from First North to the main list. There is a greater demand for the company as well, it comes to a lot of other things. There is also the possibility that other companies have made the USA listed, which is actually the largest capital in the USA, and knowledge in the bibliotech. There are such opportunities, you should do it the right way if you do it too. It also means a change from the company. Funding that goes into the company is that we should do what is best for the company. We should not do anything stupid and we should not just take the costs for the sake of it and think that I as the CEO think that we are a real stock market leader and therefore it is important to go to the top of the list, but we should do what is right for the company and what we know we can handle too. But of course there are discussions like this that everything that is about is more than a financial strategy. But if it happens and when it happens, I can't say. Men det finns alltid på agendan när det diskuteras internt.

I samband med eventuella saker som kanske skulle kunna hända så har det kommit en fråga här om ni ser några fördelar med att även ansöka om en breakthrough therapy designation. Ni har ju FastTrack och nu är det som sagt accelererar godkända förfarandet redan godkänt. Men skulle det också kunna vara någonting som ligger på datering?

Absolut, det kan jag säga. Det är klart sådana här, vi har ju varit Vi har gjort mycket på regulatoriska sidan, det är mycket som pågår som inte syns ut. Vi rapporterar ju om det som liksom vad vi ser konkreta resultat med just kring till exempel breakthrough designation är absolut ett potentiellt program som vi är intresserade av. Det är ganska likt fast track men det ger ännu vissa andra fördelar potentiellt sett till exempel på tillverkningssidan. Alltså vad som FDA förväntar sig i en BLA, vad som man kan skicka in efter den. So that and other things are absolutely also on the agenda for us to work on.

If we go back a little to LADA here, there has been a question about whether there can be more long-term training from the LADA study that is already being carried out. You had exciting results on glucagon simulation instead of measuring time simulation on the LADA study. Will there be more analysis on that?

That's a good question. There is a possibility. It's more up to the PIs. It was a study that was done in Sweden and Norway. And what we then of course financially add with a drug. But the possibilities exist, just as we have done long-term evaluations on other, for example, these Diagnode and in DNA2 we did an evaluation and so on. I can't exactly answer that, but there are of course possibilities. It should be interesting to be able to see how it Above all, on the other hand, when you are diagnosed with insulin-independence, and they were one year later after treatment, they were at the same time insulin-independent as well. So it's interesting, and there are opportunities, and it's also something that might be able to help in a possible discussion with the authorities when you start talking about what is required to get approved for some kind of long-term approval from previous studies, it could be something that helps.

Yes, and just when we maybe talk a little about such label expansion opportunities and what there is for future opportunities outside of what you are doing right now, you released a new article here in January, if I'm not mistaken, which refers a little to the results of your BOSE study, Diagnod B. Could you tell us a little bit about what the highlights really are in that article and what are the coming steps to take that further?

Yes, Diagnod B is a follow-up study on Patients who were part of Diagnose 1, some of them, and some who were part of Diagnose 2. And then Swedish patients who were asked, and who had the right HLA type, were asked if they wanted another injection, or some had been part of it, had gotten the fourth injection, and then they were asked if they wanted a fifth injection. One take-home message is that everyone who was asked wanted to be part of it, and that shows partly the convenience of the treatment and that everyone wants to have additional treatment. Then the result shows that there are few patients that you can not draw any effect conclusions from such a small study, but it shows that in addition to safety, it shows that the number of patients who go up in The blood sugar levels got better, and even the time spent on the optimal blood sugar level improved. So it's at least some kind of indication that there can be something there to give boosters. The purpose would then be to extend the effects, improve and extend the effects, and try to keep a patient above water for as long as possible, so that you can increase insulin production. Nästa steg egentligen där är ju praktiken, det är om vi får godkänt på, nu med de här tre injektionerna på vår lanseringsindikation, det kommer ju att öppna upp helt andra möjligheter kring långtidsuppföljningar och studier, var man kan liksom ta in patienter som redan fått behandlingen i verkligheten och erbjuda dem någonting nytt för ett ännu mer ingående utforskande, det här med boosters, och på det sättet kunna få potentially officially approved for boosters. Then I think there will be opportunities for so-called off-label use of boosters. But it is absolutely an extremely interesting area, because I think we have just scratched the surface of what is possible when it comes to anti-immune therapy. That is, how many injections should you actually give? When should you give them without it becoming a hard treatment? You don't want to give a chronic treatment for the rest of your life, but should you be able to achieve that at some point, that you can actually stay away from all this autoimmunity, that we don't just slow down its significance, but actually stop it. And then maybe it takes several injections and exactly when they should be given is something you would like to explore. When we talk about other possibilities, we have talked publicly about broadening to the other large HLA groups, so that we could cover up to 90% of all type 1 diabetes. with different antibodies, such as Avogad and some type of insulin antibody, and a combination of the two against patients who are on both coelacids. And we are absolutely interested in going further, and we got a patent approved in South Korea on that as well. And that is mostly a matter of resources, but absolutely something we want to move on with, and we can start to explore and come up with a strategy for how we should be able to go to the clinic there as well. And I can also say that there is a great interest from potential partners to be able to see how to treat all types of diabetes, which should be in our interest as well. So there is a great opportunity for us. And who knows, maybe in the future, to be able to prepare ourselves for other autoimmune diseases with the same concept, to find the right type of HLA. And we deal with antigen therapies in other autoimmune diseases, with the same precision medicine concept. But that is the future, where the solutions hopefully exist, but the possibilities do not exist.

And if we move on a bit, of course, there is always a resource question and so on, but you have also had a fast track for both step 1 and step 2 of FDI. Have you had any more interactions with them about how you can move on with prevention and so on?

No, not directly with the authority, and there we have all of our authority interactions, and it's about the current launch indication and both around the clinical side, about manufacturing and everything that is expected on the manufacturing side and so on. So Stage 1 and Stage 2, we may have more discussions about that. We have a collaboration with one of the Critical Path Institutes, C-Path Institute, which is an organization in the USA, where we are members who work a lot with authorities, for example, and we have a great focus on Stage 1 and Stage 2 and endpoints and what would be required for endpoints in Stage 1 and Stage 2. And there, I think it's one of them, that you don't want, if an endpoint in if you go in and treat a stage 1 patient, if the endpoint, the effect parameter in a study is to deal with the time for clinical diagnosis of type 1 diabetes, it can take 10 years for some patients. You don't want to do a 10-year study. I don't think any of our shareholders will want to finance a 10-year study. I don't think any of us as a company will be able to sit for 10 years and wait for results. And there will also not be any other kliniska nätverk som TrialNet i USA eller i Europa att kunna motivera en 10-årig studie till sina finansiärer. Där vill man då hitta de här tidigare potentiella biomarkörerna eller till exempel något baserat på CGM. a continuous glucose measurement, if you could apply something like a previous review, maybe people already see approval and you see there, and then you have a more long-term implementation for complete approval. But those discussions are a little more in cooperation with these organizations that have a unified front against the FDA and EMA and have discussions there. So we don't take those discussions directly as a company, but we do it in cooperation with these organizations.

Related to resources, we have received a question about the fact that three projects have been implemented in a relatively short time. Then we had the solution of the T3 under 2024 and the T4 that will come in March, as you mentioned in the presentation before. We set quite large requirements, of course, on small savers, including capital. Kan man då se att partnerskap skulle kunna vara ett bra sätt att få in det kapital som kommer behövas ytterligare för att inte hamna i en negativ spiral med garanter och så vidare, om ni har sådana med? Och sen så får ni även ett tack för ett bra 2024 och en bra start på 2025 här också.

Alltså partnerskap, absolut. Det är ju klart att om det kommer en partner in och med de upfront som man ser idag på marknaden, vad det handlar om med licensiering och sådant, det tar ju egentligen både and almost say that the entire risk is financed directly. Then the whole company changes completely. But it's not like we can rely on it just to happen. It's not like we just do a partnership and we're just going to do it, it's always clear. But there must be the right partner and the right conditions in place. A partner will do proper deep dive, we look properly at the partner and such. Men parallellt med alla de grejerna måste vi alltid kunna visa som bolag att vi kan gå vidare och göra de förberedelser som finns. För vi kan aldrig handla i en situation där vi är totalt beroende av en partner kommer in. För plötsligt då sitter de i en extremt bra förhandlingsposition och egentligen då kan de ju bara sitta där och vänta ut bolaget tills man är totalt desperat. Så det viktigaste är ju att vi kan förstärka bolaget hela tiden finansiellt och vi vill göra det på bästa möjliga sätt. lyckats nu med facit i hand ganska så bra. Vi har ju kunnat öka både aktiekursen, vi har finansierat bolaget och kunnat öka värdet av bolaget och inte haft med garanter, det vill säga slippa både stora rabatter och ett tryck i kursen av vissa garanter som säljer ut sina aktier. Vi vill ju kunna fortsätta på bästa möjliga sätt framåt också. Det är klart att vi har ju hamnat i en luxury position where we all our timeline has shrunk now when we have got the opportunity to accelerate approval, so there is a lot we are going to do in a much shorter period, of course, which I have also seen there, there are resource gaps in the company, but we want to continue in the best possible way to finance the company. and partner discussions will take place, but as I said, we can never rely on them to come in exactly when we want to have an independent partner to be able to see the company and do everything that is needed.

You also mentioned here a little bit about the Type C meeting that you had with FDA in December, and it came in the final meeting protocol here a few weeks ago. And then we went through the most important parameters, which was that they have given a great interview, so we can continue and that there is a consensus in between how we should proceed. But what would you say that actually the progress made with your meeting, what does it actually mean for the company's ability to reach the market via an accelerated approval, purely practical?

Practically, it's one of the things, even though there are a lot of administrative things that we agree on with FDA, but it's important because FDA sets very high requirements for an accelerated approval. Usually, you get accelerated approval in oncology, that is, when you have dying patients, and that's where the accelerated approval started, in oncology. Then it would eventually start to spread. Men if de har stora krav på att vad som krävs för det taxerade godkännande, och därför är det extremt viktigt att de är överens om allt när det kommer till säkerhetsdatabasen, effektdatabasen, hur du gör din avläsning så att den fullständiga studien inte förstörs, och hur kommer den the final results to confirm the accelerated approval and everything. So there is an extreme amount that must be on the ground so that they say that you can go for it. And they have done that for us, so it is extremely important. And it has been a very positive meeting with FD, because they have actually said that we want you to succeed, and it is rarely a authority as cooperative as they have been with us. Then it is of course a part of the day, we do the previous reading, Som jag sa tidigare, så det är först vårt säkerhetskommitté som kommer att se resultaten. De brukar vanligtvis titta på säkerhet. Den här gången kommer de också att se effektdata, och då kommer de att få ett ramverk ungefär, beroende på hur resultaten ser ut. Är det här någonting som ni skulle rekommendera till sponsor att gå vidare med, till FDI, att diskutera marknadsgodkännande? Det är klart att du behöver kunna visa den. en bra effekt för att igen taxerera och godkänna det. Då ryddar man oftast ganska högt. FDA vill inte godkänna någonting som de sen i efterhand, när fullständiga resultaten kommer, inser att det inte höll hela vägen. Då behöver de rekommendera att dra bort läkemedel från marknaden, men de har inte egentligen absoluta rätten att dra bort ett läkemedel från marknaden. without just recommending it. So that's why there is... What we expect to see is that if we can see results that we have seen before, for example in FAST-2 or in our meta-analysis, if we see something similar here, we believe that it is something that should be enough. And given our safety profile, it is now very important that we can show a very clean safety profile and a good effect. och det finns inga andra godkännande läkemedel idag på marknaden, så bör det ju finnas en god chans att få godkänt också, aktiererande godkännande.

Tolvan, thank you very much for that. If we don't have any more questions, then I think we'll round off there and thank you Ulf. We actually got the last one here that we can take before we jump off. And the Erika Milstolper you hope to be able to open in 2025 and what we as shareholders should be able to look forward to both regulatory, financial and operational.

Exactly, in the near future, of course, it is the development option, it is the next financial Milstolper, it will of course be important. And then we will continue. The financing strategy is extremely important for us and for other biotech companies. But that's one thing to look forward to, and of course to be able to see the whole way Vi vill ju kunna se till att vi sitter starkt inför den kommande avläsningen också, förbi den kommande avläsningen, både ur ett partneringperspektiv, men såklart också så att vi kan visa på att bolaget är stabilt. Vi kan driva allting så långt som möjligt här bara. Och sen såklart på business-sidan pågår, där kan man ju aldrig säga när det händer och om det händer, men det pågår ju mycket såklart. And then we have updates that will come when we prepare for a possible part of it. To be able to update further on that, both on the commercial side, how we see the manufacturing side, and that a lot also applies to us as a company, to be able to show the market what is happening. and also for larger investors and partners, so that everyone knows what preparations are made, because that is the most important thing that exists now, to be able to show that you can finance, and that there is a market. We know what the market is, we know the pricing, we know how we are going to finance this. The more we do this, the more concrete it becomes, both for large investors and partners. So we will continue with a lot of that, and then we will update where we see that it should be updated. And of course, phase 3 is also ongoing. We have achieved important repetition stops, and we will continue update on such things as well. And if we would have the opportunity to expand, for example, to start working on the insulin track and other regulatory discussions, there is a lot that can be done to be able to look forward to. And of course, we are much more transparent about that, and I think that is also important. We know as a company that we have to be very communicative, we have to be sensitive, Vi ska aldrig bli ett tråkigt bolag. Vi ska vara intressanta att kunna investera i. Vi måste påminna igen, vi befinner oss i en extremt unik position att kunna gå för ett aktuellt godkännande med ett fast resultat som kommer snart om bara ett år. Vi har en marknad som kommer att vara värd över 2 miljarder dollar. Det är inte adressärbar, men då handlar det om försäljningspotential. Vi hoppas att det ska vara It's interesting for the owners to be involved in this way, but we will make sure that we communicate and update as much as we can.

Sounds exciting. With that said, we round off there, so thank you very much Ulf for both the presentation and also all of you listeners who have asked good questions and listened in, and then we wish you all a pleasant rest of the afternoon.

And I think Anders Tamsen has a question here too.

Anders, you're welcome to ask a question in the chat if you can.

Or was it the other Anders? I don't know. There's another one with two hands up there.

You're welcome to ask a question in the chat if you had anything else you wanted to say before we end.

Otherwise, maybe it was just a high five.

I don't know. It's not impossible.

Nu kommer här en fråga.

Vi har fått en fråga också om fabriken. Vi gick igenom lite det innan, men vi kan ta det så länge medan vi ger alla tid att ställa de sista frågorna om hade det, om du bara lite snabbt igen vill gå igenom egentligen hur det ser ut med fabriken och kommande saker som hände där och vad som har utvecklats i det sen förra kvartalet.

Tack så mycket allihopa och tack så jättemycket till dig också Ulf.

Vi hörs av framöver. Ha en fortsatt trevlig dag allihopa. Hejdå.