Diamyd Medical AB (publ)

Hello everyone and a warm welcome to this report presentation that will be announced by us here at the GV Fund Commission. Linus Svensson is my name and with us today we have Diomid Medical and the company's CEO Ulf Hanelius who will be guided through the report for the second quarter of the period 2024-2025 that will come out this morning. And before I hand over the word to you Ulf, I will just draw some practical details that if you have any questions, it would be great to send them via the chat function. Det går tyvärr inte att räcka upp handen så alla frågor via chatten, tack. Med det sagt så lämnar jag över startplattformen till dig, Ulf. Varsågod.

Tusen tack och välkomna alla. Jag kommer att ge en kort introduktion också till Diabyd. Många slides som ni kanske har sett tidigare men framför allt för de som kanske är nya här eller kommer sätta det som vi kom ut idag med i rapporten i ett perspektiv och i rätt koncept. Det var ett lite mer utföljt vd-ord som ni kanske också hunnit läsa i rapporten. Så jag kommer att beröra vissa av de delarna, men vi kan absolut diskutera mycket av det också sen efter att köra presentationen. Det blir för många slides som jag ska beröra allting. Men med detta så är kanske det viktigaste just nu som vi också hade som rubrik i delårsrapporten 2, är ju att om ett år har vi fas 3 resultat. Det är den här tidigare avläsningen, den pågående fas 3. we have anchored with the FDA, that with good results there, it would be possible. Then we have a pathway for so-called accelerated approval in the USA, where we are also committed to the whole world to be able to get that opportunity. But before we get into that, again, just to touch on type 1 diabetes and what is actually the problem that we are trying to solve here. So there are at least half a million type 1 diabetics every year. This is something that I would also like to touch on. In the VD word, we also discuss this LADA that we have also done studies in, that is, what is called latent autoimmune diabetes in adults, which is a form of autoimmune disease that comes later in life. Often with diagnosis, you become insulin-independent and misdiagnosed as type 2 diabetes. But 10% of type 2 diabetics actually have autoimmune diabetes. Here we had a meeting with our scientific advisers. It was quite clear that today, LADA is actually type 1 diabetes. And that is something that the American Diabetes Organization, ADA, American Diabetes Association, in their latest guidelines also says when they talk about type 1 diabetes, it also includes LADA. And this is something that is extremely interesting for us, that we will also evaluate the possibility that the LADA population could then be included in our future label, that is, without having to do large stress studies there. We have already done studies in LADA to show safety and effect. So in the best case, this could lead to It is considered to be a type 1 diabetes, and with that we might be able to treat varicose veins patients without doing separate large studies in the future. So that's interesting and something of course we will evaluate in the future. Type 1 diabetes costs almost 100 billion dollars every year in the world, and it is primarily due to all the complications that the disease leads to. and the disease leads to a lifelong dependence on insulin therapy and blood sugar measurements. And perhaps what drives the costs the most are these serious complications, both short-term, if too much insulin is deadly, you end up in premature blood sugar, you can die. If the blood sugar is too high, it is also an acute, deadly condition. But then there are these long-term complications, where the blood sugars are usually a little too high. Blood sugar control is when the body starts to shrink, and then the eyes start to shrink first, the neurons, nerve cells, and the heart, and so on. So it is a 10 times higher risk for type 1 diabetics to get heart and kidney diseases than a healthy individual. And what is also quite obvious is that on average in the world, 35 years have lost a healthy life as a type 1. That is, it is a life without complications. This is what is called in English healthspan. Not only lifespan, but how long do you live? How long do you actually live with a healthy life? 35 years in average have lost a healthy life as a type 1. And in average 15 years short of registration time, and this comes from a Swedish study, And if you want to show that they become girls and get the diagnosis at the age of 10, it can be up to 18-19 years, shorter lifespan. This is also something that we touched on quite recently in an event with the Swedish-American Chamber of Commerce on the topic of women's health, where we were a sponsor and where we touched on type 1 diabetes from such a perspective as well. But a big, big problem, and today there is only one drug approved, in the so-called stage 2 that we are soon going into, and that is eczanthopathy, which they then pay almost 3 billion dollars for the bone marrow that had developed it. Type 1 diabetes is the immune system that destroys insulin production. You usually divide it into different stages. Stage 0 is when you have a genetic risk and environmental factors also affect about half of the population when you get type 1 diabetes. And in stage 0 you have one antibody. Formally, it is not yet type 1 diabetes. It can happen that you never go from step 0 on to clinical diagnosis. But this is where it starts. The blue box is insulin production, which gradually starts to destroy insulin production when you go down to insulin production. In step 1, autoimmune disease begins. You have two autoantibodies against these. either proteins that exist in the insulin-producing cells, and it is 100% certain that if you are in stage 1, you will get the clinical diagnosis at some point. For some it may take 15-20 years, for some it may take 5 years, but you will get it. In stage 2, even the blood sugars begin to sway, the body still manages to get enough of it itself, so you have no symptoms, but if you take a pill, you will see that you have poor blood sugar control. In stage 3, the symptoms come, you go to the doctor, you go down in weight, you get thirsty, tired, lose weight, and then you have seven high blood sugars, you are put on insulin treatment for the rest of your life, in order to survive. In stage 4, you have had the disease for a long time, and then the complications of the disease also start to appear. First, often the eyes, such a tear, and then you will do something with the kidneys and kidneys and other things. Type 1 diabetes is classed formally from step 1, then you are considered to have type 1 diabetes. And insulin dependence starts in step 3, when you get a clinical diagnosis. We as a company, we work across the entire spectrum of the disease. And we start in step 3, that is our dosage indication, where we see shortly after you have received the diagnosis, type 1, then we go in to slow down as much as possible the disease process and preserve as much of your own insulin production as possible. But the biggest for us will be step 2 and step 1, even perhaps some time in the future, step 0, that is, what you treat preventively to avoid or suppress or to avoid that you ever get as far as a type 1 diabetes that is insulin-dependent. That market, step 2 and step 1, is not yet ripe. There is a drug that is approved, T-cell is called in the USA, Men det är extremt svårt att hitta de här individerna, för de är som sagt friska individer. Endast 10 % av typ 1 diabetes är familjärt, det vill säga går i familjen. 90 % av de som har typ 1 diabetes har inte det i familjen. Så idag är det ännu svårt för de individerna att ens veta varför ska man gå och screena sig för typ 1 när man inte ens har någon aning om vad typ 1 diabetes är. Men det är på gång screeningprogram som vi också jobbar med i Sverige. När de är på plats eller andra liknande system, då är den här marknaden mogen. And there we have data from these steps 1 and 2. And with our treatment profile, this is absolutely our largest future market. But we started with step 3, which is a mobile market, but where there are no drugs approved today. Diabyd, which is our trial drug now in phase 3, it affects, as I said, the cause of type 1 diabetes and prolongs the pregnancy. We have been able to see in clinical studies, in all stages of the disease, but especially in stage 3, that we can preserve our own insulin production when compared to placebo-treated patients, and we can improve the patient's blood sugar control. These are patients who are in clinical studies that focus on insulin treatment and where the doctors try to make sure that their blood sugar control is as good as possible. And on top of that, we can still see improved blood sugar control by preventing insulin production, which shows both the importance of insulin production and also that we reach an extremely difficult variable, that is, improved blood sugar control in a clinical study on top of standard of care. The great potential ahead is to be able to reduce the complications of the disease, including cardiovascular diseases, which is one of the largest areas in the development of drugs, cardiovascular disease. We usually say that it is oncology, immunology, inflammation and cardiovascular diseases that are the really big areas, because they are also the big killers for human health. It is also important for us as a company to show that we are both an immunology company that also works to reduce complications, including heart and kidney diseases, so that we can be relevant to many different types of actors, depending on their strategy as a big pharma company. Our safety profile is one of the strongest selling points. We have a safety database of over 1,000 patients who have been treated with active There are about 600 active drugs that have received placebo. There is no difference in the safety profile between active and placebo. And we do no immunosuppression.

We do not push down the immune system, but we program the immune system.

And the exercise is much more beneficial in the safety profile. In addition to the Fast Track Designation, which is one of the FDI's Fast Track Status that we got last year for all steps to better betters, again as the first game in the world, we also have a special status from FDI since earlier, and it is completely unique to be able to have a secure database as big as we have, and also have a special status. And this Fast Track Status has given us the opportunity to have discussions with the American FDI about this accelerated approval, first in the summer last year, and then we could focus on that during the year, that we can go for a previous diagnosis in FAST-3, which can then support an accelerated approval in the USA. A short summary of our clinical results in this stage 3 type 1 diabetes, which our FAST-3 is also about. On the y-axis here you can see percent preserved self-insulin production compared to placebo after 15 months of development. And on the x-axis we have different studies, and here we have chosen those who have the right genetic profile, that is, those we know to respond positively to our treatment. So the origin of FAST3, which we then did together with Johnson & Johnson, and which did not reach the primary effect level. So when you choose the right patients who have the right genetics, you have up to 40% effect on the preserved egg insulin production. There is also statistical significance to this, I have not put out the P-values for the individual studies. In phase 2, which took place in the USA, a trial-oriented study, the trial organization ran it. It did not go all the way forward either, but when you choose the right patients with the right genetics, it had almost a 50% effect on preserving your own insulin production. And then our latest phase 2b study, Diagnose 2, where we then predefined this genetic subgroup. we could say that there was an effect of 55% on preserving own insulin production. And in total, when you put all this together in a meta-analysis, it's about a 50% effect we have on preserving our own insulin production compared to placebo. Statistically significant. And this is the population that we have chosen for our FAST-3 study, which is now in progress. And it is in progress in Europe and the USA, about 60 clinics in total. Här gick vi nyligen ut, faktiskt i vd-ordet också, och uppdaterade kring rekryteringen. Vi har nu 215 patienter inne i studien, vi siktar ju på närmare 300, och vi planerar att ha det fullrekryterat under året. Den tidigare avläsningen kommer i mars om ett år, 170 patienter ungefär som har följts i 15 månader. Det här är också viktigt att säga att det räcker med en enda fastighetsstudie för att få marknadsbokännande Both in Europe and in the USA. The common thing is that you have two solid trees. But for us it is enough with one solid tree. And we did an interim analysis last summer. It was a so-called fertility analysis. That is to say that you put up a certain rib to see if you are over that rib for effect. It was a blind analysis, but that's what we know, that we were over the rib. Which means that there is a good chance that this study will go all the way to the harbor. and succeed, so the risk is reduced further in the study. And as I said, we have the opportunity to accelerate market approval in the USA, based on the results that will come in about a year, where you then look primarily at C-peptide, which is the marker for own insulin production, where we then also as the first company in the world has been able to use C-peptide as a surrogate measure that could lead to an accelerated market approval. The whole study is confirmed to be fully approved, but in one year we have the opportunity to start an accelerated market search, depending on the results that come. This study is done in partnership with Breakthrough T1D, which is the largest patient organization in the US in diabetes, which supports us with about 6.75 million dollars. i Malmström-baserade betalningar var vi också nu under Malmström, vi fick en Malmström betalning på ungefär 250 000 dollar som nog inte syns i vår kassasong fram till slutet av februari. Viktigt också vår facilitet i Umeå, där är målet att ha den GMP-certifierade under 2025 och som ni ser den här i bilden, det är den här röda tegelbyggnaden, en del av den röda tegelbyggnaden Det är den främre delen som ni ser är allt vad vi äger, plus mark runt omkring. Den bakre delen, vad ni ser också, de vita lastbilarna, tillhör Tamro. Men det här köpte vi upp då. Vi började med att hyra in oss, sen kunde vi köpa upp faciliteten och fick tillgång till allting, så vi kunde expandera också våra varulagar, vilket var extremt viktigt. Det var vi nu har gjort en hel del ombyggnationer för att se till att det passar i vårt tillverkningsflöde. The next big milestone is the GMP certification under 2025, which we will also have to ask about, since we can discuss more about it. I just want to show this so that we can go back to covering the entire spectrum of type 1 diabetes. Diabetes is of course now our main candidate, which is in phase 3, and phase 3 study is our biggest focus. But we have also started DiPrecise, which is a minor study in studies 1 and stage 2, that is, before clinical diagnosis. We did a study in LADA patients, which we also mentioned just now, so it may be type 1 diabetes, but up to 70-year-olds, where we could show both safety and effect in the right genetic subgroup. Also published in the scientific manuscript, and this DiagnoB was also published, where we evaluated some patients. a fourth or fifth injection to show, above all, the certainty that it is safe to be able to give additional injections for the possibility of maybe extending the additional response. This would be attractive to be able to give additional injections, both for the patient, if you can extend the response, but also commercially. In commercial terms, we usually say that if it is a one-time treatment, it will be less interesting than if you can re-treat. You should absolutely make sure that you don't make it difficult for the patient, but if you could do a re-treatment once a year or once every other year, then there is also a big commercial upside just on that. Then, commercially, we have done market analysis in the USA that shows that for our launch indication with three injections for those who get sick every year and who have something left, Insulin production is still to be preserved, it is a 2 billion dollar sales potential just for that. So show a little of the possibilities here. And then we have said, we have said it earlier and we say it again now, we have absolutely now, we have gathered our scientific advice recently, which we have updated with two new members, where we discuss a whole lot about both diabetes and medical profile and positioning and strategy in the future. But it is very clear that both prevention is our big area in the future, and that we should broaden the concept towards an insulin-based diet, in order to be able to take care of the other, about 50% of the types that had the other big HLA groups, HLA-DL4 and DLK8. And this is something we call a discovery, something that we are preparing for the result. in a year, because then, if the results start in a year, which we believe in, we will be able to quickly develop this towards the clinic, so that we can then look at a platform that we can, it is perhaps up to 90% of type 1 diabetes with a precision medicine concept. And then the last slide, in a summary. Finances. The market value right now is around 860 million kronor. This is currently an emission technical value. We had before we announced the emissions that we will put into action in the technical period at the beginning of next week, we had a market value of around 1.5-1.6 billion kronor. Kassan at the end of February, a little over 100, then they came in at about 8 million kronor in March as a milestone payment from Breakthrough T1D. And then the predecessor, which of course is a very important period of development, starting on the 15th of April and then it continues until the end of April. And here it is about that you can get, as an existing shareholder, you can get a new unit for four existing shares. The coverage rate is 8 kronor. And one of the units will then contain a new share and a coverage option of series 5, that is, DO5. There is no guarantee with this, which is conscious. We have technical connections now at over 40 million kronor so far. And we have no guarantee to avoid extremely high costs and a sale pressure after the emission as well. But with full coverage we would get about 108 million kronor. Before costs, with costs that will not be much limited, given that we do not have rents with us, it is about 2 million kronor. And then two technology options in one year, in April, you can buy new shares for 20 kronor. And then with a full technology division, even those technology options could give the company an additional around 280 million kronor. And they are then based on with the so-called strong results, this should be an extremely attractive case. And the last slide, just to sum up the upcoming milestones, we expected to complete the phase 3 study by 2025, which is a very important milestone, GMP certification for the manufacturing facility in Umeå by 2025, and in one year, almost exactly, phase 3 results, which could then, after a strong result, be prepared for the next stage of the market survey in the USA. And with that, that was my last slide.

Thank you very much Ulf for a nice presentation. And then we jump straight into the Q&A. I thought now that we've had up a little with milestones and such, I've come up with some questions in the chat and it's of course good to ask more if you have something or something pops up here during the Q&A. But now that we've talked a little about milestones and so on. What if you get the entire liquid that you are aiming for, around 200 million netto, and take the liquid all the way down to the previous reading, or the previous reading, so to speak?

Exactly. We have calculated that it should pass the reading. It is important that you do not sit with a zero in the cash register when the results come, that this should actually also be passed for a few months. to pass the reading, so that we don't have to sit with zero in the cash register and have to take in money just then, but then the technical option 5 should be able to get its chance as well, and it will be important to sit with money in the cash register when the results come as well. But it is calculated that with the cash register and with the about 200 million kronor, it can pass the reading.

Toppen, you also talked a little about that you aim to have the study fully recruited during 2025. This is not something that is needed for a previous reading, because you already have the number of patients in the study. But I have received a question here about the fact that the recruitment has gone slowly throughout the entire Diagon 3 and now it looks like it is going slower. The most important thing is to get the optimal result and cover all groups. How important is it to recruit Diagon 3 finished in relation to the reading in March? and get a fine adjustment from a trigonometric group that you recruit.

Exactly. It's slow. You always want everything to go faster. I can say that our recruitment is extremely much better than most other type 1 diabetes studies in the world. Then it often goes in stages. It depends a lot on some clinics. In fact, they over-recruit. In fact, they take in a lot of patients more than expected. In some cases, they get to a point where they have to handle their patients before they have left the study. Then when they have left, they can start taking in more patients. And then it usually happens on certain weekends, for example. The clinics are not open during Christmas, for example, and some summer holidays, different countries have closed at different times. So it usually goes like this, suddenly it goes fast, then there is a little pause, then it starts again, so it's hard to just see how the recruitment goes linearly. But we have two and fifteen now, We aim to be closer to 300. In total, the study is on 330 patients, but then we have taken into account, I think, a 12.5% dropout, which we have never seen before. We usually see about a 1% dropout rate in the studies. Statistically, we need around 280 patients with more results, because that's what we have calculated. So towards the end of the year, we should have close to 300 that we have calculated as well. So that's where we see that we should go further. It is also important for the FDA, for example, when it comes to accelerated market approval, they want to know that you can complete your approved study. That is, they do not want to end up in a situation where they give an accelerated approval to a drug and then you will never be approved and get full approval. It has often happened in oncology where it is quite common with accelerated approval in the USA that you get accelerated and then you can never approve. the accelerated approval. The FDA has no right to withdraw approval. They can only recommend withdrawing approval. So they don't want to end up in that situation. And that's why they have become a little more clear that you have to be able to show that you will be able to confirm the accelerated approval. And for us it is then necessary to be able to show that we have The day we get our results, in about a year, then we will actually be fully vaccinated and most of the time fully treated. So there is no risk that we will not be able to close the study. So that's probably the most important thing for the FDA.

And now a little bit about the current environmental situation. It happens a lot in the world and so on. How are you affected when Trump is going to bet money on biotech companies and medicine production as a first question?

Yes, there is probably no one in the world who knows exactly what is happening every day. We hear something new here, and there are those who speculate that it is perhaps Trump's and their tactics to wave with their right hand and hold on with the other on the left hand, so that you should not focus on this now and then. But we'll see where it lands. But I think I have asked a few different contacts in the USA and so far in most of them, and they have their own interest in saying it pretty much in the end, I wouldn't say positive if I say that basically Trump is also a capitalist. He has no interest in disrupting, for example, the markets. On the FDA, the declines that occur, at least what has officially been announced, it's on administrative personnel that you go down on. You don't go down on reviewers, that is, the inspectors of the different divisions. Sure, it can lead to the need for inspectors to do more administrative work. We know that there can be more work, time can be affected and so on. But so far, there is nothing that indicates that the number of inspectors will decrease. Then there are those who say that what Trump and the Moscow gang want to do is to get rid of bureaucracy, that it should go faster, it should be more effective. But again, where it will end up, I don't think anyone knows today. I don't know if Trump knows where it will end up. Så det är väl för oss och för alla andra bolag och alla i världen, det är väl mest den här ovetenskapen som är väl det som man måste kunna hantera. Men det är väl lite som finlandspresident Alexander Stubbs sa, det är bara att ta en kall dopp, sitta i bastun en stund och sen går man vidare. Ingen idé att vi som bolag eller andra får panik, utan det är bara att sitta stilla i båten och titta på vad vi egentligen har för investeringscase. USA kommer att vara I would say one of the largest income markets in the world, regardless of what happens. Then there is this discussion about Kennedy and others, how to look at that. It is of course important that we have got our Accelerated anchored and our Fast Track, it is good that we have got it. It is not now that we have those discussions. Of course, they have all been positive, but as I said, I don't think they know much more than us. The most important thing is that the downfalls that occur, happen on the administrative part, not on the review side. And the ambition is to be able to speed up the development of the link media and not just make it slower.

We have received a question about what you raised when you answered that question. In your answer there, but if it is about Kennedy, for someone who does not know, Robert F. Kennedy is the junior head of the US Department of Health. Han har tillsatt en ny chef i FDA om det är någon som skulle kunna sätta käppar i hjulet för Diamide på något sätt. Just kopplat till tullar och sådant om det finns någon, det är lite tidigt kanske men finns det några tankar kring om ni kommer behöva flytta tillverkning och så vidare till USA för just den marknaden eller hur har ni diskuterat kring det?

Ja, jag tror det är bra för alla bolag oberoende av vilken industri man jobbar med så kommer jag absolut bara inse att det är en ny värld vi lever i. Man bör ha någon typ av USA-strategi överlag, liksom. Att veta att det kan innebära, det kan ju också vara oberoende av allt vad som händer idag, att man skulle i framtiden vilja ha viss tillverkning i USA ur logistiska perspektiv eller annat. Det kommer ju att vara vår största och vår första marknad också, så det finns ju absolut en rational för oss och många, många bolag att kunna sätta viss tillverkning i USA oberoende det här. Men jag tror att det är bra att kunna Vi har sådana diskussioner så att vi vet att nu om det kommer tullar, vi vet man har talat om 25-procentiga tullar, innan vi är på marknaden så hinner mycket hända här så man vet ungefär vart allt kommer att landa. Det som är bra för oss är att vi har ganska bra eller mycket bra marginaler på vårt läkemedel, alltså jämfört med den förväntade prissättningen mot tillverkningskostnaderna som med om det skulle komma tullar på det så kommer det ändå inte att påverka oss lika mycket som det påverkar många andra Kanske bolag eller industrier var marginalerna extremt mycket mindre och då kommer man påverka det mycket mera. Men man bör absolut ha en, diskussionen är på gång och inte vara naiv och tro att liksom det är bara att inte bry sig utan någon typ av planering bör man ha och veta vad det skulle kunna innebära att så småningom till exempel kunna flytta tillverkning i USA om ett antal år och sådana här, men det är ju ingenting man gör i en handvändning. But in the same way, China is now also starting to flirt a lot and say that it is a safe haven to put the manufacturing in, and they have a lot of money and a huge market and will certainly push hard towards the USA here. So it's an interesting market and an interesting world we live in, but I think you should sit steadily in the boat, but not just naively either, but know that you have to, for example, Maybe not take it into account, but think market-wise and commercially in the best possible way.

Now that we're talking about implementation, it might be a good idea to talk about the question about Umeå. You brought it up a bit in your presentation. You also mentioned in your press release in March that you aim to have it GMP certified by 2025, which is an important milestone for the company, of course. When during the year, roughly, would you be able to think that it is, and we have discussed in some previous cases that it has a very clear role in the accelerated marketing process, would you be able to describe a little what its role is there and how it comes together with a potential part of the application?

Yes, absolutely. First of all, the timing. I say 2025, I don't want to say anything, it's speculated more. You should always be careful, but it's better to say 2025 and say målet att det ska ske under 2025. Det kan ändå komma sista december, som en julklapp, eller så kommer det tidigare. Men där vill jag inte sätta förväntningarna i onödan. Det handlar om att bolaget ser att nu har vi alla system på plats, så vi känner oss GMP-färdiga. Då skickar man in en ansökan om att vi certifierar grannskadden, i det här fallet Läkemedelsverket i Sverige, And then, after a certain time, they come to the facility, go through and ask a lot of questions here and there, and go through everything. And then it takes a certain time, and then they come with permission, what it can all be for. There will always be findings, regardless. You will always find things, potential for improvement. But if you have that, it looks good, you can improve it, but you get the certification, or it can just be a lesson, you have to fix this and that later. But the goal is that it should be placed under 2025 or something. I don't want to say any more exact date, because you always get it wrong when you start speculating. And then regarding how the GNP certification relates to an American BLA application. First of all, the GNP certification is about the facility itself and the quality system and the routines that are on site that have been built up to show that you have a quality system and a routine on what and everything, in order to be able to produce, in this case, biological substances in a safe way according to GNP. So basically, it is partly independent of the GAD production. GAD production will then be done within the framework of GNP. So the important thing here is that we can show that we have a biologics facility that is GMP certified. And that means that the facility is on the ECNBL, that is, it can then start producing other substances according to GMP. So it becomes an independent value in the company, which is extremely important that not everything, everything, everything hangs on one single, in this case, GAD diamond. So it is important to influence, it should not just be dependent, it must be able to stand on its own feet. Then how it relates to a BLA, here it is above all, in the end it is the FDA, the American Medical Association, who under the BLA process, in some way, will come in and examine the facility. And then it is important that you have had another authority before it has been reviewed, so that it is not the first time ever that the facility is reviewed, that it is FDA as part of a marketing application. So this is an extremely important milestone in the way that you say that the Swedish Medical Authority has reviewed the facility. and then certify the facility. And that's something that the FDA will also see. Okay, that's good. Another authority has been in there. It's something to examine so they can feel safer. If they are the first to ever come in and be examined, then they will turn on every little stone and be even more critical and so on. So that's maybe the most important thing. A GNP-certification from the Department of Health and Welfare is not a requirement to get market approval in the US, but it is the FDA that will examine the facilities and approve them. But this is important for the facilities to show that you have the GNP-certification, a very important checkpoint. And as I said, it can also stand on its own two feet. So that's how it should be.

When we talk a little about the study as well, DMI gets access to some data from day 3 blind people, for example CGM data that participants also get access to for insulin dosage.

Do you mean now during the course of the study?

I would assume that's what he's thinking about.

Everything is blinded. What we have seen, the baseline value, has been blinded. Again, nothing connected to active placebo. We have seen that in some analyses, and I think we have also been able to see at conferences that the baseline corresponds to the value of our previous studies, which is important. The study population seems to correspond to our previous study population. It depends on how much C-peptide we had at the beginning of the study. Otherwise, you have to be extremely careful to look at any data at all in a study like this. This was done in the last summer. It was a statistician at RO-boland who looked at the results and did analyses on CPAP in this case. There was also a security committee in the study who could then see the analysis. We saw nothing because we are not allowed to be infected. With the previous analysis that will take place in a year, we have changed exactly how that analysis will go. That is, again, it will be a statistician and CRO company that will do all the analyzes on all these N-points in the study. And then the Security Committee will be able to see data and then be able to proceed with recommendations to us that this is something you should look at, this looks good. And then it's a small group in the company that half of the blind will see the results, plus then a part of the CRO company's staff. And they come after not being able to continue working with the study, because they are bad, they must isolate themselves enough from the study in order not to affect the study in any way. And this is what has been anchored with FDI, We know what to do and what not to do, so that the whole study can proceed. But all this is anchored in addition to the safety data, what is relevant and the effect data, and so on. This is also how the review goes in the right way. But otherwise, during the course of the study, this is a placebo-controlled linear study, you cannot see data in the study. These patients, they often have their own CGMs, so they see how they are, of course, in the study. We have, as part of the study, a blind CGM that they have on the other arm that they can't read, but it's data that goes in then as part of the analysis, then in the final analysis, but we, and then the doctors will be able to see how our patients are and as part of the everyday treatment, but they have no idea if they have been given active or placebo, and we as residents must be extremely careful not to get infected in any way.

Yes. Then we have a question about the environment. In this case, the emission is estimated to be under 50%. You already have, as you presented, about 100 million in the budget, and there are about 40 million in coverage for the future. But how do you look at the financing opportunities in the future, with respect to the earlier resolution in March?

Exactly. It will be important now that this emission is proposed, to see how much will come in. The more, the better, of course. But then we know With the goal of 200 million plus in the cash register, we will pass the reading in March in one year. Depending on the outcome, we have different possibilities. Of course, there are different ways to finance the company. The most important thing is to do the best possible way for the shareholders, as many in the company are also larger shareholders. And of course, if you really need to go in and prioritize, to make sure that our budget is as wide as possible, there are also those opportunities. What is the biggest focus? And there were three studies. It's youth certification, that we really think about what the key values are, and if there are other preparations, like the other two, that we don't have to do, but that are good to do, we can go on that side to really see. And I think it's extremely important. We have, of course, always look at that in the company as well, so that we know different scenarios of how we should treat it without having to compromise on the value creation in the company. I think it's important for all companies in this area, as it looks now, to look at that as well. But in the big picture, we know that 200 million kronor more today for a fast tree farm with a result of one year plus a Biologics facility with GMB certification during the year and a pre-examination of a fast tree study during the year is not much in the big picture for the biotech industry. But of course, at the same time, we are very proud that it is of course not easy to market today. Men vi försöker alltid ha allting på bordet när vi tittar på sådant här och försöker göra det bästa möjligt som vi bara kan.

Ni har ju också redan sedan tidigare erhållit FastTrack Designation och Orphan Drug Drift Designation och vi har fått en fråga här om Breakthrough Therapy Designation med Rolling Review som har potential att påkvinna tid till marknaden. Är det något ni också har förhoppning på att få beviljat från FTI?

Rolling review is a possibility when you have fast track, so it is something you will need to apply for in some way. I think you can apply for it whenever you want, but you should apply for it when you start to know what rolling review means. You can start sending in a market application during a one-year period in parts, for example, you can send in the non-clinical package if you have it ready, you can send it in first, then you take the clinical package when it's done, send it in, and then usually the last package that is finished, because it's so much work, the so-called CMC, that is, everything related to the production of both active substances and formulated drugs, and then you send that in. And you can send that in instead of making sure that everything is in place, and then you send in the entire application at once, then you send in parts at once. So it becomes a little more agile, and then the authorities will be able to at least do a check on that, okay, it looks like a non-clinical package, it seems to fill up. all the criteria, even if they may not go in and do a full review before Alta comes in. So you potentially win time on it. And that's something you can apply for as part of having a fan strike. And then we will apply when we know, when do we think we can start sending in a market survey. And then you calculate one year forward there, because they take it clearly then in one year. And then you calculate backwards to start seeing it. And then you apply for it. So it is likely to be able to get it, given that we also have a special status. So, it's not connected to breakthrough. Breakthrough is very similar to fast track. There are very few things that differ. You usually say breakthrough designation is more about investing. It's harder, even if you don't really differ in the end. It also includes role and review and priority review, that is, you can apply to get a six-month treatment instead of a ten-month one. It's included in FastTrack and Breakthrough. But it's something we also look at. Breakthrough has even higher requirements, and then it even gives... It's based on clinical data, which we have, but it's extremely high risk, and it's another part of FDA that looks at it than FastTrack. But it's possible, but it doesn't give much more than FastTrack, actually.

You also have an interest company called Nexel Pharma that delivered some results yesterday, and their results are a bit uncertain due to the fact that placebo patients have not lost much of their own insulin production. Are you uncertain or worried that placebo patients, even in your study, can show signs of significance?

Yes, as you can see, the more patients you have, the less impact you have. You can call it outliers. That is, if it is individual patients who have individually been extremely good regardless of what treatment they have received. If it is a small study, they have a large impact on the average, for example, in the media world. But if it is a large study, many patients the effect disappears in the amount. And that's why you often... We had, we can say as an example, many years ago there was this study at the University of Alabama that did a combination between GABA and Diamyd. Then Diamyd was given as two subcutaneous injections and combined with GABA as a cost contribution. Then we knew nothing about the HLA groups and what happened. And that study did not see an effect on C-peptide, but there was one patient in the placebo group, I think it was a 12-year-old boy, that increased insulin production, which destroyed the effect. And that clinic, it was one clinic that took in about 100 patients. When they went through their database, they had never seen anything like it. But that can happen, that's what you know. The individual pregnancy is individual. Most go down, but it can happen just during this honeymoon phase that some of them increase at the time and then they start to go down. But if you have a small study, it can affect a lot if you are unlucky that they are in the SEVO group. Then you can be lucky that they are in the active group, and then it looks like it doesn't work very well, even if it doesn't work. But for us it is important that we can see consequently, as I showed earlier, in all of our previous studies, we see that we see an effect. And then it's not about 10 or 20 patients, but totally in meta-analysis. With the right genetics, there are over 200 patients, and now we will have an analysis of about 170 patients in one year. So there should the effect of individual patients disappear, but it is actually the effect of the group and the effect of the vaccine that will appear.

Great. What measures are being taken when it comes to treatment with insulin antigen?

As we have said, what we want to do now is to prepare the program during this year, so that in one year, when we get the results, especially if they are strong results, we want to be able to move on as quickly as possible to the clinic. This is something we discussed with our advisory board recently. There is no idea to spend eternity in pre-clinics and try to show that you can get rid of a mouse. This has already been done, and the important thing is to do what is needed to be able to take it into the clinic. And there, of course, find a dose to see the effect. So that's the preparation we're going to do, but we're doing it in an extremely cost-effective way. Vi kommer inte att spendera mycket pengar på det, för vi måste verkligen fokusera våra resurser, men att vi kan förbereda så mycket som möjligt, så får vi resultaten från de myndometoder. Om de är starka, så då har vi på något sätt validerat vårt koncept med antingen specifik platform, and then we want to burn ourselves as quickly as possible, therefore be able to go to the clinic. So during the year, a little depending on, there can be updates to be able to say there, what type of insulin antenna we will be able to focus on, or production strategy, for example, can we connect Umeå facility also to a certain part of the production, it would be nice to be able to see the synergies as well, if not other analysis parts that can be done in Umeå and so on. So there may be a lot, but that's not what I promise. The most important thing is that we want to move forward with it, but at the same time in an extremely resource-efficient way, so that we focus right here, but at the same time can broaden ourselves.

And just with the thought of preparing you and so on, we talked a little in the VD word and we have also talked in the previous quarter a little about possible follow-up indications with, among other things, booster treatments and LADA. And there have been a lot of questions here about what, for example, LADA could commercially mean for DMI, then can such an inclusion be a market approval as in the BLA that you think you will send in after the interim reading?

My question is about everything we want to look at. Just as we said about LADA, there was also a part of the discussion with our scientific council, especially David Leslie, who is one of the really big key opinion leaders who has spent most of his scientific career on LADA. And as he actually said at the meeting, He has spent most of his career trying to prove that LADA is another type of diabetes, and he has failed. And he says that it is a type 1 diabetes. You shouldn't talk about LADA anymore. You can imagine, a bit like the American Diabetes Association guidelines, when they talk about LADA, they say that it is not a type 1 diabetes. LADA can be a good concept to use, because there are many who have heard about it, so you are separated from type 2 diabetes. autoimmune diabetes, which is often low in that age, but that it is type 1. Therefore, it should fall under the same umbrella, and then there is a possibility for us to see if we could include it in a label in the future. If we get approved now in Diagnostics 3, it's 12 to 29-year-olds, but given that we have shown certainty, up to 70-year-olds, would they be able to be included in that? Or maybe a smaller study would be needed in advance? But that's something we want to look at, because the possibility of LADA is extremely large. It is also in our market analysis that shows that our launch indication, which is more of a classic hyperdiabetes with preserved own insulin production, can show a sales potential of around two billion dollars in the United States per load, so LADA is at least as large, if not larger. What is needed on the LADA side is that there are many, a little depending on country and clinic, is that if you do not take routine antibodies, blood tests and check the antibody response for those who come in with suspected type 2 diabetes. To find them in the right way, everyone should do it routinely. It's a pretty simple procedure. And then it's usually loaded with insulin-independent diagnosis, so a little more like a stage 2 type 1 diabetic. So it's also a question of whether we get approved for diagnosis 3 and type 1 diabetes in step 3. then we are also approved to treat insulin-dependent LADA patients. Then we have stage 2 and stage 1, then we are approved to treat insulin-dependent LADA patients. But this is what we want to figure out in order to know what's going on. But there are possibilities, and it is clear that LADA is type 1 diabetes. Then it was about stage 1 and stage 2 that I mentioned, but as I said, it will be the biggest thing in the future. It was also clear in our advisory board With this, our drug profile, that is, with that safety profile, that it is an outpatient treatment, that is to say that we are not in the hospital, and basically no side effects, and with the long-term effects we see with only three injections here, so it is absolutely prevention that will be the big thing for us. The other drugs that are more immunosuppressive, are not really as strong candidates for it, while we are an extremely strong candidate to be treated as soon as possible. So that's our big future thing. And then with boosters, it has also been published and discussed within the field that it is extremely important that you should be able to re-treat, to be able to have a safety profile and a medication that you can re-treat with. So it's not just a one-time treatment and that's it, but you should be able to re-treat It is rare that you can get 100% effect with just one treatment. It is probably not expected to be treated again and extend the effect. All this is being discussed, so we have the right type of profile to be able to treat as early as possible in a safe way.

Ja, nu när vi ändå är inne lite just med LADA och så tänker jag då kan vi ta en fråga här om det pågår några analyser av gamla LADA-resultat som ni tror att ni kan presentera och även om ni har några diskussioner med FDA om just LADA?

Inga analyser just nu. Det finns ju de här Guardian LADA-studierna som publicerades 2003 som gjordes då i Sverige och Norge. Så där finns det potentiellt lång tidsuppföljning på de patienterna. So it will be interesting to see. But it is a more trial-oriented study, so we are not the sponsors for it. But there is the possibility that it can come more. So there are these really old LADA studies. Unfortunately, the first study was the one that was more of a dose-finding study for diamine, where you evaluated different doses of diamine, and then you chose this 20 microgram subprotein. But that was in the LADA patients. that showed good effects and long-term findings, a larger study was conducted at the time, which unfortunately was destroyed when the large-scale pharmacy that had placed a label on active placebo had mixed up active and placebo, which destroyed the result. So it is difficult to go back to those results, and it's mostly in sperm, I think, in the paper, sperm and so on. Maybe there could be some possibility, but it's more exploratory. Nothing that we would formally be able to use for anything, given that the study was delayed because of the problem with active and placebo. But absolutely, if there are possibilities to look at more data, it's something that we always do, especially now, to strengthen the case even more. Fast 3 reading, to be able to have as sharp a data package as possible, go to the authorities, and of course the day you can, you can start going to the market too, to be able to show the value of what we do.

And how does it look with patients who are a little younger than 12 years, how do you see the potential there and your opportunities to treat them too?

Exactly, Fast 3 is now from 12 years and up, Then we have a so-called pediatric plan that is needed in Europe, where we have defined studies to be able to go down in age. Most of our patients, given the HLA type, most of them are in the slightly older teens and adults, while if you have more insulin-driven autoimmune type 1 diabetes, they come at a young age. So, the majority of our patients, 1% will be in 12-year-olds, but we will do in the future studies to be able to go down in age. Di-Precise, which is in progress in stage 1 and stage 2, will also go down in age. It is primarily to test this, when you go into this directed injection in the lymph node, to be able to go down in age and show that it can be done. There have actually been discussions with the European Medical Association, the pediatric committee, that they themselves have said that if they go into real young age, they should do subcutaneous instead of infantile. So there is also a possibility, because our data shows that subcutaneous also works if you have a type of genetic disease. So there is a possibility, and it is not unusual that you have different formuleringar eller administrationssätt beroende på åldersgruppen också, så där finns det möjligheter att kunna titta på sådant också.

Om man tänker lite kring bolaget och aktien och så vidare, vad ser du som de mest värdedrivande för aktien under 2025 och om vi pratar lite med just Umeå, kanske en del av den, om det finns någon tanke på att avknoppa den till sitt eget bolag eller hur ni ser på det?

Yes, the most valuable thing is, of course, that there is a lot going on now, both in the study, the UMEA, of course, the GMP certification, a pre-registered study, and there will be closer and closer FAST-3 results in one year. And of course, as always, discussions are going on here with various actors, whether there can be something before the result or if you choose to wait for the result. It depends both on, of course, the other party, what risk they want to take, both to Det är ju en risk för dem att gå in innan resultat, samtidigt är det en risk för dem att inte gå in innan resultat ifall det finns andra som, som då det blir ett dyrare case den dagen vi sitter med starka fast 3-resultat. Så det är ju sådant som också pågår. Men det största caset är ju liksom fast 3-resultat på nu mindre än ett år och EBS-certifiering under året då, förutom fast 3, så det är ett ganska starkt investeringscase bara det.

And of course, many of you have questions about the discussions with Big Pharma that you have had for a long time, but can you expect that something like that could be channeled into an agreement during FY25 or before this interim review? And what do you think about the fact that there would be the advantage of having a partner in place to approve the process with part of the investigation?

As I always say, there is always a possibility. It's about both. For the other part, in this case the pharmaceutical company, there will be a risk for them to go in before. There is a clear rationale to wait until there are three results. Then you know. At least in the previous review, you get an early answer if it looks really good. Then you take the clinical risk away. You know that it works. to go in before that, so then you take a risk. Then it can happen depending on when they go in and who chooses to make the decision that it is the head that rolls, if it was not the previous reading that would show positive results. So that's more how they think. I think that in terms of money, when it comes to the cash register in these big pharma companies, they have a lot of money. That is not the big thing for them. They have money to pay if they see something attractive. The big thing for them is how they connect all the resources around a new drug, a new indication, and then they do their calculations forward, 10, 15, 20 years forward, what this will mean for them. That's more what it costs. They have attached resources. And then they don't want to take too much risk. And it's more about what risk profile they have in the company. For us, there is absolutely an advantage, especially if it is linked to a larger milestone payment, that it can strengthen financially, so that we can take away more of the financial risk from it as well. There is a great value for us and that we know that we have a larger shareholder. So for us there is absolutely a valuable idea, but we should not be totally dependent on it either, but there are three results in the end that will be the really big ones that will drive everything there in the future. So it will be a completely new situation in a year.

And as a small question on that, it has come up if you could have an option agreement as a prevention by?

Yes, as I said, it is a how it could look like if it was done before. Provincial Bayer had an option agreement shortly before the FDI decided to approve it, so they had it for the third time in the foundation, and then they had the marketing application on the way and only on the final stretch, and that was the day they went in and took an option that then led to a complete purchase after they had been approved.

Yes, I think we're getting close to the end of the time, so we'll take a little closing question before we wrap up, and that is how it goes with the recruitment to DiaPrecise, and when will it be fully recruited?

No, it will also be updated in the short term, so there are patients, or there are healthy individuals who have gone in and been treated. There are, as in all of these studies, The CNB committee, which looks at insurance, is primarily a security study. When we go down in age, there will be updates on that. It is recruited from a cohort in southern Sweden, Denmark, where you follow up patients who are at risk of getting type 1 diabetes. It is a smaller base that is recruited from as well. It is not as prioritized as our FAST-3, but there will be updates on that as well. Det är ju vår framtid, det är ju det här stage 1, stage 2. Så det kommer att komma kring det också. Men framför allt är det ju att kunna visa på att vi kan gå ner i ålder, men inte rent praktiskt, så det stora värdet där.

Ja, jag tänker att då har vi inga ytterligare frågor där, så att vi passar på att avrunda och tackar dig Ulf för en jättefin presentation och bra svar på frågorna. Såklart alla er åhörare som har lyssnat för visat intresse och bra frågor. Och så får vi önska alla en trevlig dag och vecka.

Tack så mycket.

Ha det fint.