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.