Diamyd Medical AB (publ)

Good morning everyone, my name is Linus Jönsson and I would like to welcome you to this report presentation which is held by us here at the GV Fund Commission. With us today we have, just like a few times before, Diomid Medical and the company's CEO Ulf Vanilius, who will soon be able to go through the report for the third quarter, for periods 24-25, which came out here this morning. But before Ulf can take over, I just want to mention some quick and practical details. Eventuella frågor tar vi upp efter presentationen och det går tyvärr inte att räcka upp handen utan man får ställa alla sina frågor via chatfunktionen så läser vi upp dem och så kommer Ulf besvara dem efter sen. Med det sagt så lämnar jag över ordet till dig Ulf, varsågod.

Yes, tusen tack och välkomna alla. Jag kommer till en ganska kort, som sagt det här är en kvartalsuppdatering så det blir inte egentligen. Jag förväntar mig att alla vet någonting om bolaget och bakgrunden, så jag kommer hoppa ganska rakt in i själva uppdateringen och så kan vi gå till frågor därefter. Så direkt, och jag tänkte precis som mitt vd-ord också i kvartalsrapporten, så är det fokus på några stycken grejer. Vi har ju både på vår FAST-3-studie, var vi har ett mål att den ska vara fullrekryterad i år, eller i alla fall att vi slutar patientscreeningen. Then, GMP certification is in progress in Umeå, and perhaps the most interesting is the FAS 3 result, i.e. the earlier analysis of the ongoing FAS 3 that will come in a year. And what is extremely important and what we are extremely grateful to our shareholders for is that we have a strong cash flow today of over 300 million kronor, and it is thanks to that Den företrädaren som gjordes och kompletterande riktade emissionen som då gav oss 266 miljoner kronor innan kostnader så var det ju bara 5% eller mindre i kostnader tack vare att vi inte hade några garanter involverade. Så det här har gjort att vi har en mycket stark kassa vilket är extremt viktigt i det här läget just när vi nu sviktar på avlästning med fast trean. Och sen som ni vet så har vi ju teknisk option serie 5 som då can be traded as an extra instrument on the market. And then in April next year, you can then give the opportunity to buy shares for 20 kronor each. And if it goes through, it could give the company up to 330 million kronor before costs and after costs it will be around 300 million kronor or more. So that should of course also be an extremely large value. for the company and for the shareholders as well. But I thought I would focus on these three points a little more in the update. Phase III, as I said, there will be a result within a year, a so-called earlier reading in the ongoing study, and it is done in partnership with Breakthrough T1D, which is the largest patient association in the United States. In Europe and the United States, 60 clinics in total, And as I said before, we have anchored with both the American Medical Society, FDI, and with the European Medical Society, EMA, had enough with one single fast-trigger for a market approval. It is common that you usually have two fast-triggers, but our fast-trigger is one. Partly because we have such a large security database. Previously, we have done 15 clinical studies with medical medicine candidates. And we are looking at a genetic subgroup of type 1 diabetes. So this is, we're almost getting into more now. We have a special status earlier in the USA, but now we're looking at a genetic subgroup of this, so we're almost getting into the rare disease area, where there are a few other, a little easier requirements, you could say, than for normal indications. And as I said, we have the opportunity for an accelerated market application in the USA, based on a previous analysis, where C-peptide, that is, the marker for self-insulin production, is the primary effect measure. And here we are first out in the whole world to be able to get the anchorage from the American FDA. And there is a lot of discussion going on within the field right now about C-peptide. It has actually been going on for a very long time. where the entire field considers that CPEPTID is the marker that should be the primary effect measure, while the authorities have not yet really decided. But here we have then had the opportunity to use CPEPTID as a primary effect measure for a possible accelerated market research. And then we actually have all eyes on us as a company. We also heard that recently when we were down in Chicago at this ADA conference, that Både Big Pharma och Småbolag, alla vet om oss, alla har ögonen på oss, för vi bryter nu mark här och alla hoppas på oss också. För om vi lyckas med det här med C-peptid och den här tidigare avläsningen, så kommer det att öppna upp mycket för hela fältet. Så det är inte bara viktigt för oss, det är viktigt för hela typ 1-diabetesfältet, vad vi håller på med här. When it comes to the randomization, we have now reached 250 randomized patients in the ongoing phase 3 study, so we are on track to be able to complete the screening for new patients this year. We aim to have a little more than 300 patients, so that we have a study with a margin that is powered. had a statistical power in the study of around 288 patients to be able to achieve this final primary effect measure on C-peptide and HbA1c. So we are now on track to have more than 300 patients in if we finish the screening this year, so it goes well with randomization actually here, and there is a great interest in the study, which we can talk a little about here very soon when we talk about the ADA conference as well. What is also interesting and important is that we now see consequently that around 50% of our screening individuals have the right type of HLA, that is, the type of HLA that has shown to be linked to the possible effects of our drug. So it is a consistent 50%, so it just strengthens all previous results from previous studies that this type of HLA is at least 50% in the western world. If we then look at what it looks like in different countries, we see a certain variation between the countries, which is expected. Spain is highest, which we have seen earlier, also in Southern Europe. Spain is at almost 65% of type 1 and has the right HLA type. But then the USA is at 46%. Sweden, 55%, as you can see here. From earlier data, you could see, for example, Finland. I am originally from Finland. It was only around 30%. That is actually what affects this genetic, shall we say, frequency variation on a geographical level, which shows in our previous study that it looked like it worked better in non-Nordic countries. And then we didn't really understand why. But this is the explanation for that. The more common the HLA type is, the further south in Europe it will be. And then in the previous FAST-RE study, when this subgroup analysis was done on non-Nordic countries, it looked like it worked better in non-Nordic countries. And that is the HLA type that is the explanation, nothing else. But in general, it is around 50% of Tibetans who have this. Then we Just as a reminder, also when we think about C-peptide as the primary effect model for the previous lecture, we have consequently seen an effect here in previous studies, when we go to the right genetic subgroup. So here are the previous studies, phase III on the left, the previous phase III. on an effect that is close to 40% when you only look at the right unit subgroup, and in this case it is four subcutaneous injections. And then in phase 2, which was done in the USA, i.e. trialnets phase 2, again, where you got two or three, in this case three subcutaneous injections, close to 50% effect. And then our latest phase 2 in Europe with intralymphatic injection, three injections, we were at 55% effect compared to placebo after a 15-month follow-up. And in total, when you put everything together in a meta-analysis, we have close to 50% effect and, of course, a lot of statistical significance. And this is the basis for our entire FAST-3 study, where we only record individuals with a correct genetic background. And the important thing here again, this is C-peptide. And as I said earlier, there is a lot of discussion all the time about C-peptide. And we were invited to a workshop last week, which was organized by the Critical Path Institute, which we are also members of, to share data with them. It is an organization that works with different types of indications to facilitate the development of new drugs for diseases. where they have a lot of interactions with both FDA and EMA. In this case, it is their type 1 diabetes consortium that we are members of. And this was a workshop where you discuss the most about C-peptide as an effect. Where you invited both industry, where we were a participant, Novo Nordisk was with, Sanofi was with. FDA was here from the authorities, and then we have various doctors and patient associations, including Breakthrough T1D. We are one of the biggest examples now where we are closest to having a solution to main C-peptide as a primary effect. And as I said earlier, we will set the example, and I believe that the authorities will look much more closely at our data and how they will set the future for how you can hopefully get approved in type 1 with disease-modified drugs based on C-peptide. So it's exciting that we're really breaking new ground here. And the important thing for us here is that given that we will The first possibility is that, with a C-peptide supplement, we have a large safety database, where we have treated a total of over 1,000 patients with the active drug and around 600 with placebo. We see no difference in the safety profile and our most common side effects, such as irritation. in the injection site. And I think it is important now, when you are first out, that you come up with something that is safe and simple. And that we also have a special status in the USA is important. And we go to a genetic subgroup of this orphan group, because the discussion within unusual diseases is a completely different discussion from the authorities' point of view than when you go to a slightly larger indication. In rare diseases, we usually talk about incremental changes, even small improvements are very welcome and very common with accelerated approval. So that's something that we also really emphasize in our interactions with authorities. You have to remember that we are going to a genetic subgroup in a quite rare disease. Then, GMP certification, we have as a goal now for Umeå, our manufacturing facility, för den aktiva komponenten, det rekommendanta proteinet GAD. Det är då på den här röda byggnaden, den främre delen av den röda byggnaden äger vi som 2400 kvadratmeter. Vi har renrum, labb, kontorsutrymmen och varulager. Nu pågår det förberedelser både interna, en intern inspektion pågår för tillfället just vad vi själva with experts internally, go through our systems in the same way as a company would do. And then after that, to book an external mock inspection, that is, where there will be external consultants who do the same thing, who will see how a company would look at it. And after that, we will invite the Swedish Food and Drug Administration to do an inspection, and then their findings will be presented to us. Beroende på om de inte hittar någonting konstigt så har vi möjligheten att kunna få den GNP-certifierade i år. Så det är målet. Och sen är det ju intressant också här att vårt läkemedel formuleras ju hos APL som i den här vita byggnaden som ni ser mera till vänster på bild. Så det är vår läkemedelsformulerare. Så det är ju också ur ett logistikperspektiv. Mycket bra att ha dem så nära till hands. This is a picture from the AADA conference that I recently came back from, which was held in Chicago this year. There were about 13,000 people on site. We had our own booth, where we mainly talked about the FAST-3 study, because now it is the last half of the year, the last sprint on the patient recruitment side, and where there is still a possibility All clinics should know that now there is still a chance for patients to participate. And then we had some updates to our testers. Several of our testers, especially in the USA, were on site here. But also from Europe, where we gave an update on the study. And just as you have heard here about the screening, how it goes and all that. And then we had a lot of activity around the base. Many are familiar with the study, many are familiar with us now. and we had both influencers on site who talked about us, and at the bottom right of the picture was Mark Atkinson, who is sitting in our board and is also the chairman of our scientific council. He was on site, and he is actually the chairman of the entire ADA conference committee this year and next year, so he is the one who is most responsible for organizing the conference this year and next year as well. So it's great to have such a person in our board. And we also arrange, if you see a picture to the right, we arrange a breakfast panel together with Breakthrough T1D, which also supports our FAST-3 study, where we had invited several key opinion leaders, both from patient associations en patient själv som var där och berättade om sjukdomen och sedan både prövade och som var faktiskt extremt, tog sig emot på ett extremt positivt sätt. Den fick vi höra i efterhand att det var flera som sa att det var det bästa som hände på konferensen. Det här har vi också spelat in så vi hoppas kunna göra den här tillgänglig inom kommande veckor tillsammans med Breakthrough T1 Diesel. even more can take part in everything that was said on that breakfast panel. But there it is discussed about precision medicine, about what needs to be in place if you get approved for a new drug within the new diagnosticated type 1 diabetes, what is important for the patient, what is important for the doctor. But as I said, it was very well received and talked about in the corridors as well. After a while, we heard others walk around and say that we heard that it was an extremely good breakfast that we had ordered. So it's positive to hear such words. And as I said, I think this was my last picture, so we can jump to questions now, I thought.

Great, thank you very much, Olof. I can just remind you before we jump into the Q&A session that if you have any questions, it's great to send them in via chat, so we'll raise them directly. It is not possible to raise your hand. But we have already brought in a lot of questions during the presentation, so I think we'll jump right down into the pool and start with a question here. Can we look forward to a normal start in the coming year when it comes to insulin-based antigens, and are there any other antigens that can be relevant to develop?