Hi, welcome to BioStock Studio, where we will be talking to Diamyd Medical about their phase 3 trial in diabetes. In Type 1 diabetes, the immune system mistakenly attacks the body's own insulin-producing cells. Diamyd Medical is developing Diamyd, a treatment designed to retrain the immune system, so it stops attacking the insulin-producing cells, helping the body to keep making its own insulin for longer. The company has recently shared an update following discussions with the FDA regarding its ongoing phase 3 trial, where they now plan to move the primary efficacy readout from 24 months to 15 months. I am joined by Diamyd Medical CEO, Ulf Hannelius, and Board Member, Dr. Karin Rosén, to talk more about this news. Welcome to you both. Thank you. Thank you. We will start with you, Ulf. Following the FDA discussions, what does moving the primary readout from 24 to 15 months mean for your path to market? well, to keep it simple, it's obviously all about risk reduction when you are doing clinical development and in Phase 3. This further reduces the risk in our programs, as we can get the main primary readout 9 months earlier than previously planned and communicated. That's a big thing, and we are now much more also aligned with what the field is going forward when you do your readout. Also it's aligned with our previous results, where we have the most robust results around 15 months. With the preliminary readout expected in March 2026 of this year, what can we expect to learn then? The interim readout coming now towards the end of March, it's an opportunity we have been given by the FDA to do an early readout in the ongoing phase 3 trial, where we will then kind of lift the lid early on in a very specific, blinded fashion. We will look at the primary efficacy variable, which is C-peptide, the preservation of your own endogenous insulin production. If that would be positive, meaning statistically significant treatment effect compared to placebo, that gives us an opportunity then to have a discussion with the FDA regarding a potential accelerated approval pathway. That's why it's a very interesting and a very important milestone coming up very soon here in the company. Looking at your main endpoints, which are insulin production and blood sugar control, why these? Why are these the right measurements? Insulin production, meaning the individual's own insulin-producing capacity, that's the measure you want when you do disease modification in Type 1 diabetes. Basically, change the disease at its core. We want to preserve the insulin-producing capacity, so that's really the main endpoint that we want to achieve. Blood sugar control, in this case, it's HbA1c. That's the clinically validated endpoint showing the clinical benefit, so that we can see how that we slow down the disease progression by preserving your own insulin production, and that this then also, sort of is translated into a direct clinical benefit and, in this case, better blood sugar control. Karin, turning then to you, could you just in layman's terms explain the scientific rationale behind Diamyd? Yeah. The Diamyd Phase 3 trial that's ongoing is targeted Type 1 diabetes patients that also have a specific genetic subgroup. It's an antigen-specific therapy, so it's targeting a specific protein, so GAD65, because in Type 1 diabetes, the problem is that the body mistakenly starts to break down the body's own insulin-producing cells. What you want to try to do here is to target the GAD65 to make sure that we can reprogram the immune response to blocking it from actually continuing to breaking down these insulin-producing cells, and thereby continuing to produce insulin. At the end of the day, the best insulin is the insulin that the body's producing itself. Looking a bit closer at that, what is the long-term potential if you can preserve beta cell function, and why is the body's own insulin so central to this? First of all, in order to regulate, you know, insulin, the body does that itself best. Even if you try to externally give insulin, you can never regulate it and fine-tune it the way you can do it if you can produce it yourself. That's why it's so important and critical to preserve the insulin production, the body's own insulin production. Longer term, it is that if you have fluctuating blood sugars, we know that that is going to lead to, you know, target organ disease. You destroy your kidneys, your eyes, your blood vessels. It's really instrumental in maintaining that insulin production to prevent, you know, patients from developing all these target organ diseases. Let's talk about the Nobel Prize of 2025 in medicine. That was awarded for discoveries about how the immune system avoids attacking the body's own tissue, the peripheral immune tolerance. How does that connect to what Diamyd Medical is trying to do? Yeah, the Nobel Prize for 2025 was awarded for, as you're mentioning, the peripheral immune tolerance. It was really how, you know, how the immune system is regulated peripherally in the, you know, peripheral. I think this is exciting because this is the kind of discoveries that the Diamyd treatment is sort of based on or because it's understanding how you actually can handle, you know, a situation when the body is starting to be attacked, the kind of cells that you need to control to block that destruction of your insulin-producing cells. We are super excited and very excited about the Nobel Prize because this is exactly what Diamyd's treatment is based on. Ulf, the final 2 questions go to you. You will still follow the patients for up to 24 months to evaluate durability. Why is this long-term effect so important in Type 1 diabetes? Well, in the end, obviously, we want to have the strongest possible label for our treatment, and in the end, it will be the payers who put the price for the treatment. If you can show 24-month durability, so both effect and obviously safety is always very central to these things, that's a big positive, and that will give you a huge market advantage as well as you go to market and start commercialization. In the end, that's very important, and now we do the main readout at 15, and then we have a secondary. We do the durability, so it's like the best of both worlds we have now. It's very important with durability, and that sort of sets the stage for pricing, payers, and your market positioning. Let's end by talking J.P. Morgan. It's almost time, and you will, of course, be attending. What kind of conversations are you hoping to have there in light of this news with the shortened time to primary readout? Yeah. So we are the company in Type 1 diabetes with now very shortly upcoming Phase 3 results, so that's very exciting. We have the potential for an accelerated approval pathway, second thing, and now with the latest feedback from the FDA, we have the opportunity to do the main readout 9 months earlier in the ongoing Phase 3 than previously communicated, which is very positive and shows the collaboration we have with the FDA. That's like all eyes on us right now in Type 1 diabetes, and there are not that many other companies in the world that have imminent Phase 3 results coming up, so that's really what we want to emphasize now next week in San Francisco. Maybe, Karin, you want to add something? Yes. No, we are very excited to be attending the J.P. Morgan in San Francisco, together with all the companies and investors, and having the opportunity to... also to recap what Ulf said, to be able to share with them that we have Phase 3 data coming out already in March with an opportunity for accelerated approval. This is truly exciting for a company to be able to present at J.P. Morgan, so it's at a very exciting time for Diamyd in 2026. Well, thank you so much to both of you for taking the time to talk to us. Thank you. Thank you.