Hello and welcome everyone. My name is Natasha Bank, and I'm the Cluster Manager here at Flemingsberg Science. In Flemingsberg, we have lots of ATMP-grade companies, and one of the companies we have here is NextCell Pharma, a biopharmaceutical company specialized in the development of stromal cell therapies. Their lead product, ProTrans, utilizes mesenchymal stromal cells derived from umbilical cord tissues to treat autoimmune and inflammatory disease, with a primary focus on type 1 diabetes. ProTrans- Young is a stem cell therapy trial for type 1 in children and young adults. I have with me here Lindsay Davies, the Chief Scientific Officer of NextCell Pharma, who will tell us more about this study. Hello Lindsay and welcome, and please, the floor is yours. Thank you, Natasha. Yes, today I'd like to talk a little bit about the administrative analysis we performed on the older age cohort from ProTrans- Young, our pediatric clinical trial. Very well. You released the latest dataset in the beginning of April. It was an administrative analysis of the ProTrans- Young trial. Can you please talk a little bit about this and what this means for NextCell Pharma? Of course. The trial itself is the first trial that we've actually run in the pediatric population, but it is our third trial in type 1 diabetes using our drug product ProTrans, which is an umbilical cord mesenchymal stromal cell drug product that we intravenously infuse into patients. This trial is run in collaboration with Uppsala University and is led by Per-Ola Carlsson, and we have two co-investigators in Jonny Lundkvistsen and Helena Elding Larsson. The trial itself is divided into three steps. Because this is the first time we've actually conducted a trial in the pediatric population, we started with a phase I safety trial, and that has been completed. Most importantly, we saw no severe adverse events to the drug therapy. It was tolerated extremely well by children as young as seven years old. Wow, that's great news. It's great news for us. We've also now conducted the phase II older age group, which takes us from ages 12 - 21 years old. Here this was a double-blinded randomized trial with 15 patients receiving placebo and 15 receiving active treatment with ProTrans. That's what I'm going to discuss today. At which stage were these people at? These are all newly onset type 1 diabetes within six months of their diagnosis. We are just showing now our top line data from the administrative analysis of this older age group. The younger age group is still ongoing with recruitment just about to finish before summer this year, which means that we will have our full data readout for the primary endpoint at the end of 2026. 2026. Could you tell us a little bit more about the data? Do you have anything? Absolutely. As I said, this is top line administrative data, which means that we're only looking from a company point of view that, one, the data is showing us that the treatment is safe, and two, that we are pursuing the right line of inquiry to continue on the trial from a company perspective. No statistical analyses are performed at this point. Most importantly, what we see is that with a single treatment of placebo or ProTrans, the drug product is safely tolerated. We've now got readouts from one year after that single infusion of the drug product. What we see is that the clustering of the datasets here with the ProTrans, the range here that we see between these individual patients treated is the heterogeneity that we were seeing at early stage of type 1 diabetes after diagnosis. Absolutely to be expected to see these differentials between our patients. Most importantly is with ProTrans, we're seeing that range is already reducing down, and we've got a lower standard deviation from our actual average calculation, which shows us some clinical response that we actually saw in our adult trial as well in the very early stages. When we start to look a little bit at stratifying how insulin production is changing in the males and the females treated with ProTrans and placebo, we actually see that females lose on average 25% of their insulin over the year with placebo treatment, but only 19% with ProTrans treatment. Similarly, in males, we see about a 28% decrease in insulin with placebo treatment and 22% with ProTrans. This is really encouraging that already very early in this dataset, we're starting to see trends moving in the right direction and that we are on the correct path. What does it really mean? I mean, what contributes to this heterogeneity? It's really important to remember the biology and the pathophysiology of type 1 diabetes and also how MSCs or mesenchymal stromal cell therapies work. They are a type of immunomodulatory drug product. That means that when they enter the bloodstream, they're actually looking at the immunology of that individual patient and responding accordingly. We must remember how these patients differ. We are targeting two different major differences compared to our adult trial. One is that we're very early after diagnosis now, six months as opposed to two years that we were at with the adult trial. This allows us to see whether we can actually treat earlier in the disease and preserve even more insulin in these patients. That also means that the immune responsiveness is different, and we have to account for that. Secondly, we're in the pediatric population. Here in the older age cohort, we're talking about individuals that are either entering puberty, going through puberty, or into early adulthood. Very much those sex hormones respond very differently to the immunological therapies we can offer, such as ProTrans. We see, for example, oestrogen works very much in collaboration with MSC therapy, whereas androgens such as testosterones are naturally immune suppressive. They will have a different effect again. That is why the statistic from female and male was different. This is why we see a range in the dataset of the patients. As we gather a larger dataset, we'll need to stratify that based on their age, but also based on their sex as well. We also must remember that females are much more immune responsive than males, and this is primarily due to the fact that we have an XX chromosome, and our immune genes are carried on the X chromosome. This is why generally we're more immune responsive than males are. Likewise, we have to remember with the age group as well, that very interestingly, the psychology of having a clinical trial treatment in adolescence is very, very strong. Placebo effect tends to happen in around about 50% of patients who are older than 12 and are receiving a clinical drug product. Of course, this effect waves over time, but it's why we must be very careful in how we interpret the data right now, and we need to look at that longitudinal study over the five years that these patients will be monitored for. Is it possible to directly compare this data to ProTrans- 2 in adult population? No, we would encourage against that at the moment. The primary reason for that is that we have two major shifts in this population. One is the age and the immune responsiveness of those patients and where they're at and their biological chemistry, but also two in the fact that we are treating these patients very early on in their diagnosis, as opposed to the adult population, which were two years post-diagnosis. They are already in that chronic phase of the disease, whereas many of these individuals will be entering what we call the honeymoon or partial remission response that you see early after diagnosis of type 1 diabetes. Okay. Could you please tell us a little bit how ProTrans works? Yeah, so ProTrans is a mesenchymal stromal cell therapy. It's live cells that are entering the patient's system. We take them from umbilical cord tissue, and we grow them inside the laboratory to create a drug product that's pulled together from five different individual donors. We freeze that product, and we can thaw it at the bedside of the patient in an outpatient clinic for intravenous infusion. The most important thing to know is that mesenchymal stromal cells, they inherently have this ability to modulate a patient's immune system. We call them coordinators of immune responses because they're very good at sensing their environment that they enter into and then responding accordingly to reset order. This is why they're used in dysregulated immune systems like in autoimmune disease and type 1 diabetes. What we know about these cells when they come from umbilical cord is that they remember what they were supposed to do inside the body. This is what we take major advantage of because inside of a human body, the umbilical cord tissue is grown from the baby. Those cells are very young, and they're designed to protect the baby from the mother and any infections that the mother may bring, et cetera. They're extremely good at coordinating immune responses. We take those cells, we peripherally infuse them, and what we know is that maybe over 50% of those cells will explode as soon as they enter the blood. That's because they're attacked as foreign material by the patient's own immune system, or they will explode due to things like changes in kind of osmolatic pressure, et cetera. This causes a release of many, many different chemicals, which are eaten up by the immune cells, and it kind of reprograms them to become immune dampening. They forget about this autodestructive response that they've been having up to that point. Those MSCs that survive that initial insult of going through the blood will end up trapped inside the lungs, and there they have a second ability to interact with the immune system there. What happens is that all these cells are eventually destroyed very quickly within about 24 - 48 hours and cleared from the patient's immune system. What they've done in that time is reprogrammed the immune system to be much more tolerogenic of their own cells in vivo, and therefore dampen down that autoimmune response that we see, but also leave a memory so that you have this effect that lasts for years. Wow, that's amazing. You were talking about the honeymoon effect. Yeah. The honeymoon effect is really important because when we look at what the effect is of the cells over a longer period of time, and now I'm taking data from the adult trial, we see that we have complete immune kind of immune altering disease pathway when we give a single infusion of ProTrans. Here on the top curve, you can see this is when we treat with ProTrans. This is insulin production that's retained. Over five years, we can retain over 50% of their insulin production, whereas if they receive placebo in the natural course of the disease, they lose that within one year after diagnosis. That's something that we also see in long-term other health benefits, things like lower blood pressure, but also in their ability to maintain their own body weight because of the metabolic effects that we are seeing. Patients who receive placebo generally get put on around about three to three and a half points in their BMI, which equates to around about 15 kg-20 kg. It takes them from being completely normal weight to overweight, which is obviously linked to many of the secondary complications of type 1 diabetes. This is important because when we're looking at where we are in the honeymoon phase, the honeymoon phase is this period after diagnosis of the disease where the patients will go into almost like a partial remission, and the pancreas will start to produce insulin again and control their own sugars productions. This is very short-lived, and then they will enter the chronic disease status. How long does it take usually? It varies on the individual, but normally around about three months after diagnosis is when you see the onset of this honeymoon period. That honeymoon period can last years or it can last weeks. It really depends on the individual. Our aim here is rather than treating the chronic disease is to actually come in a lot earlier and see if we can even prolong that honeymoon phase or even reverse back or add to that honeymoon phase so that those cells are having the chance to kind of respond to the therapy much better. What can we take from the data that NextCell has right now after one year post-treatment? Yeah, so when we look at where we are personally in the markets and where our competition, there's a real need for interventive therapies in type 1 diabetes. Inside of Europe, the only drugs available treat the symptoms of the disease. Inside the U.S., there are two drugs available that are available for certain subpopulations of type 1 diabetes sufferers. Both of them require some degree of immunosuppression, and they are also associated with very, very strong severe side effects. Kind of where we are at is developing a very more gentle interventive disease modulating therapy that can be tolerated by both children and by adults. That's where we really are at at one year is that we know that this drug product can be safely treated in children as young as seven and well tolerated with no side effects and no need for any immunosuppressive therapy. We're already seeing trends for clinical efficacy in the dataset, which is fantastic news for us at this early stage. We do see that because we're entering so early in the disease now, that longer monitoring for five years post-treatment is important to see the longevity of effect and to see the extent of the clinical effect as well. How long have we been for the adults? You have the data for three years, right? For five years now in the adults already. We can see that we see like a halting of the disease in the adults after a year. They're in the chronic phase of the disease, not the early phase. We see a prolonged effect over at least five years. This is a very strong safety data that you've got. Does this mean that younger patients could benefit from this therapy in the future? Yes, we think so. We've already discussed this with the European Medicines Agency. We have to be cognizant of the fact that this changes the disease pathophysiology with age. When we talk about young children down to seven years old, we're talking primarily autoimmune-based type 1 diabetes, and this is what we see extend into adulthood. The primary reason we designed this trial to begin from seven years old. We believe that the drug product can be safely tolerated younger than that, though. We have to be aware that in small children and toddlers, the disease often is due to a monogenic reason, congenital or non-autoimmune based. Because our mechanism of action is based on immunomodulatory therapy and targeting autoimmune response, this constitutes a different mechanism of action that we need to be aware of. However, saying that, we do believe that it's important to consider this age group and the potential for the therapy there. Our phase III program is focused primarily on seven to 40 years old, where we know we're targeting the autoimmune form of the disease, bringing together the data from the ProTrans -Young study when it's completed with our adult studies, ProTrans -1 and 2 and ProTrans- Repeat, where we'll have treated over 90 patients when we enter into that phase III trial design. All of them were in Sweden? Yes, all of them have been in Sweden. Yes, at three sites. Yeah. Great. What is your main takeaway message for those who are non-scientists? For non-scientists, really, when it comes to the actual product, we have an interventive therapy, which is very safe and well tolerated. Most importantly for the clinicians, it's an off-the-shelf product. They don't need a washing or a post-processing, which means it can be done in any outpatient clinic. It doesn't require a specialist physician or anything to give the drug product. It's very simple. For the patient itself, then we're talking 40 minutes for an adult, 20 minutes for a child. The quality of life for that patient and the ease of compliance is much better because it's one time they come in, they go home, forget about it. We've seen no adverse events related to this. There's no trauma for the patient. There's no pre-medication or need for continuous examinations. It's a fixed dosage of cells, so it's very easy to coordinate. The patients themselves can get very fast access to the drug product because it has an extended shelf life of the product, so it can be stored at the clinic long term. For kind of like the more industrial perspective and the healthcare perspective, the actual manufacturing can be scaled both up and outwards, which means that more patients can be treated and a lower overall cost to healthcare. When we look at where we're going as a forward vision for the company, most importantly, our take-home message is this is safe for children and adults alike. We're really encouraged to see that the disease can be potentially attacked much earlier than we'd previously thought, that we remain on track for our phase III and commercialization pathways as we've kind of shown our shareholders before, and that the primary endpoint in quarter four of 2026 for ProTrans- Young will show us more data. It is really that long-term follow-up of the patients that will be important in knowing overall just how much impact this drug product can make. I know you're a public traded company, so you might not be able to disclose a lot of information, but it's very interesting. I'm sure that there are lots of big pharmas interested in this technology. Are there any ongoing discussions that you can talk about? We're actively looking at partnerships and talking to a number of different parties involved in that. Our aim really is to form a partnership for the phase III and commercialization strategy so that we can actually develop this and move this to patients much faster. That's our primary aim is that now we know that this is safe, that we really want to have patients have access to this so that they can take full benefit as soon as possible. Thank you so much. I wish you all the luck and great. Thank you. Thanks.