Now we are ready for the first company to present on H.C. Andersen's life science seminar. With me today, I have Ascelia Pharma and the CEO, Magnus Corfitzen. Welcome, Magnus, and please start up. Yeah. Thank you. It's great to be here, and I look forward to giving you an update on Ascelia Pharma and including talking about our fantastic phase III data that we got recently. I will be making some forward-looking statements. In Ascelia Pharma, we a biotech focused on identifying, developing, and commercializing novel drugs that address unmet medical needs of people living with rare cancer conditions. Our company is based in Malmö, in Sweden, traded on Nasdaq since 2019, and we have two drugs in our pipeline. Our lead program, where we are going to talk spend the most of the time today to talk about, is Orviglance, which has now been moving to registration phase. It's a first-in-class oral diagnostic drug for a subset of patients with poor options today. We have Orphan Drug Designation, and we are addressing an $800 million commercial opportunity. So it's a really exciting program and very exciting phase. The other program we have is equally exciting, but a bit earlier. It's ready for phase II. It's a daily tablet version of irinotecan where we can improve treatment of patients with solid tumors, in particular gastric cancer. So super exciting pipeline. Looking forward to talking more about this today. First, I'll talk about Orviglance, which is our lead program, and this really summarizes why we are so excited about Orviglance and how we think it can make a huge difference to patients, and why we think the likelihood of executing on that is extremely high. First and foremost, we're targeting a patient population, a vulnerable patient population, with cancer and renal disease. This subset of patient is inadequately treated today, and it translates into an $800 million global addressable market. The reason we can address this patient population is strong, consistent rich data from 9 different clinical studies, and in particular, the very strong and compelling phase III data. Our manufacturing process has been scaled up to commercial scale, and we can have sufficient manufacturing capacity to supply the market and make sure all patients who need Orviglance will be able to get it. So with all of this in place, we have moved, transitioned Orviglance from the development phase into the registration phase. Means that we will put the NDA submission together and file for approval in the middle of next year. So let me go one step back and sort of go into a bit more depth in terms of how we're helping patients and how we, how this product makes a difference. So cancer is obviously a devastating disease. It affects millions and millions of people around the world, and a lot of cancer types spread to the liver. They metastasize to the liver, which means that they start in, for instance, the colon or the breast, and then they spread to the liver. Very often, the liver is the first organ where the cancer spreads to, and it's very often also the cause of mortality, meaning the cause of death. It's not the primary tumor, which can be more easily removed by surgery or other means. So that's why when patients have cancer, evaluating whether the cancer has spread to the liver is very important in clinical practice. So the way to do that is to do an imaging procedure of the liver, and there MRI is the, you could say, the best imaging modality for evaluating, is there cancer in the liver, yes or no? To get the best image, the best outcome of the MRI procedure, a patient today will get an injection with a gadolinium-based contrast agent. That improves the sensitivity and the accuracy of the diagnostic procedure. The issue with gadolinium, which is a toxic heavy metal, is that it has some side effects, and in particular, with patients with severe renal disease, it can cause potential fatal side effects known as nephrogenic systemic fibrosis. Regulatory agencies have put in warnings on all gadolinium products for use in this patient population. This subgroup of patients is where we're targeting Orviglance. That's the patient population we have studied in the phase III study. Orviglance is an oral drug. The patient will drink it. It's based on manganese, so it's absolutely gadolinium-free, and does not have any of the, these, potential risk of fatal side effects that gadolinium has for nephrogenic systemic fibrosis. It's also liver-specific and has a very, I think, attractive, safety profile, as we have documented in, in all our all of our studies. So this is about the, the, the issue that, we are solving and how Orviglance makes it better for patients. This is what we announced, almost a month ago to the, to the day here. Very strong and compelling results from the phase III trial. So we took all these patients. We have put the endpoint designed in the study as based on our dialogue with the FDA, with the evaluation criteria with three readers, where we needed two out of three readers with statistical significance to in favor of Orviglance to be positive. So we've not only met two out of three. We had all three readers, three out of three scored positive for Orviglance, meaning Orviglance is better than the comparator un enhanced, which is the standard of care for most patients today. But we also met it with a much higher level of statistical significance than was the threshold. So we, you know, this is a very, very strong result. Last year, we had reported some intra-reader variability challenges in the first evaluation. And the conclusion from this study is that this is our improved training of the readers has made this go away, or you know, we didn't observe it at least. And this is a strong and clear conclusion from the results. So, we were very happy to see these results, and you know, we can now move the Orviglance forward towards the patients. So, this phase III study completes the development package for clinical development package for Orviglance. So we have nine different clinical studies. So both in healthy volunteers, first to understand something about the drug and how it works and how it's absorbed. We have a number of phase II studies where we test different settings, and we have this pivotal phase III study based on the FDA guidance in terms of how to design it, so that we are very optimistic in terms of a positive outcome for moving forward. And that's exactly what we're doing. We're putting together the NDA submission. So the NDA submission is really a huge amount of data and reports, and documentation that describes the value and how Orviglance works, and that the regulatory authorities, and first and foremost, the FDA, will review this. They will analyze the database that we provide with data from our clinical studies, so they can slice and dice the data to make sure that the data is as compelling as we believe. And there are a section for clinical data, for non-clinical data, and for CMC, like the manufacturing control and quality data. So it's an extensive piece of work. We will have the full clinical study report from the SPARKLE study, with all the data and all the appendices by early Q4. We will have a meeting with the FDA based on this, and have the conclusion in Q1 next year, and then expect to submit the NDA by the middle of 2025. So, a lot of work ahead of us. We're super excited. We have the important part of the input, and so it's a lot of hard work, but it's an exciting work and bringing Orviglance to the patients. So shifting gears, what happens on the back of an FDA approval is really we need to get out to patients. The reason we're prioritizing the U.S. is that the U.S. is almost half the global addressable market. So global market is approximately $800 million, and U.S. is almost $400 million. So the opportunity to move Orviglance forward is that we are preparing here the regulatory phase, and we're looking for commercialization partners to bring Orviglance out to all patients, all in U.S., but also in all other countries where there's a need for Orviglance. So just highlighting a bit on the U.S. market, we have shared that in previous presentations, but we have analyzed this market very thoroughly to really make sure that we understand the market dynamics and opportunities. Every year, about 100,000 procedures are performed in the U.S. today in a patient population that fits our the description for a target population of Orviglance. So 50,000 patients, approximately two imaging procedures a year. What is also interesting is that they are because of their vulnerability and multiple diseases a lot of them are referred to the major hospitals. So 400 healthcare providers are, you know, caring for 75% of our target population. This means that it's a very focused commercial effort. It also means that the commercialization partner that we will work with will need to have a focused and effective footprint. We don't need a sort of a very large, very broad sales force. The pricing benchmarks that we have looked at in the past and also tested with a number of healthcare payer experts in the U.S. supports a pricing benchmark range of $3,000-$4,500 per dose. So a really attractive opportunity. Not only is it you could say value-based in terms of the value we bring to the patient and the healthcare system, but also in terms of getting access to the patients and reach them once Orviglance gets to the market. So, as mentioned, we are looking to partner with, companies that have a commercial infrastructure that will allow them to efficiently bring Orviglance to all the patients, in need. And that process is ongoing. And we're looking very much forward to updating you on the progress as we move forward. This concludes the Orviglance part of the presentation, and I'll move, shift gears and move to Oncoral, our daily irinotecan drug. So the concept of Oncoral is we take a drug that is very potent and effective in treating certain solid tumors, which is irinotecan. That molecule is given as an injectable. Where we're creating something new is that we are able to put it in a tablet where the patient can take it on a daily basis and get sort of a more steady exposure of the irinotecan to treat the tumor during all cycles of the cell life. And we believe that will potentially drive better efficacy and better safety by giving lower doses, but on a more constant level instead of very high doses every third week. So there's a lot of data in the literature and in our early trials, phase I trials, that support this potential, and that's what we need to prove further on in the development program. So the phase II program we have designed, and gotten input from, from Taiho Oncology, is we want to combine Oncoral with Lonsurf. Lonsurf is a tablet, you could say cancer drug, and it's approved as monotherapy for gastric cancer and colorectal cancer. What you can see to the left here is that when Lonsurf is combined with Irinotecan, there's a synergistic effect in treating the tumor. This trial was done with intravenous administration of Irinotecan, but being able to have a combination, all-tablet combination with Lonsurf tablets and Oncoral tablets together would be a significant benefit for the patient, and we think also better in terms of efficacy and safety, with the daily dosing of Irinotecan. So the plan is, with a phase II study, to test the combination of Oncoral and Lonsurf versus Oncoral alone. Sorry, Lonsurf alone. We think that's a very compelling treatment option for patients and look forward to getting this study started in due time. So, rounding up here on my presentation, rounding up with financials and what is ahead. So, in Q1, we had a loss of SEK 16.7 million, so slightly higher than previous quarter based on the completion of the reevaluation and some NDA activities. And, our cash position got a little higher because we did a financing with Formue Nord in February. And, since the close of the quarter, we drew down SEK 15 million to increase the cash position, so it's higher than the SEK 27 million here at end of March. With the current financing we have in place, we have a financial runway into Q2 next year. So that's the financial runway, but really, what excites us a lot is also about the opportunities to drive value. First, we have three different tracks. Track number one is getting Orviglance approved, so the key milestones will be the full clinical study report in early Q4. It will be the pre-submission meeting with the FDA, where we expect to have the conclusions in Q1 next year, and the actual submission in mid next year. In parallel with the approval process, we are ensuring launch readiness, which also includes product supply, and distribution chains, and then working on securing commercial partnership or commercial partnerships. So it could either be a global partner, or it could be various, you could say, regional partners. So that's that remains to be seen, but we are very excited about this opportunity, and we think we have a very compelling, you could say, partnering package for with Orviglance in terms of strong efficacy, good safety, Orphan Drug Designation in the U.S., and extensive market research to understand the market and the key dynamics to drive value in the company. So, and then on top of that, we have some additional, we have Oncoral, and we have even an Orviglance second-generation product that we can use to bring this forward. Super exciting times for Ascelia, and I'm looking forward now to take any questions that you may have. Thanks a lot, Magnus, for a very thorough presentation. I just experienced some technical issues here, but I fixed it. So, with that said, we open up for questions to Magnus. And Magnus, you gave a very good picture- Mm-hmm. ... of what kind of partner and where you will focus your partnering to start with. There's a question coming in here about would you focus on a U.S. partner first? I think the question is obvious from your slides. Or would you prefer a global partner who can take out Orviglance in all markets at the same time? I think it's a good question, and in the end, it will come down to the proposals and the dialogue and you could say the mutual trust between us and the other partner. I think there are some advantages with having a global partner who will drive global value, but it could also be that there are some great regional partners who can drive penetration, especially in the U.S., but also other geographies in a very efficient way. So it really all depends on the dynamics and how things pan out. I think both options can be exceptionally good for Ascelia and for Orviglance and for the partner. So we're open to sort of evaluate both of them or both structures. But I think in the end, I mean, the U.S. is by far the biggest market, so that's gonna be the most... Financially, that's gonna be the most impactful of the partnerships that we will be making. With your very strong data, you're in a very different situation now. You can also demand a little more from your partner, as you mentioned in your presentation about how many clinics to actually address. It sounds like a lot, but it's not a lot, as you mentioned. Isn't that true? That's true. So, I mean, I don't even know how many, I don't know, hundreds of thousands of doctors that there are in the U.S. So if you think about the, you could say, the approach we will be making, it's very targeted. We also have in our market data, market research, we have about 2,000 in those 400 accounts, they are sort of 2,000 names, have the majority of the procedures in those 400 accounts. So it's really about 2,000 doctors at 400 medical accounts. So it's really, from a pharmaceutical perspective, this is a very targeted approach. And that drives economics, because you need less commercial, a smaller commercial team to penetrate that population, than certain other drugs would have. Thanks a lot, Magnus. And then this question about the pricing of Orviglance. You mentioned that early on in other presentations. How is that compared to gadolinium? And I know there's a big premium, but you probably have a good explanation of that. Could you elaborate a little on that, Magnus? Yeah, so first of all, it's higher than gadolinium, and significantly higher. But it also provides value. I mean, you know, we're targeting a patient population where there's a risk of potential fatal side effect if you use gadolinium. I didn't bring it today, but we've done extensive market research, and what we hear from, you know, the results coming out of that, is that the majority of patients that are within our target population receive an unenhanced MR today. So, an unenhanced scan. So, they're not comparing with gadolinium. We are getting higher image quality, which makes it a lot, you give the doctors a much better foundation to decide on the right treatment for the patient. And these patients are very vulnerable. They have a number of comorbidities and are very sick from both the cancer and the renal disease, and very often also other diseases. That means that when you are spending tens of thousands of dollars on treatment every month, you need to make sure you expose them to the right drug. If you're not sure whether they are responding to the chemotherapy that you are giving them, or antibody therapy that you're giving them, with a lot of side effects on a very sick patient, but if you can't tell whether the patient, the tumor is shrinking or stabilizing, then you're really spending a lot of money, and you're creating comorbidities for the patient. That's what Orviglance can do. With a better and more accurate imaging technology, using Orviglance, we can assess, are there any metastasis here? Are there, you could say, opportunities to, you know, should we continue on this therapy? Is it a candidate for surgery? Do we need to bring some other drugs into the treatment cocktail, if you will? So I think that is the value we drive. It's not about a sort of crowding out gadolinium. It's about going to a patient population where gadolinium is not really a very good choice. Thanks a lot, Magnus. Really good answer to that question. And if we just could then we change focus a little to Oncoral. With your current financial situation and the roadmap you showed earlier on, when are you able to start up Oncoral, and how fast can you start up the trials again? Yeah, so I mean, we have all our focus today on Orviglance. We have our hands full. As a small company, that's, you know, it's a lot of things that are happening right now with Orviglance. And that's where we, you know, we can really move the needle in terms of value creation. So that's the main topic for us today. You know, I'd love to get going on Oncoral. I think there's a lot of potential. I think it's a really interesting drug and can do something different for patients compared to what is out there today. The IND for the study was approved a while back. We prepared... did some preparations. So obviously, you could say, a lot of things are in place. But right now the focus is on, you know, reaping the value of all the investments we've made into Orviglance, for a long period of time, and finding a partner that will help drive the commercial value. And we will take hopefully a very sizable financial stake in that opportunity, without having to invest extensive amount of capital. Thanks a lot, Magnus. Just a short question here, just before we end this session. You know, I mentioned in the beginning of this seminar, one of the big buzzwords in the industry this year is AI. Could you very briefly touch upon that, Magnus? How is that going to influence you, and how do you see it influence the industry? I think AI is gonna impact us in more ways than we can even conceive today. I think there are also a number of steps on the way before we get there. And I think it's the opportunity to do things so much more efficient that will have impact in clinical practice. And it already impacts clinical practice in the sense that previously two radiologists were looking at images. Today, very often, in some places at least, they have one radiologist and AI. And then if they disagree, they have a third one coming in. So really, they improve the productivity of image reading by 100%. So I think some of those tools are extremely good. When we look at the literature, I think there's still, you know, a good deal, a good long way to go before we will sort of don't need radiologists. Because they perform okay, they can pass the radiology bar exam, and they do, you know, in various studies, they generally do well, but not exceptionally well. So top radiologist readers are better than AI today. And there's gonna be some learning. I think from our perspective, you know, I think that would be great, if we had AI, approved AI to do image reading from our study, we'd have saved a lot of money and a lot of time. And I think it will come. I think having an Orviglance drug that will allow patients to you know have a high-quality image. It's also easier for AI to have a solid analysis of the image data based on better higher quality image with Orviglance. So I think everything goes hand in hand. I think it's not either/or. So I think to me it's super exciting and I think there's a lot of developments in this area. Thanks a lot, Magnus, and, we did it actually in 25 minutes, so that's really good. Thanks a lot, Magnus, for participating, and thanks to the audience for all the good questions. And, we will have a short break before we present the next guest.