Good morning and welcome to today's event, which will focus on the half-year financial results from Ascelia Pharma. Representing Ascelia Pharma, we are joined by Deputy CEO and CFO Julie Waras Brogren. This event will be recorded and, following editing, shared on our platform and on Ascelia 's platform as well. All investors are more than welcome to submit questions during the event, and I will pass them to Julie, and then she will, either during the presentation or after the presentation, answer the questions. With that said, I hope we get a really good event. Julie, welcome, and the microphone is yours. Thank you, Klaus. It's good to be here. I'm looking forward to the discussion. I know you have some good questions as well, so let's start going through our activities and results for this last quarter and half-year. The focus is on NDA approaching for Orviglance. I'll be making some forward-looking statements as part of this, so please pay attention to that. At Ascelia, our mission is to develop and identify and commercialize novel drugs that help unmet needs for patients with different rare cancer conditions. We have two assets. The asset we will focus on today is Orviglance. We are in the registration phase. As I mentioned, it means we have almost submitted the NDA, and I'll come back to that. Orviglance is a first-in-class diagnostic drug for use in cancer in the liver. We have an orphan drug designation from the U.S. FDA, and we address a global market opportunity of $800 million annually. As mentioned, we completed all the clinical development, and we're now submitting the application for the FDA. Our other asset is a phase II-ready daily tablet formulation of a well-known chemotherapy, and I'll just go through a little bit of Oncoral as well. We are based in Malmö, listed on Nasdaq in Stockholm. For Q2, the key events, some continued progress in the scientific community with Orviglance. The first one here is a poster presentation at a conference that's focused on payers and industry players. It's a burden of illness, as we call it, real-world data around our target patient population. We had a full publication in Investigative Radiology around Orviglance. It's a reread of an earlier phase II study using the same methodology as our phase III study. We also had the exercise of the Warrant Series TO1, which was issued as part of our rights issue last year, and we raised gross proceeds of SEK 43 million from this warrant exercise in April. We had our annual general meeting, and after the period, we updated the timeline for NDA submission, and it will be submitted now, early September. That was an update of, we said, first half of August, and now it's early September. A couple of weeks extra. We have two focus areas at the moment. One is to advance Orviglance to approval, timely submission, and approval by the FDA of our orphan drug with an optimal label. This year, we have communicated the conclusions from our meeting with the FDA in advance of the submission in Q1. As mentioned, our submission will happen early September, so very soon. Our other focus area is to secure partnering and commercialization readiness. Our strategy for launching Orviglance is to work with a commercialization partner, or perhaps more than one. This is, of course, key to bringing Orviglance to market. We also need to make sure that we're ready from a product and manufacturing perspective. We are also working with manufacturing partners to ensure we have Orviglance in the right quality available at launch. A little bit about Orviglance here, and you know we can also take questions along the way. We're very excited about the opportunities for Orviglance, and here's why. We are addressing a well-defined unmet need for liver imaging in cancer patients who also have impaired kidney function. I'll get back to this one. We have a global addressable market opportunity of $800 million annually. We've completed clinical development and have really strong results, not least from our global phase III study. We have commercial scale manufacturing, and now our focus is on the regulatory filing and approval and all of the commercial partner. Back to the unmet need here. Cancer in the liver is a key part of cancer care, and that's because not only primary liver cancer, but especially liver metastases are quite common in many cancer types. Often it's the first time of the first metastases detected, and often also the ones that could cause mortality for the patient. Colorectal cancer, metastatic breast cancer, and so forth. Liver metastases are very common. What's important is the detection of these metastases and to potentially plan a surgery or drug treatment and to follow up. The gold standard for this is an MRI scan. In MRI scanning, the standard of care is to use a contrast agent. It's a drug, diagnostic drug that improves the image compared to an MRI without contrast. These contrast agents generally available today are based on gadolinium. It's a toxic heavy metal. It's excreted through the kidneys. It was discovered that patients with kidney impairment, especially those with severe kidney impairment, had some significant safety risks, in particular a side effect called nephrogenic systemic fibrosis, which is quite mortal as well. Therefore, a black box warning was put on all the labels for these gadolinium-based contrast agents. That's the unmet need that we are addressing with Orviglance. Orviglance is a diagnostic drug for MRI imaging. It's specific to the liver because it's taken up by the healthy liver cells when it's ingested orally, as Orviglance does, and it's based on manganese. It's not associated with any of these side effects that we know from gadolinium-based contrast agents. We had completed clinical development in total nine studies with very consistent positive efficacy and safety results, not least the phase III study. In total, almost 300 patients have been part of the clinical development program. Julie, may I interrupt you just to add a specific question about your phase III data? There's a question here. It's a little technical, though, but really good question. Why wasn't specificity included as an endpoint in phase III? What is the main reason for comparable low specificity in phase II? How will this impact clinical use and pricing, given it makes it harder to evaluate long-term clinical benefit without specificity? Did you get everything, Julie? I think so. I have to follow up. Sensitivity and specificity are measures of success that are used when evaluating some diagnostic drugs. Essentially, it's saying, does the patient have a lesion? For example, sensitivity, specificity, does it not have a lesion? What is interesting for this, for Orviglance, and actually for the gadolinium-based contrast agents as well, is that you need a standard of truth. You need to say, for example, if you've done a biopsy, you know it's a lesion. Then you can use a diagnostic drug to say, do I find it? Yes or no, if that makes sense. If you have an unenhanced comparison, or even if you compare two gadolinium-based contrast agents against each other, there's no way of, you don't have the truth. If you have Orviglance and the gadolinium-based contrast agent, and one has a lesion, the other doesn't, which one is right? That is why the FDA, and both for Orviglance, but also for the gadolinium-based contrast agents approved today, the standard is to measure visualization on a scale. How is the contrast to the background? How is the border delineation on a scale of one to four? That's how you measure success. The only studies where there's sensitivity and specificity, it's because it's already confirmed to be a lesion or there's a biopsy or something. It's not a standard to use it in this world. There was a phase II study, as mentioned, with Orviglance that did use sensitivity and specificity. Actually, you can say that isn't really something you can say scientifically that a gadolinium-based contrast agent is more correct. That is exactly why the FDA is using different requirements, and that's why we've done a reread of that study, which is exactly the one that was published recently in a full publication, and the results have been presented at conferences as well. Not having specificity and sensitivity will not impact commercially because it's the standard in the industry. It's what the FDA is used to and also in clinical practice. I think that was the questions. I think you have a very good answer to that question. Of course, if the participant has a follow-up question, he or she is more than welcome with a follow-up question. If I may ask another question, it's more about the target market. I know you have a slide on that as well with the 100,000 scans. As I remember, it's two per patient. Could you just briefly answer this question? In the estimate of roughly 100,000 unenhanced scans that you use as the target market in the U.S., is that only follow-up scans, or do they include scans where diagnostic capabilities are necessary with a dynamic phase? The addressable market for Orviglance here is defined as patients who have undergone abdominal imaging procedures and who also have severe kidney impairment. This is based on real-world data, market research. In the U.S., it's 100,000 procedures, as you said, and roughly 50,000 patients. This includes both enhanced and unenhanced, and it includes all types of imaging. The vast majority of imaging will be for planning of treatment, for follow-up. If we go back to this slide, you know, you have colorectal cancer, and you do routine scans to see if you have any lesions in the liver. When you see this, yes, there is a point where you want to make sure it's cancer, but you will plan surgery. You could plan drug treatment and follow up and so forth. The vast majority is actually follow-up and planning of treatment and so forth of these scans. Yeah. Thanks a lot, Julie. Please carry on with the presentation, and then we'll take some more questions further down. Let's do that. We're now working on just the last bits for the submission of the NDA, the New Drug Application for the FDA. The key milestones on the way were, of course, the phase III results that I mentioned. Also, the full study report came in Q4 last year. Conclusions from our meeting with the FDA were very constructive, very precise feedback to us, which is really about how everything is presented in the NDA. Of course, that's a lot of documentation. Now it's early September. It's very close. Very exciting. About the addressable market, I mentioned the $800 million annually, and that is specifically for the patient population that falls under this black box warning for gadolinium-based contrast agents. Our strategy is to commercialize through partners. We talked a little bit about this, the addressable market based on real-world data. This is the U.S. case. Actually, we can also see that a lot of these patients are found at the larger hospitals because they have many complications, cancer, metastases as well, which means advanced progressed cancer, and also severe kidney impairment. It could be patients on dialysis. Four hundred accounts in the U.S. really cover the main part of this market. We've also done a lot of research and strategy work into access and pricing in the U.S. For this unmet need, we see a really attractive pricing opportunity for $3,000-$ 4,500 per dose. In clinical practice, physicians tell us that they are concerned about the issues and safety concerns with gadolinium, not least this nephrogenic systemic fibrosis. Quite a few physicians have experienced cases of NSF, although these black box warnings have been in place now for quite some years. Market research tells us that this unmet need is recognized in clinical practice. Also, when we speak to experts, they're saying we have to be accountable as physicians, and therefore, we really see a value in having an option that is not based on gadolinium. That's the clinical unmet need. There are other concerns with gadolinium that are really picking up in the industry in terms of discussion and more research also. It's well known that gadolinium is retained in all tissue, brain, other organs. There's some research and scrutiny going into understanding, could it have any long-term safety effects? We also know that gadolinium contaminates our water because it's excreted, as mentioned, kidneys, into urine. It's hard to clean from the sewerage system. You can actually measure it in drinking water and even Coca-Cola cans in larger cities. There's also some additional work to be done around understanding the long-term effects here. The industry is responding. There are some low-dose gadolinium-based contrast agents; one is launched, another is on its way to market. There's an earlier stage full body, an intravenous version of a manganese-based contrast agent. It's not liver specific like Orviglance, and it's, of course, also early stage. We are really excited to be the first to really come with a non-gadolinium agent and be first movers in this space, starting for Orviglance's part in liver imaging. Partnering is our strategy. That's really what we see as the best way to balance the investments required with the revenues for Ascelia. It also means that we can leverage the existing capabilities of a player already active in the market, not only in the field team, sales, medical, but also in a lot of the background capabilities that you need in this industry. These discussions are ongoing and progressing. We, of course, are working hard on the partnering track as well. There's actually, Julie, if I may interrupt again, a lot of questions regarding partnering. I think we can take a couple of them now. If you could just paint the big picture for a partnering model, because there's several paths you can follow. One is a local partner, a global partner, but you can also co-partner the project. Could you elaborate a little on that, so we could get a healthy discussion about partnering later on? Yeah, you're absolutely right. There There are many models, you know, everything from acquisition of the asset to licensing. You can do, as you say, co-partnering or co-promotion is another option. There are some established, you could call it outsourcing organizations. For often for smaller applications, it's not uncommon, actually, to work with someone who has all the capabilities, but it's more as an outsourced service. We are looking at, of course, we need to look at all options, but what we want, of course, is to have the best possible revenue compared to the investment. We need to evaluate these options against each other. I think it makes good sense to work with someone who actually has all this in place. You have a lot of good cards on hand. If we look into the space right now, the big players are not only, but they're really focused on late-stage companies like you with a strong data package and unmet needs. You fulfill a lot of these things. We've been talking about partnering for a long time. Do you expect to enter into partnership before year end, or will you wait until you get the approval from the FDA? I know it's a difficult question to answer, but could you elaborate a little on that, Julie? I can tell you that you will know when a partnering deal is signed. We haven't said anything specific, and it doesn't make sense either to say it because, you know, things take time, and it's not signed till it's signed. It doesn't make sense to be specific about that, neither for us, for the partner negotiations, or for our investors. When it happens, you will know. Of course. You have to publicize that. May I ask one more question, Julie? Are you allowed to, of course, you're allowed to show the partner your data package, but are they involved in the FDA process in some sense? If you sign before you get the approval, are they allowed into the process? It all depends on the terms and the roles. If you have a partnering agreement, there could be different preferences for roles. It depends on the capabilities of the partner. Is it someone who's doing more specialty, more commercial arm only, or development as well? That all depends. Technically, it's possible to involve someone. It's also technically possible to transfer the file during review from one company to another. Okay. You are, of course, interested in optimizing the outcome for you. Everything else would be stupid. Are you looking for, of course, there's a question about, you know, I think Mauro's attended that presentation some weeks ago, that you're looking for a very big amount, larger than your market cap. I could imagine that you can confirm that without being specific about the amount of money you expect from a partner. If I can say how much we expect from a partner? No, just that you are, of course, looking for maybe a higher upfront payment and, you know, the composition of the package. It all depends on the combined set of terms, right? Also the roles. How much do we invest? How much does the partner invest? It all depends on the overall set of terms. It's a combination of a share of the revenue, typically, right? A royalty setup and then some milestone payments and upfront. It's all about the totality of the terms. We've taken this as it verifies, as you said, that is the key. We are in the category of very late stage, submitted soon and approved. Like I meant, that's what we are offering, right? That's a very attractive place to be. Thanks a lot, Julie. Please carry on with the last couple of slides. Yeah. I mentioned scientific community. Since our phase III results, we've had a lot of acceptances of our data for all five poster presentations and then this latest full publication in Investigative Radiology, which is a reread of a previous phase III study with the methodology about phase III. Also, again, the results are very consistent, better visualization than unenhanced, but also comparative visualization to a gadolinium-based contrast agent. Just a little bit about Oncoral and the financials. Oncoral, again, it's a tablet formulation of a well-known chemotherapy, irinotecan. The tablet formulation means that you can dose every day. Typically, irinotecan is injected every three weeks, so you have a very high exposure and not for a continuous period of time. If you can have that exposure more stable and every day, there's a potential for improving both the efficacy and the safety for patients. We're looking at gastric cancer. That's quite attractive. It's an orphan disease. Typically, this kind of drug for phase III studies, it's a combination study. We have a clinical collaboration with Taiho Oncology. They have a drug that's also oral, LONSURF. It could be an all-oral treatment for gastric cancer. Gastric cancer is interesting because, I mean, there is some clinical demonstration of irinotecan efficacy. It's recognized. It's an orphan disease. Irinotecan in the IV formulation is approved in other indications that are potential indications for Oncoral. There's also clinical experience across many, many cancer types. There's potential beyond gastric cancer. Now, financials in Q2. Our costs were SEK 23 million. The operating loss is fairly similar to Q1. Of course, it's focused on the NDA submission preparation. We had SEK 60 million end of Q2. We had the successful warrant exercise in April. With part of these proceeds, we paid back the outstanding loan to Fenja. Our runway now reaches at least the end of this year. We do have a reserve for potential repayment of the convertibles, SEK 7.5 million to Fenja. It excludes, of course, financing from a partnering deal. All in all, good. That was, and then summarizing, our focus is to submit the NDA and to reach an approval with the optimal label and to secure the partnering and making sure a partner is ready for launch, not least from a manufacturing perspective. Thanks a lot, Julie. We already took a couple of questions, and I know that we have to finish the event in three minutes. Just very briefly, you're in a very good position right now with the company. If we see some delays to the FDA process or partnering, do you have a plan B for financing? The biotech industry is, you know, until you're cash positive, is about financing. Any responsible company has plans and plans Bs. Of course, we also have. We have SEK 60 million in cash and submitting the NDA. You know, as you said, that's also a lot of the costs in Q1 and Q2. I think we're in a good position. A final question regarding your orphan drug voucher. Could you just very briefly elaborate on that, and when and how you will use it? We actually have an orphan drug designation. That's not the same as a voucher. Actually, they're different things. A voucher is something you can sell. We have an orphan drug designation for the drug. It's not independent of the drug. It is for the drug. That is in place and has been for throughout the last part of the clinical development. We're submitting as an orphan drug, and it will be reviewed as an orphan drug. A phase III study is designed in agreement with the FDA from an orphan drug perspective. Thanks a lot, Julie. I'm sorry that we don't get more questions. If there's some questions that are not answered, please mail Julie or you can mail me afterwards, and I will do my best to answer them. By that said, first of all, I would like to thank all the investors for all the good questions. Of course, I would like to thank you for presenting on our platform. Hopefully, I see you soon. I see you at least within a couple of weeks when you get the NDA in place. By that said, I hope everybody will enjoy their Friday afternoon and also have a happy weekend. Yeah. We will end the event by that. Thanks a lot, Julie. Thank you, Klaus. Have a nice weekend. Thank you a lot.