Welcome to today's presentation where we have the pleasure to present Ascelia Pharma. Through today's presentation we are joined by Julie Brogren, Deputy CEO of the company. Today, of course, the Q3 announcement yesterday is the occasion, but as always in a biotech, of course, more focus on the regulatory and milestones on the pipeline achieved during the quarter. Of course, a short reminder of the case into Orviglance. As always, ask questions in the box down below. Do it in Danish if you feel for it. I will try and translate to the best of my ability. For now, I will hand the call over to you, Julie. Yes. Thank you, Mikael. It's good to be here. Ascelia Pharma, I'll be making some forward-looking statements, so please pay attention to this. We work in orphan oncology. We identify, develop, and commercialize novel drugs that can help people with different rare cancer conditions. We are listed on Nasdaq Stockholm. We have two assets in our portfolio. Orviglance is a first-in-class liver diagnostic drug for liver MRI. That's the drug I will be talking mostly about today because we submitted the NDA, the new drug application, to the FDA in Q3 in September this year. Oncoral is a daily tablet formulation of a well-known chemotherapy. We have the potential to help patients with a better efficacy and safety profile in treatment. It's ready for Phase II, but I will not talk so much about Oncoral today. In Q3, the key events, we submitted the NDA, as mentioned, to the FDA for the approval of Orviglance. We strengthened our balance sheet significantly. We raised SEK 30 million before costs. Fenja converted all the outstanding convertibles of SEK 7.5 million. Now we have a clean balance sheet, you can say. We did update the timeline for the NDA submission, but as mentioned, submitted that early September. Earlier this week, we announced some changes to the management team to support the future growth. We have two focus areas and opportunities to create value with Orviglance. The first one is to advance Orviglance to approval. At the time we submitted the NDA, mid-November, so very soon, the FDA is expected to communicate the continuation of the review and by which date they expect to make decision on an approval. That is a standard review with 10 months. The other focus area is to secure a partner that will commercialize Orviglance. We, of course, work in the background to make sure the product is ready for launch at approval by a partner. If we talk about Orviglance today, as mentioned, I will not focus on Oncoral. The highlights, it's an attractive opportunity. We address a well-defined unmet need for liver imaging in cancer patients who also have severely impaired kidney function. I will get back to this. We address an $800 million U.S. addressable market. We have commercial scale manufacturing established. We completed all the clinical development with very strong data, including our Phase III study. As mentioned, we submitted the NDA and our strategy is to commercialize with a partner. Orviglance, it's a first-in-class liver imaging agent which addresses a very specific unmet need for a group of patients who do not have a good alternative today. Cancer in the liver is a key challenge in cancer care, both because of primary liver cancer, but also because many cancer types develop metastases in the liver: colorectal, pancreatic cancer, and so forth. The standard for following up and identifying these metastases, for example, is to have an MRI procedure. Today, MRI procedures are done typically with a contrast agent to improve the image. Those contrast agents are based on a toxic heavy metal, gadolinium. A while back, it was discovered that gadolinium is associated with a very severe side effect called nephrogenic systemic fibrosis, a potentially lethal side effect. The regulatory authorities added warnings to the gadolinium products specifically for the patients where the risk is highest. That's patients that also have severely impaired kidney function because this gadolinium is excreted through the kidneys. With Orviglance, which is based on manganese and not on gadolinium, we aim to be the imaging option for cancer patients who need liver imaging and the option that is not associated with the potential side effects of gadolinium, including NSF. It is a manganese-based and a liver-specific contrast agent. Yeah. I have seen some, a little bit of writings about that, some of the, you might say, competitors, which might not be the gadolinium, are trying to maybe lower the dose. Everybody knows it is a very toxic agent. Is that a pressure to you, or is that not enough because the reaction will be there no matter what the dose? Any thoughts? Could that be a threat to some of your business, or what are you hearing from your key opinion leaders on that? We believe it's a strength and an opportunity for Orviglance because when we look back, let's say five years ago, the big manufacturers have had gadolinium in their portfolio for years and years. Of course, their messaging is, we don't have to worry, it's very rare, these patients are a very, very small proportion, and so forth. Actually, we know both for the patients with severely impaired kidney function, there is a potential risk. We also know gadolinium is retained in all tissue, our brains, and so forth for all patients. With these other players coming to market, talking about we should perhaps be careful about gadolinium in general, it really supports also Orviglance. Just a very interesting side note is that when the cases that have been studied with gadolinium, they do not show necessarily that the side effects are linked to the dose, size of the dose. Because if you have severely impaired kidney function and you cannot excrete the gadolinium, it does not matter what the amount of gadolinium is. So we think it is good. Looking also on the other side, I guess you have a very good overview of what is coming. I guess that's the threat you can see or threat you kind of argued for that it's not. You don't see other agents being developed. I know you can see through the pipelines and so on, something that. We are following this, of course. Yeah, we're following this closely. There is a manganese agent in early clinical development by GE, and it's a manganese IV agent, so intravenous. It enters the blood circulation. It is for full-body imaging. Orviglance is for liver-specific imaging. It's the same landscape you have for gadolinium contrast agents. Some are full-body, some are CNS. There is a liver-specific agent as well. It's the same dynamic. We are not competitors. Again, we believe it's good for Orviglance that there is movement and others building, you could say, the messaging or, let's say, the awareness and advocacy around using manganese as a contrast agent. We think this is good. That's also what we hear from key opinion leaders and what we see at the conferences and so forth. With this opportunity, we're addressing an $800 million. Market annually, U.S. dollars, and almost half of that is in the U.S. We have prepared all the work in terms of marketing research, working with payers, pricing, reimbursement, and a roadmap for a very focused launch of Orviglance because these are very few patients. Our strategy is to commercialize with a partner where we can use the synergies, capabilities of someone already having a commercial infrastructure. If we just drill a little bit further into the U.S. market, the patient population that we are targeting represents around 100,000 abdominal imaging procedures per year. It is around 50,000 patients, and we have real-world data, so actual realized procedures where we can see how many patients these are, how many imaging procedures they have. We can also see that they are at the larger hospitals. 400 accounts in the U.S. is actually a very focused launch. When you can work with these 400 accounts, you can capture 75% of the market opportunity for Orviglance. Also, we've worked with experts in pricing and reimbursement and have really strong support for very attractive pricing. We looked also at other innovative diagnostics in the U.S. A very interesting case for a focused launch of Orviglance starting in the U.S. Looking at the pricing, if you say key opinion leaders, everybody is actually acknowledging this toxic way of treating it now. Why not treat none of the kidney patients? I guess some can also not be seen as a risk, but actually it will show up anyway. Is the pricing too much? I know it's through your partner you will do this, but could it be more broad-based? Could it be a bigger population, or is the pricing and the way you want to launch it, is that a barrier to maybe see it in not only the black box warning patients? Yeah. I mean, the strategy for your label, so your target patient population and use in clinical practice starts very early on in the design of the clinical study, discussion with regulatory authorities. We believe this strategy for patients where there's a black box warning for gadolinium is where we add most value for the patients. Also, this was an opportunity for an orphan drug designation, which means the clinical development program is simpler, the launch is simpler, and there's a premium value because these patients are very vulnerable. It has very little impact for the budget holders to fund a premium product with high value for the patient. That's the strategy we've chosen. That trade-off is always there, like between volume and value. The gadolinium manufacturers, it's a volume game. They've been there for a long time. It also means in terms of commercial effort, this is the strategy chosen. If you wanted to go with the big volume of all liver imaging, then you would need data for that. You would also be under pressure from payers to say, listen, then is it for this broader patient population without these safety concerns? What is the value provided compared to the pricing? That is a different strategy. Is there somewhere where you could say the label intended says where you have severely impaired kidney function or where gadolinium may otherwise be medically inadvisable? Are there cases where gadolinium can be medically inadvisable? Yes, probably. That is again for each physician to see. Could that be someone who has just had a transplant, a kidney transplant and have been on dialysis before, for example? You may not fall under the threshold now, but you did recently and so forth. I was going to ask you already to speculate in off-label use. We are targeting the label, but of course, there are cases. I mean, it is a physician judgment when is gadolinium medically inadvisable. Of course, we have a label and data supporting our target patient population. Yeah. Just on this one, I mean, the concerns with gadolinium are recognized in clinical practice. When we speak to physicians, we've done market research, and many of them have experienced also these cases of NSF. This is about the momentum for change, the momentum for an alternative to gadolinium. You also brought up what is happening in the industry. There is the black box warning with the patient population we are addressing with severely impaired kidney function or where we should be careful about using gadolinium. As we also discussed a couple of minutes ago, we already know there might be other concerns with gadolinium. Deposition in brain, all other organs, it contaminates our water because it's excreted in urine into our sewage system, environment, and so forth. Those are some of the drivers behind these new, you could say, developments and current focus areas of the industry. We believe this is an opportunity for us because we are sort of early, first bringing to market this manganese liver-specific agent. The industry generally is talking about being careful about using gadolinium in general. We think this is very interesting for us and a really good momentum for bringing Orviglance to market. Our strategy is to launch with a partner that maximizes the value of Orviglance. We can use established capabilities and so forth. We've taken this asset very far. It's an attractive opportunity for a partner. De-risked asset, clinical development completed in the process of the NDA review, a highly recognized unmet need. Clear decision-makers, and so forth. This is an interesting opportunity for many types of partners, especially also when we move out of the space of development but into the pure, you could say, commercial execution. The dialogues with potential partners is progressing. We're very excited about this opportunity to work with a partner for the launch. All in all, addressing a very attractive $800 million U.S. addressable market for patients with a high unmet need. We've taken this asset a long way. We can also see that our data is well received by the medical community at the conferences and so forth. Let's talk a little bit about this NDA process. As mentioned, we are seeking approval for Orviglance as a liver MRI contrast agent for patients with severe kidney impairment or when gadolinium may be otherwise medically inadvisable, as I talked about. We submitted an NDA early September. Very attractive benefit-risk profile. Of course, we have the commercial-scale manufacturing orphan drug designation, which has given us advantages in development and will continue to do so into the commercial stage. Yeah. Yeah, it's just FDA, and I have to ask as an old farmer. Have you had any discussion with FDA besides what is usual? They will ask questions to conduct a review, but I need to ask whether you have had any unusual questions from the FDA. As you also said, in the review process, you receive questions along the way from fairly early on all the way until approval. Based on the questions we have received so far, we have a high confidence in the FDA continuing the review process. We have not seen anything concerning our belief and plans. So far so good. As I mentioned, I'll just jump to this next. Now, I'm jumping a bit back as the next milestone is around this day 74 letter mid-November, where the FDA will confirm the formal continuation of the review and give us a date by when they expect to make a decision. That could be 10 months after the submission, so early July next year. Of course, there are also opportunities to continue into other markets. Maybe I'll just quickly jump back. The whole clinical package, both strong efficacy compared to unenhanced imaging, which is the agreed comparator for us with this patient population and a very favorable safety profile, no concerns discovered, typically mild, moderate, and also transient, so temporary. Nausea and so forth. Nothing concerning in terms of safety. Here is an example. You can really see how on the right image here, you can both see these lesions better, but there is also a lesion that you cannot see on the left side where you do not have Orviglance-enhanced image. Visually, you can see the improvement, but on the right side, you can also see the outcome of the clinical study is a measurement on a scale from one to four where physicians score, so three readers score how much better in this case. You can see they are all to the right is Orviglance compared to unenhanced. Really strong results from our clinical study. Again, we're looking forward to this next milestone mid-November and continuing in the preparations, and we continue to be ready for questions from the FDA. I'll just wrap up on financials, and then we have time for other questions as well. In Q3, we had an operating loss, so i.e., cost of SEK 15 million. It's lower than in Q2, and that's really due to the finalization of the NDA here in Q3. We had at the end of the quarter, SEK 72 million in liquid assets. I mentioned clean balance sheet because of the conversion of the convertibles with Fenja, SEK 7.5 million, which was a loan, and now that's sort of out of the picture, and they received shares instead. Then we had the directed issue of SEK 30 million. Based on inbound investor interest, this made good sense for us because it means also now we really have a runway into Q4 next year, so well beyond the FDA approval date. That is also an advantage when we think about negotiations with a partner and so forth. Yeah. That brings me just to the summary here of our focus areas. Timely approval by the FDA of Orviglance according to our target label with a near-term milestone mid-November for the continuation of the approval and that date, and then mid-next year, early July, Orviglance is ready to be brought to market with a partner. That is an ongoing process to set up an agreement with a partner for the commercialization. Of course, make sure from a, for example, manufacturing perspective, Orviglance is ready for launch. That gives us some minutes. Questions. Let's jump into 80% of the questions, what everybody wants to know, and I think that's very natural. Partner timeline before New Year, everybody is asking. Any comments on the timeline, Julie? I understand both the questions, the curiosity, and the impatience. I think what's important is to think about it. It It is not in the interest of Ascelia and therefore also not in the interest of investors to be very specific here because a deal. We will, when it's signed, and of course, we will communicate when it's signed. Until then, we talk to investors about what kind of partners and what makes it an interesting asset and so forth. It really truly is an asset brought very far, de-risked, a focused launch with a clear unmet need. A very interesting opportunity for many types of partners, right? This is a hospital product. If you have a field team in the hospitals, there are some commercialization synergies. It depends on the partners. It's someone who works with orphan drugs, high-value drugs. This is someone working in radiology and so forth. That is our focus. I hope everyone appreciates that. That is in the interest of all of us. We have all eyes on establishing such an agreement. Perfect. A big small partner, bigger presence, small, your product is more important to them. Any thoughts you have done there? Yeah. Anything? I guess you don't need such a big partner where you could actually drown in their strategy suddenly, I guess, with your targeted audience. Is that correctly understood? It's an important point, right? Because it should be meaningful for a partner, because otherwise you can risk that the product is neglected if something else comes up or they have other issues. Meaningful can be both in terms of contribution to their P&L. It could also be meaningful in terms of portfolio strategy, future launch strategy, not the current P&L, but the other future portfolio and pipeline. There are different ways of having a synergy, not only the size. There are also other, there are some companies that are purely sort of specialty pharmas that really focus on commercial execution. There are many things that come into play. If that's your game, then you have a field team that needs a new product at certain time points, and this can be a good fit in a portfolio. Meaningful and. Contribution to the business of a partner, I think that's important for the success of Orviglance. There's also a question here a little bit older. When would the optimal time be to have a partner in and being ready to launch? I think it's a question on if you could choose what's the optimal timing, but I guess you can't choose exactly the timing. The optimal timing is when we have the right terms and we have found the right partner, we've signed the agreement. We are on track. We have a roadmap. We prepared a lot of things that are needed early on. We have relationships with experts, key opinion leaders. Manufacturing is on track. We've done, as mentioned, a lot of work on access and reimbursement and have a roadmap ready for a partner to execute. Depending on what type of partner, I mean, they do this with other assets and have the infrastructure in place. Of course, they are used to this game. The optimal time is when we have the right terms. And yeah, and the. I think that's the correct answer. It is a little about this Fenja, Fenja Capital. Did they request to convert them to shares? I guess that is in the deal structure. Yes, exactly. The deal structure with Fenja is that they can request a conversion, which is really advantageous for us because the price is fixed, right? If they do not request a conversion, then we would have needed to pay back the loan at the end of this year. It is great for us that those SEK 7.5 million, they wanted to convert. They see an opportunity and an upside to that conversion. Good for us and nice to have a clean balance sheet as well. Perfect. There is a little bit of comment about the timing of this capital raise just before potentially signing a partner. Any thoughts about that? Anything we should read into the potential timing of this capital raise you did? Yeah, no, I mean, it was good timing, right? Because as you said, also there was inbound interest. You also want to put together that you. It is some meaningful amount, but again, as is also mentioned, if we're looking into a partnering agreement as part of the strategy, we're not in a place where we should do a big raise that would not be meaningful. This is a meaningful amount. It is good timing because it extends our runway into Q4 next year, so well beyond the approval date. This is also important when we negotiate the partner, right? Because it was into Q2 next year before, now it is into Q4. So meaningful amount and suitable time. Meaningful leverage, I guess. Yeah. There is, let me see. Yeah, there is a little bit when you have taken most of the regulatory risk and did much of the groundwork, should you expect a heavy upfront payment or I guess maybe you do not want to go down to details on the partnership you are negotiating? I think. We shouldn't comment on that. I've seen some of the comments and so forth. It would be great. I think what we want to say, of course, it would be great. It's all about the right partner and the right terms. That's the key thing. I mean, I understand the questions and the, I mean, the answer is, of course, it would be great. I think that's also what is being alluded to that Magnus said. I think that's what is mentioned in the questions. Yeah, that would be great, but it's all about the right partner, the right terms. I think there's also some connection to some statement that he has made. I think you can correct that statement. I think I even have heard it was nice if it would be before end year. Is that correct? Yeah, as I said, that would be nice, but it's about the right terms and the right partner. Yeah, perfect. That's the most important. There is this question. If the visuals are better than normal dye, can it be a better substitute for normal MRI? Thinking a little bit broader on this. On your potential. Specifically, we have a small study where we're comparing to a gadolinium agent that has a liver-specific label in Europe. What we saw there was that the pictures are comparable. You could say in that sense, comparable, but I think it's really important that we're back to the portfolio strategy question. Where do we maximize the value for patients and therefore also for Orviglance? That is by addressing this unmet need where gadolinium is not medically advisable because that's where we address an unmet need and therefore can ask for a higher price. That's where we see the strongest case for Orviglance and for patients. Perfect. I think the last question here, and there are a lot of questions around the partner, but I think I have gotten you as far as I can. It is on the cost side. What should we expect for the cost side now? It went down because, of course, the heavy cost of filing the NDA and now not. What should we expect about the cost side into the next year? Yeah, I mean, you can see here, SEK 72 million. End of September, runway into Q4 next year. If you divide by quarters, based on the trend, you can see that it's lower. It's on the lower end of what it has been the last year. I think that math will tell us that it's around the average of these levels, on the lower end of what we've seen the last year. Yeah, it does. Those numbers tell us it's usually cheaper to do a review than it is to prepare the file. There is a higher question. I know your answer. You already answered that on the upfront payment, but is the licensing percentage expected to be at the same size as in drug deals all over? I think so if we look at drug deals generally, the further you've taken the asset, the higher usually the royalty, right? You see early stage assets with royalties that are low one digit. Once you've taken your asset further, the royalties go up, right? You see we've been asked before, some of the ranges are definitely double digit and strong ones as well. I mean, it's a trade-off between the upfront and the royalty. Yeah. It's an industry with many types of deals, and we're going to be somewhere in that landscape that makes most sense for the business case for Orviglance with an asset taken very far and de-risked. Check, check. I think that was the last question. Thank you to you, Julie, for taking us through your results, your case, and the milestones you delivered on the product side in the quarter. Thank you for the audience listening in and asking questions. I'm sorry, I couldn't ask 20x the same question. I guess I would have gotten the same answer on the partner side. I'm sorry for not asking all the questions exactly the same way, but I guess it would not have mattered. Thank you for asking them anyway. Yes, thank you for the questions, and thank you for sharing with us.