Welcome to Ascelia Pharma Q3 2026 report presentation. For the first part of the conference, participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing #5 on their telephone keypad. Now I will hand the conference over to CEO Magnus Corfitzen, and CSO Andreas Norlin. Please go ahead. Thank you and welcome everyone, uh, to the webcast for Ascelia Pharma's, uh, 3rd quarter report for 2026. On this call, we will be making forward-looking statements. On today's call, we will start with an overview of Ascelia Pharma and recent key events, and then head into the portfolio update with an emphasis on the recent Type A meeting with the FDA. Before moving to, uh, Oncrawl and financials and priorities ahead. After the presentation, we will open up for questions. At Ascelia Pharma, we identify, develop, and commercialise novel drugs that address unmet medical needs within rare cancer conditions. We're based in Malmö in Sweden and are listed on Nasdaq Stockholm. We have 2 drugs in our pipeline. Orviglanz is a diagnostic drug that has been submitted to the FDA to obtain approval in the US. We had a Type A meeting with the FDA in September to discuss the path to approval. Oncreol is a patented tablet formulation of irinotecan with encouraging results in phase 1 and potential to treat a range of solid tumours. In early July, we received a complete response letter from the FDA for our NDA submission for Orviglanz. Later in July, we communicated organisational changes as well as implementation of cost reduction actions to improve our financial flexibility. In September, we announced the publication of our hepatic impairment clinical study in the peer-reviewed Journal of Magnetic Resonance Imaging. And in September, we had the Type A meeting with the FDA to discuss the path to approval for Orglanz in the US. After the end of the quarter, we received the official minutes. The complete response letter was a significant setback. We continue to believe in, in the value of Orglanz and how it can help patients and build an attractive commercial potential. Our strategic direction remains steady, and our strategic priorities are to continue the partnering process for Orglanz. We envisage a partnership to now include both development and commercialization. We're preparing a meeting with the FDA to create alignment on an appropriate endpoint for reread of the SPARK images that can lead to approval in the US. And we are also preparing a dialogue with the regulatory agencies in Europe to obtain their feedback on approvability of Orglanz based on the existing data package that we have. In a cost-conscious manner, we are also preparing on-crawl development and also partnering dialogues. So we'll start the portfolio section of our presentation with Orglanz. So despite the setback with the complete response letter, we continue to be very excited by Orglanz. Orglanz is addressing a well-defined unmet medical need for a subgroup of people living with cancer. This is an $800 million addressable global market opportunity, and Orglanz is a first-in-class product to target this and has orphan drug designation from the FDA. We have commercial-scale manufacturing in place, and we have strong data from 9 clinical studies. We think Orglanz is an attractive asset, and we will work with a partner who will drive the, uh, the final part of development and commercialization. Let's talk about how Orglanz can help patients. Cancer in the liver is a significant challenge in cancer care. Many different cancer types metastasize to the liver, meaning they start in another organ and spreads to the liver. This accounts for approximately 90% of cancer in the liver in the US and Europe. The remaining 10% of cancer in the liver is when cancer originates in the liver. The liver is often the first organ where the cancer spreads to and often also the cause of death. That is why cancer in the liver is a major issue in cancer care. Therefore, it's important to perform high-quality imaging to determine if the cancer has spread to the liver or how the cancer in the liver is responding to therapy or for use in surgical planning. The best way to do this is with liver MRI, and today use a gadolinium-based contrast agent. For most patients, this works well. However, patients with severe renal disease are at risk for potentially fatal gadolinium-induced side effect known as nephrogenic systemic fibrosis. Regulatory agencies have requested black box warning on gadolinium products because of this risk. It is exactly these patients that we aim to help with OrbiGlanz. OrbiGlanz provides high-quality imaging, and because it's based on manganese, there are none of the gadolinium-associated risks. This translates into— this unmet medical need translates into a global addressable market opportunity of $800 million on an annual basis. The US market is almost half of this, and therefore the US market has been prioritized by Ascelia. Ascelia will work with partners to drive the commercialization of OrbiGlanz. And now I will hand over to Andreas to discuss the path for approval. Thank you, Magnus. So the Type A meeting with FDA was an important and constructive step forward for the OrbiGlanz program. And while FDA continues to require additional clinical evidence for approval, the meeting substantially reduced uncertainty around both the product quality and clinical components of the complete response letter. Several important areas of alignment were established during the discussions, and FDA acknowledged the significant unmet medical need in patients with severe renal impairment. Which is a patient population with limited access to contrast-enhanced MRI today. The agency also acknowledged a favorable safety profile of OrbiGlanz and its technical performance as a liver-specific T1-enhancing contrast agent. And importantly, FDA confirmed that the existing clinical data package retains value and may contribute as supportive evidence in a future submission. On the product quality side, we reached alignment on the proposed strategy to address the observations raised in the CRL, and this is important because it removes a significant area of uncertainty. And FDA expectations are now understood, and the implementation activities have already started. Finally, the meeting clarified that the key remaining regulatory question relates to demonstration of clinical utility. And this was the most important outcome of the meeting. In the CRL, FDA's recommendation was to conduct a new clinical study with new patients. During the Type A meeting, FDA confirmed that this remains one possible route of approval. However, the agency also acknowledged an alternative approach. FDA indicated that additional clinical evidence could potentially be generated through a new evaluation of the existing SPARCL image database using a different primary endpoint than originally used. We view this as a significant and encouraging development. Rather than having a single path forward based on a completely new clinical study, there is now the possibility of leveraging the substantial clinical data that have already been generated. Additional work is still required, and our immediate focus is to identify endpoints that appropriately address FDA's concerns and demonstrate clinical utility. And before initiating, initiating any image reading process, we intend to align with FDA on the selected endpoint through the Type C interaction. So having discussed the regulatory progress for Overglance, I would now like to spend a few minutes on our second oncology asset, Oncoral. Um, then while the company's immediate focus remains advancing Overglance towards approval and partnering Oncoral continues to represent an important long-term value opportunity. Over the last decade or so, oncology has seen tremendous progress through targeted therapies and immunotherapies. Despite these advances, chemotherapy continues to be used in the majority of patients with solid tumors and remains a cornerstone of cancer treatment. At the same time, patients are living longer, making treatment burden, cumulative toxicity, and quality of life increasingly important considerations. Regulators, clinicians, and oncology societies are paying greater attention to these aspects when assessing treatment value. This creates a significant opportunity for treatment approaches that preserve antitumor efficacy while reducing toxicity and improving quality of life. We believe this trend is highly relevant to Oncoral and forms part of the rationale behind our development strategy. Oncoral is designed to fundamentally change how irinotecan is delivered. Conventional irinotecan is administered intravenously at relatively high doses every few weeks, and this results in high peak drug concentrations that are frequently associated with toxicities. followed by prolonged periods with minimal exposure. Oncoral enables a very different dosing strategy through daily oral administration. The goal is to create a more sustained exposure profile over time, and this approach, sometimes referred to as metronomic dosing, has the potential to improve tolerability while maintaining antitumor activity. Sustained exposure may also allow irinotecan to affect not only tumor cells directly but also biological processes within the tumor microenvironment that are difficult to target with conventional intermittent dosing. So in simple terms, we believe Oncoral may allow us to use a proven chemotherapy in a smarter and potentially more effective way. So these slides explain why we believe Oncoral is more than simply an oral formulation of irinotecan. Many groups have attempted oral irinotecan development over the years. The challenge has been achieving sufficiently predictable pharmacokinetics and bioavailability to support reliable chronic dosing. The proprietary Oncoral tablet technology addresses this challenge and enables daily administration with a pharmacokinetic profile suitable for metronomic treatment. Our phase 1 studies provided encouraging evidence supporting this concept, and we observed predictable drug exposure, favorable tolerability, and stable disease in a number of heavily pretreated patients. Taken together, these findings support the feasibility of transforming irinotecan from an intermittent infusion therapy into a continuous metronomic treatment strategy. That is why we like to describe Oncoral as a dosing platform rather than a simple reformulation. So, Oncoral is more than just another dosage form of irinotecan, and this distinction is important. Oncoral differs from conventional irinotecan in several ways. First, the pharmacology is different because patients receive continuous low-dose exposure rather than intermittent high-dose treatment, as I just described. Second, the biology may be different. Metronomic chemotherapy has been associated with anti-angiogenic and immunomodulatory effects that extend beyond direct tumor killing— tumor cell killing. And third, the treatment feasibility is different. Daily chronic irinotecan treatment is simply not practical using intravenous administration. And finally, the clinical opportunities may be different. This approach could potentially be applicable in maintenance settings and combination regimens where conventional irinotecan is difficult to use. For these reasons, we believe Oncoral should be viewed as a platform enabling a distinct therapeutic approach. Rather than merely an oral substitute for existing irinotecan products. Our current development focus is gastric cancer, and this indication represents a significant unmet medical need, and it's an area where irinotecan already has established clinical relevance. An important part of the rationale comes from preclinical data demonstrating synergy between irinotecan and loncerf. These studies suggest greater antitumour activity when the 2 agents are combined. than when either is used alone. So this combination is particularly attractive because both treatments are administered orally and creating the possibility of a fully oral treatment regimen. While gastric cancer is our lead indication, we view it as a beginning rather than the end of the opportunity. Irinotecan has established antitumour activity across multiple solid tumours and remains included in treatment guidelines for several major cancer types. The broader vision for Oncoral is therefore to apply the daily oral dosing concept wherever irinotecan biology and clinical experience support such an approach. And as shown on this slide, several of these indications represent very substantial patient populations and commercial opportunities. This gives Oncoral the potential to evolve from a single product opportunity into a broader platform capable of generating value across multiple cancers. In summary, we are not simply developing an oral irinotecan product. We are developing a new way of using irinotecan with the potential to improve patient experience while preserving and potentially enhancing therapeutic benefits. So with that, I will hand over back to Magnus to discuss financials and outlook. Yeah, thank you, Andreas. So, um, in Q3, our operating loss was 10 million Swedish kronor. This, as you can see, this is lower than previous quarters, which relates to the end of the NDA review process and our cost reduction initiatives. That leaves us with 28 million SEK at the end of Q3, uh, and, uh, with our cost projections, this provides cash runway into Q2 next year. I'll end our presentation by reiterating our key priorities and milestones. We continue the partnering process for Oveglans. The partnership will now include both some development and as well as full commercialization. We're preparing a meeting with the FDA to create alignment on an appropriate endpoint for the reread of the Sparkle images that can lead to approval in the US, as Andreas went through. We are also preparing dialogue with regulatory agencies in Europe to obtain their feedback on the approvability of Oveglans based on the existing data package. And as mentioned, in a cost-conscious manner, we are also preparing on-crawl development and having partnering dialogues on that. We're not where we hope to be at this point. We have a clear plan, we have clear inflection points, and there continues to be an attractive opportunity for the, the drugs in our pipeline, and we're committed to bringing them to the patients who need it. Thank you for listening to our Q3 update. Uh, operator would now like to open up for questions. If you wish to ask a question, please dial #5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial #6 on your telephone keypad. The next question comes from Maria Karlsson Osipova from DNB Carnegie. Please go ahead. Hi, Magnus and Andreas. Thank you for taking our question. So we've only recently spoken about this, but yet again, a little on the FDA process. You mentioned Type C meeting as soon as possible. When would you expect to provide an update for us on your plan forward? And have you had any maybe follow-up interaction with the FDA on the topic? Convenient. Yeah, sometime in the, in the early next year, hopefully, uh, we can say more about this. Yeah, so we are aware that this is, you know, the top priority, and, and also being conscious of our cash runway. You know, I think that sets the the, the, uh, the priorities and timelines, um, in a reasonable perspective. You want to start with yours? So yeah, thank you. It's a, it's a good question. Well, we will come back with timelines when we have them more specified, but we are prioritizing this, and we are of course aware of that. We need to address this as soon as possible. So the process is ongoing, and we are planning for the meeting with FDA. And All right, thank you. You know, we always have to try. And maybe let's touch a little bit upon Europe. Any markets that are maybe the initial priority for you? And yet again, again, there, follow up on the expected timing. Yeah, I think, uh, I mean, the, the backdrop of this is that, you know, we, we believe we have a strong, compelling data package. Uh, we were surprised, uh, that we didn't get approval from the— in the US, uh, but it is what it is. Now we focus on how we get approval in the US. Having said that, you know, we have this, uh, you know, comprehensive data and we can manufacture. If that is sufficient for getting approval in, in Europe, because they may have a different regulatory perspective on the data, we will definitely pursue that. So, so that's why we are prioritizing this activity as well. All right, thank you. That will be all for me. Yeah, thank you, Maria. The next question comes from Georg Tigalonov-Bjerke from ABG Sundal Collier. Please go ahead. Hi, this is Georg from ABG. I have 2 questions, please. So firstly, could you elaborate on whether the FDA has suggested a specific new primary endpoint? for SPARCL, the data there, please? And then secondly, of course, subject to what happens to Orviglan, which I, of course, appreciate that you currently do not know. I'm wondering if you could elaborate on what is your current base case development path for Oncoral in gastric cancer, perhaps both in a positive and negative scenario for Orviglan, please? Thank you. Yeah, so the first question about what an endpoint, new endpoint, could be. No, FDA is not specific on that more than that. And yeah, I think it is always the sponsor's responsibility to develop whatever you want to develop. But I think you can, you can have a look at what others have done before, and that may of course give you some indication what FDA would consider useful endpoints. The important thing is that we can address the main question, which is demonstration of clinical utility. Um, and, um, so, so there are no— and this is my perspective, my personal perspective on this is that in this area of imaging products, there are— you can do it in different ways. And I think also the, the history shows that. When looking at different contrast agents and what their indication and what the primary endpoints in their pivotal studies have been. It's important that we find something that meets those requirements, and, and that— but they should also be feasible from a, a operational point of view, and there has to be statistical robust and so on. So, so there's some, some homework for us to do. But we are, we are very hopeful that we will be able to find something. Yeah, no, I think as Andreas also shared, I appreciate the question. As Andreas shared, you know, we have a plan and, you know, we have clinical collaboration, and Taiho has been very patient, and we appreciate that very much. And as Andreas said, you know, there are lots of different opportunities with, with this agent. Uh, so, so I think it, it— the, the important thing is to prioritize and say, where can we get the biggest impact? Uh, so I think that is the, the important element. That we continue to monitor, and also looking at what are the things happening in, in, in the oncology space. The work is progressing finally. So that was first question, a long answer. Do you want to say something about I don't know if you want to complement on— No, I think that's— but yeah, maybe just a general comment, and to take up what you ended, the oncology space is continuously evolving. Uh, it's a very important field, but there's also a lot, a lot of things going on. So, so it's important that you, you continuously monitor that and adjust the strategies accordingly. So, and what is, uh, what we see, we see some spectacular results from a number of products, uh, ADCs or others, uh, which is great for humanity and, and cancer care. But as Andreas also mentioned, a majority of patients today are getting chemotherapy, and we think we can, with Oncrawl, have a very, very good product for some of these patients, and, and that's our focus. Um, not going head-to-head with the ADCs. Yeah. Andersson, thank you. Yeah, thanks. As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad. The next question comes from Fredrik Thor from Redeye. Please go ahead. Hello and thank you. Most questions have been answered, but I just wonder a bit, you mentioned in the intro there that there is a You mentioned a new study with patients, but as you have said, that they also open up for the potential to utilize the Sparkle data. Can you maybe discuss a bit more how this was framed? I mean, was it framed exactly like this, that there is an alternative? What do you think would be enough for them to be convinced that this alternative approach could be good enough? Is it basically to find an endpoint, or is it, ja, what do you think need to see? I think it's fair to say that FDA is open to this, and they— I think you can say that. Well, then it is well known just by looking at the history and for other drugs, that rereads of certain types or reevaluation have been accepted before. So along those lines, FDA are open to consider this. The challenge with the The NDA as it was, was that we made the same type of evaluation in the reread as we did in the first read. So, so that's the sticking point, so to say. So both based on history, then, and also of course on the dialogue we had in the meeting, FDA is open to this and are quite keen on discussing how we can bring this forward. And another way to look at it, I mean, the FDA wants to ensure that patients in the U.S. get access to safe and effective medicine. And they also, as we point out, acknowledge and reiterate the unmet medical need that we address with Orlilanz. They also provide feedback on the safety profile, which is very encouraging, and the technical performance. So what they want is they want the data that will make them able to conclude that Orlilanz should be approved. And those are the different roads that they see. would be, you could say, could be sufficient for approving the product. So I think it's very much in recognition of the unmet need and you could say all the existing data but they just want a bit more. Got it. And at the Type C meeting, I mean, what would be the best outcome? How strong of an endorsement could they give you? I mean, obviously they can't promise anything, but, but, uh, can they, can they say approve this trial? Yeah. That kind of agreement we would expect from a Type C meeting. Yeah, so a very specific endpoint. Yes, that— yeah, we know this is how we're going to do it. That should be the outcome of the meeting. Got it. Thank you very much. I mean, we would expect them to agree on the strategy and plan and the how we plan to, to do this new evaluation. So it— I mean, that, that's them. Otherwise, it's not any meaning to have the meeting if we couldn't get that. But of course, they will, will not say that now we can approve it because we still need to generate the data, and they will make a new decision based on that. But having an alignment on how to do it and, and which is the measurements, what are the statistical analytical approach Yeah, thanks. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions or closing comments. Yeah, so, um, thank you everyone for joining. Uh, there were no written questions, so, um, I think we also got good coverage from, from the questions that were made, uh, here in the Q&A session. So thank you very much, and we look forward to updating you on the progress of Overglanz and Oncrol.