Welcome to Ascelia Pharma Investor update October 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.
Welcome everyone, on this Monday morning to our update following our Type A meeting with the FDA. On the call today, this morning, we have Andreas Norlin, Chief Scientific Officer, and myself, Magnus Corfitzen, CEO of Ascelia. On this call, we will be making forward-looking statements. On this brief update, we will start by having Andreas go through the key outcomes of the Type A meeting. After that, I will talk about how the outcome translates into our strategic priorities with Orviglance before opening up for questions. Andreas, please go ahead.
Thank you, Magnus. Overall, we view the Type A meeting as an important and constructive step forward for Orviglance. While FDA maintains its position that additional clinical evidence will be required for approval, the meeting substantially reduced uncertainty around the product quality and clinical aspects of the complete response letter. On the product quality side, we achieved a clear understanding of FDA's expectations and reached alignment on the path forward. Importantly, on the clinical side, the discussion moved beyond the requirement of conducting a completely new clinical trial. FDA acknowledged the medical need, the favorable safety profile, and the technical performance of Orviglance as a T1 enhancing contrast agent. Most importantly, the meeting identified an alternative approach that could potentially generate additional clinical evidence required for approval.
As a result, we now have greater clarity, reduced regulatory uncertainty, and greater flexibility in evaluating the most efficient path toward U.S. approval than we had before the meeting. The first positive outcome from the meeting relates to product quality. FDA and Ascelia thoroughly discussed the issues raised in the CRL relating to specifications and analytical methods for the drug product, and alignment was reached on the proposed strategy to address the FDA observations. This is important because it removes a significant area of uncertainty. The regulatory expectations are now understood and implementation activities have already started. While work remains, we think the meeting established a clear and actionable path to resolve the product quality component of the CRL. The most important outcome of the meeting was on the clinical and regulatory side.
In the complete response letter, FDA's recommendation was essentially to conduct a new clinical study with new patients. Following the discussions in the Type A meeting, FDA confirmed that this remains one possible route. However, and very importantly, the agency also acknowledged an alternative approach. Specifically, FDA indicated that additional clinical evidence could potentially be generated through a new evaluation of the existing SPARKLE 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 next step is to evaluate potential endpoints that could appropriately address FDA's concerns.
Before any image reading process is initiated, alignment with FDA on the selected endpoint would be obtained. While FDA continues to require additional clinical evidence, the meeting materially changed our understanding of how that evidence may potentially be generated. We believe that opening the possibility to use the existing SPARKLE database represents a meaningful opportunity and a substantially more favorable position than the original recommendation of conducting an entirely new clinical study. This is an opportunity we are now actively evaluating. To summarize, the key takeaway is that the meeting changed the conversation from a new clinical study is required to there may be more than one path to generate the clinical evidence needed for approval. Combined with the alignment achieved on product quality, we believe this represents an important reduction in regulatory uncertainty and a positive development for the Orviglance program in the U.S.
I will now give the word back to Magnus to talk about our strategic priorities for Orviglance.
Yeah. Thank you, Andreas. As Andreas presented to us, the Type A meeting provided clarity on what the FDA wants in order to approve Orviglance. It was a valuable meeting, and it provided us with more options, and it gave us further confirmation on the unmet medical need and no major safety concerns. We are confident in the strength of our Orviglance data and that Orviglance will be an attractive option for patients where use of gadolinium may be medically inadvisable. I'd like to share our key strategic priorities for Orviglance. We continue the partnering process. Given the changed situation, the deal structure would likely involve some development activities and not just commercialization, which was the core focus previously. As Andreas presented, we evaluate the most appropriate endpoint for a new read of SPARKLE images that could lead to FDA approval.
This would be the most efficient path to approval in the U.S. Thirdly, we will talk with European regulators to find out if Orviglance can be approved in Europe with the existing data and application. It has been the plan all along to go to Europe after the U.S. process. If we have a data packet that support approval in Europe, it would be value destruction not to pursue this opportunity. Given the situation and cost of capital, we think these priorities will generate the most shareholder value. We expect it to be in a different situation than where we are now. What I think it is important to focus on, we came out of the Type A meeting with more options and support than what we had when we went into the meeting.
We have some clear priorities for Orviglance to generate value, and that is what we are focusing on as we move ahead. That concludes our brief update here, and we would like to open up for questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Fredrik Thor from Redeye. Please go ahead.
Hello, and thank you. My first question was about why is a new endpoint necessary, and is it a totally different endpoint or a bit similar to the previous primary endpoint? Is it to reduce post-hoc risk or something else?
Andreas?
Yes. Thanks for the question. A new endpoint would be a way to maybe what you said at the ending here, to reduce the post-hoc risk. That is a good way of describing it. It will do that. The exact what kind of endpoint it is, that remains to be evaluated. But the important thing is that FDA has opened up for this opportunity. It is also important in this context that they did acknowledge the technical performance of Orviglance, and they agree that we have demonstrated that it actually works very well as a T1-enhancing agent.
Got it. Also in relation, you also mentioned that FDA mentioned their general post-hoc policy. Maybe if you can talk a bit about your impression before the meeting and the CRL. It seems that you had assumed a more flexible approach. Would you say that it has changed in some way, or if you can talk a bit more about that general policy.
Good question. Well, we submitted under the impression that our approach was acceptable based on the discussions and the meetings we had with FDA prior to the NDA submission. I think that we will end there.
Got it. Also maybe a final question. You mentioned here that you will select a new endpoint and that you will discuss this with FDA before a new read-
Yeah
if I understand it correctly. So what is the process? What type of meeting would that be? What is the timeline and so on?
It's a Type C meeting. The timeline is, of course, first we need to identify what we believe is an appropriate endpoint. That shouldn't take too long, and then we need to prepare some work. I cannot speculate in that exactly. I think that it's better to say that we will work as quick as we can, but the exact timelines, it's difficult to say anything about today. It is a Type C process. Of course, we will also work in parallel so that we are prepared or ready to start a new study once we have had a meeting and confirmed the approach with FDA.
Yeah. Also a final question.
Yeah. Just to complement on that, I think as Andreas Norlin said, we don't have a timeline yet, but our ambition is that the current financing should be sufficient to get that clarity from the FDA.
Got it. In terms of endpoints, are there endpoints available that you can use with the current data, so to speak? How many established endpoints are there that could be used?
There are a few ideas on the table, one or two, that we think are feasible.
Got it.
We will come back once we have more information.
Yeah. That's all from me. Thank you.
Yeah. Thanks, Fredrik.
The next question comes from Maria Karlsson Osipova from DNB Carnegie. Please go ahead.
Hi. Hello. Thank you. Just building a bit on Fredrik's question here. I haven't really gotten. Could you clarify the current financing situation? Where do you think it could take you, Magnus? You mentioned it a bit shortly in your answer.
Sorry, could you repeat the question? I think we have some problems hearing you, Maria. Can you repeat the question?
Yes. Do you hear me now, maybe?
Yeah.
Sorry. I think it is a bit echoey. Anyway, I was going to build a little bit question here and could you clarify the current financing situation where that can take you? You answered a little bit to Fredrik, but it was not really clear there.
Yes. The current financing brings us into Q2 next year.
All right. What stands between you and actually aligning design with all the whole Type C process? What have you begun doing already? What steps have you undertaken?
Your question is how far we have got in the planning.
Yeah
Yeah. Okay. We have initiated the, what should you say? The review of opportunities. I think it is a good idea to bring in our advisors, KOLs, and others that have experience of these kind of studies, and develop that further before we approach the FDA. The process is ongoing.
All right. Thank you. Last one from me. You mentioned you did not want to speculate on timelines with the FDA. Would you like to speculate a bit on the timelines with Europe? When should we expect any meetings and feedback from the European process?
Yeah, I think we'll do that when we have the meeting instead of setting a specific timeline. We are working very hard to manage both the FDA and the European process. I think the European process that we have a lot of the information available. But I think we'll balance those activities. We will come back on timeline when we know more.
All right. Thank you. That will be all from me.
Yeah. Thank you, Maria.
The next question comes from Georg Tigalonov-Bjerke from ABG Sundal Collier. Please go ahead.
Morning, and thanks for taking my questions. I have a couple left, please. Just to sort of establish the visibility on this alternative pathway, in light of the most recent feedback, how confident are you that a prospective reanalysis of the existing SPARKLE data will be sufficient for the approval? Of course, given that you find an endpoint that can be used. Then, secondly, with this scenario, what would then be the earliest realistic timeline for bringing Orviglance to the U.S. market? Thank you.
I think you asked first how confident we are that we can do a new analysis using a new endpoint. Was that right?
Yes, that is correct. Just to sort of-
Yeah
remove any doubts or not remove any doubt about the opportunity.
I mean, it is of course a new situation for us, so we need to consider this carefully. We view it as a very interesting and encouraging option because there is tons of information in the images, and if we can find a way to extract that in a way that is sufficiently different from what we did before, that would most likely satisfy the requirement and expectations from the FDA. There is work remaining, so before we have more clarity, we cannot say much more than that. We are hopeful that this is a viable path forward.
It was kind of clearly described in the minutes that the FDA considered this a viable path forward.
Great. Thank you.
There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.
Yeah, there are some questions here. One question is whether we will make the FDA minutes publicly available. In line with what is customary and what other companies do, we will not make them publicly available. There is a lot of proprietary information there that would not be in the interest of Ascelia to share openly. That's not something that we will be doing. There is another question related to elaborating on the partnering process. As we've said before, also after receiving the complete response letter, there was continued interest from potential partners, and that has not changed. We continue the partnering process. This is obviously a different situation because some more investments, and it's a different timeline for approval. On the other hand, we got validation on some important parameters.
That means that the partner has less risk than an asset that has not been through this FDA review process. I think there are some positives and some negatives. What we're focused on is engaging with the potential partner and then bring the partnership process to a signing at some point here. I think it's a different situation, but we think we will push ahead on the partnering process and see where we are. There is another question here, when we can expect the next update regarding the path forward with the FDA. Andreas, do you have any thoughts on that?
Of course, we all want to move ahead as quickly as possible. We need to find a solution within the coming, what is it? Yeah, before the end of Q2. I don't think we can say specifically when we expect to have clarity. With that, I mean when we have had the next conversation with FDA about these endpoints and plan ahead. It cannot wait too long, let's say that.
No, I can assure you this is a very high priority, and we will keep the investors updated as we progress, when we have strong confidence in the relevant endpoint, et cetera, and as we engage with the FDA. That's going to be updates throughout that process. There are no more questions. Thank you all for joining us this Monday morning. To round off, I think we came out of the meeting a lot better than we went into the meeting. I think there are good reasons to believe that we can have an efficient path for approval despite this CRL. That's what we're pursuing and prioritizing, and we will keep you updated as we move forward. Thank you and have a good day.