Half Year 2026 Ascelia Pharma AB Earnings Call

August 21, 2026

Speaker #1: As always, there's a box down below where you can ask questions. We will do the presentation and take the Q&A at the end.

[Company Representative] (HC Andersen Capital): As always, there is a box down below where you can ask questions during the presentation. We will take the Q&A in the end. We are joined by CEO, Magnus Corfitzen, to take us through the results and the process and standpoints from the company sides. With that introduction, I think I will hand the call over to you, Magnus.

Speaker #1: And of course, we are joined by CEO Mauro Scorpi to take us through the results and the process, as well as the standpoints from the company side.

Speaker #1: So, with that introduction, I think I'll hand the call over to you, Mauro.

Speaker #2: Yeah, thanks a lot, Michael. Great to be here and talk about our Q2 report. And during my talk, I will be making a number of forward-looking statements.

Magnus Corfitzen: Yeah. Thanks a lot, Michael. Great to be here and talk about our Q2 report. During my talk, I will be making a number of forward-looking statements. First, in Ascelia, we are focused on identifying, developing, and commercializing novel drugs, addressing unmet medical needs within the oncology space. Our company is based in Malmö, in Sweden, and we are traded on the main market on Nasdaq Stockholm. Our pipeline consists of primarily two clinical stage assets. Our lead program, Orviglance, is a diagnostic drug for use of imaging of the liver, MRI of the liver. We have completed the clinical development. The product has orphan drug designation from the FDA, and we have submitted a New Drug Application to obtain approval.

Speaker #2: So first, at Ascelia, we're focused on identifying, developing, and commercializing novel drugs that address unmet medical needs within the oncology space. Our company is based in Malmö, Sweden, and we're traded on the main market on Nasdaq Stockholm.

Speaker #2: Our pipeline consists primarily of two clinical-stage assets. Our lead program, Orviglance, is a diagnostic drug for use in imaging of the liver—MRI of the liver.

Speaker #2: We have completed the clinical development. We have the product, which has orphan drug designation from the FDA. And we have submitted a new drug application to obtain approval.

Speaker #2: Unfortunately, we received a complete response letter in early July, and we have a meeting scheduled for September 9 with the FDA to discuss the issues they have identified and agree on an efficient path forward to bring the product to patients in need.

Magnus Corfitzen: Unfortunately, we received a complete response letter early July, and we have a meeting scheduled on 9 September with the FDA to discuss the issues that they have identified and agree on an efficient path forward to bring the product to patients in need. We are going to spend the most of the presentation today talking about Orviglance, but we also have Oncoral, which is an important asset, an interesting asset. It is a tablet-based irinotecan product that has significant potential in various solid tumors. Q2 was busy. In April, we raised SEK 20 million in a directed share issue. Had our annual general meeting early May. We presented data, or a radiologist presented data on Orviglance at the ESGAR conference, the European Society of Gastrointestinal and Abdominal Radiology, the key gastrointestinal radiology conference in Europe.

Speaker #2: We're going to spend most of the presentation today talking about Orviglance, but we also have Oncoral, which is an important asset—an interesting asset.

Speaker #2: It's a tablet-based irinotecan product that has significant potential in various solid tumors. So, Q2 was busy. In April, we raised 20 million Swedish kronor in a directed share issue.

Speaker #2: We had our Annual General Meeting in early May. We presented data—or a radiologist presented data—on Orviglance at the ESGAR conference, the European Society of Gastrointestinal and Abdominal Radiology, which is the key gastrointestinal radiology conference in Europe.

Speaker #2: And we further expanded our IP portfolio for Orviglance by filing a new patent application at the end of June, related to packaging and manufacturing. After the end of the period, as mentioned, we received a complete response letter. We also announced that there were some organizational changes and cost reductions to extend our financial runway.

Magnus Corfitzen: We further expanded our IP portfolio for Orviglance by filing of a new patent application end of June related to packaging and manufacturing. After the end of the period, as mentioned, we received a complete response letter. We also announced that there were some organizational changes, and cost reduction to extend our financial runway. We recently announced that the Type A meeting has been scheduled for 9 September. First I will talk about Orviglance, and let me start with why we are very excited about Orviglance. It is a well-defined unmet medical need. It is a first-in-class product targeting liver imaging in patients with severely impaired kidney function. The global addressable market opportunity is $800 million, with no good solutions today. We have commercial-scale manufacturing set up and well-functioning. Completed nine different clinical studies, and we have strong results from phase III.

Speaker #2: We recently announced that the Type A meeting has been scheduled for the 9th of September. So first, I'll talk about Orbiglans, and let me start with why we are very excited about Orbiglans.

Speaker #2: It's a well-defined, unmet medical need. It's a first-in-class product targeting liver imaging in patients with severely impaired kidney function. The global addressable market opportunity is $800 million, with no good solutions today.

Speaker #2: We have commercial-scale manufacturing set up and well-functioning. We have completed nine different clinical studies, and we have strong results from phase three. As mentioned, we have the Type A meeting to clarify what is needed to get a positive outcome from the review process.

Magnus Corfitzen: As mentioned, we have the Type A meeting to clarify what is needed to get the positive outcome from the review process. We have a clearly stated strategy that we will commercialize with a partner. Let me start by saying, we were very surprised when we received the complete response letter. Based on the review process, the prior meetings with the FDA and the communication, the audits, everything, we were expecting an approval. We need to understand why the FDA has come to this conclusion and agree with the FDA on a path forward, and that is what we expect to achieve on 9 September. After reviewing, we continue to be of the opinion that Orviglance has a strong data package in terms of efficacy and safety in manufacturing, that it provides attractive risk-benefit profile for the intended patient population.

Speaker #2: And we have a clearly stated strategy that we will commercialize with a partner. So let me start by saying we were very surprised when we received the Complete Response Letter.

Speaker #2: Based on the process, the review process, the prior meetings with the FDA, and the communication, the audits—everything—we were expecting an approval. So, obviously, we need to understand why the FDA has come to this conclusion.

Speaker #2: And I agree with the FDA on a path forward, and that is what we expect to achieve on September 9. After reviewing, we continue to be of the opinion that Orviglance has a strong data package in terms of efficacy and safety in manufacturing.

Speaker #2: That it provides an attractive risk-benefit profile for the intended patient population. And all the data that we have should support an approval. So, we will work with the FDA to find an efficient path forward.

Magnus Corfitzen: All the data that we have should support an approval. We will work with the FDA to find an efficient path forward. Let me go into a little bit about the concerns, the issues the FDA puts into the complete response letter. There are basically two categories of issues. One is the clinical statistical, and where they raise issues around the justification of the re-read. They also state that there may have been bias in the training of the new readers. Then they talk about that we should demonstrate clinical utility, for evaluating only T1 images, and that is a little technical. I will come to that in a minute. There were also some issues related to specifications on the product, on the product quality related to, you can say manufacturing, in the complete response letter.

Speaker #2: So let me go into a little bit about the concerns, the issues, the FDA puts into the complete response letter. And they're basically two categories of issues.

Speaker #2: One is the clinical statistical, where they raise issues around the justification of the reread. They also state that there may have been bias in the training of the new readers.

Speaker #2: And then they talk about the fact that we should demonstrate clinical utility for evaluating only T1 images. And that's a little technical; I'll come to that in a minute.

Speaker #2: There were also some issues related to specifications of the product, on the product quality, related to, you would say, manufacturing. In the complete response letter.

Speaker #2: So, we have done—I mean, we acknowledge that the FDA has a different opinion than we have, and we need to understand that and bridge that gap.

Magnus Corfitzen: We acknowledge that the FDA has a different opinion than we have, and we need to understand that and bridge that gap. In our meeting request to obtain the meeting in 9 September, we have gone through taking a deep dive and understanding of the issues highlighted by the FDA, the data we have. You could say our position is that, as we had previously, there was a significant systematic bias in the initial read, back in 2023, where two of the three readers had a very significant bias, changing the way they scored over time, which invalidated the results of the study, and therefore a new read was warranted. We also have gone through very granularly the training of the new readers in the reread. We think we have done that in a thorough and professional manner with no significant reasons to introduce bias.

Speaker #2: So in our meeting request to obtain the meeting on September 9, we've gone through, taking a deep dive and understanding of the issues highlighted by the FDA.

Speaker #2: The data we have, and you would say our position, is that—as we had it previously—there was a significant systematic bias in the initial read back in 2023.

Speaker #2: Where two of the three readers had a very significant bias, changing the way they scored over time, which invalidated the results of the study.

Speaker #2: And therefore, a new read was warranted. We also went through, very granularly, the training of the new readers in the reread. We think we've done that in a thorough and professional manner with no significant reasons to introduce bias.

Speaker #2: And when we think about the T1 enhancing, let me sort of expand a little bit on that. So when you do a liver MRI examination, you do a different sequence—different kinds of images, different kinds of enhancement patterns of the liver.

Magnus Corfitzen: When we think about the T1 enhancing, let me expand a little bit on that. When you do a liver MRI examination, you do different sequences, different kind of images, different kinds of enhancement patterns of the liver. There are three broad categories, T1 enhancement, T2 enhancement, and diffusion-weighted enhancement. Orviglance has an effect on T1, like gadolinium has an effect on T1 as well. There is no effect on T2, there is no effect on diffusion-weighted. You would not expect to see any differences on that, and we have not and have never claimed that because the biological effect of manganese is on T1. What we have done is that we have evaluated the T1, and we say we improve T1, and better T1 is important, because you could say T1 is useful in a number of clinical settings. But we do not improve T2.

Speaker #2: And there are three broad categories: T1 enhancement, T2 enhancement, and diffusion-weighted enhancement. And Orviglance has an effect on T1, like gadolinium has an effect on T2 and on T1 as well.

Speaker #2: There's no effect on T2. There's no effect on diffusion-weighted, so you would not expect to see any differences on that. And we do not, and have never, claimed that, because the biological effect of manganese is on T1.

Speaker #2: So, what we have done is that we've evaluated the T1, and we say we've improved T1. A better T1 is important because, you could say, T1 is useful in a number of clinical settings.

Speaker #2: But we don't improve T2. We've never claimed that, and we don't think that should be in a claim for the product. So that's what we will be discussing with the FDA.

Magnus Corfitzen: We've never claimed that, and we don't think that should be in a claim for the product. That's what we will be discussing with the FDA. It's clear that if you have better T1 images, that's an advantage in a number of scenarios. If unenhanced is superior because you only need T2, then you should never use a contrast agent. I think that's where we're coming from. On the product quality, we have aligned with the FDA recommendation, which means that we've implemented the changes that they have requested, and we believe the product quality issues should be in order. But obviously, we want to confirm that at the meeting as well. When we take one step back, obviously massively disappointed about this conclusion, and we will work constructively with the FDA to turn around this and provide the information they need to make an approval.

Speaker #2: It's clear that if you have better T1 images, that's an advantage in a number of scenarios. If unenhanced is superior because you only need T2, then you should never use a contrast agent.

Speaker #2: So I think that's where we're coming from. On the product quality, we have aligned with the FDA recommendation, which means that we've implemented the changes they have requested.

Speaker #2: And so we believe the product quality issues should be in order. But obviously, we want to confirm that at the meeting as well. So, when we take one step back, obviously, we're massively disappointed about this conclusion.

Speaker #2: And we will work constructively with the FDA to sort of turn around this and provide the information they need to make an approval. We can also conclude from this that the FDA inspections conducted under the review were completed without critical findings for the NDA.

Magnus Corfitzen: We can also conclude from this that the FDA inspections conducted under the review were completed without critical findings for the NDA. The product quality issues we have addressed, which means that we believe we should not have any issues going forward on this area. The key issue here is the interpretation of the clinical imaging data of the pictures. It's not the conduct of the phase III trial, it's not the data collection or anything related to that. We don't see any safety issues as well. That's what we need to discuss with the FDA. That's on how we bridge the gap on the clinical interpretation of the clinical imaging data. We are of the opinion that the data should support an approval, but obviously need to align with the FDA.

Speaker #2: The product quality issues we have addressed, which means that we believe we should not have any issues going forward in this area.

Speaker #2: The key issue here is the interpretation of the clinical imaging data from the pictures. It's not the conduct of the Phase 3 trial.

Speaker #2: It's not data collection or anything related to that, and we don't see any safety issues as well. So that's what we need to discuss with the FDA.

Speaker #2: That is how we bridge the gap in the clinical interpretation of the clinical imaging data. And we are of the opinion that the data should support an approval.

Speaker #2: But obviously, you need to align with the FDA. So, when we think about what is ahead for Orbiglans, we have the Type A meeting.

Magnus Corfitzen: When we think about what is ahead for Orviglance, we have the Type A meeting. That's an important milestone. The minutes will be available no later than 30 days after the meeting. Once we have that information, we will communicate to the market about the outcome of the meeting. The commercial opportunity is unchanged. There continues to be an unmet medical need, and a global addressable market of $800 million, with almost half of that being in the US. We expect to have the seven years of exclusivity for the orphan drug designation in the US, and we have also filed several patent applications related to the food effect together with Orviglance and manufacturing patents in recent years. It's providing a long exclusivity opportunity for the asset. We have a clear strategy and continue to have a clear strategy that we will commercialize with a partner.

Speaker #2: That's an important milestone. The minutes will be available no later than 30 days after the meeting. Once we have that information, we will communicate to the market about the outcome of the meeting.

Speaker #2: The commercial opportunity is unchanged. There continues to be an unmet medical need and a global addressable market of $800 million, with almost half of that being in the US.

Speaker #2: We expect to have the seven years of exclusivity for the orphan drug designation in the US, and we have also filed several patent applications related to the food effect, together with Orviglance.

Speaker #2: And manufacturing patents in recent years, so it's providing a long exclusivity opportunity for the asset. We have a clear strategy and continue to have a clear strategy that we will commercialize with a partner.

Speaker #2: We have an ongoing partnering process that was running in parallel with the review process. And obviously, the complete response letter is a bump in the road in that dialogue.

Magnus Corfitzen: We have an ongoing partnering process that was running in parallel with the review process. Obviously, the complete response letter is a bump on the road in that dialogue. We have confirmed continued interest from potential partners following the complete response letter, so we continue to engage. Obviously getting clarity on what the FDA wants is important for those discussions. To summarize on Orviglance, we continue to be very optimistic and excited about the product, but obviously need clarification from the FDA on what is needed to get the approval. Let me switch gears and talk about Oncoral, which is the other clinical-stage asset that we have. Oncoral is, we take irinotecan, which is a very potent chemotherapeutic agent used widely in clinical practice today. Today, it's given every third week in very high doses.

Speaker #2: We have confirmed continued interest from potential partners following the complete response letter, so we continue to engage. And, obviously, getting clarity on what the FDA wants is important for those discussions.

Speaker #2: So we can continue to be to sort of to summarize on Orbiglans, we continue to be very optimistic and excited about the product. But obviously, you need clarification from the FDA on what is needed to get the approval.

Speaker #2: So let me switch gears and talk about Oncoral, which is the other clinical stage asset that we have. And Oncoral is—we take irinotecan, which is a very potent chemotherapeutic agent used widely in clinical practice today.

Speaker #2: Today, it's given every third week. In very high doses, we believe that we can transform the utility of this molecule by giving daily doses.

Magnus Corfitzen: We believe that we can transform the utility of this molecule by giving daily doses. Let me expand a bit on this. When you give smaller daily doses, you get a completely different, you could say, exposure profile, which means that the antitumor effects will be on a constant level throughout a longer period of time, as opposed to very high peak concentrations that will disappear after a few days. What is interesting, and there is growing evidence in the literature that this more constant exposure of antitumor activity not only utilizes the mechanism of action of irinotecan, that is topoisomerase I inhibition. There is also data supporting an anti-angiogenic effect of this constant exposure, including immune modulation and remodeling of the tumor microenvironment, which is a really interesting mechanisms that are worth exploring further.

Speaker #2: And let me expand a bit on this. So, when you give smaller daily doses, you get a completely different, you could say, exposure profile.

Speaker #2: Which means that the anti-tumor effects will be maintained at a constant level throughout a longer period of time, as opposed to very high peak concentrations that disappear after a few days.

Speaker #2: What is interesting, and there's growing evidence in the literature, is that this more constant exposure of anti-tumor activity not only utilizes the mechanism of action of irinotecan, which is topoisomerase-1 inhibition, but there's also data supporting an anti-angiogenic effect of this constant exposure, including immune modulation and remodeling of the tumor microenvironment. These are really interesting mechanisms that are worth exploring further.

Speaker #2: So it's not only—it's not just, you could say, a convenience dosing advantage, but it's really a mechanistic difference between the two different dosing schedules.

Magnus Corfitzen: It is not just, you could say, a convenience dosing advantage, but it is really a mechanistic difference between the two different dosing schedules. We also see with lower doses, daily doses, that leads to development of potential advantages of tolerability and safety. Getting a lot more out of a molecule that is well proven to improve tumor treatment. From our phase I data, we have shown that it was well-tolerated and no unexpected side effects, and generally less intense safety signals from that. An important element is also the recent guidance from the FDA called Project Optimus, where they look into the paradigm of dosing chemotherapeutic agent or anti-cancer agents to the maximum tolerated dose, to the level just below where the side effects become unbearable. Guidance on how to optimize dosing, which we think is particularly well-suited for Oncoral.

Speaker #2: So we also see it with lower daily doses that lead to potential advantages in tolerability and safety. So we are really getting a lot more out of a molecule that is well proven to improve tumor treatment.

Speaker #2: So, from our phase one data, we have shown that it was well tolerated with no unexpected side effects, and generally, less intense safety signals from that.

Speaker #2: An important element is also the recent guidance from the FDA called Project Optimus, where they look into the paradigm of dosing chemotherapeutic agents or anti-cancer agents to the maximum tolerated dose, which is the level just below where the side effects become unbearable.

Speaker #2: And guidance on how to optimize dosing, which we think is particularly well suited for oncoral. Our initial focus is on gastric cancer in combination with Lonsurf, which is an approved tablet therapy for gastric cancer and colorectal cancer.

Magnus Corfitzen: Our initial focus is on gastric cancer in combination with Lonsurf, which is an approved tablet therapy for gastric cancer and colorectal cancer. As you can see to the left, there is a synergistic effect between Lonsurf and irinotecan. That is obviously, you could say, an interesting compound to combine with Oncoral. But gastric cancer is the initial indication. There are other indications, a number of other indications where irinotecan could play a very important role, and that is the overall potential of the Oncoral asset is quite significant. Let me round off with the financials and the outlook ahead. Q2 2026, we had a deficit of SEK 12 million, so lower cost than previous quarters. You would say that is related to compared to a year ago, we are not finalizing the NDA application. We expect, you would say, having what is difficult to project.

Speaker #2: And as you can see to the left, there is a synergistic effect between Lancerf and irinotecan. So that's obviously, you could say, an interesting compound to combine with Oncoral.

Speaker #2: So, gastric cancer is the initial indication, but there are a number of other indications where irinotecan could play a very important role.

Speaker #2: And the overall potential of the Oncoral asset is quite significant. So let me round off with the financials and the outlook ahead. So, for Q2 '26, we had a deficit of €12 million.

Speaker #2: So, lower costs than previous quarters. And you could say that's related to, compared to a year ago, we're not finalizing the NDA application.

Speaker #2: And we expect—you could say, it's difficult to project. I mean, the future cost would be based on the outcome from the FDA meeting.

Magnus Corfitzen: The future cost would be based on the outcome from the FDA meeting, but we have significantly reduced some costs in the organization. Furthermore, on the liquidity side, we have SEK 38 million at the end of the quarter. With the cost projections that we see, then it will have cash runway onto Q2, obviously depending on whether we need to initiate some activities. But we expect cost, financial runway into Q2 next year. Let me conclude the presentation with the outlook ahead, the milestones and where we see the company going. We have the Type A meeting with the FDA, and we will get minutes within 30 days. That is going to be a very important milestone for us. Department interest remains intact, and clarity on the regulatory meeting is important for those activities as well.

Speaker #2: But we have significantly reduced some costs in the organization. Furthermore, on the liquidity side, we have SEK 38 million at the end of the quarter.

Speaker #2: And with the cost projections that we see, it will have cash runway into Q2; obviously, depending on whether we need to initiate some activities.

Speaker #2: But we expect cost and financial runway into Q2 next year. So, let me conclude the presentation with the outlook ahead, the milestones, and where we see the company going.

Speaker #2: We have the Type A meeting with the FDA, and we'll get minutes within 30 days. That's going to be a very important milestone for us.

Speaker #2: The partnering interest remains intact, and clarity on the regulatory meeting is important for those activities as well. Our cost reductions extend our cash runway into the second quarter of next year, providing us time and opportunity to move forward on the regulatory process.

Magnus Corfitzen: Our cost reductions extend our cash runway into Q2 of next year, providing us time and opportunity to move forward on the regulatory process. With that, I would like to open up for questions.

Speaker #2: So with that, I'd like to open it up for questions.

Speaker #1: Let's jump into it. I think you already went ahead and answered a lot of the questions that were coming in. But what would you regard as a good outcome on the 9th of September?

[Company Representative] (HC Andersen Capital): Let us jump into it then. I think you already went ahead and answered a lot of the question who was coming in. What would you regard as a good outcome on 9 September?

Speaker #2: Yeah, we have obviously some scenarios lined up and prepared—that, you could say, as part of our meeting package. And kind of scenarios, and where we want to lead the discussion.

Magnus Corfitzen: Well, we have obviously some scenarios lined up and prepared that, you could say, as part of our meeting package and kind of scenarios and where we want to lead the discussion. I think the most important thing is that we align with the FDA on the need of the, you could say, the reread, that that was necessary. We see some clear data demonstrating that the initial read was flawed by two of the three readers, and therefore you cannot conclude anything. If you know that they are not using the scale properly and consistently throughout the study, then it is invalid and you need to redo it, which has happened in a number of cases both in the oncology and other diseases, but certainly also in the contrast agent or diagnostic drug space.

[Company Representative] (HC Andersen Capital): Well, we have obviously some scenarios lined up and prepared that, you could say, as part of our meeting package and kind of scenarios and where we want to lead the discussion. I think the most important thing is that we align with the FDA on the need of the, you could say, the reread, that that was necessary. We see some clear data demonstrating that the initial read was flawed by two of the three readers, and therefore you cannot conclude anything. If you know that they are not using the scale properly and consistently throughout the study, then it is invalid and you need to redo it, which has happened in a number of cases both in the oncology and other diseases, but certainly also in the contrast agent or diagnostic drug space.

Speaker #2: I think the most important thing is that we aligned with the FDA on the need for the—you could say—the reread. That was necessary.

Speaker #2: We see some clear data demonstrating that the initial read was flawed by two of the three readers. Therefore, you can't conclude anything. If you know that they're not using the scale properly and consistently throughout the study, then it's invalid.

Speaker #2: And you need to redo it, which has happened in a number of cases—both in oncology and other diseases, but certainly also in the contraception or diagnostic drug space.

Speaker #2: There are examples of numerous other products that have been approved by the FDA where a reread has been part of the efficacy package.

Magnus Corfitzen: Where there are examples of numerous other products that have been approved by the FDA where a reread has been part of the efficacy package. So it is not that we are asking for something extraordinary. It needs to be well-documented and data-driven. We think in this case, based on the data we have and shared with the FDA, that this is warranted in this scenario. So I think that is an important win that we need to get at the meeting.

Speaker #2: So, it's not that we are asking for something extraordinary. It needs to be well documented and data-driven, and we think in this case, based on the data we have and shared with the FDA, that this is warranted in this scenario.

Speaker #2: So, I think that's an important win that we need to get at the meeting.

Speaker #1: Yeah, perfect. Will you communicate anything immediately after the meeting, or wait for the minutes? I think you kind of said that you will await the minutes, I guess.

[Company Representative] (HC Andersen Capital): Perfect. Will you communicate anything immediately after the meeting or wait for the minutes? I think you kind of asked that, you will

Magnus Corfitzen: Yeah

[Company Representative] (HC Andersen Capital): await the minutes, I guess.

Speaker #2: Yeah, absolutely. I think the minutes are the outcome of the meeting. It's not, you could say, our personal impression after the meeting.

Magnus Corfitzen: Absolutely. I think there is The minutes is the outcome of the meeting. It is not, you could say, our personal impression after the meeting. That could be, in my experience, significant differences between what you feel when you leave the meeting and what is in the final minutes. It can be in either direction. Minutes can be better for the company or it could be worse. I think it is not wise to communicate after the meeting because you may have miscommunicated in case the minutes turn out to be different.

Speaker #2: And there could be, in my experience, significant differences between what you feel when you leave the meeting and what is in the final minutes.

Speaker #2: And it can be in either direction. The minutes can be better for the company, or it could be worse. So I think it's not wise to communicate after the meeting, because you may have miscommunicated in case the minutes turn out to be different.

Speaker #1: Yeah, yeah, perfect. And I think you also touched upon it. What are you most uncertain about with the CIL that you're going to get clarified at the September 9 meeting?

[Company Representative] (HC Andersen Capital): Yeah. Perfect. I think you also touched upon this. What are you most uncertain about the CRL that you are going to get clarified on the 9 September meeting? I think you already spoke a lot about it, but if you could put a few words on it.

Speaker #1: I think you already spoke a lot about it, but if you could put a few words on it.

Speaker #2: Yeah, I think the—I mean, I'm most concerned about—I think it's, I think we really want to understand why the FDA has come to the conclusion that they came to.

Magnus Corfitzen: Yeah, I think, I mean, I am most concerned about. I think we really want to understand why the FDA has come to the conclusion that they came to.

[Company Representative] (HC Andersen Capital): Yeah.

Speaker #2: I think that's important for us because otherwise we can't really address the issues that they highlight. And, obviously, they mentioned the re-read. They say there may have been bias in the training.

Magnus Corfitzen: I think that is important for us because otherwise, we can not really address the issues that they highlight. They named the reread. They say there may have been bias in the training. We would like to understand where and how that potential bias, where they see that coming from. We also, on the T1, when we are evaluating a T1-enhancing agent, measuring on T1 seems like a reasonable thing to do because we know that if you have better T1 images, then that is better for, you could say, interpretation of the images of the patient. So, we want to go through these three issues that they bring up and understand and align with them how can we bridge the gap that they see at this point.

Speaker #2: We'd like to understand where and how that potential bias—where they see that coming from. And also, on the T1, when we are evaluating a T1-enhancing agent, measuring on T1 seems like a reasonable thing to do.

Speaker #2: Because we know that if you have better T1 images, then that's better for the, you could say, interpretation of the images of the patient.

Speaker #2: So, we want to go through these three issues that they bring up, and understand and align with them. How can we bridge the gap that they see at this point?

Speaker #1: Okay. And when I first heard that with the T1 and the T2, could there be a narrow label? I know it's not a pharma product.

[Company Representative] (HC Andersen Capital): Sure. When I first heard it, with the T1 and the T2, could there be a narrow label? I know it is not a pharma product. Could there be a narrow label and narrow market, where it specifies T1 and not T2? If you understand what I mean. If they have some worries about is it valid in a clinical setting? Could there be a narrow, because it is an unmet need, right? There are patients that either get worse treated or do not get treated or get poisoned by this because of this. Could there be any narrower definition of the patient group or something like that? Would that be a possibility, or is that not a possibility in this case?

Speaker #1: Could there be a narrow label and narrow market where it's specified T1 and not T2? If you understand what I mean—if they have some worries about whether it is valid in a clinical setting, could there be a narrow market because it's an unmet need, right?

Speaker #1: There are patients that either get worse treated, don't get treated, or get poisoned by this because of this. Could there be any narrower definition of a patient group or something like that?

Speaker #1: Would that be a possibility, or is that not a possibility in this case?

Speaker #2: Yeah, we need to see what the FDA says. But you're right in the sense that it could impact the label, right? So if we say clearly that Oreglans is a manganese agent and it enhances T1, and we put that in, let's say, the indication—that the indication is that we improve T1 images, because that's what it does.

Magnus Corfitzen: We need to see what the FDA says.

[Company Representative] (HC Andersen Capital): Yeah.

Magnus Corfitzen: But you are right in the sense that it could impact the label, right? So if we say clearly that Orviglance is a manganese agent and enhances T1, and we put that in, let's say, the indication, that the indication is that we improve T1 images because that's what it does. All radiologists know that we enhance T1.

Speaker #2: All radiologists know that we enhance T1. They don't expect it to enhance T2 or T3 diffusion rate, like gadolinium is only enhancing T1. So I think that could potentially be part of the solution—that we say, okay, but the data we have shows that we enhance T1.

[Company Representative] (HC Andersen Capital): Yeah.

Magnus Corfitzen: They don't expect it to enhance T2 or diffusion-weighted. Like gadolinium is only enhancing T1. So, I think that could potentially be part of the solution that we say, okay, but the data we have shows that we enhance T1. Let's put that in the label and that's then-

Speaker #2: Let's put that in the label, and then we can kind of—I don't see that as having any impact on the—

[Company Representative] (HC Andersen Capital): Sure

Magnus Corfitzen: we can kind of I don't see that as having any impact on the-

Speaker #1: On the market side.

[Company Representative] (HC Andersen Capital): On the market side. That's what-

Magnus Corfitzen: On the market side.

Speaker #2: On the market side.

Speaker #1: Yeah, kind of could, yeah.

[Company Representative] (HC Andersen Capital): Kind of could, yeah.

Magnus Corfitzen: It's essentially what we do, and that's what we have demonstrated in the study.

Speaker #2: It's essentially what we do, and that's what we have demonstrated in the study.

Speaker #1: And then there's a little bit about assuming a positive meeting: what determines whether a recent mission falls into a two-month or six-month review class?

[Company Representative] (HC Andersen Capital): There's a little bit about, assuming a positive meeting, what determines whether a resubmission falls into a 2-month or 6-month review class? I don't know whether you want to be that specific. Of course, everybody's trying to figure out a timeline in a positive outcome also.

Speaker #1: I don't know whether you want to be that specific. Of course, everybody is trying to figure out a timeline, and a positive outcome also.

Speaker #2: Yeah, yeah, no. And I can't give you a straight answer. Obviously, I'm more interested in a two-month review time than six months. But I think the most important thing is to understand what are the issues and how do we bridge the gap?

Magnus Corfitzen: Yeah. I cannot give you a straight answer. Obviously, I am more interested in a two-month review time than six months. I think the most important thing is to understand what are the issues, how do we bridge the gap, and how quickly can we do that. Then obviously the review time, shorter is better than longer. I think the most important thing is getting the bridging back. I think the timeline would also depend on what is needed to bridge.

Speaker #2: And how quickly can we do that? And then, obviously, the review time—shorter is better than longer—but I think the most important thing is getting the bridging back.

Speaker #2: And I think the timeline would also depend on what is needed to bridge.

Speaker #1: Yeah.

[Company Representative] (HC Andersen Capital): Yeah.

Speaker #2: So, if it's a very significant amount of information that we need to add, then I'm pretty sure it's not going to be two months.

Magnus Corfitzen: If it is a very significant amount of information that we need to add, then I am pretty sure it is not going to be a two months. I think those, without being an expert,

Speaker #2: So, I think those without being an extra.

Speaker #1: Yeah, without having the meeting, then it's hard to answer. I understand. And then I think you also have answered this too—your own runway includes any cost of any of the scenarios if the AMA require after the 9th of September.

[Company Representative] (HC Andersen Capital): Yeah. Without having the meeting, then it is hard to answer.

Magnus Corfitzen: Yeah.

[Company Representative] (HC Andersen Capital): I understand. I think you also have answered this too. Will runway include any cost of any of the scenarios FDA may require after 9 September?

Speaker #2: So our runway includes the meeting, the follow-up, and a resubmission based on minimal—nothing major needed to do the resubmission. Of course, if we need to do a reread, or a new study for that matter, we go in those scenarios.

Magnus Corfitzen: Our runway includes the meeting, the follow-up, and a resubmission based on minimal, nothing major needed to do the resubmission. Of course, if we need to do a reread or a new study for that matter, if we go in those scenarios, that is not included in the runway.

Speaker #2: That's not included in the runway.

Speaker #1: And I guess it's premature to speculate on this one. The on-call, could that be an asset that has a value to be sold off to finance something, or—I guess you don't want to speculate on that part before you know your way forward.

[Company Representative] (HC Andersen Capital): I guess it is premature to speculate on this one. The Oncoral, could that be an asset that has a value to be sold off to finance something or I guess you do not want to speculate on that part before you know your way forward.

Speaker #2: I mean, we're super excited about Oncall, and we've been doing increasing— a little bit of work whenever we had time here; not much, but some work during the review process.

Magnus Corfitzen: We are super excited about Oncoral and we have been doing, increasing a little bit of work whenever we had time here. Not much, but some work during the review process. The data is very compelling. I think really we can get I think Oncoral could be sort of a catalyst for unlocking increased clinical value of the irinotecan molecule by giving daily doses. I think that value is quite significant. So we would love to get some significant development ongoing with Oncoral. Having said that, we always look at all options whenever they are there and if there are some interesting opportunities, we could pursue those.

Speaker #2: And the data is very compelling. I think, really, we can get—I think on-call could be sort of a catalyst for unlocking increased clinical value of the irinotecan molecule by giving daily doses.

Speaker #2: And I think that value is quite significant. So we'd love to get some significant development going with Oncall. Having said that, we always look at all options whenever they are there, and if there are some interesting opportunities, we could pursue those.

Speaker #1: And then the final question, is there any technical issue in the way data was collected that hinders a reread again? I think you also alluded to that by—

[Company Representative] (HC Andersen Capital): Then the final question. Is there any technical issue in the way data was collected that hinders a reread again? I think you also alluded to that by pointing out-

Magnus Corfitzen: No. All the data is there in the database. We collected all the sequences that we need and there have been no issues raised by the FDA in relation to the conduct of the clinical study. It is only about the reading process, the three blinded readers, how they score the images and adhering to the scoring scheme, that was an issue in the initial read, but not in the second read. That is where we have confined the issue. That is what we need to agree with the FDA. The study in itself, the enrollment of the patients, and collection of the data, we think there has been no issues raised. We think it all looks good based on the work we have done and the review process.

Speaker #2: No, no, all the data is there in the database. We collected all the sequences that we need, and there have been no issues raised by the FDA in relation to the conduct of the clinical study.

Speaker #2: So it's only about the reading process, the three blinded readers, how they score the images, and adhering to the scoring screen. That was an issue in the initial read, but not in the second read.

Speaker #2: That's where we have kind of confined the issue. That is what we need to agree with the FDA. So, the study in itself—the enrollment of the patients and collection of the data—we think is, there have been no issues raised, and we think it all looks good based on the work we've done and the review process.

Speaker #2: And that's also why we don't think a new study is warranted, because we've collected the patients and participated, and we should utilize those images and that clinical data.

Magnus Corfitzen: That is also why we do not think a new study is warranted because we have collected, the patients have participated, and we should utilize those images, so that clinical data.

Speaker #1: Perfect. That was the last question. Thank you to your moms for taking us through your results and this process, and your standpoints that you're going into this meeting with, and what backs them up.

[Company Representative] (HC Andersen Capital): Perfect. That was the last question. Thank you to you, Magnus, for taking us through your results and this process and your standpoints that you are going into this meeting with, and what backs it up is even more important. So thank you to you, Magnus, for sharing that information, and thank you for the audience listening in. May everybody have a nice weekend.

Speaker #1: I think maybe more importantly, thank you to your moms for sharing that information, and thank you to the audience for listening in.

Speaker #1: Everybody have a nice weekend.

Magnus Corfitzen: Yeah. Thanks. Always great to be here.

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