Q2 2026 Fluoguide AS Earnings Call
Operator: Hi, and welcome to this live Q&A with FluoGuide, who just released their Q2 report. We are joined by CEO Morten Albrechtsen and CFO Ole Larsen. Before taking your questions, they will give you a short presentation. Please go ahead.
Operator: Hi, and welcome to this live Q&A with FluoGuide, who just released their Q2 report. We are joined by CEO Morten Albrechtsen and CFO Ole Larsen. Before taking your questions, they will give you a short presentation. Please go ahead.
Speaker #1: Hi, and welcome to this live Q&A with Fluoguide, who just released their Q2 report. We are joined by CEO Morten Albrechtsen and CFO Ulrik Vesterlind.
Speaker #1: And before taking your questions, they will give you a short presentation, so please go ahead.
Speaker #2: Thank you. Thank you for having us. Yes, we just have a few slides, just summarizing what has happened and where we are. So, as you know, we light up cancer to maximize surgical outcome.
Morten Albrechtsen: Thank you. Thank you for having us. Yes, we just have a few slides, just summarizing what has happened and where we are. As you know, we light up cancer to maximum surgical outcome. We work with a uPAR. It is in the target that is intelligent, is expressed the most, where you need it the most, so that is the forefront of the cancer. We are an oncology surgery, so we help the surgeon and the patient to get complete surgery. We have shown five positive clinical results in different indications. Every year, unfortunately, there are approximately 20 million patients that will be diagnosed with cancer, and we have the potential to help them. We are partnered with the leading med tech companies in different types of equipment.
Morten Albrechtsen: Thank you. Thank you for having us. Yes, we just have a few slides, just summarizing what has happened and where we are. As you know, we light up cancer to maximum surgical outcome. We work with a uPAR. It is in the target that is intelligent, is expressed the most, where you need it the most, so that is the forefront of the cancer. We are an oncology surgery, so we help the surgeon and the patient to get complete surgery. We have shown five positive clinical results in different indications. Every year, unfortunately, there are approximately 20 million patients that will be diagnosed with cancer, and we have the potential to help them. We are partnered with the leading med tech companies in different types of equipment.
Speaker #2: So, we work with a UPAM. It's in the target that is intelligent; it's expressed the most where you need it the most, so that's at the forefront of the cancer.
Speaker #2: We are in oncology surgery, so we help the surgeon and the patient to achieve complete surgery. We have shown five positive clinical results in different indications.
Speaker #2: And every year, unfortunately, there are approximately 20 million patients that will be diagnosed with cancer, and we have the potential to help them.
Speaker #2: We have partnered with the leading medtech companies in different types of equipment, and we were very pleased here in the first half of the year, where we got both approval for our first regulatory trial in the US for high-grade glioma. We obtained fast-track designation, and that's on top of the Orphan Drug Designation we have had earlier on.
Morten Albrechtsen: We were very pleased here in the H1 of the year where we got both approval for our first regulatory trial in US for high-grade glioma. We obtained the Fast Track designation, and that is on top of the Orphan Drug designation we have had early on. We have two ongoing trials right now. That is the high-grade glioma registration trial, and then there is a trial in H&N, all H&N cancer, where we have reported the first part of it here before summer, and we have another 10 patients to be treated there. Our lead indications are high-grade glioma and focusing on the US. It was really an interesting H1 of the year. As mentioned, we got the FDA submission and approval for our first regulatory trial, has been cleared with them in a pre-IND meeting before.
Morten Albrechtsen: We were very pleased here in the H1 of the year where we got both approval for our first regulatory trial in US for high-grade glioma. We obtained the Fast Track designation, and that is on top of the Orphan Drug designation we have had early on. We have two ongoing trials right now. That is the high-grade glioma registration trial, and then there is a trial in H&N, all H&N cancer, where we have reported the first part of it here before summer, and we have another 10 patients to be treated there. Our lead indications are high-grade glioma and focusing on the US. It was really an interesting H1 of the year. As mentioned, we got the FDA submission and approval for our first regulatory trial, has been cleared with them in a pre-IND meeting before.
Speaker #2: And we have two ongoing trials right now. That's the high-grade glioma registration trial, and then there's a trial in head and neck, all head and neck cancer, where we have reported the first part of it here before summer, and we have another 10 patients to be treated there.
Speaker #2: Our lead indication is high-grade glioma, and we're focusing on the US. So, it was really an interesting first half of the year. As mentioned, we got the FDA submission and approval for our first regulatory trial.
Speaker #2: That's been cleared with them in a pre-I&D meeting before. So we have directional alignment with them on what is needed for obtaining approval, endpoints, and the number of patients.
Morten Albrechtsen: We have directional alignment with them, what is needed for obtaining approval, endpoints, and a number of patients. We then got the Fast Track designation. We got the trial approved. We completed the first part with the 15 patients in H&N trial in Holland, in Groningen. Then we made the reporting of the result where we actually selected a dose. We had the best position we could obtain within the surgical room, we could help the patient, and then it worked on all equipment, but I will probably get more into that later. Then we have just opened the site for the first US site that we can enroll patient now in our registration trial for high-grade glioma. This is quite a smart trial, actually. I am not the only one that has been involved with it, actually, very little, but we have very good colleagues.
Morten Albrechtsen: We have directional alignment with them, what is needed for obtaining approval, endpoints, and a number of patients. We then got the Fast Track designation. We got the trial approved. We completed the first part with the 15 patients in H&N trial in Holland, in Groningen. Then we made the reporting of the result where we actually selected a dose. We had the best position we could obtain within the surgical room, we could help the patient, and then it worked on all equipment, but I will probably get more into that later. Then we have just opened the site for the first US site that we can enroll patient now in our registration trial for high-grade glioma. This is quite a smart trial, actually. I am not the only one that has been involved with it, actually, very little, but we have very good colleagues.
Speaker #2: We then got the fast-track designation, we got the trial approved, we completed the first part with the 15 patients in the head and neck trial in Holland and Groningen, and then we made the reporting of the result where we actually selected a dose, we had the most positional, best position we could obtain within a surgical room, we could help the patient, and then it worked on all equipment.
Speaker #2: But I'll probably get more into that later. And then, we have just opened the first US site, so we can now enroll patients in our registration trial for high-grade glioma.
Speaker #2: And this is a quite smart trial, actually. I'm not the only one that has been involved with it—actually, very little—but we have very good colleagues, and what they did is actually design it in a way where we both have a base case that is very predictable to have success. Of course, there's always risk when doing a clinical trial, but the base case here is really good.
Morten Albrechtsen: What they did is actually design it in a way where we both have a base case that is very predictable to have success. Of course, there is always risk when doing clinical trial, but the base case here is really good. That is because of the endpoint we choose, and that completeness of resection that is measured by MRI scan before surgery and after surgery. We have already shown in the CT-001, the first trial we did, that we are way over what is needed this trial to be successful, and that was in a trial where the surgeons were not trained and where we had a first experience with the drug. Now we have built a quite robust training program, so we are much better off. Additionally, this endpoint is what agreed to with the FDA will carry over to the phase III program.
Morten Albrechtsen: What they did is actually design it in a way where we both have a base case that is very predictable to have success. Of course, there is always risk when doing clinical trial, but the base case here is really good. That is because of the endpoint we choose, and that completeness of resection that is measured by MRI scan before surgery and after surgery. We have already shown in the CT-001, the first trial we did, that we are way over what is needed this trial to be successful, and that was in a trial where the surgeons were not trained and where we had a first experience with the drug. Now we have built a quite robust training program, so we are much better off. Additionally, this endpoint is what agreed to with the FDA will carry over to the phase III program.
Speaker #2: And that's because of the endpoint we chose, and the completeness of the section that's measured by MRI scan before surgery and after surgery. And we have already shown in the CTO-1, the first trial we did, that we are well over what is needed in this trial to be successful.
Speaker #2: And that was in a trial where the surgeons were not trained, and where we had kind of a first experience with the drug. Now, we have built a quite robust training program, so we are much better off.
Speaker #2: Then additionally, this endpoint is what agreed to with the FDA, we carry over to the phase 3 program, that is to be repeated after or not repeated, but we have to be done as well after this trial, it would be high-grade glioma, and they will be the trial would be kind of completed in 48 hours for the first endpoint, which is the primary endpoint.
Morten Albrechtsen: That is to be repeated after or, not repeated, but we have to be done as well after this trial. It will be high-grade glioma, and the trial would be kind of completed in 48 hours for the first endpoint, which is the primary endpoint. Then, that smart aspect of this trial is on the secondary endpoint, because there are actually the more commercial edge to it and really what could help patients beyond just having completeness of resection. That is that it has been shown that if the FG001 with a high likelihood passes the blood-brain barrier, and the problem for patients with high-grade glioma is that they have cancer behind the blood-brain barrier that today is not visible. That is the potential that we can visualize that and actually help the patient additionally with it.
Morten Albrechtsen: That is to be repeated after or, not repeated, but we have to be done as well after this trial. It will be high-grade glioma, and the trial would be kind of completed in 48 hours for the first endpoint, which is the primary endpoint. Then, that smart aspect of this trial is on the secondary endpoint, because there are actually the more commercial edge to it and really what could help patients beyond just having completeness of resection. That is that it has been shown that if the FG001 with a high likelihood passes the blood-brain barrier, and the problem for patients with high-grade glioma is that they have cancer behind the blood-brain barrier that today is not visible. That is the potential that we can visualize that and actually help the patient additionally with it.
Speaker #2: Then, and that's a smart aspect of this trial, is on the secondary endpoint, because there actually is the more commercial edge to it, and really what could help patients beyond just having completeness of the section.
Speaker #2: And that is that it's been shown that FG001 with high likelihood passes the blood-brain barrier, and the problem for patients with high-grade glioma is that they have cancer behind the blood-brain barrier that today is not visible.
Speaker #2: And that is the potential—that we can visualize that and actually help the patient additionally with it. That secondary endpoint, if that comes out positive, it's really a game changer in brain tumor surgery.
Morten Albrechtsen: That secondary endpoint, if that comes out positive, it is really a game changer in brain surgery, tumor surgery. So this is why it is smart. There is a good, robust base case, and then there is an upside on the trial. Turning over to the financial highlights. In H1, we had other external cost of DKK 18.3 million. If you look above, you will see that it consists of R&D and admin. Admin is including investor relation cost and also sales and marketing cost, and they were DKK 5.1 million in H1. R&D is, of course, our two clinical trials, CT-005 in head and neck and CT-006 in aggressive brain cancer, and they consisted of DKK 13.2 million in H1.
Morten Albrechtsen: That secondary endpoint, if that comes out positive, it is really a game changer in brain surgery, tumor surgery. So this is why it is smart. There is a good, robust base case, and then there is an upside on the trial. Turning over to the financial highlights. In H1, we had other external cost of DKK 18.3 million. If you look above, you will see that it consists of R&D and admin. Admin is including investor relation cost and also sales and marketing cost, and they were DKK 5.1 million in H1. R&D is, of course, our two clinical trials, CT-005 in head and neck and CT-006 in aggressive brain cancer, and they consisted of DKK 13.2 million in H1.
Speaker #2: So, this is why it's smart: there's a good, robust base case, and then there's an upside on the trial.
Speaker #3: Yeah, and turning over to the financial highlights. In the first half, we had other external costs of 18.3 million, and if you look above, you'll see that it consists of R&D and admin.
Speaker #3: Admin is including investor relation costs and also sales and marketing costs, and they were $5.1 million in the first half. R&D is, of course, our two clinical trials—CT005 in head and neck, and CT006 in aggressive brain cancer—and they consisted of $13.2 million in the first half.
Speaker #3: Then we have our staff cost, which consisted of 9.7 million in the first half, and finance, which is primarily the interest from our loan with Fenya Capital of 1.6 million.
Morten Albrechtsen: Then we have our staff cost that consisted of DKK 9.7 million in H1, and finance, which is primarily the interest from our loan with Fenja Capital of DKK 1.6 million. Then the tax credit so far this year, DKK 5.2 million. There is a cap of the tax credit of DKK 5.5 million, so we will reach that during Q3, and then this one will not increase. That means that we have a net result of H1 of -DKK 24.6 million. If we go to the balance, we have assets of DKK 65 million by 30 June. Of that, DKK 50 million was our cash position and our securities. The securities has since expired and are now in money deposits primarily like the rest of the cash.
Morten Albrechtsen: Then we have our staff cost that consisted of DKK 9.7 million in H1, and finance, which is primarily the interest from our loan with Fenja Capital of DKK 1.6 million. Then the tax credit so far this year, DKK 5.2 million. There is a cap of the tax credit of DKK 5.5 million, so we will reach that during Q3, and then this one will not increase. That means that we have a net result of H1 of -DKK 24.6 million. If we go to the balance, we have assets of DKK 65 million by 30 June. Of that, DKK 50 million was our cash position and our securities. The securities has since expired and are now in money deposits primarily like the rest of the cash.
Speaker #3: And then the tax credit so far this year is $5.2 million. There is a cap on the tax credit of $5.5 million, so we will reach that during Q3, and then this one will not increase.
Speaker #3: That means we have a net result for the first half of minus 24.6 million. If we look at the balance, we have assets of 65 million as of June 30th, and of that, 50 million was our cash position and our securities.
Speaker #3: The securities have since expired and are now in money deposits, primarily like the rest of the cash. The tax credit of 11 million is the 5.5 million from 2025, which we expect to be paid out in November or December, and then the 5.2 million that we have collected or gathered so far in 2026.
Morten Albrechtsen: The tax credit of DKK 11 million is the DKK 5.5 million from 2025, which we expect to be paid out in November, December, and then the DKK 5.2 million that we have collected or gathered so far in 2026. The liabilities consist of equity of DKK 31 million, and then the loan that we have with Fenja Capital of DKK 27 million. If you look to the right on the cash flow, we have burned DKK 29 million in H1. Of that, DKK 28.2 million is due to our operations. If we look at the outlook that we announced in November 2025 in connection with our Q3, you can see that all our goals for H1 were met apart from one, and that is the enrollment of the first patient in the US phase II trial for HGG.
Morten Albrechtsen: The tax credit of DKK 11 million is the DKK 5.5 million from 2025, which we expect to be paid out in November, December, and then the DKK 5.2 million that we have collected or gathered so far in 2026. The liabilities consist of equity of DKK 31 million, and then the loan that we have with Fenja Capital of DKK 27 million. If you look to the right on the cash flow, we have burned DKK 29 million in H1. Of that, DKK 28.2 million is due to our operations. If we look at the outlook that we announced in November 2025 in connection with our Q3, you can see that all our goals for H1 were met apart from one, and that is the enrollment of the first patient in the US phase II trial for HGG.
Speaker #3: The liabilities consist of equity of 31 million, and then the loan that we have with Fenya Capital of 27 million. And if you look to the right on the cash flow, we have burned 29 million in the first half; of that, 28.2 million is due to our operations.
Speaker #3: If we look at the outlook that we announced on November 25 in connection with our Q3, you can see that all our goals for the first half were met, apart from one—and that is the enrollment of the first patient in the US Phase 2 trial for HDG.
Speaker #3: As Morten just mentioned, we got the final green light for the first site in the US today, so now we can start enrolling patients in that clinical trial.
Morten Albrechtsen: As Morten just mentioned, we got the final green light for the first site in the US today, so now we can start enrolling patients in that clinical trial. If we look for H2, the goal is to optimize the use of FG001 and the laser system in our PTT, PDT, and we will present a plan later this half. Also in brain, we will have the interim results of the low-grade glioma investigator-initiated trial from Rigshospitalet, the last 10 patients, as well as we will present a brain tumor plan also in H2. We came out with an announcement on 2 July, telling that we wanted to amend the protocol for the head and neck trial, meaning that the interim results for the additional 10 patients will be delayed into the beginning of 2027.
Morten Albrechtsen: As Morten just mentioned, we got the final green light for the first site in the US today, so now we can start enrolling patients in that clinical trial. If we look for H2, the goal is to optimize the use of FG001 and the laser system in our PTT, PDT, and we will present a plan later this half. Also in brain, we will have the interim results of the low-grade glioma investigator-initiated trial from Rigshospitalet, the last 10 patients, as well as we will present a brain tumor plan also in H2. We came out with an announcement on 2 July, telling that we wanted to amend the protocol for the head and neck trial, meaning that the interim results for the additional 10 patients will be delayed into the beginning of 2027.
Speaker #3: If we look for H2, the goal is to optimize the use of FG001 and the laser system in our PTT and PDT, and we'll present a plan later this half.
Speaker #3: Also, in brain, we'll have the interim results of the low-grade glioma investigator-initiated trial from Research Vital, the last 10 patients. As well, we will present a brain tumor plan, also in the second half.
Speaker #3: Then we came out with an announcement on the 2nd of July, saying that we wanted to amend the protocol for the head and neck trial, meaning that the interim result for the additional 10 patients will be delayed into 2027, in the beginning of 2027.
Speaker #3: And we are still on track for an additional partnership in the second half of this year. I think that concludes our presentation.
Morten Albrechtsen: We are still on track for an additional partnership in H2 of this year. I think that concludes our presentation.
Morten Albrechtsen: We are still on track for an additional partnership in H2 of this year. I think that concludes our presentation.
Speaker #1: Thank you so much. We will move on to the question part, and we've had a couple of questions sent in already. Let's start with you, Morten.
Operator: Thank you so much. We will move on to the question part. We have had a couple of questions sent in already, and let's start with you, Morten. First question is very straightforward. Why are not any patients recruited yet in the HGG trial? As this writer points out, it has been delayed three times.
Operator: Thank you so much. We will move on to the question part. We have had a couple of questions sent in already, and let's start with you, Morten. First question is very straightforward. Why are not any patients recruited yet in the HGG trial? As this writer points out, it has been delayed three times.
Speaker #1: First question is very straightforward. Why aren't any patients recruited yet in the HDG trial? And, yeah, as this writer points out, it's been delayed three times.
Speaker #2: Yes, that's correct. We ran into the summer holiday in the US, so we missed some site-specific—there was a delay with some site-specific approvals and tests. But the important thing here now is that the FDA approved our trial, they granted us a Fast Track, and we have the first site to have a green light today. We have had patients that just couldn't be enrolled because the formality was not in place, and we have seven more sites lined up very close after, so yes.
Morten Albrechtsen: Yes, that's correct. We ran into the summer holiday in the US, so we missed some site-specific. It was delayed, some site-specific approval and tests. But the important thing here now is that the FDA approved our trial. It granted us a Fast Track designation. We have the first site to have a green light today. We have had patients that just couldn't be enrolled because the formality was not in place. And we have seven more sites lined up very close after. So, yes.
Morten Albrechtsen: Yes, that's correct. We ran into the summer holiday in the US, so we missed some site-specific. It was delayed, some site-specific approval and tests. But the important thing here now is that the FDA approved our trial. It granted us a Fast Track designation. We have the first site to have a green light today. We have had patients that just couldn't be enrolled because the formality was not in place. And we have seven more sites lined up very close after. So, yes.
Speaker #1: It's happened.
Operator: It happened.
Operator: It happened.
Morten Albrechtsen: It's very irritating, but it happened.
Morten Albrechtsen: It's very irritating, but it happened.
Speaker #2: It's very irritating, but it happened.
Speaker #1: Yeah. Let's bring you in here, Iolo, as well. A couple of months ago, Rigshospitalet announced that they will conduct a bigger H&N phase 2 trial, sponsored by them, in 2026–27.
Operator: Yeah. Let's bring you in here, Ivan, as well. A couple of months ago, Rigshospitalet announced that they will conduct a bigger H&N Phase II trial, sponsored by them in 2026/27. Have you got any thoughts on that?
Operator: Yeah. Let's bring you in here, Ivan, as well. A couple of months ago, Rigshospitalet announced that they will conduct a bigger H&N Phase II trial, sponsored by them in 2026/27. Have you got any thoughts on that?
Speaker #1: Have you got any thoughts on that?
Speaker #3: Yeah, I mean, it's more or less ready to start. And Rigshospitalet, who is in charge and controls the study, will inform soon. And I can say that it's within robotic surgery, and it's in head and neck cancer.
Ole Larsen: Yeah, it's more or less ready to start. Rigshospitalet, who is in charge and control the study, will inform soon. I can say that it's within robotic surgery, and it's in head and neck cancer. We have some public material. A detailed protocol has been submitted to the European database for clinical trials, where you can see the details on the trial.
Ole Larsen: Yeah, it's more or less ready to start. Rigshospitalet, who is in charge and control the study, will inform soon. I can say that it's within robotic surgery, and it's in head and neck cancer. We have some public material. A detailed protocol has been submitted to the European database for clinical trials, where you can see the details on the trial.
Speaker #3: And we have some public material. A detailed protocol has been submitted to the European database for clinical trials, where you can see the details on the trial.
Speaker #1: And turning to you, Morten, I think on this one—in a moment—last week you confirmed the following about the H&N trial part one, and I will have to read this.
Operator: Turning to you, Morten, I think on this one. In Malmö last week, you confirmed the following about the H&N trial, part one, and I will have to read this. That 30% to 40% that normally need reoperation, they were cured of cancer in the study, as in all cancer removed. So 100% of the patients in the trial were cured. It's possible to assess the margin live without adding operation time, and that's because of you. Well, because of you, of your product. It was done with existing equipment in the operation room. Can you confirm that all these statements are correct?
Operator: Turning to you, Morten, I think on this one. In Malmö last week, you confirmed the following about the H&N trial, part one, and I will have to read this. That 30% to 40% that normally need reoperation, they were cured of cancer in the study, as in all cancer removed. So 100% of the patients in the trial were cured. It's possible to assess the margin live without adding operation time, and that's because of you. Well, because of you, of your product. It was done with existing equipment in the operation room. Can you confirm that all these statements are correct?
Speaker #1: The 30% to 40% that normally need reoperation were cured of cancer in the study, as in all cancer was removed, so 100% of the patients in the trial were cured.
Speaker #1: It's possible to assess the margin live without adding operation time, and that's because of you—well, because of you, of your product. It was done with existing equipment in the operating room.
Speaker #1: Can you confirm that, well, that all these statements are correct?
Speaker #2: It's not completely correct. I would like to confirm what is done. So first of all, I would say that in the previous trial, 003, that we did in head and neck, importantly there, you will see that it was 16 patients that were enrolled, and, like all patients, and this trial has been made public in the public domain, so all the details are in a publication.
Morten Albrechtsen: It's not completely correct. I would like to confirm what is done. First of all, I would say that in the previous trial, 003, that we did in head and neck, importantly there, you will see that it was 16 patients that was enrolled and light up all patient. This trial has been in the public domain, so all the details are in a publication. It's interesting it was done with a camera that was optimized for fluorescence-guided surgery and produced very good results, not surprisingly. This trial for the 005, the one we just reported here, the key thing for us here is that we don't just want to do, we're going to say, nice publications and nice trials. We really would like this technique to get out and help patients in all the corner of the world.
Morten Albrechtsen: It's not completely correct. I would like to confirm what is done. First of all, I would say that in the previous trial, 003, that we did in head and neck, importantly there, you will see that it was 16 patients that was enrolled and light up all patient. This trial has been in the public domain, so all the details are in a publication. It's interesting it was done with a camera that was optimized for fluorescence-guided surgery and produced very good results, not surprisingly. This trial for the 005, the one we just reported here, the key thing for us here is that we don't just want to do, we're going to say, nice publications and nice trials. We really would like this technique to get out and help patients in all the corner of the world.
Speaker #2: It's interesting, it was done with a camera that was optimized for fluorescent guided surgery, and produced very good result, not surprisingly. This trial, for the 005, the one we just reported here, the key thing for us here is that we don't just want to do, what can I say, nice publications and nice trials, we really would like this technique to get out and help patients in all the corner of the world.
Speaker #2: And if we should do that, there are a couple of things we need to do beyond just getting it lighting up, and beyond just using it on a very specific piece of equipment.
Morten Albrechtsen: If we should do that, there's a couple of things we need to do beyond just getting it lighting up and beyond just using it on a very specific equipment. So first one, we need to get over the regulatory line. It has to be approved. We have to have it to work on multiple equipment that already is out there, and they may not be exactly as good as this very specialized equipment, but they are out there. Then last but not least, we need to have a commercial case. So we're going out having a probe, and it can be seen with a camera. No one want to buy it. I mean, helps no one. So we also need to have a commercial case. I think that the trial, what we did confirm in the trial, were that we selected a dose.
Morten Albrechtsen: If we should do that, there's a couple of things we need to do beyond just getting it lighting up and beyond just using it on a very specific equipment. So first one, we need to get over the regulatory line. It has to be approved. We have to have it to work on multiple equipment that already is out there, and they may not be exactly as good as this very specialized equipment, but they are out there. Then last but not least, we need to have a commercial case. So we're going out having a probe, and it can be seen with a camera. No one want to buy it. I mean, helps no one. So we also need to have a commercial case. I think that the trial, what we did confirm in the trial, were that we selected a dose.
Speaker #2: So first, we need to get the goal over the regulatory line. It has to be approved. We have to make sure it works on multiple pieces of equipment that are already out there, and they may not be exactly as good as this very specialized equipment, but they are out there.
Speaker #2: And then, last but not least, we need to have a commercial case. So, going out, having it approved and it can be seen with a camera, but if no one wants to buy it, I mean, it helps no one.
Speaker #2: So we also need to have a commercial case. And I think that the trial—what we did confirm in the trial was that we selected a dose, and we also selected that the most interesting positioning, being helping the surgeon in the surgical room assessing the margin, is the application we go for.
Morten Albrechtsen: We also selected that the most interesting positioning being helping the surgeon in the surgical room assessing the margin is the application we go for. That is the most valuable because it fits into the workflow. So it is the most valuable for patient and for us and for shareholders application. We did prove that it worked on all the equipment we tested, and we have different kind of equipment. So it was actually as good as it could be. What we have said before is that we have almost 500 images for each patient that still is being analyzed. So some of the things that was mentioned is still being analyzed, and as soon as we have them, we will get out with it. So we selected the dose, the most valuable value proposition in the surgical room, worked with all the camera.
Morten Albrechtsen: We also selected that the most interesting positioning being helping the surgeon in the surgical room assessing the margin is the application we go for. That is the most valuable because it fits into the workflow. So it is the most valuable for patient and for us and for shareholders application. We did prove that it worked on all the equipment we tested, and we have different kind of equipment. So it was actually as good as it could be. What we have said before is that we have almost 500 images for each patient that still is being analyzed. So some of the things that was mentioned is still being analyzed, and as soon as we have them, we will get out with it. So we selected the dose, the most valuable value proposition in the surgical room, worked with all the camera.
Speaker #2: So that's the most valuable, because it fits into the workflow, so it's the most valuable for patients and for us, and for shareholders' application.
Speaker #2: We did prove that it worked on all the equipment we tested, and we have different kinds of equipment. So it was actually as good as it could be.
Speaker #2: Then what we have said before is that we have almost 500 images for each patient that still is being analyzed, so some of the things that were mentioned are still being analyzed, and as soon as we have them, we will get out with it.
Speaker #2: So we selected the dose. The most valuable value proposition in the surgical room worked with all the cameras, and that is what we have a result for now.
Morten Albrechtsen: That is what we have a result for now.
Morten Albrechtsen: That is what we have a result for now.
Speaker #1: I will just read this next question straight off as well. There are a moderate number of investors that think it's a little bit strange that you have to wait until 2027 to release the margin data at different conferences, and articles, and so on, in different mediums.
Operator: I will just read this next question straight off as well. There is a moderate number of investors that think it is a little bit strange that you have to wait until 2027 to release the margin data at different conferences and articles and so on in different mediums. Are you still analyzing, or is there some sort of agreement with the partners and the professors at UMCG that is stopping this release?
Operator: I will just read this next question straight off as well. There is a moderate number of investors that think it is a little bit strange that you have to wait until 2027 to release the margin data at different conferences and articles and so on in different mediums. Are you still analyzing, or is there some sort of agreement with the partners and the professors at UMCG that is stopping this release?
Speaker #1: Are you still analyzing, or is this some sort of agreement with the partners and the professors that you see that is stopping this release? And they finish by saying that they are very anxiously awaiting the result.
Morten Albrechtsen: Yeah
Morten Albrechtsen: Yeah
Operator: They finish by saying that they are very anxiously awaiting the results.
Operator: They finish by saying that they are very anxiously awaiting the results.
Speaker #2: Yeah, that's fair. There's a couple of things to it. No, we don't—we haven't—we don't have the data right now, because if we see something light up, we need the pathology slide as well to confirm if it was cancer or no cancer.
Morten Albrechtsen: Yeah. That's fair. There's a couple of things to it. We don't have the data right now because if we see something light up, we need the pathology slide as well to confirm if it was cancer or no cancer. So we need the whole circle, so to speak, before we can analyze it. We cannot ask the investigator to draw on all these 500 images for all the patients and then redraw afterwards. Of course, it takes time, but that's not the point. The point is more that we could impact the result of it. So we need to do it once and only once. Then we will come out with the data when it's there. This is a sponsored study, so it means that we own the data, and we can come out with the result when we are ready.
Morten Albrechtsen: Yeah. That's fair. There's a couple of things to it. We don't have the data right now because if we see something light up, we need the pathology slide as well to confirm if it was cancer or no cancer. So we need the whole circle, so to speak, before we can analyze it. We cannot ask the investigator to draw on all these 500 images for all the patients and then redraw afterwards. Of course, it takes time, but that's not the point. The point is more that we could impact the result of it. So we need to do it once and only once. Then we will come out with the data when it's there. This is a sponsored study, so it means that we own the data, and we can come out with the result when we are ready.
Speaker #2: So we need, we need the whole circle, so to speak, before we can analyze it. We cannot ask the investigator to draw on all these 500 images for all the patients, and then redraw afterwards.
Speaker #2: Of course, it takes time, but that's not the point. The point is more that we could impact the result of it.
Speaker #2: So we need to do it once, and only once. And then, last, we will come out with the data when it's there. This is a sponsored study, so it means that we own the data, and we can come out with the result when we are ready.
Speaker #2: But when there's no meaning coming out with them before we're ready, we could say something rubbish, which would make no sense. So really, for us, what's important to select the dose and work with the equipment is that we build this automated market assessment that we can implement into the next 10 patients, and we've put an amendment in for that.
Morten Albrechtsen: There's no meaning coming out with them before we're ready. We could say something rubbish which will make no sense. So really for us was important to select the dose. We work with the equipment. We build this automated market assessment that we can implement into the next gen patients, and we put an amendment for that. So we are more prepared for a regulatory trial after this one here. Well, that's all we can say now. I would love to say more, but it's not serious really.
Morten Albrechtsen: There's no meaning coming out with them before we're ready. We could say something rubbish which will make no sense. So really for us was important to select the dose. We work with the equipment. We build this automated market assessment that we can implement into the next gen patients, and we put an amendment for that. So we are more prepared for a regulatory trial after this one here. Well, that's all we can say now. I would love to say more, but it's not serious really.
Speaker #2: So we're more prepared for a regulatory style after this one here. So, well, that's all we can say now. I would love to say more, but it's not serious, really.
Speaker #1: Staying a bit with results and the academic side of things, earlier this year, Max Wietjes, who I understand is a leading surgeon, or?
Operator: Staying a bit with results and the academic side of things. Earlier this year, Max Witjes, who I understand is a leading surgeon or-
Operator: Staying a bit with results and the academic side of things. Earlier this year, Max Witjes, who I understand is a leading surgeon or-
Morten Albrechtsen: Yes, head and neck surgeon.
Morten Albrechtsen: Yes, head and neck surgeon.
Speaker #2: Yes, head and neck surgeon.
Operator: head and neck surgeon within
Operator: head and neck surgeon within
Speaker #1: A head and neck surgeon within this field published results in Nature about fluorescent-guided surgeries and live margin assessment. It showed that even with the fluorescent molecule used, it was not enough to assess the margin correctly.
Morten Albrechtsen: Yeah
Morten Albrechtsen: Yeah
Operator: this field. He published results in Nature about fluorescence-guided surgeries and live margin assessment.
Operator: this field. He published results in Nature about fluorescence-guided surgeries and live margin assessment.
Morten Albrechtsen: Yes.
Morten Albrechtsen: Yes.
Operator: It showed that even with the fluorescent molecule used, it was not enough to assess the margin correctly. They had to freeze the sample and then slice it before a final decision could be made. Is this a problem when it comes to your product, and is the plan to make some meticulous analysis such as done in this Nature article?
Operator: It showed that even with the fluorescent molecule used, it was not enough to assess the margin correctly. They had to freeze the sample and then slice it before a final decision could be made. Is this a problem when it comes to your product, and is the plan to make some meticulous analysis such as done in this Nature article?
Speaker #1: They had to freeze the sample, and then slice it, before a final decision could be made. Is this a problem when it comes to your product, and is the plan to make some meticulous analysis, such as what was done in this Nature article?
Morten Albrechtsen: Yeah. No, let's take one step back. One of the reasons we work with Max Witjes is because he is one of the leading head and neck surgeon within margin assessment and how to bring that into the workflow in surgeons. They really would like to do it, as also mentioned from the publication and the question here, they would like to do it in the surgical room because that is where the surgeon need it the most. If it should be implemented on sites beyond Max Witjes' place, then it also need to fit into the camera and be quick so it don't take up time. That is the whole idea of all his work, and that is why he loved to work with us as well because we could provide that opportunity potentially. This publication he did is based on a cetuximab dye that he has been worked with academically.
Morten Albrechtsen: Yeah. No, let's take one step back. One of the reasons we work with Max Witjes is because he is one of the leading head and neck surgeon within margin assessment and how to bring that into the workflow in surgeons. They really would like to do it, as also mentioned from the publication and the question here, they would like to do it in the surgical room because that is where the surgeon need it the most. If it should be implemented on sites beyond Max Witjes' place, then it also need to fit into the camera and be quick so it don't take up time. That is the whole idea of all his work, and that is why he loved to work with us as well because we could provide that opportunity potentially. This publication he did is based on a cetuximab dye that he has been worked with academically.
Speaker #2: Yeah. No, I mean, one of the reasons—let's take one step back. One of the reasons we work with Max Wietjes is because he's one of the leading head and neck surgeons within margin assessment, and how to bring that into the workflow in surgeries.
Speaker #2: And they really would like to do it, as also mentioned in the publication and the question here. They would like to do it in the surgical room because that's where the surgeon is needed the most.
Speaker #2: And if it should be implemented on site beyond Max Wietjes' place, then they also need to fit into the camera and be quick so it doesn't take up time.
Speaker #2: That's the whole idea of all his work, and that's why he loved to work with us as well, because we can provide that opportunity, potentially.
Speaker #2: So this publication he did is based on a situation map, die, that he's been working with academically, and it has some—what can I say—well, it will be used for this application that is mentioned here.
Morten Albrechtsen: Well, it will be used for this application that is mentioned here, so it is fluorescence-guided biopsy, and that is one of the endpoint we also looked at in our trials. But the best one to have is to help in the surgical room so we do not need to involve the pathologist or wait on it. The sooner and the closer to the surgeon we can provide the answers where they can make a complete resection and then avoid patient get into a radiotherapy afterward would be fantastic. Of course, one patient out of 15 is not much, but the one I visit, the last one I visit actually, there they find extra cancer in that particular patient that was helped remove. If the patient is cured or not, we do not know before after seeing the final result.
Morten Albrechtsen: Well, it will be used for this application that is mentioned here, so it is fluorescence-guided biopsy, and that is one of the endpoint we also looked at in our trials. But the best one to have is to help in the surgical room so we do not need to involve the pathologist or wait on it. The sooner and the closer to the surgeon we can provide the answers where they can make a complete resection and then avoid patient get into a radiotherapy afterward would be fantastic. Of course, one patient out of 15 is not much, but the one I visit, the last one I visit actually, there they find extra cancer in that particular patient that was helped remove. If the patient is cured or not, we do not know before after seeing the final result.
Speaker #2: So, it's fluorescent-guided biopsying, and that's one of the endpoints we also looked at in our trials. But the best one to have is to help in the surgical room, so we don't need to involve the pathologist or wait on it.
Speaker #2: So the sooner and the closer to the surgeon we can provide the answer so they can make a complete resection and then avoid the patient getting radiotherapy afterward would be fantastic.
Speaker #2: And of course, one patient out of 15 is not much, but the one I visited—the last one I visited actually—there, they found extra cancer in that particular patient.
Speaker #2: That was helped removed. If the patient is cured or not, we don't know before or after seeing the final result, but that was a really good case, you can say.
Morten Albrechtsen: But that was a really good case you can say. So it does help. To answer the question, that is one of the endpoint we have in the trial, but we think we have a better endpoint in our trial that we can do it real-time in the surgical suite.
Morten Albrechtsen: But that was a really good case you can say. So it does help. To answer the question, that is one of the endpoint we have in the trial, but we think we have a better endpoint in our trial that we can do it real-time in the surgical suite.
Speaker #2: So it does help. But to answer the question, there's one of the endpoints we have in the trial, but we think we have a better endpoint in our trial that we can do in real time in the surgical suite.
Speaker #1: And turning to you, Ole, again, to ask more questions about clinical trials then. How is the LGG trial moving along, and is Yannis still positive that they will be able to present results before the end of this year?
Operator: Turning to you, Ole, again, to ask more questions about clinical trials then. How is the LGG trial moving along, and is Jane still positive that they will be able to present results before the end of this year?
Operator: Turning to you, Ole, again, to ask more questions about clinical trials then. How is the LGG trial moving along, and is Jane still positive that they will be able to present results before the end of this year?
Speaker #3: Yeah, we came out in May that the first patient was enrolled, and the enrollment continues in the expected mode. So we haven't heard anything negative from Yannis, that she will still be able to provide some data.
Ole Larsen: Yeah. We came out in May that the first patient was enrolled, and the enrollment continues in the expected mode. So we have not heard anything negatively from Jane that she will still be able to provide some data. But again, we need to understand that they are in charge of the study, so they are the decision-makers. I do not know if you recall, but when we had the first 20 patients, the 10 in low-grade glioma and the 10 in meningioma, we actually got the results but were not able to publish them because she had to publish them at a conference. If that is the case this time, I am not sure, but for now, we still think that we will have the data within H2.
Ole Larsen: Yeah. We came out in May that the first patient was enrolled, and the enrollment continues in the expected mode. So we have not heard anything negatively from Jane that she will still be able to provide some data. But again, we need to understand that they are in charge of the study, so they are the decision-makers. I do not know if you recall, but when we had the first 20 patients, the 10 in low-grade glioma and the 10 in meningioma, we actually got the results but were not able to publish them because she had to publish them at a conference. If that is the case this time, I am not sure, but for now, we still think that we will have the data within H2.
Speaker #3: But again, we need to understand that they are in charge of the study, so they are the decision makers. I don't know if you recall, but when we had the first 20 patients, the 10 in low-grade glioma and the 10 in mini glioma, we actually got the results, but we were not able to publish them because she had to publish them at a conference.
Speaker #3: If that is the case this time, I'm not sure. But for now, we still think that we'll have the data within the second half.
Speaker #1: But the main thing to remember there is that they are in charge of that. Yeah. And as a final question, then, for you, Martin—in April, you mentioned during a presentation that you expected to present a conversation plan within a couple of months.
Operator: The main thing to remember there is that they are in charge of that.
Operator: The main thing to remember there is that they are in charge of that.
Morten Albrechtsen: Yeah.
Morten Albrechtsen: Yeah.
Operator: As a final question then for you, Morten, in April, you mentioned during a presentation that you expected to present a commercialization plan within a couple of months. Could you share any details about the plan, and when can we expect it to be presented?
Operator: As a final question then for you, Morten, in April, you mentioned during a presentation that you expected to present a commercialization plan within a couple of months. Could you share any details about the plan, and when can we expect it to be presented?
Speaker #1: Could you share any details about the plan, and when can we expect it to be presented?
Speaker #2: Mm-hmm. I mean, in the high-grade glioma, it's a low—it's a non-contrast enhancing angle. That's on the product that really will be the unique selling point and will drive it through.
Morten Albrechtsen: In high-grade glioma, it is a non-contrast-enhancing angle that is on the product that really will be a unique selling point, and we would drive it through. This was not validated, but it was supported by the Fast Track designation of FDA. To be clear, they grant it when you have potential, and then we have to address the secondary endpoint of the trial, and that is why they grant it. It is not necessarily you will keep it. It is only if you prove it, of course, going forward. That is what we aim for. So that is really the angle there. Seeing a brain tumor behind the blood-brain barrier is the holy grail in brain tumor surgery. This is really the hook. Of course, we have to see data for the trial, but then that one is on a home run.
Morten Albrechtsen: In high-grade glioma, it is a non-contrast-enhancing angle that is on the product that really will be a unique selling point, and we would drive it through. This was not validated, but it was supported by the Fast Track designation of FDA. To be clear, they grant it when you have potential, and then we have to address the secondary endpoint of the trial, and that is why they grant it. It is not necessarily you will keep it. It is only if you prove it, of course, going forward. That is what we aim for. So that is really the angle there. Seeing a brain tumor behind the blood-brain barrier is the holy grail in brain tumor surgery. This is really the hook. Of course, we have to see data for the trial, but then that one is on a home run.
Speaker #2: This was not validated, but it was supported by the Fast Track designation of FDA. To be clear, they grant it when you have potential; then we have to address it in a secondary endpoint in the trial, and that's why they grant it. It's not necessarily that you will keep it—it's only if you prove it, of course, going forward.
Speaker #2: But that's what we aim for. So that is really the angle there. And seeing brain tumors behind the blood-brain barrier is a holy grail in brain tumor surgery.
Speaker #2: So this is really the hook. Of course, we have to see data for the trial, but then that one is a home run.
Speaker #2: Then the next one is on the head and neck. There, it will take a few more months because we would like to present this more automated margin assessment, together with the rest of the data that's being analyzed.
Morten Albrechtsen: The next one is on the H&N. There, it will take a few more months because we would like to present this more automated margin assessment and together with the rest of the data that is being analyzed. It will take a few more months, but it is the automated margin assessment within surgical room fitting into the workflow that is the core headline.
Morten Albrechtsen: The next one is on the H&N. There, it will take a few more months because we would like to present this more automated margin assessment and together with the rest of the data that is being analyzed. It will take a few more months, but it is the automated margin assessment within surgical room fitting into the workflow that is the core headline.
Speaker #2: So it will take a few more months. But it is automated margin assessment within the surgical room, fitting into the workflow, that is the core headline.
Speaker #1: And with that, those were actually all the questions for now, but I am sure if you have any more questions, the gentlemen are happy to receive emails.
Operator: And with that was actually all the questions for now. But I am sure if you have any more questions, the gentlemen are happy to receive emails.
Operator: And with that was actually all the questions for now. But I am sure if you have any more questions, the gentlemen are happy to receive emails.
Speaker #2: Please, always.
Morten Albrechtsen: Please, always.
Morten Albrechtsen: Please, always.
Speaker #1: And again, thank you so much for coming here and presenting, and for answering the questions.
Operator: And again, thank you so much for coming here and presenting and answering the questions.
Operator: And again, thank you so much for coming here and presenting and answering the questions.
Speaker #2: Thank you for having us.
Morten Albrechtsen: Thank you for having us.
Morten Albrechtsen: Thank you for having us.
