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. 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 uPAR as 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. We have the potential to help them. We have partnered with the leading med tech companies in different types of equipment. We were very pleased here in the first half of the year where we got both approval for our first regulatory trial in U.S. 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 head and neck, oral 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. Our lead indications are high-grade glioma and focusing on the U.S. It was really an interesting first half of the year. As mentioned, we got the FDA submission and approval for our first regulatory trial. That has been cleared with them in a pre-IND meeting before. 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 15 patients in head and neck trial in Holland, in Groningen. Then we made the reporting of the result where we actually selected a dose. We had the most precision, best precision we could obtain within the surgical room, we could help the patient, and then it worked on all equipment. I will probably get more into that later. Then we have just opened the site for the first U.S. site that we can enroll patient now in our registration trial for high-grade glioma. This is a quite smart trial, actually. I am not the only one that has been involved with it. Actually, very little, but we have very good colleagues. 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 is 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 in this trial to be successful. 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. Additionally, this endpoint is what agreed to with the FDA will carry over to the phase III program. 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 a primary endpoint. Then, and that is a smart aspect of this trial, is on the secondary endpoint because there, 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 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. 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. Yeah. Turning over to the financial highlights. In first half, 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 the first half. 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 the first half. Then we have our staff cost that consisted of DKK 9.7 million in the first half, 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. That one will not increase. That means that we have a net result of the first half of -DKK 24.6 million. If we go to the balance, we have assets of DKK 65 million by 30th of 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. 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 burnt DKK 29 million in the first half. 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 first half was met apart from one. That is the enrollment of the first patient in the U.S. phase II trial for HGG. As Morten just mentioned, we got the final green light for the first site in the U.S. 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. 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 second half. We came out with an announcement on 2nd of July, telling 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 the beginning of 2027. We are still on track for an additional partnership in the second half of this year. I think that concludes our presentation. Thank you so much. We will move on to the question part. We have had a couple of questions sent in already. Let us 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. Yes. That is correct. We ran into the summer holiday in the U.S., so we missed some site-specific. It was delayed, some site-specific approval and tests. The important thing here now is that FDA approved our trial. They granted us a Fast Track. We have the first site. They have a green light today. We have had patients that just couldn't be enrolled because the formality was not in place. We have seven more sites lined up very close after. Yes. It happened. It is very irritating, but it happened. Yeah. Let's bring you in here, Ole, as well. A couple of months ago, Rigshospitalet announced that they will conduct a bigger HNN phase II trial, sponsored by them in 2026/2027. Have you got any thoughts on that? Yeah. It's more or less ready to start. Rigshospitalet, who is in charge and control the study, will inform soon. Okay. I can say that it's within robotic surgery, and it's in head and neck cancer, 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. Turning to you, Morten, I think on this one. In Børsen last week, you confirmed the following about the HNN trial part one, and I will have to read this. That 30%-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. That's because of you. Well, because of your product. It was done with existing equipment in the operation room. Can you confirm that all these statements are correct? It's not completely correct. I would like to confirm Absolutely 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 16 patients were enrolled and light up all patients. This trial has been public, 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 05, the one we just reported here, the key thing for us here is that we don't just want to do a, 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 corners of the world. 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. First one, we need to get over the line, 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 approved, and it can be seen with a camera and no one wants 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. 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's the most valuable because it fits into the workflow, so it's 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. Then what we have said before that we have almost 500 images for each patient that still is being analyzed. So some of the thing that was mentioned is still being analyzed, and as soon 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, that what we have a result for now. Right. I will just read this next question straight off as well. There is 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. Are you still analyzing, or is there some sort of agreement with the partners and the professors at University Medical Center Groningen that is stopping this release? And they finish by saying that they are very anxiously awaiting the result. Yeah, that's fair. There's a couple of things to it. No, 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 patient 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 mean that we own the data, and we can come out with the result when we are ready. 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, work with the equipments. We build this automated market assessment that we can implement into the next 10 patients, and we put an amendment for that, so we're more prepared for 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. Staying a bit with results and the academic side of things. Earlier this year, Max Wicha, who I understand is a leading surgeon or Yes, head and neck surgeon. head and neck surgeon Yeah within this field. He published results in Nature about fluorescence-guided surgeries and live margin assessment. Yes. 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? No, let me take one step back. One of the reasons we work with Max Wicha 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 Wicha's 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 work with academically. It has some, what can I say? 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 don't need to involve the pathologist or wait on it. The sooner and the closer to the surgeon we can provide the answers so they can make a complete resection and then avoid patient get into 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 removed. If the patient is cured or not, we do not know before after seeing the final result, but that was a really good case you can say. 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. Turning to you, Ole, again to ask more questions about clinical trials. How is the LGG trial moving along, and is Janux still positive that they will be able to present results before the end of this year? Yeah. We came out in May that the first patient was enrolled, and the enrollment continues in the expected mode. We have not heard anything negatively from Janux 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 second half. The main thing to remember there is that they are in charge of that. Yeah. Yeah. As a final question then for you, Morten, in April, you mentioned during a presentation that you expected to present a conversation plan within a couple of months. Could you share any details about the plan, and when can we expect it to be presented? Mm-hmm. In the high-grade glioma, it's this non-contrast enhancing angle that's on the product that really will be a unique selling point, and we will 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 it in the secondary endpoint in the trial, and that's why they grant it. It's not necessarily you will keep it's only if you prove it, of course, going forward. But that's 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, so this is really the hook. Of course, we have to see data for the trial, but then that one is on a home run. 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 and together with the rest of the data that's being analyzed, so 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. 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. Please. Something like that. Always. Again, thank you so much for coming here and presenting and answering the questions. Thank you for having us.
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