FluoGuide A/S (FLUO) April 2026 Conference Transcript

Hi, and welcome to this live Q&A with FluoGuide, who just released their Q2 report. And we are joined by CEO Martin Alvidsson and CFO Willassen. And before taking your questions, they will give you a short presentation. So please go ahead.

We just have a few slides, just summarizing what has happened and where we are. So, as you know, we light up cancer to maximum surgical outcome. So we work with a U-Palm. is in the target that is intelligent, is expressed the most where you need it the most, so that's the forefront of the cancer. We are on oncology surgery, so we help the surgeon and the patient to get complete surgery. We have shown five positive clinical results in different indications, and every year, unfortunately, there are approximately 20 million patients that will be diagnosed with cancer, and we have the potential to help them. 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 US for high-grade glioma. We obtained the fast-track designation and that's on top on the orphan drug designation we have had earlier on. And we have the two ongoing trials right now, that's the high-grade glioma registration 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. Our lead indications is high grade glomer and 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 first regulatory trial that's been cleared with them in a pre-IND meeting before. So 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 and had a neck trial in Holland in Gruningen. And then we make 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 equipments, but I'll probably get more into that later. And 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. And this is a quite smart trial actually. I'm not the only one that have 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, as always risk when doing clinical trial. But the base case here is really good. And that's because of the end point we choose and that completeness of the section that's measured by MRI scan before surgery and after surgery. And 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. 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. Then additionally, this endpoint is what agreed to with the FDA would carry over to the phase 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 the trial would be kind of completed in 48 hours for the first endpoint which is the primary endpoint. And that's 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. And that is that it's been shown that if the COCO1 with a high likelihood passes the blood-brain barrier, and the problem for patients with high great glioma is that they have cancer behind the blood-brain barrier that today is not visible. And that is the potential that we can visualize that and actually help the patient additionally That secondary endpoint, if that comes out positive, is really a game changer in brain surgery, tumor surgery. So this is why it's smart. There's a good robust base case and then there's an upside on the trial.

Yeah. And turning over to the financial highlights. In first half, we had other external cost of 18.3 million. And 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 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 13.2 million in the first half. Then we have our staff cost that consisted of 9.7 million in the first half and finance which is primarily the interest from our loan with Fenja Capital of 1.6 million. and then the tax credit so far this year 5.2 million. There is a cap of the tax credit of 5.5 million so we will reach that during Q3 and then this one will not increase. Then that means that we have a net result of the first half of minus 24.6 million. If we go to the balance, we have assets of 65 million by the 30th of June, and of that, 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 11 million is the 5.5 million from 2025, which we expect to be paid out in November, December. and then the 5.2 million that we have collected or gathered so far in 26. 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. If we look at the outlook that we announced in November 25 in connection with our Q3, you can see that all our goals for first half was met apart from one, and that is the enrollment of the first patient in the U.S. Phase II trial for HDG. 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 for the last 10 patients, as well as we will present a tumor brain, a brain tumor plan also in second half. Then 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 27, in the beginning of 27. And we are still on track for an additional partnership in the second half of this year. And I think that concludes our presentation.

Thank you so much.

We will move on to the question part. And we've had a couple of questions sent in already. And let's start with you, Motten. First question is very straightforward. Why aren't any patients recruited yet in the HGG trial? And as this writer points out, it's been delayed three times.

Yes, that's correct. We ran into the summer holiday in the US, so we missed some site-specific approval and tests. But the important thing here now is that FDA approved our trial. It granted us a fast track. 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, it's very irritating, but it happened.

Yeah. Let's bring you in here, Iola, as well. A couple of months ago, Riksphospital announced that they will conduct a bigger H&N Phase 2 trial sponsored by them in 2026-27. Have you got any thoughts on that?

Yeah, I mean, it's more or less ready to start. And Richard Spitali, who is in charge and control the study, will inform soon. And 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.

And turning to you, Martin, I think on this one, in Marmbos last week, you confirmed the following about the HNN trial part one, and I will have to read this, The 30% to 40% that normally need re-operation, 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?

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 light up all patients. And this trial has been public in the public domain, so all the details are in the 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 O5, the one we just reported here, the key thing for us here is that we don't just want to do nice publications and nice trials. We really would like this technique to get out and help patients in all the corners of the world. And 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 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. And then last but not least, we need to have a commercial case. So we're going out having a proof and it can be seen with the camera and we cannot, no one wants to buy it, I mean helps no one. So we also need to have a commercial case and 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. So 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 in 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 is 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 as we have them we will get out with it. So we selected the dose, the most valuable value proposition in the surgical room, work with all the camera, that's what we have a result for now.

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 UMCG that that is stopping this release? And they finish by saying that they are very anxiously awaiting them.

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, no cancer. 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. 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. And then last 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. But when 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, it was important to select the dose, work with the equipment. 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 a regulatory trial 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.

Staying a bit with results and the academic side of things, earlier this year, Max Vietjes, who I understand is a leading surgeon or head and neck surgeon within this field, he 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. 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?

Yeah. No, I mean, one of the reasons, let's take one step back, one of the reasons we work with Max Vietjes is because he's one of the leading head and neck surgeons within a market assessment and how to bring that into the workflow in surgeons. And 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's where the surgeon needed the most. And if it should be implemented on sites beyond Max Vici's place, then it also needs to fit into the camera and be quick so it don't take up time. That's the whole idea of all his work. And that's why he loves to work with us as well, because we can provide that opportunity potentially. So this publication he did is based on a cetuximab dye 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. So it's fluorescence-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 a surgical room so we don't need to involve the pathologist or wait on it. So the sooner and the closer to the surgeon, we can provide the answer so they can make a complete resection and then a white patient get into radiotherapy after what would be fantastic. And, 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 don't know before after seeing the final result, but that was a really good case, you can say. 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 it real-time in the surgical suite.

And turning to you, Ole, again to ask more questions about clinical trials then. How is the LGG trial moving along? And is Janis 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. So we haven't 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 don't know if you recall, but when we had the first 20 patients, the 10 in low-grade glioma and the 10 in minigioma, 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'm not sure. But for now, we still think that we will have the data within the second half.

But the main thing to remember there is that they are in charge. And 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?

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 a unique selling point and will drive it through. This was not validated, but it was supported by the fast-track designation of FDA. To be clear, they're granted when you have potential, and then we have to address it in a secondary endpoint in a trial, and that's why they're granted. It's not necessarily you will keep it. 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. And seeing a brain tumor behind the blood-brain barrier is a holy gray 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. 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 and together with the rest of the data that's being analyzed.

So it'll a few more months but it is the automated market assessment within surgical room fitting into the workflow that is the the core headline and with that that was actually all the questions for now but i am sure that if you have any more questions the gentlemen are happy to receive emails please always and again thank you so much for coming here and presenting and answering the questions Thank you for having us.