FluoGuide A/S ($FLUO)

[Audio Gap] have the penetrated truck brain barrier. And that means today that the nose will not all be able to see their cancer. And for about 20% to 30% of the patient that will have some illuminating all cancer for those patients. And that was the second thing that started playing into the [indiscernible] trials in its terms that we have some endpoints that addresses this. And then the last thing was that FDA granted us a fast track, which means that they will I think it's an important thing that's an unmet medical need and that they will really like to support us to get to the market as fast as possible. This, of course, means that we get more and more questions from them, but also mean that they help us and consult with us more frequently. So really, really a good quarter for us. And yes. And if we look at the numbers, we still are a company in development so we don't have any revenues. We have other external costs in the quarter of DKK 8.6 million, which is a combination of our R&D primarily the head and neck study, but also the upstart of the Phase II study in high grade glioma in U.S. That consisted of DKK 6.7 million and then admin cost of DKK 1.9 million. Then the staff cost of DKK 4.6 million. We had some finance costs due to the fact that we have a loan with Fine Capital. And then we have a tax credit in Denmark that we are earning as we are developing and that was a positive of DKK 2.4 million. So our net result for the first quarter was minus DKK 11.8 million. If we look at our balance sheet, also very simple. Our assets consist of DKK 76 million, of which our cash and securities are DKK 63 million. Then the tax credit from last year and what we have gained so far this year consists of DKK 8 million. And then we have other assets of DKK 5 million. On the liabilities, equally simple, equity of DKK 43 million. The loan just mentioned at DKK 28 million and then we had payables of DKK 5 million. And if we look at the cash flow for the period, you can see that it's primarily the operations of DKK 15.2 million, and that is more or less the net result minus the tax credit that has not had a cash impact yet, and some other noncash items. So the cash flow for the entire period is minus DKK 15.6 million. Then if we look at the KPIs, we have put up the outlook that we have put up for '26, you will see that we did get the submission into for the IND to FDA and we also got it approved, we got the authorization. We are still aiming for the first patient to be enrolled in our U.S. Phase II study in the high-grade glioma. And then on the investigator-initiated study, Morten mentioned that we got the interim results for the first 10 patients in low-grade glioma and also 10 patients in mini glioma. But in this first half, we have also initiated or [indiscernible] has initiated the enrollment of the first patient in the remaining 10 patients in that study. We still expect interim result of 50 patients for the first phase of the CT-005 trial in head and neck. We enrolled the last patient in early May and expect to see results in June. If we look at the goals for second half, we haven't met any of them yet, but we are still on track. And I think that -- the key word for the first quarter, and I think for the '26 will be execution of the plans that we basically put together last year.

Let's move on to the Q&A section of the proceedings. You did talk here about the head and neck study, and it was postponed from H2 '25 to H1 '26 because 3 patients did not meet the inclusion criteria. We've had a question here about whether or not the second half of the study will be delayed in a similar way, and if you can -- do you understand that the market might be a little bit nervous about this study is what the.

Well, of course, you can be nerve. If you don't know, but that's why we had to tell and explain what happened. So it was correct, it was delayed, but it's not only because of 3 patients. It was also because in the patient, we didn't want to have bone involvement in the cancer and there were more patients that have grown involvement than they used to be in this site. So it was what happened. When we do try a single site location, we are more valuable, but this trial was really very dependent on the expertise. So that was why we have set it up like this. Now answer your question, we will get the result, and we have the last patient has been enrolled into the study. And I could say that we were quite confident that this happened a month earlier than the 8th of May. But unfortunately, the patient did not stop taking his anti-correlation. I was actually at the site with a partner. We were sitting there the whole day waiting on them making a decision and they decided not to do the strategy of the patient. So that's what happened. So it took more months for the last patient that we then we thought. So no reason to be nervous we are seeing data as we said.

So no big drama there, but something that happens in clinical studies.

Yes.

We've also had a question here about the R&D costs, which jumped significantly if you compare to Q1 last year, and that's largely due to the U.S. trial starting up, obviously. How are you thinking about the cash run rate given that the credit facility matures in April.

Yes. As we have mentioned earlier, we still have the cash runway until the end of Q1 '27. The increased R&D spending in the first quarter is absolutely according to plans. So nothing changed in that.

And we always get questions about Fast Track designation and what that means. So with the Fast Track designation, if you should get conditional approval after the Phase IIb study, is the Phase III trial still needed. Does that still need to be performed for FG001?

I mean if there is always extremely data-driven, they want to see data before they make any kind of decisions -- so any promise or anything will just be speculation at this point in time. But what is interesting is, as I mentioned, with the noncontrast enhancements, so being the cancer that's hidden behind the blood-brain barrier. And it actually means that that the patient today will not get a proper surgery because -- or it can be difficult to get a proper surgery because it's difficult to see that part of cancer hid behind the broad brain barrier. So that needless to say, very important for patients. We've seen this being an important point for the neurosurgeons as well. They find it very interesting in our drug for that reason. And the Fast Track was a recognition of this as well as FDIC, there's an unmet medical need in this indication, meaning that even if there's a product approved, they believe our product can do something that is solving an unmet medical need, which we believe is that property. We build that in a secondary endpoint in the trial. And of course, if we have a very good extraordinary result, things can change. But the default situation is that we need 2 trials for getting approval. That's what FDA has they never commit like that, but that's what they have indicated they are directionally aligned with us. And then we have to see data. I mean, that's the best I can say now. But of course, we'll push ahead. All we can if we get good data. It will be for the sake of patience, it will be for the shareholders. It will be for everyone. Of course, we will do that.

And I know that the topics are -- they jump a bit because I'm just literally going through the questions as they come through the chat. But we're staying a little bit on the clinical side of things. So someone was wondering here about an estimate for when PTT, which is [indiscernible] and photodynamic therapy can go into the clinic. Can you say anything about that?

Yes. We looked into the PTT, I mean, the channel part of it, we looked into that and that could potentially have gone in to be combined with this program. we realized then that the dose needed for the PTT was much higher than we need for the fluorescence guidance, and that means that we will not be able to combine the two. So what we're looking into now is the other aspect of the PDT, which is a chemical free radical creation, because that could better flow into the same application as we are looking for, for the presence guidance [indiscernible]. What we promise is that we look into this rest of the year and then we make a decision. But for now, we cannot go into the same clinical program as we run for the [indiscernible] surgery. And when it will go into clinical testing, we'll need to see the data for this year before it makes sense to put it into a trial.

Turning a bit more to the business side of things or to the partnership side of things, at least. Is there what would you say the likelihood of potentially 1 additional partnership this year is? What's the status there?

That's extremely high. we believe. But I think it's important we don't want to have many partnership really. We want to have 1 of each kind. So we want to 1 from microscope or robotic surgery endoscope and so on. But what we saw when we have covered and that what we have covered now in the head and neck trial, we cover 1 of each kind. And what we saw is that we have interest for other partners as well, now we close 1 of each. And of course, if we could take 1 more or maybe 2 more in that could be fine. But we don't want as many as possible. We don't want to have a kind of a throw out our drug to all partners. So we want to have the next phase, and that's important. Now we have the result of the head and neck during this next month. And then there will be the start of a dialogue with partners, how we could take to the next phase. And we have some ideas. And of course, we will need to see what they think and that's what we have to explore.

And there are many exciting things happening in FluoGuide, and we have some interest here in. I know you're hosting an event on the 2nd of June. Someone wants to know if it's too late to sign up for the live simulation of that event.

No. It's not Unfortunately, it will be in Danish. So it's primarily for Danish investors, and it will be on site.

But it's not too late.

Not too late.

Turning back to the clinical trial. So the clinical trial in HTG, you have mentioned 66 patients, the 10 patients from low-grade glioma, they do not count in this estimate or are they included in that?

No, that does not count that. And also the low grade glioma is investigating trial. So that's a completely different site, different protocols. So it's not under our responsibility investigators responsibility. So no, it does not include in there. And I mean, that was an example of the Fast Track designation FDA comes back to us and say, "Well, we think you should reconsider the number of the patient because then it will better support us going forward." And it means in normal language, you mean that, that's what we should consider very seriously. So that's, of course, what we do.

You take the hint.

we take the hint, I mean, and that's a very sound hint. So it makes sense what they're doing. But that's part of being under the Fast Track as well. that they sometimes suggest you to do more than you think you should do yourself, but it may have a good reason further down the road. So it's also why having a Fast Track designation often means that the higher likelihood of approval for the companies that get it. It's not the way around that you can say, but you will have a higher approval because you got it. But that is exactly why because FDA trial look around the corners for us.

Turning back to the PTT and the PDT and a question about valuation of U.S. company. So once it goes into clinic, would you then be able to be valued as a company that treats cancer, like you're going from diagnostics to a cancer treating company? And would that -- yes, would that be how you value them?

I think it's very early days with the PTD and PTT. We are still in preclinic. And as Morten mentioned, we'll see the preclinical data and make some kind of a conclusion of how to further develop by the end of the year. How that will be. I think we simply need to see the conclusions from the preclinical and how we will go about this.

Because there's also a question about how many areas that these 2 can be applied within, but that will then be based on the preclinical data. That's the next step.

Yes.

With the head and neck cancer trial, like I said, you just finished enrolling the first patient, what should investors be looking out for in the -- as the next milestones in that trial?

Yes, as you look out for the data, the plans for what it means and how we go on from here. That's a key thing I would look out for.

Just got a new question here that in April, you spoke about a plan for commercialization for head and neck within a couple of months. Is that a plan that you can elaborate on?

Plan for complication now I think, well, we can share our thoughts on it. But I think on the head and neck, what is important for us is the partnering there. And it is because we believe that 1 of the reasons for having this multiple partnership in [indiscernible] is also because 1 of the key issues for companies of our kind, we have a big unmet medical need, but we need to get the routines changed a hospital. So we need big forces to do that. So that's why we have -- we think it's important that we partner up with the large medtech companies. So they will be part of that in our belief. So we cannot say exactly how that will be rolled out in the next month or so, but we will say what the plans will be and then we can executing on them.

So that was actually all the questions that had come in. I just wanted to ask you if you have any final words before we end the broadcast.

No.

Everything according to plan. Things are just progressing.

As I mentioned, execution, execution and execution is a buzzword for '26.

Those will be my questions for when we see you again for the Q2 then.

That's good.

Thank you so much, gentlemen, for coming and for answering the questions. And thank you so much for watching. And we will hopefully see you soon.