...that will have some part of the cancer hidden behind the blood-brain barrier. Having a drug that can pass the blood-brain barrier is really essential for illuminating all cancer for those patients.

That was the second thing that start playing into high-grade glioma trials in the terms that we have some endpoints that addresses this. Then the last thing, important, they think there'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 it also means that they help us and consult with us more frequently. Really, really a good quarter for us.

Yeah.

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 8.6 million Danish kroner, which is a combination of our R&D, primarily the head and neck study, but also the upstart of the Phase 2 study in high-grade glioma in US.

That consisted of 6.7 million, and then admin costs of 1.9 million. Then the staff costs of 4.6 million.

We had some finance costs due to the fact that we have a loan with Fenja Capital. Then we have a tax credit in Denmark that we are earning as we are developing, and that was a positive of 2.4.

Our net result for the first quarter was -11.8 million. If we look at our balance sheet, also very simple.

Our assets consist of 76 million, of which our cash and securities are 63 million. Then the tax credit from last year and what we have gained so far this year consists of 8 million, and then we have other assets of 5 million.

On the liabilities, equally simple: equity of 43 million, the loan just mentioned at 28 million Danish kroner, and then we have payables of 5 million kroner. If we look at the cash flow for the period, you can see that it's primarily the operations of 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 non-cash items.

The cash flow for the entire period is -15.6 million kroner. Then if we look at the KPIs we have put up, the outlook that we put up for '26, you'll see that we did get the submission for the IND to FDA, and we also got it approved, or we got the authorization.

We are still aiming for the first patient to be enrolled in our US Phase 2 study in the high-grade glioma. 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 meningioma.

In this first half, Rigshospitalet has initiated the enrollment of the first patient in the remaining 10 patients in that study. We still expect interim results of 50 patients for the first phase of the CT005 trial in head and neck.

We enrolled the last patient 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.

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 three 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. Do you understand that the market might be a little bit nervous about this study

is what the-- Of course, you could be nervous if you don't know, but that's why we're here to tell and explain what happened. It was correct it was delayed, but it was not only because of three 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 had bone involvement than used to be in this site. It was what happened.

When we do trials a single-site location, we are more vulnerable. We were very dependent on their expertise, so that was why we have set it up like this.

No, to answer your question, we will get the result, and the last patient has been enrolled into the study, and I could say that we was quite confident that this happened a month earlier than the 8th of May, but, unfortunately, the patient did not stop taking his anticoagulation. 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 surgery of the patient. That what happened.

It took one more month for the last patient than we thought. No reason to be nervous.

We are chewing data as we speak.

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 US trial starting up, obviously. How are you thinking about the cash runway given that the credit facility matures in April '27?

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, nothing changed in that.

We always get questions about fast track designation and what that means. With the fast track designation, if you should get conditional approval after the Phase 2b study, is the Phase 3 trial still needed?

Does that still need to be performed for FG-001?

FDA is always extremely data-driven. They want to see data before they make any kind of decisions.

Any promise or anything will just be speculation at this point in time. What is interesting is that, as I mentioned, with the non-contrast enhancement, being the cancer that hidden behind the blood-brain barrier.

That actually means that the patient today will not get a proper surgery, or it can be difficult to get a proper surgery because it's difficult to see that part of cancer hidden behind the blood-brain barrier. That needless to say very important for patients.

We've seen this being an important point for the neurosurgeons as well that they find it very interesting our drug for that reason. The fast track was an recognition of this as well as FDA see 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 built that in as secondary endpoint in the trial. Of course, if we have a very good, extraordinary result, things can change.

The default situation is that we need two trials for getting approval. That's what FDA has- They never commit like that, but that's what they've indicated they are directionally aligned with us on.

Then we have to see data. That's the best I can say now.

Of course, we will push ahead all we can if we get good data. It will be for the sake of patients, it'd be for the shareholders, it would be for everyone.

Of course, we will do that.

I know that the topics jump a bit because I'm just literally going through the questions as they come through the chat. We're staying a little bit on the clinical side of things.

Someone is wondering here about an estimate for when PTT and PDT, which is photothermal and photodynamic therapy, can go into the clinic. Can you say anything about that?

Yeah. We looked into the PTT, the thermal part of it.

We looked into that, and that could potentially have gone into 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'll not be able to combine the two.

What we're looking into now is other aspect of it, the PDT, which is a chemical, free radical creation, because that could better flow into the same application as we're looking for the fluorescence-guided surgery. What we promise is that we look into this rest of the year, and then we make a decision.

For now, it cannot go into the same clinical program as we run for the fluorescence-guided surgery. 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, What would you say the likelihood of potentially one additional partnership this year is? What's the status there?

Oh, that's extremely high, we believe. I think it's important, we don't want to have many partnerships really.

We want to have one of each kind, we want one for microscope, robotic surgery, endoscope, and so on. What we saw when we have covered, and that what we are covered now in the head and neck trial, we covered one of each kind.

What we saw is that we have interest for other partners as well. Now we close one of each, and, of course, if we could take one more in or maybe two more in, that could be fine.

We don't want as many as possible. We don't want to have a kind of, throw our drug to all partners.

We want to have for 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. We have some ideas, and, of course, we need to see what they think.

That's what we have to explore.

There are many exciting things happening in FluoGuide, and we have some interest here, 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, it's primarily for Danish investors.

It will be on site.

It's not too late.

Not too late.

Not too late. Turning back to the clinical trials, for the clinical trial in HGG, 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. No, that does not count in that, and also the low-grade glioma is investigator-initiated trial, so that's a couple of different sites, different protocols, it's not under our responsibility.

It is an investigator's responsibility. No, it does not include in there.

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.'

It means in normal language, it means that that's what we should consider very seriously. That, of course, what we do.

You take the hint.

We take the hint. That's a very sound hint,

and so

it makes sense what they're doing. 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.

It's also why having the fast track designation often means that there are higher likelihood of approval for the companies that get it. It's not the other way around, that you can say you will have a higher approval because you got it, but that is exactly why, because FDA tries to look around the corners for us.

Turning back to the PTT and the PDT and a question about valuation of US company. Once it goes into clinic, would you then be able to be valued as a company that treats cancer?

You're going from diagnostics to a cancer-treating company, and would that, yeah, would that be how you're valued then?

I think it's very early days with the PDT and PTT. We are still in pre-clinic.

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 two can be applied within, but that will then be based on the preclinical data. That's the next step.

Yeah.

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

They should look out for the data, the plans for what it means and how we go on from here. That's the 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?'

A plan for commercialization now? I think, well, we can share our thoughts on it, but I think on the head and neck, what's important for us is the partnering there, and it is because if we believe that one of the reasons for having this multiple partnership in head and neck is also because one of the key issues for companies of our kind, we have a big unmet medical need, but we need to get the routines changed at hospital, we need big forces to do that.

That's why we think it's important that we partner up with the large medtech companies, they will be part of that in our belief. We cannot say exactly how that will be rolled out in the next months or so, but we will say what the plans will be and then we can start executing on them.

Great. 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.

No?

I think we've been around.

Everything according to plan,

and

things are just progressing.

As I mentioned, execution, execution, execution is the buzzword for '26.

Those will be my questions for when we see you again

for the

Q2, then.

Sounds good.

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