Much for the introduction, and thank you for listening in here. I am going to give a status of FluoGuide, introduce FluoGuide to those of you that do not know it today. Unfortunately, quite many patients have cancer, and unfortunately, quite many of those patients will experience local recurrence of the cancer after surgery. That is what we try to solve. The way we solve it is that we light up cancer. If you look at this one, that is how the surgeon will see a tissue today, and they should decide where to cut, because in here there will be cancer. With our product, we can switch on the light. That is a patient that had been given our drug prior to surgery, and then during surgery, it is being visualized with the equipment. That is basically what we do. Please make your own assessment in this one. In FluoGuide, we have quite a large potential. There will be 45 million procedures done in patients with cancer in 2030, so quite a huge market. We have an intelligent solution to it. We target the uPAR, which is an enzyme system that is placed in front of the cancer. The more aggressive the cancer is, the more they want to spread, the more uPAR is expressed, and the more relevant it will come for being lighten up with us. We have been validated. We have clinical trials. We have the first endorsement by a regulatory agency. It is FDA that granted us a Fast Track designation in the U.S., meaning that they see an unmet medical need in our lead indication. That lead indication is high-grade glioma, and it is just a small fraction of the total number of patients, but it is a very interesting entrance point for us. We have done partnership agreements with the med tech companies of each kind, so a microscope vendor, we can say robotic equipment manufacturer, and open field camera. Many of the big ones. We do that, takes time, but we do that now to prepare a more smooth penetration. Last but not least, we have several value inflating point coming up over the next 12 months. What we do is on the left side, that is a freeze-dried powder. It is a drug. It has been injected into the patient prior to surgery. Then it will circulate in the body or bind to the cancer. What is not bound to the cancer will be removed, and then during surgery, the surgeon can switch on the light, and they can see the cancer. Out on the right side, you can see two presentation of it in different equipment. The one you saw before with the color, the other one below that one is a black and white presentation of it. That is how it looks on equipment. We are focusing in, although that as mentioned before, it could be relevant for all solid states cancer that undergo surgery. We are focusing in on two areas. One is the brain tumors, and the other one is head and neck cancer. Within the brain tumors, we are focusing in on a small indication there, high-grade glioma, because it is very aggressive and because we have shown very good data, and we have been granted the Fast Track by FDA. The next image, it will be a bit bloody, so if you do not like blood, close your eyes. I will say when you can open them again. I just want to show you how it looks for a surgeon. The left side, that is how it looks today for a surgeon. On the right side, that is how it looks when they turn on the light, and they can see the cancer. This one is where they have removed the bone, and they look onto the surface of the dura, it is called, it is on top of the brain. The cancer is hidden down underneath, but you can see it shine through on the image over there with some light coming up. You can see it is there down underneath. Then the surgeon will remove this dura so they can get to the tissue. You will see that in a second. Then they remove the dura, and they still have a lot of normal tissue on top of the cancer. Here you can see it, and you can still see the cancer that shines through this normal tissue. What the surgeon then want to do is that they do not want to remove all that normal tissue. They want to just kind of push it apart so they get underneath it to get into the tumor underneath. Now you can see on the right side how it looks that they begin to see some white strong lighting tissue down in the bottom of the cavity, and that is how our drug actually light it up. What you will see is that it is not kind of a round, well-defined portion of cancer. Cancer in the brain particularly is not very well-defined. That is why it is a need for being light up. It is how it looks, and it will be different concentration of cancer cell in the tissue. The surgeons have an educated information now how risky it is for the patient if they leave this tissue behind and what it actually mean functional for the patient if they remove it. As you can see on the right side, that is what they today should make a judgment of on the left side over here on the right tissue. Pretty difficult, really. That is what we do. When you even open your eyes again, if you have closed them, what we do then in terms of doing the diagnosis is that when patient gets in, when you have very aggressive brain cancer tumor, the blood-brain barrier will normally have been destroyed. The way you do the diagnosis for the neurosurgeons, that you give them some contrast agent, gadolinium, and you see that gadolinium is mark the area in the brain where you have a suspicion that there could be a cancer. If it does, then it is a red area, and that is called contrast enhancement of the tumor. That is the way the surgeon make a decision and say, "Well, it is most likely a very aggressive cancer because the blood-brain barrier have been destroyed. We have to do immediately surgery and remove it out." They are now educated that this is the area where they have contrast enhancement, where the blood-brain barrier is destroyed, and then on the right side, that is where they will remove it. Now, what they do not see, they do not see the small green spot that is infiltrative cancer. 20%- 30% of this high-grade glioma will have that infiltrative cancer that is not visible on the contrast enhancement, but should ideally be removed as well. What you have a risk in that case is that the cancer comes back because its non-enhancing infiltrative cancer will actually regrow and make the patient ill again. The neurosurgeon knows about this, of course. What they have tried to then find an MRI scan that make a larger area. They have this FLAIR, they call it, and it visualize a tissue water in the tissue, for instance, edema or things like that, but it is still normal tissue. What the surgeon then do, they get the infiltrative cancer, but they also get a lot of more tissue out, and that you can see on the right side with a lot of bigger area of brain that is removed. The problem there is that the patient gets functional impairment because they remove too much. The holy grail in brain tumor surgery is actually removing the cancer as well as the non-contrast enhancing infiltrative cancer. That is a green spot. That is exactly why FDA granted us a Fast Track, because they have a reasonable belief that this is what we can do. In our trials, we have had a discussion with Ahmed both on a phase II trial we are now running and also on a protocol for the phase III trials. What the primary endpoint will be would be the first line. That will be contrast enhancement of the tumor. How much and how complete will we do that removal? Let us say it is an easy endpoint, but it is a relatively easy endpoint because that the least you should have removed for the patient to do some good to them. That is the endpoint FDA like us to prove on a regulatory trial. Then if we can remove them additionally, some of the infiltrative cancer as well, that we look at on secondary endpoint, that would be a major gain because that actually is a whole grail really now. That was why they granted us the Fast Track, because they believe there will be a reason that we can do that. The phase II trial look at this primary endpoint, so that just the contrast enhancement on complete surgery, how much have we removed there? Then we have on a secondary endpoint, we look at these other endpoints, and we have the result. We do a trials right now, and then we have in a year's time, we have the result of it. We go to the FDA with the end of phase II meetings, and if we have positive finding on the secondary endpoint, we have a possibility to reduce the phase III. It could be a shorter phase III trial, it could be no phase III trial, or it could be a conditional phase III trial. We have a kind of a base case for the primary endpoint, which is a relatively, I am not say easy, but relatively simple to demonstrate. Then we have upside on a secondary endpoint that is really what the surgeon and FDA would like to see. That is the brain. Then there is head and neck, the other indication we are looking at. There is two aspect of the head and neck. One is all cavity cancers where you today you take out the tumor, you look at the margin. You would like to have normal tissue around the cancer when you remove it, 5 mm. If you do not have normal tissue around the tumor, then the patient will be determined or being categorized as non-complete surgery, and then they have additional treatment after surgery. The problem is that you first get this knowledge 7-14 days after surgery. What you would like to the neurosurgeon, or sorry, not the neurosurgeon, the head and neck surgeon would like is that information in the surgical room instantly, because then they can act on it. They can see that the patient had not normal margin around the tumor, so they can remove more tumor for the cavity. They can actually move the patient from having an incomplete surgery to complete surgery and save them radiotherapy and chemotherapy after surgery. The other aspect of head and neck surgeons are the complex located those in the neck or throat and pharynx. You cannot get there without an equipment. So there, this robotic system where you have all the arms, you can get down to the throat, but what they need, they need a product that could actually see the cancer like ours. So in that case, we will be a kind of enabler for them. That means that we have two partnership opportunity in the head and neck space. One is for this instant assessment of the margin in the surgical room. The other one is for robotic surgery or scope surgeries. That is what we pursue now with the data we have. More data will come next summer, but we start that process now. That is the companies we have agreements with now. So we have one of each kind of equipment, more or less. In terms of the market size, we start out with this high-grade glioma in the U.S., 13,000 patient. Then there is head and neck and brain. Europe and U.S. is 640,000 patient, DKK 2 billion market share. Then you have the sky the limit almost if you look all solid states cancer. But we start out with this high-grade glioma in the U.S. and build the case around that one. We have ample of endpoints coming up. With that, I thank you for your attention. Well done. Maybe you want to talk about some milestones you have coming up. Yes. Yeah. Key milestones coming up is that we are running at this low-grade glioma as well, which is demonstrating the blood-brain barrier penetration of our drug. That will come data on that in Q4. We will come more data on head and neck trial. We had the first 15 patients where we have the top line. That was selection of dose that came out in summer. We will have more information about the instant detection of the margin, how we do it and what it will mean in our trial coming out end of the year. We probably have one to two more partnership will come out as well on the same kind that we've done today, and then we have kind of completed the plate. That's just in the next six months time. Right. I think Natasha has a question. Yes. Thank you so much for your presentation. I see that this drug will ultimately work together with these imaging hardwares. Who will own the customer relation? Is it you or is it the hardware company and what is the model there? Yes. Thank you. The model is different from brain and head and neck. In the brain, all neurosurgeon have a microscope, so that means that and our product fit into the microscope. The microscope out there today can see our product. So it's an easy implementation. We sell the drug and they can use it. In head and neck, they have less equipment out there. So there we want to work with equipment manufacturers because they can sell more equipment and particularly for the complex located cancer, a company like Intuitive Surgical or the scope manufacturers, Olympus, Karl Storz, companies like that, they can sell more equipment to get down to the throat. So you can say we will both own the customers, but particularly in the brain, we will own them completely. In head and neck, we will work together with the equipment manufacturers about them. As a final question then, you need a first patient in, don't you? In a- Yes. Thank you for asking that. Yes, we need a patient in. We promised the first patient in in June. You did. We still haven't had the first patient in, but we are so close, and I keep saying that, I know. But yes, everything's clear. The physician is back from vacation. Everything is ready to go. It is happening. We need a patient. The delay is partly due to physicians being away or- Yeah factors. Some qualification of an MRI scanner and so on. It is all ready and it is absorbed in the extra time we gave for the study. There is no issue, but it is just irritating. Right. Well, thank you so much, Morten. Thank you.
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