Good morning, [audio distortion] welcome, Andreas. Thank you very much, good morning to everybody attending this morning. We're very excited about having reached a milestone in our clinical data. Before that, just a reminder of how our combined phase I and II study is. [audio distortion] It is studying our compound, the safety and the efficacy in malignant glioma. This is one of the most aggressive types of cancer in the brain. You see with the two green boxes, you see the phase I. The phase I is the first time this compound has been in humans. It's looking at safety, PK, which is the concentration in the body at different time points, and then also the efficacy. This is, does it light up the cancer? That's the whole idea to guide the surgeons. In this, we have up to eight cohorts in escalating doses. You always start with a low dose for safety reason, and then you gradually increase. We then follow if it keeps being safe when you go up in dose. In this study, in contrast to a lot of other studies, we also get a readout already here of the efficacy because we see whether it lights up the cancer. This is what we have now finished this dose escalation. Based on this, we will select a dose to move forward in the phase II study. We will there only operate with one, the optimal dose. We will also, before we embark on the phase II, we will also look at the optimal timing, when to administer the drug. Is it the evening before? Is it the same morning? There will be the Phase II study, which is really the efficacy part. Here we will compare where the cancer lights up with whether there is cancer in the tissue. This is where we actually are now. The phase I part is what we already finalized, or the dose-escalation part of the phase I. This is really the results from the phase I. How you read this table is that every cohort is a dose. You can see the dose increased from one to 36 mg. In these cohorts, it was planned that there were at least three patients at each dose. The patients had GBM, which is the aggressive cancer type in the brain. Two had another cancer, and I come a little bit back to that. You can see in the column saying light seen, how many of the cases it lighted up. You can see it was, apart from the lowest doses, it has been 100% that lights up. The most important thing, of course, in this phase I study is was it safe? Were there any issues? You can see there's a yes all the way down. There had been no major events with any of these patients, so we can conclude that this is a safe drug, and we can go into the phase II part. If we should summarize the results from the table, then a total of 27 patients have been enrolled. 25 of these had aggressive brain cancer, which was the idea, our indication, high-grade glioma. Two had other cancer types. The question is, why did we include patients that weren't high-grade glioma? We didn't. In reality, in the clinical reality, patients sometimes turn out to have another disease. These were patients where it was believed based on their MRI scan and other indications that this should be a high-grade glioma, but it turned out to be another cancer type. Interestingly, both of these cancers also lighted up. This already indicates that uPAR is not specific for one cancer type, which is what FluoGuide basically also is built on and will expand into. We got an early indication that it also works in other indication, that high-grade glioma. It has a very satisfactory safety and tolerability in all 27 patients. As mentioned previously, light was detected in 25 patients. Please remember that the two patients where it didn't light up were the patients at the very low dose, and these were basically not intended for moving into phase II but were basically part of the safety. That was not a surprise. Also, there was an increasing light intensity with increasing dose level. We gained something by increasing the dose, and this is what will be the background for which dose we will select to move into the phase II studies. Then again, the contrast was also seen and evaluated, of course, by the neurosurgeon. They lighted up, and this was very positive feedback we had from them. This means that we can proceed to phase II in aggressive brain cancer. You need phase I to be able to do that. We now will select the final dose regime, which is ongoing. We have all the doses now, but what remains to be seen is that on some few selected doses, we will look at when the optimal timing is. We gave the majority of the patients you saw in the table the compound the same morning, one group also the evening before. Now we will expand with a couple of extra doses also at other time points to make sure that we move forward with both the right dose and the right timing on when to give the dose to get the most out of FG001 to ensure a success when it goes into the phase II trial. The efficacy data from phase II, this is the study where we compare the biopsies where it lights up with whether it is cancer on pathology, that is expected mid-2022. Yes, FG001 can now initiate phase II clinical development. In other prevalent indications, I mentioned that we did see it in other brain malignancy. We will move into some of the prevalent indications like lung or breast. We are very pleased with the data we obtained so far. They are really positive and as good as we could have hoped for. Okay. Just give you an outlook of the future. One of the things that is extremely interesting and why this is such an interesting milestone for FluoGuide is that we have very short clinical trials in general. That means that we get a very short path to the market. Now we have the first product that demonstrated in the indication that it works and that is safe. That really means that we can expand it quickly into more advanced development, more patient for other cancer types, and we can do that very fast. The reason why we have such a short study is that the design of the study are very simple. The patient are included only 48 hrs in the study. They're included. The neurosurgeon or the surgeon are doing the operation under white light. They switch to the fluorescent light, the near-infrared light, the pathology will validate if the tissue that have been removed, in fact, is cancer or not. We have the result of our studies. We don't have to wait long time. We can actually do this in 48 hrs. We need basically two studies in principle to get approval. The 1st study, that's the one we have ongoing now in aggressive brain cancer, that addressing safety. We get a proof of concept in the sense that the cancer lights up, we get an estimation of the magnitude of benefit. What we mean by that is that how much benefit we can actually provide to the patient. That will be quite important because that will give an indication of the price we can take for the product in a fair way and then also the value of the company. That will be addressed with the histology data when we get them in Q1, then we get the first estimation of the magnitude of benefit we can achieve with FG001 in aggressive brain cancer. When we have this data, we go into a phase III study. Basically, it's the same design as our second part of the study. We just do it in a larger scale and address safety and efficacy in a larger scale. As you can see, we expect that we need more patients to document safety than efficacy, and that we can pool across different indications, meaning that we can also generate them in more prevalent indications. We can actually file in 2024. I should say, in all honesty, that in the 2024, meaning this, of course, will go next year, we will have regulatory interaction, and that is best estimation we have at the moment. Our pipeline also demonstrate how we expand the clinical benefit for FluoGuide over the coming years and how we expand the value of the company. We'll do that in three direction. The first one is that we will advance the development of FG001 in aggressive brain cancer toward approval. That we will do as fast as we can because that's a key value driver for the company. Another key value driver for the company is that we expand it into the more prevalent indications such as lung, breast, and colorectal cancer, as we then can get more patients treated and provide the benefit to more patients. Therefore, again, is a very significant value driver for FluoGuide. The last one is that the photothermal therapy, where we can remove cancer that has been invaded, for instance, in the brain, where in 30% of the cases, the surgeon will actually leave cancer behind because it has invaded into some critical function of the brain, and they cannot remove it without disabling the patient. With the photothermal therapy, we can actually sweep that area and potentially clean it for cancer without affecting the sensitive or critical function of the brain. It will be a major benefit for the patient, and then also potentially a value for the company. That way, we will add to the clinical benefit we provide to the patient. Advanced into late-stage development, more patients treated, more value to provide. That's the way we will actually work on the next year. Of course, we have FG002 that we have started up and will initially formally develop now here in Q4. The main reason for that is giving us more flexibility in the commercialization in the sense that we can price differentiate, and we can sell it complete compound to a partner. We should not sell it indication by indication. We feel in a quite good shape. Really to summarize the FluoGuide as we see it right now, we have a very large market we address. We have a very attractive platform, the uPAR guidance of surgery relevant for most patients. As Andreas said, it's very specific for cancer, but unspecific for the cancer type. We can go into the glioblastoma or the high-grade glioma, and we can spread out to the more prevalent indication. We've demonstrated the first product, it works and is safe, and we have a very scalable business model with quite high margins and prices. We have a lot of milestones coming up. Just a very near-term one is that we prepare our prevalent indication. It will be prepared in this year and be submitted next year, Q1. We have FG002 where we start up development. We have histology data in Q1 that will come into Q1 next year. We will use them to start the second part of the study, and we have result of that mid-next year. We have regulatory interaction with the EMA next year. We prepare for the phase III program that we start early in 2023. We have the photothermal therapy that we started up in development. We haven't put exact timing on that yet, and that will be announced when we have the development plan laid out. Then we will do the phase II result on our prevalent indication, the first of them. Really very dense news flow we have and very exciting year we are going in ahead. With that, I open up for the questions, and we're happy to answer whatever you would ask us for. Yes. My name is Thomas. I'm a consultant who is helping ask some questions here and moderate the Q&A. I have prepared a few questions for the two gentlemen here to start out with. For everyone attending the webinar, please look to your lower right side of the screen. There should be a small chat blue button that you can click on and find a place to enter a question. Then we will address as many questions as we can during this session. My first question is, does this mean that FluoGuide is able to go into any kind of treatment of any kind of cancer based on the safety data? I think that's why it's so important for FluoGuide and why we say it's a very important milestone for us because first, we have shown that it's well-tolerated. We have shown that it lights up cancer in a uPAR expressing cancer. That means basically all of them. Yes, we can for now, we don't have to have the safety set up when we test the study. Give an example, the prevalent indication we're now going into will go straight into a Phase II program. It will be an explorative program in the first one, most likely, but it will be a Phase II. Then actually, we have the efficacy data coming in next year. We can start up basically as many as we want. We can treat as many patients as we want. We don't have to wait certain time between the patient, as you typically do in a phase I setting, to be cautious and take care of the patient's safety. Really, we can expand quite quickly into quite many indication. The one that have attention for us, of course, is advances aggressive brain cancer toward phase III, and then is to take one of the two prevalent indications to start with and have key focus on that first. We can expand into any other indication quickly. I thought of a second question. What is the clinical investigator's experience with using the FG001? Do you have any kind of impression of that? Yeah, I might answer that. It's a very interesting question. First of all, it's important to understand that if this was a traditional drug clinical trial, then a phase I would just give you the safety and maybe the maximum tolerated dose. It's quite unique that you cannot blind this. The surgeons, they actually see whether it lights up. That's why we also say we have some degree of efficacy data as part of phase I. It lights up, but the question is it also useful? The feedback we have gotten from the surgeons involved in this study is that they, in particular now, when it lights more up at the higher doses, they are extremely excited. They actually say that they can really see that this could be useful. It should, with all fairness, be said that the real gold standard, of course, is that we need to see the pathology, that what lights up is actually cancer tissue. As they look at it subjectively, they say this can be of real need and where used. Really what's seen during surgery is that the tumor lights up, and then the tumor is removed, and then they can see whether it has been cleaned totally up. If there's something back that lights up, that's probably cancer. The tool for exactly the idea that FluoGuide is built on, that this should be a tool to make sure if you removed everything. All right. We actually have a few questions coming already. I'll save my last one for the very end, I think. One question is, what is the youngest age group included in the studies, given that 10% of patients are below the age of 18? I think I might also answer that. It's correct, that's one of the very interesting aspects of using it in brain cancer, that 10% of these patients are children. Of course, the potential gain of getting better surgery in saved lives or outcome and not getting disabled is of course even larger when it's in children. However, there are a lot of special things that come with doing pediatric studies. The logical way to do it is that what we do is an adult study. The answer is there are no children in our study group. Once, hopefully, that it has been shown to be very valuable and efficient, that would be an obvious thing to move into the pediatric population. As a first step and to see safety, it's always fair to start in adults if the disease is a disease shared by adults and children. Thank you. A new question. Can you elaborate on why it's exactly breast and lung cancer you have chosen for the next prevalent indication? Yeah. Yeah, I can also take that. It's a combination of many things and discussion with key opinion leaders within the different areas. It's the unmet need, how well in an indication where surgery normally is successful or in the majority, it's less interesting than in surgeries where often cancer is left behind. It's also the adoption. How used are surgeons in the field to use aids that use image guidance. For that reason, we have identified these indications, the prevalent ones as lung and as breast. It's still exactly the first we go into, that's still under discussion. It's a mixture of the unmet need and how it would be adopted. Yeah, I could maybe add to that. We'll definitely go for all of them. We'll just take them one at a row, we want to stay focused. What we do, we do successfully. We want to take them and be sure we have resources enough to take one by one. This is just important to say why we're not spreading out and jumping on all indications at the same time. Another aspect on that I just want to mention is that the equipment and the partnering is also quite important. There are some kind of surgery where the equipment are more present already, and that's one of the reason why we started out in aggressive brain cancer because all neurosurgeon have a microscope and it'll be more plug and play for us to introduce our product. There are some other kind of surgeries that are more open and where the equipment penetration would be lower, and that would be, we're going to say, timing-wise, it makes sense to come into those indications a little later. That also imprints the order we are selecting the indication into. Thank you. The next question, which may be a bit shorter to answer. Was there anything surprising for you with respect to the safety data readout? No. It may be a wrong word to use, but the safety was clean. We just do not overdo it when we release it in the press releases, but there were no issues at all. It was safe and well-tolerated. All right. Yeah. Maybe if I may add to that. One of the rationale for us choosing the product were that we're building on building blocks that are well-known, and the fluorophore we use been approved in the market since 1959 or 1960 in the U.S., and there's a lot of safety data generated on that fluorophore, and it's clean. It reduces the risk for surprises significantly. Also we did a toxicology program in our preclinical safety program that actually almost complete what we need for going into the market. We actually see on a very high dose that we see no side effect in the animals. The prediction were there would be no side effect, but always it's nice to see it in man as well. I think in a way we could sum it up in the way that we didn't see any issues, and it didn't come to us as a surprise. No, exactly. All right. Thank you. There is one amongst the audience who say congratulations with the excellent results. If all the trials keep on going well, when is the actual product ready to hit the market worldwide? Our current estimation is that we submit in 2024. I would say that next year we will have two meetings with the FDA, and we've chosen to take the regulatory meetings when we have data, because then the feedback we get from the agencies, I mean, the first data, which we have now. Because when we have the first data, the feedback we get from the agency will be much more reliable, and it will be more clear what is the guidance we get from them. Next year will be quite important for us to fine-tune that time. 2024 for submission is our current estimation. All right. Next question. Can you explain the difference between histologic data and the efficacy data? How is it possible to estimate the magnitude of benefit prior to the efficacy data? Yeah. Basically what this tool does or should do is that it should indicate where the cancer is. This is the efficacy we are going for. That's why histology is really the main efficacy readout. If it lights up, then it's cancer. If it doesn't light up, it's not cancer. That is why the efficacy is the histology data, because then it's a tool to be used across cancers for surgeons. That's the link. All right, thank you. Do you have anything you'd like to add, Morten? You look a bit like you may have something to add. Yeah, I'm just thinking. The magnitude of benefit, the one thing that is problematic from the surgeon nowadays is that it's easy for them to see the middle of the cancer. It could be necrotic, and it's easy for them to see. What is really difficult is to see where it's going to the normal tissue, so delineating between the cancer tissue from the normal tissue. Our expectation is that we can see that very precisely well-defined. If that's the case, which the histology will demonstrate, then it'll be a major benefit for the surgeon to make that precise removal of the cancer. That's what we mean with the magnitude of benefit, that the better we can do that, the better it will generate data for the patients in terms of clinical benefit and the higher the price potentially would be. The magnitude of the histology result will really give an indication of how good and how high we can price it. Also maybe one should remember that in neurosurgery in particular, that it's really both that you need to remove the cancer, but you should not remove too much healthy tissue, because for obvious reasons, that will give you neurological deficits afterwards. This is kind of in the long term, it hopefully will improve the lives for the patient in several ways across cancers, and that's both more precise operations, more gentle operations if you want, but also giving a better outcome by removing all the cancer. All right, thank you very much. The next question is I think is typical in the oncologist space. How many of the operated or the patients that has been operated on have had relapses or are dead? Yeah. I can answer that. It is a very good question. This is not an endpoint in the study. You have to remember that because we haven't proven finally that we demonstrate cancer, then the surgeons, they have this, they can look at it, but they don't use it. They do the surgery as they do normally. The outcome in these patients will be like on the population in general, and that is unfortunately with a median survival of only a little more than one year and 95% of patients being dead after five years. For this population, the rates of relapse and death is not different from the overall, but that's because the surgery is not yet guided by our technology. All right, thank you. There is someone asking, thank you very much for the presentation. Going forward, how do you expect to finance new tests, expansion, etc.? When do you expect new liquidity to be raised and so on? I would say this is a general financing question. Yes, thank you for that. I think one of the things what we have done so far in FluoGuide, we've been very capital efficiency, very high. We get a long way from the capital we have raised. We raised SEK 75 million just before summer, and that actually will bring us through next year. We are quite well-financed for what our plan. Of course, down the road, if we should expand and utilize our values, that is what we'll have look at at that time. For now, we are well-financed to do what we have outlined in milestones. One more question, and this is looking a bit further out into the future, I think. What would be the market size of the prevalent indications compared to the brain cancer setting? Do you have any current figures on that or ballpark figures? Yeah, just roughly, there's about 330,000 patients with high-grade glioma in U.S. and Europe per year incidence. In lungs, about 1 million. It's a quite much higher number than it is in lung cancer patients. The value we create is higher in brain cancer that justify a higher price. The value of the market could be not that different, but the number of course is significantly different. All right. Thank you. I think that those were the questions. I have a final question. Anyone in the audience would like to ask additional questions, please come forward now. What are the next milestones to look forward to for the company? Would that be one particular one, or is there a few? The nice thing with FluoGuide that we have such shorter development time that we produce ample of milestone. I just mentioned them on the slide. We have the result of the histology result in Q1. We start the second part of the study. Have result mid-next year, aggressive brain cancer. We will start a prevalent indication, have the result next year. We will prepare the phase III next year, start at beginning of 2023. Regulatory meetings next year. Photothermal therapy. There'll be a huge number of very important milestones for patients and investors. We look forward to extremely exciting next 12 months. Thank you, Morten and Andreas, for giving us this presentation. We have now reached the end. We don't have any more questions. Do any of you have any closing remarks before we end the presentation? I think it's great. We expected to get to where we are now is of course nice, but really it's going exactly as we planned it and we have no other belief that it will continue this way. We look forward to extremely, as I said, exciting 12 months ahead of us now. I should remember to say as the last comment, then someone in the audience is saying, "Great by you and the team. Please continue the good work and the great job." This greeting has hereby been passed on, so I wish you good luck with the future development. Yeah. Thank you. Thank you. Thank you. Thank you for your support as well. Yeah. Thank you for attending. I'll close the presentation now.