Investor Call

Oct 11, 2021

Good morning and welcome to the presentation of the Thank you very much and Good morning to everybody attending this morning. So we're very excited about having reached a milestone in our clinical data. But before that, just a reminder of how our combined Phase 1 and 2 study is And we target this market when you are that is expressed across cancers but also in glioblastoma, aggressive breast cancer. It's an open label, non randomized dose escalation study. And it will be in several sites when we move into So you see with the 2 green boxes, you see the Phase 1. And the Phase 1 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. So this is, does it light up the cancer? That's the whole idea to guide the surgeons. In this, we have up to 8 cohorts in escalating doses. You always start with a low dose for safety reason and then you gradually increase. And we then follow if it keeps being safe when you go up in dose. And 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. So, and this is what we we have now finished this dose escalation. Based on this, we will then select a dose to move forward in the Phase II study. We will there only operate with 1, the optimal dose. And 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? And then there will be the Phase II study, which is really the efficacy part. And here, we will compare where the cancer lights up with whether there is cancer in the tissue. So, this is where we actually are now. But the Phase 1 part is what we already finalized. And, or the dose escalation part of the phase 1. And this is really the results from the phase 1 and how you read this table is that every cohort is a dose and you can see the dose increase from 1 to 36 milligrams. And then in these cohorts, it was planned that there were at least 3 patients in at each dose. The patients had GBM, which is the aggressive cancer type in the brain, 2 had another cancer and I'll come a little bit back to that. And you can see then in the column saying light scene, How many of the cases it lighted up and you can see it was apart from the lowest doses, it has been 100% that lights up. And then the most important thing, of course, in this Phase 1 study is, was it safe? So, were there any issues and you can see there's a yes all the way down. So, there had been no major events with any of these patients. So we can conclude that this is a safe drug and we can So 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 And then 2 had other cancer types. And then the question is why did we include patients that weren't high grade glioma and we didn't. But in reality, in the clinical reality, patients sometimes turn out to have another disease. So 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 and this already indicates that uPAR is not specific For one cancer type, which is what FluorGuide basically also is built on and will expand into, but we got kind of an early indication that it also works in other indication that high grade glioma. It has a very satisfactory safety and tolerability In all 25 patients 27 patients and as mentioned previously, light was detected in 25 patients, but please remember that the 2 patients where it didn't light up, where the patient at the very low dose and these were basically not intended for moving into Phase 2, but were basically part of the safety. So that was not a surprise. And also there was an increasing light intensity with increasing dose So 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 study. And yes, and then again, the contrast was also seen and evaluated, of course, by the neurosurgeon. They lighted up and this was very, Very positive feedback we had from them. Yes. And so this means that we can proceed to Phase II in aggressive brain cancer. So You need Phase 1 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 we 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 and 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 FG-one to ensure a success when it goes into the Phase II trial. And then the efficacy data from Phase II, this is the study where we Compare the biopsies where it lights up with whether it's cancer on pathology, that is expected mid 2022. So yes, FG1 can now initiate Phase II clinical development. In other prevalent indications, I mentioned that we did see it in other brain malignancy, but we will move into what some of the prevalent indications like lung or breast. So we are very, Very pleased with the data we obtained so far. They are really positive and as good as we could have hoped for. Okay. So just to give you an outlook of the future, one of the things that is extremely interesting and why this is such an interesting milestone for ProGuide is that we have very short clinical trials in general and that means that we get a very short path to the market. And now we have the 1st product that demonstrated in the indication that it works and that is safe. And 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. And 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 hours in the study. They're included. They're doing the neurosurgeon or the surgeon are doing the operation on the white light, they switch to the fluorescent light, the night light, and then the pathology will validate if the tissue that had been removed in fact is cancer or not. And then we have the result of our studies. So we don't have to wait a long time, we can actually do this in 48 hours. And we need basically 2 studies in principle to get approval. So the first study, that's the one we have ongoing now in aggressive brain cancer, That is addressing safety. We get a proof of concept in the sense that the cancer lights up and then we get an estimation of the magnitude of benefit. And what we mean with that is that how much benefit we can actually provide to the patient and that would be quite important because that would give an indication of the price we can take for the product in a fair way and then also the value of the company. And that will be addressed with histology days when we get them in Q1, then we get the first estimation of the magnitude benefit we can achieve with FG1 in aggressive brain cancer. When we have the stage, we go into a Phase 3 study and 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. And as you can see, we expect that we need more patients to document safety and efficacy, and that we can pool across different indications, Meaning that we can also generate them in more prevalent indication. And then we can actually file in 2024. I should say in all honesty that in the 2024, I mean, this, of course, we will go next year, we will have regulatory interaction, and that is best estimation we have at the moment. So our pipeline also demonstrates how we expand the clinical benefit of FluGuide over the coming years and how we expand the value of the company. We'll do that in 3 directions. The first one is that we will advance the development of FT1 in a regressive brain cancer approval and 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 expanded into the more prevalent indications such as lung, breast and colon and rectal cancer as we then can get more patients treated and provide the benefit to more patients And therefore, again, is very significant value driver for Flugide. And 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 disable the patient. And with the phototherapy, we can actually sweep that area and potentially clean it for cancer without affecting the sensitive or critical function of the brain. So, it will be a major benefit for the patient and they are also potentially value for the company and that way we will add to the clinical benefit we provide the patient. So advanced into late stage development, more patients treated, more value to provide it. That's the way we will actually work on the next year. And then of course, we have FT2 that we have started up and will initiate formally develop a non here in Q4. And 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 by indication, by indication. So we feel in a quite good shape. And really to summarize the flu guide as we see it right now, we're very large market, we addressed, we have a very platform, uPAR guidance of surgery, relevant for most patients. And as Andreas said, it's very specific for cancer, but unspecific for the cancer type. And we can go into the glioblastoma, the high grade glioma, and we can spread out to the more prevalent indications. We've demonstrated the first product, it works and is safe And a very scalable model business model with quite high margins and prices. And 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 we submitted next year Q1. And then we have H2 with start up development. We have histology data in Q1 that will come in into Q1 next year. We will use them to start the second part of the study and we have resolved that mid next year. Then we have regulatory interaction, next year. We prepare for the Phase 3 program that we start early in 'twenty three. And then we have the photothermal therapy that we start 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. And then we will do the Phase 2 result on our prevalent indication, the first of them. So really very dense neutral we have and very exciting year we are going ahead. So 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 and I'm a consultant who is helping ask some questions here and moderate the Q and A. I have prepared a few questions for the 2 gentlemen here To start out with and for everyone attending the webinar, please look to lower right side of the screen. There should be a small chat blue button that you can click on and find a place to answer a question and then we will address as many questions as we can during this session. My first question is, Does this mean that FluorGuide 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 TRUCAIL and why we say it's a very important milestone for us because we have first we have shown that it's well tolerated And we have shown that a light up cancer in the uPAR expression cancer, and that means basically all of them. So, yes, we can for now, we don't have to have the safety set up when we test the study. So, to give you an example, the prevalent indication we're now going into, we'll go straight into a Phase 2 program. It will be an explorative program in the first one most likely, but it will be a Phase 2. And then actually we have the efficacy data coming in next year. And we start off basically as many as we want. We can treat as many patients as we want. We don't have to wait time between the patient as you typically do in a Phase 1 setting to be cautious and take care of the patient safety. So really we can expand quite quickly to quite many indications, but the one that have attention for us, Of course, it advances aggressive brain cancer toward Phase 3. And then it's to take 1 of the 2 prevalent indications to start with and have key focus on that first, But we can expand into any indication very quickly. And I thought of the second question, what is the clinical investigators experience with using the FT-one. Do you have any kind of impression of that? Yes, 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 1 would just give you the safety and maybe the max tolerated dose and it's quite unique That you cannot blind this, the surgeons they actually see whether it lights up. So that's why we also say we have some degree of efficacy data As part of Phase 1 and it lights up, but the question is, is it also useful? And the feedback we have gone 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. So they actually say that they can really see that this could be useful. It should with all fairness be step that the real gold standard of course is that we need to see the pathology that what lights up is actually cancer tissue. But as they look at it subjectively, they say this can be of real need and where use and 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. So the tool for exactly the idea the flow guide is built on, but this should be a tool to make sure if you removed everything. All right. We actually have a few questions that have come in already. So I'll save my last one for the very end I think. So one question is, what is the youngest age group Including included in the studies, given that 10% of patients are below the age of 18? Yes. I think I might also answer It's correct. And that's one of the very interesting aspects of using it in brain cancer that 10% of these patients are children. And of course, the potential gain of meeting better surgery in safe lives, our 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. So the logical way to do it is that what we do is an adult study. So the answer is There are no children in our study group, but 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. But 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. And new question, Can you elaborate on why it's exactly breast and lung cancer you have chosen for the next prevalent indication? Yes. I can also take that. I mean, it's a combination of many things and discussion with key opinion leaders within the different areas. So 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. Then it's also the adoption. So how used are surgeons in the field to use aids that use image guidance. And for that reason, we have identified these indications, the prevalent ones as long and as breast. But it's still exactly the first we go into that, that's still under discussion. But that is it's a mixture of the unmet need and how it would be adopted. Yes, I could maybe add to that. We'll definitely go for all of them. We'll just take them 1 in a row. And we want to So what we do, we do successfully. So we want to take them and be sure we have resources enough to take 1 by 1. So this is just important to say why we are 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 is some kind of surgery where the equipment are more present already. And that's one of the reasons why we started out in aggressive brain cancer, because all neurosurgeons have a microscope and it will 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 bit later. So that's also imprints the order we are selecting the indication engine. 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. I mean, it's maybe a wrong word to use, but the safety was clean. So we just do not overdo it when we release it in the press releases, but there were no issues at all. So it was safe and yes, and well tolerated. All right. Maybe if you may add to that, one of the rationale for us to choosing the product where that we're building on Building Blocks are well known and the full floor we use been approved in the market since 'fifty 9 or 'sixty in the U. S. And there's a lot of safety data generated on that flu form. And we actually VeniceClean. So it reduces the risk for surprises significantly. And then also we did a tox program in our preclinical safety program that actually almost complete what we need for going into the market and we actually see on a very high dose that we see no side effect in the animals. So the prediction where there would be no sign of it, but always it's nice to see it in management. 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 And then there is one amongst the audience who say congratulations with the excellent results. If all trials keep ongoing well, when is the actual product ready to hit the market worldwide? Our current estimation is that we submitted in 'twenty four. I would say that next year, we will have a couple of meetings with the FDA. And we've chosen to take the regulatory meetings when we have data because 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. So next year would be quite important for us to fine tune that time, but 2024 for submission is our current estimation. All right. Next question. Can you explain the difference between histology 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. So this is the efficacy we are going for. So 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. So that is why the efficacy is the histology data because then it's a tool to be used across cancers for surgeons. So that's the link. All right. Thank you. Do you have anything right to add, Martin? You look a bit like you may have something to add? Yes, I'm just thinking. I mean, the magnitude of benefit, the thing the one other thing that is problematic from the surgeon nowadays is that, I mean, 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, really difficult is to see where it's going to the normal tissue, so delineated from the cancer tissue from the normal tissue. And our expectation is that we can see that very precisely well defined. And if that's the case, which the histology will demonstrate, Then it will be a major benefit for the surgeon to make that precise removal of the cancer. And that's what we mean with the magnitude benefit that if we can 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. So the magnitude of the histology result will really give an indication of how good and how high we can price it. And 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. So this is Kind of in the long term, it hopefully will improve the lives for the patients 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 it's typical in the oncology space. How many of the operated Or the patients that has been operated on have had relapses or are dead? Yes. I can answer that. It's a very good question. We are not this is not an endpoint in the study. You have to remember that this 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. So the outcome in these patients will be like on the population in general and that is unfortunately with a median survival of only little more than 1 year and 95% of patients being dead after 5 years. So for this population, the rates of relapsing death is not different from the overall, but that's because the surgery is not yet guided by our technology. All right. Thank you. Then there is one asking, thank you very much for the presentation. Going forward, how do you expect to finance new test 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 thing what we have done so far in Flow Guide, we've been very capital efficiency, very high. So we get a long way from the capital we have raised. We raised SEK 75,000,000 just before summer and that actually will bring us True next year. So we are quite well financed for what our plan. But of course, down the road, we should expand and utilize our values. That is what we had to look at that time. But for now, we will finance to do what we have outlined in milestones. And one more question, and this is looking a bit further out in 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? Just roughly, I mean, there's about 33,000 patients with high grade glioma in U. S. And Europe per year incidence and in lung is about million. So it's a quite much higher number than in lung cancer patients. But the value we create is higher in brain cancer than justify a higher price. So 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 and anyone in the audience would like to answer ask additional questions, please come forward now. So what are the next milestones to look forward to for the company? Would that be one particular one or is there a few? I mean, that's the nice thing through guide that we have to shorten development time that we produced 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. We have the result mid next year aggressive brain cancer. We have we will start a prevalent indication, have the result next year. We will prepare the Phase 3 next year, started beginning of 'twenty three, regulatory meetings next year, phototherapy, I mean, there will be huge number of very important milestones for patients and investors. So 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. I mean, we expected to get to where we are now. It's, course, nice, but really it's going exactly as we planned it. And we have no other belief that they'll continue this way. So we look forward to extremely, It is an exciting 12 months ahead of us now. And I should remember to say as the last comment that someone in the audience is saying great about you and the team. Please continue the good work and the great job. And this greeting has hereby been passed on. So I wish you good luck with the future development. Thank you. Thank you for your support as well. Thank you for attending. And I'll close the presentation now.