Ja, snabba och roliga cast idag. Nu beger vi oss över till biotech igen. We are also going to switch languages because I have with me Jack Egelund-Madsen, CEO of Diagonal Bio. Welcome. Thank you very much. Please tell us what's happening at Diagonal Bio. Thank you very much for the introduction. I will tell you about quick, accurate and cost-efficient point of care diagnostics. My name is Jack Egelund-Madsen. I'm the CEO of Diagonal Bio. Before I start, I actually want to show this quote from the high impact journal Nature. It states that every single time we have an outbreak, we are always one step behind because we don't have rapid diagnostics to detect the new organism. I think that was really evident during the COVID-19 crisis. Of course, this will also be evident in the new crisis to come unless we do something about it. What are the problems with diagnostic testing today? The main problem is that most of these diagnostic tests, they are outsourced to external laboratories. That means long response times, delay in treatment, and also risk of spread of infection. It also means long and costly logistics solution. There's a lot of errors because there's a lot of manual handling of the samples. Actually talking to some of these centralized laboratories, sometimes it's up to 10% of the samples that needs to be rerun. Of course, the central laboratories needs expensive and complicated equipment. There is of course alternatives. I'm pretty sure that most of the audience sitting here, and also the listeners, have tried this during the COVID-19 pandemic. You know, that's a trade-off always. Either you go for the accuracy, but then you have something that's slow, complicated, and costly. You have the quick tests, for example. Very easy to use. You use them at point of care, but the accuracy is not very high. Actually, there's several studies that have shown that the accuracy from the, from the quick tests is well below 50%. There's another problem with today's diagnostic tests, and that is that they are very diagnose-specific. Again, I'm pretty sure that a lot of you here in the audience have actually tried this during the COVID-19 pandemic. If you have flu symptoms, you would go to the test center and then you get an answer back. It's very binary. Yes, no. This would be the same for other types of diagnostic tests as well. If you don't hit it the right one the first time, you will need to go back to the test center and again, you're losing time. What is the solution? At Diagonal Bio, we have developed PANVIRAL. This is a universal diagnostic system or platform. This is unlike any other system on the market today. You see a schematic here on the picture on the left side, it's actually a neat little box. I didn't bring it with me today. It has a very easy-to-use touchscreen. Then we have a cartridge, as you can also see here, where we have eight channels. That means we can analyze eight samples at the same time. I will get back to that. Highlighting some of the benefits of PANVIRAL and why we are unique. First of all, we are ultra-fast. The whole process from actually taking a sample to get the result can be done within 10-15 minutes, meaning you can do that at point of care. We have very high accuracy. The studies that we have done have shown accuracy around 98%-100%. We are totally in line here with the PCR-based technologies that's considered the gold standard of diagnostics today. We can also do parallel testing, and that's, as I said, with the cartridge here, where we have eight channels. That means that instead of having these very binary answers, yes, no, we will potentially be able to make a respiratory panel. If you have COVID symptoms or flu symptoms, you can go to the test or to the medical facility and get tested for all of those at the same time within 10-15 minutes. That could potentially be different types of COVID, influenza A and B, and respiratory bacteria. PANVIRAL is also a universal system, so we can also use it for testing all different types of sexually transmitted diseases, for example. Ebola, you name it, PANVIRAL can basically test everything. The only thing we need is genetic material. It's also a highly flexible system. As long as we know the genetic code for what we're looking for, it will take from a few days to a maximum a week, then we can actually detect the new organism with the PANVIRAL system. It's extremely easy to use, and I will actually show a picture, a couple of pictures later on in the presentation. This touchscreen has five simple steps, big buttons. Anybody can basically use it. You do not need medical training. Because of the technology enable us to make something that's extremely cost-efficient. This is an example of how data looks with the PANVIRAL technology. In the bottom here, you have negative COVID samples. You see there's an orange threshold, and then you see lines that goes above the threshold where we have exponential amplification, and that's a marker for samples that's positive for COVID. As you can see here, it's crystal clear. This is actually the first PANVIRAL system that came off the assembly line in 5th of October, and you can see the same graph here. We are of course, very happy and that we already have the machine and I will also get back to what we plan to do with the machine. Little bit about the technology without getting into too many technical details. Essentially, what we're doing is that we're using an old technique called LAMP, for loop-mediated isothermal amplification. What we are doing here, again, without being too technical, is that we amplify a genetic marker within the virus, fungi, bacteria, potentially also it could be certain cancer types if there's a genetic marker for that. We can amplify that exponentially with this technique. By copying it to electrochemical sensors, we can detect that very early on and very precisely. That's, of course, what we have protected with our patent. The patent gives us protection until 2041. That's, of course, the whole, you could say, the whole foundation for the commercial process, is that we can protect the technology. Why is it that we are so much better than the existing gold standard technology that we use today, for example, in the PCR-based methods? If you look into how these normally nucleic acid amplification steps function, then you need to know your target, then you need to purify your sample, then you add resources, you find your target, then you amplify it, and then you need some way of visualizing it. With the PCR-based system, it looks more or less like this. You need to know the genetic sequence. You need to ship your sample to a centralized laboratory where you then purify the sample. You add enzymes. You need primers with fluorescent tags, and then you need to go to what's called thermal cycling. That means that you need equipment that can go up and down in temperature very fast in a very specific sequence. It's a time-consuming step and also sets demands for the device. To detect the amplifier, the genetic marker, you need something like LEDs and photodiodes within the hardware. With PANVIRAL, the process looks much more simple. We still need to know the genetic code. We do not need to purify the sample. We can add it directly, which means we save a lot of time and cost for shipment, also for purification of the sample. We still need to add enzyme. We also need to add primers, but we do not need the fluorescent tag, which means that we are actually better for the environment. We also need heat. We can do everything at a single temperature. We avoid having a device that needs to be controlled and go up and down at a very specific sequence of temperature cycles, like the PCR-based technology. Again, we save time, money, and also have a more simplified device. For the detection of the amplified genetic marker here, we are dipping a sensor directly into the solution. We do not need photodiodes or LEDs or anything like that in the device. I tried to highlight some of the benefits here for PANVIRAL on this slide. First of all, as, again, you have probably all tried this, instead of having these long times for the technique of diagnosing, which in the best case, I have experience with COVID-19, for example, it was eight hours, but typically it takes several days. We can do that whole process in 10-15 minutes directly near the patient. We can basically reduce sample pre-preparation massively. Hands-on time and effort we can also reduce. That also means less human errors. We have less electronics in the device, which means less failure by design, and also you can say less manufacturing complexity. We can totally eliminate optical hardware and also these fluorescent and toxic reagents, so we're also better for the environment. This is a small study I want to show you. This is a nasopharyngeal samples that we got from one of our university partners. This is clinical samples, 30 patients who had COVID. What you see in the bottom of this graph is actually the time it took, or not the time, it's the cycling number on the RT-PCR machines. We compared it to how long it took with the PANVIRAL system. Just to stress out, even with an optimized protocol, and this is, again, taken from the high impact journal Nature, the average time on the RT-PCR would be 105 minutes. If you compare to PANVIRAL, these 30 samples were identified as positive within 8.6 minutes. Even in the extreme case here, where you have a cycle time value in the RT PCR machine that's on the x-axis, which gets close to 37, that's quite extreme. In that case, PANVIRAL detected that below 11 minutes. One thing you have to remember here, this was, of course, sample we got to one of our collaborators. They had already been shipped to a laboratory, and they've already purified. We do not need that step with PANVIRAL. If you add that to the equation here, PANVIRAL was not 10 times faster, but PANVIRAL would have been 250 or maybe 500 times faster than the RT-PCR technology. This is where we really make the big difference. Why is time then so important? This is actually modified from a study that was published between Harvard and Ohio University back in 2021. They used COVID as a, you could say, model virus. What you can see here on the gray bar is actually in this control group, if you have no testing at all, you have 100% spread of the disease into the con group, into this control group. Then as you can imagine, the more frequent you test, of course, the more you can actually reduce infections. That's pretty straightforward. In this case here, they actually tested every three days. What you can see is that if it takes more than two hours until you actually get the result, you still have up to 45% spread of the disease into the group. If you, however, can get the results instantaneously when you're sitting at the test facility or the medical doctor or wherever you get the test done, then you can limit the spread of infections to almost zero. That's exactly what we can offer with PANVIRAL. PANVIRAL offers quick and accurate diagnosis of essentially any type of infectious disease. The system doesn't really care whether it's identifying a genetic marker for Ebola, sepsis, whatever it is. We can do everything. It's a very easy one-step process. The operator, when you have the taking the sample for the patient, you just sit in front of the device. You don't need to move away. You can do everything at once. You can test multiple samples at the same time. That gives us this possibility of having a holistic view on these different disease indications. Instead of, I mean, basically moving away from these very binary answers, we can test a whole range of different diseases at the same time. We could also use this for mass testing, and then we could test 8 patients at the same time. This would give a lot of benefits. You can imagine people using this at the hospitals, for example, for treating sepsis. Instead of using broad-spectrum antibiotics, with PANVIRAL within 10-15 minutes, you would know exactly which type of antibiotics to use and treat the patient correctly. With respiratory bacteria again, you would know exactly whether you have COVID-19, influenza, or respiratory bacteria to treat. Sexually transmitted diseases, and so on. Basically, no limitations here. What we essentially are doing is that we are taking the gold standard of diagnostics and bring it down to point of care or near-patient testing. Very briefly about the market. Currently, the, you could say, the diagnostic market for infectious disease is valued at around $40 billion. Of course, it will always vary a little bit on depending on which market report you read, but it will include anything from COVID, influenza, sepsis, mpox, and so on. How do we then plan to go to market with PANVIRAL? The system actually consists of three different components. We have the machine, which you can, of course, use multiple times. Then we have two different types of consumables. We have the cartridge. This with the eight channels. That's a single-time use, that will also be used together with the reagents that are specific for each in individual diseases. Those two will be the main driver of the revenue. We will also do everything we can to ensure we start early commercialization. Now that we have a research-use-only device out, we can actually approach potential partners for in-licensing deals, and discussion that way. This is something we are doing right now. We are also trying now to make a version of PANVIRAL where we can start the early commercialization phase. That means moving far away from a research use only, but where we actually have done some safety testing and also fulfilled the Low Voltage Directive. This will enable us to expand the initial markets and segments that was initially planned for PANVIRAL. Here we can actually use PANVIRAL for identification of genetic markers and use it, for example, in the agro or vet industries. Very briefly about the history of the company and also some of the important milestones that we have reached in this period. First of all, we are a very young company. We were founded in Q1 2020 but have already come a very long way. In this initial phase, we brought in around SEK 10 million from private investors. Last year, we listed at Nasdaq First North Growth Market in Stockholm, and brought in additional around SEK 40 million. This year in June, we have our patent granted by the European Patent Office. That's, of course, the whole foundation for starting the commercial process with PANVIRAL. We are now pushing that out into the rest of the world. We also did a study where we showed PANVIRAL can detect different viruses. Here again, just as a proof of concept, we used COVID-19, influenza A and B, and RSV and showed that the system can detect all of these in an average of 10 minutes. As I said before, the system doesn't really care what genetic marker it is actually amplifying. We also signed our first letter of intent with Centre for Diagnostics at Technical University of Denmark. They're an accredited laboratory that used to test up to 12,000 COVID-19 samples per day for the Danish government. They will do a comparison study where they have PANVIRAL compared to the RT-PCR technology and also to the Quick Test. This will give us important data on speed, cost, accuracy, and so forth. That will be extremely important for us. We also had a new design registration. Oh, sorry. We got the first instrument was released or came off the assembly line 5th of October. We now have multiple devices for research-use-only. This is the first step and also enable us to contact these potential partners and set up pilot testing with external partners for external validation. We've also done design registration of the cartridge with the trademark office, again, to try to protect the whole technology here so nobody else can copy us. We signed a royalty agreement with our development partner, OIM, that's located in Malmö. That will ensure us that we have control of our supply chain and also our costs moving forward. You're probably thinking, "So then what's next? You have done a lot of things. It's basically within two years, so what's coming next?" We have recently announced we are going into a new share issue, which starts 3rd of December and ends at 15th of December. Of course, if you're interested, I will encourage you to go into our webpage diagonalbio.com/in-investors, there you can find the both the teaser and also the memorandum. Here you also see a very nice picture of PANVIRAL for research-use-only. Big buttons, as I explained before. It's an easy five-step process. Anybody can basically use the system. All of this is, of course, only possible because we had a very strong team helping us go all the way here. I'm not going to specific contributions here, but just say we have a lot of expertise in both science, innovation, business development, and so forth. We continue to push forward. We are, of course, also supported by a very professional and strong board that will help us all the way. Just before I wrap up here, I just want to say our vision is to limit the spread of infectious disease by creating an accurate, easy-to-use, cost-efficient, quick, and universal diagnostic platform. It has truly been an amazing journey so far, and I would welcome any of you to actually go in and follow us on our webpage and also follow this new share issue. With that, I would like to say thank you, and I will be ready to take some questions. Thank you so much, Jack. What a year. What a two years. It's quite amazing how much we actually accomplished in a very short period of time, and... Yeah. How did you do it? We have been pushing very, very hard, of course, all the time. Then it's also the amazing team behind it, of course. Everybody's working really hard and really wanna get this done. Was this also a good moment in time, thinking of the pandemic and the new awareness of detecting new threats and? Yeah. Yeah. I think, of course, we were founded during the midst of the COVID-19 pandemic and, of course, that means that everybody, and even in the room and all the listeners here, they understand the difference between the PCR-based technologies and also the quick tests. That makes it, of course, easy for us to come across with our message. Everybody can basically see the benefit. I also think that's why we, in the initial phase here, were able to raise SEK 10 million during the initial investments, private investments. It also got fully subscribed the first time we listed at Nasdaq First North in last year. Mm ... because it's so tangible for people to, yeah, to grasp. Yeah. It's easy to understand the advantages when you look at the existing technologies in the markets. I mean, there must be competitors coming in since this is such an urgent question. What is your competition when it comes to upcoming technologies? I would start by saying that, of course, COVID got a lot of attention. No doubt about that. Of course, there's a lot of company who has gone that way. You have to remember, we are making a platform technology, so we are not a COVID testing company. We can test COVID, yes, but we can also test Ebola, sexually transmitted disease, or whatever it is. We are more like trying to change the whole industry, the way that you're actually doing diagnostic testing, not just focusing on one specific area. Still there must be competition, I guess. No? Yeah, yeah. There's a lot of. If there's a lot of money, there's always a lot of competition. Yeah, yeah. Exactly. That's always how it is, right? That's also why I'm saying, so the whole foundation for our commercialization process is that we got the patent granted, because that means that we are protected our technology. You're absolutely right, there are other technologies out there. I would, though, say that I have not seen anybody who combined the speed, the accuracy, with the possibility of doing this, where we can test multiple samples at the same time. Good job there. I'm also wondering, 'cause you said you don't even need a medical degree to use this machine. Will there be more parties in our society that will want to track disease than before? I think, I mean, even some places where you go into a big, company, before you're allowed to enter from the reception and go into the meetings, you will be tested. Of course, if you are somewhere in Africa and want to go back, it could be that you test people at the airport. I think you will see this more and more frequent that the easier it gets, it's easier will also be to test people in general, I think. Does your technology help this development, that it will be easier to do it? The technology is basically made for point of care testing or near the patient. You could basically have the machine standing wherever you need it. Yeah. Again, it's very, very easy to use. Basically the process will be more or less like what you see with the quick tests. In that sense, it's extremely simple. Maybe you mentioned it, but now you have the first device out there. That's amazing. What is the pace we're looking at getting more devices out there? Right now we had the first device off the assembly line. Of course, we will continue to build more. It's all set up. The first devices here are for research use only, which will enable us to start pilot testing with external partners. That to actually get external validation of, you can say the technology and also the benefits. Next step will of course to make, you can say a commercial viable unit. Actually we see it as three steps. The first one was for research use only. We're gonna make sure we comply with the safety, general safety, things, and also the Low Voltage Directive, it's basically, it's called, which will enable us to actually have a commercial system, but it will be for markets outside the in vitro diagnostics. It will be more like, you can say, for use for identification of genetic markers, or it could be that it could be used in the vet or agricultural industry or something like that. We can take the last step, which will be the in vitro diagnostic device. Yeah. How should we understand it? When could be the big breakthrough? That's what we all wonder-...investors in this room and- Yes at home. Yeah. I know it's always, you can say the key question. Yeah. Of course, if I were to answer this right here, I would get into a lot of trouble, I think. Okay. I have to post it anyway. Yes. Yeah. Of course it can, it can happen sooner or later. That's what I can say. We are of course having a discussion with potential partners for in-licensing deals. We are pushing very hard to get a commercial system out there, I think I will leave it at that. Then this letter of intent with the Technical University of Denmark, why are they a good partner for you? They actually have done a lot of testing. I said during the COVID-19 pandemic, they tested up to 12,000 COVID samples per day for the Danish government. They are fully aware of how the benefits of our system if that can actually be used instead. They will take our system now and do this comparison study so we get some external validation. How long is this supposed to take? The study? Yeah. It depends on a number of different things. Of course, you need to have a certain number of patients that are positive and actually get it to use the system. If this turns out well, is it likely that they will be a big customer of yours? They have definitely show interest in the technology. Again, I think I will leave it at that. Yeah. yeah, I think I can disclose. Yeah. Okay. Do they come with a network, that it could give a good, well, how do I even say that? Could it mean business to you in the bigger picture? They of course have very close ties both to the government but also all the hospitals, in different disease areas. Of course, that could have a huge potential. If this comes out positive, that would of course have a huge impact for us as well. Also this royalty agreement with OIM Sweden. Yes. Can you tell us a bit more about this opportunity? During the development of the PANVIRAL instrument, we have actually developed our own technology and part of that we have made a royalty agreement on. It's the primary focus of this actually to ensure our supply chain and also to control our costs moving forward. Of course, if somebody else wants to use the technology, that could also be, you can say it's a royalty fee for us later on in the process, but that's not the primary focus here. The design registration or approval of the cartridge, is there anything else remaining like this, or do you have what you need now? I mean, this is an ongoing process. You can always try to find other ways to try to protect your system. Of course, the better you protect it, the more secure you are moving forward. I would say right now we have the core technology protected. We also have part of the consumable protected, so we feel we are in a very secure place. Of course, we will continue to look in for options to try to make sure we cover everything. I'm thinking, I mean, this is an attractive offer. The world wants this. Now there's a unit out there, and that's also very tempting. Do you get a lot of interest? Do potential future customers approach you, or do you get some interest from outside, or how? Is your phone ringing? We have a lot of Yeah I can say that and for all over the world basically. Yeah ... that's interested in this device because everybody see the benefit. Yeah. Uh- You switch off your phone signal at night, right? Yes. It's on mute most of the time I would say. Yeah. ... it's, Right now, for example. Yeah. Okay. That's fascinating. What do you tell them at this moment? I'm saying that we will be ready to do a pilot testing with them, and of course, if they're interested in the system, we can go into a discussion about either partnership agreements, outlining the technology or it could be commercial sales. That's basically the message that we have right now. Yeah. You have them lined up now for the future? Yes. We have a couple that we have a dialogue going. That's interesting. I'm wondering, like we also have to talk about risks of course, not just the opportunities. I mean, the potential investors here in this room, what can you tell them about what are your main risks and challenges going forward? I think one of the main risks or, well, challenges would be the regulatory process to get the in vitro diagnostic system to the market. The EU made a new legislation, the IVDR, that we need to follow, which requires that you need to have a notified body. There is a limitation of notified bodies in Europe, which means that that could be a bottleneck. That means many companies are looking into the U.S. or Canada because then it would be an easier way to commercialize. I think we have tried to take the best measures now, and that's why I'm saying instead of going, all the way the first in one go, we will also see if we can make an intermediate step here where we can try to commercialize, even if that would be, expanding into other segments or markets than we had in the initial plan. For these investors, why is this risk worth taking? Who don't want to be part of a journey where you actually sell, save people's life? I mean, this could actually have a huge benefit. yeah. you're also seeing how far we have come in a very short period of time. Far, we've reached all our milestones. I can also say that very proudly. The team have been working very, very hard. We will continue to push forward and, yeah. Yeah. Hardworking team, hardworking CEO. Okay. Good luck. Keep that phone signal on mute. Thank you so much. Thank you.