Good afternoon, everybody. Tony, congrats with the clearance. To the audience, well, you've really been active on posting questions, and we really appreciate that. I know Tony will try to address as many of those questions during his presentation today. Of course, I will post those questions that we don't that Tony don't address in his presentation. The topic for today is, of course, the 510(k) clearance from FDA on ProNephro AKI. With me today, I have the CEO, Tony Pare, from BioPorto. Welcome, Tony, and please carry on. Thank you, Claus. As Claus indicated, I have a short presentation today to address the many questions that we have received through our investor portal from the investment community since we received our 510(k) clearance. And first off, though, I do want to thank our shareholder community for supporting BioPorto up to this very important milestone. And hopefully, we'll continue to support BioPorto as we move through our next value inflection points. There are forward-looking statements in this conversation, but and here is their forward-looking statement disclaimer. But first, this past Friday, BioPorto achieved the largest milestone in the history of the company. It obtained clearance to market ProNephro AKI, which is our new name for our NGAL assay for release in the U.S. This is a picture of our very happy team in Hellerup, Denmark, last Friday. The achievement was 10+ years in the making, with several past submissions to the FDA that were not approved or withdrawn. The difference this time was the execution of clinical trials. We designed a clinical study that was very specific to the approval we were trying to obtain, which is the assessment of Acute Kidney Injury in pediatric patients. In previous submissions to the FDA, the trials were not designed specifically for this use. Retrospective data was used and was not sufficiently clean for the FDA to give their approval. For those that have inquired, the FDA never really approves a specific product. What they do is they give you a clearance to market and sell. So don't be fooled by the word clearance versus approval. They never actually approve anything. Because they do this because you've established significant equivalence to products in the category that you submitted for. This means that the FDA found the product to be safe and effective. Because there have been many inquiries, let me briefly review what specifically was cleared. The wording on this slide is much of what BioPorto's and FDA's questions and negotiations were focused on for the last few months. Yes, it is somewhat of a negotiation with the FDA. But I've highlighted some things that I'll you know talk about a little bit. First, let me highlight that the new name for the product is ProNephro AKI. This will be our brand moving forward for this clear product. Immunoassay, it is an immunoassay that's used with, human urine samples. This is not a blood test. It wasn't approved for blood. It was approved for urine, which is where, the highest levels of NGAL are when Acute Kidney Injury, occurs. The determination of NGAL is intended to be, to be used in clinical evaluation of pediatric patients. This is patients between 3 months and less than 22 years, that have been admitted to the ICU without underlying kidney, disease or compromise. So two points here. One is, it is a pediatric test that is used combined with other vital signs, to evaluate the patients. And two, the age does go into the adult range, so we will have access to adult ICUs for discussion. But we will also make plans for clinical trials to support an adult indication as well. More details on these plans will be provided in future communications. The particle-enhanced turbidimetric immunoassay is for use on a Roche cobas c 501 clinical chemistry analyzer. The first question you may have is: What about the other Roche instruments? Well, with this submission, we utilize the FDA's family approach guidance, which allows you to get clearance only on one master instrument, and then subsequently file for other analyzer validations for a clear classification. It's just a notification filing. It's not an approval process. This is our plan for expanding to other Roche instruments before we officially launch with Roche in the second half of next year. Our test will be impactful since it addresses an unmet clinical need. As a reminder, Acute Kidney Injury occurs when you lose blood flow or have good perfusion of the kidney, even temporarily, and or the kidney is damaged by nephrotoxic drugs or contrast agents. When the injury occurs, you start to lose kidney function... AKI happens early in the disease progression life cycle and is currently difficult to diagnose, as typically there are no symptoms of AKI. But if you can detect its onset early enough, you can save the kidney. Current diagnostics, namely s erum creatinine, are not adequate because AKI isn't identified until it can be too late in the progression of losing the kidney function. As such, clinicians operate in the dark for the first couple of days in the ICU, and based on their training and experience, will either choose to wait and make any kind of therapy changes or perform prophylactic early intervention measures such as dialysis, which takes time, people, instruments, and money. When AKI is detected too late and does not resolve on its own, the kidney can progress through the stages of the AKI, through acute kidney disease, and then ultimately chronic kidney disease and maybe even renal stage failure, which is, you know, essentially a measure or a disease that leads to death. ProNephro AKI can detect early when kidney-sparing techniques can still be used. Feedback with ProNephro AKI used in conjunction with other elements of clinical evaluation, clinicians can take action. This means, you know, feedback from the clinician community has been overwhelmingly positive because now they can do something earlier in the process. We do hope that NGAL test can transform or supplant current standard of care. Ultimately, our diagnostic can be used as an intervention tool to measure kidney function, and on an ongoing basis, determine the best treatment path forward when evaluating patients for AKI across the continuum of care. As you can see from the timeline, we've made some great strides already and continue to deploy a de-risked commercial plans that are outlined on this roadmap. In addition to the FDA clearance, we have already delivered on a few milestones and market commitments in the last two years. You know, we've developed a plan two years ago. We are executing on that plan. This marketing authorization will allow us to launch commercially in the U.S. with an eager clinician base. We anticipate that this will occur in the second half of 2024, when Roche can add the product to their catalog for ordering. In the meantime, we will continue to expand our sales in other geographies and expand the cleared indication for use into the adult areas. The initial FDA submission under review is limited in scope to the Roche cobas® c 501 analyzer, as I just indicated, with the intention to get fast approval on this initial filing for simpler, additional clear classifications for additional Roche instruments. We plan to add several Roche instruments for use with the test. Our first priority for us next is to expand this instrument base, but beyond this, to select an adult population to expand the market access for the rest of our test. Outside of the U.S., the test is already being used on adult populations, and you can see the market size that is associated with this. So the pediatric market in the U.S., if you look at the right side of the slide, is approximately $134 million. If you expand to adults in the U.S., that market now expands to $1.2 billion. The global market size for NGAL is approximately $3 billion, for those interested in the market size. Lastly, we will likely need capital to achieve our long-term commercialization and expansion plans. Now that we have achieved this milestone, I am working with the board of directors to more fully develop these capital plans along with our timelines. Our expectation is that our immediate plans will leverage our existing Copenhagen NASDAQ listing. There will be more to come in future communications. With that, Claus, I think we can open it up for questions. Thanks a lot, Tony, for a short and good presentation. As I mentioned in the beginning, there's a lot of questions, some of them you already addressed in your presentation. But let's start with the last slide first, so about your financial situation. You emphasized that if you're going out with a share issue, it will be in the Copenhagen NASDAQ code. So because there's some questions about U.S. listing and so on and so forth, and I know you've been mentioning that before, could you... Of course, it's a board decision as well, Tony. Could you update us on this? Do you have any immediate plans going to U.S. and by that, have a dual listing? Yeah. So, you know, for us to list in the U.S., the timing really has to be right. Not only does the company have to be positioned well for U.S. listing, and the FDA clearance, you know, takes us a long way there to making the company attractive to US investors, but the capital markets in the U.S. also have to be ready. If you actually look at the number of medtech IPOs that occurred in 2023 in the U.S., I believe that number is zero. There have been none that have occurred, and this has been primarily due to institutional investors when it comes to med tech continuing to fund their existing portfolios before bringing in new companies, you know, into their portfolio. The markets just aren't right, right now, with, you know, with interest rates where they're at today, you know, the overall economy for investors in the U.S. to take on an IPO. Just to remind folks, listing in the U.S. through an IPO not only requires a level of preparation, meaning a lot of legal fees and so forth to bring it onto the market, which right now, we, you know, we would have to raise money to actually perform that exercise. But it also requires sufficient investors to underwrite the IPO and, you know, what you wanna achieve is an oversubscription to the shares before you ever attempt to make a listing. The market's not right to do that right now. So as such, we will focus on, and leverage our Danish, our, Copenhagen NASDAQ listing, and, seek out investors that will, you know, invest in, companies that are listed on the NASDAQ Copenhagen. And it, it's not limited to Denmark, it's, you know, the, there are investors, that, do exist in the U.S., there are investors that exist throughout the Nordics that will invest in a company listed on the NASDAQ Copenhagen. I can just add on to that, we had this discussion, Tony and me as well, that we have plenty of smaller, midsize, and bigger companies listed in the Nordics that don't have a dual listing, but actually attract a lot of institutional investors from both the Nordics, Europe, and abroad. It's really up to management, to marketing the case towards the right investors, and you will do a great job doing that, Tony, I'm sure. Well, let's dive into when we talk financials, let's dive into guidance and stuff like that. Because Tony, you mentioned that, and there's a lot of questions here. Are you coming back guiding us more overall what we should expect, both in 2024, but perhaps also going one, two years out when we look at the total addressable market and what kind of margins we should look into? Sure. So at this point in time, I'm not providing specific guidance. I won't provide specific guidance until we report our Q4 results. However, that being said, I do wanna set the expectation that the product won't actually launch in the U.S. until the second half of next year, and there are reasons for that. One is our distribution partner, Roche, needs to actually put this product, this product in their catalog of products to sell in the U.S. They need to prepare their U.S. organization to actually sell the product. And, you know, so that's the Roche side of things. We will also, we, being BioPorto, will also invest in medical science liaisons and NGAL specialists in the U.S. to drive market demand. So ultimately, when Roche lists the product in their catalog for ordering, the market will be prepared. The wonderful thing about Roche is they have contracts already with all the major U.S. hospital systems in the U.S. This is just another checkbox of assays on their catalog that a customer can now can check to actually order the test. So that's next year. In terms of the outer years, you know, we're not prepared to provide guidance at this point in time. Our goal is to provide is to, you know, obtain as much of the pediatric market as we can while we have this approved product. But also, we do want to invest in achieving that adult indication as well through a clinical trials, which will require some level of capital. Yeah, and you mentioned that in your, you know, press release Thursday night about other partnerships or other instruments you mentioned. So we have other players than Roche. So if we look into the $134 million market for pediatric, we have players like Abbott and Siemens. What are your plans in terms of those players? Could you update? Yeah. So we have to now that we have this primary assay, you know, through the clearance process, we have to adapt that assay to use on these other instruments. You know, it's getting the first one that's hard. Yeah. Getting the subsequent ones is a lot easier. Whether we choose to utilize them as distribution partners or not, I am not going to provide you know any definitive information there, other than to say that we are in discussions with all of them. The other thing I wanted to mention is that hospitals aren't specific to one instrument manufacturer or another. They typically have, you know, three, four different instrument manufacturers within their hospital. So they, it's not like a hospital will be an all Siemens laboratory or an all Abbott laboratory. They typically have, you know, some from every one of those instruments. So typically, they have an instrument that they can utilize our tests, even if it's limited to a Roche. ... Thanks a lot. And if we look into different guidelines, so now you've got this clearance. We have other guidelines like the KDIGO and also NICE, and that would, of course, add on top of what you're already addressing. What are the next steps addressing that, Tony? Yeah, I'd love to say that we try to influence the timing of those guidelines, and we stay very close to them. We talk to the folks that develop them. The KDIGO guidelines specifically, this is a major change in terms of adding a biomarker to diagnose, you know, kidney disease or kidney loss of kidney function. And there's definitely a lot of support for adding biomarkers to diagnose kidney, you know, kidney disease. That being said, these are well-respected volunteer organizations that are not operating to a specific timeline. And so, you know, we like to think that in 2024, they will issue a new timeline, but I can't predict when they will do that. But a new guideline, not a new timeline, a new guideline. Good. And then, in the press release, and there's also a couple of questions about that, you also address different hospital settings. So now you receive this first approval. Could you just give an example for the audience, what a typical setting is, and how do you progress into different settings? Yeah. So different settings means different clinical trials, if you wanna advertise that this is specific for the, you know, physician's office or the emergency room. We chose the intensive care unit for a very specific reason. One is, you know, that's where it, there's a lot of incidents of AKI, but it's also where people coming out of transplant operations, coming out of cardiac surgery, cirrhosis patients, all show up into the intensive care unit. So, we could, and we are evaluating, develop tests for use in the clinician offices or use in emergency departments. But we want to focus on the areas where we believe there'll be a higher level of adoption, or at least initial adoption. Thanks a lot, Tony. And, so now you've got the FDA approval, and we know other countries piggyback on that. I know especially China, it's very easy to get a CFDA over there, and there's probably a lot of countries in Latin America. You outlined earlier this year that your strategic focus is, of course, NGAL approval in the U.S. Yeah, that's on target now. And you also started with your CE marking in Europe, marketing the product. Are those the two strategic priorities for the next couple of years, or do you have plans for the rest of the world? I think so. I think, those are the areas where we will build our files for registrations, right? So now we've built a file for registering a pediatric claim in the ICU, in the U.S. If we can leverage that file to obtain other registrations, we will do that, especially if it doesn't require additional clinical data. So we're always looking for countries that will take the file as is, and, you know, implement it into the registration process. I will tell you, the CFDA, the Chinese FDA, typically ask for a lot more, than what the FDA requires. The other thing is that we still need to develop our file for, IVDR, which is the new regulation- Yeah ... in Europe for medical devices. I believe right now, they're not requiring that assays have IVDR until 2026. This is a deadline that keeps getting pushed out. But now we can take our pediatric file that we've used for the U.S. FDA, and now apply that to obtain IVDR registrations as well. Doesn't mean we don't have to do additional work. We do have to do some additional work, but that is part of the plan moving forward. Good. Yeah, so you can, you can actually—you have the CE marking in Europe, and I, I know you also ramped up sales efforts, spring 2023. But what you tell us here is that we're going to see a major ramp-up when you got the IVDR, or, or is that wrong? I think, I think adoption in the U.S. will help drive demand in Europe. I think change of the KDIGO guidelines helps immensely in terms of not only driving adoption, but being able to establish reimbursement in many countries. Because in many countries, if it's not part of the KDIGO guideline, then, you know, the reimbursement may or may not happen. So there was continue to be a push. I'm not saying that there, there's not gonna be a push, but there'll continue to be a push. Some of these other things make it a lot easier. Good. Thanks a lot. And then if we turn to, we talk a little about in terms of production capacity. So now you're addressing this very huge market, and, well, and you're also addressing, Europe and a couple of other countries. Do you have sufficient production capacity for those markets yet? ... Yes, I mean, the product is fairly. I I won't say that it's easy to make, but to ramp from small volumes to large volumes is very easy to do. Remember, you're talking about products that the raw material actually comes to us for packaging. It comes, you know, in essentially in either vials or in five-liter bottles, and we'll vial it out. But it's not, you know, it's not large volumes of you know, reagents and buffers. So the scaling up is fairly easy. And packaging is fairly easy as well. I'm not concerned at this point in time about production volumes. Good. Good. You mentioned in your presentation, Tony, about the, the adult use, that you are already, at the border between adults, at least from, from the authorities perspective. And there's a lot of questions asking about, you know, when should we expect, some news about adults? Yeah. Is it the same procedure that we have to wait several years, or can you actually gain something from already having the pediatric approval? Could you elaborate a little on your plans and your thoughts about adult indications, Tony? Yes. I mean, this is... You know, I do wanna set the expectation that this is, you know, a three-year process, at least three-year process, to get an adult indication. The biggest factor in that process is actually doing the clinical trials. The clinical trials are actually broken up into, you have to do a feasibility study, you have to do a cutoff study, and then you have to do a clinical validation study. We are looking at ways to shorten that timeline, and we'll come back with a little more detail on, you know, when we believe we'll have a submission ready for the FDA when it comes to the adult indication. But I don't wanna set the expectation that this is gonna happen, you know, that this is a matter of months. This is really a matter of, you know, to get the adult claim. That's nice. Thanks a lot, Tony. There's a follow-up question here to Roche and your dependence on Roche Are Roche able to grow with you in other indications? Oh, absolutely. Yeah. Absolutely. They're, you know, in the U.S., they have 550 sales reps. They have a very large organization that has the ability to help us with this. And the same goes for other of these big partners, Abbott- They're all big, they're all big companies. Yeah. Yeah, they're all That's right. Manufacturers. There's a very specific question here in relation to IVDR item. Is NGAL a Class B or Class C product? I don't wanna say, because I probably will say it wrong. But we can get back to that. We can get back to that. Yeah. Yeah. Let me see if there's... I hope I addressed more or less all questions so far, even though the list is long. So if somebody out there feels that their question didn't get answered, please post it again or just let me know, and I will forward it to Tony. Two different guidelines, the rest of the world we've been through. Maybe you could elaborate a little on what you're seeing in Europe for the moment with the CE marking, how is sales progressing and stuff like that, Tony? Yeah, I mean, we're starting to talk to customers that wanna adopt. They, you know, they have to take it through their process. It's one thing to get the interest of the nephrologist or the head of nephrology for the institution. It's another thing to actually get it implemented in the institution because there's various committees, there's budgets, and so forth, that you have to take them through. We did add recently a medical science liaison to help our sales team to, you know, promote the clinical value of the product to, you know, to various clinicians throughout Europe. Thanks a lot. Well, then there's a couple of question about the latest development in the board, and I know that's probably a personal question. But Jan Leth left the company a couple of weeks ago or a week ago, I think. And one of your members in the board, I think, or one of your managers, sold some shares after the announcement. I don't know if you can comment on this, Tony. I know it's personal reasons, but you can- Yeah. So, you know, in, you know, I think it's two totally different... They're unrelated to each other. Yeah. But you know, Jan Lett leaving the board was a personal decision on his part. It wasn't that the board didn't invite him to leave the board. And I can say that at the time he left, there was no insider information that he was reacting to, right? So if people are concerned that he knows something, and that's the reason why he left the board, I can definitely tell you that he didn't know anything in advance of his leaving. In terms of one of our board members, Michael Singer, selling shares, that's an entirely personal thing as well as anybody that invests in stocks. Michael doesn't have any insider information at this point in time either, that he could be reacting to. Like I said, it's a personal decision as to when you want to sell some of your shares of stock. ... Thanks a lot. And then, luckily, we got some more good questions here. So the competitive landscape, you are quite unique right now and have an edge when it comes to this. Do you see any competition coming out there, Tony? Well, you know, we do have one competitor, and that's bioMérieux's NEPHROCHECK product. bioMérieux is an infectious disease company. They chose not to invest in promoting the NEPHROCHECK product. You know, I could talk about how ours is better, but I won't. But they, you know, if they're out there promoting their product, and we're out here promoting our product for use in Acute Kidney Injury, that's good news, right? Yeah. 'Cause what you're basically telling the market is Acute Kidney Injury is a significant disease state. It's an unmet clinical need, and both of us marketing that unmet clinical need, I think can only, you know, raise interest in having a biomarker like this. But at this point in time, it doesn't seem like bioMérieux is really investing in the advertising of this. Like I said, they're an infectious disease company. They're not a kidney diagnostics company. Good. Thanks a lot. And with this approval, you're allowed to sell directly to the hospitals, with or without Roche? That's right, yeah? That, that's exactly right. Yeah. And regarding the royalty... Sorry. Regarding the Roche agreement, is it purely royalty-based, so no upfront payments? Can you comment on that? There, there was no upfront payments by either party to each other, on this, on this, distribution arrangement. It is a buy resell arrangement. So Roche buys the product from us and resells, you know, with a, you know, with a margin. Yeah. The value that they have, like I said, is they have contracts throughout the U.S. with all these hospitals. So it's a contract that we don't have to negotiate if we try to go out on our own. And then, final question here. If you're going to market other AKI biomarkers than NGAL, I don't know if you know of others, but I think this is important, of course. Yeah. So building our portfolio needs to be part of our you know our long-term plan, right? So what other markers beyond NGAL can we add to our portfolio, add to our you know to our bag to sell in the future? And we're always evaluating other markers other tests that we can add to our portfolio. None that I want to talk about today. Oh, good. Well, by that said, I think we have to close the event for today. But, I'm really happy to see all the good questions, and there's a lot of the audience who, of course, congratulate you as well with the very important indication. So by that said, Tony, first of all, I'm very happy that you could join with so short notice and update the investor community. So by that said... Wait, wait, wait. There's one coming here just to see if we addressed this one. Okay. Well, that's one again about: "Is it correct that U.S. approval makes it easier to sell NGAL in the rest of the world, due to the fact other countries wait for U.S.?" We talked about that earlier on with piggybacking. And then, there's one here also: "Would you consider selling a stake in the company to the right partner, or sell the whole company?" And that's a good question. I'll answer it in this way, right? Yeah. We will look at any, and all offers that are reasonable, that come into the company, right? Yeah. Are we actively out there promoting the company for sale? Absolutely not. No. I will tell you that I, in my history, I have acquired a number of companies, and the worst companies to acquire are the ones that are actually promoting themselves to get acquired, because they're not making the right investments in the company. We will continue to operate the company as if we will be an independent company for the long haul, and make the right investments in the company. However, if somebody approaches us, you know, I have a responsibility to our shareholders to listen to any and all, you know, transaction opportunities. Yeah. Thanks a lot, Tony. And by that said, I will close our presentation for today. Thanks a lot to the audience for all the very good and very good questions. And Tony, as always, thanks a lot, and I know we're going to see each other not so far away. So, enjoy your day, Tony, and to the audience, enjoy your day, and thanks a lot. Thank you, Claus, and thank you to all our shareholders.