Yes, it's 2:00 PM on this warm summer day in Copenhagen. Welcome to this Digital Event with BioPorto. My name is Henrik Ekman. I'm Equity Analyst here at Handelsbanken Capital Markets, and with me today I have the management team of BioPorto, streaming from US, CEO Tony Pare and CFO Neil Goldman. Before we kick off this special Q&A event as we have called it, just a quick reminder of the format. Feel free to forward your questions in the chat, and I will do my best to try and forward them to Neil and Tony. As always, we will broadcast this on our platforms as well afterwards. With that, i t has happened a lot in the company recently and of course, the big announcement from yesterday night is of great importance both to your company and to the investors. With that, please take us through this very positive announcement from yesterday, Tony. Sure. For those that have seen, we put out a release indicating that we have met our targeted enrollment numbers for our third trial out of a three-part clinical trial series. What that means is we've put a lot of risk behind us. You may remember in the past, the company has announced delays in enrollment due to COVID, due to the pandemic. It was difficult to get the samples that we needed in order to perform our clinical analysis. I'm happy to say that we have taken that element of risk you know out of the equation now, and that is now behind us. Really the focus now is to analyze the data, finish analyzing the data, I should say, and complete the submission to the FDA. I'm very happy with the team, with our clinical trial partners for making this part possible and look forward to finally assembling this package. Good to hear. Of course, this is one of the major milestones for you as a company and as a new management team. Try and take us through what would happen now from here on and until later this year, where you're about to make the application. Sure. Let me talk a little bit about the clinical analysis that is required. Since there is no gold standard out there today for NGAL, you have to look at a number of factors to determine whether the patient actually had NGAL or not and then compare that to what was the result that was received on the NGAL test. What we're looking at is not only the serum creatinine levels, which is the standard of care, which is a very poor standard of care. It has a very low sensitivity, low specificity. We look at that. We look at urine output. We look at the way the patient presented themselves, whether they were put on renal replacement therapy or not. All of that requires a clinical judgment. We have clinical partners that we work with to perform that clinical judgment to determine whether or not that patient actually had AKI. Then from that, we can compare to what the NGAL result was. The only true gold standard out there is a biopsy, which means, you know, after the patient has died, you can, you know, perform a biopsy on the kidney. That's unfortunately or fortunately, that's not the way, you know, we perform our clinical trials. That will take a level of time to actually complete that. We are also in parallel continuing to perform our validation testing, our analytical testing, and preparing the files that are required for the FDA submission. Okay. Can you be more specific as to which sort of data you're looking for in this analysis process in terms of efficacy of the testing? Because I know you mentioned earlier that the interim readout from some of these studies has been positive. What sort of data are you looking for? Sure. We take multiple NGAL samples. Many times the patient will have an NGAL level that has already been recorded as their baseline, and then we take a sample at the time they are registered into the ICU to make a risk assessment as to whether the NGAL levels have risen, and then we'll take a sample downstream. It could be after the patient is discharged to see whether there was an improvement. Multiple NGAL levels, again, serum creatinine, which is, you know, a standard of care for measuring kidney injury, and then urine output, and then whether, and the types of medications that the patient may have been on. There's tens of variables that we look at in order to make this determination. Ultimately, it's up to a clinician. We have a number of clinicians working with us that will make the decision that this patient had AKI. They are blind to the NGAL levels, right? They're telling us whether the patient had AKI, and then we look at our principal investigators at the various sites to you know compare that and say, "Yes or no, the NGAL test picked up on this fact or not. In this process, are you in dialogue with FDA, or is it that just after when you have submitted your application of the data? Yeah. We don't share the data with the FDA until we actually make the submission. However, to be very clear, you know, what's different about this time versus, you know, past submissions is that there is complete alignment with the FDA on the design of the trials, the type of data that needed to be collected and what would constitute a AKI, you know, through the test of NGAL. We have complete alignment with them in terms of how this study was to progress and the type of data that they needed to see. That being said, if we don't see the quality of data that we believe or provides us with a high level of confidence that the FDA is going to approve a submission, we won't submit. We won't submit. We'll go back to our principal investigator partners, our clinical partners, to see how we recover from that. There's nothing that tells me that that's going to be the case, but you'll know or not whether you know we have very good data by whether we submit or not. Mm-hmm. In that comment... [crosstalk] about the communication with the FDA and in your earlier question, Henrik, about the kind of test performance that we're looking for, where those really come together and are important to understand is, as Tony said from the beginning, the current standard of care is recognized globally by clinicians as not being great. When you're, if you will, the bar is not great, you don't want a test that does great relative to a not-so-great bar. You want something that is different because it's better. Right. That's certainly something that our medical and regulatory team and the FDA are aligned on when Tony talks about that alignment from the pre-submission meetings. Right. These additional data elements, you know, were reviewed with the FDA. They know exactly what data we are collecting and how we will make the determination. There is a clarification question. I know there's been some confusion yesterday evening and this morning regarding when is the latest date for your submission to FDA? Our guidance right now is by fourth quarter, right? That means, you know, by the end of the absolute end of the year, our anticipation is that we'll make the submission. Will we make the submission earlier if we can? Absolutely. Right? But it's, you know, these things take some time and, I wanted to make sure that we set guidance that was reasonable, but not overly conservative. Okay. There is also a question relating to sort of the reading of the trial data. If some of the patient falls out of the trial, do you have to start all over or? Because you mentioned this number 600 in the announcement. So, if some of these data is being lost in some for some reason, do you have to start all over or how do you come about that? Yeah. The 600 number was a conservative number. It was based on the prevalence of AKI in the population that we were going after. We anticipated some patients would fall out. You know, our target was actually, I believe like 25% to 30% higher than, you know, if every patient was usable. The other thing that we're doing is keeping the enrollment sites open. What I mean by that is not necessarily closing the enrollment sites just in case we need additional data. The last thing, though, we wanted to do was close the enrollment sites and then have to restart if there's some reason or another that we had to go back and get additional data. We're keeping them open just in case. Now, a question relating to... [crosstalk] It's all about the risk-managed approach that we've tried to take with the business overall since we started. Okay. There's a question relating to the comparison of the earlier attempts to submit. What makes you more confident that this time it's for real and you're finally ready with all the data? What makes you think it's different? Yep. You know, just one word, alignment. Alignment with the FDA. You know, if we look at the past submissions, you know, that alignment with the FDA was not there. And in some cases, the FDA had made some suggestions that the company didn't move forward on. Also, you know, How do I want to say? I think we were looking for too much all at once. Going after, you know, adult indications, both the urine and serum sample types, we were looking to get a lot out of a submission and all of that requires more data. I think we have a very focused submission with pediatric and urine samples and that gives us some level of confidence. Like I said, if I were to put one word to it would be alignment. Okay. Great. Yeah. In fact, Henrik, that focus on patients that are from three months up to age 22, that was the population the FDA asked the company to focus on first. That's part of that alignment Tony's talking about. Yeah. Okay. Given that you submit in fourth quarter this year, is it the normal 150-day response time from FDA or you have this breakthrough designation, does that change that or will they, when are you to expect FDA to respond? Yeah. Those are two different questions, right? In terms of, I'll start with the breakthrough designation. The breakthrough designation basically gives you a priority. It gets you to the front of the line when you look at the inbox that the FDA has to deal with and which applications they need to review. What the FDA has told us, and they've told the industry, is they are reviewing COVID applications for anything related to COVID, and then secondly, any breakthrough designations, and then anything after that will get a third priority. That's, you know, which submission they'll open up first. The second question is, will it shorten the time for FDA review? The answer is likely not because we are performing a De Novo submission. We're the first test of this kind. The FDA is looking for more data. There is not a gold standard out there, right? This clinical trial would have been a lot easier if there was a gold standard that we could compare ourselves to, but there wasn't. It's a complex trial. They have to look at a lot of data. It's likely they'll take their time. The 150 days is the FDA's guidance of how fast they will respond. As I've indicated before, the response could be, "We need more data. We need some clarification on this data." You know, the clock stops whenever they ask that question, and then we need to respond very quickly. That response could be, you know, just answering a question or it could be collecting more data. Good. Of course, this is an important milestone for you to complete this enrollment for pediatrics. From a commercial standpoint, the bigger market is of course adults. What will happen after here? What can we expect in terms of sort of use that as to go for the adult indication? Yeah. You know, the beauty of getting the first indication is it provides the standard for the future. After the submission, we will focus on exactly what the indication will be for the next submission. It will be adult, right? It will be adult. We have to make a determination as to whether it's an adult for risk assessment or it's an adult for a diagnostic for certain disease states, like post-cardiac surgery. We are assembling a scientific advisory board to assist us in that decision. Of course, you know, the total market opportunity will be considered when we look at what that next indication is going to be. The next indication definitely will be an adult indication of some sort. Okay. Yeah. Important to understanding that while certainly our team, assuming we get this approval for this age range, has us focused on and only permitted to sell for the age range of three months up to, but not including age 22, it we use the word pediatric, but pediatric includes young adults. There are certainly young adults that are in intensive care units, not just in pediatric intensive care units or PICUs. We'll certainly go after both of those because we're permitted to do so. As you go for some of these adult indications, just to get a better understanding of how much time can you save now that you've done the sort of work with pediatrics. Is there anything you can reuse of these data or what should we expect? Yeah. You know. Yeah. We'll have to collect some adult samples, but there are some adult samples that could be available to us. In which case, depending on the type of indication we're moving forward with, could be existing samples that are out there that we can leverage or it can be, you know, a new trial. The two things that we're doing, you know, with this pediatric submission is we're establishing what the gold standard is, right? So, we're establishing when we say an NGAL level is this, it truly is this. That analytical testing won't need to be redone. The next one will likely be a 510(k) submission versus a De Novo submission. There's less data that's required. This first one is always tough. De Novo is always the toughest of all of them. Are you able to in any way to put sort of a timeline as to what we should expect regarding the process for the adult submission? Not yet. I'm not gonna guide to that yet until you know, until we make a decision on which adult submission that we'll make, and we analyze those timelines ourselves. Okay. There are some questions relating to the potential competition for this, as there has been delays previously. Some might be concerned that competitors will catch up or as one question here is chasing you, so you don't have that much advance from a time perspective. What are your thoughts on that, the potential competition? Yeah. We don't know of anybody that's you know actively developing an NGAL test for the US market today. That being said, you know a big part of our commercialization and market adoption strategy will be medical education, right? Will be driving up the interest in the test. I suspect that you know once we start to drive interest in the test you know that's when competitors will start to take a look at this and make a determination as to whether they will develop their own NGAL test. That being said, it takes you know a long time to develop a test, and it all starts with the right antibodies and antigens to actually clone and develop the reagents, and that takes some time. Okay. It takes years... [crosstalk] It takes years, not months. Okay. Okay. To your point, Henrik, you know, one of the things that we're very excited about, and as we announced about a week ago, is that Dr. Prasad Devarajan has joined us as a Senior Medical Director. I was listening... [crosstalk] NGAL is almost his middle name... [crosstalk] Nice to hear of this. It is almost his middle name. He is, you know, one of the co-discoverers of what that biomarker is and what it can mean. We're certainly expecting that will, because of his reputation and his knowledge and expertise, be very value-creating as it relates to our customers, the clinicians, the education that Tony is talking about, as well as coordinating with Dr. Chris Bird, our Chief Medical Officer, on the scientific advisory board that Tony just described, as we look at focusing on what the next indications will look like in the adult area. Yeah. I've been meaning to ask about that, what he actually brings to the table in terms of. Because it's my understanding he will work part-time for BioPorto and remain as CEO for pediatric hospital. Yes. He is the chief of nephrology and hypertension at Cincinnati Children's Hospital today. As Neil indicated, this is the world-renowned expert when it comes to pediatric nephrology. He has the respect of pediatric nephrologists as well as critical care clinicians around the world. You know, he will be helping us develop that education, you know, that set of education materials, talking on our behalf, you know, at the various conferences and forums where, you know, critical care clinicians listen to these types of things. He will be a, you know, very important as we go to commercialize and, absolutely a, like I said, a very well-respected resource for us. Would it be fair to say that he would primarily be a value to you as a company from a commercial and educational point of view? It's not like the fact that he's on board with you makes the process relating to FDA any easier. No. No. Okay. Yeah. The FDA is not going to look at this appointment and say, "We need to approve this submission." His real value is that he's a practicing clinician that uses his test for clinical care, right? He can talk about his own practice. He can talk about how to implement a program if you don't have a program, an NGAL program today, right? I think that's really important as we roll this out, because this is an incremental test to the lab. It doesn't replace anything that's in the lab. It is very, very valuable when it comes to reducing overall length of stay, reducing, you know, the cost, the overall cost of handling AKI patient. It reduces the amount of renal replacement therapy that could potentially be used for a patient that doesn't necessarily need it. Has he in any way, since he's known to be the primary expert within the field, affected the development of the NGAL test in any way in the sense that the things he proposed a good NGAL test would be, that has been included in the test or how it's been developed or? Yeah. He's very well aware of the way we designed the test and very supportive of the way we designed our trials. He will be very important as we look at the next indications, even though he's a pediatric nephrologist, you know, there is a lot of parallels with the adult population, will be helpful there. As well as the many adult clinicians, critical care clinicians that will involve in the scientific advisory board. Okay. Now, of course, the big focus is for the NGAL test and that is what we've talked about. You do have other things in your portfolio, and you have previously done the COVID-19 test and the sepsis test. Just a few words on that. Are they on standby or what should we expect? The COVID test is still very much in that discovery phase. We haven't moved it from discovery to development, and to be honest with you, I want the development team focused on the NGAL test for this time period, right? Even though we haven't you know necessarily closed that project or stopped that project, we're still investigating the COVID test, and if we find something that you know is very exciting, we will need to invest in it and add resources to take it to market. At this point in time, we are not giving it to our current development team to develop it into a product. The sepsis test, and just to clarify, the sepsis test is really the thrombomodulin biomarker that occurs when there's endothelial damage as a result of sepsis. That one, the Rigshospitalet, that is still doing their testing. The interim data was good, but we're still waiting for them to put out their final report on the testing that they're doing. Okay. Just as you are trying to leverage the data from the pediatric trials to going for the adult indication, to what extent can you use that to go outside hospitals for emergency setting and what you call certain outpatient settings? What's the priority of going to those markets? Yeah. Right now, our test is run on core lab instruments, clinical chemistry instruments in the core lab. Even though, you know, we've had started in the past the development on, you know, these dipsticks that could be used in for outpatient populations, our focus right now is on the core lab reagents. The idea is let's go after these in-hospital markets or inpatient markets and then expand from that. That's a, you know, patient population expansion that, you know, we can explore after we get our next adult indication out there. Okay. It's just that I know some would argue that in the hospitals you also on the equipment you use, you also meet potential competitors for tests from the likes of Roche, Abbott and those. Whereas these companies will most likely not go for the emergency settings and certain outdoor settings. Well, yes. You know, for one thing, we need to make those instrument manufacturers our partners, right? We don't manufacture our own instrument. We need to be reliant on those. In fact, this past earlier this week, we were with Roche senior leadership talking about commercialization in the US, what roles and responsibilities each party is going to play so that we can leverage their, you know, their number of sales reps that they have throughout the US, right? Those are hundreds of sales reps that, you know, we don't necessarily have that we would have to invest in. How do we leverage that, and then utilize our team to provide the medical education out there? I see us working hand-in-hand with those manufacturers moving forward. At this point, they're more partners than competitors, potential competitors. Absolutely. They're strategic partners. Strategic partners, yep. Yeah. Time is running, but just a final question relating to the current environment within biotech is of course challenging a lot of your colleagues to raise capital and so on. You just did it and have a good position in that regard at this point. Down the line, I expect that you will have to consider perhaps to raise capital again. Or what are your considerations as to the current environment and to when you will need capital again? Well, Henrik... [crosstalk] Yeah. It's a process that is done over time. I guess I'll start by directly answering your question that we haven't set a specific timeline, an amount or a process or structure. What we have done and what some of our shareholders, I should start by saying we're very appreciative of the support that we received in the rights offering from our longtime shareholders, and that's enabling us to reach the milestone that we announced last night. That's very important to recognize. Looking forward, what some may have noticed in our announcements over the last couple weeks is in addition to our longstanding investor relations colleague, Tim Eriksen from Zenith Advisory, who's very attentive to all of our shareholders here in Copenhagen and Denmark, and I'm here in Hellerup right now. I'm not in the States. We've recently engaged with a firm called LifeSci Advisors, and they are one of the preeminent life sciences investor relations firms in the States. As we have said, we are focused also on the US capital markets as a source, not the only source, but as a source for capital for this company as it moves forward and achieves all the things, all the great things we hope and expect to do that we've been talking about today. That's the start of doing that and working towards that process. When there's more to talk about for that, you know, at the right time, we'll do that. Okay. Sounds interesting. Okay. Gentlemen, I think we are about to run out of time. Thank you very much for participating and also to the audience for all the good questions. We'll be looking forward to hear more about the submission later this year. Tony Pare and Neil Goldman, thank you very much. Thank you, Henrik. Thank you. Have a great afternoon. Thank you. Enjoy the holidays. Thank you.