Good morning, and welcome to the BioPorto A/S third quarter earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Tony Pare. Please go ahead. Thank you, operator, and a warm welcome to everyone participating on this Q3 2022 financial results and business update call. We are thankful that you have chosen to spend your morning with us to review the latest interim quarterly report. Along with me today is Neil Goldman, our Executive Vice President and Chief Financial Officer. Before we begin, let me remind you that the company's remarks made during this conference call today, November ninth, 2022, may include predictions, estimates, or other information that may be considered forward-looking. Let me begin with an update on our submission of the De Novo application to the US Food and Drug Administration or FDA of the NGAL Test to aid in identifying pediatric patients aged at least three months and up to 22 years at risk of moderate to severe acute kidney injury or AKI. We have committed that we will submit by Q4 of this year, and today we are reiterating that commitment. Additional work remains, and our team is completely focused on getting it right. That includes, for example, engaging former FDA reviewers to advise on the submission's analytical approach, documentation, and presentation. We will not submit unless we are reasonably confident that we have met the objectives defined at the beginning of the trial. That said, remember, this is a very complex clinical trial comprised of three separate studies that contain hundreds of data elements that are being analyzed, documented, and reviewed. Ultimately, of course, the FDA is the judge. Depending on the outcome of the very last details, all of which are important, we maintain an expectation of submission this quarter. Turning to the financials. We saw revenues of DKK 5.3 million or $0.7 million in the third quarter of 2022, which was on par with the prior year's revenue in the same period. Year to date, our revenue was DKK 20.3 million or $2.9 million, a 16% increase over the same period last year. Year to date revenue from sales of NGAL tests totaled DKK 9.7 million, which is a 15% increase over the prior year period. While we are pleased with this growth, it is important to understand that most hospitals around the world are still waiting for BioPorto to receive marketing authorization from the FDA before adopting NGAL test for clinical use. These year-to-date revenues are within our expectations, and we are maintaining our revenue guidance for the financial year. As Neil will discuss further, we exercised appropriate cost control and deferred certain commercialization expenses, thereby reducing costs below prior expectations. Therefore, we have improved our expectations for full year 2022 EBIT and adjusted EBITDA losses. The strategy we set at the beginning of this year for 2022 and 2023 is built around launching an FDA-cleared test in the U.S. That strategy has three pillars, drive market adoption of the NGAL test and have a pipeline of products that deliver high medical value, strengthen the company to scale and execute, and attract, develop, retain the best and brightest employees aligned with our values and with clear roles and responsibilities. As our first pillar, and we get closer to the prospective U.S. launch, we will be investing more heavily in our commercialization strategy, including hiring personnel and continuing to prepare manufacturing and quality systems. Those personnel will include, for example, medical affairs specialists to educate key large accounts on the clinical value of NGAL Test. As we have done this year, we will balance managing our costs while also preparing for prospective commercial launch in the U.S. Along the way, we will sustain our other revenue streams and continue developing a pipeline of potential new products which I will talk about later. Our second pillar is to strengthen the company to scale and execute by investing in our production, quality, and documentation systems while solidifying our supplier relationships. In addition to working on the FDA submission, these systems have and will continue to be an important area of focus by our team so that the company can be FDA audit ready. Following our planned submission, BioPorto will continue executing its commercialization strategy, including hiring personnel and preparing manufacturing and quality systems while working to make the NGAL Test available for adult populations, which are age 22 and over. In addition to building the company's own commercial team, we will work with our strategic partner, Roche Diagnostics to refine our market access plan. I'll talk more about that in a bit. This strategy also means focusing our core business operations and financing the company. Assessing our capital needs and exploring future financing pathways is and will continue to be an ongoing activity. Our third pillar is to attract, develop, and retain the best and brightest employees aligned with our values. Building the right team for the future of BioPorto, we need to recruit the very best to help drive success. As a team, we are becoming increasingly selective. We are pleased to have attracted a top-tier team to date based on the quality of the company and prospects of NGAL test. It is our job to continuously ensure that BioPorto is a company where employees are motivated to join, grow, and stay. As we approach the time to commercialize NGAL test in the U.S., I would like to describe our go-to-market model. Our model follows an industry-tested approach for reagent companies like BioPorto that manufacture products that run on clinical chemistry analyzers in the core labs of hospitals. Recall that there are five recognized leading global analyzer manufacturers. They are Roche Diagnostics, Abbott, Siemens, Beckman Coulter, and QuidelOrtho. Companies like BioPorto are generally responsible for product development, regulatory approval, intellectual property, manufacturing, clinical education, and marketing, and ongoing studies in reimbursement. Because the instrument manufacturers have existing customer hospital relationships through sizable and wide-reaching sales teams, they have a vested interest in making NGAL test part of their product portfolio to meet customer demands. The instrument manufacturers also have comprehensive supply chain and distribution channels that we will leverage. We have a non-exclusive strategic relationship with Roche Diagnostics today and are naturally in discussions with the other major manufacturers. In this model, BioPorto will benefit from the analyzer manufacturer's large sales and support organization. This means that BioPorto can build its commercial organization around medical and scientific education that promotes the use of NGAL test and their ability to detect acute kidney injury. When Neil and I joined BioPorto nearly a year ago, the company was working on a diverse set of possible tests. We quickly made a strategic decision to focus on gaining De Novo marketing authorization from the FDA for an NGAL test for pediatric use for AKI. The top half of the chart on this slide illustrates how we have continued to investigate other potential critical care biomarkers and the next generation of NGAL products. The bottom half of the chart illustrates potential targets for expanding our NGAL test into adult critical care applications. Our currently planned submission sets up the gold standard against which future submissions will be measured. Therefore, the analytical requirements for an adult submission to the FDA should be less complex. We are investigating the regulatory feasibility, clinical development requirements, cost, and market potential for each of these targets to drive our prioritization decisions. Now turning to a refresher on acute kidney injury, or AKI, as well as NGAL test, the clinical need, and BioPorto's market opportunity. AKI is indeed a significant global health issue. AKI represents up to a $24 billion burden in the U.S. alone. It is pervasive, affecting one in five of all hospital patients and one in four of all hospitalized children. AKI is preventable and treatable if detected early. 70% of clinicians believe they are missing it. They are missing it because AKI is currently clinically silent, which means there's no apparent symptom, and it is not reliably detectable with current tools. Unfortunately, if AKI is not detected timely, patients face irreversible kidney damage leading to a lifetime of dialysis or death. That's where NGAL tests come in. NGAL stands for neutrophil gelatinase-associated lipocalin. It is a protein that is expressed at various locations within the kidney's urine filtration pathway. It is detectable within two to three hours after the time injury occurs and before the kidney has lost any functional capability. NGAL test results can help clinicians move from one non-treatment or indeterminate prophylactic approaches to targeted reactive treatment of AKI that can save kidneys and lives and also improve the efficiency of hospital intensive care unit operations. The current approach to attempting to identify AKI is to monitor urine output and measure serum creatinine, which may rise, but not until days after your kidney is injured, and may not be detectable until 50% of the kidney function is lost. That essentially means losing the equivalent of one full kidney before the doctor becomes aware and can intervene. The good news is that leading physician researchers recognize this and are actively publishing more and more studies that support the value of NGAL test. Of course, we will use these as part of our clinical education and commercial work that I talked about earlier. To illustrate, I'll now share with you some examples of a couple of studies that were published and/or presented in the past two months. The first is the kidney and cirrhosis of the liver. The liver and the kidney work together to remove waste from the bloodstream. Damage to the liver in the form of cirrhosis can result in a couple of types of prerenal AKI. Determining the type of AKI is key to determining the pharmaceutical therapy to prescribe. There are emerging pharmaceutical treatments such as terlipressin that have been studied as a vasoactive drug in the management of low blood pressure that may treat the liver, but are only appropriate for one type of prerenal AKI called hepatorenal syndrome AKI. This study was published in September in a peer-reviewed journal, Hepatology, and was presented just last weekend in Orlando at the American Society of Nephrology's 2022 Kidney Week and annual meeting. This study demonstrated that NGAL is an excellent urinary biomarker in differential diagnosis between two types of AKI and can therefore play a significant role in refining patient diagnosis so clinicians know when terlipressin can be effective and should be prescribed. The study also concluded that NGAL is a predictor of in-hospital mortality. The second presentation I would like to highlight was presented at the International Symposium on AKI in Children in Cincinnati, Ohio, last month. I attended the conference with approximately 300 nephrology experts and witnessed this slide being presented. It depicts how rapidly the timing of AKI progresses and the impact of the short timing windows. These short timing windows have on when different types of therapeutics should be prescribed to be effective. As you can see, NGAL stands out among other kidney biomarkers as the best predictive diagnostic because of how quickly it is measured after the kidney is injured. In particular, this slide and its underlying peer-reviewed study that was published in Pediatric Nephrology highlights how a difference of a couple of hours changes the appropriate therapy and the importance of near real-time diagnostics. These therapies can be applied during the preventative and restorative phases of AKI before permanent damage to the kidney is done. The bottom line is that the science for the treatment of AKI continues to emerge and depends on a biomarker like NGAL to be available to administer new life-saving therapies. At this stage, I'll turn the call over to Neil to review our financial results. Thanks, Tony, and hello, everyone. From a financial perspective, things have also progressed positively and according to plan. Starting off with revenues, on the left side chart, which shows revenue by quarter for 2022 and 2021, you can see that revenue in the third quarter of 2022 was DKK 5.3 million, or $0.7 million, which was on par with the same period last year. I'll further describe the components of this in a moment. For the first nine months of 2022, total revenue was DKK 20.3 million, or $2.9 million, representing a growth of 16% over the prior year period. The chart on the right shows year-to-date revenue by product group. Each bar also shows the contribution by quarter, and the labels at the top of the bars are the year-to-date amounts in DKK millions. Our revenue for the third quarter of 2022 reflected growth over the prior year quarter in our two largest product groups, NGAL Tests and Antibodies, which was offset by a decline in sales of ELISA Kits and Royalty and Other Revenue combined. NGAL Test revenue for the first nine months of 2022 was DKK 9.7 million, a 15% increase over the prior year period. Revenue from Antibodies for the first nine months of 2022 was DKK 9 million, an increase of 27% over the prior year period. Gains in those areas were somewhat offset by sales in our smallest product revenue group of ELISA Kits and Royalty and Other Revenue, which combined for the first nine months of 2022 was DKK 1.6 million, a 19% decline over the prior year period. As it is presently a research use only product in the U.S., NGAL Test sales may have timing variability among customers, as we discussed on the second quarter call. This next slide provides further historical trend information on sales of NGAL Tests, which, as I said, are up 15% on a year-to-date basis over the prior year period. The chart on the right shows rolling last 12-month NGAL Test sales. Now turning to operating results for the third quarter of 2022. EBIT loss for the month was DKK 20 million, or $2.7 million, a 38% increase over the prior year period. Adjusted EBITDA loss for the third quarter of 2022 was DKK 17.1 million, or $2.3 million, a 14% increase over the prior year period. These are reflected in the chart on the left, which shows historical quarterly adjusted EBITDA and cash balances. Moving to the balance sheet, which is summarized on the right. We had cash and cash equivalents of DKK 98.9 million, or $13 million, as of September 30, 2022. I'm pleased to report that we reduced our year-to-date cash used in operations by DKK 14.5 million over the prior year period. More specifically, that reduction is from an operations burn of DKK 50.5 million in the first nine months of 2021, down to DKK 35.9 million in the first nine months of 2022. The improvement was principally related to our management of working capital that started with a focus in the beginning of this year and with an accelerated impact into Q3. Now I will discuss our updated guidance for 2022. The company has a small base of customers that provide dependable repeat business. Large bulk orders for antibodies, such as those we experienced in the first and second quarter of 2022, could be forecasted but are not yet of a reasonable level of probability. Also, the fourth quarter of 2022 is expected to reflect continuing costs of finalizing clinical trials and incremental costs intended to support the commercialization strategy that Tony described earlier in the call. These include hiring personnel and continuing to prepare manufacturing and quality systems. During the first nine months of 2022, we have exercised appropriate cost control and deferred certain commercialization expenses that have reduced costs below expectations. Therefore, BioPorto has revised its 2022 guidance for operating EBIT loss from approximately DKK 95-100 million down to approximately 83-88 million. An adjusted EBITDA loss from approximately DKK 76-81 million down to approximately DKK 71-75 million. BioPorto maintains its 2022 revenue guidance of approximately DKK 24-27 million. Now handing it back to you, Tony, for closing remarks. Thank you, Neil. It has been almost one year to the day since I joined BioPorto as its CEO. Since then, we've developed a strategy that focused our team on execution, and we are delivering on our commitment. I am very proud of the entire BioPorto team and appreciative of our clinical trial partners and the study participants for their important roles in making an exciting new life-saving test available. As I shared at the beginning of the call, our next key milestone is the FDA submission during this quarter, at which time we will provide an update. I also wanna take this opportunity to thank all of our shareholders for their continued support of BioPorto on our important mission. We have indeed accomplished a lot in this short time, and our focus continues to be on delivering results and our commitment to keep you and the market informed of our progress within the framework of what is prudent to disclose, considering both Nasdaq rules and the competitive environment. With that, I will hand over the call to you, operator, as we are happy to take questions. We will now begin the question- and- answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from the line of Yi Chen from H.C. Wainwright. Please go ahead. Thank you for taking my questions. Could you give us some color on how long could the review time be by the FDA once you submit the application later this year? Sure, Yi. No problem. We have one thing going for us, which is the Breakthrough Therapy on our submission, which allows or basically gets us to the front of the line in terms of the review process. However, that being said, this is a De Novo application and a complex one at that. I don't expect that the FDA will turn this around overnight. There is no current gold standard out there that you know basically provides a predicate for this submission. The FDA has issued their guidelines for review and approval targets for 2023, and they are basically targeting 70% approvals will come within 150 days. That 150 days is basically the time that the FDA has the application in hand. If they stop the review process and ask us questions or ask us to get more data, it doesn't count towards that 150 days. Got it. Would you be able to discuss potential pricing and gross margin upwards? Which is right in line with other high medical value tests that are on the market today, such as procalcitonin, such as troponin, some of the others that are out there. Our margins are right around 70%, you know, right in line with other reagents of our, you know, our type. Remember, we don't have an instrument that we are selling or or providing. As such, we're able to, you know, achieve good levels of margin right off the bat. Got it. My last question is, how large is the sales team to successfully market this test in the U.S., and does the company have sufficient capital to establish this team? The sales team or the commercial, I will refer to it as the commercial team. The commercial team will be primarily medical affairs specialists, so folks that go out and promote the clinical value of the test, you know, to clinicians, but work hand in hand with our strategic partners such as Roche. Roche Diagnostics in the U.S. has close to 50 sales reps. You know, we'll obviously work with Roche to determine how many of those sales reps will be in a position to actually sell our product. We'll leverage their sales team. We'll have a medical affairs team. We will have some sales folks as well to continue to, you know, work with Roche as well as nurture the business with non-Roche instrument customers. Got it. Thank you. Yep. No problem, Yi. For any further questions, please press star and one. Gentlemen, there are no further questions. Would you like to add any final comments? Only, again, I wanna reiterate my thanks to employees as well as our shareholders as well as our partners in getting us to the point where we're at today. With that, we'll sign off. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.