Okay, I think the appointed time has arrived. Welcome everybody to the Pacific Edge 23rd Annual Shareholder Meeting. My name is Chris Gallaher, and I'm the Chairman of Pacific Edge. I believe we have a quorum present. I now declare the meeting open. On behalf of the board, I thank you very much for attending this annual meeting, and to those virtually online, welcome to you as well. This is our first meeting outside of Dunedin. We thought it was appropriate and the right time to give our Auckland shareholders and investors an opportunity to interact firsthand with the company and the board. Special welcome to you all. Before we start the formal meeting, business of the meeting, I have a couple of housekeeping points. First, could you please make sure your phones are on silent? Secondly, the fire exit is just past the registration desk that you passed on the way in. In the case of an emergency, follow the Link staff. Bathrooms are located in the foyer. Turn right upon exiting this room, then turn left. Firstly, some introductions. To my left, Sarah Park, who's Chair of the Audit and Risk Committee. Tony Barclay, Anatole Masfen, Anna Stove, Chair of our People and Culture Committee. Mark Green, Chair of our Capital and M&A Committee. We have with us from management, Dr. Peter Menzies. Now, Peter managed to catch himself a nasty virus yesterday and was unable to fly up to the meeting, but he will be online. We have our Chief Financial Officer, Grant Gibson, here, and a couple of special guests from the U.S. David Levison, who's the President of Pacific Edge Diagnostics in the U.S., and Dr. Tamer Aboushwareb, our Chief Medical Officer from the U.S.. You'll be hearing from both David and Tamer as we go through the session. It's a great opportunity to have our two key leaders from the U.S. business with us today to answer questions on all matters that relate to the U.S., which, as everybody knows, is the giant part of our business. Our auditors, PricewaterhouseCoopers, are represented here today by John Dixon, our Audit Partner, while our External Legal Counsel, Anne McLeod from Anderson Lloyd, is joining us virtually. Welcome to everybody. This meeting will follow the agenda set out on the notice of meeting, sent to shareholders on the 26th of June. We'll take your questions as a panel, and I hope that you will be able to join us for a cup of tea and a scone after the meeting. Firstly, to apologies, we have received none, I believe, Grant? No apologies from the floor. The minutes of last year's annual meeting, held in Dunedin on the 28th of July, 2022, are available for viewing on the NZX website. Would you like to get a seat, sir? Okay. All good. Okay, to slide 5, meeting agenda. I'd now like to make a few remarks on the financial year that's just passed. The Novatest local coverage situation, which I'm sure is top of mind for everybody in this room, as it is for all of us in board and management, and our responses thus far to it. When thinking about the year behind us, the year ended March 2023, when we released our results in May of this year, we were looking ahead to 2024 with some confidence. We had grown significantly in 2023, and our focus was on continuing that growth as we delivered on our strategy and plan. Peter and his team had delivered an excellent result for shareholders in 2023. They made significant advances in our strategic objectives to drive the adoption and more frequent use of Cxbladder. They advanced our program for the tests to be included in global standards, and they built on the intellectual property that's embedded in our tests. Confident that we had the momentum, which came off the investment that we'd made into the business, we invested for growth, particularly in the U.S. market. We expanded direct sales support teams, virtual selling teams, introduced a new medical affairs team, one of whom is here with us today in Tamer, and we invested in market access capabilities for the company. We were rewarded for that investment with a 37% increase in test volumes to 31,565 tests. A rise that was principally driven by a strong increase in commercial sales in the U.S. This translated into a 71% increase in operating revenue, which reached $19.6 million. As a direct result of this, the investment in particular, our net loss after tax did increase to $27 million. Again, exchange rates did have some role to play in both the revenue side and the cost side. We proceeded with our investment program cautiously. All of our investments were linked to revenue milestones, and were underpinned by the legal and industry advice that we consistently received through the year, that a loss of our Medicare coverage, although a possibility, was a very low probability. We consequently ended the year with a strong balance sheet, with cash and cash equivalents totaling $77.8 million. These reserves give the company options in the event of an adverse Medicare coverage determination. As we are now very well aware, that caution was warranted. In June, shortly after we announced our results, the most significant risk that we had identified on our risk register materialized. We first obtained our LCD in 2020, over the two years that followed, reimbursement was smooth, including passing several routine audits that CMS applied. There were no adverse findings on our test efficacy. It came as a complete surprise to see the Novitas draft determination in July 2022, which changed the landscape for the company. The draft LCD made it clear that Medicare coverage of our Detect and Monitor tests was under threat, consequently, we began scenario planning for a non-coverage decision. As I noted earlier, this planning was undertaken in the context of advice from our lawyers and industry experts that the LCD would not survive in its current form. This view was reinforced in subsequent months, as we took part in a series of open meetings and made numerous representations to Novitas. Over this period, we received vocal and public support from industry, patients, and many customers, who highlighted the significant clinical value our tests offered in sparing patients from invasive urological procedures, and the role they could have in helping urologists solve diagnostic dilemmas. It's important to note and not lose sight of the fact, this draft LCD was not solely directed at Pacific Edge, and was directed at a number of companies, including some very large ones, in Castle Biosciences and Abbott, where they had biomarker tests that were previously covered. Our view was also reinforced at the start of the year, when our triage test gained Medicare coverage under the same provisions that provided for the coverage of our detect and monitor tests. There's one hand, other hand going on. Given this expectation, Novitas' June 23 determination included an unprecedented amount of new content in the final version, including non-coverage of all Pacific Edge's tests. It was completely unexpected and surprising, and in the words of some, "a black swan event" over which we had little control. Overturning arrangements that had been in place since 2020, Novitas declared that Cxbladder tests were not medically reasonable and necessary, and therefore not eligible for Medicare coverage. Until that point, Novitas had left the clinical decision-making to individual urologists. Peter is going to cover our objections to the LCD in detail. I want to spend my time focusing on the strategic steps the board of management have taken following that Novitas determination back in July. The board very quickly formed an LCD subcommittee that has met twice a week for the last six weeks. We began to pursue all legal and political strategies at our disposal to overturn the LCD, not the least of which, because we firmly believe Novitas had not followed their statutory regulated process that they are required to follow as a Medicare Administrative Contractor. We were very pleased earlier this month, when our objections to this point appeared to have been heard, and Novitas agreed that the 17th July date was now off the table, and would not become effective from that date, but would be republished to follow procedure and allow for notice and comment on the LCD. Our LCD is still live, still in place, and is still up and running. Secondly, while we continue to refute Novitas' evidentiary review on substantial and procedural grounds, we have committed to making a number of changes to our expense profile and to redimension the business for scenarios that include a potential loss of Medicare coverage at some time in the future. As to this review, I'll now turn. The board's overriding objective is to ensure we use our capital to see us through to regaining Medicare coverage. A process that we believe could take up to 4 years, in the event that Novitas makes another adverse decision. As the largest individual contract globally for our business, we recognize that we must prioritize Medicare coverage, and that we will have a much greater chance of realizing the significant value inherent in Cxbladder's intellectual property across other geographies when we have Medicare secured. We set out in June the strategic pathways that we had under consideration. The first was legal challenges and appeals. The first appeal, we were successful. The next round of appeals and challenges will follow the release of the new draft LCD, whenever that may happen. We continue to explore paths of continuation of coverage with Novitas or an alternative MAC, and work has commenced on looking at our alternatives in that space. We have examined alternative billing practices that would increase patient responsibility for payment. Lastly, we identified that we would look at all things strategic, including what marketing, distribution, joint venture opportunities were out there to enable us to achieve our goals faster. We've made progress on several of these strategic pathways. As I mentioned, we've got to stay on the LCD. Pete will talk some more on for how long that may be with us, but for the moment, we know last time around, when the draft LCD came out in June of 2022, it took a year or just under a year for the final LCD to be released. There's quite some time to play out before any new draft LCD would take effect. We continue to promote Cxbladder and process all tests ordered by U.S. clinicians with the current team. That's evidenced by the fact that for the Q1, the April to June quarter, our year-on-year growth for test volumes was up another 38%. The business continued to grow strongly despite the uncertainty of the LCD that sits with us. We have announced our program to enhance patient responsibility for payment for our tests and began rolling out that program for the middle of this month. David Levison will talk more to you in more detail on this particular pathway in his presentation. Tamer, Dr Tamer, will meanwhile set out how we are refocusing our evidence development and our current coverage and guideline strategies for increased coverage certainty. We have begun the process of exploring our other strategic options, and more on that in due course. This review is ongoing. We do now have more time than we had originally. We have coverage, we have revenue, we have test volumes growing, so we do have that time now to not take a breath, but to just get it right, and not rush into things that we probably may have if we had have lost our coverage on the 17th of July, we wouldn't have had that leeway of time that we now have. In evaluating these strategic pathways, the board is looking at impact on revenue, the impact on cash and our cash reserves, time and resources to implement, the expected likelihood of success, and most important of all, the expected impact on shareholder value. Just before I hand over to Pete, it's been a tumultuous year for everybody, shareholders, staff, board, I would like to take this opportunity to thank the board for their time and commitment over the last 12 months. We didn't see this coming. It's demanded an awful lot of time and consideration from the board, I'm very grateful for their support. Also, to Pete and his team. I particularly want to pay tribute to Pete. He joined us in January last year, having no sense that this could ever come down the pipeline. He's dealt with it in a very balanced and unperturbed way. He's shown terrific leadership to the business in what is a very, very difficult time. Thanks to Pete, in particular, and his team for the way that they've led us through this process to date. I'd now like to hand over to Pete for his presentation. Well, thank you very much, Chris. I appreciate all the kind words. My name is Dr. Peter Meintjes, and apologies from me for not being able to make it there in person. I did get struck by a virus on Tuesday and am still recovering, but expect to be able to talk you through the next couple of slides. As Chris mentioned, Novitas is very much on our minds. You know, we've done our best to maintain regular updates to our shareholders through the quarterly updates, and through the kind of real-time announcements to the market. We made a particular effort in the last quarterly update to go through in some depth what we mean when we talk about what this unprecedented and flawed decision. The summary here, you know, is that there are some significant criticisms of our data and our evidence that were published in Genetic Testing for Oncology, the LCD in question here. From our perspective, all of them have sound arguments from Pacific Edge as to why they are not actually very good arguments. We've done our best to, A, articulate that for investors. B, as of this morning, we did have a face-to-face meeting virtually with Novitas to outline our position. We don't expect that will change their trajectory on republishing the LCD, but we have now had the opportunity, an opportunity that was not previously afforded to us, to make the case for our products, their clinical value, and some of the misunderstandings that we have seen in the LCD. This is obviously critical for us because Medicare is our largest customer. As you all know, Cxbladder has a majority Medicare and Medicare Advantage population because the average age of somebody presenting with hematuria is over the age of 73, this accounts for a significant portion of our revenue. As we look to try to understand what are the scenarios that we need to plan for, we are navigating an uncertain environment where we now acknowledge that what we previously called a high impact but low probability event may have a higher probability than we previously understood from our legal advisors and industry partners. We are preparing to manage that uncertainty. The best knowledge that we have at the moment, in Novitas' own words, in terms of a timeline, is that they will republish the LCD in the near future. From that time, we will have 45 days to provide our comments after we review the revised LCD. Management and board are planning for a scenario where the new LCD largely resembles the old LCD and that they will publish relatively quickly. We will have 45 days to make our arguments in both a public-open forum and in written form. The written form is the most important of these because Novitas is then required to respond to each of those written comments. Although sometimes they will respond to a summary of multiple similar written comments, explaining their reasons for why they either have accepted those or not accepted those responses from us as companies, and how they will incorporate that feedback. As a note of encouragement this morning, they did say that the arguments that we had made to them verbally in our meeting today, should be well represented in those written comments. That's obviously no commitment either way from them, but it is clear how they expect us to interact with them, and how they will look at that feedback. On the more positive note, in terms of what we, you know, of what we have achieved despite all of this, is that adoption among clinicians, has continued to rise. We have seen with the June 2nd announcement, we have had the opportunity to reach out to a large number of key opinion leaders in our field, and we have received a groundswell of support from run-of-the-mill urologists using our tests on a regular basis, through to many of the key opinion leaders with whom we run clinical studies and who can influence public policy at the highest levels in our industry. That support from those clinicians will be an invaluable input in the review and comment period, and subsequently, you know, pose some challenges for Novitas as they respond to those comments in the next 320 days that would come after the close of the comment period. Moving on to the financial performance here, you know, as Chris already highlighted the key messages. For me, it's really important that despite this LCD uncertainty, which did hang over our heads in a different capacity during FY 2023, we delivered standout growth. We understand as a business how to continue to execute despite these kinds of uncertainty, managing capital cautiously, and investing in only the things that matter in terms of generating additional revenue and making sure that we have ongoing coverage for our products. In that regard, global laboratory throughput increased 37% to 31,565 tests. Global commercial test volumes increased 39% to 26,691. What's also useful for everyone to understand is the breakdown by product, where the TLT in globally is driven by, firstly, the U.S. Then, of course, within the context of the U.S., this is driven predominantly by the use of Detect, which is in the hematuria evaluation setting. The hematuria evaluation setting is the largest market opportunity for us, three times the size of the bladder cancer surveillance market. We repost this to acknowledge two things. One, that in the face of coverage uncertainty, our strategy actually remains remarkably resilient. The adoption, retention, and revenue generation has been a key focus for us over the last 12 months because we have coverage and because we have the opportunity because we have a contract with Kaiser Permanente. The second pillar here is the one that is of most relevance in the immediate sense. Usually, we talk about this in the medium-term context. Evidence, coverage, and guidelines underpins our ability to be paid, and has been a focus since I joined the company. It's actually been a focus, you know, prior to that, of course, as well. To really be more laser-focused on the guidelines component of that, given the coverage situation we have had for the last 3 years. Inclusion in guidelines requires a higher standard of evidence. It is something we have been building towards, with the reshaping of our clinical evidence program, consequently, we believe we are as well positioned as we can be, given existing updates to our strategy, as we can be. Of course, research and innovation is the longer term. We continue to make product improvements to our existing, to the existing products that we have for hematuria evaluation and surveillance, continue to look for opportunities within the urology landscape for further products that can deliver value, that is ongoing. The main focus here is on the evidence, coverage, and guidelines, and the adjustments that we need to make to ensure guidelines inclusion. Refining our focus on adoption, retention, and revenue generation, and David will focus on this in a specific sense for the United States. Dimensioning the U.S. business to reflect the increased probability of a future adverse Medicare determination. The kinds of things that we are looking at, as we redimension the business, are to focus on national accounts and virtual teams to support Kaiser, VA, and other potentially capitated systems that may better be attuned for the true clinical value of Cxbladder, which is to, you know, reduce the cystoscopy burden on physicians and patients. To look at enhanced patient responsibility, where we create a patient assistance program that has a positive gross margin on average per test, based on the discounts to the federal poverty level. We are continuing to invest in our Asia Pacific expansion, and through our U.S. team, ex-U.S. opportunities in Israel and Latin America, as these, you know, have a different coverage landscape. While the volumes that we anticipate in these areas is currently still quite low, you know, we do believe that it is important to invest in these areas as ways of de-risking our business and just general opportunities for growth. As I outlined in the financial results in May, we have focused a number of internal efforts on improving the digitalization of our environment to make ourselves more efficient. We want to grow not just by... We know that we can't continue to grow just by adding additional headcount. That's a very expensive way to grow. We can grow in effectiveness and efficiency by analyzing our systems through performance excellence programs and building digital frameworks, from which we can, you know, from which we can deliver more through fewer individuals. We continue to market and amplify our clinical development program within the urology community. Although we have already agreed to scale this back, given the coverage uncertainty. We will continue to promote our key messages at major meetings through our medical affairs program and our marketing program. We do acknowledge that patients have always been core to the value proposition of Pacific Edge. We will have to spend more time communicating those messages initially to physicians and directly to patients, as we ask patients to take on a greater responsibility, either as a component of balance billing on commercial insurance or through the ABN process for Medicare. Both of which, you know, we will implement in phases as and when we lose coverage. Importantly, looking at the growth in the APAC region, things have been largely constant. There hasn't been a huge amount of growth, but we have expanded in terms of the coverage with additional contracts. Activating some of those contracts has taken some time, and Australia and the Southeast Asian regions continue to be in a business development phase. We have, of course, announced already in our quarterly update that we have a distribution agreement with TransViet and High Precision for Vietnam and the Philippines. It takes a little while, but we've already undertaken some test shipments. We will obviously spend some of our time educating the, you know, our distribution partners and of course, the physicians that they have great relationships with. Evidence, coverage, and guidelines. I had the benefit of having David and Tamer in New Zealand, over the last couple of days, and we spent Monday and Tuesday of this week in strategy sessions. A key component of this is really focusing in on changing clinical practice and selling the value of our tests. Both David and Tamer will talk more about this. As it relates to our strategic pillar of evidence, coverage, and guidelines, we really need to, or we continue to remind investors that we are focused on generating high-quality clinical validity and clinical view and clinical utility evidence through clinical studies. The studies we've done to date have been good enough to secure us initial coverage. Nova Test has challenged that. We have, for, you know, many years already, recognized the value of an ongoing investment in clinical evidence generation because we were not yet in guidelines, and we are not yet covered by private payers outside of Kaiser Permanente. The ways to get coverage from those entities is through an increasingly robust clinical evidence generation program that focuses on a very defined patient population and the endpoints that matter to the decision-makers on guidelines committees. We will show in Tamer's presentation a roadmap with our best estimates of how long these studies will need to enroll for, and how long it will take to get all the patients in, to monitor the data, to perform the data analysis, and ultimately publish. He'll speak to that. That includes two studies that are still as yet proposed, that focus, again, on the clinical utility that would be necessary for guidelines inclusion that private payers typically need to see. The fourth bullet here is that we continue to consider the merits of the MolDX program. Where we are with that, as we know, this is something our investors have asked us about because we are not in MolDX's jurisdiction. There are some steps that we have been able to take, even without moving a lab, and we now have a Z-Code assigned through approaching MolDX, and we have also initiated, or we have not yet submitted the data, but we intend to submit the data for a technical assessment by MolDX out of jurisdiction, and that, we will update shareholders as and when we know the result of that technical assessment. On the research and innovation front, we continue to think about the various, you know, the other future opportunities in neurology, but our major focus is on improving the current product, so Detect and Monitor. We are adding DNA markers to both of them to have Detect+ and Monitor+ available. That is improving the performance of the test. Other things that we have not yet done, is actually just improving the workflows of those tests for scalability, reduction of no results, and various other things that improve the operations, lowering cost of goods, among other things, lowering the headcount requirement, the hands-on time of staff, automating, et cetera, et cetera. So those are the kinds of things that our R&D team will continue to focus on. An added challenge that is that we now that we have some level of clarity is coming our way is that the FDA have announced their intent to regulate laboratory-developed tests. How they expect to do that is not yet known, but they expect to provide us with a framework for comment in August this year. If this, well, the last attempt at this was the VALID Act, which did not pass Congress at the end of 2022. It had a grandfathering provision that would allow any test five years to adapt to the new framework. We view this as something that we need to invest in today to ensure that we are compatible in the framework of three to five years with the FDA requirements. Our new products, we will make sure that they are compliant with FDA clearance. Pacific Edge maintains a commitment to ESG, and one of the key areas of ESG that we focus on is improving social outcomes. You know, our, for example, our in-home sampling kits are able to reach rural areas that may not have the kinds of access to healthcare that people who live in cities may more easily access. You know, we use this as a key example for how Pacific Edge is delivering this not just in New Zealand, but to rural areas in the United States, and focus on a mission of improving social outcomes. We are working through the climate standards, and we expect to, by working with Toitū Envirocare, develop the strategies and policies that will allow us to do accurate reporting for FY 2024. Looking towards the remainder of FY 2024, we will continue to be focused on execution in an uncertain framework. Pacific Edge is taking a cautious approach to managing cash reserves, in the event of an adverse Medicare coverage decision, until we gain recovery, you know, we expect to be able to manage our current capital to last for up to four years. We may not need the entirety of those 4 years, but that's the approach that we're taking, that if we need all 4 years, that we will be able to do that. We expect to refocus the business on clinical development for guidelines inclusion and increased coverage certainty, with a particular focus on 2 products, Detect+ and Monitor+. From a commercial standpoint, we're going to be focused on selling the clinical value as the driver of higher throughput per headcount. That's as in per sales headcount on our side, and higher throughput per clinician, so on the customer side. Of course, the fairly obvious headwinds are that there is a possible non-coverage determination from Novitas on a new proposed LCD after they have now followed the appropriate procedure of notice and comment. There is also the possible negative reaction to the balance billing that we have already initiated for commercial insurance and subsequent ABN billing, you know, should we or ABN notices when we do the same, when we lose coverage and have to do the same for Medicare patients. There are also possible catalysts for Pacific Edge. It is not a foregone conclusion, and we will make the best arguments possible, and we believe that we have the right of it, that Cxbladder should continue to be a covered test, both our Monitor and Detect products, but also our Triage product. Other catalysts, of course, are we are still working very closely with Kaiser, and we hear only positive signals, although that we continue to not have a confirmed go-live date. We are working very closely with them to ensure the EMR integration in Southern California. We have also submitted, with the support of key opinion leaders in the urology group, who have come to our aid. We have made a submission to the NCCN guidelines. There is a low possibility that we would have increased guidelines inclusion as early as this August. It is the commitment from this management team that every August, when there is new published evidence available, that we will submit in an attempt to gain guidelines inclusion for both hematuria evaluation and for surveillance. We continue to work with contacts in the New Zealand healthcare system on a global, sorry, a national rather, Te Whatu Ora contract. There are certainly some internal champions helping to try to make that the case. There is we have wide adoption of our products, and a number of our customers are generating clinical utility evidence in their own hands. We, as a, particularly our medical affairs team, are engaged with those folks, and understand that they may, even though completely independently of us, they may publish additional articles that have, that highlight the clinical utility evidence of our products in a real-world setting, and that we can also use as independent validation of our products, both in New Zealand and in the United States. As a summary here, we have world-leading technology, a strong balance sheet, and we are building momentum in the U.S. and around the world to establish footholds in new markets. Thank you very much for your time. I look forward to taking your questions as part of the panel later. Our next speaker will be David Levison, who will focus on PEDUSA. Thank you very much, Pete, and thank everybody for allowing us to come and speak here. Next slide, please. Pete has already covered this slide, so I want to dig down a little bit into the things that are specific from a United States perspective. Our focus has been and will continue to be on adoption of our technology into clinic and offices, retention of that product in those offices, and revenue generation. The uncertainty we currently face around our revenue, particularly as it relates to Medicare, has accelerated several things that we were already doing to continue to drive both the adoption and the retention and revenue generation. Pete had mentioned a number of these things. Kaiser, we've talked about a lot. I can spend a little bit more time on that. You know, historically, we have gone to our customers and said, "Here is an interesting technology that we think has tremendous value to you." We are getting much better with the evidence that Tamer and his team are generating and the experience we have in the marketplace to be much more specific about how we suggest to those clinicians that they order our test. For this patient population, you should use a test in this way, and this is the action that you should take with a positive or negative result. That kind of specificity in terms of working with the clinician is certainly driving additional adoption and retention. That's work that we have started a while ago, and the uncertainty around Medicare has allowed us and forced us to some extent, to accelerate those efforts. Pete mentioned being more specific about the way we talk about our tests. That's the practical way in which we do it. The other piece that we're also accelerating is what we call digitalization of the experience that our customers have with our products and with our company. When we first launched several years ago, everything was paper-based. That was the way of the world. That is not the way of the world today. We are accelerating the work we're doing to create digital interfaces between our systems and our customer systems, so that instead of writing things down on a piece of paper, they can, like they order Amazon or anything else, can put it in the computer, and it saves them time. It facilitates the interaction with our organization, so it provides value to the clinician. It also provides tremendous value to us as well, because we can make sure that all those fields on our test requisition form are filled out correctly, and we don't have to call the physician back. It's a win-win across the board, and we're accelerating those opportunities. We've just finished a large project with Kaiser, as you know. We have yet to have the go-live date, much of the work that we did for that Kaiser integration, obviously, as you can imagine, Kaiser is a much more complicated system than most of our individual clinician offices. The backbone that we built with the Kaiser integration, will leverage to virtually all of our other customers. The last point I wanna make is we sometimes don't talk enough about the patient being at the center of what we do, but it is absolutely true. We exist because we believe there are better solutions for patients that are either suspected of or have bladder cancer. Our daily lives are a lot of talking about marketing and sales and clinicians and those kinds of things, but at the end of the day, it's all around making sure the patient is better off, and our tools allow the practice to do that, allow the health system to benefit from those tools. We are doing a much better job today and going forward to articulating the value not only to the clinicians, but also to the patients. Next slide, please. This is a slide you may have seen before. It just sort of outlines where our products sit in the continuum of care. On the far left-hand side, we're all born with a set of DNA markers or DNA, and that individually may predispose us for some disease. Eventually, that disease may or may not manifest itself in terms of some symptoms. But we don't start interacting with the patient until that symptom has come into play. In our case, hematuria, blood in the urine. Virtually all diagnostic tests in the world today are on the right-hand side of where that little figure is. Basically, once you are suspected or have an increased risk of a particular indication of disease, that's when the medical system sort of kicks in. There's a lot of really interesting R&D work going on around the world today on the left-hand side of this thing, where we can find, particularly cancer, early detection cancer, well before the symptoms have shown themselves. That is not an area that we are participating in today, but it may be something we do. Well, it's not where we are today. Once that patient has an increased risk or a symptom, that's where we jump in. We can tell the physician whether their signs and symptoms are indicative of a higher or lower risk of having, in our case, bladder cancer. If it's a lower risk, we recommend to the clinician, they don't need to go through all of the many procedures that are often invasive and expensive to determine, because we can determine from our test, both our Triage and our Detect tests, that that patient, even though they have blood in the urine, have a very low risk of actually having bladder cancer. If that patient is diagnosed and then treated with bladder cancer, on the far right-hand side under the surveillance piece, that's where our Monitor product is most appropriate. Because bladder cancer has a relatively high risk of recurrence, so we're often monitoring this patient to see whether the disease has come back, even after it's been treated and removed. Like our hematuria test, our monitoring test allows the physician to say, "Yes, you've had bladder cancer. We are monitoring to see if it recurs, but based on the test from Cxbladder, from Pacific Edge, you are at a very low risk of having a recurrence right now. Instead of going through all those invasive procedures every 6 months or every 12 months, let's intersperse. Let's do the Cxbladder test once, wait a longer period of time, come back and do all the procedures, and then sort of do this interleaving. That's how we add value to the system. That's how we add value to the patients. That's how we add value to the clinicians. Next slide, please. That clinical pathway that I just described translates into market opportunities. These are some of the numbers around those market opportunities. There are approximately 7 million patients in the U.S. that show up with their doctor's office with some form of blood in the urine. Either it's gross hematuria, which you can see, or microscopic hematuria, which you can only see under a microscope. Of those 7 million patients that present with hematuria to the healthcare system, about half of those, 3.4%, go on to a clinical workup. That clinical workup has multiple components to it. One of them is a cystoscopy, that we've mentioned many times. It's a procedure that none of us would like to have. There are about 1 million patients in the U.S. that get a cystoscopy associated with a determination of bladder cancer. That 1 million patients is where our Triage and our Detect products really fit. Of those patients that get, you know, or of patients in general, about 82,000 new cases of bladder cancer are diagnosed in the U.S. every year. Those patients typically will go on for treatment or removal of the tumor, potentially some chemical treatment as well. There are about 725,000 patients that are living with bladder cancer in the U.S. That is the population where our monitor test is the most useful. These patients have to come back frequently for this full workup, again, as we're working with our clinicians to sort of de-intensify or remove some portion of those invasive procedures over a period of time. That translates to about a $3.5 billion opportunity in the U.S. with full market share. Obviously, we are a long way from that today. Next slide, please. While we focus on the clinical value, we can't forget about the economic value of what we're doing. Our tests, like many tests, add clinical value, but also help the system, and that's why Kaiser is such a big advocate of what we do. Kaiser is a unique system in the U.S. where they're a health insurance company, and they're also a provider of services. You cannot go to a Kaiser clinic unless you are covered by the Kaiser insurance plan, basically, and that's a unique system in the U.S. It covers multiple tens of millions of patients in the U.S., and it's one where the system advocates for both clinical value, making sure the patient is healthy as possible, but also that the cost of that care is as low as possible. It's a great experimentation for us because it adds both clinical value and economic value. The economic value that we create, we have recently worked on a theoretical model with an outside firm to sort of demonstrate what that economic value is. If you start with the AUA guidelines of how all these patients should be treated, then you take our test and its sensitivity and specificity and how much it costs to do a cystoscopy and a UA and a, you know, a CT urogram, you pull that all into the model, and you say, "Okay, if the Cxbladder test allows the doctor to say, 'I'm not going to do a cystoscopy and a full workup every six months, I'll do it every twelve months,'" that then translates into what the savings to the system could be. As I said, we were just finishing up this initial work. This is a theoretical model. Once you have that theoretical model that we believe will show that there is a savings to the system, so far it has, then you go out and you get some real-world data to say, "Okay, here's what the theoretical model said. Do we see that, those same economics in real life?" That's the next steps of this process. Once we have that data, it all gets published, and it's very valuable not only to the payers that are paying for this, but also clinicians to understand that this adds value to the system. Next slide, please. This is just a depiction of our resources today, in the U.S. in terms of our sales team. Obviously, I'll talk in a minute about the redimensioning of that. The blue dots represent customers, and then the orange circle is where our lab is in Hershey, Pennsylvania. We approach this market with multiple different types of individuals. You can see from the bottom left, our account executives, those are our salespeople. They're responsible for geography, and they're responsible for calling on the clinicians in that geography and driving our test volume. Those account executives are managed right above them by 3 regional sales directors today. Those are Well, the player-coach, they are primarily managing those AEs. They have 8 to 10 AEs, but they also have strong relationships with key accounts in their territory, and they manage those. In the last year and a half, we've added national account managers, 2 of them. Those folks are also salespeople, but they're focused on some of the larger national accounts that have sort of large, longer selling cycles. We've brought two of those folks in, and then Tamer and his team have done a wonderful job of providing us with a series of MSLs, Medical Science Liaisons. Those are the clinically trained individuals that can have a different conversation with our clinicians than our salespeople can. Our salespeople are very good. They understand our data extraordinarily well, but they cannot have a conversation with a clinician that another clinician can. That's just the way it is. This is a very typical structure in virtually every company in the U.S. that I have worked for and run. Next. Pete talked about it, and I want to talk about it a little bit more. Obviously, the potential disruption in our Medicare coverage is forcing us to rethink how we deploy our resources, so we can maintain our current cash reserves all the way through a recovery if we're losing it. We are in, I'd call it, the late stages of making those decisions. Basically, what we're going to do is we're going to say, "Okay, how can we continue to drive volume with fewer people?" That's fewer people, both on the sales side, but also in some of the other portions of our organization. We want to do it thoughtfully, and Chris mentioned that this has given us a little more time, and that's helpful. We're in the late stages of making those decisions. We obviously need to finalize those, working with Grant to make sure that it meets the requirements and if we're getting us down to the cash burn that we'll need if we lose coverage. It's not a fun process. It's a painful process. We've all gone through it before, we will do it with dignity for our employees and our customers, and we will get out the other end of this with a leaner, and I think, much more efficient organization. The other piece that Pete has talked about is this enhanced patient responsibility. Today, and always, we have always gone to the patient when the insurance company doesn't pay and says, "You know, this test hasn't been covered by the insurance company. Here's what your responsibility is. What we're talking about now is doing that in a, just a slightly different way, same thing. We're going to increase the dollar amounts that the patients are responsible for and do a better job of communicating that this patient has responsibility, so they are knowledgeable about that responsibility when they're getting the test, not afterwards. It's a tweaking of the system we're already doing. We do believe that it will be able to allow us to drive more revenue, not burdensome to the patient. It's never gonna be a burdensome to the patient, you know, but it is another area. As we're looking for every way that we can generate revenue, the patients are an important part of that because the patients, again, are at the center of this. This is where the value is created. Okay, next slide, please. We've talked a little bit about digitalization. I just want to give you a couple of examples and some of the work we're doing outside the U.S. When we first got launched 10 years ago, as I said, everything was paper-based. We haven't moved as quickly into digitalization as I think I would have liked to have. Now we're accelerating that. That digitalization allows us to go to our customers and say, "Hey, if you'd like to order the test, it's already in your electronic medical record." The computer system that the clinician uses to do everything else in their practice, we want to be integrated into that, so they can just pull down the menu that says, Cxbladder Detect, push a button, it prints out on their printer. They fold that piece of paper up, put it in with the urine sample, and send it off. That's the kind of integrations we're working with. That's what will be our base for our expansion in Kaiser. It's a relatively large part of my time spent making sure I understand where those opportunities are and driving and working with Andy and his clinical team, or his digital team rather, to get those things done. We've got some more work to do, but we're well down the way. That's really what's translated to our opportunity to have a much stronger and broader relationship, with Kaiser and with the VA, actually. The Veterans Administration is another large potential customer. It's a different beast in the U.S. There are, you know, hundreds of Veterans Administration clinics around the country. They each work a little independently. We have been on the federal supply schedule, which means we are allowed to go in and sell to the VA, but that's nothing more than a hunting license to go into each and every one of those VAs and describe our clinical value. The other piece I want to talk about is really a nascent opportunity that we've just gotten started with, and that is setting up distribution arrangements outside of the U.S. and outside of APAC. Our first one's in Israel, second one's in South America, where we are training the distributor about the value of our tests. They are going to their clinician relationships, and they are then getting those clinicians to say, "Yes, this would be a valuable test." The same kit, same process, except done in Israel or South America. They package it up, put it in DHL, ends up in our lab in Hershey, Pennsylvania, and we will result it back to the clinician. We have a handful of those tests that have come in over the last couple of months since we've just gotten started this program, but it has some real upside and potential for us. Next slide, please. I want to just end on this slide to sort of talk about where we are today with our product portfolio and then where we're going with our product portfolio. On the left-hand side, you can see the three products we have today: Triage, Detect, and Monitor. And the words we often use, intensifying, deintensifying workups, and adjudicate diagnostic dilemmas. Sometimes the physician will run the normal tests, they'll be one will say positive, one will say negative, and say, "What do I do now?" Our tests can often be used as a tiebreaker to some extent. Those products are really good. They certainly can get better. All products can get better. Particularly the fact that we have two products in the hematuria space, our clinicians more often than I would like, say: "I don't know which product to use. Which one should I use?" We aren't clear enough. These physicians are really, really busy. The more specific we can be, the more directive we can be, the better for them, because they are really busy folks. One of the things that we're doing, have done, and we've published some on this, is we're going from our 3 products, 2 in hematuria, 1 in monitor, to 2 products going forward. We'll have a Detect+ product that has the best of both the Triage product and Detect. It has both higher sensitivity and specificity. It's actually simpler to use because it doesn't have some clinical factors, and we're working on an enhanced Monitor product as well. That will be, I think, game-changing for us to be able to be very clear and very simple to our clinicians. When you have a patient that hasn't been diagnosed, but has blood in the urine, this is the product you use, and this is how you use it. When you have a patient that has already been diagnosed and treated, here's how you use our products. That simplicity will be very helpful to us. That's the future. We hope to be there pretty quickly, but we've got some work to do to generate the data around those products, and Tamer will talk quite a bit about that. I think that is my last slide, and I'll turn it over to Tamer. Thank you very much. Be happy to answer questions later on. Well, thank you very much, David and Pete and everyone. I appreciate the opportunity to be here with you, and hopefully, I can give you a little bit more information, although I think Pete and David really did the majority of the work, so I'm just gonna be very, very brief, if I can. I think Pete already presented this slide. Excuse me. The main point that I really want to make here is, you know, when we talk about the focus area on reconfiguring evidence program, it was essential for us, since I've, you know, joined the company and with Pete and David's support, to understand what do we need to move forward. It's important for everybody to understand when, you know, when you are a commercial organization seeking coverage from Medicare and private insurance, as well as guideline inclusion, the level of evidence that is needed is not only at a higher level, but it's also, like David and Pete said before, has to be specific. You have to go to these organizations and say, "In this particular patient population, the test is used in such and such way, and thus, when the physician uses it that way, the outcome is binary. One patient can go this way, the other patient goes that way. That makes it easier for both the physicians and these organizations to assess what the value of this product is. Historically, our data did not support that binary decision. It was a lot more of our tests can do a lot of different things, none of them is supported straightforward with one of that decisions. Our evidence, our reconfiguration of evidence generation has focused on exactly what I just said, is every study we're doing is targeted towards a specific patient population with a specific indication that has a 1 outcome, okay? That will cost more, and I'll be honest, but that is what is necessary to gain these coverages and guideline inclusions. The other part of reconfiguration here was, as David just mentioned, refocusing our, you know, all of our interests towards the two products that we believe will be taking us into the future: the DetectPlus and the MonitorPlus. Focusing on those products, getting them over the hump, getting them into guidelines, will ensure the viability of this company moving forward, as well as our increases, our opportunities to further do R&D and increase our products in the future. Without at least one product that can actually support the company, I think we can all agree that it's not gonna be sustainable for long. We do have a goal to use the clinical utility evidence, which, and I'll explain in the next few slides, is important as well to understand. Sometimes guidelines will include a test without clinical utility, but it'll always be, "Okay, it's an option. You may use the test in these particular things, there's no definitive guidance. Clinical utility is intended and meant to do exactly what I said earlier, to show the physicians and the guideline committees, as well as payers, when you use the test in this particular way, this is the benefit that you're gonna gain from it. That's why these, sorry, these clinical utility studies are important. They will take a little bit longer time. We may actually be included in guidelines before the clinical utility, hopefully, are out. Clinical utility evidence not only ensures the inclusion, but it also defines the inclusion and makes it easier for everyone to understand how to use our tests in the right way. This slide is, again, meant to just show you what I just said. It's a circle. It's not a binary thing. We're not gonna just do one study, create evidence, it's over, we're done. We create evidence, gets inclusion into guidelines in a specific population, maybe in a very general sense, it improves utility. We do more studies, we focus on another patient population, so forth. Our clinical validation data sets are usually standard, meaning we don't necessarily have to redo or do more clinical validation once we actually show the right amount of it. Clinical utility is the ones that we can increase adoption with in different patient populations as we move forward, and that's gonna be the goal for our evidence generation program. It's also important for kind of when we talk about guidelines, you know, a lot of time we just say, "Guidelines, guidelines," and I don't know if everyone understands what are these guidelines? There are three main organizations that are sort of universally tasked by putting together guidelines for urology or oncology. In the US and Europe, American Urological Association, European Association of Urology, are the two major worldwide organizations for urology. The National Comprehensive Cancer Network is the sort of worldwide known center for oncology guidelines. It's important to also differentiate those because the current LCD mentions the NCCN as the target or one of the databases that they will... if the test is included in them, they would include. NCCN, like I said, is intended only for patients that have already been diagnosed for cancer, which inherently means that our hematuria evaluation testing is not going to be included in these guidelines. That is not what they intended. They will, and hopefully, that's what we're targeting, is it to be included in American Urological Association. They actually are, I mean, one of our test piece, the Monitor, is included in the European Association of Urology right now. That's the goal, is that we're not just focusing on one guidelines, we're focusing on all guideline committees to add, to become standard of care. That's the goal of our profile or, sorry, the portfolio. This is to show you sort of what we're talking about. Those are the currently approved ongoing studies, and then I'm gonna show you the two... in the timeline slides, I'm gonna talk to you about the, at least proposed studies that have not yet been approved for clinical utility. As you can see, the STRATA study has been ongoing for a while now. The STRATA study was intended, and still is obviously, to provide clinical utility for the Triage test. STRATA has actually achieved the goal of, for the, in the randomized portion of patients, and thus we had already stopped recruiting. We are now monitoring the rest of the data. We will be analyzing the data, hopefully by the end of this year, early next year, with a expected submission, paper submission, sometime mid 2024. This, like I said, intended specifically for clinical utility of Triage. We will make an attempt to do a retrospective analysis using the Detect+, which again, just setting expectations, is not going to be a high level or high quality clinical utility. However, it will certainly at least help in making the point of how Detect+ is going to be a better product. DRIVE, AUSSIE, and MicroDRIVE are all very similarly designed, except MicroDRIVE is specific for microscopic hematuria, while DRIVE and AUSSIE include both microscopic and gross hematuria. The goal of these three trials is to achieve clinical validation for the Detect+ or the hematuria evaluation test. Some of you will ask, "Why do we need three trials?" I will answer, even if you don't. We need 3 trials because the probability of cancer in these patients is very low, and thus we need a number, a specific number of sorry, of tumors to achieve the statistical significance. The other thing that's also incredibly important is that physicians and guidelines look at reproducibility of your test. When you do 1 study and have whatever data it is, there is no guarantee that if you do another study, you have the same exact actual outcome. By us having 3 different populations, we will have 3 different results. Hopefully, they will be very similar or at least close, and then we will do the pooled analysis, which will combine these 3 datasets and have a true average performance of our test. That should, and hopefully will, convince everybody that this needs to be in the guidelines as standard of care. The last study here is the LOBSTER study, which is the clinical validation for Monitor. We put Monitor Plus. The reason we don't specifically say Monitor Plus yet is that we don't yet have Monitor Plus. We are working very hard to create right now, this new algorithm. We have the data set to do that. That's already gone. We are considering LOBSTER right now to be sort of a sample collection study for the right population, for validation, and we will be finishing this study hopefully mid-next year, which we will have the Monitor Plus by then. That I can guarantee that. This is only meant to just show you an, a framework for what I'm gonna talk about. I did talk up to you about clinical validation studies or analytical validation studies are usually what's called single-arm trials, meaning we just collect samples from patients, we do the test, we compare the test to what's clinical truth. Simple, straightforward, no problem. Clinical utility study, on the other hand, are randomized controlled trials. Those are complicated trials. This is obviously not the final thing, but this is sort of just to give you an idea of what this can look like. When you run randomized clinical trials with two arms, you have a control arm, and you have the test arm. The test arm is obviously gonna be our test, to show to the payers and the guideline committees, if you use our test in this very specific clinical pathway, compared to what is the standard of care today. The control arm is the standard of care. If the patient goes to the physician right now, that's what they get, and this is how we use our test, and at the end, if we can show reduction in procedures, improvement in diagnosis or finding tumors, even if we don't actually find more tumors, if we just find the same exact tumors, but then reduce not just the cost... I think it's also very important when we talk about the value to the system and the patient, we cannot ignore the fact that a patient getting a cystoscopy is not a comfortable thing. I think urologists underplay or downplay cystoscopy because they do it very simply. I'm pretty sure anyone in this room, if they have to get a cystoscopy and they can avoid it, they will want to avoid it. That's also very important to understand and figure. All right. These are the timelines that I talked about. These are the studies that we're I've talked about a little bit earlier. As you can see, our timelines are extremely aggressive. Since the LCD announcement and so forth, we have very aggressively worked on these timelines and tried to create the best potential outcomes that we can. Obviously, this needs more resources, which we have asked for, and our board has graciously accepted and given us these resources since this is our target to create the value for the shareholders. We have two studies that should be published. Like I said, the DRIVE and STRATA will be published sometime next year. AUSSIE will be done recruitment by the end of next year, hopefully publication 2025. MicroDRIVE will also be done mid-next year, and we hope to be able to publish that at the end of next year. As you can see, there will be, by the end of 2024, at least 2-3 publications that will be high quality, targeted towards the microscopic hematuria evaluation, and followed by another one potentially in 2025, and then further than that. The goal is to submit to the guideline committees, like Pete and David said, every year. Now, that is not a guarantee that they're gonna just accept everything we submit, but we will submit every single year. We will submit to the guidelines. We will also submit to Novitas and say, "Here is more data. See what happens." Maybe, you know, maybe it'll be acceptable. Again, if it is, which I would obviously, everybody would have to... I go back to the first study. It's a circle. It's not an end. Even if we get coverage for a specific population, that does not mean that we stop doing the rest. Everything will help future-proofing our business from ever having to go through this again. This is the rest of the platform, and the two studies that I talked about, that were, oh, I guess not. The CU Heme and the CU Surveillance. Those studies are the ones that are not yet approved. These are future proposed studies. We have not even planned or put together protocols for those, but those will be the ones that we will request funding for from the board and hope to start them. The hematuria one should be theoretically ready to start sometime mid Q2, Q3 2024, and one quarter afterwards, we would be ready to do the surveillance trial. That's sort of the pathway that we have set, and this is the plan that we are now committed to executing. Again, I think I already mentioned this, so I'm not gonna go through it again. This just tells you that every study we do, we complete, we'll submit, we'll do everything in our power to continue pushing both guidelines as well as our payers to actually accept our clinical evidence. Finally, well, this is completely almost on a different angle, is that everything I talked about right now is sort of the clinical development part, but we also, our medical organization has the clinic or the medical affairs part. The medical affairs part, like David said, include the MSLs, as well the, as a medical director, who is also a urologist in the United States, and we do a lot of education programs. You know, having data is very important, but without education about this data, it's not going to get anywhere. Physicians, unfortunately, don't read as much as we would like them to read, we have to tell them how to do it. I think it's a combination of both. There's a couple of things. This picture right here shows me a lot more handsome than I really am, we did this presentation last year with Dr. Neal Shore and Dr. Josh Meeks. It was a, you know, online forum, like you see, it had 4,100 views. Consider that we only have less than 4,000 physicians that have ever used our test. That's quite a lot within the urology, you know, field. Things like that, we've done multiple afterwards. This is just one example. These are the things that we do on a routine basis to make sure that the physicians understand and know our data, understand how to use the test, and continue to educate them. We do have, you know, multiple other things that we do. The clinical dossier development is something that we've undertaken. It's almost done. This is a dossier that contains every single piece of information that we have, created as a company, that is now put in a very sophisticated and professional manner to be submitted to all payers, whether it be Novitas or private payers in the future, as well as, of course, building KOL relationships, which is sort of in the core of medical affairs mission, and that's what we're doing. Ultimately, at the end, we can't have a product if we can't actually do the test, right? We can create all of this information and the data and all of this, but if we can't sell the actual product and have a lab that can produce it efficiently and without, you know, fail, then we don't have a, we don't have a company either. This is exactly what this slide is meant to be, to do, is we are working with our R&D teams, with our digital teams, with our operational teams, to make sure that when we are ready, when we have the data, when we have guideline inclusion, the lab is also ready to do these tests at a very high number. 'Cause our expectation is when we get into guidelines, we're not gonna be selling 30,000 tests, all right? That's, that should not be anybody's expectation. We'll be selling hundreds of thousands of tests, and if our test, our lab cannot accommodate that, then we're in trouble. Last thing, of course, and I think Pete already mentioned this, and there's not much to say other than part of this whole program that we've built is built into it, what's called GCP or Good Clinical Practice. This is how we run the studies. Running clinical trials are, can be done at very different levels. We can run a clinical trial in an academic institution with just, you know, myself and a fellow, and we can publish that. That's not very hard. But running a clinical trial that can pass FDA muster, very different situation. That's why we've built different teams now, a team in the US as well as the team in New Zealand. The team in New Zealand is responsible for the creation and development of all the, and the contracting of all the sites and so forth. Now the team in the US is specifically responsible for initiation of the sites, site management, data monitoring, ensuring that every single piece of information that we get from these studies are GCP compliant and at the level of FDA regulation. Whether we get FDA regulated or not, I think it's the right thing to do, and that is what we are committed to doing. Thank you very much, and, Chris. Thank you, Tamer. Appreciate it. Thank you to Pete, David, and Tamer. I've got a major mea culpa, I think. Is Bryan Williams online? Yes, he is. 'Cause when I was introducing directors, I was looking across the table. Brian's is in Cleveland at the moment, so good evening, Brian, and I owe. Hello, Chris. I owe you. I'll hold you to it. I know you will. Now, now, having heard from myself, Pete, Tamer, and David, we will open the meeting up to questions. It's been terrific that we were able to have David and Tamer here with us, and they'll be lingering whilst we're having our cup of tea, and we'll be here for another day or so. I'll open it up to questions. How do you want to handle the online questions, Grant? I can read them out, but do you wanna do questions from the floor first? We'll do it from the floor first. I've actually got a couple of text questions, there'll be some questions online as well, we'll deal with those. If that's okay. I will certainly look to spread around the team the questions. I'm not, I don't intend to answer them all, but... With that, any questions from the floor? What's LCD? Local Coverage Determination. Oh, sorry. Yep, if you're gonna ask a question, yeah, we'll pass the mic to you. Chris, my name is Haley Cheng, and I've been a shareholder for this company for exactly 10 years because I believe in the product that will save the pain of when detecting bladder cancer. I am also from the medical field family. I'm already a baby boomer, my grandfather, grand uncle, et cetera, they were Western practitioners and surgeons and et cetera, et cetera. Many of them are in medical field long time ago. It's very easy for me to read the annual report, that sort of thing. I wish to inquire about Texas. How many people are stayed there for promoting the Kaiser product? That is, the patients pay pays then for the Texas, this province. Hopefully I've got that right. If we can break it down, how do we support Kaiser? I mean, how many staff are there to explore the Pacific Edge market in the Texas province? Got you. field force or the U.S. field force, David, and staff in the U.S. Today, our account executives I talked about, they're responsible for a particular geography is 26 people. It fluctuates between 26 and 30. As I said, we're going through a dimensioning, my guess is that number will be lower. Today, we have 2 individuals in the great state of Texas. It's a big state, and we certainly that's true of all our geographies, not just Texas. You know, we with 26 people, you can't cover the 330 million people in the United States. We focus on the large geographic areas, Texas in particular. Houston is a very large medical center, and there are a lot of patients that come to Houston for UT Southwestern, those kinds of things. Right now we have 2 people in Texas. The other question, I think, is around Kaiser, and a little bit about the reimbursement. Kaiser, we have a separate contract with. The Medicare issue, that we've been talking about does not impact our Kaiser revenue at all. Those are separate and distinct contracts. Yeah. Why I mentioned Texas is that Texas now is the number one state in U.S.A. in producing revenue. Just last year, it had $350 billion, and it's the number one U.S.A. state, the richest one, because of its oil, not just of its oil, and oil is only 30-odd%, and the others is IT, also 30-odd%, and the rest is computer. No, sorry, not for many tough manufacturing, like the Tesla, et cetera, et cetera. Why I mentioned Texas is that this is the state without income tax, people like to move there. No income tax, they are very rich. If you count 50 states of U.S.A., Texas is the number one revenue-producing state now in U.S.A. Now I wish to point out that we wish to earn revenue. Yeah. Let me finish. Thank you very much. As a fourth generation Californian, there's a friendly rivalry between whether California or Texas is bigger. I won't opine on that right now. Clearly, whether it's Texas or Massachusetts or California, we go to where the patients are, regardless of what's going on in the state. Texas is a big focus for us. One of our national account managers is actually also based in Texas. Texas is an absolute strong hold for us. Thank you very much. Thank you. Yeah, I just wish to. Please wait before I finish up. You're taking a very long time. No, no. About yourself. No. Can, could, can- I advise you to read The Economist, dated the 18th of March this year. It had a very detailed information about Texas, the income, revenue. Yeah. It's a good thing to explore in that market. Thank you. Thank you. We will. Next, please. Thank you. Aaron Bhatnagar. Hi, Aaron. I have a couple of questions. The first question regards to consultants who could potentially assist Pacific Edge with applications to regain your LCD coverage. Do you currently use external consultants to assist with these sorts of applications and NCCN coverage and all the other various means by which you can gain some kind of inclusion? If you don't use an external consultant, I presume that you're familiar with opinions of experts in healthcare, like Dr. Bruce Quinn in Los Angeles, who I understand has some very strong opinions as to how companies should go about gaining LCD coverage for diagnostics. Thanks, Aaron. I mean, I can. David- Why don't I, why don't I start, and then I'll have Pete join in. The answer to the question is yes, we absolutely use outside consultants, both on the lawyer side, some very good folks that I've used for many, many years that are really experts. I've known Bruce Quinn for almost 20 years. Bruce is certainly part of that cadre of folks we go to. Absolutely, we understand that while we know our products the best, we wanna get outside opinions about how do we get through the process, both with Novitas and with NCCN. We use those folks extensively and have historically. Pete, do you wanna add anything to that? Yeah, there's there's not much I can add to that, except just to say that we have different consultants for different purposes. As David said, we have lawyers who understand the Medicare appeals process and how to combat things from a procedural perspective. We also have folks who are tightly aligned with MolDX and who understand, you know, how the, you know, the process for being granted coverage through the MolDX program. We also have consultants that try to work from a lobbying perspective. There are a number of different consulting groups that we use, depending on the specific purpose that we need them for. Thanks, Pete. Aaron, just so I don't forget it, and we're talking about coverage and guidelines, and the meeting that Pete and Tamer, and David had this morning with Novitas. Dr. Eugene Rhee, who's the head of urology for all of Kaiser Southern California, was on that call supporting us, unsolicited. That, that gives you some sense of their commitment to Cxbladder. If I may have a follow-up. My understanding is that other Medicare administrative contractors like Noridian and Palmetto have a higher approval rate for inclusion of cancer diagnostics tools. I could happily stand corrected on that, but is there a perspective that there may be an alternative MAC that is more accepting of using, you know, urine-based biomarkers or, you know, a molecular diagnostics testing over that of Novitas, who may perhaps have a more old-fashioned view on what should be included in coverage? Thanks, Aaron. I'll start, Pete and Tamer and David, you can leap in. I think Pete referred to it in his presentation, that we've commenced the MolDX conversations with, I think it's a technical assessment that we are looking to get underway. Which MACs are using MolDX, Dave? MolDX, just a little explanation. MolDX is a separate entity that was formed so that there was expertise within the Medicare Administrative Contractors' universe for re-evaluating molecular tests. I was involved in the, in the first test that came through, actually, MolDX, almost 20 years ago now. You're right in that Noridian, which is responsible for California and several other states, has a higher number of molecular diagnostic tests that they've approved. That's primarily because most of this innovation has been done in California over the last 20 years. There are many more labs in California than there are in Hershey, Pennsylvania. Novitas doesn't do this very often. Novitas has decided that they're not gonna participate in the MolDX program. They're gonna do the evaluation themselves. You mentioned something about old-fashioned. I wouldn't disagree with that approach. We are investigating any place that we think we can get our test covered. The MolDX program is very much more routinized. It's very specific. I've known the people that run it for a long time. The bar is very high on MolDX in terms of getting over that to get coverage. I mean, when we got coverage from Novitas, we would not have taken that same data and gotten coverage in the MolDX territory. Now that we're developing more data, we think we can get over that bar, but we're exploring every opportunity to get coverage, regardless of what MAC it is. Next. Hi. Good day. My name is Richard Chapman. My question may be more than one question. The first question is, when will the Kaiser EMR integration go live? Look, I've now been, I think, at this box for 7 years, and Kaiser has been front and center of our conversation for 7 years, and we do have a, not pejorative, but we do refer to things in Kaiser time. David met with Kaiser as recently as last week, so I'll probably throw that one to you. Certainly, I will be blunt and say there is no go-live date. There was a go-live date on February 14th. It got paused right before because Kaiser wanted to do 2 more Kaiser things. Literally, Kaiser things. There was nothing wrong with us. We don't yet have a date. I was with all of the Kaiser Urology chiefs on Thursday before I got on an airplane to fly to New Zealand. They expressed their continued support. The 2 key leaders, Eugene Rhee and Dr. Ron Lu, who are our biggest supporters, they're the ones that are shepherding us through the Kaiser process. They have articulated 1 or 2 more other people they need to talk to before we can get that revised go-live date. The go-live date is going to have to be pushed. It's gonna have to be in a little bit of extra time, because we're gonna have to go back and do some retesting of our interface, because Kaiser has updated their Cerner and their Epic systems since we last did the testing. There's gonna be several weeks' worth of work that are gonna have to be done before we can set that go-live date. Just one addendum comment, if I can. Yes. Yeah, 1 just addendum comment is, what we've committed to in terms of, when we will make an announcement is we will not be announcing, when we have a go-live date. We will only be announcing when we go live, because of the unpredictability associated with even, you know, Kaiser giving us a go-live date, in the past. You know, we just want to set that expectation for investors. Okay, my nervousness is because this was announced last year in June, with a number of months before it was going in. This feels a bit like it's become as long as a piece of string. Look, it feels that way to us all. I think there's no. There's little question that the Kaiser commitment is wavering. The fact that their head of urology was on the phone call this morning with Novitas would seem to suggest that they are committed and bought in. David, this is frustrating for you as it is everybody else, but it's Kaiser. They're a unique. Yes. They're a unique animal that walks at their own pace. It is Kaiser, and they are intensely, very, very siloed, because when Kaiser does something, they do it all in, and so everybody has to sign off. What we're finding now is we're just having to go back and retouch the silos that we had already touched before. This is a big deal for Kaiser. This is a significant change to the way they practice urology in Southern California. It is the good news for us. It's a big budget impact for Kaiser, because that means it's a big revenue impact for us. This is a frustrating process for us and for Kaiser to some extent, but it is the Kaiser process. I have dealt with Kaiser in the past, and I wish it was different, but it's not. We just have to be patient. Yes, test volumes from Kaiser are increasing, we're getting more and more tests coming through. Hi, my name is Minggang Chen. My question is on the LCD republish. It seems that they accepted the challenge on their inappropriate procedure and open for public comments. What about their position of referring the 3 database to identify whether the test is included or not? What do you expect at the end of the day, after the public comments, do you expect they completely withdraw their applications? I'm supposed to mean the LCD proposal, or do you expect they leave an exclusion for particular tests like Pacific Edge as a positive outcome? Yeah. Yeah. Firstly, that's an excellent question. The publicly available information is silent on what the office of the general counsel think of that approach. It remains an argument available for us to continue should they elect to go down that path with no changes. There are substantial reasons why that is not appropriate. The concept of automatic non-coverage of a test without LCD consideration on the basis that you don't appear in 1 of these 3 databases is very clearly not within the intended way that Medicare want local administrative contractors to behave. Now, we have not, while we made that argument previously to the Office of General Counsel, that argument, their position on that argument has not been made clear to us. We need to wait and see what comes out in the new LCD, whether they stick to this, but preemptive non-coverage on the basis of being in, not included in three databases does not appear to be supported by statutory and regulatory elements of the Social Security Act and the 21st Century Cures Act. We believe we still have paths available to us if they continue down that path. Thank you. Thank you. Next. One here, and there's, I think, one up the back. Jim Fairmorton, shareholder. Hi. Can I just ask where your main research and development is done? Is it in Dunedin, you've got a people there? Is it associated with the university? How many people have you got? It is. Are they keeping ahead of all the? Professor Parry Guilford from University of Otago is our Chief Scientific Officer, and we have him, Pete, I think, for one day a week. Yeah, roughly. I'll hand it to you. Yeah, the product development is done in Dunedin. As Chris said, the product development, all R&D is done within Pacific Edge. We do have an existing licensing agreement with Parry's group and the University of Otago for additional new intellectual property, should we need any. For our current products, our focus is more on the development of those products. Taking a really good scientific concept and turning that into a robust product and then validating it, and that's where the focus of our R&D resources are today. All of the development work is done in Dunedin, and then the clinical development work is done in a combination of Dunedin and the United States. How many people have you got working in Dunedin? Head count in Dunedin, Pete? I think there are 11 people on Justin's team, but there is also significant input from the digital team, so there's probably, you know, another 5 or 6 people from the digital team. Then if you add clinical development on top of that, you're talking about another 8 or so, when you factor in the infield and home-based resources and all the executives. There's a few number of people. Essentially, 30 out of 120. Thank you. Yeah. Next. Next, I think there's one over the back. How are we going online, Grant? You've got about eight or nine questions. Okay. I just have a comment. You do a lot of studies, they seem to be specifically aimed companies in America or organizations in America. You didn't talk very much about publishing and getting peer review on the products that we're offering. I'm sure if you're doing that, it becomes a more worldwide thing that you're promoting, rather than focusing on where we're focusing at the moment, America and Asia, I think. Isn't that we said? Yeah. Yeah. That's my comment anyway. Pete? Yeah. Our patient recruitment has focused in the main on U.S. patients. Well, or originally it was probably more New Zealand focused than anywhere else, for our more recent studies, it's predominantly on patient recruitment comes from the United States. However, you're absolutely right that when you publish the information, that is available to a worldwide audience, and that is the intent. On the roadmaps that Tamer published, there was a point that was the last patient in, at which point, there is patient follow-up and data analysis, and the conclusion of the patient follow-up and data analysis is a publication that will come out as well. Because, you have to have for coverage and guidelines reviews, you have to have published, peer-reviewed evidence. That is a necessary step, and that takes roughly 3 to 6 months from the conclusion of data analysis, in our very aggressive timelines. Tamer? I don't argue. There's not much to add. I think Pete said exactly. I apologize if I did not make that clear in the timeline slides, that every study that we do will have to be published. The publication is an essential part of the study. We also will have what's called clinical study report, which is a sort of the compilation of everything that we've done in the study. That's a much, much bigger document that is not outward facing. It's an internal document for FDA and so forth. The peer review publication is an essential part of every single study. Yes. In fact, I'll add a tiny additional piece of color there. We would like, or what we would like the publication to say. We essentially write that when we're writing the protocol and the statistical analysis plan up front, so that if we recruit 1,000 patients, this is what we will be able to say. We essentially know what will be in the publication. We're just trying to gather the evidence for those statements during the course of the clinical study. We have done a Singapore study in recent times, so it's just not all U.S. AUSSIE is actually on Australian. AUSSIE is Australian, so we're starting to cover the field a little bit. Next, before we go online, anybody? No, I think we go online now. There's a number here, so let's- Okay. Let's start. Mr. Online? Yeah. Okay, I'll link two of them together. The first question is from Ty, who was giving the advice about the Novitas determination, that it will most likely not go ahead. That's also linked with, why were you not prepared for an adverse Medicare coverage decision, given that you had 12 months plus to prepare for such a scenario? How can we have confidence that you are prepared sufficiently for the scenario of the adverse decision on coverage to remain in place once the ongoing LCD formalizes? Hmm, could you just repeat that? All right, the first one was around what advice did we receive around the proposed Medicare coverage? Let's just do it in chunks. Pete, feel free to leap in, but we took extensive legal and commercial advice from our industry partners when the first draft came out, and the assessment was it was low probability that this LCD would survive in the form that it was released. That then took a 365, not almost, day period of presentations and discussions and engagement with Novitas to try and get it withdrawn. Pete, do you want to add to that? Yeah, I will. One of the first things that we did is we actually brought two legal experts into the boardroom to advise our board, representing two different law firms that we had engaged with previously. Through this process, we have actually engaged with three different law firms, one of which advises the Century for 21st, sorry, the Coalition for 21st Century Medicine, C21. We've not just got one legal opinion from our lawyers. We have industry lawyers, who helped us try to understand this particular situation. What I think is very important to remember, with the, with the comment that's being made here, is this is unprecedented. No one has attempted what Novitas is trying to do right now. All of the people in the industry are doing their best to try to understand what is Novitas's intention. Why are they trying to change the dynamic of the responsibilities of the MACs? Novitas have been difficult to engage with. In addition to engaging with the lawyers and in addition to engaging with C21 did facilitate a meeting with the CEO of GuideWell, on which I participated, as well as other members of my team. In which they said very clearly to us that they will follow the law. Which, you know, the, all of the indications that we have is that some of their proposals may have overstepped that law. We stand by the advice that we received at the time. We stand by the fact that this is unprecedented, and we will continue to combat it where it makes sense. You know, right now, we've prevailed, at least on a procedural merit, and we will continue to hold our arguments and keep our powder dry on some of the substantive merits. Yeah, I'll probably pause there. David, if you would like to add anything else about the guidance that we received in the US? Look, I think now with the deferral, we have more time to plan for the worst and hope for the best. When the new LCD emerges, if it's favorable, terrific, we're in a good spot to go forward. If it's not favorable, then we have the scenarios and planning in place to move. Sorry, Chris, if I can maybe add just one little bit more there as well. In terms of the We also did scenario planning as far back as October for this scenario. We have, we modeled what how the business may be affected for 1 years, 2 years, 3 years of non-coverage, and the kinds of decisions that we would now have to make. All of those plans were available to us, and we revisited all of them responsibly on June second, or very shortly thereafter, in the meetings that Chris referred to, where the board was meeting initially, daily, and then I think twice weekly to make sure that we had all of this under control. This, so it was, it was unprecedented. It was a crisis. We reacted appropriately, and we also focused on what's really important here. The best outcome that we could have got, given what Novitas did, is the outcome we had. As Chris pointed out, we now have the benefit of additional time to implement any changes that we have been contemplating, and working towards since at least October of last year, when I presented some initial scenarios to the board. We haven't been sitting on our hands, I think is the bottom line. Great. Thanks, Chris. Thanks, Pete. I think that actually answers the next question that I'd raised. Yeah. Unless there's anything else, I think we move to the next one. This one's probably for Tanner. The Novitas LCD decision stated the majority of Cxbladder papers avoid disclosing the PPV, that's Positive Predictive Value, and the number of false positives of their tests. Cxbladder tests generally have low PPVs, down to 15%-16%, and high numbers of false positives. Is this correct? How many values do you have a PPV from studies? Thank you. This is a complicated question to answer, but I'll do my best. Our PPV, the test's PPV is definitely very low, but that is by design. It's important to understand that these tests were developed and designed to identify the patients who do not have cancer, not the ones that do. Meaning, the intention here is to reduce the cost, not just the cost, but the burden of these interventions on patients. Thus, if just with it, let's put a numerical value. If 100 patients go to the office today, they all get cystoscopies, and they all get CT scans or ultrasound. With our tests, we can take away 50 to 60, maybe 70 of those patients and send them home safely, knowing that they will not have disease. Out of the 30, 40 patients that will now get all of the stuff, we may find, or the physicians may find, only 7 or 8. Initially, they were also finding the 7 or 8 cancers out of 100 patients. Yes, our PPV is low. It is not intended to be high. What we care about is that the 50, 60, 70 patients that we send home, we are confident that they do not have a disease, and that's why the test is this way. Thanks, Tamer. Great, thank you. Does Pacific Edge have a main competitor doing essentially the same tests, and if so, are they covered under the LCD? Tamer? Glad you came over. All right, we currently do not have another competitor. Well, it's not true. We do have one competitor in the U.S., and another one that sort of thinks that they're a competitor, they're not really. There is a test that's called URO17, which is an immunohistochemistry test. It's basically a pathology-done test in the lab, where they put a color for a specific gene and identify that. That test is really more of a replacement or an adjunct for cytology, which I personally do not consider a competitor, but again, depending on how you define it. There is another test that is called Oncuria? Oncuria. Oncuria. That is available. I don't think they are covered at this point. I believe they are not. Their lab is in a different jurisdiction as well, so they're not in this particular LCD, and that's something, again, I don't know if everybody understands. Depending on where their lab is, their jurisdiction differs. They may be covered potentially under some other LCD for another MAC. That does not necessarily mean that they have better or worse data. Having said that, I did read their data. I mean, we do competitive analysis. They don't have much better. Their probability of getting coverage is equivalent to ours, and they do not have the current name recognition and you know, kind of presence in the market as Cxbladder. If I can make a small addendum to that. There are probably even a few more companies than that make competing claims about their products, but none of them have more than analytical validation. That's one of the reasons why we place a big emphasis on the clinical validation and the clinical utility that we already have and that we will continue to develop. There is no other product making similar claims that has coverage anywhere. Great, thank you. bit of a change of tact. Please advise us the status and risks associated with the company's crucial patents. When will they run out, and are valuable intellectual property become common property? Either Pete or Bryan, or both. Yeah, I'm happy to speak to that. Look, some of our patents are quite old, and some of them will become open within 2 years. I don't have specific dates in mind. I would need to go and review them more precisely. You know, we've got to think a little bit about, you know, what is a patent meant for? A patent is essentially a government-granted monopoly so that you can gain a first-mover advantage, right? Which we have. Those patents have largely served their purpose. That is, that's an important recognition that we need to have. It's also, it's a little thought experiment that I did with David Levison a little while ago. If any of us could think up any situation in which someone had taken intellectual property and that it expired in the molecular diagnostics space and created a successful company off the back of it, and none of us could come up with anything, any single example where that had happened. Part of the reason is that the technology is evolving. If you want to compete with us, you would not copy us. You would try to do something similar with different intellectual property. You know, while the intellectual property that we have safeguards us for our technology, and we can continue to expand and protect it for additional iterations of technologies, which we have an ongoing program to do, you know, there'll likely always be alternatives that somebody can create non-infringing IP. Our best protection is the clinical evidence that we have developed and the market penetration and brand recognition that we enjoy. Anything to add, Bryan? Because I'm, I can't forget you now. We did go over the patent portfolio at Pete's behest. I worked with David Darling, who'd been involved in the company for a long, very long time, as you know. What we did is we cleaned out a lot of intellectual property that was, first of all, very old. To your point, the questioner's point, some of that was really reaching its end of life. It did not pertain to Cxbladder. I mean, these were early studies that were done on other cancers before Pacific Edge had developed a defined interest in analysis using urine. So the patent portfolio has been tidied up, and that's clearly a saving of annual fees. The current patents that are there still have several years' worth of life. Thanks, Bryan. Great. There's a couple of questions, one from Colin and one from Michael, that are on the same theme, so I'll paraphrase it a little bit. What does breakeven look like? How many tests equal breakeven and stops the cash burn? Another component from Michael on that is that the% growth, given the number of years that the company's been involved in the market, is still off a low base. Is the business model going to work before cash runs out? Well, we said right at the outset of what I had to say, that we will live within the capital that we have to get recovered. That essentially means that Tamer and all the work his team are going to be doing, and the clinical evidence and clinical study space is funded. We approved yesterday his plan. That's the board's objective, is to live within our means and achieve coverage within four years. If you guys can do it faster, all the better. The question of breakeven and burn rate kind of all follow. obviously, if we do lose coverage, you know, the scenario plans that we have in place will kick in, and we'll be redimensioning the business to enable us to continue to live within the capital base that we have whilst we get recoverage. I think that's about... It's pointless really speculating on breakeven until we actually know with some certainty which way we're going with this LCD. Sure. I'll maybe add just one tiny bit to that. In a situation of coverage, and that's the situation in which we will, you know, endeavor to reach breakeven. It depends also on our payer mix. You know, historically, we've had, you know, an almost 70%, Medicare and Medicare Advantage payer mix. That has dropped recently to around 60%. There's a significant chunk coming from commercial insurance. It's that commercial insurance that we're also going to look to balance bill, in the immediate term. We can increase our ASP as a consequence of that. We also, again, and I believe we've appropriately notified the market of our intent with Detect+, without specifics, because it would be impossible to give specifics. There are independent coding, coverage, and pricing decisions for Cxbladder Detect+ and for Monitor+. $760 reimbursable for Medicare, for Cxbladder Detect and Cxbladder Monitor and Cxbladder Triage. It may be that we can have a higher price associated with our combined DNA and RNA tests, and that is, of course, what we expect. How much higher? That's the part we can't be clear on at this point. That will, of course, aid with the profitability discussion, as will the publication that we are working on about the economics of the products, the health economics that Tamer and David spoke about. Right now, we have a theoretical model. That theoretical model is being built into a series of abstracts and will be submitted to conferences. We will present that data, and we will write it up as a publication for peer review, and we will announce that when it has been peer-reviewed. We believe that this is important messaging that will drive adoption, that will help people understand, you know, why they should be paying for our tests, and consequently drive us towards profitability. Thanks, Pete. Yeah, there are some other variables at play as well. How quickly Kaiser ramps up once they go live, how we go with the VA. There's a number of things at play that are just simply uncertain at the moment. Great. Yeah. To continue the open and transparent questions, are the directors and executive management prepared to back up the confidence of the future success of Pacific Edge by becoming significant shareholders in the company? I've got that question on my phone as well. I'm a shareholder, I've bought those shares out of my own pocket, so they weren't granted or optioned. That's a question for each individual director. I don't think it's for the company to mandate to directors how they do their private investing. We need to be independent, if, when we've got directors becoming substantial shareholders, you start to blur the boundaries of independence and acting in the best interest of all shareholders. It's a topic that we do address. At the moment, we're not clean, by that I mean, we're inside and we're inside in terms of scenario planning and various things, we're not able to purchase on the market. It's a really decision, I think, as chair, that I would leave to individual directors. I don't think there's any value in mandating how individual directors should do their personal investing. Have you any planning for the scenario in which Kaiser decide not to go ahead? What risk response strategy for this is documented? Yeah, okay, Pete, you take that one first. While I think about what I was gonna say. Yes, we have, we do understand what the consequences would be for the business if Kaiser were to not go ahead, and even if they just, you know, continue the delay that we see. But what we, what we've ruled out is a contagion effect regarding Novitas. And we base our decision about the probability of them, you know, not proceeding on the basis of the interactions that we have with Kaiser and their medical team. The anecdote I'll share with you, is one where, firstly, Eugene rejoined the call, on our behalf, but, at, also as a member of the AUA Public Policy, sorry, as Chair of AUA Public Policy, because he believes that Novitas are getting that decision wrong. Supported us, rather than us actually requesting. He offered his support rather than us requesting it, which we think is very, very important. He has said it is one of the three things that he expects to deliver in his goals for this financial year. That is, that's something that he has articulated to us, but we cannot use those words as a guide, other than to show that there is a strong commitment. We need to get the project managers to tell us when we have a go live date. Ultimately, we need to see it in routine before we have ultimate confidence. I think there might have been one other anecdote, Pete, that I've certainly picked up on. Kaiser are said to have said that they pay no attention to what Novitas and Medicare do when they're making their own decisions. Kaiser very much makes its own decisions. We've got 2 more questions and then a couple more comments. One of the questions is, do we have confidence in PwC to continue to be auditors? Yeah, that's come up on my phone as well. I think everyone's probably aware that PricewaterhouseCoopers have had some issues in Australia, where I live. The firms are separate. There is no flow across the Tasman from Pricewaterhouse, Australia, to Pricewaterhouse, New Zealand. We don't take tax advice from Pricewaterhouse, which was the subject of the Australian problems that they have. We have a good relationship with Pricewaterhouse in New Zealand. They've been to the U.S., they understand the reimbursement system, which is complex. They ask the tough questions and of management and the board. When it comes to the resolution to reappoint Pricewaterhouse, certainly, the board are unanimous in support of that, but I'll talk more at the resolution. Yes, and, we have asked the question of John, "What's been the flow-on consequence of what's happening in Australia to you in New Zealand?" We're comfortable that there is nothing that we need to be concerned about. Thank you. This one's a common question. I'm a foundation and very patient shareholder and a retired primary care physician. Cxbladder would have been a boom to my practice and would have benefited so many of my patients and lightened the load on secondary care. There are many who dreaded going for the repeat cystoscopies. What steps have you taken to engage in primary care? Some pressure from primary care would have provided some influence. Okay. Tamer, and David, and Pete? Yeah. Okay. I'll start just from the clinical perspective. We actually just had an ad board recently, last year, with our urology advisors, and we talked specifically about that. I think it needs to be clear that our ultimate goal is for at least the hematuria evaluation test to actually be a primary care test in the U.S. Now, different markets have different dynamics. Obviously, in New Zealand, for instance, it is already in the primary care in a specific portion in New Zealand, in the Canterbury healthcare system, and that's how they use it there. It is not as easy to do that in the United States based on the market dynamics and how people assess risk. The primary care physicians in the US, generally speaking, do not adopt new tests unless they are in guidelines and they are recommended specifically for the screening portion. Our target is to establish that first, enter into urologic guidelines, have, you know, hopefully cover or support from all of our urology, or urologists around the country. Then we can potentially go into that, the next step, which would be go into the primary care market. That's at least the current plan. Pete, if you wanna add anything. David, it might just be worthy of mentioning how Kaiser are planning to use the test. Sure. Be happy to, and Tamer is exactly right. I in a previous life, had done just that, started with a specialty in cardiology and moved to primary care, the plan that Tamer laid out is exactly right. You gotta remember, from a primary care standpoint, particularly as it relates to cancer, their liability is quite high. Anytime there's a patient that has a potential having a cancer diagnosis in primary care, their first reaction is to refer it. We need to sort of work to make sure that they're comfortable that doing our test and not referring that patient doesn't add any increased liability to them. Kaiser is using it just as this retired primary care physician would think about it. On the hematuria evaluation side, a patient comes into primary care, which is always where you start at Kaiser. If they have either gross hematuria or microhematuria, they are referred to urology. That referral then triggers us to send a home test kit to that patient. The sample is drawn, the kit comes back to our lab in Hershey, we result it, and only when that result comes back does Kaiser decide what to do with that patient in the urology clinic. If it's a low score, low probability, they will defer a visit for 6 months. If it is a non-low score, they will bring that patient in for a full workup. That is the system that Kaiser's working on. One of the things we didn't mention is Kaiser has a lot of data because they've run a lot of tests. They typically keep that data to themselves, as they should. We are now working with them to sort of publish some of that data, because it will be very helpful to the rest of the world to see how the Kaiser system is using it, both from a clinical standpoint and an economic standpoint. Thanks, David. Grant, any further? Just a couple of comments. I'll keep it quick. A comment from one of the founders of Pacific Edge, Professor Nick Kasabov. "I'm impressed by the presented plan by Pacific Edge to develop new ways to further communicate with individual patients and clinicians in order to present more evidence about the science behind the diagnostic test results, along with providing statistical analysis of overpopulation of patients. The proposed Cxbladder Detect+ and Cxbladder Monitor+ are excellent continuations." From Simon: "Not a question, but kudos to the Pacific Edge teams for very regular and full communications to the shareholders. It really helps us out to understand the company and something other companies could learn from. Thanks, Grant. I've one more from my phone. "Have the directors considered a share buyback, given you have money in the bank and the shares trading where they are, that could be a good value investment?" Yeah. Yes, we have talked about it. Even a small NZD 2-5 million share buyback, there's more value for Pacific Edge in investing that money in clinical work, clinical evidence gathering, than it is in a share buyback, which may give a short-term little kick to the share price. The share price will settle where it settles until we have real clarity around the LCD. We've thought about it, but it's probably not the best use of our funds. If there's no further questions, then we're now in serious overtime, so we'll move to the formal resolutions that we have in front of us. Yes, sir? Sorry, can I ask a quick question? Sure. Before you round up? We'll give you the microphone. Yeah. Just a quick comment on the when the news came out on the 6th of July, where there was a trading halt, and it was only given 15 minutes before it, the trade resumed. Actually, I think it would be preferably to have a longer time for shareholders to process the news, and also for the shareholders in Australia, because they have stock market open at 12 o'clock New Zealand time. Australian Eastern Time is 10 o'clock. Yeah. It would be better even to hold it for 1 extra day for, you know, the shareholders or other potential shareholders to react to share price. I noticed that on that day, the share price traded violently, you know, from NZD 0.05 to NZD 0.30, you know... no, sorry, on that day when the price traded very wildly. I've got a second question, is regarding for New Zealand, the coverage currently stands at 75%. 70, but close. About that, yeah. What holds it back from having 100%? That would have a better optic for the rest of the world that New Zealand have 100% coverage. Pete? Actually, many DHBs that are now under Te Whatu Ora that are almost too small to make a contract with, that accounts for some of it. One holdout is Auckland. They don't have a contract. Some of the difference is also that they might have a contract just for the monitor product and not for the triage product, or vice versa. At this point, it's more about the utilization than it is about the percentage of covered lives. Even though we've got 75% of the country covered, we're probably still only at about 40-45% utilized because we have not managed to push it in towards primary care in all of the locations where we do have a contract. That's actually one of our focuses as well. You know, with this potential initiative with a national Te Whatu Ora contract, we don't believe it is currently worth the effort to go after some of these smaller groups, because we will get all of those groups with a single contract as we go through that. That's the opportunity in front of us. Thanks, Pete. If that's the finish of questions, we can now move to the formal business. The first resolution is that Bryan Williams, who retires by rotation and is eligible for re-election, be re-elected as a Director of the company. Bryan is an internationally recognized cancer researcher and research administrator with significant business experience. He's held several governance roles, including chairing a Nasdaq-listed biotechnology company. Bryan is presently on assignment at the world-renowned Cleveland Clinic in the States, hence, he's up on the screen. He presently serves on the boards of two privately held Australian biotech companies, and Bryan was the Director and Chief Executive Officer of the Hudson Institute of Medical Research in Melbourne, which is a very highly regarded medical institute. He is currently Emeritus Director and distinguished scientist at the Hudson Institute in Melbourne. He has a BSc Honors and a PhD in microbiology from the University of Otago. The board has determined that Bryan Williams is an independent director for the purposes of the listing rules and unanimously supports his re-election. I'll now ask Bryan to say a few words. If you are happy to do so, Bryan. Here he is. Yeah, certainly, Chris. Thank you for that. I'm pleased to serve the Pacific Edge shareholders for a further term. I thank you for the support that you've given me to date. I look forward to the vote. I just want to say that I am a shareholder in Pacific Edge, and I have purchased all those shares myself. Now, I would have preferred to thank you in person, but I think flying a director from the U.S. and then back to the U.S. again, not the best use of funds, and I think it was much better used for David and Tamer. Last three years, the company has really passed through a period of enormous change and growth. We had a successful cap raise under former CEO, David Darling. Hired the new CEO, Peter Meintjes, after a worldwide search, led by Chris, our Chairman, and Anna Stove and myself, members of the committee. More recently, we've dealt with the fallout from obviously the LCD that we've heard much about today. I think our strong and cohesive board has really worked terrific, terrifically well. To support our CEO and our U.S. team, we've pursued a strategy that has positioned the company to swiftly adapt to this period of change and the challenges that we've faced. Along with the rest of the board, I have great confidence in the clinical value of Cxbladder, and we've heard more about that today. I think that, again, just to reiterate the point, that this view is shared by our customers, and that's demonstrated by the volume of tests processed in the lab, particularly the new record in the Q1 of the 2024 financial year. It's also demonstrated by strong industry and customer support that we've re-received since the publication of the LCD. I mean, urologists view our test as a valuable asset in the bladder cancer clinical pathway, and that's in opposition to Novitas's views, as you've heard. We're gonna continue to pursue a broad range of strategies. You've heard some of those, and opportunities that we see for Cxbladder around the world, and you also heard some of the countries that we're now pursuing interactions with. We hopefully will move towards a positive outcome from that adverse LCD. We've got a strong U.S.-based team, and you've heard from both David and Tamer, how they're leading our strategy to retain Medicare coverage. We've reconfigured it, reconfigured our clinical program. You've heard about that as well. That, I think, data evidence will add to our ability to achieve guidelines. Now, as many of you know, I, and as Chris iterated, I bring to Pacific Edge a background as a cancer researcher, but more recently, as experience in guiding early-stage medical technology and pharmaceutical companies to commercialize their IP. I'm a consultant at the Cleveland Clinic, and I serve as Scientific Director of Strategic Alliances and Technology Development. I do most of this remotely, but I do come here three or four months a year, so I can meet individually with the science and scientists and with the commercialization group. It's through these activities that I keep abreast of developments of diagnostic testing for cancers, and I think that in that way, I can help position Pacific Edge for success. I'm convinced that Pacific Edge is and will remain the leader in cancer, bladder cancer diagnostics, and it's well positioned to take advantage of the positive changes that will ultimately see Cxbladder embedded in standards of care. I look forward to your continuing support and thank you for the support I've had so far. Thank you. Thank you, Brian. Are there any comments or questions on the resolution to reappoint Brian? From the floor, online, Grant? Nope. Okay, in terms of the voting, Grant, proxies? On the next slide. Votes in the room? We're gonna hand those around. Thank you. People should have them on their chair when they came in. If we could fill those out, that would be terrific. Resolution two is the meeting records the reappointment of PricewaterhouseCoopers as auditor of the company and to authorize the directors to fix the auditor's remuneration for the ensuing year. We've had one question, which I dealt with earlier. Are there any other questions from the floor on this resolution? Nope, nothing online. Grant, thank you. We will now move to vote on the resolutions. Those of you who have yet to cast your vote, the forms you have in front of you, and they will be collected by the Link folks. Those voting electronically, please follow the instructions on your screen. If you have any questions about your voting, please direct them to the Links team who are here today. I think there's one vote to come. I'm, I can safely assume, Grant, those online have done their thing. Now, the results of the poll will be released to the market tomorrow, Grant? I think later today. Later today? Okay. Later today, the results of those two polls will be released. We are seriously in overdraft. Any general items, any items of general business from the floor? Nope. Well, look, we have gone over time, I'm not sad about that because it's great to have Tamer and David L. here that shareholders can talk to directly and see directly and hear firsthand how we're leading our business in the U.S. I hope and trust you found it useful. It's time now for a cup of tea and a scone. I'll wrap up by thanking all the guys that presented, and thank you all for attending, and wish you a good day. Thank you.