Verici DX (LSE:VRCI) — Progress and strategy update

0:01 Good afternoon, ladies and gentlemen, and welcome to the VERICI DX PLC Progress and Strategy Update Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Please simply type in your questions and press send. The company may not be in a position to answer every question that it received during the meeting itself. However, the company will review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I would like to submit the following poll. And if you could give that your kind attention, I'm sure the company will be most grateful. I would now like to hand you over to Sarah Barrington, CEO and David Anderson, CFO. Good afternoon to you, David, and good morning, Sarah. Thank you. Good morning, everybody.

0:50 Okay. Welcome, everybody. Thank you for taking the time to hear the update. I'm gonna flip into our slides. And I thought it would be useful, you know, in the past year, we have made made a number of announcements. And I think it's really useful to understand the context of why some of those announcements were so valuable and where we're going in the next few years. So as you know, on IPO, when we launched, we were a company of focused on two tests, Clorava, pretransplant and Tutiva, very early stage damage. And obviously, those are both high performing tests in their own right, and we'll just refresh ourselves on those during the presentation.

1:45 We were very fortunate enough upon IPO. We had the IP for a tissue based test for the later stage, but we were able to obtain rights to the blood based, testing in this area on a very similar approach to Clarava and Juteva. And this is what we've called Protago. It's late stage risk of fibrosis, which is one of the major adverse events for kidney transplants. So being able to do this had the advantage that now we were launching as three tests and covered the time continuum. So pretransplant, early stage, late stage damage. And why it was so important to be able to get that in early into our year last year was that we were able to add it into our clinical trial.

2:38 So we're opening up a validation, study for Carava and Trutiva that was promised, to be done last year. And I'm very pleased to say that happened. But being able to add in Protaga, was useful for two reasons. One, it added into the existing resources, and David will mention this later that financial, efficiency. But two, early data shows that each of these tests, inform one another. So some information that you get right from pretransplant can have a bearing and add to the information you get at the later stage and so on and so forth. This integration of these tests was very valuable to study in one study.

3:29 And so adding in Protaga for that further analysis to further down the line was incredibly important. So now instead of launching just as three individual tests, which we will do initially to get to those kind of commercial milestones, what we are able to offer in the future will be an integrated solution. And, again, you know, one of the things that became apparent is what we call partnering with the clinician with this suite of products started what we call the clinicians platform. Now if you look in the industry, one of our main competitors, CareDx, they're probably the only one that are taking what we call a platform approach. And what they're doing is they have a stated aim to partner with the patient.

4:18 And so you'll see applications that they're putting together on a digitized platform, for things like remind you to take your medicine. That is about patient compliance at the later stage to improve outcomes. And so they're looking to do a patient's platform. What we're doing, our technology lends itself to being partnering with the clinicians for patient care, and so we're building a clinician's platform. And, obviously, you know, there are two different approaches there. As we realized that our company really lends itself to the clinician's platform, we realized that we can provide a lot of depth by looking for complementary technologies in this area. What are the large clinical questions that are still confounding the community?

5:13 And are there developments and innovation that would sit very well with this Clarava, Tutiva, Protaga suite to be able to complement some of that? And, you know, we've we've spent the last year identifying some very interesting pieces. We rejected some others. But, you know, as we continue building out this platform, the idea would it would be a very integrated suite. Clinicians would first turn to the VERICI solution. And then obviously, you're looking at not only entry point in adoption, which clearly that helps, you're looking at how sticky are you against future competitors. And obviously, with that end to end testing that offers huge advantage and quite hard to dislodge.

6:00 Now at IPO, I also talked about data. Just to remind everyone, we sequence the entire transcriptome. What that really is because that's measuring all the messaging in the body. It's very noisy, but essentially it's got everything that you need to know there. And as you know, how we developed Clarava, Tutiva, and Protaga was to take all of that noise and find, you know, the answers to clinical questions. Clorava, for example, how aggressive or benign is the immune system likely to be in a patient towards a kidney transplant? It's a clinical question. It's one of the advantages to our testing that it's very pertinent information.

6:46 But obviously what we've got in the background is an incredible amount of noise. So if we want to ask another clinical question that's not quite developed yet, we have that data. And obviously, you can understand that that's hugely exciting for drug development, you know, other developments, you know, at some point you ask how well is my patient likely to, you know, to be very up to date, you know, look at, a gene altered, animal organ. All of those kind of clinical questions within that dataset. Now you can have just a lot of noise or a lot of data, and we do well organize our data. But understanding how to take something that's just information and put it into a an environment that is not only good at processing that, obviously, that distinction of taking out a lot of key messages from a lot of noise, but also in an environment that's good for collaboration with external parties.

7:51 And, obviously, we were extremely pleased to be able to announce recently our collaboration with Illumina. That's our first step in curating our data from what is just a data into a data asset, to be monetized. This becomes a research project, and further down the line becomes its own revenue centers. You can, have paid for collaborations. There'll be enough data to compress sometimes in terms of being able to do a retrospective clinical trial rather than the perspective one. The data's already there. And so, you know, that was a very exciting opportunity for us is to move another value driver of the company forward with that collaboration. And obviously, we'll, over the course of this year, work out how to create that asset and how to offer it out to the research community.

8:46 But we have now market leader in sequencing and data management, Illumina, to partner with on that. So very exciting opportunity. So the growth story here, which is both biomarkers, the clinicians platform, and the matching data asset behind it is obviously at the moment just focusing on kidneys. But it's clear that in the future, we will be addressing the other organs and, you know, the the whole premise of measuring biological systems where the immune system is obviously a major one. You can see it would apply to other diseases, for example, autoimmune diseases. Now I want to be very clear. We're not focused in on those right now. We've got some near term milestones we really need to achieve.

9:36 But I think it's very helpful to be able to see the vision of the company, what and the depth of of the offerings and the growth story, that we have. Okay. So this is supposed to be an update meeting, so I thought it'd be useful to have, an update on the page as well. And I'll just dig into a couple of these things, further on, in the presentation. So this year, this past year was all, what we termed our foundational year. And what we promised was to take those first two lead products, put them into a clinical validation trial, and to, finish that by the end of the year. And I'm very pleased to be able to report that we're either ahead on time on those milestones.

10:27 When we say ahead, we were able to get more patients, more sites earlier enrolled. And then at the end of the year, we were content that we had enough to cover our endpoints and then go into basically pull them out of what we call the clinical validation study, the sites not enrolling anymore, and go into data analysis. That will take us a quarter. We're on track track, and we are looking to do data readouts by about the end of q one of this year. Excuse me. We also looked at the commercial path and thought, you know, looked at stuff that that could be done a little earlier and clear the way our commercial path this year.

11:21 One of the things we had discussed was we will be offering what they call a clear lab. That's where we do not have to go to the FDA for our products. We get the blood sent to a central lab, process it in our hands, and then return the clinician an answer, a report. And to do that, it's a faster track through the regulatory process. We were identifying a certain area to open it up but that was to do with reimbursement, the Palmetto region, and we've done that. So we opened up a lab earlier in the frank in Franklin, just outside of Nashville and Tennessee, and we're able to get our approval sorted this year. Now I do have to register for New York State next year because they need the clinical data that the the state that do.

12:13 But to all intents and purposes, we are free to launch our product whenever we want to. We are approved to do that from a regulatory point of view. On the reimbursement path, a couple of really good pieces of news. We pull for our application for the codes. Remember, reimbursement is code, price, and coverage determination. The first stage being the codes. And we did get approval for two unique codes for one for each of the products. That was done at the end of the year and will go effective at the end of q one. So that's done. That's great news. Price that puts us on track for pricing. It has an annual meeting that's in the summer, and we're on track to submit that. And if we get crossover, that means that we would have that done by the end of the year.

13:03 So we're on track with that. And then the third part, which is reimbursement coverage, that normally happens after you've got the code and the price. We received some really good news. It did validate our instincts to set up in the Palmetto region when in April of this past year, they issued what we call a local coverage determination. And that covered Tutiva. So they said if you fit a certain criteria, which Tutiva does, then you will be covered already. We already know it's useful in this area. And so you do not have to do a proof or a study to to to submit to us. We already know it's useful. So just meet the criteria, and you've got coverage determination.

13:48 That saved about twelve to eighteen months after the process. So you can imagine that that was extremely good news. And we're, you know, focused transplant attention on the area of Palmetto. That also sets us up having determined that it's useful to have testing in, you know, blood based testing in transplant care. They should be very open to the idea that there are the time points in that testing continuum that would also be useful. And, you know, we're looking to put those files together. Carava, as you remember, is unique. There's nothing before it. So we will need to do that submission in the old fashioned kind of way, but we are looking for a good reception. So that was about 2021 being our foundational year, either hitting our milestones on time or being ahead of them.

14:41 There's a few other things that we, addressed we felt were important to add into the mix. I've already talked about Protago and how that completes our end to end suite of testing products. And I'm gonna talk about our collaboration with the CTOT study. It's a sort of insider, you know, high profile tech study that obviously is well known to the industry, but perhaps it's not well known to the wider community. And I'll come back to that. Clearly, we spent some time assessing new technologies and, working out how to on the growth part of our value, working out how to add to that clinician's platform. And lastly, you know, we've covered the fact that we did a collaboration with a market leader and that was very encouraging for our future growth and development story.

15:38 So let's just return back to basics. Just a reminder of of the testing modalities here. Clorava pre transplant answers the clinical question, how aggressive or benign is the patient likely to be? That informs post transplant care. And, again, when you think about that balancing act we talked about with the clinicians saying, I probably am over treating. I'd like to know which patients I can taper off my immunosuppressant therapies to a lower level quicker, is very vital information. And one of those that I need to spend more time in my clinic because they're high risk. I already know that. I'm gonna schedule them a little bit more time, Management of clinical time. All of that's very valuable information to the clinician and not something they have right now. If you recall, they have no other products offered to them.

16:31 They rely on clinical factors which are by and large very poorly performing. Tutiva, that's the early stage damage. And just a reminder, it's bay basically trying to answer for the clinician the clinical question. Is that graft being damaged, and is the body not able to deal with that? Right? And that becomes a very pertinent question. As you know, the competitors can tell you there's something happening, but I don't know what it is. It could be a passing infection. It could be something more important, or there's nothing that's happened that rule out tests. But, you know, clinicians say that they get a very good indication of nothing from serum creatinine, So that's not so useful.

17:18 So useful to a point is the competitive assessment to achieve a being able to say no, something's happening and you need to intervene that high PPV. That's really important to clinicians and gives us a very large competitive advantage. Protagor, what's my risk of my patient having fibrosis to a point where it's failure? Long term prognostic there and very, you know, clearly a very important part for the clinician to get ahead of that. What can we do or how can we change clinical care to be able to accommodate that risk? And, again, very important to the clinicians to be able to get something ahead of time. We've talked about addressable market beforehand.

18:04 And, here you'll see just an updated slide where we've had to put to normalize to Protegra, which of course is in that because it's longer stage and being able to be run over say five years. We've had to sort of look at the addressable market to be normalized in that way. I think what's interesting is that every company has their own approach to calculating the addressable market. Our approach says 5,000,000,000 over for five years. That's big enough. But I think it's very interesting to look at other companies' estimations. Natera just came out. Their estimation at JPMorgan conference was that transplant testing was worth 50,000,000,000. Now that's across all organs, but obviously, kidney is a major part of that. So my 5,000,000,000 is starting to look maybe a little anemic compared to their estimations.

18:55 But the real proof point and what we're all really interested in is how can we really get to that revenue figure? And KDX is probably the best place for analysis on that. So when we looked at that, David was able to work out that in 2020, their revenue for both kidney and heart, so it is mixed in, was just under 140,000,000. And their per you know, forecasts for this year are over 200,000,000. So clearly, there's a lot of revenue to be had in these areas. And I feel that, you know, this is hugely exciting from us as, obviously, as a pre revenue company to be able to address some of that. And CareDx, of course, are only one of the major three competitors in that area. So I think there's enough. I think it's big enough.

19:50 Now the c top study, I just wanted to return back to, you know, it is industry leading and it's funded by the NIH. And there's a series of these studies. They're multi centered, they're high prestige, and they are seeking to advance innovation in the area. We have seen in the past that other products have been launched off the back. TruGraph, for example, was launched off the back of their collaboration with a previous CTOT study. And so we were thrilled to be asked to collaborate on this one. It's a 15 transplant center and they've already got two years of clinical follow-up as well as all of their participation.

20:35 They've already done the cell free DNA analysis on that sample set, and that's right for future publications. When they do our analysis, they'll be able to independently publish a head to head comparison. And we know that we're going to do well on that. Already, they presented on the cell free DNA at a conference last year, and it wasn't good. So I'm looking forward to that publication. Obviously, that supports a very favorable, you know, launch during this year. It's very exciting to be done this because of that independence, and there will be publications done this year. That's a little ahead of where you normally expect to get the independent validation publications.

21:23 Normally, you would expect to launch in the in the next couple of years when people have it in their own hands. You know, we're going to have it early, and that's very important for not only our credibility but supports rapid adoption as other people see that it's not just our data that we're talking about. Other people are talking about our data. It's also a good proof point. It's got a lot of information in there. We offered to do the sequencing for all of their patients and knowing that this would be very useful for us to be able to do test out some of our future studies or some of our future in, innovation in this dataset knowing that we will have a dataset that enables us to compress the timeline on a validation study.

22:11 So you're taking innovation that could take years, if you do it prospectively and being able to condense it into biobanked well curated data. So it's extremely important to us to be the collaborators on c top 19 and very exciting looking forward to the potential for the growth the growth story and supporting the income story with those valid those publications. And when we talk about the growth area, you know, we've talked about why we are excited about our own products, that end to end testing suite, but where we're focused on looking for other, biomarkers, other technologies, and why we're not particularly focused on the area of Tutiva.

22:56 If you look at the pretransplant space, we we obviously have a test that focus on the patient. What we're looking at is other are there other areas that could be very complementary to this area? The organ, the matching, the compatibility between the patient and the organ. And as we assess that, being able to move not only from a position of having a unique offering, no one else is offering pretransplant testing, but being able to quickly dominate that area by having that kind of end to end organ patient compatibility offerings would be hugely beneficial. And then at the late stage, there are a number of opportunities for us, not only in collaborations, but to look at other testing modalities.

23:43 One of the things that I think is very important here, we've been talking about since Bio Techne came out with their pilot data on urine based testing and there's a couple of others, urine based testing is being seen as an a very important area for the at home market. Now I think that they're in the early stages, the wrong timing for that. That's the time when you wanna see your clinician. You've got thousands of questions. My favorite was the clinician that told me that he had a question from a late at night from a patient who'd sprained their ankle and how is that going to affect their kidney. Not a normal question. This is very transplant oriented. I'm nervous about my transplant. I wanna have access to my clinician. Two or three years into it, suddenly you don't want you know, you've got all of those questions. You've been living with your transplant for a while. You've kind of got got it down.

24:35 At that point, the inconvenience of going to the transplant center waiting around to get your testing and then the results, etcetera. If, you know, that's when the burden is. And that's the time I believe that urine based testing and then at home market would be way more compelling. So you can see that we're focused in on looking at the depth of this platform. And the reason that I'm not focusing on Tutiva is there's already enough for clinicians to be considering right now between Tutiva and the competitive products and and emerging urine based testing. I don't think it's a good use of our time to pull in yet another new piece of technology for them to assess. Instead, if I'm going to make use development dollars, I'm gonna be focused on how can I make Tutiva better? Can I make it more commercial?

25:25 For example, take you know, taking that signature and saying, can I move from next generation sequencing, a service based offering? Can I distill it down into a kit? And maybe more important for Europe than, for The US. But still you can see that we could spend our time focusing and leveraging the commercial applicability of that product. And I think that given the Tutiva is so well performing and it stands very strongly in the marketplace, that would be where I spend our time and effort. And then, obviously, we've talked about this data asset. I talked about the 20 your entire transcription. That's 25,000 genes. That's a lot of shouting messages from the body that we've got captured in one place.

26:11 But the really interesting thing is when you're trying to work out what's what's pertinent information, having the matched clinical data, that's patient information. It can be age. It could be gender. But also what we collect is therapeutic and comorbidity information. That that clinical data is very deep and rich. And then, obviously, it needs to be matched patient outcomes. What happened to that patient either from the patient records or from a result from a pathology slide, the biopsy. And we've asked for them to be digitized because we see techniques coming up fast and and thick in terms of the AI, the ability to standardize the readings. So that makes those slides more valuable. The ability to make new discoveries that you can't just see with if you like the the

27:00 human eye looking at a read. So, again, putting all of that together is no small task. And having that collaboration in that area was incredibly important to turn all of this information into an asset. Let's just I've talked quite a bit about our future growth, the driver of the business in terms of the growth area. Let's turn our attention to the driver of value, that we see from this, commercial path and the focus of this year. So as I've said, you know, we went for that clear approval. We've got it. There's, you know, obviously maintenance and New York state to do this year, but we're good to go. We don't have a regulatory hurdle to be able to launch done. Reimbursement, we're well on the path remembering that we've got the codes, we're on track for pricing, and we've already got one product covered under a coverage determination.

27:54 That's really good. And the point of that, that's all Medicare. And I've say that the importance of that is simplicity. Not only can Medicare patients get reimbursed under that system, but it becomes, if you like, the, you know, the retail, the list price for other organizations in the private field to be able to refer to. So there's a simplicity and there's a validation done through Medicare that is applicable to other areas. So we look at payers, hospitals, etcetera. Now one of the things that they've got is they've got some extra things they think are really important. Budget impact, for example. And, you know, what we've got there is is something that we we developed to health economics models. Those help to answer those questions. We're published on the kind of normalized, you know, version of of those answers. But then we'll have a tool that we can tailor. We'll take as part of the selling process to our payer, to us network, and say, your own information in and see what your answer is. And that's very compelling. And when we talk about employer plans, we need to know things like productivity and days absence, etcetera.

29:15 So that's well underway. That should be done by q one of this year. And then we've talked about Palmetto, how it's good, and how we can compress compress any kind of movement forward in that area to be an efficient process. This is our timelines. It's a busy slide. It's designed to be. Right? What we're doing here is we had a fairly quiet year. In health care, you don't get ahead of your skis. You don't get ahead of your data. So we were quietly educating the clinical community on this underlying approach. What's a mRNA signature and why is this important, etcetera, making sure everybody is kind of up to speed working with the influencers doing our trial, which, you know, during COVID, you know, and all the delays that that can present, all the supply chain issues that we had to manage. You know, we were very internally focused.

30:13 I'm pleased to say it was successful, but it was a quiet year. And now it's a noisy year. We're now able to take our data, go and shout about it, go and publish, go and webinars, go on to the community. We're now on that commercial track. So if you remember, I talked about 2022 being our commercial proof of concept. You know, by the end of the year, we want to launch Tutiva. We want to have, Clarava into some studies or and even better, maybe real world evidence. So it is you know, the metrics of this year are not so much revenue. If you ask me how much revenue, I'm gonna say it should be probably fairly anemic. We won't get to that point of launch towards the end of the year. But ask me if we're in centers, if I've got KOLs that are independently using ours in a real life setting and then being able to talk about that at conferences and to their peers, that's really important.

31:10 And that's, you know, an important step in the commercial rollout is to have what I call that commercial proof of concept. 2023 is the year we'll talk about revenues. We'll be then, you know, bringing on the major part of our sales force to do that rollout to to bring on both products through the clinical community, and then we'll talk about revenue. So you can see how this is all laid out. It's a busy year. It's a noisy year, and it's incredibly exciting to finally be able to really promote what we're doing here. David, I've talked too much. It's the financial update. It's your turn. Thank you. Thank you, Sarah. Good afternoon, everybody. So at the time of IPO, we were projecting a cash runway to mid twenty twenty three, always with the expectation that there'll be additional funding requirement in 2022.

32:01 The inflection point there being when we move essentially from an r and d operation to a commercial operation, which is where we are now heading. Cash at the end of December last year, $10,300,000, in line with expectations when you take account of the timing difference on some CapEx. In terms of our current revised base case projections based on the expedited development of Protaga as Sarah was talking about, the work in terms of development of the CLEAR lab in Tennessee and commercialization takes us to cash runway to early twenty twenty three. So the big differences between what we were projecting at the time of IPO and where we find ourselves now based on our current projections, Really, the biggest one is clearly Protaga.

32:47 But the development of Protaga is being done in an efficient manner. It's being done as a continuum of the existing clinical trials that we've had on Clorava and Totiva. It's being done with the existing the the continuum of existing relationships and also using the samples that we have taken for those for those patients. So the we're maintaining momentum. It's not a stop start approach in terms of the development of that new product, which is clearly less efficient. In terms of our clinical trial costs, they've been higher than we were expected, but higher because we took on more sites. We took on more patients. So arguably, you could argue that is positive in terms of adding to the the the value of the asset, if you will. And, also, there was cost in terms of some biopsies that we didn't anticipate. Then there's been the cost incurred in terms of the acceleration of the ClearLab, all of that offset by savings on across a range of other areas.

33:41 And And then then so looking beyond that base case projection period in terms of what we have in the future, clearly, we need to want to finish the validation trials for Protaga. There's work that we want to continue doing with advocates and other associations to really turbocharge that that, support the community out there. And as Sarah alluded to, there's other opportunities that always present themselves in terms of, technologies that we would

34:06 look to developing the platform and assisting the platform. Thank you, Sarah. Back to you. Thanks, David. And so just to, look at a a quick summary, you know, I I'm not going to read out the slides, at all. But I think you'll see that what we're doing is, first of all, it's hugely gratifying to to make such good progress under some difficult circumstances and to hit our milestones either on time or ahead of time. I'm very proud of my team for that. They've worked hard. It's great to be able to say, look, we have an opportunity as a company to to drive value in in two ways. There's a growth story there, and then there's the commercial story, and we're doing both.

34:54 So I think that's very important where where we started. We're now being able to offer a bigger value proposition as a company because we've grown on both of those fronts. And then thirdly, the the the point I'd like to make, is it's hugely exciting, this fourth forthcoming year. You know, we've buckled down. We've done our homework. It's now time to to see the results of that and to be able to go and, you know, really push the advantages of what we're offering. I know the clinical community are excited to see this and they have been asking when it's coming right from before the company was formed when they saw this approach in the marketplace.

35:41 And I'm delighted to be able to say this is our year. So a hugely exciting year ahead. Okay, so that concludes the presentation. I do see a couple of questions. Sarah, David, thank you very much for your presentation this afternoon. And ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen. But just while the company take a few moments to review those questions submitted today, I would like to remind you the recording of this presentation along with a copy of the slides and the published Q and A can be accessed via your investor dashboard. Sarah, David, we received one pre submitted question ahead of today's event, and I wanted to start off the Q and A session with this. The question relates to funding and reads as follows.

36:27 In the update on January 12, you said that cash resources remain sufficient to continue progress into early twenty twenty three. Is this an elegant way of saying that you will need to raise more capital next year?

36:39 How easy do you think accessing that would be? And would it be better to consider doing this sooner rather than later? Thank you. I'll I'll take that one actually because I'd just like to remind everybody that at IPO, we always did say that we would do a small initial raise and that we would come back to the markets in 2022 as we turned from an inflection point from essentially an r and d company into a commercial one. And so I think that expectation's already baked in. And, certainly, I'm you know, we we will we will continue to meet that expectation. You know, as as regards to timing and amounts and all of that, that's to be determined.

37:30 Clearly, need to look at market conditions as well as, you know, our needs. So looking at that becomes, you know, fairly strategic, and we will continue to make assessments on that. And then thirdly, David will always tell me earlier is better. Whoever asked that question is gonna find a good ally in in the financial folks there. So David would agree earlier is always better. But we do have to be mindful about perhaps looking at the most optimal time. Sarah, thank you for that. Sarah, David, if I could ask you just to open up the Q and A tab. And as you can see, we received a number of questions throughout today's presentation.

38:15 And thank you to all investors for submitting their questions. Could I please ask you to read out the questions and give responses where it's appropriate to do so? And I'll pick up from you at the end. Thank you so much. Okay. So first one from Max is what do successful validation results of Colorava and Tutiva look like? Thanks for the question. I'm not going to get into precise numbers, but I want to point out something that we we did at IPO, which is we said very much we're focused on delivering tests that perform in a well balanced way, so high sensitivity and specificity, And that had competitive advantage. So let's take Trutiva and Carava follows suit.

39:02 But Trutiva in the marketplace, the competitive tests have high NPV. They're a rule out test, which is I once worked in prostate cancer. That's that's a disease group that really lends itself to a rule out test, telling clinicians that they don't have to take action. So in the case of prostate, you don't have to take a risky biopsy. You can put a man on the wait and see list. Right? So that's very important information. That's the focus of that disease. Very slow progressing. You want to know that you have more certainty about not taking action. But that's not kidney disease. You know that something's probably happening. And so that rule out test approach from the competitors has been found to be limited.

39:51 And our early data showed that our PPV was was very, very high. So where we our competitors are sitting in the twenties, thirties, sometimes even fifties, but but that's not good enough. Our early data suggested we'd be sitting in the seventies and eighties, and that is compelling for the clinician because now they know that they've got a high NPV and PV. So when it's negative and they they're being told by a test and they agree with their clinical judgment that they don't have to take action, they've got that to support. But now they've got something that they don't have, which is to say something's going on and you need to intervene. And they want that information to be able to modulate the drug therapy.

40:39 So success to us is continuing that pilot data of both high metrics and that competitive advantage on the PPV. Okay. Our next question. What are your thoughts on timings and scale of the commercial opportunities and what do you see as the routes to market. Okay. So first of all, we're talking about near term commercial efforts and that's on Clorava and Tutiva. And so how do we talk about the timings? We're talking about launching Tutiva formally this year and doing a soft approach with Clarava as we've got to produce additional data on utility.

41:26 And so, you know, I'm looking at taking some of those trials and seeing if we can do them in a real world evidence perspective. But really the timing for Clarava is in 2023 as a a formal launch as we finish those studies. So that's timing. Scale. I talked about IPO that I said when we will come back to fund that scale up, it wouldn't be a big scary number. You know, as we we don't have a product where we need to go and talk to all the doctors in the world as it were, all the primary care physicians, all the generalists, etcetera. Instead, we've got under 250 transplant centers in The US that we need to address. And and quite frankly, about a 180 of those are really sort of high producing.

42:16 So when you're looking at a scale, I don't have to have a big scary number to address those. I use a metric of about a one to 10, so for the sales folks. And I would look at these as more business developments, a little bit more of a business to business. You know, we're going to go in. We're gonna have a health economics model. We're gonna talk to the clinicians about the clinical data. We want the entire team, including the c suites kind of involved in that decision making to put us in the protocol of the center. It's much more of a sophisticated kind of development conversation. But if I'm using a one to 10 and I'm trying to cover, say, 250 sites at most, you can see that realistically, I don't have to have hundreds of people.

43:03 I would just need 25 there. So that gives you an order of magnitude on the scale. It's not, as scary as as some of the other things that you would need to do in health care. And the routes to market, we do have an option. You know, we talk to everybody, and everyone's come to chat to us as the new kid on the block as it were. And we look at potentials for collaboration. We do have an opportunity and it has been offered to us to use effectively a distributor model or using someone else's Salesforce. And that's a possibility. I I can't say we've come to a conclusion on that. It is an option, but you lose control of the of the patient or sorry. The the customer, which is the clinician at that point.

43:54 And, you know, that can be very valuable when you you're coming back to to basically partner with them. And so I feel like as we don't need to have a huge business development team, that may be something that we wanna keep in house. But there are alternatives, and there are different routes to to market, and we will consider them more until we've come up with what we think to be the most efficient. Simon asked, good progress to see pro good to see progress across the board. Do you foresee the need to raise further funding? I think we've answered that. So I just refer you back to the previous answer. And then I'm being asked, great opportunity, but what are are the greatest risks moving forward?

44:43 I think they're just normal risks, quite frankly. I think that, you know, in terms of launching a new product, you have all the same execution risks. You know, can I build the right team to address this in the most efficient manner? You know, I think we have bigger risks at IPO because, you know, we didn't know how that trial was going to go in COVID. And I think we chatted quite a lot about how I might mitigate that risk. Now we're out of that. We've got those patients and the data. It's now about performance, publications, execution, and quite frankly, you know, can I build the right team to address that execution and rollout?

45:34 And I believe we can. So for when I'm hiring, this company attracts an incredibly high caliber of person. There's a lot of people that are very excited about what we can do. And so building that team is really aided by that level of excitement and people wanting to join us. And so I'm very hopeful that in the time we've got, we can do that. But it takes time and, you know, we're still a small company. So maybe our greatest risk moving forward is that we can't move fast enough because we're too small, and it takes us time to build that team. So that's what I would see as the greatest risk. Sarah, thank you for addressing all those questions.

46:19 And of course, ladies and gentlemen, the company will review all questions submitted today, and we'll publish those responses on the investment company platform. Sarah, David, before redirecting investors to provide you with their feedback, which I know is particularly important to the company, could I please ask you for a few closing comments? Yeah. I'd like to thank everybody for their time to listen to this update. We wanted to get to the beginning of the year to give the ups update because we were actually very busy last year, but a little quiet. Also, it would be a good time to reach out and say, we're very proud of what we able able to achieve last year. We're hugely excited about what we're going to achieve this year. And, you know, being able to be in a situation where the company has huge potential for value on both a growth story and a commercial story is hugely exciting for us, and we're looking forward to the rest of the year.

47:15 Sarah, David, thank you for updating investors this afternoon. Could I please ask investors not to close this session as you will now be automatically redirected for the opportunity to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of VERICI DX PLC, we would like to thank you for attending today's presentation, and good afternoon to you all. Thank you very much. Bye bye. Thank you.