Good afternoon, and welcome to the Verici Dx plc Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time by the Q&A tab situated in the right-hand corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Sara Barrington, CEO. Good afternoon. Good afternoon. Thank you everybody for attending. This is obviously to present our interim results at the half year, and also to give an update on the progress of the company. Usual standards. I just want to start off by reminding everybody where everything fits into the wider vision of the company and what we're doing here. We obviously have three individual tests, a pre-transplant test, Clarava, an early-stage damage test, Tutivia, and a later stage damage test focused on fibrosis called Protega. What we said we would do is we would launch these as individual tests. The real power for us is being able to offer these as an end-to-end platform, knowing that not only is it covering the time continuum of kidney transplants, but that each test is likely to inform the other. This around that end-to-end testing and the platform idea is what we call the clinicians platform. We are looking to sort of partner with clinicians, answer their major questions, based on RNA signatures. Then behind that is the data that we collect. Just a reminder that we do collaborations in research to promote innovation in the field, and that our data really in conjunction with the ICA programming from Illumina offers a secure place to do these collaborations and to properly curate the data that we've got. That's the ultimate vision. We're in kidney transplants now. You can see that we have a long-term vision of other organs and then into other disease groups, because RNA signatures are really at the forefront of diagnostic care now. What we've been able to do is translate that now, not once, but now twice, with Clarava's results coming across from an academic, from an R&D environment into the clinic. Tutivia, we announced earlier in the year around May, June of this year. Clarava has just been announced yesterday. What this does is this really starts to support the fact that although we're looking at these individual tests, we're now really proving the platform of RNA signatures and their applicability into the clinic. Let me just run you through some of the milestones. Thank you. Obviously what we've done put up here is really the commercial pathway. I think there's a big emphasis now in this transitional year from us just being an R&D company into one of commerciality on what that pathway looks like and what the progress is. This is what this table seeks to do. Obviously with Tutivia, the clinical trial results, you know, was completed and, you know, is presented at AST conference, and we're now in the second half of this year in what we call the commercial soft launch. What we mean by that is being able to work with some very early adopters in understanding how to integrate it into a hospital system. It's like what I call the easy button, making sure that all the logistics work, the turnaround times, all the things that can trip you up in a mature launch, we've got covered, we understand. Also to give more material to our KOLs as they go out and talk to the wider community on that. That's well underway. Clarava clinical trial, we issued that yesterday. Did note that the good news, bad news story for Clarava being so novel is that it has no competitors in the marketplace. That's the good news. Obviously in a novel test environment, more and more data is needed to support that, and that's what we're looking at. We're expanding the enrollment to support the commercial adoption, the utility studies, the reimbursement pathway, so on and so forth, publications, and presentations. I think that was very encouraging and a testament to its success. Looking at reimbursements, if you remember the code, the price, the coverage. We got PLA codes for each of those tests at the beginning of the year, so each has a unique code. This year is all about going through the process of pricing. There's two choices. We may be recommended for crosswalk or gap fill. Crosswalk would be issued at the end of this year. Gap fill would be into next year. That would give us a pricing recognized by Medicare. Then you go into the coverage determinations. Tutivia, obviously didn't need that extra work. Because there are already other tests in this area, even though they're not the same technology, but it gave a local coverage determination in the Palmetto region, which is what we needed. We need to apply for that. We'll do that once we've got the publication out on the validation data, and then look for an answer coming back from the Palmetto region early next year. Obviously, the Clarava coverage determination will take longer. We always said at this point, this year is the year where the two tests take different pathways. This is what we're seeing now. We'll move from, you know, from validation into utility work into publications, and we'll be making an application for the local coverage determination with all of those data points, and that looking to have that within the Medicare system and then obviously be looking for both products into the private situation. New York State on the regulatory side, that submission we need to complete a CLIA audit, which apparently we're in line for, and so that's pending. Once we have the results of that we can include in the file, we'll make that submission. Obviously in terms of publicizing, you know, the results and the nuances of the tests, one of the big ones, big paths to our marketing on the conferences. Sorry, my words are stumbling today. We had a positive reception for the Tutivia data at ATC. We're very pleased to be given a speaking slot. It's a quite competitive situation at ASN in the Kidney Week, so that's coming up in November, and that's a big splash to the wider kidney community. Then we'll be building upon that with our soft launch and, you know, subsequent publications. We announced that we had engaged our commercial team. They're now up operational and out in the field, and obviously they're active on this soft launch for Tutivia. Then for the wider, longer-term revenue story outside of the U.S., obviously we are leveraging our clinical validation sites in Europe and in Australia for that wider adoption further down the line. As you can see, when we're looking at the commercial pathway, there's been a substantial amount of progress during the first half of this year, and obviously we're looking forward to more information and more milestones achieved by the end of this year and into next. Thank you. Just to cover the other aspects when we're looking in the period which includes right up to today, one of the key studies that needed to be done over and above the validation, the clinical validation studies, were the analytical validations. Those were completed in February. They will be submitted for publication before the end of this year. They obviously go into our both our regulatory and our reimbursement pathways, and an important key milestone towards commercialization. We also announced a collaboration with Illumina. Again, if I can refer everybody back to our long-term vision, one of the aspects to the company that we were keen to promote is not only are we a biomarker company, but we are a data company. That collaboration with Illumina is a very important step forward in curating that data in such a way that it expedites the operational launch of research collaborations, you know, within that environment, to speed up the pace of innovation in other areas. We're looking forward to launching that a little bit more formally by the end of the year and moving that forward into collaborations into next year. Obviously in the period we did a fundraise of GBP 10 million in March and completed that. Obviously we'll talk about the financials and the interim results and the cash runway in subsequent slides. We've already noted we've got a commercial team. We've already noted that essentially we're now two shots on goal, I think the expression is. Improving the individual tests will be moved into the clinical environment and proving the worth of that platform. David, over to you. Thank you, Sara. Good afternoon, everybody. Starting with the cash flow statement. In terms of operating activities, cash burn there broadly in line with expectations. In terms of investing, we spent GBP 560-odd thousand on the CLIA lab. The total cost of that is gonna be around GBP 800 thousand. I'd assumed that we would have a little bit more spend up to the end of June, so a little timing aspect there. Then GBP 160-odd thousand on patents and licenses. The GBP 2.6 reflects the net inflow from the fundraise. There's another GBP 90 thousand of costs which are included within those operating activities. Taking our cash to the end of June at GBP 15.7. Current cash is GBP 13.5. Now, at the time of the March fundraise, we were expecting cash runway to August 2023. We're now expecting cash runway to early 2024. The big movement there is really in terms of head count and the way that we are planning on building out the team. As Sara mentioned earlier, we have the generals, as I call them, in terms of the commercial team. We've got three individuals. They are out in the field, and they're out in the field talking to the hospitals, talking to clinicians, and really to get a better understanding in terms of what we need, and more particularly, how hospitals can order the test in as easy a way as possible. From that, we will take that and build out the business development team on the back of that knowledge. That together with other actions will help us take cash runway out to early 2024. In terms of the income statement, adjusted EBITDA of 4.9. Largest items of expenditure continue to be wages and R&D. In terms of headcount, at the end of June, we had 13 people in the business. We currently have 14. We're looking to hire another three by the end of this year and another seven by the end of 2023. In terms of the balance sheet, as I mentioned earlier, we spent GBP 560,000-odd on the CLIA lab to date. Our intangible asset base of that is GBP 1.5 million that we paid Renalytix at the start for the original license and then further costs which have been incurred to date. Receivables is mainly prepayments. Then, trade and other payables. The biggest item there is accruals, and the biggest item of that is our site accruals. This is where individual sites have incurred costs on our behalf in respect to the trials, but have yet to bill us. The lead time on that can be some months. Those are included within accruals. Thank you, David. Back to you, Sara. Just you know obviously the key points on this is that we did make very strong progress to date. I think this transition from being just an R&D company to a commercial one is proving to be very successful. You know obviously with soft launch by the end of the year. You know we did say that they wouldn't represent high amounts of revenues this year because it's a soft launch. It is actually to be able to sort of really integrate the test in proper way through our commercial readiness program to those key early adopter sites. I'm very pleased to be able to say that we have got the right team in place to be able to implement that. Couple of other things that we're doing. You know, we've talked about the health economics model that's now drawing to a close. That's ready for another sub-publication that's going to be submitted by the year-end. Obviously, as we're moving forward out of just the validation into the commercial arena, we would expect to see more studies supporting that in terms of utility and real-world evidence studies, not only done by us, but by other members of this clinical community, to support our body of evidence, and publications. We've always said that the true test is when you get independent publications that's very supportive in terms of the larger scale adoption. We're on track for that. The pricing determination, you know, is well underway. We'll know by the end of the year if that's crosswalk, but even if it's gapfill, it's sort of in line with our adoption curve for revenue next year. That would be, you know, known in the first half of the year. What we would say is obviously we were looking for this year to be a springboard in terms of that transition. We're looking forward to next year, planning on how to do the hard launch, the mature launch, and for 2023 and 2024 revenues. Okay. That concludes just the update. I see we have a number of questions. Did you want me to go straight into that? Yeah. Sara and David, just like to thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated in the top right-hand corner of your screen. Just while the company take a few moments to review those questions submitted today, I'd like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor dashboard. As you mentioned, we've received a number of questions, and thank you to the investors for submitting those. Sara, could I just ask you to read out those questions and give responses where it's appropriate to do so, and then I'll pick up from you at the end. Great. Yeah. The first question we have is: Has there been any interest in the products from any companies already addressing the kidney transplant market? Yes. There's a lot of interest in these products from the scientific community, and that does obviously include competitors that are already operating in this space. I see the next question is about companies not yet operating in the area of transplant rejection. I think that, you know, what's really important here is the adoption from the scientific community. When we're talking about other companies, they of course are monitoring our progress. We talk all the time. It's quite a closed community. You know, we meet at conferences. We are constantly reviewing their work. They're constantly reviewing our work. There's definitely interest in that. In terms of outside of the traditional, you know, we are being showcased by Illumina as first of their clinical offerings or content offerings on their ICA products. We know that we, you know, we also got a case study from Amazon AWS as they're hosting that in terms of promoting the clinical adoption of these tools and techniques into the marketplace. How that is manifesting into outside of kidney transplant rejection is unclear to me. It's not necessarily on our immediate horizon, but we are going to those conferences, and obviously we do have quite a lot of publicity on that side. What are the expected costs of the planned improvements to the CLIA-approved lab? GBP 800,000 What's the stage of the lab improvements at? It's pretty much complete. Do we have a date for moving in? It's within the next month we're moving in. It's part of our commercial readiness. You know, and part of the soft launch was to be ready at that time and to be able to process the commercial tests within that environment to check that we would be ready for the wider adoption. That's all on track. Is the pricing decision required for you to start your soft launch later this year? How long do you envisage the soft launch lasting? The soft launch, no, we do not need Medicare's pricing determination. That is actually really. The way I like to explain it is it's like a list price for Medicare. The pricing determination is that it will be recognized across the whole of the nation. We can, in the meantime, put a price up there. Obviously you wanna be close to where you think you're going to end up. Yes, you put a price out there that you're charging, and part of our soft launch is to sort of test that through the process, even though we haven't got a pricing determination nor the official check in the box from the coverage determination. You know, clearly those are things that we'll be testing out through this soft launch. I like to think of the soft launch as being for the rest of this year. It realistically is, as I said, on two fronts. One is commercial readiness, which as you can hear, we're on track internally. It's good to now understand it externally, work out all those little kinks. I always like to say find the easy button, and that will speed up adoption. It's also for us to explore our marketing messages, what resonates, what doesn't, and also for the KOLs that are the early adopters to be able to gather their own data, see what it's like in their own hands, and be able to talk it to the wider community next year. Early January, you know, I think it's January the second, we have to say, is our hard launch rather than January the first. You know, essentially that's when we're going to be going out outside of these very early adopters into the wider community to make what I would call the hard sales, the cold selling. Obviously, there's still networks that we can leverage, but that's really where I'm seeing that next, is next year. Any events happening in the broader kidney area which might have an effect on you, good or bad? There's always the legislative activities that are going on in the background. You know, it's one of the rare areas of bipartisan support, so that's good news for us that there continues to be support in terms of widening access, and improving some of the coverage for healthcare in the kidney area, and that continues to march forward. I would say that that's a very good background. Clearly, they still haven't solved a lot of the issues in terms of the progress of kidney disease. You know, the underlying causes such as diabetes, that's still on the increase, as was the effect from COVID. Obviously you've probably read that kidney's one of the major organs that got affected by COVID, particularly in long COVID, and you know, we've yet to see that really play through. There are other innovation ideas. There's some interesting things on artificial organs, but they'll be years away from really hitting the market. I think those are the kind of general sort of trends in kidney that we see right now. Okay, what sort of revenue would you need to enable you to stand on your own feet? Yeah, I think then that's about cash flow breakeven. Essentially we would be predicting that not out of this round. We've never promised that, and certainly that wouldn't be expected. It was all about the getting to a situation of the early revenues. The next phase is where you could expect that to happen, and that's more likely to be in the sort of year of 2023. Am I seeing any other questions? I see a note. No, nothing there. Nothing. I'll just give it a couple of minutes. Oh, that's 'cause it's a very long question. Hang on a moment. Okay. Can you tell us about your plans to make Tutivia and Clarava available to clinics in a real-world setting? Are there many locations that are key to work with you in the role of early adopters in the current year? Yes, I can. Quite excitingly, we targeted between 2 and 4 centers to work with us in this soft launch. We wanted centers that had multiple clinicians as well. I'm pleased to say that we're already engaged in 2 centers, and we're being actively considered by another 2. There may be more than that, but we'll see. We don't necessarily want to overegg it in terms of when you're doing the sort of early adopter learning. I would be looking to make that sort of something that we do well in because that's obviously what you want communicated out to the wider community. Expect it to be about 2-4 centers. The real-world setting is very interesting and healthcare is always about could you give us more data? Could you give us more data? I think that this sort of need to have data sort of drive some of these real-world activities, and we've seen this through other companies. CareDx, for example, did a lot of that in their early days and continue to do studies. Of course, you know, one of the things that we are trying to move on to very quickly is instead of us funding the studies, that it's done in what we call a real-world evidence. For example, if you want to understand the impact of our tests in the interaction of a drug modulation, that's not necessarily something we would fund. That is something that we would expect clinicians in their own hands, in their own ways to be doing. You do have this sort of period of transition where for what we call the utility studies will be done, but they'll still be revenue generating, so they're part of your sales, even though it's because people are looking to see how it operates within your own hands or whether they're interested in a subsection of data, such as the interaction with a certain drug or et cetera. That's what we mean by real world. Yes, we will definitely be seeing that in both tests, alongside just, you know, straightforward clinical settings. With regards to strategic partners, is there scope to work with the bigger players such as the big pharma companies and to use the results in drug trial and development? Absolutely. Again, you know, when we talk about that research asset and the need to have it in an environment that is as flexible and as helpful as ICA, that is exactly what we're doing, and we are looking to do collaborations. One of the things I said earlier is that we're hoping to launch that, you know, by the end of the year, early into next, and we're looking for collaborations next year to come into that space and to prove that asset out. Yes, that is one, a definite area for us. Is there a scope for such potential partners to help fund the rollout and accelerate the adoption? Absolutely. I think that is part of the rollout is where your, you know, companies are looking to collaborate and extend the use of your tests into areas where there aren't necessarily just the first intended use. Yes, I do think so. Lastly, regarding your comment about being well-funded, how much runway do you perceive you have in your current? I think when we went out back in March we had a runway out to the end of August. Clearly, given the current circumstances you know, we've been reviewing our budget and prioritizing. We're now extended the runway out to you know, the end of 2023, the start of 2024. We'll have to see if there are any more things that we can leverage into doing that. That's with fairly conservative views on revenue, just so that we don't get caught short on that. Yeah, we are very mindful in how we are preserving our cash and how we're spending it. Obviously, there's a need to grow, and we do need to do some hires and to put some resources in, but at the same time, we're doing it very mindfully, and not trying to get too ahead of our skis, as the expression is, so that we can extend that runway as far as possible. Are you depressed at the share price? Sorry. No, I think I can read it. Are you depressed at the share price? Oh, right. Hang on. I'm I'm not there yet. Oh. I calculate net monthly burn is about GBP 750-GBP 800. Oh, I think I've answered that. You've answered that. Yes, I've answered that.(crosstalk) Yes. It does include some revenues, but we've been very reasonable on those so that we don't get caught short. Are you depressed at the share price? Isn't everyone? You know, unfortunately, we're all faced with the same market conditions that stocks that clearly have accrued value in a very tangible sense are not having that reflected in their share price. Here we are underneath an IPO price, and yet we've got two validated tests. But at the end of the day, when the markets turn like this, the only thing you can do in the company is put your head down and keep executing and making sure that our progress is continued and very tangible, and wait for that to be, you know, reflected in market conditions. Sarah, David, thank you very much for that. I think you've addressed all those questions from investors. Of course, the company will review all questions submitted today and will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to you both, Sarah, could I just ask you for a few closing comments? My closing comments are. I'm sorry that I was so stuttery earlier on. Sometimes it happens, doesn't it? We just- I'd like to say in my closing comments. Just come off the flight. I have a huge amount of excitement about the progress that we've made. I mean, if you look at this, you know, we took some information and some technology, and we've been able to translate two products all the way through to the clinic. I think that this is a great achievement. I'm very proud of what we've been able to do, and I'm really looking forward to what we'll be able to do with this commercial launch. It's a very exciting time, and it's great to see the transition going from just the R&D into the clinical reality. Sara, David, thanks once again for updating investors today. Could I please ask investors not to close this session, as you'll now be automatically redirected 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 will be greatly valued by the company. On behalf of the management team of Verici Dx pLC, we'd like to thank you for attending today's presentation, and good afternoon to you all. Thank you very much. Thank you.