Verici DX (LSE:VRCI) — Investor Update: Outlining positive data from the Tuteva™ clinical validation study

0:01 Good afternoon, ladies and gentlemen, and welcome to the VERICI DX PLC Investor Presentation Outline the Positive Data from the TUTIVA Clinical Validation Study. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Just please simply type in your question at any time and press send. The company may not be in a position to answer every question it receives during today's meeting. However, the company will review all questions submitted today and publish responses where it's appropriate to do so.

0:32 Before we begin, we would like to submit the following poll and as ever, would appreciate your participation. And I'd now like to hand over to CEO, Sarah Barrington. Good afternoon. Good afternoon, everybody. And I want to thank you all for joining us on a hot Friday afternoon. Obviously, we did the results and indicative coverage of positive results from Tutiva a few weeks ago and promised to come back once we have presented at the scientific conference, ATC, with a little bit more detail on those results, and that's the purpose of today. So shorter than normal, but obviously, you know, it's still subject to a disclaimer. And this sort of summarizes the press release that we had to put out before, which indicated that the results were good. But let's get into a little bit more detail.

1:26 A lot of this is from the presentation at the conference, so maybe just a little bit more in-depth than we need. But I thought it would be interesting for everybody to look through and see what was presented. The first, part of, the the interest in our study is, one of study design. And, one of the things that we showed, was what we called an all comers trial design. So first of all, this was international covering both all The US, The EU, and Australia. So a fair representation across across transplant centers, different protocols, etcetera. And had very little exclusion criteria.

2:15 The point of all of this is to make sure that we ran a trial, it's what I call up to FDA standards. It is truly something that the clinician can expect to see in their clinic, the clinical reality I call that. So that when they, you know, are are asked to use it in the clinic, they do not have any further questions. Not all products have done this trial design. In fact, we're probably the first to do it in an all comers design up to that level. And there was a lot of interest in that because the the industry had been heavily critical of biomarkers that had not followed this trial's design. And this gives us a distinct advantage and, you know, moves us ahead in terms of development.

3:04 The other part that was exciting was that it covered all types of rejection. It was not segregated in any way. That's both t cell and antibody rejection, but also, excuse me, different types of rejection that have confounded other studies so that we were able to pick up, borderline subclinical, no rejection, mixed rejection, and and clinical rejection. And, again, you know, multiple inputs, multiple outputs made an incredibly strong study. And that that that was very well received. Another table here which sort of goes to the idea that we reflected clinical reality.

3:50 This is the underlying demographics and split. The good news for us was that it did indeed reflect what we see in the general industry, probably just a little bit light on the Asian population. But as we will be adding, further patients as we go forward, in the trial, it's still open if you recall for the third product, Protaga, then, you know, obviously, we will be able to address that. But again, very solid underneath clinical reality. And this is the curve. So if anybody, loves science, you'll, enjoy this curve. Two things, to note. One, in the discovery set, we had to, you know, have a intermediate group. And that's always tricky. What do you do with intermediate risk? Is it high risk or is it low risk?

4:40 And in the results, were able to cut off and cut out an intermediate group, making it either a binary issue, either high or low. And then obviously that has clinical advantages because then clinician is directed towards what they might see. The NPV curve, that is the negative predictive value. And let me just take a little step back actually and remind everybody of the importance of both of those measures. NPV is about if you have no rejection, what's happening there. And PPV is about if you have a rejection, do we pick it up? NPV here, you know, other tests have have focused in on the NPV story. That would be a rule out. Again, in transplant care where up to fifty percent of organs have an event having a negative result is is low probability and not that helpful, being able to be picked up in other standards of care.

5:39 What has been missing from, the environment is a PPV story. Other tests, other genomic tests have been under twenty percent or slightly above. And other cell free DNA, so that's later in stage. Again, very anemic PPV figures and especially in likes that they had selected high risk populations. Very surprising that they couldn't get that. It comes from her being highly nonspecific. Some things happen, but we don't know what. With the RNA signatures, with this technology, we are able to be way more specific. This was very, highly regarded, this result, and puts us at, an order of magnitude, ahead of the game. Why is that important?

6:28 First of all, we're in the set of early, biomarkers that is a prognostic. What's the risk of getting damaged? Am I having damage right now? As opposed to damage has occurred and being kind of late to that therapeutic partner party. And then the second thing is that the PPV is in an order of magnitude that hadn't been seen before and was very well received. This was really just the narrative around that. It also indicating that we were able to distinguish between not only rejection, but but a a couple of other diseases that graphs do see. And again, that was well received. The AUC is is for the clinical community to know that it wasn't artificially distorted by a particular cutoff point.

7:21 And this again of almost point seven was a very solid result. Everyone was very happy with that. It's much higher than anybody seen, in the industry, for this kind of, classifier. And then finally, we, we presented this table. As everybody knows, that although this validation tie trial was designed to be a point in time, the one test, we've always said that in fact this, this, technology being highly dynamic, RNA is about what's actively going on in the body, the body's messages, that we would be pursuing monitoring claims next. And we were very fortunate that we had 12 patients that had had two biopsies. So that's our comparator and deemed to be the gold standard here that we needed to compare ourselves to. But we'd had 12 that had had different results, and we mapped our blood test against them.

8:19 We didn't double count them, by the way, in our trial. It's only the first result that got put into trial. But this was a a very interesting subsection of information. Why? Because the majority of it, the test also changed. So it showed two things. One, it's a little bit of the proof of pudding. Again, another evidence points that the test really works. And secondly, that movement, that longitudinal, view was an early start on, the data that we want to collect. Admittedly, is a small it's like a discovery set, but it was, highly intriguing to people that have wanted to know whether this would be used and useful in a monitoring set. And obviously, this shows that it will be. So as you can say, this is a reminder of the timelines that we've talked about, before. And where are we in that timeline?

9:08 Well, we did present, as promised. And, what was nice in in that was we were selected, in the in the conference roundup in the what's hot, what's new session. And we were referencing, very few translational scientific offers offerings such as ours get picked. So that was quite the honor. We have obviously now been at the point with Tutiva to be able to commercially launch. So this was our first presentation to the clinical community. We were obviously making more throughout during the year. And as you saw from the recent recent press releases that I've hired the commercial team, You know, we have to have a medical science liaison and a business development person.

9:54 They are already being invited to centers to, to present. So that's very exciting. That's the start of our commercial track. Just a reminder, this year is what we call commercial proof of concept. Less about big revenue numbers and more about whether we can get it into sites. It's almost like beta testing. You try it out with clinicians, you work out how to order it, how to get it into the hospital systems of Epic, and then make it easy for the clinician not only to order it, but to read the results. It takes a little bit of time, a little bit of trial and error. And most importantly, it gets it in the hands of what we call key opinion leaders. These early adopters will use it in their clinic, and then they will talk to other physicians about their findings. Again, you know, a properly run validation trial is very compelling, and we will be publishing that this year. But there's nothing like physicians listening to other physicians.

10:48 That's really what the proof of pudding is. Just in terms of the reimbursement timeline, the as you remember, we've already got code for both tests that we've already submitted into the pricing committee that meets on the twenty third, so in a few days. For its first meetings, they have a series of meetings and we'll get a decision by the end of the year. And then, obviously, for Tutiva, there's already a coverage termination in place with Palmetto. And so we are you know, once we've got the pricing meeting over and done with, then we can address that, what we call a technical assessment file, which is basically a glorified checklist to say that we do qualify under that local coverage determination, and that's due for in the latter part of this year. So on track with Tutiva.

11:37 Clarava, we're still collecting what piece of information that's important for Clarava, which is the mismatching information. It's called HLA. So in a few centers, we're about halfway through collecting that from all the centers. It's very important for Clarava, not so much for Tutiva. And so that's what's slowing that down a little bit, but we expect something in the next few weeks. In terms of timelines, it's not really holding us back. We've submitted in for the pricing. And then obviously, in preparation for coverage determinations, we've always said this is the point where the two tests start diverging. We do need to do utility studies. Those are ones that are in the clinic to show that it is clinically useful, I. It changes clinicians behavior, therapeutic modulation that improves outcomes, etcetera. We do need to do that. We've got three centers that are self identified as interested in doing that with us.

12:29 And so we continue to move for that process forward whilst we're waiting for the validation data. And I think that that's so that's all the financials which I presented before. So that is the extent of the briefing from the scientific communities. Okay. I'm going to turn to questions now. I see one which says, what barriers do you see to clinical adoption and in turn commercialization? How can commercialization be accelerated? I think the barriers are always clinicians sort of trust into the study results.

13:20 And we removed that barrier in most parts by doing a trial that's up to FDA

13:33 standards. Something that clinicians were very excited about. Idea is getting that across, getting that message across. You never have the in in such a study design, you don't necessarily have the, you know, top line flashing numbers that you would get if you picked a a subgroup that was that would yield that. And so it's a question of getting that disseminated through the the clinical community, and that's our job this year, which is it to be out there making presentations, being invited into centers, and generally going to conferences. I'm at one now to be able to sort of spread that that message. So in terms of the barrier, which is just, you know, share communication, you know, obviously, we're addressing that as fast as we can.

14:21 How can commercialization be accelerated?

14:24 You know, I'm I'm very conscious that that it it it will be really about the centers promoting to other centers. And that's something that we'll be very focused on, which is getting that credibility not only from our study design and the trust, which I think has already come and just needs to be communicated, but also in getting that sort of clinician to clinician community. News flow, to be honest with you, I think that, you know, obviously, we'll let you know if we're presenting at conferences. We're heads down at the moment realistically with the commercial team getting into centers. Looking at the pricing decision won't be until the end of the year. Same with the coverage determination.

15:12 And so realistically, I think the very short term would be on Clarava. What milestones can you achieve with current funding and when do you yeah. As everybody knows, we did a small round at the beginning of the year to extend our runway so that we could really get through not only commercial proof of concept, which is what we had funded to IPO, but also the first year of revenue. And so although we stated at the at the time that it would get us through to August '23, We do have a state given the state of the markets to get that through to 2023. I'm really seeing in the current doldrums a distinction between many funds between pre revenue and revenue companies.

16:04 And I think it's very important for us to be addressing a kind of revenue potential and, you know, with first revenues in 2023 before we could anticipate doing any other kind of fundraising in this current community. You mentioned earlier doctors that are keen to trial TUTIVA in a real world clinical setting. Can you talk a little more about what that could look like in terms of numbers and the process and timing of the test and getting results back to clinician? Yes. Certainly. At the moment, without going out to the marketplace, we've had three centers that have come and expressed interest on an inbound way. So I think that realistically, we need to work out how to get that into their processes and what that might look like. It will probably be one or two clinicians in their center using it, and then ordering it in a sort of reasonably light way.

17:09 But being able to ensure that they can test it both in terms of, you know, I I think a population that that is probably in a three month period would be realistic for for the end of the year. So I'm not sure whether I can really give you any specific on numbers, but I think that that's, you know, it's numbers of centers. And although we projected three, I am looking to stretch the team to be beyond that in terms of numbers of centers. The process is light for the centers. I think this is really important. We only ask them to collect blood, to put it into their system, send the blood tube to us, we do the rest. That's the definition of a clear lab. We basically just return the results. So from the center's perspective, implementation is not that tough. They're very familiar with blood draws.

18:03 The real implementation is making sure that everybody knows how to order it and it's in their own system. So we took to the people that are involved with Epic and we get it put, you know, established and put in there. And then we train the transplant team where to find it, make sure that there's no kind of small issues like that that would trip us up, and the results get back within within five business working days. That's very comparable to what we're seeing in the marketplace. So so I think that that's that's very acceptable. And as I said, because it's light touch for the clinicians, then I think that's that would be what they're looking for. I see a question on what percentage adoption of Tutiva would would I expect at peak adoption.

19:07 I think that that's that's kind of a hard question to answer, you know, in terms of knowing exactly how the how the industry plays out. I will say that we saw and we often point people to CareDx's numbers just because you can extract those from the financials. One of the things we saw is that after about five years of adoption, they had about 200,000,000 in revenue from kidney transplants. And they're only one of three major players in that marketplace. So how much of that can can we dislodge? I would say a lot of it. There's a lot of dissatisfaction with cell free DNA technologies. And there has been a desire to move towards these earlier biomarkers.

19:57 And, you know, being able to dislodge that with such credible results, I think, would be very promising. We do have a lot of enthusiasm. So I hope that gives you little bit of sizing expectation there. That's great, Sarah. I think you've taken every question from investors. So thank you to all of those investors that have submitted questions. And Sarah, if any further questions do come through, I'll make those available to you on I today's know investor feedback is going be important to you as ever, and I'll shortly redirect those on the call to give you their thoughts and expectations. But I guess before doing so, Sarah, if I may, just ask you for a few closing comments. Certainly. You know, I think I think I'd like to just say how pleased not only was the company, its clinical advisers, but also the clinical community was from these results.

20:51 You know, this is something that's highly dynamic information. It's early. It's exactly what they want and it was done in a way that clinicians have been starting to demand in terms of study design, something that they can trust. So incredibly positive information. And, you know, I I I think that this sort of sets us up very nicely for the rest of the year to set up our our trial sites and early adopters so that we can truly iron out all of those last nets so that, you know, all of our marketing dollars are very well spent and not wasted because no one knows how to order it. So we're looking forward to this next phase. I think that kinda concludes us on this product as being an r and d company. Obviously, we're going to do further studies. There'll be extra work and there was a high degree of interest in using this moving forward.

21:46 So I think that this really establishes as Tutiva as a cornerstone product for us. That's great, Sarah. Thank you very much indeed, and thank you for updating investors this afternoon. Kindly please ask investors not to close the sessions. We're now automatically redirect you for the opportunity to provide your feedback in order the management team can really 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 may I wish you all a very pleasant afternoon.