Genincode (LSE:GENI) — Interim Results Investor Presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the GENINCODE PLC Interim Results Investor Presentation. Throughout this presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time via the Q and A tab situated in the right hand corner of the screen. Simply type in your question and press send. The company may not be in a position to answer every question it receives today. However, the company will review all questions submitted and publish responses where it's appropriate to do so. These will be available via your investment company dashboard, and we'll notify you by email when these

0:32 are ready for your review. I'd also like to remind everyone that today's presentation is being recorded. But before we begin, I'd like to submit the following poll. And now I'd like to hand you over to Matthew Wall, CEO, and Paul Folger, CFO. Good afternoon to you both. Good afternoon, Alessandro. Thank you very much for the introduction. Good afternoon, and welcome, everybody. Very good. I think from here on in, Alessandra, I think we can take it. So many thanks, and good afternoon to you, Paul, too. Thank you. Good afternoon to you too. So what we're going to do is we're we're going to whiz through over the next half an hour or so the interim presentation. So these are the interim results for the company for the June period ending June 30 of this year, so the first half of this year.

1:25 We yeah. A little bit unusually. We we've just come through the IPO process some eight weeks ago. So a lot of the information is is very fresh. For those who are familiar with the the story, then there'll there'll certainly be an awful lot of overlap with perhaps some things you've heard previously. But nevertheless, what it does is it gives a very good summary of what what we've done over the last six months, where we currently are, and what we're going to do over the the forthcoming, let's say, medium term. So if I if I move us through step by step, what we'll start with is a a quick introduction to the board and the company. We'll take a look at the highlights of the first half. We'll also remind the group on the on the call about our product portfolio, cardiovascular disease prevention, diagnosis and treatment. So that's the main core focus of what we do as a company. We'll take a look at The US strategy, UK and EU strategy. We have a a single slide on COVID. We're not a COVID company

2:26 as such, albeit there is some interesting links to what we're doing with COVID. So we'll share some of that too, and then we'll finish on a summary and outlook. Okay. So the the board, I'm I'm Matthew Wall, CEO, and together here with with Paul, we won't spend a lot of time going through the rest of the board members other than to say, I think we have a strong, wise, and and and particularly well

2:53 experienced and respected board, I think. Paul, any thoughts from from your side just before we kick off? No. Just that, you know, as you'll see, over the coming slides, although this is an interims presentation, given that we only came to AIM two months ago and, that we had a trading update in that admission document. The financials, we're not we're not concentrating on financials in this, in this presentation here. I'm sure most of you will want to hear and see what we are doing as a company going forward. So, we've got more than happy to answer questions on finance at the end, but most of them were disclosed in the admission documents, so we want to tell you what's happening over the next few months. Absolutely.

3:39 Very good. Thanks, Paul. Okay. So let let's just go into a quick introduction on the company. So we're a a clinical genetic diagnostic company, a bit of a mouthful, but, essentially, it's made up of two or three important things. We're not only dealing with molecular diagnostics and the ability to be able to work at a level of extracting and working with DNA, but we then take that DNA through our bioinformatics, our algorithms. We risk score it for a particular patient in relation to the diagnostic area of interest, and then we provide that as a reported process back to a physician or health practitioner. And we do that all in the area of cardiovascular disease. We're revenue generating mainly here in in Europe. We're setting up our our stall of offering of offerings here in The UK.

4:26 We'll come back to that as well. And, also, we filed on our first regulatory positions in The US. Again, we'll we'll talk through these points in more detail as we go through the presentation. We're CE marked. As I mentioned, we filed with The US two for our breakthrough device designation in the first half. We've had a significant amount of investment in the company from Groupe Ferrer. So they started back in 2007 investing in understanding the diagnostics of cardiovascular disease. And three years ago, we acquired the assets IP and technology of the Ferrer Group as what was then called FerrenCODE and set up the company as GENINCODE. We've also got a very deep clinical evidence base, much of that done with Kaiser Permanente in The US, and we continue to work very closely with them in in progressing what we're doing at a product level.

5:20 We've also got IP protection on our products. And importantly, we're not a single product offering where we have a a broad group of products that are focused on and in and around cardiovascular disease. And the reason for cardiovascular disease is it is globally the leading cause of mortality. It accounts for a significant amount of burden both in health care as well as economic terms. And for our piece of it, the approach we take is we bring a genetic insight to the onset of cardiovascular disease. It's something that is not included in the current standard of care, and by including it gives a much more comprehensive diagnostic risk assessment position. You'll see as we go through, that's what we're now introducing into each of the markets that we grow the business.

6:09 So in terms of then the interim highlights, as Paul said, were dominated in the first half by preparations for the IPO. We're we're pleased and was that we had a successful process. It led to a 17,000,000 raise, and we're now pressing on with delivering the the admission plan and the IPO process that we've that we set out a few weeks ago. First half sales, albeit still relatively small, were up partly as a result of COVID moving away. So as COVID settled away from us, the business is able to step up and deliver more revenue. We expect to see that continue in the second half. Operating losses increased mainly as a result of us setting up business here in The U. K. And expanding into The U. S. And as a result of that, the cash position at the end of June was just shy of $1,000,000 But as a result of the IPO, the proceeds at the end of July, cash is significantly up in the company at present.

7:07 But as Paul said, importantly, the operational side is what we're focused on. We announced in the first half our collaboration with Evarsana Life Science. That's our integrated commercial provider for taking our products into The US market. We announced the Royal Brompton and Guy's and St. Thomas collaboration around Lipid Encode as the first product in with the NHS, and that's for treatment and diagnosis of familial hypercholesterolemia. We filed our first breakthrough submission with the FDA in the first half. And then more recently, we've we've had the green light to now set up to put forward our de novo filing for cardio encoder with the FDA as well, and that's expected a little bit later this year. And we also announced just after we listed the publication from the Karolinska Institute where it shows strongly that the ThromboInCode product for inherited thrombophilia is at the leading edge, leading product in the area of identifying individuals with thrombophilia and thrombosis issues.

8:12 So that's a quick summary of the interims. And again, if you've had a chance to read through the interim report, this is spelt out in a little bit more detail. Just to refresh everyone's memories, especially those of you who are familiar with the company, we therefore have four products in the portfolio: CardioEncode, Lipid, Thrombo, and SUD. CardioEncode is for coronary genetic risk and recognizing the onset of cardiovascular disease. LipidEncode for measurement and treatment of hypercholesterolemia, so that's an inability to metabolize cholesterol, thrombo encode for inherited thrombophilia, and then sodium code for sudden death, cardiac death markers and cardiomyopathies, so largely around congenital and issues that are recognized at a genetic level. And all of those have got regulatory approval in Europe.

9:02 We're now bringing lipid encode as the first product into The UK, and we're setting up to regulatory submit to the FDA for our leading product, cardio encode, in The US.

9:16 Okay. Moving on. So again, by way of an introduction, this is how we operate. So we collect samples from patients. At the highest level, it's pretty straightforward. We collect a sample not dissimilar from the process we've gone through recently with all the COVID work. We collect a sample. It goes to the lab. We process it through the lab and send the results back online. So we have our own infrastructure and portal for delivering the processed results back to the physician. At a little bit more detail, what we do is a health care practitioner will refer the patient for a test. We'll extract the DNA from the sample. It goes through genotyping sequencing. Our bioinformatics and AI will then risk score that sample in terms of whether the patient is at high or low genetic load and burden. And then that goes on to then producing the report, which goes then to the health care practitioner for downstream treatment pathway, all done through our in house system called SITAB.

10:10 And we produce the products in two forms: a service based form and a kit based. So service, we receive samples in, process them, and let the reports then go back to the physician directly from the company, or we send kits out to third party laboratories, process who process the kits, feed the details into our sit up system, and then get their results back online. So two forms in which we provide our products. So if we take a look at the The US market, so this is, as I mentioned, the the core part to The US. We announced our collaboration with Eversana Health. Eversana, an integrated commercial service provider. We had a choice. Did we set up our own company in The US with our own headcount, build out our own expertise?

10:59 And given the last eighteen months with COVID, there wasn't a lot of sense in us trying to set that up at arm's length from The UK. So by collaborating with Eversana, we have a partner who's very much focused on commercial introduction of health care and diagnostic products. And as you can see from from the slide, they cover off coding, reimbursement, sales in market code, branding, marketing, and so on. They're quite a broad subset of services that they deliver. We're working very closely with them on a number of different fronts, and I'll share some of that with you in a moment. In addition to that, we filed our breakthrough device designation in the in the first half as well. And more recently, the FDA have given given us a green light to submit a de novo filing, so that's likely to be in November of this year.

11:53 And we're still targeting the intention is to target June of next year, halfway through next year, for when we expect to receive approval. A lot happening in this space at the moment. We're working with or we're intending to work with the CMS around how we then gain reimbursement. There may be for those who are familiar with it, you may be aware of the M process. The CMS decided earlier this week that M SIT would not be going ahead. They've repealed that process, which means that we meet we will be working more closely with the CMS in driving through reimbursement as we go. And the reimbursement discussions take place with the CMS and also with commercial payers. In addition to that, we're also working with some flagship institutions. That's Indiana Health, the Indiana University Group based in Indiana, and also NYP, New York Presbyterian, and the Will Cornell Group there for introduction of our products for The US health care system. They will be the flagship groups who take our products in the first instance. And in addition, we're also now starting to talk a little bit more engaged with some of the pharma discussions we started earlier in the year. We expect to report more information on that over the coming months too.

13:07 So that's a quick update and intro as to what's happening in The US. This, again, it's a little bit detailed, but suffice it, this is an extract of our plan for delivery of the launch program for CardioCode for The US market. It's broken into a number of different areas. We're currently working on physician, payer, and patient analysis that will lead to our tactical road map and our planning for how we go about launching then midway through next year. We're also dealing a lot at the moment with coding in preparation for the coding process with the AMA, American Medical Association. So quite a lot happening on that on that side too. And the other piece that's an ongoing piece it's been ongoing for most of this year is the regulatory process with the FDA through breakthrough and now the the de novo submission. So they're the main pieces we're working with Evisana at the moment, and they support us in taking those in taking those products and processes forward.

14:08 I'm conscious that it's probably difficult to read this on this presentation, but it certainly is on mine. It's a it's relatively small, so apologies if you can't see some of the descriptions on that. This is another similar slide to what we presented at the IPO. It's both covering off the regulatory pathway for the next twelve months together with the reimbursement position that we're moving forward with. So on the on the regulatory side, we filed our breakthrough submission. We've had some long ongoing constructive discussions with the FDA, long because things tend to be somewhat delayed at the moment in the processing times that they're moving through. But having said that, it's also been a really useful thing in terms of bringing them up to speed, advising them whilst they have a good understanding of what we do, they don't have an understanding at the level of significant improvement in the standard of care. So we spent a lot of time working through the clinical evidence we have, bringing them up to speed with our submission, and we're pleased with progress. On the breakthrough side, we're pretty well placed. We're coming towards the end of the process. We think we have a strong chance of gaining breakthrough. We haven't received it yet, but it's been good, strong, constructive discussions with them. As a result of those discussions, about a month ago, they advised us that they would now be prepared to receive the de novo submission. So again, the same group that we've

15:40 worked with through breakthrough will be taking the process through into the de novo submission as well. So we feel we're building a good rapport relationship with them, but there has been an awful lot of education in making sure that the team at the FDA understand in detail what we do. And it is a long process. It takes time. But it's still consistent with what we've said in terms of time scale for delivering our regulatory plans into next year. We're working on the coding, as I mentioned. That will be filed at the it's in quarterly points. So the next quarterly point is actually beginning of October. It's unlikely we'll be filing in that. We'll probably go for the beginning of January coding application. It takes about three months to get the coding back. And once that coding goes in, the other piece that we'll be starting is the discussions with the payers, mainly with the CMS.

16:31 If I move to that, that's the lower half of this slide on the CMS side. That means discussions around the product, its capabilities, its indications for use, how we'll manufacture that, the pricing of it. So they're the first discussions we'll have with the CMS. We expect to have it as what we call an expedited coverage, so we'll look to accelerate it through the CMS process. And it normally takes, through the process of working with the CMS, It should take up to three months, something like that, to work through that process. So we expect to, on the basis we start in the next few months after we file the de novo, we expect to hear back from the CMS maybe midway towards the end of the first quarter, maybe the beginning of the second quarter of next year.

17:17 Having established a position with pricing for CMS, we then move on to the commercial payers. We've had some discussions with them, but they're likely to be much more engaged once we have CMS reimbursement in place. And so that's the likes of Kaiser, Aetna, UHG, Cigna. And, again, they they equally provide reimbursement on a commercial basis. They will will obviously have to talk with through with them the details of the indications for use, how the product operates, and so on. So there's a whole host of discussions we'll have with them there as well. And you can see on that lower level how that maps out. We've also made provision, as we did in the IPO, for further outcome work. At this point, we're not moving ahead with that quickly, partly because we're in discussions with a number of groups around what the shape of that might look like. And it may be that some of the outcome data we've already got is sufficient, but we've put aside a provision for outcome trials and publications if we need to do that too.

18:13 So that's the time scale from the point at which we submit regulatory submission around about November. We're looking at for approval midway through next year. And on the regulatory side, discussions with the CMS once we've filed our de novo submission in November. Okay. Again, for those who are familiar, this is an extract of the market assessment for Cardio ENCODE for The US market. So overall in The US market, are about eighty five million people who are suffering with some form of cardiovascular disease, so it's a significant burden to both the population and the economy. And of that, around about twenty one million have been classified at what we call low or intermediate risk. But that lower intermediate risk is based on the classic risk factors, the existing current standard of care.

19:06 So that's the first market we go to with our genetic approach. By running our genetic CARDiENCODE product across that market or those individuals who are at low and intermediate risk, we're able to add in a genetic factor to that. And that's important because we expect to see numbers from there then that are reclassified into a much higher risk category, simply because at the moment the current standard of care does not include a genetic risk assessment. The other point just to make on that is that the genetic risk is now recognized as representing about fifty percent of the onset probability for cardiovascular disease. So the biggest single factor is currently not included standard of care. So hence, it's been recognized for quite some time by the American College of Cardiologists and many cardiologists and physicians that the current standard of care is imperfect. It is inadequate and needs to now move on. So that's the first part of the market we'll be addressing that low and intermediate risk. Moving on from that, having got the product into market, we're then looking at at guideline changes at the American College level. So that then requires a product to be in market so that they can look at guideline changes.

20:22 So we see that as being a next phase then beyond. But that's perhaps a few years ahead from where we are now, but at least it gives a flavor for the direction of where we're moving to. So, yeah, I won't go through. That's a summary of what I've just discussed, but our main focus at the moment is to complete the breakthrough process, get our de novo regulatory submission filed, and that's still uppermost for us. And the breakthrough with the the MSIT process that the CMS were going to introduce would have been a nice to have. It would have been, but

20:53 it's not a must have for us. Our main focus remains on the regulatory submission with the with the FDA. CPT coding will start in the next few months. We've already started preparing it, but it will be by it looks as though beginning of January, we'll file that with the American Medical Association. And we will we're obviously continuing to develop and and map out in detail the launch program with with Eversana. We'll complete the work with Indiana and New York Presbyterian, and we'll also be setting up our clear laboratories for the delivery of the test service in The US market.

21:28 And, also, we'll be updating the market on some of the pharma discussions we're we're having as well. So a lot to do in The US, but all moving in line with the plan that we set out at the IPO. Coming to The UK. So we announced at the beginning of the year or earlier this year the Royal Brompton guys in Saint Thomas collaboration. So this is an exciting collaboration for us. It's the first we're leading with the Lipidene code product in the area of familial hypercholesterolemia. So as I said, this is to do with an inability by virtue of your genetics to properly metabolize cholesterol. What it leads to is accelerated onset of atherosclerosis. The problem with that is that if it's not recognized that an individual can go about their lifestyle, living their lives without the knowledge that over a period of time cholesterol is circulating at higher levels within their blood giving rise to a build of a plaque in the arteries, and that is the beginning of then the onset of cardiovascular disease.

22:34 If we can identify people in the population effectively, and that's what our product Lipid and Co does, then you can start to effectively treat that population. And it can be effectively treated, again, with low dose statins or high dose more aggressive treatments, depending on where the individual is and identifying them within the population. So the NHS ten year plan sets out a program to identify at least twenty five percent of that population by 2024.

23:03 They're not quite in line with where they should be. They're somewhat behind this. And as a result of the discussions with the guys, Saint Thomas and Royal Brompton groups, we this gave rise to the the setup of the collaboration with the with the team there. So we're currently commissioning our labs. We expect in the next couple of months to be up and running at the Royal Brompton, and we'll be delivering a product that's more comprehensive risk assessment, so it's probably the gold standard for hypercholesterolemia testing globally. It's a lower cost test to the NHS, so it's cost effective, and it's got a very fast turnaround. So on a number of different scores, it's a superior and more advanced product. So that's the first product we're leading with with the Royal Brompton. We expect the early part of next year, we'll be bringing our second product, which will be cardio encode.

23:56 So just by by way of an introduction, if you're not familiar with that. In Europe, it it's, yeah, much much the same as what we described at the the IPO. We're leading with Cardio ENCODE into two regions for piloting, Andalusia and Catalonia. There are 17 regions in Spain, and so it's a little bit more fragmented than working directly with the NHS or with the FDA for The US market. But nevertheless, it's still a similar issue where individuals are suffering with onset or early onset of cardiovascular disease, and an ability to be able to recognize that so that we can go about preventing that is vitally important. So the same measures that we're applying in The US and The UK are very much apparent in Spain too.

24:48 We are also expanding the sales team in Italy and France. So back end of this year, we'll be growing a number of headcount there. But importantly, perhaps the more the bigger growth pieces, the collaborations that we're looking at at the moment. So in those markets that we're not actively operating, which tend to be Spain and Italy were more active France is coming online.

25:11 But in the other markets, we'll look to collaborate with other diagnostic providers, and we're in discussions with a number of those at the moment. So that'll be more to come over the coming months. Thromboincode oncology is a new product coming later next year, and we also are talking with the German lab, Uniclinicum, about a similar collaboration to what we've set up with the Royal Brompton Hospital here in The UK. So that's the program that we're running through for expanding and growing the European business. And again, just a summary of of those key points and deliverables over the next next few months. It's fair to say the other one that that I didn't mention, we've got a publication coming out with the NHS for hypercholesterolemia, which should be available over the coming months as well.

26:01 And that's, again, pretty exciting because it becomes clear as to how we'll operate with the NHS going forward. With the advent of some of the bigger drugs coming through now, Novartis, Inclisiran,

26:14 there is going to need to be a stratification of patients to receive some of these drugs, especially where they have a higher cost tag. So in terms of aligning the patients in the right way for the right therapies, there will need to be a well constructed process for the delivery of those therapies, and that's where we will help process those and differentiate those patients most effectively.

26:44 One slide on COVID. We're not a COVID company, but we recognized last year that as part of the high levels of mortality, a number of the patients were suffering with cardiovascular disease or what appeared to be related thrombosis. We did some proof of concept work and recognized that there was indeed a close correlation between the onset of inherited thrombophilia and those patients who have a high risk or more severe onset of COVID. So we have four studies ongoing now, two in Europe and two in The US. The first of those will be reporting back over the coming months, and it's continued to correlate with what we saw last year, that individuals who have a predisposition to thrombosis are also at higher risk of severity of onset of COVID, and that manifests itself from a reduced oxygen position for those individuals who are struggling to breathe and ventilate.

27:47 They're not only struggling to to get high oxygen saturation in the blood, but because that's been restricted. But at the same time, if they also have clotting risk, then it can become quite a severe and quite a complicated position. So we have the publication coming together. It's likely to be issued later this year. If it's

28:10 consistent with when the publication is made, we'll then likely accelerate our ThromboinkoDE COVID product for perhaps an emergency use application with the FDA as well as talking to the NHS about this as a a further product line. And it's interesting because it's this is looking at the individual now in relation to COVID,

28:32 in terms of identifying those individuals who are at higher risk before they're infected with COVID as opposed to, obviously treatment through solely through the vaccination process. So it's likely that going forward, we're looking at individuals who will be aware that they're at high risk because they know that they have some inherited thrombophilia aspects. So a lot happening in that area. We'll be publishing on that in the coming months, but it's certainly one to watch, it's been very interesting from a polygenic perspective of how we apply our technology in COVID. This is a summary of what we're doing there for over the next few months, next year, mapping out. They're the key milestones. I've talked through all of those so far, so I won't go back through them again. But suffice to say, we'll be advising the market as and when they come through, dominated by the FDA in The US side and also NHS on The UK side. And then as we get into next year, we start our reimbursement discussions with CMS.

29:33 And that's pretty much it just to wrap up. We're delivering now against the scale up plan and the IPO admission document that we put together just a few weeks back. We're very happy with progress. We're at a very exciting period with what's happening in The US. We expect to position ourselves strongly opposite both the FDA regulatory process, but also in preparation for reimbursement.

29:58 UK is starting to come on stream. So coupled with European revenues that have started to grow, UK will start to come on stream, and next year we start to see the advent of The US. And that's really what's driving us, continued revenue growth. So that's it pretty much as an interim summary. If we pause there maybe to take some questions. Paul, I don't know whether you've got the Yeah. We have If we can move straight into q and a. So,

30:30 for everybody's benefit, as, as Mark initially said at the beginning, there is an opportunity for you to submit questions here. We had a couple of pre submitted ones, and we've got some others here as well. So we'll basically carry on and see how far we can get through these. First one, Matthew, I'll just read these aloud. It was suggested that after approval to sell our services in The US,

30:53 that the pricing is more elastic than sales pricing in Mainland Europe. However, it was said that our offering to market would be in a full service and the pack only offering. Would company profits be greatly if either service offering became the dominant market option?

31:12 So I think, Matthew, from memory at the IPO, I think this was referring to probably our comment that, at the moment, Europe is probably the most competitive pricing scenario. And then The UK is the the next, least competitive, and then the The US is probably, the highest price points. And, we've discussed previously about having a a circa $500 price point. So I guess the question is referring to, do we intend to carry on with our full service offering or kit offering or a blend of both? And and the the answer is for the time being, it will be both until we get a better understanding as to the the appreciation application and demand for either the service or the kit. The good thing about the kit is it allows us to access a broader reach in some ways than some of the service side. I mean, the service side can work just as well, but there's a lot of couriering of samples happening to and from the laboratory.

32:18 And especially in The US as we set up, we're still not we we have to get the lay of the land before we start to make one call or another. It's a way it's premature at this stage to decide in favor of one or the other. So we'll go with both, test the water with both. Just to come back to the the maybe the inference that the service cost and the margin on services is either higher or lower than the kit cost,

32:45 Not necessarily. I mean, for what you lose in higher cost of goods on the service side, you perhaps gain through a higher price point for that service. And where you go on the kit side, the kit side will still be using our sit up system. Large parts of the end result will still rely on us providing the technology to get them through to the end result. So the kit could have a higher margin over a period of time, but it may well be from the point of view of them wanting to do the work locally. We'll have to sell it at a lower price point to them. So it's a little early to say exactly where we're gonna be on mix, margins, and the the weighting of one product over the other. And and I think for us at the moment as a company, it's really important we keep ourselves flexible and all options open until we know where the lay of the land is.

33:37 Exactly. So I think the key here is that we're offering as broader solution as possible for customers. And indeed, it depends also on turnaround time, demands from our customers. If customers demand a a really, really tight turnaround time, then they'll probably go for a kit and analyze the test themselves. If that isn't such a critical issue, then they'll probably be more than happy to go for a service, which may take a few more days because the sample has to come to our lab. Okay. Next question.

34:11 What hurdles can you see that could either prevent or delay FDA approval after submission, and how do we rectify any of these barriers if they arise? It's again, what what we try to do whenever we're putting a submission together, whether it be this or historic submissions, you're always trying to preempt or or try to see where your your weaknesses are and try and address them as appropriate as you can before you make the submission. Assuming you make the submission, then the FDA start to review that. They come in from lots of different angles. The good thing about the de novo filing that we're going to make is, though, we've been working with the core team at the FDA for the last six months. So they're familiar with the technology.

34:57 They're familiar with the product. So there there won't be as much educating that needs to be done. They've also invited us to submit, which is is helpful because they feel that we're now ready. I mean, inevitably, as always with these things, there's a degree of I would say the outcome and evidence base is probably the biggest hurdle, And and that that there's a big assumption behind that because building out the product, you've obviously had to go through standardization, product validation, all of the design setup, all of the calibration, all of the standards that we need to put in place to put the product into play, and then you have to use it in the clinic to show that it's a valid and a worthy product with evidence base.

35:42 Now, inevitably, the last bit of that is the evidence base. So it tends to be most submissions will be a little leaner on evidence base simply because it's the last piece. It's also highly time consuming at a point when you want to get the product regulatory approved. However, we have a pretty strong evidence base. I don't know that it's perfect, and I don't know that the FDA might pick holes in it, but so far, they accept that we have a strong argument. Hence, they wouldn't have asked us to submit our our de novo submission. But that again, I can't I can't preempt what they may decide they want to ask questions about, but I think we're pretty well placed. I don't perceive any major obstacle at this stage, partly because we've been through a lot of this over the last six months with them. So I think that's where we are. I think we're well placed. And in November, when we submit, We will be upbeat and expect that by midway through next year. We have regulatory approval for cardio and code Okay, and similarly James has asked the question What has led to a slight slippage in the de novo submission timeline from q three twenty one?

36:46 I think we just changed it from q three twenty one to h two twenty one. Yeah. I mean, I I when you say slight slippage, I mean, we we've gone from, you know, the IPO process is was quite heavily, you know, engaged. It it it that that kinda takes up a lot of time. I mean, it's been marginal, if anything, in terms of the de novo side. And we've obviously had long and ongoing discussions with the FDA. I mean, FDA aren't aren't always the fastest turnaround time. Things have been delayed at their end. They've had COVID issues and lots of other things to contend with. So, yeah, a lot on everybody's plate. I think being realistic about it, the the more appropriate thing for us is to have a good relationship, good rapport, and for them to to, you know, invite that they're now ready for us to receive a a submission, I think, is a better place than, you know, rushing rushing it and and maybe not getting them right where we want to be. I think I think we're pretty well placed, and I can't see we're too far away from the timelines we said.

37:50 Okay. Another question from James. The admission document implies that CTAP is licensed and not owned. Can you clarify the arrangement we have in place? Yeah. We we it's not it's not licensed. It is a proprietary owned by us. We we took a copy of the system from Ferra Pharmaceuticals when we acquired the company. It belongs to us as a proprietary system. Since then, that's three years ago, we've continued to build it, develop it, improve it. So, no, it it belongs to us. As I think most people are aware, we pay a royalty to Ferra for the sales that we make. So that usually is around about five to 6% on sales, and that will pay back over a period of ten, fifteen years up to 15.2 sorry, €10,200,000 to them as the final royalty.

38:48 We expect over the coming years to pay that back, but then that's it. We fully own and have full ownership rights and IP coverage of the sit up system for us. Just so you know, the same system is used by the Ferro Group internally. So they've maintained their own system, and they keep they they they continue to develop that totally independently of us. Ours is on separate server and is owned source code and all other aspects by us as a company. Thank you. Two similar questions. One from Matthew, one from James. Could you expand on the purpose of a joint broker and how The US company, Stifel, will add value to GENINCODE in the short to medium term? Do you see possible secondary listing or US investors participating in any future raise?

39:38 Yeah. I mean, all of the above there are are key points in the growth and development of the company. So when we set out a few years ago with the the discussions around how we grow out and develop what we're doing in The US, it was always in the knowledge that we would spend increasing amount of time and effort focused on The US market. And, therefore, it made sense for us to have someone in The US who was familiar with what we would be doing as a a financial broker position. Before, just prior to COVID, I'd had discussions with US teams, some of the banks in The US. And then, obviously, COVID broke, and we we we were then positioned back in The UK. So it made sense for us to find someone who could both take us through an AIM process because we're a UK based company with a view to a dual listing in The US as we grow the company in The US, and Stifel met both of those those positions. They've also got good molecular diagnostic understanding. And just, I think, the last bit of the question, we do have US investors who are invested in the company just so that whoever raised that question is aware.

40:52 So we already have US investment. And I think this is part of the journey that we're on, that as we grow and develop the company and as we expand especially into The US, that we expect to see that US group grow in investment size. Indeed. Next question from James. Can you confirm outside the regulatory news service how the company intends to promote the company and its compelling story? By comparison to other newly IPO ed companies, the market interest in GENINCODE is low, and this relates to poor liquidity and share performance to date. Yeah. I mean, there's a there's a lot wrapped up in that. The first thing is that it's eight weeks ago since we did the IPO. This is the first formal update.

41:38 We knew it was coming, and given it was so close to the IPO that we decided to make sure that this was the point at which we would we would focus our efforts on, one, updating on the first half. And secondly, setting out the stall of what we're gonna do over the next six, twelve months, and that's exactly exactly what we're doing. The profile of the company will start to engage more so as we deliver more of the plan that I've just walked through. We're not funnily enough, we're not and I will certainly, I'm not. I'm interested in delivering solid structured building blocks that we are that are tangible real, and we can certainly build the next level of growth on them.

42:24 And that therefore, it means that the plan we've set out, whether it be de novo filing, pharma collaborations, expansion of revenues and growth in Europe, setting up with the NHS, all of these things are to be done. As we do them step by step, the profile, the growth, the news flow, the RNS, the updates will all start to go with it. We're not ones for galloping into the market with a little bit of news and making a big deal about it. We are though about making sure footed improvement in the development of the company and then telling the story. I agree, and I think just to add to that, liquidity is poor, but we've got to remember that we've got something like, 40% of shareholders locked up for a year, which is good for stability of the share price and good for longevity.

43:16 And and secondly, we've got a large proportion of the incoming investors under EIS and VCT. They're long term holders. So, you know, at this stage, liquidity is relatively low, but that should increase naturally, as time progresses. I mean, the the other point just to add to that, what you've just said there, Paul, and, again, for anybody who's somewhat familiar with that because it it the the comment is it it's a fair comment, but it actually doesn't recognize as well that that lack of, let's call it, liquidity a number of different reasons for it. But at this stage of the company's growth, it's really important that we don't have and I'm not particularly happy I wouldn't be happy if we had a lot of volatility in the share price. And as a result of the EIS and the lock ins and everything else around us, it means that, to some extent, volatility is a little bit capped, which is a good thing. And it's moving in the direction of what the overall sensible trend is for the company as we deliver and as we grow.

44:20 So I like that. And having been in this position before with other companies in the same space, it's a good position to be in at this point. And as we grow over time, then clearly liquidity improves The company moves on to a more sure footed position But for right where we are now as a growing fledgling company on AIM. It's a good place to be Yep Charlie has asked regarding your COVID slide have you considered an autopsy sample from those few that died or had clotting issues from the AZ vaccine? Well, we we are obviously the when you become when you start to put two and two together on this and you're aware of what the clotting side of what we're doing you inevitably start thinking about AZ and other clotting things like that at the moment we're focused on making sure all of the studies go effectively and get that right.

45:16 So I think if Charlie raised it, it's a good point. First and foremost, though, we need to get the diagnostic right, and then thereafter, we can have lots of discussions with those groups about how it could be applied more appropriately. But no, we haven't talked to AZ or any of that elk yet, but in the coming months on the back of the publication and the strength of the evidence base we'll start to engage some of those discussions more fully. Okay. Philip asks, can you give us a feeling for the revenue flows and the growth we might hope to see over the next six to twelve months? Well, for the for the remainder of this financial year, if we keep it in financial years rather than kinda half one year and half the next, we'd expect to see continued growth of what we've seen.

46:06 So first half would be replicated continued growth into the second half. So again, consistent with what I think the early forecasts that we've put out. And as we move into next year, again, aligned with what we've just discussed around regulatory timing and launching the product in The US, we still expect to see a step up again, but for two reasons next year. One, because The UK is coming on stream, and also The US will, latter part of next year, also be coming on stream. So that's our estimate. The forecasts are still very much consistent with what we believe is achievable, but that's our runway over the next six and then twelve months beyond that for next financial year. Yep. And I guess we can add that the the research notes are out there. I mean, the market consensus is, is is numbers that we are both comfortable with.

46:56 Yep. And, from a guidance perspective, there is nothing to suggest to suggest that those aren't achievable, and nothing material has happened since the admission document was published. So, all on track as far as we're concerned. And in terms of cash flows, we we raised sufficient money to get us through, broadly, early twenty three, so about a twenty month timeline. Yep. Yep. Okay. Anymore? We have a couple more questions. Have we got time for a couple more? Yeah. No. Of course we have. Of course we have. Let's carry on. Yeah. James has asked, how do you see, an emergency use authorization for ThromboInCODE developing commercially or globally in the event of a successful outcome? Same can be said for pharma discussions. Is this for distribution or as a companion diagnostic tool?

47:46 Okay. Well, both both are good questions, and the first one, has got a lot to do with when we position it with the data that we have, how locally at a national level someone would like to consider a clotting assessment as another risk identifier for the onset of COVID. Is it, for example, that over a period of time people in the population need to be made aware that they're at higher risk than others because of predisposition to thrombophilia? At this point, it's too early to say what what each nation and how they'll approach it will will think, but that's that's what we'll be thinking around how does it unfold within a health system. So I think and then the second part of the the question, I think, which was related to just remind me the second part again.

48:37 Same can be said for pharma discussions. Is this for distribution or as a companion diagnostic tool? No. So so, again, it it's more to do it's not with the it depends what you mean by distribution. It tends to be around the this is a combination of a number of things here. Firstly, the by virtue of some of our our products, especially lipid encode, it has an ability to identify, those patients who would be very appropriate to receive certain drugs. So that's what it does. And it does it by not only showing that they're very appropriate to it, but also giving them a risk assessment too. So for those who are under more aggressive treatment, the bigger pharma groups would like to see, well, that's something that they could work with. However, there's a kind of flip side to this is because if you think about stratifying patients for receipt of a pharma drug, it doesn't necessarily fit with the pharma company's view of what they believe is the right way to consider their drug. They may believe that their drug is the panacea for all ills. We don't need a diagnostic to tell us that we're suitable for this patient. So some of them will enter that domain.

49:50 But where it's kind of pressed back is the regulator will step in and say, Well, hold on, or the healthcare system will step in and say, We can't afford this therapy at this level for this number of people in the population, so therefore we have to limit it. We have to prioritize it, and that's where the diagnostic comes in to stratify and risk assess. And that's where we see most of the interest coming from pharma because there's a growing recognition that they need to align themselves now with. We'll call it a companion diagnostic, but it's not the true mechanism for what a companion diagnostic is. But in our instance, that's what they're thinking They're trying to align in a way that they can see that they can access the right patient population with their drugs by using our diagnostic Okay, and one more question I And company's would you consider to be a reasonable valuation a based on achieving these corporate financial objectives over the next twelve months?

51:00 Key being to reduce future dilution. I mean, I think in essence, the the kind of question is revolving around, as we grow and develop as a company, then we expect that the valuation will reflect that. We're not into soothsaying and coming up with ideas around what we believe our valuation is. The market will determine that. That will be based on our forecast revenues and growth over the coming years. And also for those investors who are investing early, the fact that they're aware that as the company grows and significantly grows in the coming years, that, that it's a good long term investment play. And for us and for me and for the company, long term investment play is what we're most we want journeymen who are with us.

51:53 The company over the next few years is not generating significant revenues, but over the next three to five years beyond, it starts to ramp up quickly with the products in the market and and an awareness as to how they can help improve the standard of care. So, you know, we won't be guessing at what the valuation is. We'll be putting it together in a sensible, thought out, structured way. The brokers will put together their estimates of where they think it is as to whether it's buy, hold, sell. But, you know, I I don't think it's for us to second guess what the market says. If the market sells and and comes down and the price comes down, then, you know, we have to add that someone doesn't believe that something's happening in the right way. We have to pull our socks up and deliver. But at the moment, you know, we're we're eight weeks into post IPO. We're setting out the stall. We're on track with what we said.

52:41 And if I look forward over the next six months around what we're going to deliver, it's significant. Agreed. And, I guess, to add, James, you know, Matthew Matthew pulled up a slide earlier on saying our initial target market is 21,000,000 patients, and that's just the initial stage one target. At our $500 target price, that's a $10,000,000,000 revenue grab, for us to attack. The if you put it into perspective, the market forecasts at the moment suggests, the and the valuation that Stifel stroke CENTCODE are putting on the company suggests that we would grab 3% of that in the next five years.

53:28 And that's what they're basing a £1.75 target price on. So I'm not suggesting that's the price by any means. I'm suggesting that the market size is enormous, particularly in The US. And if we get this right, the, the value of the company should, commensurately, increase over the coming months and years. And, there is a useful in in especially in GENCODE's note, there is a useful peer comparison analysis as well. So that might be worth a read. There's half a dozen other companies that Chris has suggested are in our peer group, and they are all significantly higher valuation than ourselves at this stage. Matthew, Paul, I thought I thought now would be a good time to cut in because I think you've pretty much addressed all those questions, being very generous with your time, and every question that you answer, another one seems to come in. And of course, the company will will The conversation.

54:23 Yeah. And, of course, anycom the company will review any further questions submitted and published responses where where it is appropriate to do so. Just before just before closing things off, Matthew, I wondered if I could ask you for a few closing comments. Yeah. No. No. First of all, I'd like to thank everyone who's who's stuck with it for this maybe elongated session. We, Paul and I, and the rest of the team at the company, were were driven to deliver against the the plan we set out in the admission document, and we're now starting to do that. We'll be updating the market over the coming months as we progress, but it's an exciting time for the company. But if anybody has any further questions and they want to kind of follow-up with us separately, then maybe If you can go via Walbrook, that's the key, and then we'll try and answer them as best we can. But but, no, thank you everyone for your time, your support, and, hopefully, your investment, and we'll continue to keep everyone up to speed as we progress.

55:22 Matthew, Paul, thanks again for updating investors today. Could I please ask investors not to close this session as you'll now be automatically redirected for the opportunity to provide your feedback in order that the management team can better understand your views and expectations? And this will only take a few minutes to complete, However, it's greatly value valued by the company. On behalf of GENINCODE PLC management team, we'd like to thank you for attending today's presentation. That now concludes today's session, and good afternoon to you. Thank you. Thank you. Goodbye.