Genedrive (LSE:GDR) — Interim results presentation

0:01 Good morning, and welcome to the GENEDRIVE PLC Interim Results 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 and A tab situated in the right hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company can review all the questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to James Cheek, CEO. Good morning to you, sir.

0:31 Good morning, and good morning to everybody. Welcome for joining us. Just to go through the interim results and give a discussion about where we currently are. So here is the disclaimer. I'll just through that, but, obviously, be aware of that if you look through the results. Today, we have myself, we have Russ, and we have Gino. Obviously, I've only been here since September 2023, and I just wanted to say at the moment a big thanks to the whole of the the management team, the executive,

1:05 and the nonexec board members for all of the support that they've given me and the challenge as well as we've tried to really move this organization forward and and really concentrate on our focus, specifically on our commercial focus going forward. So, Russ, do you wanna introduce yourself?

1:25 Yeah. Sure. So I'm Russ Shaw, CFO. I've been with the business for two years now. I've got twenty five years experience across life life sciences, technology, also PLC experience spending ten years with a a driver group.

1:46 Gino? Hi, everyone. I'm Gino, CSO of GENEDRIVE. So I was appointed to the board in September 2024. Background, very much molecular biology, translational genomics, and I've been with the business in various incarnations since 2011, a long time. Thank you. So this agenda for today, and we're gonna start off. I wanted to really talk about what GENEDRIVE do and and try to explain things because they can get a little bit confusing. If you remember last time, I explained that we were moving away from doing infectious diseases, and we were going to be concentrating on pharmacogenetics, mainly because we saw that as a real niche market for us, a place where no one else is playing, in that point of care market and something we thought we could really exploit with our capabilities that we have.

2:42 But when we talk about genetics, I think sometimes, as I said, or genomics, there can be a bit of confusion, and I wanted to explain where we sit with everything that's happening. You have at the very, very far end these novel therapeutics such as gene therapies that you'll see advertised, and also new targeted treatments. And you also see things around where they're looking at sequencing cancers and and really trying to understand the genomic makeup of things. And that really sits at that sort of top end. And then you've got work going on where they're repurposing certain medicines based on the genetic makeup of the medicines as well as the results they can get. And then you've got the predictive side of things where you look at drug resistance and pathogen resistance based on the genetic makeups of things.

3:33 Where we sit within the fiber genetics is really around looking at genomic data to predict drug responses. So what does that mean in reality? Well, gene variants can actually dictate, you know, what a drug is going to do to you personally, whether it's going to be effective, where it's not gonna be effective, but also where it can potentially, cause some unintended harm. And if you look at our MTR and r one, we'll can specifically go through that there.

4:08 And then if you look at phylogenetics on the whole, things are really starting to gain pace. Specifically, if we look at The UK, you can see there's expanding genetic tests within the the National Genomic testing directory. There's a license of medicines with pharmacogenetic guidance around dosing now that's specific to to the genetics, for different, ethnicities. There's NICE guidelines and assessments coming out with regards to pharmacogenetic testing, and there's professional body guidelines as well and recommendations for practice and and, obviously, the fairly recent one that we've seen that's come out from NICE for our c c two c nineteen product. And, ultimately, pharmacokinetics is actually part of the core UK genomic strategy.

4:59 And it really started to as I said, from where we we came from and people were trying to understand what is it we were doing, it's really starting to pick up pace and and become so, so important, within medicines as we go forward. And if you look at, you know, the diagnostics genomics and diagnostics is really key, really key in health care shifts towards personalized medicine and improving patient outcomes. But also for a lot of really stressed health, economies around the world, it does help within with regards to reducing costs. You know, why are you going to be paying for a drug that isn't necessarily going to do anybody any good at all if they had specific genetic variances that stop that particular product from working?

5:44 Or if it's gonna cause harm and have some other kind of effect that's that's gonna gonna cost even more money trying to put that right. I'm now gonna pass over to Gino who's gonna pick up from here. Thanks, Gino. Thanks, James. So what what I wanted to do was just give a little bit of a summary in in revision of our our products, our system, and our tests. So what you see here is the GENEDRIVE platform. So all of our tests run off this platform. And on the right hand side, you see an example of, how we provide our kits in the format, that they're used by customers. So importantly, just some top top line statements about the instrument itself. It's low cost, and that's very advantageous for us in the markets that we're working in. It has it's a rapid thermocycler, so it allows for both PCR and isothermal technologies such as you may have heard, like LAMP, for example.

6:50 And it's touch screen operated. That's the top line. In terms of time to result, it can be as little as twenty six minutes for our RNR one test and around about seventy minutes for our CYP2C19 test. And I'll go into those in a little bit more detail later. Our positioning is very much outside of core laboratories. So core laboratories can do these tests, but they take many days to weeks to return the results. And and they're used by, professional, you know, lab technicians, for example. So it's really important that this instrumentation in this paradigm can be used by, a nonlaboratory personnel at the point of care in emergency care settings. And that's where we're really positioned. And you see an example of that down on the bottom left, where this is the RNR1 test being used in neonatal intensive care units over in the MRI in Manchester.

7:45 The chemistry that we deploy on it is mostly proprietary. Importantly, we have no requirement for preparing the sample to isolate nucleic acids like DNA or RNA, like you do in laboratory settings. And very importantly for our products is that they're all freeze dried, so lyophilized. What that means is that there's no requirement for coaching logistics or no fridges, no freezers that would cause a real barrier tent re in place of like the NHS. And again, very importantly as well as a system in the NHS use has to be able to integrate with health care record systems, which ours can do. So just going to RNR1 in the first instance. So RNR1 is a mitochondrial gene.

8:36 There is a mutation in that gene that predisposes individuals to antibiotic induced hearing loss on administration of aminoglycoside class of antibiotics like gentamicin. We're really excited about this product. It's the world's first point of care pharmacogenetic test in NICU settings globally, not just in The UK. And as you know, as we've communicated before, NICE have given it recommendation, for use in the NHS whilst further evidence is generated. So that's conditional at the moment. It can be used in the NHS, and we hope to shift that to a full recommendation once that evidence gap is closed. NICE have published the evidence that they require to to address those gaps. We've been aware of those since middle of last year.

9:26 But in that time, we've been waiting to some extent for, the National Institute of Health, the NIHR and the Office for Life Sciences, which is a government body to to come out with a funding call. We knew it was coming. And this was to fund consortia led programs to address each of the EVAs, the the early value assessment that had been reviewed by NICE. So there's 13 of these EVAs. We're one of them. And in some of them, there are multiple technologies. In our EVA, we're the only technology. So we we also communicated that we've applied for that. We have a a consortia led program to address those gaps. If it's successful, it will be the 10/01/2024 start date.

10:15 And it's planned to be an eighteen month program across 14 hospitals in The UK, throughout The UK, all the four regions, and importantly,

10:24 tier settings. So what that means is all of our evidence so far was generated in a relatively large hospital. And NICE are interested to understand how the device performs when it's in, smaller smaller smaller units, for example. Whilst it's eighteen months, we do have the option or the ability to submit to NICE earlier if we generate enough data in an earlier time frame. And, of course, we'll seek to do that. Ultimately, the aim being, to change the NICE guidance or transition the NICE guidance from conditional to full, and we can do that as early as we've got the evidence generated. NIHR and NICE are committed to, trying to get these technologies that they've put through their EVA process into practice in the NHS through The UK.

11:18 As I said, there are no predicate tests for this in The UK nor globally, and that obviously includes The USA. It's a unique paradigm. You know, you're you're doing genetic testing at point of care in emergency care settings, with nurses, for example, being the being the users. And it's a it's a a relatively rare genetic variant that you're you're trying to detect. So there's a lot of unique challenges with with that. And there's no predicate in the in the in The US. And what that means is that it's a it's a new submission. It's a new paradigm for submission. And because of the uniqueness, of, you know, some of the the activities that have to evidence safety and performance, we've had to obviously embark on a a liaison with the FDA to understand what they would find acceptable or satisfactory in clinical studies that we would do prospectively to address that. And it's important to do that. Otherwise, you don't want to get to the end of those studies and find that there's gaps that the FDA wouldn't necessarily accept. So we've done that. We've had two pre submission meetings with the FDA. We're clear on what they would find satisfactory for evidence and performance and safety.

12:39 And we're going to be pursuing the de novo submission route. We've communicated that previously pending funding. And with that, obviously, you know, logistics of operating in The US require that we have a US clinical partner to look after and access all of the neonatal intensive care units that we need to do studies in. And that's in final contractual stages. We have communicated that we've appointed distributor in The US, International Biomedical. And that's, of course, for land and product in The US and dealing with sort of in country training, and moving product around. So we anticipate, starting that process in late twenty twenty four.

13:25 And obviously, that's subject to funding. It is very cost effective route, but it's pending funding. So if I move on to CYP2C19, again, this is our second pharmacogenetic test for use in emergency care. Again, it's the only known point of care test globally that identifies six variants in this gene that are responsible for ineffective metabolism of the drug called clopidogrel. It's known that certain variants in the CYP2C19 gene result in what's called loss of function. And that loss of function translates to not being able to metabolize clopidogrel as well as non variants and therefore the drug doesn't work as well for those people.

14:15 The frequency of the variants differ in the population. An important aspect of our test is that it covers a lot of different ethnic groups that aren't necessarily represented in some in one of the competitor products, and in some, lab tests. And as you know, we just communicated yesterday on April 3 that NICE have given a recommendation, for CYP2C19 genotyping in ischemic stroke and transient ischemic attack, and that has to be done within twenty four hours prior to the administration of clopidogrel. So at the moment, this is a draft recommendation. It's in public consultation at the moment. But in that draft guidance, they've recommended the use of the GENEDRIVE test for point of care testing for CYP2C19 testing in the NHS. And the final guidance is expected to be issued in in July.

15:08 We don't anticipate any changes, and we hope that becomes a full recommendation in July. Importantly, the benefits of our test and the reason why it was chosen, we believe, is because we cover, multiple we cover variants that are represented in, different ethnicities, greater than than than other tests. Very important. It's all about equitable access to care in the NHS. We don't require any fridges and freezers, which again, as I've said before, is a big barrier, to point of care tests if they require fridges and freezers. We integrate with electronic health records. And also importantly, in all of the health economic model and that NICE did, we were dominant with respect to cost effectiveness, which is a very important factor as well.

15:59 As I said, the NICE guidance is for CYP2C19 genotyping and clopidogrel use in ischemic stroke and transient ischemic attack only at this moment in time. But when you think about clopidogrel, it's it's a very commonly used drug. It's ranked number 37 in drug use in The

16:17 US in 2021. Obviously, that include, indications other than ischemic stroke and transient transient ischemic attack. And that was over about four point two million patients and seventeen million prescription events. So a very, very, very well used drug. And there are alternatives to clopidogrel, for example, tisagrelor. And whilst tisagrelor doesn't require CYP2C19 genotyping, it's more expensive. It has increased risk of bleeding. And importantly, it doesn't have market authorization in The UK for prevention of TIA or further strokes, which is quite important. So at the moment, we're UKCA certified for CYP2C19 or CYP2C19 point of care test. And that obviously permits us to commercialize in The UK.

17:09 And to go to Europe with CEIVD, certification, we required another study, and that's funded under the, Innovate funded devote program, which we've communicated previously as well. And this is all about generating, clinical validation evidence in, you know, another intended setting in in acute medicine units in the local Manchester region. That's well underway. And once that's completed, we will continue, to to embark on our our commercialization efforts in the in The UK. But what that also does with us for us is it generates the data that's required for CE IVD submission. That's a lengthy process. We anticipate finishing the study in May this year with submission to the regulatory body shortly thereafter.

18:05 And that's about a five to seven month

18:08 review process. And then that will allow us to commercialize in non UK geographies and those countries that recognize the CEIVD mark early twenty twenty five. And I'll pass back to James. Thanks, Gina. Okay. I'm just really gonna be going back to some data that we had before around what does this actually mean for us as a company financially. So you would have seen potentially seen this before. There's a lot of work that's gone on in the background to try to understand where this market fits for us. But let's be blunt and honest with everybody here at the moment. Do I want it faster? Do I want more? Absolutely.

18:57 Yes. And, potentially, where where we've got to in The UK has really moved us forward, but not necessarily as quick and as fast as I'd like it to be. But that's work that we're continuing to do. But let's give everybody an understanding of what this means from a from a market, angle. So there's around about a thousand sorry, a 100,000, neonatal intensive care unit admissions per annum. So there's a potential there for us to to be part of that 100,000 testing in The UK. There's a total addressable market of around about a £100,000,000 when you look across the the whole piece. And this particular product is CE IVD certificated, so we can sell it outside The UK, into Europe and other parts of the world.

19:48 And if you look, we have a number of distributors already, working for us around the world in trying to to get this product out there. And that expansion will continue and won't stop, but we need to make sure that we're working with the right partners as we move forward. We do have a positive health economic case that we've been using in in a number of places, but it really was focused purely on the cost implications of the dual cochlear implants that a patient would get if they lost their hearing. What we've tried to do now is develop a case that now looks at that cost a little bit differently and looks across the whole lifespan of a patient. So if you think a patient would have a sixty to eighty year lifespan, what does that look like in total cost, to somebody that has pre speech hearing loss?

20:47 Because we believe that the cost could be potentially an awful lot higher, and we really want to develop that plan even more as we start to talk to different people around the world and in in different markets. We've already talked about the NICE recommendation. It being conditional with the the EVA process or the early value assessment process. And the work is gonna continue as you've seen with regards to generating data to get the full recommendation, and that that funding application's already been put forward. A little bit frustrated because I really was hoping that we could have talked about our, strategic partner in The US. We still need to, let's say, put some signatures on some documents, but we have the distributor already in place.

21:36 As soon as we have that strategic partner signed up, we'll share all the data with you, and then we can try to move forward as quickly as possible with our FDA submission. There are some some some, let's say, t's across an ice dot with regards to, the kind of data we've got, but we we're pretty sure that we have everything in place and we're ready to go. So as soon as we've got all of, as I said, all of our documentation in order and contract signed, we should be able to press go. It will also depend on some funding because there's a cost implication to that, and that will be part of our, funding raise discussions later on.

22:18 So CYP two c 19. This is really the most exciting, thing for us. And, you know, we were fairly sure that we were going to get the absolute agreement from the NICE recommendation. But you're always on a bit tender hooks until you see the data come through. We're really, really pleased with the way we assess their data. Can't see any reason at all that anything will change between the draft submission that's out there now and the final submission that'll come out in July. Cannot see any reason why anything would happen and change in that meantime. So, you know, really looking forward to drive this forward. What I would say to you, though, again, when we look at this from a UK marketplace, CYP2C19 testing is not done anywhere in the NHS at this moment in time.

23:15 So it's brand spanking new, and there are some things we'll talk about a bit later on. But just be aware that this, again, is gonna be a little challenge for us around the funding side of things, but totally different from m t r and r one because there are massive, UK national programs around stroke, which we can tap into, will make things an awful lot easier, and this is incredibly exciting. It will impact us a little bit because we won't have the c IVDI mark until the end of the year, beginning of next year. But on that, we've got a great collaboration that's happening with Manchester around the devote program where they're going to be doing an awful lot of that assessment work for the CEIVD market for us, which is something we would have had to pay for, which we're not now having to pay for, which is a great advantage, and then we can really start to push this product outside.

24:13 What I will say to you, though, we have had interest from a number of parties outside The UK to look at this on a research only basis, and we will be pushing for sales on a research only basis as well outside of The UK. So from a UK point of view, you know, we look at a 100,000 strokes per annum. Mind you, I looked at a recent bit of data that came out that said that's increased to a 110,000. So, again, you know, that's improved, probability for our number of tests that could be done in The UK. So things are things are looking exceptionally good for us here. And although the addressable market, you know, we've tried to be look at a number of assumptions, it's down at 220,000,000.

24:58 You know, potentially, that could be greater. So if you look at the market overall, there's about twelve million strokes per annum globally. In The UK, as I said, there's about a hundred thousand per annum, and that means thirty eight thousand stroke related deaths in The UK alone per annum. So, you know, there's a real interest in this particular product. The one thing that's really interesting is if you look at a a study that was done a little while ago by Oxford, they discussed about the incidence of, strokes increasing by around about sixty percent, per annum, sixty percent, between 2015 and 2035. Now a lot of that is, if you look at the paper linked to sort of obesity and aging population, but it looks like the numbers are only gonna increase. They're not gonna drop.

25:54 And that, you know, in an estimated thirty percent now we we say an estimated thirty percent. In the normal, let's say, Caucasian population in The UK, that's around about twenty to thirty percent, but that increases up to fifty percent in other ethnic diversities that we'll see. So if we estimate around thirty percent of patients will have some kind of antiplatelet problem or make it ineffective for them to use. So we we really can see a a great impact for this product going forward. Now if you look at why why would why would anybody want to come and use a point of care genetic or phylogenetic test when there's these large, testing labs around The UK?

26:41 Well, you know, these particular labs are done on rather expensive equipment, and it's also very difficult to do things with any kind of of speed, and and a lot of cases closest as a patient. So if you send a test to Genomic Hub in The UK at the moment, the minimum turnaround time that they've got is two days, but the average you look at is an awful lot higher. And then then if you look at the guidance that's just come out, the guidance suggests that the test has to be done in twenty four hours. So there's a real, real good reason why you would use our test in a point of care setting. And if you think there are only seven genomic hubs around The UK and you've gotta shift the test from your hospital to that genomics hub and get the result back all within twenty four hours when they can't even turn around anything less than two days at this moment in time.

27:34 Also, you'll see that if you look at the stroke centers around The UK, they run a hub and spoke model. We've already started to target all those hubs around The UK, and where are we going to start to attack this market. We've also started to look at, where are the where are the particular conferences that we should be attending. There's a there's a stroke conference that comes at the end of the year or around about the autumn time. And there's also a Favarmac genetic test conference that happens in June, which we'd like to go to, as well as starting to do webinars, as well as really starting to push this through the health innovation network. You know, as soon as that actual full publication comes out in July. As I said, this test isn't done anywhere in The UK at the moment. And, really, with that full backing behind us, we can really start to attack this marketplace in The UK. And as I've said, that's not gonna stop there.

28:32 We know that we can start to look at, selling this product as research only outside of The UK, and that's something we will also start to be pushing.

28:44 So now I'm gonna come to the the summary of the financials and hand over to Ross. Ross, I'll leave this to you. K? Thanks, James. So just a couple of slides summarizing the financials for the six month period to December 23. Revenue and other income was 238,000, an increase of over 200,000 when compared to h one of last year. And that's as we continue gaining commercial traction. And in December, we saw the first r and r one sales outside of The UK. R and d costs have reduced by 100,000 to 1,900,000, and that was heavily weighted towards the CYP2C19 near commercialization product development. We had 700,000 of admin costs, which is consistent with last year as expenses remain tightly managed.

29:32 Loss for the year is 2,400,000, and that's 300,000 less than h one twenty three. The r and d tax credit estimate is 350,000, and that's reflective of the reduction in tax relief rates from HMRC. So the end result was a 2,000,000 loss after tax.

29:56 Looking at how that impacts cash flow. The operating loss before changes in working capital is 2,200,000, and that's 300,000 less than the prior year as we see the cash benefit of the increased income received and the reduction in r and d spend. Working capital consumption was 200,000, mainly due to the movement in creditors. There was 1,200,000 received from the investor funding, giving us a net cash outflow of 1,400,000 and a closing cash position of 1,200,000. The cash position on the March 20 was also 1,200,000 following the 800,000 receipt from the r and d tax credit, And this is in line with our monthly burn rate of just over 400,000.

30:43 James is gonna talk to you about cash about news flow now, so I'll hand back over. Thank you. Thanks, Ross. So just to give a bit of a summary on where we are and what we're trying to do and what's happened with the organization moving forward.

31:06 So in the near term, we're still going to be pushing for revenue from additional sites, as they go live across The UK, and we had two two new sites actually coming on this week. So, just to as I said before, I'm sure everybody is as frustrated as I am. I'd rather it be quicker and more, but it is it is something that we're pushing harder. Specialist commissioning. Still know that we are or or let's say we've been indicated when we talked to Sue Hill at NHSE that we would be on specialist commissioning from April 2025. As I said last time, I would push and push as hard as I could to try to bring that into April 2024.

31:53 I would say the reality is, when you're trying to do anything with government at this particular moment in time, things are becoming a little bit stagnating, a little bit difficult, as their focus, let's say, is more on the election than anything else. That doesn't mean I won't stop pushing. It doesn't mean I won't stop trying to to get some kind of bridging solutions that we can between now and then. But the fact that we're starting to see sites come on board, even without any kind of central funding shows that if you have the right kind of discussion and the right kind of customer, you really can continue to to get this picked up and driven forward. So we'll continue to target specific customers.

32:38 And we have a number that we were already talking to that are really interested in working with us. It just happens to be that we have to work with them quite closely on business cases to really help them get that funding received from from internally for them. But it's it's something we'll continue to push really hard on. But like you, I'm as frustrated as everybody else that it's it's never goes quick enough for everybody. I understand that. The FDA registration requirement for m t r I one, as I said, we we're really close to that now. I'd really like if if we can get the funding in place for this to push us forward. I'd really start to kick wanna kick this off as soon as we possibly can.

33:26 And then, you know, potentially, depending on how quickly we can get the data, you know, we're probably still talking around about a twelve month period, to get that full dataset that they'd require to get it through. Hence, why I really like to start this as soon as we possibly can. But we've got a great partner lined up. And as I said, if we can, if we can get things signed off, and I can share that with you as soon as possible.

33:54 There's a completion of the devote clinical study, as we said, that's happening. That has a potential to involve around about 14 different hospitals. My apologies. That's that's for NICE NICE gathering recommendation. That could include around about 14 different hospitals, and really help us drive that message home for the MTR and I one, and really help us with the take up as well. The devote study for CYP two c 19 for the CEIVDR accreditation, you know, that's really started already. It's gonna continue, and that really helps us get all the data we need to give to our auditors to make sure that we get that accreditation as soon as possible, and we can start to sell that outside The UK.

34:42 As I said, we're starting on our sales and marketing activities, CYP two c 19. That's really gonna be focused on those stroke hubs as well as certain key opinion leaders. As I said to you before, this is a test that hasn't been done anywhere in The UK. So we we really were looking for the NICE, report to come out. Now it's out in its draft form. That's gonna help us push. And and we can start having conversations, as I said, with those health innovation networks that really are in place to push this

35:15 kind of innovation out there, and also looking at where can we, work with other partners around getting those messages out in webinars and in conferences and and really start to ramp that up now. But also at the same time, you know, with the the contacts that we have outside The UK, really start to look at what our sales strategy is about research on the opportunities, to get this product out there ahead of ahead of any kind of,

35:48 accreditation for the CIVD market. We know there's interest in it. We know that our competitor out there, which is GENEDRIVE, is selling this product, and we've talked to many of their particular customers who would be really interested in looking at what we've got, even ahead of the CEIVD market because we have a a much wider capture of the patients than their product. So, you know, really interested in working with us on that. So we we really hope that that happens soon.

36:21 There's continuation of the the instrument design. You know, we're continually working on it. You know, we are a kind of company that allows us to keep moving, keep moving forward. We get a lot of patient feedback sorry, a lot of customer usage feedback on the product. You know, how can we improve this? How can we improve that? And and really looking at, you know, how do we make it as simple as easy to use for our users out there? And then there's expansion of the test menu. You know, we're constantly looking at other things we can use for this particular product, and we have a a wide range of things. What I would say to you, though, is we've you know, in recent terms, because of the way that the organization is at the moment, and and really helpful from Gino and his guys, starting to focus less on the research side, more on the development side. We've got great products out there that we really need to make sure that we are, you know, as perfect as perfect can be as we

37:23 start to push out from the sales cycle. So really been getting everybody focused on there as we go forward, and and a really big thanks from me to Gino and the team for all the work and everything they've done there. So we talk about fund future funding activities. You know, we will be looking quite soon to go out to talk to you around funding activities for us, specifically for that support for the FDA study,

37:51 other regulatory reviews that we'll need to do to allow us to sell products outside of The UK into other marketplaces, the product development that we've got, and also the expected growth. Because if we've got expected growth, we need to expand our capabilities. You know? We have a lot of internal capability around producing the products that we have at the moment. And if this really takes off, then we're gonna need to expand, and we're gonna need to grow, and we're gonna need to be able to be in a place where we can really address that market growth through, you know, the the manufacturing and production side of things. So that will help us on that side.

38:31 Medium to long term, as we said, we'll have the IVDR registration that commences, and we're hoping to have that completed by the end of this year, let's say early twenty twenty five. The launch of the SIP, in those non UK, territories following the CE IVD certification. And as I've said to you, in the short term, we're gonna be looking at, can we sell this as research only, which we think we can. That means we don't need the CE IVD certification, but it will also help seed the market. It'll also help us really start to identify what kind of distribution partners are out there for us to really work with to get this out. Because, let's be honest, it may be different distribution partners for this product, which is related to stroke, to our other product, which is specifically related to neonatal patients.

39:28 We will absolutely commence the FDA registration. And as I said, that's a push go as soon as we possibly can, depending on funding and the signature of of, the certain contracts that we have in place. And then there's the commencement of business cases that we have for our future target pipeline tests. You know, we really can start to work on that once we have the security of the organization going forward and the sales coming from the two big products that we have at the moment. So in summary, I'd just like to say that we've got you know, our commercial activity is moving forward. We drive in the right direction. Everything seems to be, you know, working well for us with regards to the SIP two c 19 product.

40:15 Everything is in place to go forward. We just need potentially, you know, some funding to help us really try start to look at how we can expand outside The UK and push our market in different territories for our m t r and r one, as said The US, as well as, you know, really finalizing those things for the c two c 19. And not only in Europe, you know, we would look to other places around the world for CYP. You know, as you said, there are about twelve million strokes per annum. We really know we can make a difference to to patients all around the world. So in summary, that's that's where we're driving forward. So that's the end of the slides for us. So if I can hand back for questions, that'd be really appreciated. Perfect. James, Ross, Gina, thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions just by using the q and a tab, which is situated on the top right hand corner of your screen. We have already received a number of questions, both pre submitted and throughout today's presentation from investors.

41:15 And I want to start the Q and A session with this one here, which reads as follows. Why was there an r and s issued to announce the tax rebate, which we already knew was coming from the previous presentation? And why was there further acknowledgment of the limited cash flow position the business was in? This r and s provided no new news while further stimulating greater anxiety regarding ongoing concern and and hence the share price action. Maybe one for you, Russ. Yeah. So as you may be aware, there's no absolute certainty that the r and d tax credit would be received. Although, you know, for the record, the company has a great track record of receiving them promptly and without any adjustments from HMRC. So in light of the company's cash runway, we've considered it very important to update the market when we received the payment and at the same time provided an update around the financing plans, and we saw further elaborated on those in the interim results.

42:14 Perfect. Thank you very much. Maybe another one for you here, Russ. How many more shares does Riverfort have to offload? The deal has clearly been a serious drag on the share price with Riverfort apparently offloading shares at every opportunity. How much has RiverFort got back from the deal excluding warrants? Also, how many warrants do they have do they have and exercise or at what prices? Finally, who persuaded David Budd to agree to what is universally regarded as a terrible deal for both the company and shareholders? So it was announced on the April 3 that the application for listing of approximately 4,700,000 shares was to satisfy all of the amounts currently outstanding under the Riverfork facility. And then following the recent elevated trading volumes, we believe that Riverfork no longer hold any shares in the company.

43:04 Regarding the warrants, there's 8,600,000 warrants with exercise prices ranging from 10.4 p up to 41.6 p. And in certain circumstances, these exercise prices are subject to adjustment. At the time of entering the facility, that was in March 2023. We confirmed at the time that the directors assessed a number of financing options that did include an equity raise, but we believe that the Riverfork facility was the best option for the company at the time and has largely funded the company over the over the past year. Perfect. Thank you very much. Next question here. Many forecasts were made at the last IMC.

43:49 Why is only one being the Brighton rollout come about and that this greatly diminished trust in the company? Maybe one for you, James. Yeah. I'm sad to hear that in some ways because I I remember saying last time that there was one due to come in, and and Brighton literally came in around a week later. I've said that, you know, we would be pushing hard for for other sites and, obviously, that we would be looking for centralized funding. I did say that the the centralized funding or, let's say, the specialist commissioning, that it was originally stated that we would have it for April 2025, when I would be pushing hard to get it for April 2024. I agree that that's been a lot more difficult than I thought, but, again, I don't have much control over those timelines. It's around what the government and the government departments can get through with regards to policy changes.

44:48 And, unfortunately, as I said to you earlier, the with the the changes that are happening from a government point of view, the the focus is more on the the current election rather than trying to do any kind of policy changes. But that that doesn't mean there aren't things happening. It's just it's just frustrating. I don't believe that I said there'd be any other kind of sales coming in or or suggested that there were other sites other than Brighton that was gonna happen or, I did say, just one site. So it's disappointing if people think that I've let them down. As I've said here now, you know, we've got another number of other sites that we're pushing on for MTR on our one. You know, it really isn't an issue with regards to customers wanting the product. It is purely down to funding. And if I try to explain to people that there is a test, there is a an MTR and r one test. It's available on the NHS. It's done in the genomics hubs. It's called r 65.

45:48 It has a budget associated with it, but it sits separately not with a trust, sits with the genomic hubs. At the same time, there is a fund available to fund the cochlear implants. Doesn't sit with the trust. It sits essentially with with, with government. So we know that our particular test is going should be being funded. But when you trust and you look to that funding, you know, you can see the money sitting there in the genomics hubs side of things, you can see the money sitting there in public health specialist commissioning for cochlear implants. And there's no real easy way to access that funding. So we're really trying to convince the government, let's say, that they should take some of that funding from the genomics hubs, from the public health purse, and stick it into the trust or stick it into a budget that can be accessed.

46:46 But at the same time, time isn't you know, all things aren't lost because we're still driving forward even without that. So if you took Brighton, for example. Now Brighton came on board without any kind of specialist commissioning? You know, had somebody wanting to drive it forward, and we were able to work with them on the business case and get that over the line, which is what we're doing at the moment with a number of other hospitals really trying to drive that over the line with business cases. So it's frustrating, I understand, but it's it's not lost. And as I said to you before, if people feel that I misled them, I do apologize. I'm fairly sure I said that the agreement was April 2025 for specialist commissioning, and that we only had one site due to go live very soon. But apologies if people felt that was different.

47:36 Thank you very much, James. The next question here. Will the data being collected through the routine use of CYP2C19 testing in Manchester inform the NICE review? And why has this been delayed? Maybe one for you, Gina. Yes, sure. So yes, as we've talked about and as we communicated on the April 3, NICE have published their draft guidance for a public consultation. And then that will become, you know, fully published in July. And the GENEDRIVE test is recommended as a platform of choice for use in the NHS for point of care. The the the Manchester Devote program is independent of this. It doesn't influence the NICE process, at all. It gives us the data we need for CEIVD admission.

48:22 However, NICE do make a comment in their, their guidance to, you know, any users, they would welcome the, outcomes of any studies to be shared with NICE. And so there we absolutely intend to, share the DEVOTE study with NICE when, when it's when it's complete. It's got it's underway. It's going very well, and there would be no reason not to. So, yeah, we we absolutely intend to share that with NICE, but it doesn't influence the process, of moving to full recommendation in July, hopefully. Thank you very much. When will FDA submission begin for m tRNA AI chain gel test? Yeah. So m t r n r one.

49:08 So, yeah, I mean, you know, the FDA submission is is, for medical devices lengthy. There there there's no doubt about it. And we're a small company as well. I'm I'm, you know, with the same challenges as a company a 100 times our size also operate in medical devices. You know, as I said before, this is a world's first. There are no predicate for that test, and there's a number of unique challenges that are associated with evidencing performance in the population in The US that we have to, I would say, get the FDA on the same pages, our thoughts and our thinking. And so we know we know what's required, and we're going through their we've gone through their presubmission process. That that's complete, and we're clear what they would find acceptable, as I said earlier on.

49:53 We have a clinical group partner, which, you know, we'll announce in due course and a US distributor to handle the materials. It is lengthy. But to answer the question, we anticipate starting that in Q2 twenty twenty four. As James said, we really want to push it as quickly as we possibly can. It is pending funding because whilst it's cost effective, it is still costly. And we anticipate and this is this is just a bit of finger in the air at the moment. We anticipate the studies to take about a year to generate that evidence. But then, of course, you have the the subsequent FDA process, the submission process, the review process. And that is a timeline that is out of our control. As with other review processes, we anticipate that we could also take about a year. Again, you know, those are just, you know, straw man numbers at the moment.

50:45 But as James said, we're absolutely focused on trying to make this happen as quickly as we possibly can. Thank you very much, Gina. The board intends to provide a mechanism for retail shareholders to participate in any equity financing. Does this mean that after the previous dilutions in the River Fork financial structure that the only option to give us considerable finances in the interim is a further dilution to private investors? No. Not exactly. What what that means is in the event that we do proceed with an equity raise, we'd ensure that there's a mechanism in place for retail shareholders to participate on similar terms. So something like an open offer, for example, would sit alongside a placing. Perfect. Thank you very much, Ross.

51:33 Will the company need to go through the same letter regulatory approval process in The UK for any new tests developed in the GENEDRIVE system to customers such as the NHS? Maybe another one for you, Gina. Yeah. Sure. I think the the short answer is absolutely yes. You know, you have to remember, we we're developing complex molecular medical tests, and these are quite rightly subject to rigorous approval from regulatory bodies in The UK and Europe. And that that that's time consuming. The regulatory process in Europe is undergoing a period of transition. I wouldn't say it's become less complex. It's probably become more complex. But again, quite rightly so, these are medical tests that are being used for making, clinical decisions on patient treatment. So it's quite right that they go through these rigorous processes.

52:24 Nonetheless, they are lengthy. If you imagine a development process for a new product can take anything two, three years, and then you can add probably another ten months to a year on top of that for the regulatory review process if it's not self certified. So so, yeah, short answer is absolutely yes to that question. Perfect. Thank you very much, Gina. Does the company see AI as a threat or an opportunity in commercializing its new products? Suppose I'll take that one. It's I don't really see it as threat or an opportunity at the moment, and I'll I'll try to explain why. If you look at the AI that's out there within the medical world at the moment, I'd I'd like rather call it machine learning rather than AI.

53:14 You see a lot of really good work in where a diagnostic test sometimes needs some kind of interpretation, be it an image or or whatever. And you can train a system to look at that particular image or whatever they're looking at to identify, you know, a particular diagnosis should be positive or negative. That's you you see a lot of that for things like breast cancer imaging and and things like that. It's it's it's really helped, you know, with regards to to that sort of thing. So if you look at point of care, there isn't anything with regards to that sort of machine learning AI anywhere in any kind of point of care device at the moment. Will it come? Maybe. But our our test is a little bit different. It doesn't need interpretation.

54:05 You know? You either have the genetic variation or you don't have the genetic variation. There isn't really something for an expert to to look at and that's the problem with point of care because with point of care you're trying to make it simple easy for a non medically trained person to make a decision and that's why I don't necessarily see it as an impact for us. There are stuff like if you look at big data, could we use big data for helping us develop products and things in the future? Yes. Absolutely. That that could happen. But as I said, I I don't see it as a as either a threat or an opportunity right at this particular moment in time. Perfect. Thank you very much, James. Next question here reads as follows. How many gene tests does the company anticipate be available on the GENEDRIVE system in the short to medium term, maybe up to five years?

54:59 I'll I'll I'll take this one. So yeah. So, I mean, as as we've communicated before, we've focused on positioning out of infectious diseases in pharmacogenetic testing, and that's where our products and platform and our capabilities are are are world leading, to be honest. The two most obvious targets here are the ones we've discussed, RNR one for antibiotic induced hearing loss and CYP2C19 for stroke. And I think, you know, James touched on this earlier on. It's really important that we focus the majority of our efforts on, you know, commercializing those two products as world's first around the world. And that's not to say, you know and and also to stay ahead of competition. You know, that's that's not to say that, you know, we're not looking at other menu items. We are. Pharmacogenetics is an emerging field at the moment and even more so point of care. Pharmacogenetics is even newer.

55:55 And there are many potential targets that could be deployed on the GENEDRIVE system, but they all need careful consideration around, strong clinical case, who's budget pays for it, who's the payer, but these will be continually assessed for alignment to our platform as we go forward. As of right now, we're very focused on RNR1 and CYP2C19. Perfect. Thank you very much. And and that question that maybe follows on, what was the cause of the missed timelines? Yeah. I can take that as well as probably, you know, I'm responsible predominantly for for some of the missed timeline. So both of our tests are really novel. Right? I mean, they're they're they're like I said before, they're they're they're first in the world. The paradigm they're being used in is first. Complex genetic tests with complex development and regulatory paths, and some of that is outside of our some of it is outside of our control.

56:46 Some of it is in our control, the development, to some degree, and a lot is outside our control and you know, the downstream commercialization routes while we're developing, you know, these these new streams and market. So we're in control of some of it, but not in control of a lot of it. The NICE guidance that came out recently was a good good example of that. You know, we expected it like everyone else in in late last year, and there was a three month delay, you know, not of our making. In the end, it actually, you know, turned out, to be to be an excellent outcome for us. So in retrospect, I don't mind that three month delay, but it is frustrating. You know? And and and and that said, you know, while we we do do our best to be as accurate as we can in communicating timelines both internally and externally, but, you know, I'm you know, we do acknowledge that's an area that we'll try and improve on as we learn more about these paradigms being implemented around the world.

57:38 Perfect. Thanks very much, Gina. A question here for you, James, which I'm not sure if you will be able to answer, but I'll read it out anyway. Have there been any discussions about taking the company private? It's an interesting question. Let's just say, it's not something I'd want to comment on. It's, yes, not something I'd want to discuss. Perfect. Thank you very much. One for you here, Russ. When is the company targeting EBITDA breakeven? Will the Board consider M and A opportunities, which expand the product range, realize efficiencies and support a positive EBITDA position? So we've not provided any guidance on this, but clearly, obtaining profitability is a key objective of the board.

58:24 And we, yeah, we remain open to m and a opportunities that would be accretive to the company's overall positioning. Perfect. Thank you very much, Ross. Gino, one for you. Who are GENEDRIVE's main competitors in The UK and internationally? Yeah. Okay. So we provide point of care genetic testing. So these tests can be done in laboratories, as you've heard already, but there is no point of care platform competitor product for RNR one globally that we're aware of. So again, world's first. We're the first to market there. For CYP2C19, there is a Canadian company called Genomatics, and you'll be aware of them if you've reviewed the NICE draft guidance, and and we've been aware of them obviously for some time.

59:11 But our product has many differentiating features, and that's discussed in the NICE guidance. Greater review greater coverage of ethnic groups, which is really important for equitable access to health care, lower cost, no requirement for fridges and freezers, and ability to integrate with electronic health records. And it's for those reasons that the GENEDRIVE system was recommended currently in the draft format over over GENOMADIC. Other than GENOMADICs, we're not aware of any other competitor platform for point care c c nineteen testing. But I think it's important to end that question with, you know, the barriers of entry, as you've seen, for the processes that we've gone through, both in generating the clinical evidence, in going through the regulatory approval process, in going through the clinical guidance approval process, you know, that that barrier tent was really quite high for any newcomers, coming. Not not to say that they won't be, but we're well ahead of the game there with respect to competition as far as I know.

1:00:14 Perfect. Thank you very much, Gina. The next question here. Do you have any future plans to enter India and Asian markets with CYP2C19 stroke test kit? I'll take that. I don't think there's any markets that are off limits. Let's be perfectly honest. We have to make sure we have the right partners, and we have to make sure that we have the right regulation. But, ultimately, there is no no place, as far as I'm concerned, worldwide that's off limits for us. So, yes, if the the the regulation we can meet the regulation and we can find the right partners to partner with us as a distributor, then absolutely. Perfect. Thank you very much. The next question here. Do you have a target date for the FDA application and approval of our MTR and L1 test?

1:01:08 Yeah. So I think I I can just maybe comment on that. I think I just, covered that in in in some of the articulation I tried to give around the timelines. So we hope to kick it off, you know, last quarter of this year pending funding, and then probably about a year of data collection, and then probably a year of FDA review, subsequently. Again, all these timelines are subject to change, quicker or longer, to be frank. Thanks very much. Turning to the next question. Further to NICE draft recommendation to the NHS to use us CYP2C19 ID genotype test, is it likely that NICE will give their full recommendation on the July 10 after consideration of their current diagnostics consultation of our SIP diagnostics test without the need for further information?

1:01:59 I'll jump in. I think the answer to that is yes. Our expectation is that it will be, but it's at the moment, it's draft guidance. It's in public consultation, and the final recommendation will be in early July. So we do anticipate there being no changes, but it is a draft guidance at the moment. Perfect. Thank you very much. Next question here. What is the prize to look forward to for the product upgrade which James referred to? I think I'd I'd try and answer that because you've been onto quite a few, Gino, on these ones. I think the prize is more around, you know, take up of the product. The the simpler and easier you make it, the easier and simpler it is for people to use, the the more take up you're gonna get.

1:02:48 I think that's the size of the prize is the fact that, you know, it it's trying to look at how how we have a I suppose we have a product that we believe is right for the marketplace and it ticks all of the boxes for somebody using it. The feedback that we get helps us understand, have we got that right? Do we need to change certain things? And how do we make it easier? And it's all around take up, helping us get that take up of that product and use used more and more wherever we can. So it it really the the size of the prize is selling more products ultimately. Perfect. I think we've got time just for one final question here. Looking at all the RNSs since March 2023, you've drawn down 3.5 of the 5,000,000 River Fork facility. If this is correct, why are you not drawing down the remaining 1,500,000, thereby extending your cash runway?

1:03:46 Russ, can I put you on the spot for that one? Yeah. So we we've still got 1,500,000 available under the facilities to be drawn down. We we've currently settled the the outstanding balance, so so, you know, it's certainly an option for future funding. I I I think in reality, we would like to be able to, you know, offer all of our current investors opportunities, rather than continuing with the River Ford deal if we can make that happen. So, yeah, there is money on the table, but whether we actually take that up or not is not something we want to potentially do at this moment in time.

1:04:33 Perfect. Thank you very much, James. Ross, Gina, thank you very much for answering those questions you can for investors. And, course, the company can review all the questions that have been submitted today, and we'll publish those responses on the Investor Meet company platform. But just before redirecting investors to provide you their feedback, which you know is particularly important to the company, James, could I just ask you for a few closing comments? Yeah. Thank you. Look. I think we've got the company headed in the right direction. We have the right focus. As I said, the commercialization has commenced. We've got great things happening with regards to the CYP2C 19 product, You know, really trying to get a grip on both our costs as well as our sales going forward. I just think we're at a great place. You know? It's it's I know there's been an awful lot of false doors in the past, as you might say, but I can really see we're in the right place, moving in the right direction.

1:05:29 Everything's you know, everything is just great at the moment for us. We just need, you know, that kind of help support. As I said, companies, you know, really, really have great ideas. They just need the support to make these things happen. We have good great ideas. We're in the right place. The the the whole drive forward from a a commercial point is great. As I said, I just think we're in a brilliant place, and and I'm really grateful for the support we've had from the investors to date, and I hope you can continue to support us as you go forward. So thank you. Perfect. James, Ross, Gino, thank you very much for updating investors today. Could I please ask investors not to close the session as you now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations.

1:06:20 This will only take a few members to complete, so I'm sure you'll be greatly valued by the company. On behalf of the management team of GENEDRIVE PLC, we'd like to thank you for attending today's presentation, and good morning to you all. Thank you.