Genedrive (LSE:GDR) — Full Year Results Briefing

0:00 Good morning, and welcome to the GENEDRIVE PLC Full Year Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll. And I would now like to hand you over to

0:30 CEO, James Cheek. Good morning to you. Good morning, and good morning, everybody. This is my first one as the new CEO. So just to go through a brief introduction of myself. We're joined by Russell, chief financial officer. We're not joined by Gino, but Gino is the the new member of the exec team as a scientific officer and very much part of the the drive for us and being able to bring new technologies to the marketplace. So just a brief introduction about why have I come on board. You know, the the board were very clear that they wanted to really commercialize the products that we had, and that's where I've come into. So what I'm going to do is gonna give you a brief understanding of what I've been working on for the last two and a half months since I've joined.

1:31 I'm also going to start off by just giving you a bit of a a view of the direction of the company that I now wanted to take, we'll talk a little bit more about the commercialization of things a bit later.

1:49 So just to start off, you know, who are we? You know, a lot of people should know who we are, but we you know, we're really there for a low cost, you know, rapid molecular device that can do lots of things in an emergency setting. So really for rapid delivery of actual test. Now we're really gonna be concentrating on, you know, the genetic information and how genetics can be used to really support support the health care industry. We developed the first, obviously, pharmacogenetic test to avoid antibiotic hearing loss that you'll know about, the m t r n l one product. And then we've started to work on our second product, which is CYP2C19, which is really around making sure, clopidogrel, treatment is actually effective for isometric stroke patients.

2:44 If you don't understand what that means, just to give you a brief understanding, the clavigrel is known as a dormant a dormant medicine or dormant treatment, and it becomes active once it interacts in the liver. You need to be able to metabolize that particular product to make it effective for you. So, really, what we're looking at is, do you genetically able to metabolize that product or not that makes it effective or not effective for you?

3:22 So I just wanted to say that why pharmacogenetics? So really wanting to pivot the company towards pharmacogenetics and away from from infectious diseases. You might want to ask why are we trying to steer away from infectious diseases. Well, my understanding in the marketplace is it's fairly flooded. You've got a lot of players in there and a lot of people that are already in that marketplace. Unless you can really do something incredibly different, it's very difficult to break into that market and to sell. And it's really dominated by quite a lot of big players. So you've gotta come up with something more or less exceptional. However, we've already proved ourselves in that pharmacogenetics marketplace by bringing the first point of care product for hearing loss, so antibiotic induced hearing loss. So we know that that's our strength.

4:19 So really then trying to work on, well, if we've already done this in one place, can we do it in others? So really trying to look at and explain what fibogenetics really is. It's really looking at medications and how genes can affect those medications being effective or not effective with patients. And then it comes down to the fact that you have adverse drug reactions. So if you have the a specific gene variation, you can have an adverse drug reaction to that particular medicine. Now Now what we've if you look at the data that's available, you can see that about thirty percent of those adverse drug reactions can be impacted by pharmacokinetic testing.

5:07 So there's a fair size of market there if you think thirty percent of all adverse drug reactions we can be we can be effective on. So what does that mean from purely a numbers point of view?

5:22 So we know that about fifteen percent of patients, inpatients in hospitals hospitals in in the The UK actually have an adverse drug drug reaction while they're in hospital. And that leads to about eight thousand overnight extra stays per year for the NHS. We also know that about sixteen and a half percent of UK admissions are specifically related to adverse drug reactions. And then we know that thirty percent of all those adverse drug reactions can be affected by pharmacogenetics testing. So we know we have a marketplace for this. What does it look like from a numbers point of view? Well, we know that the data that we get from the NHS shows that about 2 point two billion is is the the impact impact cost for adverse drug reactions. Obviously, you have obesity and smoking as the biggest impact, and adverse drug reactions are impacted by about 2,200,000,000.

6:19 We know we could impact about 30% of that, and that then comes to about a total market impact that we can affect for the NHS of about £660,000,000. So it's attractive for the NHS to be looking at this and to work with us on this going forward.

6:40 So we're gonna talk about the m t r and o one product. But before I do, I suppose the big question a lot of people are gonna ask is, what are you doing with regards to commercialization? And why haven't you sold this product specifically heavily within The UK and the NHS and more broadly abroad? So I'm gonna just touch on that and what I've understood and what I've uncovered since I've been here. So if you look at abroad, first of all, you'll see that we signed up quite a number of distributors in Europe and at a wider abroad worldwide. What you won't know is the fact that we didn't have any of the product available in local languages until I came aboard, and we boarded out in the last month.

7:31 So in the last month, these particular countries now have a product they can actually sell because it's it's in their local language. The software's in their local language, and their the actual materials, training materials are all in local languages. So they can now start to sell these. So we are expecting to start to see orders come in in in December for these products. And the fact that you haven't seen anything to date is reason why is purely because they couldn't sell them because they couldn't actually sell them because they didn't have the product in their local language. Now they do, and we're expected to see that take off. So now we're gonna look at the NHS. And I think what I'm gonna do is come back and talk to you about an experience I had when I was at Roche.

8:20 So when I was at Roche, Roche brought out a brand new test for preeclampsia. So the previous patient pathway for a patient with preeclampsia or or suspected preeclampsia was a midwife would do a blood test if the if the would do a sort of a a blood pressure test. If the blood pressure was high and it looked like they had hypertension, that particular patient would then be brought into hospital, stay overnight, constantly bled to check their vitals to see if it was preeclampsia or not. What Roche did is they actually produced a test, so a single test, identify straight away whether the patient had preeclampsia or not.

9:08 So it meant that the fact that they didn't have to bring the patient into hospital, so it improved the patient pathway straight away. What Roche did is they went and spoke to the hospitals and said, look, we have this great test. Do you want it? And they said, look, this is brilliant because, actually, then we don't have to bring patients in overnight. It saves money on overnight stays. It's really brilliant. Yes. We absolutely want it. But, actually, we don't pay for the testing. The testing is paid for by the CCGs at the time. Go and talk to the CCGs. So we went and talked to the CCGs explained the test. And they said, this is brilliant. We want it because our maternity services are on their knees, and anything that's gonna free up the the midwives is something we want. So, yes, we want it. But we're not gonna pay for it because we already pay the trust a big lump of money to do that testing for us, and we expect them to be able to do it with the amount of money we're already paying them.

10:10 And so we went round the loop for four years. So for four years, they didn't sell the product into the NHS even though it was wanted, and it didn't sell until they got specialist commissioning for the product. What I've noticed is that GENEDRIVE have been more or less going down the same rabbit hole. Let's talk to the clinicians. Let's convince them that this is a great product, and they'll want it, and they'll buy it. No one has been talking to anybody that actually has control of budgets. So the first thing that I did when I came on board was start to talk to people about specialist commissioning first off. Let's Let's get that done before anything else.

10:56 So I've had conversations with people like Sue Hill, who's a chief scientific officer for NHSE, and other people like Alex McLaughlin, a deputy director for innovation at the Office of Life Science, and really started to work on those guys to convince them that we need specialist commissioning for these products sooner rather than later. So I think there is now an acceptance that specialty commission will happen for this product. The next bit for me is to push it to happen sooner rather than later, and that's the bit that I'm working on now. The next part is the fact that we have the what was the academic health science networks, which was set up deliberately to bring innovation into the NHS.

11:43 And they're called health innovation, different health innovation networks.

11:48 And they really have funding and are able to support bringing these products to the marketplace. Now we've done a lot of work with Manchester, and they've been incredibly helpful and have funded the product and how we bring it to market in Manchester. But there are several other of these around the country, including Scotland and including Wales. No one has been talking to these guys. So So the the first thing again that I did was start to open a dialogue with all of the different health innovation network partners around the country to start to get them to really look at our products, see what they could do, where could we work together, what funding could be available, what support they could give us. Like, that's where we are at the moment. We're in the first throes of that because that's, as I said, and we've been here two and a half months. We've really pushed on that, and we're really starting to see some commercial traction starting to happen.

12:42 Wanted to talk to us about how they can work with us to get this product available in their networks. So some brilliant brilliant forward movement there. So in a nutshell, I think, really, the concentration of the organization has been a little bit off. And now that focus has been brought much more forward, talking to the right people, trying to make sure we get to people which is talking about budgets and funding rather than the clinical experts, and then making sure that we actually give the right product to our distributors abroad so they can sell it for us. So a big move forward with that. So, again, we need to look at what are the numbers here with regards to the MTN r o one product.

13:32 We know we have a total addressable market of about a 100,000,000, and and I believe that we're now starting to move things forward in those areas.

13:42 And things are starting to happen. We've got a good positive case, and we believe that we are, you know, really set in a great place to really open up that market because there's nothing else. And I mean, absolutely nothing else out there that can really do what we do. One of my focuses on here is going to be The US. You'll know that there's been some discussions in the past about FDA. I've had a lot of time talking to different partners and different people about trying to find the right kind of combination of partners for us for for the the launch in The US. It can be very expensive to to bring a product to The US with FDA approval, and I really want to concentrate on making sure we have the right partners for us so that we can do this in a cost effective way but also a quick, quick way to market.

14:38 We've had some great discussions with the FDA, and they're incredibly supportive of what we want to do. So, really, all we are at the stage now is just making sure we finalize the the the contracts and the deals that we've got with those partners so we can then move that forward. And I hope to be able to bring you some more news on that as soon as I can, hopefully, towards the the end of this year, beginning of next year.

15:06 So then we come to the CYP2C19 product. I'm gonna touch first of all on the the marketplace so you can see the total addressable market. So, again, a much bigger market than we had for the m t r n o one product. This really is something I feel could really drive our business forward. We have approval for The UK. We've done a lot of work with Manchester, and we will have Manchester starting to test using this product towards the end of this year, beginning of next year. We're also then looking to see how can we roll that out across The UK and really again starting to talk to that health innovation network around how can they support us to bring this product to market.

15:58 Now things are a little bit different for this product because we've just spent the last, what, year and a bit talking to clinicians in neonatal area. And now we need to talk to clinicians in the stroke area, so we do need to bring this to different people. But, again, my focus is on the money. My focus is on who has the budgets and where can we secure money for this particular test in The UK. We're then gonna look at bringing this product into other countries, specifically into Europe, first of all, as they're gonna move across. There's some work to do with regards to making sure that we have the right regulatory approvals. But I'm also gonna think about, can we access Europe by making this product available as a research only product?

16:46 I think there are customers out there that would be interested in it as a research only product so we can sell it before we have the regulatory approval, and we can also start to seek the market about this product. This product does have a competitor in the marketplace, not necessarily point of care, but their actual product isn't anywhere near as good as ours and is often not seen as a proper point of care product because it has to have things like the reagents have to be all frozen, and there's certain elements that you have to do which really does limit its capability in a pool of care place. But we are absolutely set to to smash this market, I'm really looking forward to to really pushing this forward.

17:37 The one thing about this particular product, as I said, it's around about the the metabolism of clopidogrel. And someone did say to me and asked me a question and said, why would somebody spend a £120 to get tested for a product that maybe cost less than a £120? We have the effort, fact that the impact on stroke, so you've got stroke patients that could be given medicine that's not doing them any good at all. But actually, there's a recent study that you can all access and have a look at, you know, June 2023 in The US. Where they looked at what the the financial impact was of hospitalization for adverse drug effects for clopidogrel specifically. And they looked and estimated that the actual cost is somewhere somewhere between 8 and 20,000 per patient.

18:28 So there is a good reason for doing this test and a specific reason around trying to save money for the health systems, but it also brings great, you know, contributions to patient safety and patient health and patient pathways by being able to make sure that whatever medicines you give to the patient are actually effective.

18:55 I'm now gonna hand over to Ross to talk about the financial summary, but I'm hopefully, I've given you a bit of a steer on the directions of the company and what I've been doing in the last two and a half months. And I'll come back to a bit of a news flow a bit later on. So, Russ, are you happy to take over from here? Yep. Thanks, James. Good morning, everyone. I just have a couple of slides summarizing the financials for the year. Revenue was 55,000, which we saw the very early stages of commercial traction with the r and r one test now in routine use in the NHS. The r and d cost of 3.5 mil sorry, 3,900,000 are consistent with last year, and that was a heavy focus on the sick two c 19 product development. Admin costs have been reduced by 400,000 to 1,400,000 as we continue to manage the costs tightly.

19:48 And there was a finance cost in the year of 800,000,700,000 of which was a noncash fair value adjustment. The r and d tax credit is 800,000, and that's reflective of the reduction in the tax relief rates. So that results in a loss for the year of 5,200,000. Moving on to cash flow. The operating loss before changes in working capital is 4,900,000, and that's 500,000 less than the prior year as we see the benefit of the reduction in overheads. Working capital movements are also 500,000 variable favorable when compared to the prior year, and that's largely down to reduced expenditure on stock and materials.

20:34 A 1,000,000 r and d tax refund was received in March of this year, and we received gross proceeds from investors of 2,300,000 in the year. So a net cash outflow of 2,000,000 gave us a cash position of 2,600,000 at the year end. And to give an update on the post year end cash position on the November 23, we have 1,000,000 of cash, and we're expecting a 300,000 proceeds from the drawdown in the in the coming days. This is in line with our monthly burn rate, which is just over 400,000, which is adjusted to 327,000 when you factor in the r and d tax refund.

21:20 Okay. Thank you. That concludes the financial summary. I'll hand back over to James who can talk you through the expected news flow. Thank you, Ross. Appreciate it. So let's have a look at the news flow for us. In the near term, we're gonna be looking at the revenues of the Go live sites in The UK and abroad. So as I've said to you, we expect to get some income from the sites abroad now that they have a product that they can actually provide to their end customers.

21:53 We also have other sites in The UK which we know are due to go live soon, and I hope to be able to update you on those in the very, very near future. There are sites outside of Manchester that we've progressed with. I can't say too much at the moment, but as I said, I think it'll be in the very, very near future we can advise of of others that have gone live. And I know that the work we've done, as I said, with the innovation network is really starting to bear some fruit. Again, as I said, I've only been here two and a half months. It's been very difficult to to get things done in a very, very quick way. But all I'd say to you is there really is traction there. And and the fact that we're talking to these guys and they want to talk to us about funding opportunities and how they can get these products into their different regions is is much better than I've seen movement previously looking at all the details from before.

22:54 I'm gonna continue with my progression around that special commissioning. As I said, I've pretty much now got absolute 100% clarity that it's happening. But my big driver now is to make sure this happens as quickly as possible. And I will continue to to lobby and press and chase and harry the people that are the decision makers around that. We've got a great place, as I said, with regards to the FDA registration. Again, I can't talk to you about it until all of the the i's are dotted and the t's are crossed. We have what I believe some some great partners that are gonna help us get that product into The US and support us really getting that registration.

23:42 So the fact is, let's be honest, it's very expensive to bring products into The US with FDA registration. You You know, know, the partners that I think we've got lined up are gonna be able to help us do that in a in a very cost effective way. And, again, I'd like to bring you more information on that as soon as I possibly can. As I said, I can't until everything's all all cleared. All the contracts are completed and signed. As you know, and it's been talked about quite a few times around the fact that there's work going on with NICE around gathering further data for the full recommendation of MTR and Iran. I'm gonna say to you that the EVA process that we had with NICE has been both a blessing and a curse from my from my viewpoint.

24:31 A blessing in the fact that we can actually talk about it, which is great. A curse in the fact that the EVA process is not fully formed within NICE. We're one of the first companies to go through it. And, unfortunately, everything's getting very much delayed why they try to work out the next stage of the process. So things should have happened earlier on in the year, think end of September, beginning of October, And now things have been pushed out until January. I continue to to push on that. And it's also one of the things that I I did discuss with Alex McLaughlin in the office of life science who really is one of the the main drivers around that particular process and the the communication with NICE around the fact that actually the EVA process hasn't really been that helpful for us. And what can he do to help us and and push us forward with that? But we'll continue to go on that because getting getting the the full full recommendation really ties down trust to have to use the test, and that doesn't give them any kind of out to not use it.

25:42 There's also the NICE review for the SIP two c 19 product, which again is delayed. The reason it was delayed is because they're going back to review again. The the data has nothing to do with us, has nothing to do with anything that we've put forward. It's just the general review of the whole of the project or project around that CYP2C19. And we're really again hoping to get the information coming out in January, which should recommend that product.

26:12 We're going to commence the testing with Manchester Royal Infirmary for CYP2C19, and that has the potential if we can get that taken up across the whole of that Manchester network to to really be quite sizable. That'll be a number of instruments and a number of tests, you know, far greater than we would have with the MTN RNL product. And we've got real hope for that because we really believe we've got the right product for the right market.

26:41 The next is around the continuation of the the design of the the instrumentation. You know, I like to be able to look at other types of tests much more complex, much more, let's say, needing more or or several different targets. And to be able to do that, we need to really work on the instrument. The instrument itself is very good. It does what it says on the tin. But, actually, you know, we can improve on that. And I really want to concentrate on how we get that instrument designed better and able to to perform different types of tests for us. We will be coming for future funding activities.

27:27 Let's be clear about that. But those funding activities are really to support us to get the FDA approval approval of the line and for product development. I generally believe there's real proper commercial traction. We really won't be coming to for funding for hairy fairy staff or around predicting or getting sort of product development. This is really going to be talking about funding to really commercialize and push forward what we've got. And that starts, as I said, with that FDA approval. And if we look at the medium to long term, you know, we're gonna be working on that commercial to commence for the IVDR registration for CYP2C19 so we can sell it into Europe.

28:15 That will commence early next year. We'll have the launch of that product in the territories that we get the registration for and also look to push it into other territories around the globe. We will then, as I said, hopefully have commenced the FDA registration for the m t r n o one product and hopefully get, you know, big slice of that US market, which looks quite profitable for us. And then, as I said, with the design of the the instrumentation, we can then start to look at pipeline for multiple target tests, which takes us into a different place altogether.

28:54 So in summary, what I'm what is the issue or or what is the main thing from myself? I think we've got great commercial traction for MTR and o one, both UK and abroad. Understand people's skepticism around this, you know, by seeing what might have happened in the past. But I can say there's a real focus now within the company, and there's a real change in the discussions we're having and in the messaging that we're having. Things are gonna be very, very different to before. And, you've seen from the the presentation today around the fact that we're really trying to pivot the company in a different direction. But I'm also trying to make sure everybody's focused on the commercial aspects of the products that we've got.

29:45 So if there's anything in the in the the project plan that we've got that's going to help us from a commercialization process, that goes to the top of the tree, and that's where we move things forward. Hence, as I said, around the languages for the products abroad, And we're gonna continue to to push on all of the elements that are gonna help us with that commercial traction. There is real clinical and commercial interest in that CYP2C19 product both in and outside The UK. And I just sent you to the point of that that even without the registration for the IVDR, I'm fairly sure that I can start to sell a product into Europe as a research only product because of the fact of the interest that's there. And I'm really, really quite excited about where that can take us.

30:37 You know, we're first to market with those unique point of care pharmacogenetic testing. There's nobody out there really doing what we do, really wanna play on that fact and build on it as well. You know? It is a unique place for us to be, and it's it's it's getting interest out there for what we do.

30:56 And then lastly, as I said, there is gonna be investment required, but it's really gonna be required for that growth capital to support the sales strategy. That's what I need the money for in the future to really, really deliver on all of the things that I have in the plan for that commercialization. I hope that's clear for everybody. I'm now just gonna pass that back and hopefully look at answering some of the questions that have come through. Perfect, James, Ross. Thank you very much indeed for your presentation this morning. Ladies and gentlemen, please do continue to submit your questions using the q and a tab situated on the top right corner of your screen. While While the company take a few moments to review those questions submitted today, I would like to remind you that a recording of this presentation along with a copy of the slides and the published Q and A can be accessed via our investor dashboard.

31:48 James, Russ, we did receive a number of pre submitted questions from investors, and I wanted to start off the Q and A session with these. The first one reads as follows. How do you see GENEDRIVE's technological advantage being maintained or even strengthened in the light of AI enabled disruption across medical diagnostics? Do you see AI as a threat? And if not, why not? If so, how do you manage the threat? And over what time frame do you see that threat emerging? A that's a really interesting question because we are starting to see some some real movement and developments in artificial intelligence or I'd I'd prefer to call it more machine learning from from what I've actually seen is more akin to machine learning than actual artificial intelligence.

32:38 I think if you look at from a medical point of view, there's a lot of there's a lot of challenges for this. There's a lot of external validation that needs to be done. Data exchange and privacy and also implementation logistics sort of remain the main obstacles. Also, if you look at where we are subs positioned in the point of care market, you haven't really seen anything coming through in the point of care market with regards to machine learning or or AI. And and a lot of this is because, you know, there are the regulatory repent re regulator requirements for this really depend on the risk associated with the medical product that it's aligned to.

33:27 And a lot of the the the sort of requirements or regulatory requirements are still being very much developed for for this, you know, for machine learning AI products. So do I see in the short term? No. I don't necessarily think there is a challenge for us in our marketplace. Do I expect that things to to rise and and, you know, around specifically around sort of informed information for for clinicians, yes. I absolutely do. Probably not here yet. I think in the porta care market, it's probably more likely gonna be things like, you know, dose where you're you're looking at sort of specific dose information.

34:17 You know, how do you do you dose a patient in a port of care setting and the the the data that can be provided to help support that kind of dosage stuff. For at the moment, no. There is going to be potential use for us, you know, with things like big data and so on around developing products. So I definitely think that that it could be useful for us in developing products in the future. But as as of today, I don't necessarily see it as a threat in our particular marketplace. Perfect, James. And the next question reads as follows. Why did the company sign a UK and ROI distribution agreement with Inspiration Healthcare PLC if it focuses on national adoption into NHS England?

35:04 Will commissions still be payable to Inspiration Healthcare PLC if the NHS adopted the test nationally? Okay. So it's an interesting question. And and what I'll say is, firstly, that everything is still on the table with regards to the commercialization. So nothing is off the table, and I'm still looking at a lot of things. Inspiration have been absolutely brilliant for us in getting us to access neonatologists and helping us win that clinical argument. I think the reality is that that clinical argument has now been won, and we now need to look at having different discussions with different people in the NHS.

35:54 I think when it comes to Inspiration Healthcare who are a distributor, We we need to understand whether they are able to come with us and have those different discussions because I said you you you need to have it's a different a different place. So if I'm selling an incubator, you know, there's budgets already available for incubators in the NHS, either maintaining or replacing, and accessing those budgets is fairly straightforward. When you bring in something completely new, there is no budget for it, and you've gotta create something that delivers a budget. And it's it's a different discussion. It's a different conversation with different people.

36:39 I think where we are at the moment is just understanding whether our distributor is able to come with us and have those discussions or not. And then, obviously, that then filters down to, you know, around the the income part for the you know, if we get the specialist commissioning while they're still, you know, still our distributor in The UK. So, again, you know, everything's really still to be discussed and reviewed from a a commercial point of view. But, hopefully, for us, I'm still more concentrating on trying to get that specialist commissioning through because that's where things change a big big place for us. Sorry. Bit of a convoluted answer to the question, but, hopefully, answered it for you. Perfect.

37:25 Is the company exploring other hospital medical research partnerships in The UK, US or around the world alongside its successful relationship with NHS in Manchester, England? There's a very short answer to that, which is yes. Absolutely. We have we have been you know, we have had a really successful partnership with Manchester. Let's let's be clear there. The the genetic guy, the the geneticist there have have really worked with us and and and we've done some great stuff. Am I tied to them? No. Will I look at other opportunities? Yes. You know, now we're in this pharmacogenetics marketplace. You know, the logic would say that we can start talking to pharmaceutical companies about how we could actually tie up with those because, let's be honest, we're talking about adverse drug reactions. So So there is a real clear affinity with what we want to do and potentially with what drugs may be coming forward in the marketplace.

38:25 So, yes, it's a simple answer. Have I got anything concrete I can give to you at this moment in time? No. But, you know, we are very much wanting to do that going forward. That's great. Thank you very much for that. And, James, we have also received a number of live questions. And if I may now hand back to you to address those, give responses where appropriate to do so, and I will pick up from you at the end. Okay. If you can give me just two seconds just to have a look at some of these. So one of the questions is, we roll out AIHL test in any hospitals in The UK outside Manchester if so? Did allude to the fact earlier that we have moved things forward with other hospitals.

39:17 I I would would hope to be able to bring you some good news on that very, very shortly. So in answer, yes, we can, and we have, and you will set to hear about that soon. Okay. The next one is what happened happened to to working with financial modelers to supply an easy to use budget justification for the NHS Trust hospital to use as stated would happen? I think you've got a point there. I'm I'm not entirely convinced that the right let's say we do have a model.

40:11 Did we use it in the right way? Potentially not. Are we using something now? Yes. Are we engaged with the health innovation networks that are really tied in with us around that particular modeling? Because there's there's a a big big justification they need to do to be able to secure funds for us. So I I think you have a good point in the fact that maybe we weren't, but we absolutely are now. We do have a model we can use. But to be honest with you, the work we're doing with the HI the the health innovation networks has really moved that on even further. And he's really supporting us in securing funding across the NHS. So, you know, I'm really pleased with the work that's happened and but we'll continue to do that, and we'll continue to to really show those justifications of those, you know, cost effectiveness of what we're doing.

41:16 My apologies. I'm trying to read some of these questions. Sorry for the delay. So there's a question here saying, in regard to MTR n o one, I know the data on the effectiveness of the ID kit is good, but do GDR have a business case to be be able able to to describe describe how this test might be an investment to save program, the cost improvement in any one NHS site? Yes. To be clear, we do. If you look at simply the the NICE EVA evaluation, they did a cost effectiveness business case purely based on the provision of dual cochlear implants.

42:07 So if you look at the evaluation, it sort of says that, you know, you look at the the the number of tests you have to do and the cost of those tests based upon the number of cochlear implants that would have to be provided. It's cost effective just on that simple simple scenario. What I like to build on is slightly a bit more than that when I talk to to trusts and and and health innovation networks because there is a lot of wider cost. There's a wider implication cost for the socioeconomic impact of trying to bring the child up with hearing loss or pre speech hearing loss that never really got calculated into any of that piece that happened with NICE. So we have a broader element not only from, you know, on the business case, purely and simply around the fact that invest and save for a hospital point of view is a is a wider social economic impact as well.

43:07 There's also the fact that this test gives a result not only for the patient, but it also gives a result for the patient's mother and the patient's grandmother and subsequent siblings. Because the actual gene variation is passed down the mitochondrial DNA, you actually have a sort of bigger hit from from the the test test result. So if you identify a child with this particular gene variation, you've pretty much identified the mother with the gene variation, as I said, and the grandmother and potential siblings for that. So you do get a a wider impact, and that's something, again, that we try and build into the discussions that we're having.

43:56 But, ultimately, you know, if you look at the NHS and you you look at the financial situation it's in, even the tests that we do, you know, are not going to save the NHS hundreds of millions of pounds. You know? The the it is millions of pounds this is going to save the NHS, but it's not hundreds of millions of pounds. So we are in a a group of companies with a similar sort of saving impact. But one hour where we have a really massive difference someone coming along saying, you know, if you if you do this, you'll save so many bed days. What we're doing is not only, you know, saying you're gonna save costs, you're actually going to save hundreds of babies here in, which is, you know, a patient safety, you know, absolute great story.

44:51 So I'm really convinced that we don't even only have to talk about the financials. Can talk about the patient impact as well. And patient safety is another area that I've very much been trying to to engage with the NHS on. Because, let's be honest, if they don't do this test, they are potentially causing harm. And we really need to make sure that they understand that there is an alternative to stop causing harm. But, that's answered that one for you. Question. Do you anticipate coming up against large path track providers and DNA sequencing providers, all of whom will insist they will be presumed for the care testing in a clinical implied market?

45:52 Can you describe how much faster your tests are versus these path track approaches and a typical DNS sequencing approach? Okay. If we take m t n r n r one, you can actually get that test done at the moment on the NHS in one of the genetic hubs. The current turnaround time for that test is somewhere between one and two weeks. And I do see some hospitals requesting that test for patients that are calling in for elective surgery. So, automatically, I I have an argument there to say that there is an inequality in service provision because you're testing patients that are due to come in for elective surgery in two or three weeks time, but they have the gene variant.

46:48 But But you're you're not not testing patients that are in an emergency circumstance because you can't get the test done quick enough. So our test, as you know, for MTR in r one, it takes twenty six minutes for the test to happen. You know, if you take the time it takes to get the swab and it's a very easy test. You know, a couple of swabs in a baby's cheek into an ELISA buffer into the instrument, half an hour at tops, you know, really is incredibly quick, and there is nothing else even close to it in the marketplace. Do I expect, you know, other providers to come in? Let let's be honest. There are already providers that are in these genetic hubs.

47:35 The genetic hubs have a difficulty in the fact that there are few of them. They are difficult to staff, and they're, you know, quite expensive to to run. So do I anticipate there being an impact on us in the short term? No. In the long term, you know, there is always going to be challenges. There are always going to be people coming into the market. We're the first. I'm sure everybody will be waiting to see just how much we smash the market before they start thinking about entering. Let us do all the hard work, I know, but it's always good to be first. And it's always good to be known as this particular provider, as the first one to really bring pharma genetic testing to that pool of care arena.

48:26 I really believe that, you know, the the other people will come on board because they will see how we start to really develop this marketplace as we go forward. At the moment, no. I'm not worried. Let's Let's talk talk about about the CYP2C19 product. Again, that particular test can be done in a in a large genetic sequencing hub. It can also be done with one of our competitors' tests in a a bit more of a, let's say, small lab scenario rather than a pool of care scenario. Again, the tests take a bit of time to do. The the competitor test that's in small labs is quite fiddly and complex, isn't really a point of care test. And as I said, you you have to have frozen you have to keep everything frozen to make it happen, which, you know, doesn't really work in a point of care scenario.

49:31 Also, the competitors' test actually identifies very few of the particular targets. So to give an example, if you do a full sequencing, you'll identify 12 targets. If you do this competitor's test, you'll only identify three targets. If you do our test, you'll identify six. And those six targets actually make up more or less 90% of the reasons why you can't metabolize the clopidogrel. So we have a massive advantage. And, the test can be done in in less than an hour, which is, you know, really important. And if you look at The UK and the models we've done in The UK, especially for Manchester where we've modeled this out, you know, they've had to shift the test from, you know, whatever hospital they've got in that Greater Manchester area to the genetic hub.

50:25 So there's a cost to test. It's taking the test. There's a cost of transporting the test, then there's cost of doing the test. Whereas we can actually have a particular instrument right next to the patient. Soon as the, you know, the patient comes in, you can do the test and you can make the decision straight away on whether you give clopidrogil or not. Whereas you would have to wait for these tests. It could take, you know, a day or two to come back with the result. So, you you know, know, there's there's a a real real benefit to us in the market. I hope that answered the question. I'm not sure if there's many more. Let me have a quick look, but I can go down and answer quickly. Okay.

51:14 There's a question here. It says, has it been said we will receive nought 200,000 through the devout funding process? We'll receive the full 1,200,000 over the course of the next year. No. I don't think we will in a nutshell. I don't think we'll we'll get the full 1,200,000. I think we will get some more. Will it be the whole full 1.2? I'm not entirely I don't believe it will be. There are other funding opportunities for us outside of Devote, which pursuing. So Devote is the isn't the only source of funding.

51:59 There is other med tech funding capabilities and options for us. And as I said to you, you know, by engaging with that health innovation network, they also have access to funding as well, which we are accessing. So all I'd say to you is, okay, maybe not the 1.2 from Devote, but there are other funding opportunities out there we can pursue in as well. There's quite a lot of other questions. I'm not gonna be able to have time to go through many more. We will or I will try to answer as many, many, if not all, of the questions later so that you get a response to everything you've put forward. I'm I'm really keen to make sure that you feel engaged with us.

52:48 Hopefully, this looks and feels very different to what you had with David previously. And I hope you can understand, you know, it's been a short term that I've been here, but I really have got that commercial traction moving and and really feel that that, you know, there's a real positivity that probably wasn't in the organization prior. And I'm really looking forward to to how that drives forward. So for for me, me, I think that's that's probably as far as I can go for the questions from there. That's great. Thank you for that, James. And that and for addressing those questions today. And, of course, as James said, the company will review all questions submitted today. Publish those responses on the investment company platform.

53:35 But before we direct investors to provide you with their feedback, which is this particular importance of the company, James, can I please ask you for a few closing comments? I think I can understand the frustration, and I can see some of the questions, some of the frustration coming out and and where this company is going. Hopefully, I've given you a real clear steer on where I see the company going and on what I'm doing to drive things forward and really starting to deliver on promises that were probably made a long time ago. Really starting to see some of the things come to fruition. I hope that you will, you know, really genuinely get a feel that it's a different organization.

54:22 I do want to interact with you as much as I can, and continue to to do these kind of forums in the future and give you every opportunity to to to press and push and make sure that, you know, I am as as I can be and driving it forward as I can be. I really think I have a great team around me, you know, with Ross and with Gino and the others within the organization. You know, they're a great r and d team. They've done some great things. I know we're gonna do some more great things together. And now the focus is on that commercialization. You know, I can really start to see some of the the fruit and the fruition to come through.

55:09 And and I'd say just stay tuned. You know, we've got some news coming out in the not too distant future which we will share with you as soon as we can. And, you can genuinely see where where we're moving in the direction we're going in. So thank you for your time in asking the questions today. Perfect. James, Ross, thank you once again for updating investors today. Could I please ask investors not to close this session as you will now be automatically redirected to provide your feedback in order that the Board can better understand your views and expectations. This will only take a few moments to complete, and I'm sure will be greatly valued by the company. On behalf of the management team of GENEDRIVE PLC, we would like to thank you for attending today's presentation, and good morning to you all.