Genedrive (LSE:GDR) — Interim results presentation

0:03 Good morning, ladies and gentlemen, and welcome to the GENEDRIVE PLC Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Just please simply type in your question at any time and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company will review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. And if you give that your kind attention, I'm sure the

0:34 company will be most grateful. And I'd now like to hand over to Matthew Fowler, CFO, and David Budd, CEO from GENEDRIVE. Good morning to you both. Morning, Mark. Thanks for the, introduction, and good morning to everyone. My name is Dave Budd. I'm the chief executive here at GENEDRIVE. And as Mark mentioned, Matthew Fowler, our our chief financial officer is joining. And we're here to present, our highlights from our interim results to December 2021 and update you on the progress of the company since that point of time. Usual, document disclaimer there that you can read. For those of you potentially new to the GENEDRIVE story, just a little bit of background. The GENEDRIVE device itself is a small portable genetic reader, which is used to derive genetic information about people or or pathogens or environments.

1:23 And then we use that genetic information often to give us, you know, the the option to make different medical decisions based on on someone's genetic status. Some of these products themselves and the important pieces needed to launch them were just coming into place at the end of this reporting period. However, since then, you know, with these new product introductions, our installations, and, some key clinical publications that have recently occurred have put us in a really good position to discuss about how our commercial progress is accelerating post period close. Specifically, we have two new launch opportunities listed on the slide here around our antibiotic induced hearing loss test, which we have reported on previously, and our GENEDRIVE point of care COP nineteen test.

2:14 So again, a little bit of background. The original GENEDRIVE system is pictured there on the slide on the top left. Now, originally, GENEDRIVE was developed for low and middle income markets where cost to the user and ease of use were really fundamental in its design. Over the last couple of years, we've been refocusing the company towards more western market applications. And today, I'll be describing products that are mostly targeted into those markets. And increasingly, I guess, what we'd refer to as emergency medical environments or medical care environments, where the urgency of genetic information is really important. A lot of these Western markets, hospitals, for example, have more complex requirements than we'd see in low and middle income markets.

3:02 And there those can be things like, for example, the number of, you know, of users, so ease of use becomes increasingly more important. Hospitals have IT requirements in terms of data transmission, etcetera. And that led to the development last year of our next generation GENEDRIVE instrument platform, which is shown there on the bottom left, and that's the one that we're using for our antibiotic induced hearing loss test. This is a a sort of new platform of choice for us going forward for emergency medicine applications. And then the original GENEDRIVE, on the top left again, is the one that we're using for our COVID point of care test because that's not, you know, primarily targeted at at hospital installations.

3:49 In all cases, the platforms share a lot of similarities of being able to give rapid results, be easy to use, and typically, these teams are are these items are quite affordable, you know, typically two to five times more affordable than competitive systems.

4:07 So our short and medium term revenue opportunities, really, we anticipate to be driven by by COVID point of care and AIHL. Both of these are at launch opportunities, these are taken in turn in the presentation and and described in some more detail. AIHL is clearly a flagship product for the company. Right? It's a a unique commercial product for us. No other company has developed a commercial AI l AIHL test at all, and certainly no one has it on a point of care platform. Our point of care COVID nineteen product, became available through CE marking in December, is our rapid molecular COVID nineteen detection system. And that has a number of very attractive and differentiating performance features.

4:53 We also have a portfolio of products including hepatitis c, our military DOD products, and our high throughput, co COVID nineteen bead product, all of which, we have discussed, in terms of commercial progress previously. These are all detailed in the interim results announcement. They're all good performing products. They all have good quality. But in some cases, the timing and the opportunity and and the commercial execution hasn't been in their their favor and has impacted their product adoption. All of these things do remain on market, but they don't sit currently with underpinned revenue forecasts at this point in time. Additionally, in this presentation, it'll be the first time, I think, that we introduce our newest assay which we have in development, which is used for, what's often termed as guided antiplatelet therapy, for stroke patients.

5:45 So let's get into antibiotic induced hearing loss. So I already commented that the GENEDRIVE MTRN r one system is a unique commercial product for the company. Again, for those not familiar, the test is used to screen for a genetic variant that some children will carry that will cause lifelong deafness as a consequence of receiving certain antibiotics. The GENEDRIVE test is used in this circumstance to test babies for the variant. And if they have it, they can be given a safer alternative treatment. Although MTRN1 is a genetic variant that's been known since, I guess, about the 1980s, it's never been possible to rapidly perform the test in an emergency care situation before GENEDRIVE's advancement, in this particular area.

6:38 Our test was developed in 2019 and clinically validated in 2020. And following a series of improvements that led to the development of the new GENEDRIVE platform that I previously, showed you, the test was made commercially available. And as I said, this rep you know, this represents a unique product for the company. But even more interestingly, I think, it represents the very first time any commercial point of care molecular test has been done in a neonatal intensive care unit environment. So it's a really, really groundbreaking, forward thinking test that we're doing here.

7:14 The PAYLO trial, and PAYLO stands for pharmacogenomics to avoid hearing loss, trial was published this week in the journal, the American Medical Association Journal called Pediatrics or JAMA Pediatrics. And I think the results have broadly been, known already because some of the authors have, presented this at conferences and things over the course of of last year. However, the JAMA publication is really important for us because it formally defines a lot of the things that we were looking for. Right? As you as you read it through, it's it's freely available online for anybody to read. It tells you that, indeed, the test does what it's supposed to do. It tells you that the GENEDRIVE point of care test does detect m t r and r one in a clinical setting. It tells you that clinicians are able to prescribe alternatives, which is the purpose of the test.

8:09 In the JAMA study or in the PAYLO study, three newborns were detected, as having the the variant, and their hearing was saved as a result of our test. The publication confirms that the GENEDRIVE technology allows setting to be done in such a rapid time frame that it doesn't impact the preexisting sort of admission processes for babies into a neonatal intensive care setting. And the last thing it talks a little bit about is it talks about some of the improvements that we drove in the product, in in the test over the course of the payload study that resulted in the system that we now have on the market and delivers the sort of specificity, accuracy, and first pass rates that are demonstrated here on the slide. So I think, listen, we've got a lot that we can be really justifiably proud of that we've developed in this product.

9:02 The the parallel publication itself was originally due to be published in December of last year, but then it was delayed because JAMA decided that they wanted to write an editorial around the product. And although the JAMA publication is freely available, the editorial, unfortunately, is not. So not everyone has had a chance to read it in its entirety. But the editorial is entitled Genetic Testing in Newborns Moves from Rare to Routine Application. And the comment from the authors really is that this represents entering a new era in genetic testing, right, and a really important step in reducing the burden of antibiotic induced hearing loss in children. So very, very positive commentary from a very prestigious American publication, I think, frames up what we're doing really, really nicely.

9:52 There's also a little bit of commentary, I guess, on market in there. The editorial really is only viewed from a sepsis viewpoint of children admitted for sepsis, but the the editor in there also mentions a market opportunity of around 7,000,000, children a year, which, to be fair, is a larger market, I think, than we have previously, previously described. Our forecasts have been more restricted to European and and and US markets. So, again, a lot a lot to be happy there in terms of supporting, the company's launch of that product. So here on this slide, I think what we wanted to, illustrate was that there's a number of really important puzzle pieces that need to be in place in order to target the market aggressively.

10:38 Right? And those are things on the top of the slide in the green, the green arrows, that we thought needed to be in place in order to really hit the go button. Clearly, the the the pilot study, the payload study needed to be finished, which it is, but it also needs to be published. Right? As we go to new hospitals, to new clinicians, to new neonatal intensive care units and talk about it, absolutely, as a new test, it needs to have documented and peer reviewed performance data. Right? They're not just gonna take what a company says. So that has now been done. The next important thing is this test was developed in collaboration with clinicians and geneticists at Manchester Royal Infirmary, and it was also very important that those those sites were up and running with the system so that they could be advocates and key opinion leaders for us going forward.

11:34 And that's happened in March, as well. And then, I guess, not on the slide, but the last important thing is, you know, our distribution partners. Our commercial route needs to be in place. We signed our contract with Inspiration Healthcare some time ago, but we worked, you know, through with them through February and March to put them into place. They're sort of in a, I guess, what you call a soft launch phase at this point in time. They'll make their market splash and and noise when they're when they're ready to. But they are now out there accessing the market and and driving sales opportunities. So I think we're pleased about where where we are. So for The UK, we recognize a key element is to get the use of the product recommended into clinical guidelines. And that can happen faster if we get perhaps additional data, additional user advocacy, and perhaps even some additional health economic data to support the product. That process, you know, takes probably, you know, twelve to eighteen months. It's something that we've already started, and that will help support a more broad adoption in the marketplace. Initially, in the absence of that, we think a realistic placement target of around 30 to 45 installations in a sort of twelve month period is a reasonable number to target.

12:46 It could grow with the support of an increasingly, you know, positive market engagement, of course. And then ultimately, know, once it gets into clinical guidelines, we would expect, you know, up to a 100% of hospitals to adopt or maternity hospitals or or hospitals with NICU units, at least, to adopt this test. I think end unit pricing details, cost per test details are well described in the NICE med tech innovation briefing that was released this week. And then like all diagnostic companies, Inspiration Healthcare, not us, but Inspiration Healthcare will either be placing or selling the units in return for long term contracts on purchasing the test. And that's really where the the money is made. It's not really made off the box placements. It's made off the reoccurring revenue that you get from from test procurement.

13:37 Okay. So so in summary, I guess, before I move on, I think we've got a lot to be to be pleased of, you know, we've, pleased with. We've got an AIHL test that's unique to the company. It's got a very, very clear, clinical intent and purpose. It's shown, you know, excellent performance in the real world. And although we've always described it as as a Western market, you know, European, North American product, certainly, does have global market potential over time. And I think at this stage, you know, we feel we can feel very confident of where we are in terms of the tools, the information, the key opinion leader engagement, and the advocacy that we have behind the product to roll this out now within the NHS. And, you know, over the course of the next, you know, several months, we'll be able to comment additionally on sort of what additional engagement we're getting from NHS and support in the NHS to roll this out.

14:34 So now moving on to the GENEDRIVE COV nineteen IDKIT. This is our point of care test for COVID testing. I'm not gonna say a lot about the actual product specs and performance of the product because I think we we have covered that previously in our company presentations and reports. I think it's important to say that we do have, like, a really unique product. Right? We can get a molecular result in seven to seventeen minutes, which, you know, is is faster than 95% of of of stuff that's out there. So Mhmm. It's pretty impressive performance. Since we see marked in December, we've also expanded our our clinical cohort. So, you know, not things that necessarily be visible to investors, but our instructions for use, for example, have been updated with claims for, asymptomatic and symptomatic patients, and that gives you sort of more broad applicability of the product in the marketplace. So there has been work going on, in the background as well.

15:35 And then if we talk about sort of COVID markets, I don't think it's any surprise to say that COVID markets are are highly variable. Right? And they change from country to country. Now since December, when we see market, we're promoting the product mostly into Europe because those are the products where we already have our regulatory approval to sell. And it's fair to say that the market appetite for COVID testing is is country specific and often driven by maybe not often, maybe always driven by by government testing policy. Right? We have seen in the past that it's also driven by epidemiology. Right? Interest in testing is driven by the emergence of new variants. It's driven by rapid increases in the level of infection. And all of those dynamics make it a bit difficult to say exactly what's gonna what's gonna happen next. Certainly, we've got distributor arrangements now in four countries, with distribution partners who felt that there were good sustainable opportunities in their markets going forward. Right?

16:32 And that's based on their knowledge of local dynamics, government policy, etcetera. And those arrangements that we have currently cover Spain, Portugal, United Arab Emirates, and Oman. The Middle East, stuff sort of came, a bit by, I guess, coincidence in the fact that we were engaging a European parent company that then in turn targeted those those those countries. But our focus commercially really has been on Europe. And then just to give you a flavor of what people are doing. So for example, in Spain, I think our partner there is really excited about the opportunity. They've been very entrepreneurial. They've set up a demonstration sort of showroom in Madrid, and they're really pushing the product in earnest. Now they're they're they are targeting hospitals, but they're also targeting pharmacies, and they're also targeting insurers.

17:22 So there's an interesting dynamic with insurers, for example. So in Spain, we're told that that, insurers will bear a burden of the occupational health costs when workers aren't able to attend work because of COVID. So that weekly testing in Spain, and you need to self isolate at this point in time if you have COVID, and that drives, an increased cost to insurers, obviously. And having a test where you can really definitively tell whether someone has COVID or not is better than the inaccuracies that are provided by bilateral flow. Now that's the sort of opportunity that we haven't got in The UK. Right? There's a there's a occupational health insurance system operating in Spain that we don't have here. So we don't see that type of opportunity. I think it's just, you know, a good example to highlight that opportunities do exist in other markets that maybe a UK based person wouldn't see.

18:15 The this the company that we're working with is also targeting pharmacies. There are around 12,000 pharmacies, you know, 12,000 pharmacies in Spain, and something between twelve hundred and fifteen hundred of those pharmacies are accredited or qualified to offer COVID testing. Right? So in terms of access to the market and where people can get testing through insurers, for example, pharmacies are a good route for that. So again, pharmacy based molecular testing, not that common here in The UK. So I'll just conclude and say that our partners in these countries are really very positive about the opportunities that they have and the things that they're progressing. Most of these guys were all of these guys were signed up just at the end of February. So it's still early days. Think it will take a little bit more time really to be in a position to properly quantify the size and longevity of of of the business for this.

19:14 Okay. And then lastly for me, I wanted to move on to a little discussion around future development. I think our AIHL test has really solidified for us the advantages and the capabilities of GENEDRIVE in an emergency care setting. Right? The ability to rapidly generate genetic information in an easy to use way will open up a lot of new opportunities in pharmacogenomics for the company. Many of these applications and opportunities fit into the sweet spot of GENEDRIVE in terms of being able to have an actionable genetic test in a timeframe that allows emergency care clinicians to make better informed decisions and improve the outcome of patients.

20:00 Now, the example that we're talking about now in our development pipeline is a new test for what is generally referred to as pharmacogenomic or genetically guided antiplatelet therapy, which is a bit of a mouthful, but that's what it's called. But here, we're targeting patients that are admitted with emergency cardiac issues such as a stroke. Right? So currently, what happens is these patients are admitted, They're put on what are called antiplatelet drugs, which stop the formation of further blood clots because these can result in, you know, additional cardiac events. So we want to avoid those by putting people on antiplatelet drugs. The most common antiplatelet drug out there is something called clopidogrel.

20:46 And the way that clopidogrel works is it needs to be administered to the patient. The patient then metabolizes the drug into an active form. And some of those patients are able to metabolize the drug well, some of them not at all, and some in a very sort of intermediate way. So you can classify people as being sort of metabolizers, non metabolizers, and intermediate metabolizers. And the ability to test these patients and triage them into these categories is really important and really relevant. And there are already existing clinical guidelines that say and suggest that this type of testing should be done. Now there isn't the same, immediate one hour urgency that we see in AIHL to have the test done. Right? It needs to sort of be done within a day of admission, twelve to twenty four hours of admission.

21:39 But to be honest, most hospital genetic services would only turn things around in two to three days. So the ability to have it in a point of care setting is certainly very, very relevant. And the rationale of having on a gene drive, CYP2C19 assay, as it's called, on gene drive, I think is is pretty clear. So that's where we're that's where we're going for that. I think that's the next assay that you're gonna that you're gonna see from the company. Just as a little side point, I often get asked the question of if these frontline drugs have these problems, then why don't people just prescribe the second line drugs, for example, clopidogrel, not give it at all. And in general, it's because there's some adverse issue associated with the second line drugs. Right?

22:25 So in the case of clopidogrel, the alternatives to it cause more or have the propensity to cause more internal bleeding in a patient. Right? So if you can avoid that, then you'll want to do that. In the case of AIHL, the alternative drugs tigantamycin, are simply just prone to promoting the development of antimicrobial resistance in bacteria. And that's a huge looming healthcare issue that globally clinicians want to avoid. So that's why being able to use these frontline drugs and ensuring that you're using them safely before you go on to alternatives is really important. And that's really what's behind the whole concept of genetically guided therapy that we see in AIHL and we'll soon see in CYP2C19.

23:14 All right. I'm going to hand it over to Matthew, take you through the financial slide, and then I will come back, give you a little flavor of what the news flow will look like coming forward, and then we'll be in a position to wrap up and take questions.

23:32 K. Thanks, David. I have one slide here where I am gonna talk about cash. I think overall, we've been managing cash very carefully over the past period, and I'm hoping to demonstrate the benefits of that management in the current position and also as we look forward. In terms of the specifics, underlying cash consumption was 2.9 compared to 4.1 in the same period to December 20, with the December 20 number being impacted by working capital movements mainly on creditors. Below operating cash, the notable number is the 6,600,000 fund raise from October. But unlike prior periods, there's no cash movements associated with the convertibles as the company is now debt free. So adding the 6.6 from the fund raise to the underlying cash flows, the net cash inflow from all activities was £3,700,000 giving a closing cash number at the December 31 of £6,300,000 You'll see that the taxation line for December 21 and December 20 is empty, and this is because we can only submit our r and d tax claim once the full year accounts have been signed and the tax comp submitted.

24:42 Adding in HMR's processing time, this generally means we tend to get the cash in the following calendar year, so the early part of twenty two. So for December 21, we received our cash in March, and the amount was 1,200,000. And so to give the latest cash position, I've quoted our number on the March 25, which was £6,000,000.

25:03 So effectively, the r and d cash receipt in March has funded the cash burn January, February, March, and we're at a very similar position as we were at the end of the interims. So if the period to 20¢, excuse me. So if the period December 21, the gross consumption per month is $4.80 and the net consumption $3.80. So even at this gross consumption level of $4.80 a month, we have over a twelve month cash runway. But importantly, this $4.80 number that I've arrived at there, I'm using the six months to December, and there were very low revenue numbers. So if we do add our revenue forecast for the two at launch products, both highly cash generative being the POC and AIHL, then the cash position looks attractive, and there's a degree of confidence there that the 6,000,000 allows us to launch and manage the AIHL and POC assays respectively.

25:57 So overall, pretty comfortable with the cash position. And as I say, the latest being 6,000,000 after the r and d credit. Okay? Thank you. Okay. Thanks, Matthew. Just moving on to the last slide now is our anticipated news flow. You know, all our focus, you know, from news flow is gonna be around commercial progress in the short term, obtaining new distribution partners in Europe for our MTR and r one product and driving the necessary activities with key opinion leaders to gain adopt adoption more broadly. In the medium term, as I mentioned during the presentation, formal clinical guidelines are critical to move to a more aggressive market expansion expectation and and commercial revenue for MTRN r one.

26:47 And the company has and is putting in specialist resources in place to make that happen as quickly as possible. Now we wanna be in a position where we've got the, you know, the enthusiasm and the level of adoption in Europe for AIHL that makes launching the product into The United States something that's practical and realistic for us. And then and lastly, of course, we're gonna update you on the progress a SIP two c 19. Although we don't have a formal launch date to communicate as of yet as we're early in development, I would say that based on our understanding and our work to date, most of the development pathway follows processes that we've done previously and and and risk mitigated. So we'll be as aggressive as we can in terms of releasing that product as as quickly as possible.

27:37 Okay. So I think, Mark, that does that does take us to the end of the presentation. If I could just make a a a quick comment to thank Matthew Fowler for all the work that he's done in in the company. As as many of you will know, Matthew is is moving on, and Russ Shaw has now joined us and will be taking a post of chief financial officer on the on the April 7. I'd like to wish Matthew all all the best on behalf of the people in the company, and and welcome Russ as well. And on that, I can turn it over to, to questions. That's great. Matthew, David, thank you very much indeed for updating investors this morning. Ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen. But just while Matthew and David take a few moments to review the questions you've submitted already, I'd like to remind you that the recording this presentation along with a copy of the slides and the published Q and A can be accessed via your Investor Meet company dashboard.

28:29 David, Matthew, obviously, you received a number of pre submitted questions. And just for the for those that did submit those questions, the management have provided written responses, which we'll publish a little later on today. But if I may, Matthew, David, just hand back to you if I could ask you to read out the questions that you've received today and and give a response where it's appropriate to do so, and I'll pick up from you a little bit later. Yeah. Sure. Okay. Thanks, Mark. I I would just just to to build on on that comment there. We we do get a lot of pre submitted questions, and they often come in before the actual results are released. So a lot of questions that people do ask do then get obviously answered in in the documentation that we that we reply. So in in many cases, we don't answer the question because it's because it's because it's already there, I think, probably, and and our people are now aware of the answers. But, anyways, let me just go over and just look at the law at the the the live questions, anyways, that have come in. So there's the the top one.

29:26 There's a bunch of questions here actually from Allan Allan M. So I'll just take one or two of those. Mhmm. Yeah. First question is, has the UK government completely stalled approval of our point of care COV test through CTDA? Are we now in the same position with CTDA as we are with FDA approval for RT PCR COVID nineteen test? So we we attended a webinar, I guess, seminar last week with the CTDA people. And maybe before I get into all that, there is there is a a little a little sort of glimmer of I could be could be good news, I guess. We did receive some questions in from CTDA this week around our application. So at least we know it's under review.

30:15 That doesn't mean it has a positive outcome, and it doesn't give it a timeline, but at least we know it's not sitting in an in tray. So I think that's I'll view that as as being positive. What we heard from the CTDA team was that they have essentially implemented a process, that they're unable to staff appropriately to manage at speed. So it's quite a technical review process. It requires technical reviewers, and there aren't necessarily a lot of reviewers out there that can do it. So they're not able to get through applications in a well, frankly, in an acceptable time frame. But as I said, at least we know that we are our our file's been open, and we're we're we're under review.

31:01 They they don't they don't give any time lines. So it's not like we're we're, you know, trying not to communicate something. They don't give any timelines, and they actually don't even reply to individual queries about your your file. You know, they they published some statistics in this webinar that we went to. They, to date, have had 219 applications, of which a 165 of those are still, quote, unquote, in in progress. They've approved 33 products to date, and 21 have either failed or the companies have withdrawn those those products. I'm not aware of any any issue or reason why we shouldn't be able to achieve CTDA.

31:47 It's just that they need to go through their review, and they need to go need to go through their process. Right? So that's that's sort of sort of where we are.

32:00 Just, again, sort of just scrolling down. This question is from Steven w. It's as the as the pandemic shifts to an to an endemic, marked by Boris Johnson announcing plans for how the country begins living with COVID, lateral flow and PCR tests will no longer be free with official testing data showing that over 900,000 tests are taken a day. What is GENEDRIVE doing to bestly market the new COVID p point of care test to private and public section of The UK? Well well, the answer is very little, to be honest, because we need CTDA approval in order to sell. Right? And if you can't sell a product, customers aren't really gonna engage with you. You know, we we said in terms of our point of care product that our focus on it was going to be Europe because, you know, we understand the dynamics of COVID in The UK. We understand it's a little bit of a I don't know if outlier is the right word, but but the NHS is an outlier in terms of health care how health care is managed. Right? Not many countries have a very centralized health care management organization like we have in the NHS. So we've tried to target European countries where there's more options around buyers. You know, they're they're private markers markets, they're public markets. It could be that health care boards are run regionally rather than nationally. And we have we have sort of specifically said that The UK was not our number one one focus. So, hopefully, that answers your your your question there.

33:31 And then the next one is from Alan again. Are you are are we in a good place to facilitate inquiries for the purchase of our AIA from our for our AIHL test from from big from big companies in various countries inside and out of Europe. Listen. There's a lot of there's a lot of awareness about our AIHL test, and that awareness is growing. We're the product is starting to get picked up by mainstream news and trade publications, and certainly the JAMA pediatric publication being an American publication raises the profile of of the product there. Our initial focus for AIHL, however, is in The UK. As we detailed in the presentation, we think there's a number of key things that need to be in place to make this a successful product introduction.

34:18 And and one of them is around is around clinical advocates. Right? Our clinical advocates now are UK based. So the focus, you know, with with directly ourselves and with our distribution partners is is building a base in The UK. As we are doing that, we are assessing and trying to find the right routes to market in Europe. And that, again, for us is around priorities, which which countries do we wanna go into, and how do we find the right routes. Know? Is it a distribution partner? Is it is it direct? You know, we're not a we're not a we're not a huge company, and we can't, you know, we can't take on 30 countries at the same time. Having some focus and making sure that we can maximize our opportunities, I think, is is where we wanna go. Next question on here is Paul. Will you be targeting China with AIHL?

35:06 Listen, again, just to build on the previous question, you know, maybe someday, but but not not currently in scope at all. Next one is Sam Samuel d. In regards to the AIHL test, will these units be wholesale, or will they be manufactured to order? Do we have stock of these presently? So listen. GENEDRIVE units themselves, we manufacture through sub suppliers. Right? They're the ultimate the finished product is assembled by us, but, you know, most of the assembly is done externally. We have two sources of of GENEDRIVE systems. And when they come in, we repurpose them in either, you know, GENEDRIVE original or GENEDRIVE AIHL format. So we do keep a stock of them, and we have outstanding purchase orders with the suppliers in terms of supply. So we think we're in a, you know, perfectly reasonable inventory position in order to to sort of meet sales expectations or our internal forecast, expectations.

36:15 How Charles, how do commercially attractive emergency point of care opportunities get identified? So so we have a advisory team that we work with Charles that that helps us through clinical advisory team that helps us sort of populate that list. And what we try to think about is, you know, where where GENEDRIVE can make a difference that maybe competitive systems can't. So we'll think about, you know, a speed to result. But you can have you can have point of care technology like we have for a couple of different purposes. Sometimes it's just about offering molecular diagnostic test in a setting that isn't appropriate for, you know, bigger mainline hospital analyzers.

37:02 So I'm trying to get, like well, actually, our our HCV test is a good example of that. Right? You can get an HCV test in a big hospital setting, but difficult to get out in a rural village. And so there, it's about providing molecular diagnostics in a decentralized setting. Recently, in the last sort of eighteen months or so, we've we've been refocusing our development activities at more of what we call emergency care. So that's about the same idea of offering molecular diagnostics in a setting that isn't isn't historically hasn't been catered to isn't typical, but it's also about providing a molecular diagnostic result rapidly. You know? So I think that's what we do. We work with we work with a clinical team to sort of get the list of what what's appropriate for us to look at, and then we whittle that list down to, well, can we do that in a setting that's nontraditional, and is there value to that? And then secondly, does that customer need it in a very timely fashion, and can we meet that that timeline?

37:59 That's how we sort of think about that. And then I think probably the third thing that we also think about is, you know, what's the technical the technical obstacles in in trying to achieve that. You know, like working AIHL and and c two c nineteen are both tests that work off buccal swabs, cheek swab cells. The workflow for those is more simple than HCV where you're starting from plasma. So, again, we we we prefer if we can to work on, you know, those more straightforward workflows because that helps us generate a rapid time to resolve. Okay. Next question I have here is what's the current position regarding development of the company's TB kit? So we we did pause development of our TB assay pre pre pandemic as then we focused on on other things.

38:49 I think where we are with TB is it's sort of it's sort of half developed, but the market pricing for TB is pretty low. You know, in most countries, you know, you require a price per test at the customer, you know, not from us, but at the customer of less than, you know, 11 US dollars. It's pretty low. So I think when we think about what were the options that we can develop commercially, that's probably no longer in our top in our top list. What we do have, though, as a result of our t d TB development, though, is some interesting technology and IP around sample preparation and things like that, which we can put into play for assays going forward. I'll just look at the time mark. Let's take a couple a couple more.

39:39 This is this is also different name, maybe not the same Samuel. Is the company bidding either on its own or with other partners for any r and d grant funding from sources such as GMCA or UK government? We we we do we do apply for a nondilutive funding when we see it. And I think it we actually have a pretty good track record. We're not currently framed up for any GMCA, which I think is I think that's Greater Manchester Authority or something, I think is what that is, or UK government. So, typically, we would look at things like innovate grants, for example, but we're not we don't have any active innovate grants out right now. And then I've got a question here. Is the company able to utilize DOD funded technology on the BioPlex, namely the battery version of the GENEDRIVE instrument to provide further hardware options for COVID nineteen kit?

40:36 Okay. Well, there isn't a there isn't a battery version of the GENEDRIVE. There's a battery that GENEDRIVE can run off. But to be honest, the setting, think, for this isn't, you know, it isn't based in the field. This is still hospital application really typically or or not not necessarily hospital, but, you know, there's there's mains power. Right? You're in a building with with a plug. So I think a a battery isn't really isn't really required here. But there is maybe unrelated to the battery, There is a lot of interesting know how around bioplex assays, the US DOD assay, because it's a very complex assay. Right? You're looking at lots of different targets. And we will undoubtedly use a very similar style of chemistry for our CYP2C19 assay because that also is a complex target to look at. The workflow is straightforward, but the target itself can be quite can be quite difficult.

41:28 Okay. So, Mark, maybe I'll I'll pause there. That's great, David, thank you very much indeed. And of course, any further questions that we receive, we'll make available to the company after this presentation has concluded. Matthew, David, I know investor feedback is important, and I'll surely be redirecting investors to give you their thoughts and expectations. I wondered if I may, before doing so, just hand back to you, David, just for a few closing comments to wrap up with. And then as I say, I'll redirect investors to give you their feedback. Closing questions. Well, listen, I what what we tried to communicate here today, I think, is that we are in a position where we have, you know, some very, you know, good, unique performing assets in the company, and the job moving forward is simply is simply to commercialize them well. Right? And that's what the focus of the the company is.

42:17 We're very we are very appreciative of the support of our investors. We try to put some mechanisms in place for people to communicate and and engage with us, and and this is one of those. I would encourage people if they do have questions that weren't answered in the presentation that they can submit those directly to us or or through our our financial PR partners at at Wallbrook, and and happy to follow those up. But we certainly do appreciate the engagement of the many hundreds of people that dialed in and took their time to listen to us That's great. David and Matthew, thank you once again for your time this morning and for updating investors. Can I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order that the company can better understand your views and expectations? This will only take a few moments to complete, but I'm sure will be greatly valued by the company. On behalf of the management team of GENEDRIVE PLC, we'd like to thank you for attending today's presentation.

43:09 That now concludes today's session. Good morning to you all.