Genedrive (LSE:GDR) — Full year results briefing

0:01 Good afternoon, ladies and gentlemen, 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. They can be submitted at any time via the q and a tab that's just situated on the right hand corner of your screen. Please just 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 we'll publish those responses where it is appropriate to do so. And before we begin, as usual, we would just like to submit the following poll. And if you could give that your kind attention, I'm sure the company would be most grateful. And I would now like to hand you over to the executive management team from GENEDRIVE PLC. Gino, good afternoon, sir. Good afternoon, and thank you everyone for joining us today.

0:47 I'm Gino. I'm the CEO of GENEDRIVE. So I was appointed in August 2024, and but I've been with the company in its various incarnation since 2011. So very much behind the development of the instrument, the assays, and tests that we put on that instrument and and the positioning of our company into what we call pharmacogenetic testing. And I'm joined by, our CFO, Russ Shaw. Russ, do you want to introduce yourself? Thank you, Gino. Yeah. I'm Russ Shaw, CFO. I've been with GENEDRIVE since April 22. I've got twenty five years international experience in high growth companies across multiple sectors, including life sciences, diagnostics, technology, and industrials. Predominantly, a name quoted companies, I've also been CFO of, private businesses as well.

1:37 Okay. Thanks, Ross. Okay. So what I'd like to do today is here's our agenda. I'd like to take you through a little bit of background of our product and some highlights from our FY twenty four that you'll have seen in our recent final report. A little bit about our positioning, our company positioning, and the progress that we've made. I'll hand over to Ross to take you through some of the summary financials from FY twenty four, and then I'd just like to finish up with a little bit on outlook for the company and future news flow that you can expect. So with respect to our products, our main instrument is called the GENEDRIVE system. It's a low cost, simple to use molecular diagnostic device and it's primarily positioned for what we call emergency care testing where rapid actionable results are required to a clinician.

2:29 These are pharmacogenetic test results. And on that instrument, we've developed two pioneering point of care tests that we use. One of these are called MTRN1. So this is the first in the world to do genetic testing to help avoid what we call antibiotic induced hearing loss, predominantly in neonatal intensive care. And the second rapid genetic test that we deploy on that system is called CYP2C19. So it's a genetic test which enables more effective management of stroke patients. And again, that's the first point of care product to maximize coverage across different ethnic groups and we'll come into that in a little bit more detail in some of the following slides. At the heart of all of this, simplicity and speed to result is key. Remember this is an emergency care setting, they're time critical and the clinicians need a rapid answer in order to make prescribing decisions.

3:27 So it's designed to be used by healthcare professionals in these paradigms. And with that, you know, lot of the features and functionality of the instrument is with those end users in mind. So very much being developed with those end users, user feedback, helping us develop what they need and what they want in those paradigms. Very simple to take a test sample. It's a simple cheek swab, so it's minimally invasive and that's from the adult or the neonate, obviously depending on the test. And very important as well is there's absolutely no requirement for fridges, freezers, cold chain logistics in storage and in transportation. And we use freeze dried ambient temperature stable reagents with which the sample is used to reconstitute.

4:15 The instrument, a lot going on under the bonnet, but all the user sees is simply insert the test cartridge, wait for the appropriate amount of time, so that's twenty six minutes for R and R one, sixty nine minutes for CYP2C19, and then you get a result on the screen. No requirement for any data interpretation, so it's fully clinically actionable. And importantly, that's within timeframes required for both of those paradigms. So before I just go on to some of the positioning around the product, let me just give you a little background on a little briefing on the FY '24 highlights. So on the operational side with the MTR and r one test, you'll know that we had initial orders for new sites in The UK. Royal Sussex County Hospital Brighton has become our routine user.

5:03 And very important for us, the the NIHR and the Office for Life Sciences recently awarded our funding package to our collaborators to enable them to address the evidence gaps that NICE highlighted when they awarded us conditional recommendation. So that takes us to 14 hospitals in The UK, and sales revenue to GENEDRIVE under that program is approximately 500,000 over the lifetime of the award. Again, significant for us was we were awarded breakthrough device designation by The US FDA. So very important as we look to enter The US market, and again, we'll talk a little bit about that in when we get to the the later slides. Alongside that designation from the FDA, we have a US distributor in place, and we have a a physician led clinical research partner, which has broad multi state coverage of US NICU sites. So again, very important for us that we have that positioning in order to facilitate a rent reent to The US market.

6:06 And whilst it's not 2024, very recently, we we get a positive value assessment from the Scottish Health Technology Group as they look to make a case for implementation in Scotland. And And obviously, that was ongoing in in in terms of preparation for that throughout the FY. If we move to CYP2C 19, this is currently UKCA marked, so that permits commercialization in The UK. Importantly But in some regions in The Middle East also recognize UKCA mark. And that's in advance of us submitting for our CEIVD certification, which we've completed the clinical studies for and that submission process is underway. And importantly with those clinical studies, what was very, very satisfying was that the GENEDRIVE point of care test was superior in terms of performance to the laboratory platform, which was very nice to see. And of course NICE gave full recommendation to GENEDRIVE as a point of care method of choice for use in the NHS as they look to implement CYP2C19 into standard clinical practice.

7:12 And following on from that, we had our first sales of SIPTC 19 and notably that was to one of the largest hyperacute stroke centres in NHS England. And as with RNR1, there's also a positive value assessment by the Scottish Health Technology Group for implementation of CYP2C19 genotyping in Scotland. And with regards to the financial side, our revenues and other income increased from prior year 60,000 to approximately 500,000 this year. And of course, we did a successful equity fundraise of 6,000,000 gross in June 2024, and those funds have been continued to be utilized to focus very heavily towards our commercial growth initiatives. So let me just take you back a little, a little step and just ask a question, what is pharmacogenetics?

8:02 And this is the this is the area that we're fully positioned into now. Well very simply, it's a study of DNA variations that relate to how you respond to drugs that are given to you. And it's very well described, ninety percent of medications work only in about thirty or fifty percent of people. And underpinning that is DNA variation and that can lead to ineffective response or in fact adverse responses. And these adverse drug reactions as they're called account for six point five percent of hospital admissions. It's a very high number. And that costs the NHS approximately 2,200,000,000, these figures are from twenty two-twenty three. And it's estimated that approximately thirty percent of these adverse drug reactions could be preventable by pharmacogenetic testing.

8:49 Meaning that you could save the NHS up to $660,000,000 per year, by reducing pharmacogenetic testing. And that's exactly where we're positioned. The availability of that information to the clinician can do several things. It can help address an effective medication, prevent adverse events, it can inform better medicine selection and dosing regimens. Ultimately, it improves patient outcomes and also in parallel, it should reduce health care costs that are associated with dealing with the effect rather than, intervening at the cause. So pharmacogenetic testing mainly performed on, complicated, expensive, centralized laboratory equipment and you'll know yourself when you go to the doctor, get a sample taken, two to three weeks later if you're lucky you'll get a result on what the outcome of that test was.

9:47 And that's okay in a lot of paradigm, but there are certain emergency care situations where that just doesn't work. And these are the two that we're primarily positioned in. And it's where that laboratory equipment can't address emergency care requirements. Now rapid result at the bedside near patient is required. So this requires, tests to be available quicker, than laboratory based testing can currently provide. And that's exactly what we provide the solutions to with currently the two products that we have commercialized. With respect to our potential, this paradigm is emerging clinical paradigm. There is a high regulatory framework, it's complex market access and reimbursement framework and that's because the whole area is emerging.

10:33 And that's true in The UK, but it's also true in other countries as well. However, both of our pharmacogenetic tests have a very, very clear unmet clinical need globally, not just in The UK. And importantly they've been developed with the NHS for the NHS. So substantial NHS feedback has gone into the incarnation of the products that are currently commercialized, at this moment in time. Both of our tests offer huge benefits to patients, financial savings to healthcare systems and very importantly they're recommended by NICE for use in the UK NHS. Our markets are significant relative to our size. Global opportunity is estimated over 300,000,000 per annum and we'll come on to that a little bit later.

11:20 Importantly for both of these, there's no comparably position competition to both of these tests. They offer the same functionality in this in this space. And obviously we're actively in commercialization phase. For both products we have a direct customer strategy in The UK and internationally we focus on distributor networks. So first product, MTRN1, antibiotic induced hearing loss or AIHL for short. In summary, one of seven babies in The UK, this is true in other countries, predominantly as well, one in seven babies are admitted to neonatal units. That's about a hundred thousand in The UK, and a significant proportion of those require antibiotics, certain class of antibiotics.

12:06 And those need to be given within one hour, it's called the golden hour, of the decision to treat for suspected sepsis. And that's fine, but one in five hundred approximately of these individuals will carry a DNA variant in the MTRN1 gene and that places them at very high risk of antibiotic induced hearing loss. And this is profound bilateral irreversible hearing loss requiring cochlear implants, at later stage of life. So GENEDRIVE's MTRN r one test identifies those individuals prior to the administration of antibiotics, reducing that risk of AIHL, and the downstream consequences. And this is the world's first point of care pharmacogenetic test for AIHL and and neonatal intensive care, unit settings. And it's CEIVD certified, permitting commercialization in The UK, Europe, and other countries recognizing the CE mark.

13:01 And you know, the market is, as I said, extensive for our size. We estimate it's in the order of a 100,000,000 addressable market globally. Obviously, The US is an important part of that market and I'll come to that in in a second. You know, as well as massive improvement to patient outcomes, at the same time it saves money. By doing the intervention, it's estimated that NHS England save approximately £5,000,000 per year. So that's financial saving as well as the significant qualitative aspects and patient outcomes that that those individuals expect to receive. In terms of progress, as I mentioned, we have a direct sales model in The UK and a focused distributor network internationally.

13:51 It's recommended by NICE for use in NHS England, whilst further evidence is gathered. And that's a very reasonable recommendation for NICE under that program. It was the highest level of recommendation they could give under what was called the EVA program. We also received positive assessment from the Scottish Health Technology Group for use in NHS Scotland, and that was just in October 2024. So with this conditional recommendation for NICE, what that means is that they recognize it has a significant potential to improve patient outcomes, but there's further evidence that require it to be generated to understand how that can be rolled out at scale across the across the nation. And this is what the NIHR and Government Office for Life Science funding package was there to do. It was there to enable people like us, our collaborators, to ask those questions and understand the logistics of implementation at a national scale.

14:54 So as I said previously, that's 500 k sales revenue to GENEDRIVE over the course of eighteen months. And the purpose of that program is ultimately to generate the evidence that's required to transition from NICE conditional recommendation to full recommendation. And that covers 14 hospitals across all of The UK nations. So we're very happy that program's in place. It started on November 1 and we look forward to that progressing and concluding with those goals in mind. We do have growing commercial traction with this product. It's in routine clinical use in nine hospitals in The UK at the moment, with a further five committed. And importantly with both these tests, it's about placing instruments in live sites and generating a recurring revenue business model. And with respect to R and R one, that's currently 4,000 babies per year.

15:50 In terms of the, total market or the total number of babies in The UK that would receive that test, it's currently 4% and growing. Importantly, so far approximately ten babies have who've had the test, have avoided being administered the antibiotics that will cause them harm. They have gone on to receive alternative antibiotics and effectively been saved from lifelong, profound and irreversible hearing loss. And we have initial international traction via a distributor network internationally. We do have live sites in Europe and The Middle East and that is that is growing. It's not just about signing up distributors, it's about getting sites live, using the product, and making the intervention.

16:39 As I mentioned earlier, we received FDA breakthrough device designation for this product. And this is very important, that recognizes that there is no equivalent predicate test in existence and therefore that's why the FDA awarded this breakthrough device designation. It's a formal identification that a device should be expedited for patient access because of the potential benefit that it brings to that patient population in diagnosing life threatening or irreversibly debilitating, human diseases such as AIHL. So with respect to progress there, as you know, we have a US distributor, International Biomedical. We have this large US clinical research partner which will be very intimately involved with us as we continue the progress through the FDA submission.

17:33 And notably, they are of a stature where they have multi state coverage of US NICU. Currently we're in consultation phase with the FDA on the study requirements. So remember there's a, again, there's a new paradigm never been done before and there's there's a lot of nuances around genetic testing for relatively rare variants in challenging, and vulnerable patient populations. So we're in the consultation phase with the FDA at the moment for study requirements. And that includes internal studies and it also includes the clinical studies. But what we're hopeful for is that US in country studies may not be required if the FDA accept what we call the Paler UK program, which is the NIHR study that I just told you about.

18:25 As a as a in place of, you know, in country US studies. And bear in mind again, it's, 14 hospitals across the four nations and in NICUs of varying size. And you know, we estimate, it's very difficult to give precise timelines for this. I know everyone wants to hear what those timelines are, but again being first through this process with this type of test, we estimate that it's about twelve months for the studies themselves and the FDA process can for reviewing can vary significantly, but we estimate again that that's approximately one year under this program. So that brings us to late twenty twenty six for anticipated approval by FDA to enter The US market.

19:16 This is on track with previously communicated timeline, but of course we're expediting that as much as possible where possible. And one example is, as I just mentioned, seeking to use the paleo UK clinical evidence to mitigate how much in country studies are required to be done. So moving on to CYP2C19 and stroke management. There's lots of factored figures out there. What's important to note in The UK, there's over a hundred thousand strokes per annum. That's estimated to be twelve million globally and it's rising, currently. There's over a hundred million people globally living with the effect of stroke and the cost is staggering. In 2017 it cost healthcare systems approximately 451,000,000,000 to deal with those people affected by stroke.

20:09 Stroke is treated with antiplatelet drugs commonly. One of those is called clopidogrel and stroke recommendation, stroke guidance recommendation in The UK recommends administering clopidogrel within twenty four hours of stroke occurrence. And again, coming back to the laboratory question, laboratories can't address that where a rapid actionable decision on clopidogrel treatment is required within twenty four hours. And there are lots of instances where that's the case. Clopidogrels are an antiplatelet drug as I mentioned, but it needs to be broken down by the gene called CYP2C19 to become active. So it's only active when it's broken down by CYP2C19 and it only exerts its effect when it's broken down.

20:55 But importantly, there's variants in the DNA of the CYP2C19 gene that can impair this. These are called star alleles or targets. And some examples of that are star two, star three, eight, 35 and so on. Our test covers these. If you're an individual that has these star alleles, you will you will experience a worse outcome from being administered clopidogrel because it won't be working as well as it should and ultimately lead that leads to poorer patient outcomes. So our CYP2C19 test is a rapid point of care pharmacogenetic test for identifying these DNA variants two, three, four, eight and thirty five predominantly in the CYP2C19 gene. It's currently UKCA certified, which permits commercialization in The UK, and as I mentioned some regions of The Middle East which accept or recognize the UKCA mark.

21:53 Importantly, it's the only point of care test that covers those five key variants. And some of these variants are very important in underrepresented ethnic groups. So it's the only test that covers all of those variants. And you know, in contrast to RNR1 where approximately one in five hundred individuals have this what's called actionable pharmacogen. In CYP2C19 approximately thirty percent of people carry variants that are known to impair the efficacy of clopidogrel. And that can rise to fifty percent in certain ethnic groups, which is why we cover some of those additional variants in our target assay. The GENEDRIVE test identifies five of these. The results are available to clinician within seventy minutes, well within the clinically actionable time frame that is required.

22:47 Again, I'm, staggering numbers, but interventional CYP2C19 testing in stroke has been estimated to save the NHS a 160,000,000 per year as well as offering significantly better patient outcomes. So, you know, a significant savings to health care systems, not just NHS England alone. With respect to addressable market for CYPTC nineteen, again, we estimate it's in the region of 200 and twenty million per annum. The US is certainly a key key market there, so is The Middle East. You know, one, whereas in The The UK for example, the age of onset of stroke is frequently greater than 70 years old for example. Over fifty percent of people who experience a stroke in The Middle East are 45 years in The UAE, sorry.

23:39 And so we're pursuing that very heavily and we're also pursuing entry to The US market via the five ten ks route. So this isn't the same de novo route or breakthrough route, it's through the five ten k route as there is a predicate test already in existence that we will go in on the back of. In terms of progress, as with our one direct sales model in The UK, distributor network internationally is planned, and we're in the early stages of identifying those suitable distributors to distribute our test. It's currently UKCA certified. We estimate end of q one two thousand and twenty four for receiving CEIVD. It is also recommended by NICE as the point of care test of choice for NHS England.

24:28 There was a positive value assessment by the Scottish Health Technology Group for use in Scotland. And as I said earlier on, you know, we were very pleased to see the clinical study under the devote program, which was Innovate funded, Innovate UK funded, that demonstrated superior performance relative to this the laboratory reference test. And that was with respect to obviously speed, accuracy in terms of its ability to accurately identify those key DNA variants, And the number of successful tests and how many failed and failed to give a result was better in the GENEDRIVE test and also target coverage. And that's really important, you know, in that in that relatively small study, we identified four percent of patients that would be unlikely to respond to clopidogrel would not have been identified with a focus on the restricted number of targets that the comparator point of care test utilizes or indeed some lab tests. So we're very happy that our test increases ethnic inclusivity and it facilitates equitable access to health care for those underrepresented individuals.

25:40 Our focus is on regions recognizing the UKCA mark currently, so that is The UK, some areas of The Middle East, and that will be followed by the regions recognizing the CEIVD mark after q one next year, and obviously, US FDA entry to that market. Most of you I think will be aware that in NHS England at the moment, there is a pilot, data gathering exercise ongoing at the moment. And the purpose of that is to understand the logistics of implementing CYP2C19 testing throughout NHS England at scale and what the methods are for that and the patient pathway and such like. And how to implement that into stroke and transient ischemic attack care throughout NHS England.

26:30 We expect that to conclude in April 2025 and at that point we'll have more clarity on our UK business model and how much of that is point of care and how much of that is laboratory based testing. And of course, we had our first sales to what is the largest hyperacute stroke centre in NHS England and Sulphur. And there are several other stroke centers expected to implement the GENEDRIVE CYPTC nineteen test in advance of that NHS E pilot concluding. With respect to Europe and The Middle East, we have a heavy focus on on those regions in the in Middle East at the moment that recognize The UK CE mark and subsequently, we'll focus with the network in Europe when we get CEIVD certification.

27:16 And as I mentioned, we fully intend to pursue entry to The US market via the five ten k route. And with that, I'm gonna hand over to Ross to spend a couple of slides taking you through some of the summary financials. Thanks, Gino. Start with the income statement. So revenue and other income was at 500,000, a credible increase from the 55,000 in the prior year. As we saw r and r one testing routine use within the NHS, We currently have a pipeline of opportunities for both tests that, if converted, would see revenue step up significantly during the calendar year 2025. The r and d costs increased by 250,000 to 4,200,000 with the focus on the near commercialization product development of CYP2C19, and it also included the costs associated with the devote program.

28:09 We had 1,600,000 admin costs, a 300,000 increase mainly due to employment costs as we enhance the sales and support efforts. And finance costs were 2,500,000 and consisted of a 1.5 1,900,000 non cash fair value adjustment to the derivative financial instrument and 600,000 of transaction costs related to investment funding. The r and d tax credit estimate was 700,000, and that's reflective of the reduction in tax relief rates from HMRC, resulting in a loss after tax of 7,100,000. So looking at the impact on cash flow, the operating loss before changes in working capital was 5,000,000.

28:58 Working capital inflows of 400,000, which is 300,000 higher than f y twenty three, mainly due to creditor movements. We received 800,000 in r and d tax refund. So the net cash flow from operations was 3,800,000, a slight decrease from the prior year. Gross proceeds from investment activities of 7.2 offset by 600,000 transaction costs, lease repayments of 200,000, giving us a net cash inflow of 2.6 and a debt free cash position of 5.2 at the year end. The underlying cash consumption was 400,000 per month, and that was consistent with FY '23. And then post year end, the group's operating expenses are currently running at approximately 500,000 per month, and they're expected to be maintained around this level pending increased commercial traction.

29:53 The unaudited cash position on the November 21 was 3,000,000, and that concludes the financial summary. So I'll hand back over to Gino, who's gonna talk you through the summary outlook and expected news flow. Thanks, Russ. So, yeah, with with respect to summary and outlook, we believe at GENEDRIVE, we're very well positioned to capitalize on this emerging paradigm of near patient pharmacogenetic testing. We have two world leading genetic tests for use in this near patient time critical emergency care settings. Both of them have clear unmet clinical need globally and are recommended by NICE. It's a very well respected organization, other countries look to and recognize as well.

30:40 It's underpinned by positive clinical guidance recommendations and positive value assessments. Very strong health economic cases for both, and that's both patient focused and financial. Overall, there's an estimated global addressable market of approximately 320,000,000 per annum. Importantly, there are no competitors currently similarly positioned with an equivalent offering and functionality to the tests that we provide. And in terms of our regulatory and registration process for a target reason regions, we remain on track. And we do have growing domestic and international traction for both of these both of these tests. So in terms of news flow and what to expect in the near term, we expect to provide an update on the implementation plans for MTN R1 testing in Scotland.

31:31 Similarly, implementation plans for CYP2C19 testing in Scotland. We will be publishing or collaborators will be publishing the results of the CYP2C19 kit performance against the laboratory platform. I'll go into more detail about, some of the highlights that I gave earlier on. Obviously, there's the CYP2C19 C IVD certification process, which we estimate will be concluded at the end of Q1 twenty twenty five. And, you'll continue to hear about commercial progress for both of these product domestically and internationally when it's significant. And that will be throughout the throughout the FY. With respect to medium to longer term, you'll hear some more about our product improvement and further product development.

32:19 Our progress for the five ten k submission, progress for CYP2C19 to the FDA. And longer term, you'll hear about the Paleo UK study, the NICE evidence gap closure progress, and our progress with the US FDA through the breakthrough device de novo submission program. And I just want to finish up with this last slide. And I hope that we've shown you, you know, at GENEDRIVE, we believe we're innovative entrepreneurial. We're very, very commercially focused. And our individuals, our team here have a deep expertise in pioneering, you know, this new area of molecular diagnostics into emergency care settings into and complex healthcare systems.

33:06 We're very passionate about both of these products. They enable far, far better patient outcomes. They address health inequalities as I've mentioned earlier and at the same time they offer significant financial savings to healthcare systems at a time when these systems are overburdened. So we're very committed to growing our company, to be a world leader in this area of patient and near patient pharmacogenetic testing, and delivering value for our shareholders and our stakeholders. And with that, I will conclude and we can move to the q and a section. Perfect. Gino, Russ, if I may just jump back in there. Thank you very much indeed for your presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions just by using the q and a tab that's situated on the right hand corner of your screen. But just while the team take a few moments to review those questions that were submitted already, I'd just like to remind you that a recording of this presentation along with a copy of the slides and the published q and a can all be accessed via your investor dashboard.

34:04 Guys, we have received a number of questions that were both presubmitted ahead of today's event as well as those that have come in throughout your presentation this afternoon. And thank you to all of those on the call for taking the time to submit their questions. But, guys, perhaps if we dive straight into it, the first question that we have here reads as follows. Why is the adoption very slow for both tests? Okay. Thank you. I'll I'll take that one. So I think I think it's it's it's very worth remembering and reiterating that we're at the forefront of this near patient genetic testing setting in emergency care. It's never been done before, and we're effectively creating those markets both domestically and internationally. And those are against a backdrop of, as you would expect, complicated regulatory processes, defining the market access and reimbursement routes, and also generating support at national level via value cases and clinical body recommendations.

34:58 It's it's it's probably accurate to say that healthcare innovation moves slowly or implementation of it does, and the reimbursement routes are convoluted. For example, one example of that is you know, the difficulties in re attributing funding that's directed at care of the effect, addressing the effect, and not easily redirecting that to the site of prevention, I. E. The diagnostics, the interventional diagnostics. But it's important that we have these very strong recommendations from NICE, the endorsement of NICE and significant back end from clinicians, which is at heart the most important element of all of this. Being first to market, there's a high level of, clinical awareness to generate it to generate. Sorry. But that said, our sales and other revenues have increased in this FY to 500,000 and we as we begin to see commercial traction initiate, and we expect this to continue and grow. But, yes, it is slow.

36:04 Thanks, Gino. Just turning to the next question. The share price has plummeted 90% in the last twenty four months. Many investors have lost heavily on GENEDRIVE. What measures are being taken to improve the share price and well-being of loyal investors? Market conditions for small cap loss making companies have been increasingly challenging. And I think that backdrop has played significant part on our share price performance. We do, of course, recognize that, you know, many of our shareholders will be nursing losses, but our focus as a management team is on delivering against the plan and communicating effectively that delivery to the market and our shareholders. I think to add the the share price has constantly traded above the issue price of the May 24 fundraise, but we are, of course, you know, very focused on building further value for our shareholders.

37:02 Thanks, Russ. The next question that we have here asks, bearing in mind that, clopidogrel is the second most common antiaggregant to aspirin for treating myocardial infections and post stenting, will the POC test for CVA patients also be proposed for ischemic heart disease and or PVD patients? Yeah. I'll I'll take that. So that's a very, very good question. I'm and and you're you're absolutely right. CYP2C19 genotype guided prescription of clopidogrel is clinically relevant in those cardiovascular indications in addition to ischemic stroke and TIA. The NICE assessment process focused on IS and TIA in the first instance and the subsequent value and health economic assessments have been built around those indications.

37:48 However, the American Heart Association published a strong scientific statement in June 2024 that supports CYP2C19 genotyping prior to administration of clopidogrel in acute coronary syndrome and peripheral arterial disease. So there's a growing body of evidence from, you know, well regarded key opinion leader literature that supports expansion of CYP2C19 genotyping into other higher need areas. And that that gives us confidence that there's potential for our test to be adopted more broadly than the current requirement of rapid testing in ischemic stroke and TIA. The UK NICE recommendations as I said focus solely on new strokes, and they stated that the recommendations weren't intended to change prescription practice for those people who are already taking clopidogrel.

38:41 So just new strokes, not people who are already on clopidogrel. But the impact and value of CYP2C9E genotyping in de escalating patients from clopidogrel has been published also. And we would expect that CYP2C19 genotyping begins to be used as a reactive intervention in those patient groups also. So in in short, yes, we're confident that it will expand outside of ischemic stroke and TIA, but that's where the clinical body recommendations and the economic value cases are currently focused around, and that's where we're focused on commercialization in the first instance. Thanks, Gino. We have someone asking here, noticed a number of new recruits recently. Has the headcount increased due to workload?

39:28 Short answer, yes. We purposely focus growth of personnel on our sales and marketing teams together with QA personnel. Obviously, you've heard about, you know, the regulatory submissions that we've that we've been doing. Every country has a a regulatory registration process. So that's where we've we've we've focused growth in the company that you would notice the headcount increasing. And and, of course, that was flagged at the time of the May fundraising, that would be the case. Thanks, Gino. The next question that we have here, I think you guys touched on briefly during the presentation, but perhaps if there's anything further to add. The question asks, why hasn't CEIVD designation in September 2021 for the m t r n r one test led to sales in The EU and related territories?

40:15 Yeah. I I I think the answer is it has. I'm but as we noted earlier, you know, it is a it is a slow process. So CIVD certification is the very first regulatory step. Following that, there's a number of steps that have to follow, including identification and contracting of suitable distributors, not just any distributor, those that are able to deal with that product in the the target the intended setting and the intended user, understanding the in country market access and reimbursement route, generating the in country clinical guidance, identification of key opinion leaders, generation of business cases like we've done in The UK, and identification of adopting sites that go live and become routine clinical users.

41:06 And that process that we've seen in The UK for a novel device such as ours and mirror in in EU territories, it's the same same everywhere. Many countries recognized NICE guidance and looked to it, and and that recommendation in 2023 by NICE is is probably the true baseline date, not the CIVD registration. Thanks, Gino. Is the company currently in discussions with stroke research charities and foundations about funding to accelerate the rollout of CYP two c nineteen testing in The UK, or overseas? Yes. We we actively explore and pursue a wide range of market access funding and reimbursement routes, and, these are all, currently being, being pursued. Yes.

41:56 Thank you. And a number of questions have actually come in on this topic. So perhaps if we take this one, as I think it speaks to a few of the questions that have come in. Is the company actively working on developing an expanded range of tests on the GENEDRIVE system? So, our focus is commercialization of the two products that we we have currently got to the stage that we have. So RNR1 and CYP2C19, and that's both domestically and internationally. Excuse me. And and our positioning is in near patient pharmacogenetic testing where rapid results are required to be available to clinicians. So we continue to improve these products based on user feedback and to further facilitate implementation and use and gain a growing foothold across our target markets and domestically and internationally.

42:50 Expansion outside of that is obviously in our mind and our eyesight, but that will be a similar focus on whether it's a clear unmet clinical opportunity where rapid test testing is required to return a result to the clinician. Thank you. And just sticking with, the GENEDRIVE system, why hasn't the company opened up access to other test manufacturers for use on the GENEDRIVE system? For example, GENERMADICS have signed a licensing agreement with Lumen Ultra to develop new tests on their platform. Sure. So we don't currently view open access model like that as our business model that we wish to focus on right now. But we continue to keep an open mind on it. Instead, as I said in the previous answer, I hope we're prioritizing development of assay content which firmly addresses near patient genetic testing in which rapid actionable results are required.

43:53 And, that's without opening up to other vendors to put tests on that. We would prioritize developing those tests ourselves. Thanks, Gina. Just turning to the next question. When does the company expect to be able to start providing more data on its forward sales pipeline? Yeah. No. I I I I appreciate the question. So our our as I said before, our focus is on growing adoption, implementation, and live site in The UK and internationally. Live site being being the key where each of those become a a source of recurring revenue. And as as these grow and become predictable in this emerging, area of near patient pharmacogenetic testing, we will look to provide more granular forecasts to the market.

44:41 Perfect. Thank you, Gino. Why doesn't the chairman join management on investor calls? Does the company anticipate any changes to its board membership over the next twelve months as part of succession planning? So I think the the the second the answer to the second part is no, not as far as I'm aware. These investor relation activities are almost always led by company's executive management team And, Ian Gillum, our chairman, you know, we wouldn't expect a non executive chairman to have an active role, like that in, meetings such as those. Thanks, Gino. How can the company expand the availability of its rapid POC tests in developing world markets where its price point is outside the reach of most patients?

45:27 Does the company see a role for the World Health Organization and Ingo funding to widen access to this new technology? Yeah. I mean, it's a great question. I'm so again, our focus is on developed world interventional health care at this moment with the price point model independently to save, as I said previously, million per annum R and R one NHS England and a 160,000,000 per annum CYPTC 19 in NHS England. And that that's that's using GENEDRIVE products. So even at the price point that we set, those savings are still made. So developing world markets would absolutely equally benefit from these interventions, and definitely NGOs have a role play here. Although in our experience, they're primarily focused on infectious disease diagnostics, which is something that we've pivoted away from in the in more recent years.

46:22 Thanks, Gino. The next question that we have here asks, the results include a statement that the company is actively seeking non dilutive funding. What more can the company say about this? Does the company intend at present to access the remaining funds in the Riverfort drawdown facility? So the nondilutive funding that we referred to was more, kind of conventional grant funding. So that would be contributions towards, you know, product development. An example of that was the Innovate funded that we received from the devote program. Thanks, Russ. Why hasn't the company signed a strategic partnership with a larger medical devices company to provide additional scale and expertise and to help derisk the commercialization journey?

47:12 Great question. And and, of course, we're we're open to those types of arrangement. But at the moment, our focus is on growing implementation of both of our products in The UK internationally and growing generation of a recurring revenue stream. That's our focus at the moment. Perfect. Thank you, Gino. There has been considerable speculation, around the future of the AIM market. Does the company still view AIM and London as the best market for listing of its shares? So GENEDRIVE has been admitted to AIM since 2007, and I think, overall, the experiences have been very positive. We continue to have high liquidity in our shares and see The UK growth market aim as, you know, well suited to our growth profile.

48:06 I think the main market has a 30,000,000 market cap threshold, so we're currently too too small to consider that. Thanks, Russ. Just turning to the next question. The company advised at its last results presentation that national commissioning for the MT RNR1 test was as good as guaranteed from April 2025. Is this still the case? I I I can take that. So, you know, obviously, you know, NHS funding decisions are outside of our control, but we remain confident that NHS England certainly at the moment will identify funding routes to maintain and grow routine clinical use of our RNR one product, which is is obviously as I said earlier, in routine use at the moment.

48:57 And we expect, you know, funding mechanisms to be put in place for that. But it's NHS, funding, decisions that are outside of our control. But, yes, we remain confident on that being the case. Thank you, Gino. And perhaps one for you, Russ. How long is your forecast cash runway? Yes. So we've guided on the level of OpEx that we're currently running at and also indicated that that's likely to be maintained around the same level pending increased commercial traction. Our cash runway naturally is gonna be significantly influenced by revenue growth, and delivering that is a key focus for the group. And I think our going concern statement provided further details on that area as a whole.

49:46 Thanks, Russ. A couple of final questions that we've got here. To what extent, if any, would the American partner assist with the FDA submission? Yeah. I I I can take that. So our US clinical research partner is central in our FDA breakthrough device program. Very important in our FDA pre submission study design sessions. And so so, yeah, integral, very important. You know, they're a very large multi state physician led organization. They have coverage of a large number of NICUs across The US and are aligned with us on the huge patient, and economic value of our r r one test and that what that can bring to The US population. So, yeah, in summary, very important.

50:36 Thanks, Gino. And perhaps one final question that we've got here. In the eight years GENEDRIVE PLC has been a listed company, investors have provided around £40,000,000 in funding to support the company to this point. This is a significant vote of confidence in the strategy, which is gaining commercial traction. However, given the latest results highlight that pharma cog economic POC testing is a newly emerging market and regulatory approval time scales and commissioning decisions are largely outside GENEDRIVE's control. Is the board still confident that the company can deliver meaningful returns, for long term shareholders? Yeah. I think the the market opportunity is a significant relative to the company's size, and we're making continued progress towards building adoption and and revenue generation.

51:26 So we absolutely see a significant opportunity to deliver future value for the shareholders, and we appreciate the support of all of our shareholders. Thanks, Russ, and and thanks, Gina, as well. Thank you both for being so generous of your time and addressing all of those questions that came in from investors this afternoon. And, of course, given the significant attendance on today's call, we will be able to give you back all of the questions that have come in today back immediately after the presentation has ended just for you to review and to then add any additional responses, of course, where it's appropriate to do so. And we'll publish all those responses out on the platform. But, Gino, perhaps, really, just before looking to redirect those on the call to provide you with their feedback, which I know is particularly important to yourself and the company, if I could please just ask you for a few closing comments to wrap up with, that'd be great.

52:14 Sure. Well, listen, first of all, thank you everyone for your time and attention. We at GENEDRIVE, as I indicated in that last slide, are very excited about what the the future holds for our company. The two products that we have in commercialization phase have a huge clinical unmet need globally. I'm in The UK, internationally. I'm and, you know, at the moment, we are we have we have no competition equivalently positioned. We have strong clinical guidance behind us. We have a very strong clinical collaborator network. And we're excited about again what the future holds for these two tests.

53:01 You know, just for GENEDRIVE as a company, but also for the patient, you know. At the end of the day, they're the people who will have significantly better outcomes if they have access to these tests. And that's what we're fully focused on enabling, that these tests are available across nations, across countries, and these patients can rightly expect to receive positive health outcomes as a result of using them. And and, you know, we we thank you for your your support and and staying with us as we continue through this journey. So thank you. That's great. Gino, Russ, thank you once again for updating investors this afternoon. Could I please ask investors not to close this session as you will now be automatically redirected for the opportunity to provide your feedback in order that the management team can really better understand your views and expectations?

53:55 This will only take a few moments to complete, but I'm sure it'll 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. That now concludes today's session. So good afternoon to you all. Thank you.