Good afternoon, ladies and gentlemen. 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&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 will publish those responses where it's 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. I'm Gino. I'm the CEO of Genedrive. So I was appointed in August 2024, but I've been with the company in its various incarnations since 2011, so very much behind the development of the instrument, the assays, and tests that we put on that instrument, and the positioning of our company into what we call pharmaceutical 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 2022. I've got 25 years of international experience in high-growth companies across multiple sectors, including life sciences, diagnostics, technology, and industrials, predominantly in quoted companies, but I've also been CFO of private businesses as well.
Okay, thanks, Russ. 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 about our product, some highlights from our FY 2024 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 Russ to take you through some of the summary financials from FY 2024. 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 product, 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. These are pharmacogenetic test results.
And on that instrument, we've developed two pioneering point-of-care tests that we use. One of these is called MT-RNR1. 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.
It's designed to be used by healthcare professionals in these paradigms. And with that, a 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. 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 26 minutes for MT-RNR1, 69 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 the time frame that's 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 2024 highlights. So on the operational side with the MT-RNR1 test, you'll know that we had initial orders for new sites in the U.K. Royal Sussex County Hospital Brighton has become our routine user. And very important for us, the NIHR and the Office for Life Sciences recently awarded a funding package to our collaborators to enable them to address the evidence gaps that NICE highlighted when they awarded us conditional recommendation.
That takes us to 14 hospitals in the U.K. Sales revenue to Genedrive under that program is approximately GBP 500,000 over the lifetime of the award. Again, very significant for us was we were awarded a breakthrough device designation by the U.S. FDA. Very important as we look to enter the U.S. market. Again, we'll talk a little bit about that when we get to the later slides. Alongside that designation from the FDA, we have a U.S. distributor in place, and we have a physician-led clinical research partner which has broad multi-state coverage of U.S. NICU sites. Again, very important for us that we have that positioning in order to facilitate a ramp rate into the U.S. market.
While it's not 2024, very recently, we get a positive value assessment from the Scottish Health Technologies Group as they look to make a case for implementation in Scotland. Obviously, that was ongoing in terms of preparation for that throughout the FY. If we move to CYP2C19, this is currently UKCA marked, so that permits commercialization in the U.K. , but importantly, in some regions in the Middle East, but also recognized UKCA marked. That's in advance of us submitting for our CE-IVD certification, which we've completed the clinical studies for, and that submission process is underway. 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 is very nice to see.
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. Following on from that, we had our first sales of CYP2C19, and notably, that was to one of the largest hyperacute stroke centers in NHS England. As with RNR1, there's also a positive value assessment by the Scottish Health Technologies Group for implementation of CYP2C19 genotyping in Scotland. With regards to the financial side, our revenues and other income increased from prior year at GBP 60,000 to approximately GBP 500,000 this year. Of course, we did a successful equity fundraiser of GBP 6 million gross in June 2024, and those funds have continued to be utilized to focus very heavily towards our commercial growth initiatives.
Let me just take you back a little step and just ask a question: what is pharmacogenetics? And 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: 90% of medications work only in about 30%-50% 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 6.5% of hospital admissions. It's a very high number. And that costs the NHS approximately GBP 2.2 billion. These figures are from 2022, 2023.
And it's estimated that approximately 30% of these adverse drug reactions could be preventable by pharmacogenetic testing, meaning that you could save the NHS up to GBP 660 million 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 ineffective 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 healthcare costs that are associated with dealing with the effect rather than intervening at the cause. So pharmacogenetic testing is mainly performed on complicated, expensive, centralized laboratory equipment. And you'll know yourself when you go to the doctor, you 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.
And that's okay in a lot of paradigms, 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, and a rapid result at the bedside near a 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 an emerging clinical paradigm. There is a high regulatory framework. It's a complex market access and reimbursement framework. And that's because the whole area is emerging. And that's true in the U.K., 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 U.K. . 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 U.K. NHS. Our markets are significant relative to our size. Global opportunity is estimated at over GBP 300 million per annum. And we'll come on to that a little bit later. Importantly, for both of these, there's no comparably positioned competition to both of these tests that offer the same functionality in this space. And obviously, we're actively in commercialization phase.
For both products, we have a direct customer strategy in the U.K. , and internationally, we focus on distributor networks. So first product, MT-RNR1, antibiotic-induced hearing loss, or AIHL for short. In summary, one in seven babies in the U.K. , and this is true in other countries predominantly as well, but one in seven babies are admitted to neonatal units. That's about 100,000 in the U.K. . And a significant proportion of those require antibiotics, certain classes of antibiotics. 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 500, approximately, of these individuals will carry a DNA variant in the MT-RNR1 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 a later stage of life.
Genedrive's MT-RNR1 test identifies those individuals prior to the administration of antibiotics, reducing that risk of AIHL and the downstream consequences. This is the world's first point-of-care pharmacogenetic test for AIHL in neonatal intensive care unit settings. It's CE-IVD certified, permitting commercialization in the U.K., Europe, and other countries recognizing the CE mark. The market is, as I said, extensive for our size. We estimate it's in the order of GBP 100 million addressable market globally. Obviously, the U.S. is an important part of that market, and I'll come to that in a second. 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 GBP 5 million per year. That's financial saving as well as the significant qualitative aspects and patient outcomes that those individuals expect to receive.
In terms of progress, as I mentioned, we have a direct sales model in the U.K. and a focused distributor network internationally. 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. And we also received positive assessment from the Scottish Health Technologies 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 requires to be generated to understand how that can be rolled out at scale across the nation.
This is what the NIHR and Office for Life Sciences 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. As I said previously, that's GBP 500,000 sales revenue to Genedrive over the course of 18 months. The purpose of that program is ultimately to generate the evidence that's required to transition from NICE conditional recommendation to full recommendation. That covers 14 hospitals across all of the U.K. nations. We're very happy that that program's in place. It started on the 1st of November, 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 U.K. 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 RNR1, that's currently 4,000 babies per year. In terms of the total market or the total number of babies in the U.K. that would receive that test, it's currently 4% and growing. Importantly, so far, approximately 10 babies 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 growing. And it's not just about signing up distributors.
It's about getting sites live, using the product, and making the intervention. As I mentioned earlier, we received FDA breakthrough device designation for this product. 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. With respect to progress there, as you know, we have a U.S. distributor International Biomedical. We have this large U.S. clinical research partner, which will be very intimately involved with us as we continue to progress through the FDA submission. Notably, they are of a stature where they have multi-state coverage of U.S. NICUs.
Currently, we're in consultation phase with the FDA on the study requirements. So remember, again, this is a new paradigm, never been done before, and 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 the study requirements. And that includes internal studies, and it also includes the clinical studies. But what we're hopeful for is that U.S. in-country studies may not be required if the FDA accepts what we call the PALOH U.K. program, which is the NIHR study that I just told you about, in place of in-country U.S. studies. And bear in mind, again, it's 14 hospitals across the four nations and in NICUs of varying size. And 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 12 months for the studies themselves, and the FDA process for reviewing can vary significantly, but we estimate, again, that that's approximately one year under this program, so that brings us to late 2026 for anticipated approval by FDA to enter the US market, and this is on track with previously communicated timelines, 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 PALOH U.K. 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 facts and figures out there. What's important to note that in the U.K. , there's over 100,000 strokes per annum.
That's estimated to be 12 million globally, and it's rising currently. There's over 100 million people globally living with the effect of stroke, and the cost is staggering. In 2017, it cost healthcare systems approximately $451 billion to deal with those people affected by stroke. Stroke is treated with antiplatelet drugs commonly. One of those is called clopidogrel, and stroke guidance recommendation in the U.K. recommends administering clopidogrel within 24 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 24 hours, and there are lots of instances where that's the case. Clopidogrel is an antiplatelet drug, as I mentioned, but it needs to be broken down by the gene called CYP2C19 to become active.
It's only active when it's broken down by CYP2C19, and it only exerts its effect when it's broken down. Importantly, there's variants in the DNA of the CYP2C19 gene that can impair this. These are called star alleles or targets. Some examples of that are star 2, star 3, 4, 8, 35, and so on. Our test covers these. If you're an individual that has these star alleles, you will experience a worse outcome from being administered clopidogrel because it won't be working as well as it should. Ultimately, that leads to poorer patient outcomes. Our CYP2C19 test is a rapid point-of-care pharmacogenetic test for identifying these DNA variants 2, 3, 4, 8, and 35 predominantly in the CYP2C19 gene. It's currently UKCA certified, which permits commercialization in the U.K .
As I mentioned, some regions of the Middle East accept or recognize the UKCA mark. Importantly, it is the only point-of-care test that covers those five key variants. Some of these variants are very important in underrepresented ethnic groups. It is the only test that covers all of those variants. In contrast to RNR1, where approximately one in 500 individuals have this, what is called actionable pharmacogene, in CYP2C19, approximately 30% of people carry variants that are known to impair the efficacy of clopidogrel. That can rise to 50% 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 clinicians within 70 minutes, well within the clinically actionable timeframe that is required.
Again, staggering numbers, but interventional CYP2C19 testing in stroke has been estimated to save the NHS 160 million GBP per year, as well as offering significantly better patient outcomes. So significant savings to healthcare systems, not just NHS England alone. With respect to addressable market for CYP2C19, again, we estimate it's in the region of 220 million GBP per annum. The U.S. is certainly a key market there, but so is the Middle East. Whereas in the U.K., for example, the age of onset of stroke is frequently greater than 70 years old, for example. Over 50% of people who experience a stroke in the Middle East are under 45 years in the UAE, sorry. And so we're pursuing that very heavily, and we're also pursuing entry to the U.S. market via the 510(k) route. So this isn't the same de novo route or breakthrough route.
It's through the 510(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 RNR1, direct sales model in the U.K., 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 Q1 2024 for receiving CE-IVD. It is also recommended by NICE as the point-of-care test of choice for NHS England. There was a positive value assessment by the Scottish Health Technologies Group for use in Scotland. And as I said earlier on, we were very pleased to see the clinical study under the DEVOTE program, which was Innovate U.K. funded. That demonstrated superior performance relative to 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, 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. In that relatively small study, we identified 4% 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 healthcare for those underrepresented individuals.
Our focus is on regions recognizing UKCA mark currently, so that is the U.K., some areas of the Middle East, and that will be followed by the regions recognizing the CE-IVD mark after Q1 next year, and obviously, U.S. 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. 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.
We expect that to conclude in April 2025, and at that point, we'll have more clarity on our U.K. 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 center in NHS England at Salford, and there are several other stroke centers expected to implement the Genedrive CYP2C19 test in advance of that NHSE pilot concluding. With respect to Europe and the Middle East, we have a heavy focus on those regions in the Middle East at the moment that recognize the UKCA mark, and subsequently, we'll focus with the Genedrive network in Europe when we get the CE-IVD certification. And as I mentioned, we fully intend to pursue entry to the U.S. market via the 510(k) route.
With that, I'm going to hand over to Russ 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 GBP 500,000, a credible increase from the GBP 55,000 in the prior year, as we saw RNR1 testing routine use within the NHS. We currently have a pipeline of opportunities for both tests that, if converted, would see revenues step up significantly during the calendar year 2025. The R&D costs increased by GBP 250,000 to GBP 4.2 million, with the focus on the near-commercialization product development of CYP2C19, and it also included the costs associated with the DEVOTE program. We had GBP 1.6 million admin costs, a GBP 300,000 increase, mainly due to employment costs as we enhanced the sales and support efforts. Finance costs were GBP 2.5 million and consisted of a GBP 1.9 million non-cash fair value adjustment to the derivative financial instrument and GBP 600,000 of transaction costs related to investment funding.
The R&D tax credit estimate was GBP 700,000, and that's reflective of the reduction in tax relief rates from HMRC, resulting in a loss after tax of GBP 7.1 million. So looking at the impact on cash flow, the operating loss before changes in working capital is GBP 5 million. Working capital inflows of GBP 400,000, which is GBP 300,000 higher than FY 2023, mainly due to credit improvements. We received GBP 800,000 in R&D tax refund. So the net cash flow from operations was GBP 3.8 million, a slight decrease from the prior year. Gross proceeds from investment activities of GBP 7.2 million, offset by GBP 600,000 transaction costs, lease repayments of GBP 200,000, giving us a net cash inflow of GBP 2.6 million, and a debt-free cash position of GBP 5.2 million at the year-end. The underlying cash consumption was GBP 400,000 per month, and that was consistent with FY 2023.
Post-year-end, the group's operating expenses are currently running at approximately GBP 500,000 per month, and they're expected to be maintained around this level pending increased commercial traction. The unaudited cash position on the 21st of November was GBP 3 million, and that concludes the financial summary. I'll hand back over to Gino, who's going to talk you through the summary outlook and expected news flow.
Thanks, Russ. So yeah, 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 setting. 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. 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 GBP 320 million per annum. Importantly, there are no competitors currently similarly positioned with an equivalent offering and functionality to the tests that we provide.
In terms of our regulatory and registration process for target regions, we remain on track, and we do have growing domestic and international commercial traction for both of these tests. In terms of news flow and what to expect in the near term, we expect to provide an update on the implementation plans for MT-RNR1 testing in Scotland. 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. That'll go into more detail about some of the highlights that I gave earlier on. Obviously, there's the CYP2C19 CE-IVD certification process, which we estimate will be concluded at the end of Q1 2025. You'll continue to hear about commercial progress for both of these products domestically and internationally when it's significant, and that'll be throughout the FY.
With respect to medium to longer term, you'll hear some more about our product improvement and further product development, our progress for the 510(k) submission for CYP2C19 to the FDA. And longer term, you'll hear about the PALOH U.K. study, the NICE evidence gap closure progress, and our progress with the U.S. 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 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 this new area of molecular diagnostics into emergency care settings and complex healthcare systems. 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&A section.
Perfect. Gino, Russ, if I may just jump back in there, and 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&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&A, can all be accessed via your Investor Dashboard. Guys, we have received a number of questions that were both pre-submitted 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 take that one. So I think 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 this is 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. 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 the difficulties in reattributing 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 backing 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. But that said, our sales and other revenues have increased in this FY to GBP 500,000 as we begin to see commercial traction initiate, and we expect this to continue and grow. But yes, it is slow.
Thanks, Gino. Just turning to the next question. The share price has plummeted 90% in the last 24 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 a significant part on our share price performance. We do, of course, recognize that many of our shareholders will be nursing losses, but our focus as the management team is on delivering against the plan and communicating effectively that delivery to the market and our shareholders. I think to add, the share price has constantly traded above the issue price of the May 2024 fundraise, but we are, of course, very focused on building further value for our shareholders.
Thanks, Russ. The next question that we have here asks, bearing in mind that Clopidogrel is the second most common antiplatelet to aspirin for treating myocardial infarctions and post-stenting, will the POC test for CVA patients also be proposed for ischemic heart disease and/or PVD patients?
Yeah, I'll take that. So that's a very good question. And 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. 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 well-regarded key opinion leader literature that supports expansion of CYP2C19 genotyping into other higher need areas. And 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 U.K. 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 were already taking Clopidogrel. So just new strokes, not people who are already on Clopidogrel. But the impact and value of CYP2C19 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 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, notice the number of new recruits recently. Has the headcount increased due to workload?
Short answer, yes. We've purposely focused growth of personnel in our sales and marketing teams together with QA personnel. Obviously, you've heard about the regulatory submissions that we've been doing. Every country has a regulatory registration process, so that's where we've focused growth in the company. You'll have noticed the headcount increasing, and of course, that was flagged at the time of the May fundraising that 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 CE-IVD designation in September 2021 for the MT-RNR1 test led to sales in the EU and related territories?
Yeah, I think the answer is it has, but as we noted earlier, it is a slow process. So CE-IVD 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 intended setting and the intended user, understanding the in-country market access and reimbursement routes, generating the in-country clinical guidance, identification of key opinion leaders, and generation of business cases like we've done in the U.K. , and identification of adopting sites that go live and become routine clinical users, and that process that we've seen in the U.K. for a novel device such as ours and mirrors in EU territories, it's the same everywhere.
Many countries recognize NICE guidance and look to it, and that recommendation in 2023 by NICE is probably the true baseline date, not the CE-IVD registration.
Thanks, Gino. Is the company currently in discussions with stroke research charities and foundations about funding to accelerate the rollout of CYP2C19 testing in the U.K. or overseas?
Yes, we actively explore and pursue a wide range of market access funding and reimbursement routes, and these are all currently being pursued, yes.
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 have currently got to the stage that we have, so RNR1 and CYP2C19, and that's both domestically and internationally. Excuse me. And our positioning is in near-patient pharmacogenetic testing where rapid results are required to be available to the clinicians. So we continue to improve these products based on user feedback to further facilitate implementation and use and gain a growing foothold across our target markets domestically and internationally. 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 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, Genomadix have signed a licensing agreement with LumenUltra 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, and that's without opening it up to other vendors to put tests on that. We would prioritize developing those tests ourselves.
Thanks, Gino. 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 appreciate the question. So as I said before, our focus is on growing adoption, implementation, and live sites in the U.K. and internationally. Live sites being the key where each of those become a source of recurring revenue, and 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.
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 12 months as part of succession planning?
I think the answer to the second part is no, not as far as I'm aware. These investor relation activities are almost always led by companies' executive management teams, and Ian Gilham are chairmen. 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? 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. So again, our focus is on developed world interventional healthcare at this moment with the price point modeled independently to save, as I said previously, GBP five million per annum RNR1 NHS England and GBP 160 million per annum CYP2C19 in NHS England. And 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 to play here, although in our experience, they're primarily focused on infectious disease diagnostics, which is something that we've pivoted away from in more recent years.
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?
The non-dilutive funding that we referred to was more kind of conventional grant funding, so that would be contributions towards product development. An example of that was the Innovate funding 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 de-risk the commercialization journey?
Great question. And of course, we're open to those types of arrangements, but at the moment, our focus is on growing implementation of both of our products in the U.K. , 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?
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 U.K. growth market AIM as well-suited to our growth profile. I think the main market has a 30 million market cap threshold, so we're currently 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 can take that. So obviously, NHS London 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 RNR1 product, which is obviously, as I said earlier, in routine use at the moment. We expect funding mechanisms to be put in place for that, but it's NHS funding decisions that are outside of our control. 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?
Yeah, 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 going to 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.
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 can take that. Our U.S. clinical research partner is central in our FDA breakthrough device program, very important in our FDA pre-submission study design sessions. Yeah, integral, very important. They are a very large multi-state physician-led organization. They have coverage of a large number of NICUs across the U.S. and are aligned with us on the huge patient and economic value of our RNR1 test and what that can bring to the U.S. population. Yeah, in summary, very important.
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 GBP 40 million 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 pharmacoeconomic POC testing is a newly emerging market and regulatory approval timescales 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 market opportunities are significant relative to the company's size, and we're making continued progress towards building adoption and revenue generation. 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 thanks, Gino, 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. 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.
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 future holds for our company. The two products that we have in commercialization phase have a huge clinical unmet need globally in the U.K., internationally. And at the moment, 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, not just for Genedrive as a company, but also for the patients. At the end of the day, they're the people who will have significantly better outcomes if they have access to these tests.
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. We thank you for your support and staying with us as we continue through this journey. 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? 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 with 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.