Genedrive (LSE:GDR) — Full year results briefing

0:02 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 and can be submitted at any time using the Q and A tab just situated on the right hand corner of your screen. Just simply type in your questions at any time and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company view your questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll and your participation, I'm sure, will be greatly received by the company. And I'd like to hand over to CEO, David Budd. Good afternoon.

0:35 Yeah. Good afternoon, Mark. Thanks very much. Good afternoon, everyone. I'm Dave Budd. I'm the chief executive of GENEDRIVE, and I'm joined today by Russ Shaw, our new chief financial officer who's just joined GENEDRIVE in in March of this year. Thanks to all of you for joining us on this Monday to review the company's activities and progress during our fiscal year to June 2022. Presentation run about twenty five to thirty minutes, I think, total. I'll take you through the company's product development and commercialization progress, at least those sections of the presentation, and and Russ will take you through our finance slide, And we'll both participate, as appropriate with any questions that you have, towards the end. As usual with the investor meets company platform, there have been some questions submitted in advance.

1:24 So we had a little bit of an opportunity to take some of those and elaborate them on the, within the slides themselves so we can cover some of them there. As a company, we've been building and refining our development capabilities, but also putting a lot of time and effort behind our commercial capabilities as well, working with selected partners that have the ability to develop the market for our products. We'll highlight some of our progress and processes in today's overview.

1:54 So slide two, these are the normal disclaimers for company presentations, which you can, read in your own time, of course. There's no need to try to capture, slide images. The presentation itself will be posted onto the GENEDRIVE PLC website following the presentation, today.

2:16 So, as many of you know, the company's foundation is the GENEDRIVE instrument platform with two different versions to serve different user needs. The original small handheld version and a slightly larger benchtop version are now available. The system is closed, meaning that users need to purchase preformulated test cartridges in order to run the system, and then the results are interpreted by a preloaded software algorithm. Either unit is operated by loading a patient sample into the cartridge and then inserting the cartridge into the front of the instrument and then either pressing the start button or initiating a test from the new, interactive touch screen. After the test run time is complete, clearly actionable results are displayed on the screen for the nurse, or the clinician.

3:03 Total analysis time can be as fast as seven and a half minutes. And it was with our antibiotic induced hearing loss tests as well as our COVID nineteen test that we really honed in on our development and assay capability to deliver genetic results much faster than other companies' systems. And that's really important as we think about the strategic focus of the company and how we can make a meaningful difference in specific markets, how we, try to keep our differentiation over the long term, and, of course, how we improve on patient outcomes. It's critically important that devices, are able, excuse me, are able to be used, in the environments in which they're intended. And it's maybe not something that's in forefront of of your mind, but even running a simple test at the point of care is a new frontier.

3:55 Right? I should say a simple genetic test at the point of care is a new frontier. So so instruments and tests and software need to be able to be used by people like nurses that have no previous molecular diagnostic experience. And certainly, that's something that we can demonstrate quite easily now, in our publications of our products, and we've even progressed that further with the introduction of our benchtop GENEDRIVE system. Again, this is really important for the strategic fit of the company as we are introducing genetic testing into new areas of the hospital that have not had the benefit or experience of molecular diagnostic testing, on their wards previously. So I think it's fair to say that GENEDRIVE now has a solid track record of innovation in hardware, software, and test development.

4:44 We were the first company to introduce a decentralized molecular test for HCV, hepatitis c. We were the very first to deliver, our antibiotic induced hearing loss test, into the neonate environment, and we soon hope to be the first company with a point of care test for CYP2C19 that best fits with all of the newest clinical recommendations and guidelines, for for stroke management. And as I mentioned, with our patented technology, we've refined our strategy to focus on emergency medicine, where genetic information can help improve urgent medical care if you're able to deliver a result quickly. So we're focusing on applications where getting results in under an hour is really meaningful.

5:29 So broadly speaking, our development initiatives are focused on, a market or an area that is known as pharmacogenomics. Now pharmacogenomics is admittedly an emerging field in patient management where knowledge of a person's DNA variation enables what's known as precision medicine, which means giving the right drug to the right people at the right time. Now a key requirement here is to move the complex lab based results closer to the prescribing physician and deliver these test results in an unambiguously clear format. And it's here that the GENEDRIVE point of care system promises real impact. So we believe there are really important, excuse me, advantages to this, this focus.

6:15 Now most competitive companies depend on a large menu of assays that can be run on, on their single instrument. And that's because they're relatively high instrument cost, demands a suite of tests to make it economical for the company and the customer to do any testing at all. Now we're maintaining our focus on keeping instrumentation and chemistry manufacturing costs comparably low, and then we're able to focus on really interesting and impactful opportunities that are much more discreet in their nature. And it means we don't require extended user menu. These are applications that we hope to own today and are potentially less subject to future competitive pressure. Lastly, our ability to generate genetic results very rapidly compared to competitive systems and demonstrate the ability to implement in decentralized health care settings means that emergency medicine is an area where we are differentiated from others and we can impact on precision medicine approaches.

7:16 Large potential market markets exist where we can make both commercial progress and a real clinical difference. So here's an overview of some of our operational highlights for the fiscal year to current. As I think probably all of you know by now, the seminal JAMA Pediatrics paper on the PAYLO trial was published. This was the implementation for our our MTR and r one test within the NHS. This paper is the foundation we're working on, to support the commercialization and implementation of the GENEDRIVE MTRN r one test in the neonatal intensive care environment. We've covered with this with you before, but as a result of our real world work, with the PAYLO trial and the PAYLO team, we created and launched a new GENEDRIVE system, which was specifically created for the needs of an urgent critical care environment.

8:13 We had our first system sales, system asset sales and and system deployments, the GENEDRIVE system for, r and r one, which happened at Saint Mary's, women's children's hospital in in Manchester. Two other Northwest hospitals are now in the process of training and install, and I'll go into some more details on our commercial progress, on the next slide, I think it is. We're very pleased to be included in two product review initiatives from The UK's National Institute of Clinical Excellence. One has now become an accelerated evaluation of the GENEDRIVE MTRN r one test, and the other is, I guess, a standard evaluation for the use of CYP2C nineteen genotyping for managing, stroke patients or, I guess, probably for, the administration of clopidogrel is exactly what it's for. Most of these programs serve to collect and publish the supporting evidence, for the NHS and then provide recommendations for use of these tests going forward.

9:17 Now while not specifically connected, both the process of NICE reviews and national commissioning go hand in hand to allow sort of the standard broad commercialization of new products at least, in The UK. And and by that, I mean that products are recommended, the funding is in place at a national level for, for hospital purchasing. Next, our point of, care GENEDRIVE COV nineteen, test received a CTDA or or coronavirus test device approval in in May. Albeit, as you know, this was, after the wave of COVID testing, was coming to its completion. And lastly, most recently, we filed with the US FDA our our pre submission for the GENEDRIVE MTRNR1 kit.

10:04 Now we had previously indicated that we would wait for sufficient funding to be in place in order to pay for the entire FDA process. But now we feel that we at least can make a start and have identified some partners in The USA who can support us to make their all the overall process more, more cost effective. Our FDA pre sub is really just the first phase to get agreement from the FDA on the clinical and study approaches of our registration process given the, unique nature of the GENEDRIVE MTR and r one product.

10:45 So I'm gonna give you a little bit of a discussion around, the commercial activities that have been going on. So over the second half of the year, we did put a new commercial, sales structure into place at the company. We recruited some new business development people, and created a specific marketing communications team. Together, they've been, very active, and I think that many of the people joining the call today would have seen the market impact and engagement of their outreach, in places like mainstream newspapers and some of the specialized, clinical, publications and press. Primarily, the activities of the team have been around supporting the commercialization process of RR one, within The UK, as well as, broadening our footprint into Europe with new, with new partners.

11:35 So, I mean, we have we have, so I guess, stepped back and asked ourselves, you know, some questions about why the distribution partners we've had historically haven't been very successful at selling. And the recognition that selling disruptive new products into new markets, you know, actually is a different job than, you know, selling perhaps an improved product into a market that's already established. So we now have quite an extensive, sort of checklist, I guess, or list of requirements that we work through in order to onboard new commercial partners. And that's gonna help us give some additional confidence that the partners, can define, not a wall not only define a clear path to market, but they're actually able to, put the plan and action into place and make it happen for us. So over on the right here, a little, graphic there under commercial onboarding.

12:27 We're currently working with 22 different distribution partners throughout the process. We've now contracted two partners, one of which is Inspiration Healthcare and our newest partner, which is in Spain, which is a different company than the one that we contracted for for COVID nineteen. We've got three partners in what we term the negotiation stage, which means that we're talking around the terms of the contract, but they've made it through the sort of checklist process. And we've got an additional five partners that have now been fully qualified through the checklist and which we're just beginning negotiation with. The checklist process is quite a rigorous, you know, process. It requires the partner to do quite a lot of due diligence and market research and really shows that they have the capabilities to take our products on board and drive market adoption for the GENEDRIVE MTR and r one test. So in addition to those 10 partners that have been fully qualified, we have an additional 14 partners which are now at a prequalified stage. So these are partners that, again, we're having active discussions with.

13:31 They look like the right people, but we're working through the checklist with them. We're having active conversations to see if they're gonna be the right partners to develop the market for us. So overall, there's been a lot of, you know, a lot that's happened over the last sort of five months, a lot of progress there, I think. Our commercial marketing team, is engaged with funders, payers, influential bodies such as NICE. So they're responsible for supporting and kicking off and and and providing, data, and supporting documentation to the NICE reviews. And they've also done things like developed quite, thorough health economic models, which we're using to support, NHS trusts through their various business cases as they establish funding.

14:22 And just a little bit more on the commercial marketing side. Again, I think most of you that are engaged with the story, GENEDRIVE story would have seen, you know, the dozens of of of articles and and news highlights that appeared in the press, you know, since sort of April time frame. They're all have been in mainstream, press, clinical press, etcetera. And all of this stuff actually is really critical in the market development work that we're doing to raise awareness of what our tests can do.

14:57 So on the, on the assays, first, I'm gonna take you through the progress for AIHL with the GENEDRIVE MTRN r one test. So as I already mentioned, the PALO study was published in JAMA Pediatrics. And this was the, you know, the culmination of three years of development planning, performance evaluation studies, further product development and product improvement, much of that which was actually during a difficult time during during the COVID years. This was a really groundbreaking study demonstrating the first time that point of care genetic testing had ever been done in an acute care environment. I mean, in this case, specifically a neonatal intensive care environment. But to our knowledge, it's the first time that a genetic test was used in any or point of care genetic test was used in in any acute care setting. So, really, really sort of pivotal, groundbreaking study.

16:00 The study itself tested 751 babies during the course of just under a year, and it demonstrated that our rapid test could be successfully implemented in this critical neonatal environment. It showed that neonates, at risk of deafness could be identified and that, critically, physicians were able to alter their prescribing as needed without negatively affecting the patient's care pathway. So, really, to be honest, it was everything you could have wanted in a pharmacogenomics paper. Right? The journal reviewers themselves concluded that the study was an example of pharmacogenomics entering a new era. Right? And so needless to say, there was a lot of excitement around the paleo publication. And it now serves as the documented basis on which we are building our commercialization activities.

16:49 I think, obviously, during the the the trial, you know, the the trial itself identified three babies with the gene variant, and they were subsequently given alternative treatments. Right? And as a result, those kids are leading, you know, fundamentally different lives than they would have had in the absence of the work that we've done at GENEDRIVE. So it's something that we are all genuinely very, very proud of.

17:18 So autotoxicity or or deafness from antibiotics is widely known, but previously, people couldn't really do much about it. Right? With the emergency care requirement to administer antibiotics urgently that overrode the side effects of or the risks of using them. So coinciding with the completion of the payload study were clinical guidelines released by an organization known as CPIC, and they advised clinicians that they should seek to understand the patient's genetic makeup prior to administering gentamicin. And that's one of the key things that, helped kick off the NICE reviews for the GENEDRIVE MTR and r one test. So it's clear that this is a really exciting opportunity for us. We're the only company with a commercial test, and to be fair, probably one of the very few companies with an instrument platform proven to be appropriate for use in this type of environment.

18:15 Based on the rates that MTR one is present in the population and national birth rates, we estimate the total global market opportunity to be worth, in excess of a £100,000,000. Now it makes absolute sense that we first introduced this product into The UK and the NHS as this is where the initial evidence is, generated, and it's where the the the thought leaders on this topic are are known. Right? It's not the most transparent or easy place to launch a product, because the NHS tends to, very much operate as a as a single buyer. But I think we've done a really excellent job to get the critical factors for success moving. We have, Saint Mary's Hospital fully up and running. We've got, two more in process.

19:05 We've got a further eight hospital clusters. So those are hospital groups, now in the sales funnel. All of these, of course, are gonna be subject to successful contracting to bring through. And this actually does align with our expectations. Right? We we recognize that today, this is a market development activity, and it's not just a simple selling activity. Right? The NHS is not a washing cash, and we all know that. But if you have a positive health economic story, it does allow budgets to be put into place, and purchasing to follow. Now, ultimately, for it to be a very sort of straightforward selling process, we would wanna have a nice recommendation. We would want national commissioning in place. We wanna have a very positive health economic story, and we want, you know, reference sites using the product. And and actually, two of the four of these are already in place and the other two are in process.

20:09 So the clinical interest is certainly encouraging, but in the absence of of national commissioning, which means cash, trusts need to establish the funding themselves currently. Right? The test is being introduced to a user group, a neonate laboratory, a neonate environment that didn't previously have to budget for this sort of thing in their department. Right? So we've worked with independent health economic modelers to develop quite a a comprehensive spreadsheet or analysis tool that can illustrate very effectively the net cost savings to a hospital or a hospital system or, in fact, the NHS as a whole. And we're engaged with these, various trusts that I mentioned to set up their own business cases and to get funding established.

20:56 The screenshot that I got in there is is just sort of the cover page of what it looks like, but it is a very, in-depth and comprehensive study. Overall, it demonstrates the positive health economic model in using a GENEDRIVE test compared to the avoided costs of cochlear implants and many of the additional health care costs that can arise as a result of lifelong deafness.

21:19 So I guess the summary is that we're making a lot of good progress, and actually, we should feel positive about that. Right? We we wish the overall selling process was faster, but it's not a straightforward selling activity. Right? It's a it is a market development activity. Prior to the publication of Paylo, many people were were skeptical that this could even happen and certainly unaware of the sort of innovation that we had at hand. We've put excellent processes and tools into place to support the market development activity. We've recruited, focused and knowledgeable people that I'm I'm very happy with that are working to ensure that all of our distribution partners have the means and the capabilities to drive our innovation in their various markets and countries.

22:08 So the next test that, I'm gonna cover is our CYP2C19 product, which is a product that we still have in development, but it's also another acute care pharmacogenomic test. So I think it makes sort of sense to discuss that next. And it clearly demonstrates the opportunities and capabilities that we have in acute and urgent care environments, which as I mentioned, really is an untapped market segment in our industry.

22:39 So CYP2C19, is a gene which is involved in processing many drugs. Right? I mean, we we talk about clopidogrel, I guess, when we're talking about this. But, actually, it's involved with a with a lot of different drugs, right, such as antidepressants, statins, all sorts of things. And then so in many ways, it's quite a commercially exciting marker because its potential uses are across a wide variety of clinical of clinical use of clinical indications. So in future,

23:13 the hope is that we'll be able to expand the claim of the products into other areas, which wouldn't actually require, much in terms of product modification at all, just the clinical justification of why your test can be used elsewhere. But in the case of ischemic strokes anyways, which is where clopidogrel comes in, that is the most widely prescribed drug along, alongside or or prescribed in together with with aspirin to prevent further instances of strokes or further blood clots, after a patient has an initial incident. However, clopidogrel's effectiveness really depends on a person's CYP2C19 genetic makeup. Right? Their ability to metabolize this this drug with up to twenty percent of patients actually not responding to clopidogrel at all. Right?

24:05 So it's clear that these are large markets. Right? If we look at The UK last year, there were over 32,000,000 antiplatelet items prescribed, and the NHS spent £78,000,000 on them. You know? And our population is, you know, I don't know exactly what it is, six six probably 77%, you know, a single digit fraction of the entire Western health care economy. So you can see that this is a huge market. The process of testing for CYP2C nineteen is actually very similar to AHL AIHL from a user's, standpoint. Although the test formulation itself is quite complicated, and I've got a slide on that to show you.

24:51 But for the user, it's effectively the same. Right? It's a it's a buccal swab of the mouth, resuspend that into the cartridge and and into the machine. The vision for the product has has a lot of parallels to antibiotic induced hearing loss. Right? A patient is admitted into hospital or into A and E, and they, they'll be able to get their genetic basis of their CYP2C19 metabolizer status known within an hour, right, which gives clinicians every opportunity opportunity to safely then put them on clopidogrel or, importantly, if they're if they're a non metabolizer for clopidogrel to put them on alternative drugs. Right? Clearly getting patients on the correct treatment at the right time as soon as possible is a critical goal of precision medicine.

25:44 I would say actually that the market itself is actually more developed than MTR and r one. CYP2C19 has been around for a little while as a known clinical marker, And there are already existing guidelines on testing for clopidogrel and CYP2C19.

26:01 And there have been in some areas other point of care devices available. But from our view, they're not very easy to use, and they're actually not very rapid. So they're somewhat limited into the level, in which they can, they can play within precision medicine and the acute care environment.

26:24 I mean, interestingly, if we look at The US, for example, there is already specific reimbursement established for CYP2C19, testing, which is $291 per test. So that's the that's the price that an insurer or a patient or whatever would pay to have the test done. Right? And if you just look at ischemic strokes, again, remember I mentioned that this test could be used beyond strokes. But if you just look at those, there's around seven hundred thousand of those in The US alone every single year. So our our inclusion, again, in a nice review can only be seen, as a very positive development to support the future launch of this this product.

27:13 So this is maybe slightly technical, but I don't I don't think I don't think I've shown this to you before. So just to understand how it differs from AIHL. So unlike r n r one, where where you're just looking actually for a single gene variant, here with CYP2C19, we're actually looking at six different variants. And each of these work alone or in concert to drive different metabolic statuses or I should say metabolizer statuses, I guess,

27:43 is what you'd say. So, if a patient has the common variant, which is shown, like, in green, they'll just be normal metabolizers or or responders. Right? But if they possess a variant in in any of these things, like we've shown in red here, their ability to metabolize the drug is then compromised, right, with some not responding and some not responding at all.

28:05 And the GENEDRIVE software on the system will interpret, these these signals and output the various clinical options in a very simple straightforward way to the user. For patients that carry, one of the variants of concern, as I mentioned, they're put on alternative treatment. Tricagrelorol is the is the prime one that people go on to. There's an increased risk of bleeding with this drug, is where the literature sits today. But using this genotype guided approach, it avoids giving these patients clopidogrel to whom it simply wouldn't work at all. Right? So it's a it's a great example of using genetics to guide the appropriate therapy for a patient at a very critical time of their life.

28:53 We anticipate that the product will be released around the same price point, has around the same manufacturing costs as well for MTR one and, the end user pricing might differ a little bit depending on the reimbursement rates by by various countries. Our business development team is following up with, you with our our our diligence, process to establish commercial partners in various markets for this. It's they could be or could not be the same ones as r and r one. It really just depends on how they're set up in their in their various countries. The last slide I'm gonna report out today is on our COVID nineteen, point of care test. And, I think we know it doesn't come as much surprise this morning when we reported that we haven't made any sort of significant commercial advancements on the test since we can all see in hindsight that it was launched at a time when the rate of COVID testing was coming down quite dramatically, and the requirement for testing for things like travel was being, eliminated.

29:59 So a good thing for the world, of course, but not a great thing for diagnostic businesses trying to drive COVID uptake. And and the reality is this COVID testing has just not returned as of yet. Right? None of us is out there really getting COVID tests done anymore. We we have our distribution partners in place in in The Middle East and Spain who actually have been working very diligently to find opportunities, but they simply have not materialized simply because the epidemic hasn't hasn't really reemerged yet, and government testing policies haven't looked at reintroducing testing. So we do stand ready and poised for future opportunities, should the testing demand, return. But similar to you, we're not in a in a position to judge if and when that's, when that might happen.

30:51 Okay. So I'm going to, hand the discussion over to Russ to take you through our summary financials. I'll come back and, go through our news flow, expected news sort of publications over the next six months, and then we'll, we'll go over into our, our q and a session. So Russ? Thanks, Dave. Good afternoon, everybody. I'm Roshaw, the chief financial officer.

31:17 I have just one slide summarizing the financials for the year. As Dave has just explained earlier in the presentation, there was limited sales traction in the year. This was in no small part due to receiving our CTDA in May, which coincided with the lifting of the lockdown restrictions.

31:34 Operating costs of 5,700,000 reduced by 500,000, which reflects the continued tight cost management. This year's r and d tax credit is 1,000,000, which takes the loss after tax for the current year to 4,700,000. In terms of cash flow, the cash consumption from operations was 5,300,000, which is broadly in line with the previous year.

31:58 Working capital consumed was 500,000 less than the prior year, which is consistent with the reduction in operating costs. And we received 1,200,000 from HMRC regarding last year's r and d tax claim. There was a 6,700,000 cash injection from the sale of shares, which included the place seen and open offer of 6,600,000 in October 21.

32:23 And this gives us a net cash inflow of 2,000,000 for the year, which when added to the 2,600,000 brought forward, means we ended the year debt free with 4,600,000 of cash in the bank. And just to give an update on the post year end cash position, as at the October 31, we had 3,000,000, which was in line with our current 400,000 per month burn rate. And that concludes the financial summary. Thank you. Okay. Thanks, Russ. So last slide, I hope hopefully, we're on hopefully, we're on time. This is the anticipated sort of news flow at a high level. So in the next six months, clearly, we intend to be signing up and contracting additional distribution partners for MTR and r one.

33:15 Right? It's obviously critical that we expand the footprint, into Europe and begin market development activities there. We, expect to have additional go live sites in The UK for MTR and r one. As I mentioned, two in process already, at eight clusters, in the funnel. Our, the consultation for R and R one through NICE, will be completed in less than the next six months and expecting the output from that. We will, continue the promotion and launch of the GENEDRIVE MTR one assay in the EU countries following signing up of distribution partners. And we will also be launching our CYP2C19 product in The UK under what's now known as The UK CA mark. So this is sort of a post Brexit CE marking that is, specific for The UK. So we'll see that, we're targeting around the April time frame.

34:10 If I look on the longer than six months time frame, the the second NICE review, the one for clopidogrel and CYP two c 19, will be completed, in that time frame. We'll be launching the CYP two c 19 into other territories following what's now known as the IVDR registration. So we have UKCA mark now for The UK, for this product, and then we have IVDR for Europe. So that's a different registration process now, and it will take a little bit longer, which is why, it's slated for longer than six months. And then we have our, initial presub meeting, with the FDA in December. And then pending, pending those discussions, we'll know where we are in terms of what the trial work looks like going forward.

35:02 So, hopefully, we'll be able to say something positively there. Okay? So that's where we're sitting in terms of news flow. That brings us to the end of the sort of the formal presentation. And thanks very much, Mark. And I guess, I'll hand it over to Q and A. That's great. David, thank you very much indeed for updating investors this afternoon. Ladies and gentlemen, please do continue to submit your questions. I just want the company to take a few moments to review those questions submitted already. I'd like to remind you the recording of this presentation along with a copy of the slides and the published Q and A will be accessible via your investor dashboard. I'd also like to submit that poll that I inversely consent to you earlier. So if you would give that your kind attention, I'm sure that the company will be most grateful. David, as you can see, and Russ, you can see you've had a number of questions from investors today. You also received a number of pre submitted questions. So if I may, David, just hand back to you. And if I could ask you to read out those questions and give a response where it's appropriate to do so, I'll pick up from you at the end. Sure. Great. Thanks very much, Mark.

36:01 What what I'll probably try to do is try to group some of the questions into into themes, I guess. Lots of the questions do come in actually before the results even get published or before the presentation is is given. So we do try to sort of answer a lot of those things in the presentation itself. So, hopefully, now that we've been been through that, some of the initial queries have been have been answered. But there's a there's a few here that we can go into a bit more, detail. So the first one is following the, the huge leap forward in product development and approvals, over the past twelve months, is it feasible or plan to license out certain products for a fee and royalty to allow GENEDRIVE to concentrate on what you do best, developing innovative new new products? So, I mean, the question really is is around, you know, revenue and how we're driving revenue. We tried to cover some of that in the presentation.

36:53 I would say that from a a licensing standpoint, this is effectively what you do when you when you enroll distributors. Right? You're giving up a part of your potential margin to another company to pay for their activities of selling, And then you don't bear the cost of a national or or global Salesforce. We we don't sell directly to users. We work through distributors to reach end user customers. And they're and the reason is that if they're selected well, they should know the end customers in terms of who they are, what their influences are, etcetera, and they're able to manage the sales process, you know, then we would be, say, based in Manchester trying to manage a a customer in Italy, for example. So the challenge is that, you know, and I have said this before that no one will ever, you know, care about or be as passionate about your products as as you are. And and that's why it's important that we work, side by side and sort of hand in hand with distributors. So we do have a commercial sales team, and their job is to work out in the field with distributors to make sure that they're, making the sales calls, that they're able to handle objections and do the things necessary to get the sales process going.

38:04 You know, I I guess in the future, licensing is something that would be possible. But at this stage, this is a market development activity, and I think we need to get through that that stage through, through that stage first. This the second question mark that I'll I'll, I'll tackle, I guess, is just around is about fundraising. We mentioned fundraising, in the, RNS releases this morning and lots of questions on the panel here on the right about fundraising. So it says it's clear that GENEDRIVE will need access to additional funding to remain a going concern ahead of expansion and sales linked to AIHL and stroke. Existing shareholders would like some clarity on, on further dilution that would come from an equity issue.

38:53 Are there alternative sources of loan or debt finance that can be accessed to finance growth plans until the company is sufficiently cash generative, to fund its own growth, removing the need for another round of equity. So we again, we touched on it a a a little bit, especially in the going concern section. But maybe, Russ, do you wanna, do you just wanna pick up on that one if you could? Yeah. Sure. I think, you know, it's fair to say as a board, we do continually assess the company's future funding requirements and the cash runway. That's all been set out quite clearly in the annual reports and accounts. I don't think it'd be appropriate to sort of comment on any specific financing activity, but we do have the options of, you know, reducing our expenditure to extend the cash runway.

39:44 We're looking at alternative non dilutive financing options. We have grant applications in process as well. Okay. Next question is around the commercialization process for m t r r one in Europe. It appears to be taking longer than you would have hoped. Why is this? And what can be done to accelerate, sales growth in The UK to, and in The UK and acts and what could be done to accelerate sales growth in The UK and access the core European markets? Okay. Sorry. Apologies. The wording was a bit, off there. Was obviously, the the point in the question is why why don't you sell them faster? Right? Internally, we always understood that there was initial sort of phases of this. Right? It was about selling into Manchester. It was about selling into key opinion leaders, working on national commissioning before broad adoption, could happen. So our ambitions our initial ambitions were always, somewhat modest in terms of numbers of customers that we would be able to get in this first phase. Right? We knew that there was a requirement to let the market know about our products. We had to work with them to fund get funding into place on a case by cases. And that and that's what we're doing before any sort of national pot of money, can be available. Right? So we're cognizant that initially it really wasn't a key opinion leader, market at first.

41:15 I think the also in the point, could we have gotten into European markets faster? The answer is probably probably yes. We have the same sort of process to go through in most countries, right, in terms of of, you know, market development and and market education. So I think right now, the issue is that we're putting a lot of diligence into making sure we get the right partners. But part of that is them doing that market assessment now before we sign them up. Right? I think we found ourselves in a position before where we had distributors in some cases that weren't able to drive the market because they realized afterwards that actually it was more complicated. And they weren't prepared to put the resources into place to to make it happen, and we don't wanna find ourselves in that position as well. So I did in the presentation take you through sort of the various stages and the numbers of countries and distributors that that we're working with.

42:12 And I actually think it's time well spent to make sure that we get the right people that can do the job for us. Right? Distributors will want exclusive contracts in countries. And if you sign a contract and then they turn out to be not the right, you know, not the right people, you you can be a little bit stuck. So it's really critical that we focus on getting the right people in place in the various European countries that we're that we're focused on. Next question. Could you could you expand on the reasons for the timing for the pre submission to the FDA for MTR one? How long do you expect to take for the FDA to make a decision on the pre submission? And then what are the next steps and expected timeline for these assuming the pre submission is successful?

43:00 Okay. So just so everyone's clear, we filed for a with a pre submission or pre sub as it's as it's called, which is an initial meeting with the FDA to get their view on our product, right, and our plans for the FDA process. So we filed a, you know, a dossier with them, and we have our first meeting with them in the middle of December. So it's an eight, eight well, estimated eight week time frame from the time we originally submit. And then what happens after that is really, dependent on on what the FDA what the FDA has to say, to be honest. Most of the time, you go through a process which is called a five ten k. And a five ten k is a process of showing that your product is what they what they call substantially equivalent.

43:49 So basically similar to another product that's on the market. Right? So if you're introducing a product that's faster or, you know, more sensitive or something like that, you'll go through a five ten k process. And one of the advantages of that is that you can just look at that other company's FDA filings and and what they did in order to get approval and essentially replicate that. In the case of m t r and r one, there there isn't a replicate product. There are other point of care tests in the market. There are other molecular tests in the market, but there isn't really any a product exactly the same as us. So there is nothing that we can look at, already in advance of chatting with the FDA to say this is what we need to do. So we put our proposals forward, and the pre sub is about them getting or trying to get some, agreement with the FDA in advance of what studies it is that we're doing. So we really need to have this meeting, and then get their feedback. And then that will drive the number of studies that are needed to be done, whether patients need to be enrolled or not, how many sites we need to do evaluations at. That drives the cost calculation, and it and it drives the time. Right?

45:01 So that's where we are right now. So I guess the question was is what happens with the timeline for the pre sub. I suspect we'll get feedback from the FDA in January or early February would be my guess. And then we'll be in a position, to figure out what it looks like going forward. Next question is around, in well, interest rates, global inflation, all that sort of stuff. How has GENEDRIVE been in fact impacted by the recent rises in global inflation and interest rates. Right? Russ, do you wanna take that one? Yeah. Sure. Well, we're debt free, and we've got cash reserves. So we've benefited to some extent for the higher interest rates. Energy costs are fixed until around the end of Q1 of twenty twenty three.

45:53 So that gives us a good level of protection so far today. Sales price is denominated in sterling, which potentially is more attractive for international opportunities. So, yeah, overall, I think we've mitigated the impact rather well. Okay. Ross, the next question is also a slightly financed oriented question. How much further investment does the company expect to make in, the CYP2C19 test? Okay. Well, we've made excellent progress in the product development. And although there's increased complexity of the CYP2C19 assay, we have benefited from applying the lessons learned from previous developments, particularly RNR1 and the evolution of the GENEDRIVE instrument itself.

46:47 I'd estimate that kind of 90% of the test development process follows a well proven path for us, and that includes the development of the test reagents, the the cartridge, creating the software. And then once all those things are fixed, it's the process of driving those changes through the documentation. So the instructions for use, training materials, etcetera. So alongside, there is some element that would be unique for each test, and that will what drives kind of the variable element of it. So, you know, if there's a new technical issue or the level of patient customer data that might need to be generated. So, you know, in the main, I think a test takes twelve to eighteen months to develop and has an average r and d expenditure of around 125,000 per month.

47:37 And and then the the so the real variable depends on the cost of getting it to market and, you know, the clinical trials, whether that be sort of FDA or IVDR. Okay. Thanks, Russ. There's a question here on the panel from Jason. Why are you waiting for NICE to conclude before going to Europe? We're not. NICE is a UK, oriented, organization. Globally, lots of countries do look at what NICE has to say, but but we're not. From a UK perspective, we'd like to have NICE. We'd like to have reimbursement in place, but that's not obviously relevant for other European countries. So so we're not waiting.

48:23 Our our work is really around the diligence that we're putting in and selecting partners. So I mentioned in the deck, we've got two two partners contracted now, another three quite imminent. So, we will have five in a very short time frame, and and those other ones are are European based. There's a question from Miles. When thinking about ER, I guess, emergency room, when thinking about ER acute testing and on the back of CYP2C19, how many more similar diagnostic assays might you be able to work on assuming cash was not an issue? So I guess, Miles, where we where we sort of get our initial, list of tentative targets is the CPEC. If you go online and type in CPEC, pharmacogenomics, for example, this is the clinical advisory board that tells patients or tells clinicians about how to manage, patients with using genetic information. And there's quite a long list of, potential targets there.

49:22 So there's a few things that we think about when we wanna bring a target on board. One is, is there a need to do it in the point of care? Is there a need to do it in an emergency setting? Is time relevant? How complex is it? Some some genetic tests are very complex and would exceed the capabilities, for example, of a gene drive device. So all of those things we factor in, and and and the reasons that we're working on r n r one and CYP2C19 is that they're high up on that list. So a lot of the clinical, rationale already exists. But in terms of how many, we we generally run the run the business to run two development activities at a time, recognizing that once a product is out the door, it doesn't mean it's done. So our r and d team, for example, still works on AIHL.

50:14 Right? They we we have you know, we do product modifications. We do updates on software, all of that sort of stuff, which does occupy some bandwidth of the r and d team. So, typically, we're running, two assays at a time. And as, as Russ mentioned, you know, on average, it's around a 125 k a month per assay, which is r and d expenditure. And and so that's clearly something that we're able to to flex if we if we want to. Next question, Mark. I'll do I'll do the maybe maybe two more just cognizant of the time. Next question is, some of the some of the social media activity around the company can feel quite toxic.

51:01 Does the company take action against abusive, vexatious, or potentially defamatory social media posts or emails, which mean direct to the company? The answer is no, really, to be honest. Like, it's a it's it's a free world, and and and people can say whatever they like, right, provided that it's not not illegal. It's just the the world that we live in. You know, genuine investors can ask genuine questions, and our our primary route that we use is is VO Ballbrook. Right? So you put, put questions through there, we speak to them very often in terms of trying to get answers back to to people. On the social media side, I guess we don't really engage in social media that's anonymous. Right? So places like, like Twitter, forums, things like that where where you could be anyone, we we don't participate in other than Twitter we use as an outgoing, channel, but we don't we don't follow-up on on post there at all.

52:00 And I and I guess the you know, it's it's obvious to say, but if someone was a genuis a genuine, investor and wants to see positive share price appreciation, they're they're not gonna be online, you know, be being abusive. Right? That these are are not investors. So we we just tend to ignore them. The only place that we do any sort of a back what's the way active, I guess, social media management is just our LinkedIn page. Because for me, that's our sort of shopfront on the world. We don't use it for for financial or investor purposes, and so we do we do manage things a little bit there. And then, I guess, Mark, last question will be on how how long after the successful completion of the the NICE DAP evaluation for our m t r one test should we expect widespread NHS take up? So I did I did cover it a little bit, but just to, I guess, be clear about what's what's in our, what's in our abilities.

53:00 We today, we are driving uptake, and we are driving sales activities in trust, but we're doing it at a trust by trust basis. So we have to we're focusing on what we call hospital clusters, so groups of hospitals, and we're working through the health economic model and working with them to put budgets into place so that they can purchase. That's that's what's in our control right now. Ultimately, we would love to have a nice approval. Clearly, that's very beneficial. And we and we can work on that. Right? We are supplying data, evidence, all that sort of stuff into the NICE review to best support the products the best that we can. We have we have references and clinicians that speak on our behalf, as reference sites, so that's that's, certainly very positive.

53:48 The the one thing that we don't have direct control as a company because not really possible is national commissioning. So we know we're told that national commissioning is ongoing, but it's not a process that we are engaged in or influencing, really. And so we sort of have to let that. Well, not let it go. It's not the right word, but it's it's it's less in our control. But, ultimately, when that hits in place, that will drive the timeline that you ask about. So, I think the NICE review in itself helps on the case by case trust discussion, but it is national commissioning once it's put into place, which makes buying of the product, at least in the NHS and in The UK, more of a routine, activity.

54:35 That's great, David. Thank you very much indeed. And thank you to all the investors that have submitted questions throughout today's meeting. We just simply haven't had time given the number of investors on today's calls to get through all of them. But David, I'll make all the questions available. If there's anything that we have missed or whatever, then obviously we can publish those when the meeting has concluded. I'll shortly redirect investors on the call to provide you with their feedback, Dave, which I know is particularly important to you and the company. But before doing so, I wonder if I may just ask you for a few closing comments. And then as I say, I'll redirect investors for their feedback. Sure. Well, thanks, Mark. Appreciate your, your stewardship of the presentation today. We listen. We we we recognize, you know, the the investor sentiment that that we're good on developing products and haven't done a great job in commercializing.

55:21 And we do take the comment on board, and we spent a a lot of effort over the over the the time since the launch of of MTR one to get good commercial traction. And I do feel that we're making good progress. We are we are keen to hear from you. And if you have ideas or suggestions, again, you can use the normal normal channels to communicate with us, and I'm happy to discuss with you further. Okay? That's great. David, Russ, thank you very much indeed for updating investors this afternoon. Can I please ask investors on the call not to close the session as we're now automatically redirect you for the opportunity to provide your feedback in order the company can better understand your views and expectations? This only take a few moments to complete, but I'm sure will be greatly valued by the company. On behalf of the management team at GENEDRIVE, we'd like to thank you for attending today's presentation. Good afternoon.