Genedrive (LSE:GDR) — Preliminary results for the year ended 30th June 2021

0:02 Good afternoon, ladies and gentlemen, and welcome to the GENEDRIVE PLC Results Investor Presentation. Throughout this presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Just 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 today's meeting given the attendance on today's call. However, the company will review all questions submitted today and publish responses where it's appropriate to do so. These will be available via your investment company dashboard, and we will send you an

0:32 email to notify you when they are ready for your review. I'd also like to remind you that this presentation is being recorded. Before we begin, we would like to submit the following poll, and I'm sure the company will be most grateful for your response. And I'd now like to hand over to Matthew Fowler, CFO, and David Budd, CEO from GENEDRIVE. So, good afternoon, Mark, and thanks everyone for joining us today to review the company's activities and progress for our fiscal year to June 2021. As Mark mentioned, I'm David Butt. I'm the chief executive of GENEDRIVE, and I'm joined today by Matthew Fowler, who's our chief financial officer. Presentation follows our results released from Tuesday of this week. There were lots of questions submitted to us prior to the presentation, and so had the opportunity to address some of those within the slides. And so there's some additional detail in there for you as well.

1:23 Despite our well documented challenges last year, we are looking forward very optimistically with several innovative products on the market, and we've used the past year to develop two very new exciting tests which are at launch phase. We believe that both of these new products are highly attractive proposition and present an opportunity for significant long term value to the company and to investors. For those of you new to the company, we should, I guess, just start from the understanding that our tests run off a common technology platform housed within our GENEDRIVE instruments. It's a low volume DNA amplification technology capable of yielding genetic analysis in as quickly as as as ten minutes or in some cases, perhaps even faster. The technology is now a tried and proven platform with positive clinical data, a peer reviewed data independently generated, all of which demonstrate that these systems work very well as described. And I think from a technology perspective, we think of them as effectively derisked.

2:25 We have a number of near term and exciting opportunities, as I mentioned, which have the opportunity to drive revenue, and we believe our device and our tests have clear competitive advantages for our target applications. So the GENEDRIVE device is essentially a portable genetic reader, as I mentioned, and it gives information about genetic sequences. So specific genetic sequences can then be interpreted by the device to give information to a person around whether they might be infected or not, if they're a carrier for a specific mutation, or if they would benefit from a specific therapy. The device amplifies or magnifies DNA into a quantity that can be analyzed, and a significant advantage of the product is both its ease of use and its speed.

3:11 As I mentioned, it's now been extensively performance validated by the US Department of Defense by FIND, the foundation for innovation and new diagnostics, and and extensively here in The UK last year by the NHS. The instrument itself is cartridge based, meaning that every test requires the purchase of a new cartridge to run the test. And the unit itself is operated by just inserting the cartridge into the front of the instrument and either pressing the the start button, which is located in the in the photo on the top left, just on the front of the screen, or on the bottom left there from our new interactive touchscreen version. It's very simple to use, as I mentioned, and it's been shown to be able to be accurately used by people that have no previous experience in diagnostic testing at all.

4:05 So as I mentioned, our near term revenue will be driven by antibiotic induced hearing loss or AIHL as we shorten it to, and the GENEDRIVE COVID nineteen ID kit, which is our new point of care test for COVID nineteen. All of the assays that are listed here on this slide will have more detail on slides to follow. So this is just a quick overview. At the top, in 2020, a large scale NHS trial was completed for our GENEDRIVE m t r n r one test, which is the formal name for the AIHL product. And this has informed and prepared us for the very first phase of product launch, which we initiated in October. We have overcome lots of technical issues in the development of our point of care COF nineteen assays. We're at the very final stages now that are needed to support or generate the the supporting data for CE marking and its its subsequent launch. And these two new products build upon our already existing portfolio of BioPlex, which is our range of tests for military applications, as well as our GENEDRIVE HCV test.

5:08 So all four of these these assays, AIHL, COV nineteen, BioPlex, and HCV, all run on the GENEDRIVE platform itself. Last year, we also developed a high throughput product called the GENEDRIVE 96 SARS COV two test, which is independent of the platform. It's not a a GENEDRIVE platform product. And and I think, you know, obviously, we're all frustrated about the lack of commercial traction around this high throughput test, which only generated around a 500,000 US dollars in the last period. And this is mainly driven by a failure to gain, you know, the critical emergency regulatory clearances that we needed in a timely fashion in the markets which we were targeted. And this, obviously, is a very key issue which we've all recognized and are disappointed about.

5:59 But we've tried to correct, I think, our errors with this in our go to market strategy for our two new upcoming product introductions, and I I'll go into a little bit of detail about that as well. So I think we do have reason to be confident that we have a compelling product offering, that we're able to go to market in conjunction with good focus partners, and able to generate significant and sustainable revenue for the company. So the first product that we're gonna review is our antibiotic induced hearing loss test, which is formerly known as the GENEDRIVE m t r n r one ID kit. So this is a test that's been in development in conjunction with the NHS for the past three years. So many of you will have heard about this during its development pathway. The test is unique to GENEDRIVE as a point of care test, and it does represent the world's first use of point of care molecular testing in a neonatal intensive care setting.

6:49 The test screens for a genetic mutation called RNR one, And those with the mutation will suffer lifelong hearing loss following the administration of the common antibiotic gentamicin. The test screens babies for this mutation. And if it's found, they can be given an alternative treatment which preserves their hearing. So this is so called guided therapy. We estimate a total available market of approximately a 100,000 tests per year in The UK and approximately five to six times that in Europe and five to six times that in The United States. So it's a very substantial market relative to where we are. In terms of progress, we spent much of 2020 and the beginning half of twenty twenty one completing clinical performance validation work with our NHS partners at the Manchester Royal Infirmary.

7:35 The results of the trial have been accepted for publication in a in a top influential American pediatric scientific journal, which will be ideal to raise the awareness and visibility of GENEDRIVE and our new test. So we'll shortly have an excellent publication to powerfully evidence the product's capabilities. The results have been presented at a conference recently by MRI. So I can disclose that three MTR and r one positive babies were discovered from the 750 that were screened. There were no incidents of incorrect negative. And the trial found that the test is easily accommodated into current care protocols. It has been demonstrated that the test will save the NHS money overall versus the long term cost of deafness of deafness, excuse me.

8:22 And of course, this improves the life opportunity of potentially hundreds of children every year. So we have the opportunity to be the very first company to support a new standard of care in the NHS and potentially around the world. A number of suggested improvements were made by the NHS users to the device, which has led to the creation of a new generation GENEDRIVE product, which is pictured in the middle of the slide there. And I'll briefly cover that on the next slide as well. It incorporates improvement mainly centered around IT and user ergonomics. In terms of Outlook, this is a new test being used in a new market, and we have the benefit and opportunity to leverage the the excellent advocacy and goodwill that we've generated to our work with the Manchester hospitals and their clinicians during the development of the test with them.

9:09 So we've divided our initial launch essentially into two phases, one of which is a key opinion leader or KOL phase, and the second is a more broad commercial launch. We're executing a plan related to The UK separately from the one for Europe. KOL launch is focused at the people that have been involved in the trials to date and close clinical collaborators of theirs. The publication of the performance data really is needed to support a full commercial launch in phase two. Implementation of the first five KOL instruments is currently scheduled for the first week of December. As a consequence of the recent fundraise, we've expanded our business development team to work in conjunction with new distribution partners and our existing partnership with Inspiration Healthcare, and also allow us to expand the new partnerships in selected European Union countries.

10:04 Developing payment pathways, engaging with clinicians, and promoting and establishing formal clinical guidelines as all viewed as being really important activities to maximize the market opportunity for this product. So following KOL and commercial traction in The UK, as I mentioned, we will expand into EU markets. We already have our initial pilot site up and running in Greece, and our business development team is focusing on European expansion through very, very early in the new year. Now our focus, excuse me, on The UK and The EU means that we won't require any additional regulatory clearances. We have mentioned that The USA is a very attractive market and that we have every interest to enter once funding can be established, recognizing that the FDA process is costly and time consuming.

10:56 Excuse me. So here's the new GENEDRIVE system that was developed following feedback from our performance trials at the Manchester Hospital. Effectively, of the improvements that we've incorporated are driven around data communication and ergonomic workflow improvements. So this is the very first time that GENEDRIVE has been targeted for use in a, you know, effectively a modern hospital environment. Know, traditionally, we focused on more rural, decentralized, potentially less sophisticated settings. So here, we needed to add modern data communication. So, for example, the ability to hook directly into a hospital information system and transmit data directly into that. We needed to have the ability, for example, to scan a nurse's ID barcode so that user access can be controlled and and monitored.

11:46 And, ultimately, there was a request from the nursing staff to develop a very streamlined and bespoke graphical user interface specific to needle nail intensive cord care unit requirements, which we've done for them. So the other major change was a lock in capability for the cartridge simply because during the trials, we had some errors related to users being uncertain if they had fully engaged the test cartridge properly in the instrument. So I think in summary, it represents a very, very exciting opportunity for the company. We've developed a very innovative product that's been shown to work effectively now in an NHS environment. We've we've responded and addressed to essentially every observation during the development trials and put those into the new GENEDRIVE system to support the AIHL rollout more broadly.

12:39 We've got an excellent commercial established commercial partner established, excuse me, in in The UK for our rollout. It's a commercial assay that's unique to us. It's got easily demonstrable health, economic, and clinical benefits, and we're able to serve markets directly or engage additional focused specialist distribution partners. We've got good clinical advocates for us backing the performance and the rollout of products in The UK, and we've got a product which presents us with a great opportunity to make a very significant difference in the standard of care of insulin. So it's something that we are very proud of, and I think investors should look at very positively in terms of opportunity for the company going forward.

13:24 The second product in the presentation is our point of care SARS CoV two test. This is a rapid point of care test running on the GENEDRIVE device that generates positive results in as quickly as as ten minutes. So while most countries remain below ideal vaccination thresholds, we now understand that while vaccinated people generally don't suffer from severe infection, they still can transmit COVID nineteen to a lesser degree. It seems broadly accepted now that COVID nineteen is not a disease that's going to be eradicated soon, but a disease that will require long term management through testing and treatment, which is now becoming available. Noticeable is the more recent news of the oral antiviral drug efficacies. Individuals often only have initial symptoms when SARS CoV two is reaching its peak replication.

14:15 And this is the time in which antivirals would effectively be the most efficacious. So accurate and rapid molecular tests may play a very important role in patient management in detecting infection as soon as possible. All that said, vaccination does lead to lower infection rates, making targeted lower throughput application specific testing approaches like that offered by GENEDRIVE point of care test, our preferred approach, we believe, going forward. I'll come back to the finishing off that slide, but I just thought toggle forward. This is a very busy slide. It will get uploaded to the company's website, and you can copy it from there so you don't necessarily need to screen capture of this. I'm not gonna go through a lot of detail here, but I think we need to just just put it into context, at the European marketplace anyways.

15:02 You know, there there's probably a dozen companies with point of care offerings for SARS CoV two. And here, I've I've created this slide the left with some of the international players, Abbott, Roche, Thermo, etcetera. And on the right are more UK specific suppliers, which you might be more familiar with. Now I the first thing to say is that the landscape differs quite dramatically from high throughput COVID testing where there are probably six to 700 different suppliers in the market now. So it is a much more focused competitive field. The key advantages to the GENEDRIVE system against the competitors are are highlighted here on the on the chart. You know, green where we feel we have a competitive advantage, amber where maybe neutral or slight advantage, or red where, you know, we don't think competitors, you know, have a have a, you know, the best possible solution.

15:55 So I think the key thing is there that the GENEDRIVE test targets multiple genes. Right? We know that that's important with the emergence of of new strains. For example, things like delta, targeting multiple genes is a necessary component of a test to ensure accuracy. The test, as we see it currently, is the fastest in the market, and we previously said that you would get results in as quickly as ten minutes. In our current trial work, it does in fact look that the positives or some positives anyways may resolve more quickly than that. And negatives probably actually resolve faster than the twenty minutes which we initially determined. So exact specifications, of course, come from the clinical trial work, is currently in its final stages. Room temperature storage for reagents is important because that means the testing is practical outside of a formal laboratory setting where they don't have fridges and freezers. And the test itself doesn't require any additional laboratory components because that's often incompatible with the people in the skill set of a of a point of care setting.

17:00 So so we think that those four things, although none of them are specifically unique to us, the combination of having that suite of features will provide a competitive advantage for the company and make the GENEDRIVE system an attractive option in the marketplace. So as I mentioned, clinical validation in its final stage slowed really just due to the availability of samples from our clinical partner site. I'll just toggle back to the previous slide and just finish that one off. In the middle here, or at the bottom, excuse me, is an overflow of the workflow of the point of care test. And you can see the parallels with the lateral flow test. It is identical, essentially, to lateral flow testing. A sample is taken from the patient's nose. The swab is placed in a buffer. It gets mixed to release the virus.

17:48 The swab is is is sort of squeezed into the fluid. Swab's removed and then discarded, and then the the liquid gets deposited into the GENEDRIVE cartridge. Now one drop is placed in each of the wells of the cartridge, and then the cartridge gets placed into the instrument. You press start, and you'll get a result in, as I said, something slightly less than 10 to something slightly less than twenty minutes. Now during our development, since the last time we talked about this, we have moved away from the dropper bottle that was originally part of this workflow because we found that its dispense accuracy was variable from one user to the other when we were doing validation of the product. So a new disposable, what's called Pastep, plastic dropper, is now part of the the kit components.

18:35 So we're still running clinical samples to get the overall cohort of data that we need for CE marking. And as I mentioned, it's taken longer than expected primarily due to the rate at which our r and d team have been able to acquire these clinical samples from our clinical partner site. Then often in the validation of diagnostic tests, companies are able to use, you know, remaining patient samples that have previously been used in another test or or that you can purchase stored samples from commercial sources. But because the GENEDRIVE test uses a a fresh swab into a proprietary buffer, those traditional sources of samples haven't been usable for us. So we need to collect specific samples for our validation work, and and just the incoming rate of receipt of those samples hasn't been as fast as we would've I would've needed. But we've said imminently, results do imminently in our results commentary.

19:25 By imminently, we mean days or weeks. We're not we're not talking months here. You know, we're we are very close. In order to get that overall clinical dataset together, and then that assigns the performance characteristics of the kit. So quite all that look look looks good. We'll certify for CE marking shortly, but then there is an small additional time period for CE marking on top of that now that The UK is not part of the EU. So we need to make an application through our US based authorized representative. Again, it's not it's not burdensome, but we pay for accelerated review, and that's normally around ten days or so. So reasonably quick and and a and a paperwork formality. In terms of outlook, once our our our data is all confirmed, puts us in a position to hand the product over to the commercial partners, which we've been engaging over the past many months. They'll be able then to evaluate product in their own hands, choose markets, give forecast, and and execute on agreed commercial plans.

20:28 So we're aware of the increased requirements from the from the UK government, which were recently published to put product on the market here. It doesn't really impact our commercial planning as we actually had always initially intended to go to the European Union first. But, of course, we do intend to follow in The UK. There is a requirement, which sort of it is in excess of CE marking in terms of sample sizes and things of that. So we'll continue to recruit samples and go through the desktop re review required for The UK market shortly. In terms of where the product will be targeted, there's a wide variety of environments that require molecular tests and require rapid molecular tests. So it's important to remember that while lateral flow tests may be inexpensive and rapid, the fact that they're not very accurate means that they're not a first choice for many specific applications.

21:20 I think travel is probably a well known example. So a point of care test like GENEDRIVE offers should be analytically superior to lateral flow virtually in every way except for cost. It will be more expensive. As such, we're targeting environments that require PCR level sensitivity or are more interested in accuracy over cost. So these environments include things like travel, specifically urgent travel, high value occupational health settings, things like elite sports, businesses, cruises, fee paying schools. There's lots of environments where this product can be can be useful. And, of course, as I mentioned at the beginning, there is now also a new emerging application for diagnosis for for therapy, which is also potentially very interesting for us.

22:06 Our commercial approach with the product will be different than what we've done in the past. We're not gonna be targeting traditional distributors or diagnostic distributors. A lot of these markets that we're focusing at, you know, frankly, didn't exist twelve months ago, and so traditional distributors are probably not the route. We're So gonna be targeting what we classify as solution or testing providers, which means companies that themselves offer a consolidated testing package to end users.

22:36 So an example of that could be a testing offered in pharmacies, for example. We wouldn't target a pharmacy chain or chemist directly, but we would target one of the several service providers that have emerged over the year that now support these sort of unique testing solutions offered out of out of pharmacies, if if that makes sense. So overall testing solution providers rather than the end users themselves.

23:02 I'm now gonna go through products that were on market. So the first one to cover is the GENEDRIVE 96 SARS CoV two test. As I mentioned at beginning, obviously, disappointing for us last year, especially off the back of so much optimism and good performance data for the product. This was our first development of a PCR bead product using SITIVA's technology. It's given us lots of experience and know how on beads that we're now targeting and planning to use for future products. So the product, think, internally from r and d standpoint was was successful development. And the beads and the plates have worked really well in commercial hands. But initial sales, as I mentioned, around a 500,000 US. But we didn't really gain any material traction beyond beyond that for a number of factors. I think we we partially covered anyways. But I think in summary, the key elements are that by the time we got to market, there were already hundreds of suppliers.

23:58 And once the tester had adopted the technology, we found it difficult and our commercial partners found it difficult to convert people to the GENEDRIVE test. Conversion was problematic owing to the fact that customers needed to convert their entire process over to us. Our our chemistry style was different and customers often had robotic systems involved in sample prep, and and it required a wholesale changeover. And unless customers had a key supply issue, it became a difficult thing to try to get customers to do. Secondly, we focused our efforts quite heavily on the American market. And while originally the FDA allowed a number of emergency use authorization quite quickly, Once they hit a critical mass, they didn't really have an incentive to approve further products.

24:50 So they had sufficient sort of EUA approved products on the market to meet their current demand. And so they began to focus on approving different and alternative solutions. And so we've been effectively parked, unable to get approval. So

25:04 our application is still under the FDA, but I think it's probably unrealistic to expect that it will be reviewed anytime soon or if reviewed at all. And looking forward, we continue to manage some opportunities in selected markets, but, clearly, these are gonna be smaller than the the massive opportunities that were there early in in 2020.

25:28 On to just to conclude on the military applications and GENEDRIVE HCV. We have the biopathogen assays that we've developed over a longer period with with the US military, and that development ended in 2020, and then we moved into a commercial phase. As a result of that, we appointed Mountain Horse Solutions, which is a specialist US based military distributor in March 2021. And the involvement of Mountain Horse actually has been really, really good and given us access to a number of opportunities and requests for information that we we just wouldn't have have seen here from a distance. So I think they've doing a really good job for us. And then looking forward, we see revenue opportunities coming from potentially two avenues. First, one of these multiple opportunities that Mountain Horse are able to identify and bring to us from within the US military, they're likely to be in sort of the 6 figure amounts and and periodic or occasional.

26:25 And then secondly, there is this large fielding opportunity that we announced back in March 20 of around 500 units. And this is still live, and we expect some resolution, hopefully, by the end of q one twenty twenty two. And given the patch of time since that initial indication, I think, again, it's prudent to remain neutral as to whether this is gonna conclude or not, conclude successfully, or whether the DOD is gonna buy or not. But, listen, we're working really hard with Mountain Horse to do all we can to convert this successfully for us. And and the last element I'm gonna cover is HCV. So we've had this, you know, frankly, very good test validated and reviewed by a number of parties now. The latest one was the was the FIND study, the foundation for innovation and new diagnostics, and it was really, really positive received by them. In our recent communications to to shareholders, we indicated that the WHO

27:25 PQ status for this product was under review. I know there is a a question about this later, and I can go into a little bit more detail then. But this is because their third party reference lab has been unable to reverify our claim around the limit of detection. So that's sort of how how sensitive the product is. It's, again, a frustrating conclusion. And we believe entirely down to the experimental protocol that the labs are using and and not really related to the performance of the GENEDRIVE device itself. But again, I'll get into that in the q and a a little bit more. So the key for us is that the performance of the product in places like the FIND study has been shown to be really excellent in a real world setting. And we think that the products has an opportunity to play in the eradication of HCV.

28:16 But the key thing that fueling this market is gonna be the availability and supply of drugs for HCV elimination, which, especially during this COVID period, really really hasn't hasn't happened. Okay. So that takes us through products that we have at the launch phase, products that we have in in market. I'll hand over now briefly to Matthew Fowler, our CFO, just to go through financial status of the company. Thanks, David. Good afternoon, everybody. I just have a single slide here to bring information up to date on our financials. So starting with the income statement, our revenue for the year was 700,000, and this is split pretty much equally across our military and high throughput COVID assays.

29:02 Operating costs slightly reduced on the prior year, 6.2 versus 6.7, and this is mainly owing to, reduced activity ever so slightly. And this gives us an operating loss of 5.5. So below this, we had a low note on the balance sheet at the start of the year, and this was converted during h one. And conversion created a gain, which has gone through finance income to give us a loss before tax of 1.9. And then below that, loss making tax credit at 1,200,000, giving us a loss after tax of 700 k significantly down on the prior year. Moving on to cash flow. Cash consumption from operations slightly down on prior year, again related to those operating costs.

29:49 Underneath this, fairly large outflow in working capital, and this essentially is the reversal of a of a high creditors balance at June 20 contributing to that 900,000 consumption in the year for working capital. Below this, I just mentioned taxation. So we're the recipient of the HMRC's tax scheme, which we get paid in cash, and that was 1,000,000 from the prior year. Looking forwards, our tax credit in the p and l, the 1,161,000, we'd expect that, to get paid early in calendar year 2022. Now the accounts are signed, we can submit our claim into the government. So net cash outflow from operations 5.2. And below operations, just to reference back that convertible, some deferred interest paid on the convertible loan note leaving as a cash consumption net for the year five point five and a net cash position 2.6.

30:45 Just to bring that up to date post year end, we completed a fundraise that was announced in September and completed October. So the net fundraise from that was 6.6, and the unaudited cash at the end of October was 7,300,000. So June's cash was 2.6. We raised 6.6, and we have 7.3 at October, meaning the cash burn for the four months to October is 1,900,000. So broadly in line with our expectations and historic rates. But obviously that burn rate will adjust as we look forward to the receipts from COV POC and our AIHL installations. Okay. So that's it. Everything on the financials. Thank you.

31:32 Okay. Thanks thanks, Matthew. So So just in terms of of new news flow, so we are rapidly approaching the end of the calendar year for 2021. So what we hope and plan to get completed by the end of the year, clearly, is the clinical test data available for the GENEDRIVE COV nineteen ID kit, which as I mentioned, should be due imminently. That will support the application for the GENEDRIVE COV nineteen ID kit CE marking, and we are on track to install our first KOL sites for AIHL in The UK in December. Looking forward into the first half of next year, and to be fair, I think most of these are are probably q one or earlier earlier h one activities, is the the commercial partner launch for GENEDRIVE COVID nineteen IDKIT.

32:26 So we'll be telling you about how and where we're going to market with that product. The publication for AIHL from Manchester Royal Infirmary, the performance trial data, as I mentioned, has has been accepted. So that should be available very soon. I think it's quite unlikely it'll hit by the end of this year, but it probably trickled into next year. And then following the commercial partner launches, we'll be able, obviously, to give you sales updates on progress for that. We'll be launching AIHL into the European Union in the first half of next year, early in the first half. And the two military applications that I spoke about should resolve within the first quarter of next year. Okay. So that that takes us to the conclusion of our of our presentation for today.

33:15 Mark, I'll turn it back over to you, and we can take we can take questions that have been submitted online. That's great, David. Thank you very much indeed, Matthew, for updating investors this afternoon. Ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen. I just want the company to take a few moments to review questions submitted already. I'd like to remind you that the recording of this presentation along with a copy of the slides and the published q and a can be accessed via your investor meet company dashboard. We will notify you when that's ready for your review. I'd also like to remind you that your feedback is important to the company. And immediately after this presentation's ended, we'll redirect you in order that you can provide the company with your thoughts and expectations. Matthew, David, I know we received a number of questions ahead of today's event, and you've obviously received a number throughout today's event. Would you mind if I just hand back to you? And if I could ask you to read out the questions and give a response where it's appropriate to do so, That'd be grateful, and I will pick up from you at the end. Yeah. Okay. Thanks, Mark.

34:12 So listen. With there there are a good number of questions, there are some common themes. So maybe I'll try to sort of put them together a little bit. And actually looking at the the questions coming in online as well. I'm not seeing any there yet anyways that are are completely different than what was than what was submitted in advance. But so let me just go through some of these for you. So I would also add that people do submit questions in advance before they've seen the presentation or before they even read the the annual account. So I I think a lot of questions have already been covered, but nonetheless, we can recover some ground. So the first question I have here is, can you provide more information on the commercialization profile of the IHL in The UK and across Europe? How are sales likely to evolve in terms of scale and time frame from discussions that you have had?

35:06 So, again, we covered some of this in the presentation. But from a financial standpoint, one thing I did wanna point out again, common question, the detailed revenue placement financial expectations are in a thin cap broker note. So if people don't have that note, it is available from thin cap. You just have to register on their site to get it. If you go to the GENEDRIVE website in the investor section under analyst, there is a link from there where you can register with with SynCap. Okay? So so all of those things are there, and I think everybody should try to try to get a copy of those. But, however, in summary, so AIHL in The UK, as we mentioned, is gonna be driven off the back of a key opinion leader launch, right, which is currently ongoing. And by key opinion leader leader, we need launching it at key sites that are gonna be, you know, advocates and and references. These are the the sort of thought leaders in the neonatal intensive care world. Right? This is a a new test that hasn't been available before. So there is an element of market development activities to do.

36:11 So there's gonna be a a phase where adoption is gonna be modest given that people need to establish funding in some hospitals, whereas others will be able to choose just to alter internal funding mechanisms more readily. Right? But we've got a real benefit launching in The UK. Right? We've got we've got clinical advocates here, strong clinical data that's been generated at a very large and and well known UK hospital. But the real key lever to aggressive growth in The UK anyways is the product being written to the Royal College of Pediatric Care guidelines. Right? Because when that's done, that effectively mandates hospitals to use a product. Right? And that could probably happen in a in a twelve to eighteen month time frame that those guidelines get reviewed annually.

37:01 For for Europe, in some countries, the dynamics and the timing are gonna be faster than than that. The clinical procurement is is not essentially managed as it is in in the NHS and not essentially controlled. So, for example, our initial installation that we've got up and running now in Greece is is actually a private health care facility. Right? And they can take more commercial decisions on testing and and offering this because because, you know, the the users are are private payers. Yeah. As we move around the European Union, some of screen countries can be targeted based on their, you know, their complexity, their market size, opportunity, our ability to put good commercial structure in in into those markets. So a number of of factors. And I think in the same way that we prioritize Greece, countries that have more private access generally are gonna get prioritized.

37:56 Yeah. But, you know, again, in the EU, we're gonna have to move through a similar key opinion leader engagement process as we are in The UK given that this is a, you know, a a new product that hasn't been offered before. Yeah. Okay. Looking the next question is what kind of revenue could be generated next year for GENEDRIVE if the new COVID testing system currently being trialed is successful, and who would be your customers? And that was the question was submitted by Gary. So, again, all of those numbers are in that in that the thin cap note. There's a number of assumptions built into the revenue model, but we assume that distribution partners will initially take around a 100 units and building to about 200 units by the end of our fiscal year.

38:42 And then the model's got an additional 200 units placed the following year. And when you convert that to revenue, key things are or or key what's the word? Variables are when the units get installed and how many tests do they do, etcetera, what's the pull through. But the FinCap analyst note is predicting revenue at the end of fiscal year of around just under 3,000,000 and then 12,000,000 in the following year.

39:11 Okay? So that gives you some sense of what it is. But but again, I would urge you to get the FinCap note and and point through the detail on that. The next question is what is now happening with Beckman Coulter? Is there an expiration on how long they host host products on their website? And this this question also came in on the side panel as well during the presentation. So Beck and Culture remains a commercial partner of the company indeed. They retain the ninety six hours cog two product on their website. They continue to manage inquiries and opportunities. Right? But as I said in the presentation, the absence of having a an EUA and their focus on The US market, there's not a lot of point for them to continue to to push the product at their events and conferences and things like that when they've got current current products to sell. So they've got they are a partner of ours.

40:02 They remain in place. Again, as I said in the presentation, you know, we we think it's unlikely that EUA will happen, and and there's another question here. We'll go in a little bit more detail on that. Simply just due to the passage of time. Right? There's no tangible thing that we can point to to say, oh, it's gonna happen tomorrow or or next week. So it would be disingenuous for us to say that it's gonna happen imminently. We we just don't know, actually. We're in the dark. Actually, the next next question actually here is about the FDA. So what because I'm aware companies have periodic communications with the double with the, excuse me, with the FDA and with the WHO regarding applications. What's the latest on both? So we haven't heard anything from the WHO probably in six or seven months. And, obviously, we we inquire, but but we actually from WHO, we I literally don't get a reply.

40:56 So there's nothing to update on on WHO. The FDA normally just acknowledges that they've received our request, and they tell us that our application is still in the queue. On the FDA website, currently, there is a review around their own evolving EUA priorities. And while high throughput PCR was very prominent in in 2020, it does say on the front of their their website that they're they're focusing most of their efforts on on home testing currently. And there's also a document on there that sort of talks through around what happened last year and and what their issues were in approving things. They point to things around IT IT management and the number of staff they had in place, etcetera. So it's just been a really frustrating difficult process.

41:47 You know, we had to really have a really good innovative product that we tried to get into market in The US. I think if we had gotten in, it would have been an amazing amazing result. But, unfortunately, we weren't we weren't able to. So never say never, but, you know, as I said, there's there's no single tangible piece of information that I can point to that suggests that it's gonna get begin a review tomorrow. Next question. Why why is more information not made available to private investors, particularly in relation to progress and problems with the products that our investment is supporting? So it's a good it's a good question. Certainly, we've gone longer periods than we would have liked to issue any any any news and updates. Right? But that's it just reflected us not having anything anything material to say and update. You know, we've we've been waiting.

42:44 You know, we do work closely with our advisers and ensure that we do communicate when and where we we need to, I guess. But, you know, sometimes, you know, we might be aware of risks internally of things not proceeding in a in a direction that we want or that we expect. But if we have opportunities to correct or modify that or or do something to affect the the outcome, you know, we'll we'll discuss with our advisers and see if we need to disclose something. But, you know, investors don't I don't think anyways, want us to issue r and s's about about issues that we felt we have a reasonable chance of of addressing or or issues that aren't gonna materialize. Right? You know, the reality is is is RNS and news can be can be positive and and and negative, you know. But, similarly, in relation to positive news, you know, we we wanna make sure that things are fully resolved until we announce them. Right? We don't wanna have to announce things and then retract information later on.

43:37 The next question is around of the WHO. Could you clarify exactly what concerns WHO have over HCD and what's required from GENEDRIVE now in order to ensure that the HCV is available for sale in all relevant and targeted countries. So an important part of or not well, a part of the WHO PQ process includes them sending the product to an independent lab to evaluate your performance claims. Right? So there'll there'll be things like your product sensitivity, your your performance across genotypes, your limited detection. Does the product perform the same from one operator to the other?

44:24 And and for the limited detection calculation, we we the lab's fallen short. Right? The independent lab was unable to achieve the same number that we have in our package insert. So I actually can't remember what the exact number is, but it's something like 2800 copies per mil we say we can detect. And the lab detect their limited detection was something like 10 times higher than that, and it wasn't really even close, which is not right. Right? We know this is not a correct number. And we believe that that discrepancy is more related to the lab procedures that they used rather than the performance of the product. Right? So the GENEDRIVE test only uses a few microliters of sample.

45:11 Right? So it's critical that when you're evaluating a limited detection, the specimen sample has to be mixed really well. Right? It has to be homogeneous. Right? At our lowest level of detection, you know, we've got three plastic detection tubes in our cartridge. At our lowest level of detection, there could only be one or two viral particles to see. Right? And if the if the standard which you're measuring yourself against isn't, you know, mixed well enough that you get one or two particles in every one of the wells, then you're gonna have problems. Now we we don't experience that in our hands. We don't we don't have that problem, but but they weren't able to reverify that. Yeah. So we're not we're not sure where we're where we're at exactly quite yet.

45:59 I think it's unlikely that the WHO PQ status will be maintained. We do have the opportunity to to reapply if that's what happens. But I think back to the question, WHO PQ itself is not a regulatory status in terms of being able to put your product in the market. It doesn't prevent us from putting the product and selling it. So your original question was, is the test how can the test be available in all relevant entire countries? That's not related to WHO PQ. WHO PQ is around people's ability to procure it from donor money. So it primarily affects Africa, to be fair, where most of HOPQ things operate. And, you know, again, to be transparent, you know, it's we'd rather have it than not have it. But not having it doesn't mean that we can't put the product to market and do what we can do to help eradicate HCV.

46:52 As as we mentioned in the presentation, the key the key factor in that market is actually the availability of drugs and funding for drugs. Next question on is how is the double digit million COVID test deal going with the European Ministry of Health? So in September, we already did communicate out to shareholders that that that that was unlikely. We're not aware that that opportunity has ever been awarded, unfortunately. We haven't had any updates from procurement department now for for several months. So, again, it's prudent to assume, as I mentioned in the in the presentation, that that probably won't resolve. But none of that revenue does factor into any of the financial forecast that are currently out in the in the market.

47:41 The next question is just so it's quite a long question. This is I'm sorry if I abbreviate. This is around the new UK requirements, the coronavirus test device approval process that was recently announced, and you would have seen that a number of companies had to suspend sales of their products. And I guess the question really is is how does that that impact us? So so in respect to The UK, for any company, the requirements to put a COVID test in The UK market are now higher than elsewhere. Right? It's a higher level of scrutiny than CE marking does. Right? It includes things like a higher number of clinical samples that you need to look at.

48:29 There are some specific performance required criteria that you need to make, and there's a what they call a desktop review of company documentation. So it's sort of just an expanded additional process. So for us, it means that we need to continue to recruit more clinical specimens to meet this expanded requirement, but it doesn't really it doesn't really affect our go to market strategy because we were always intending to initially go into markets that they just accepted CE Mark. Yeah. So we always expected to go into The UK a little bit a little bit later. I think with this new process, this DHSC process, the the key thing is it's not known what time delay this adds to anything. Right?

49:14 There's been no commitment from the government on review times, review periods, and, again, that's that's applicable for for for every every every company. So but, again, for us, our our our focus is gonna be into Europe first. We'll continue to recruit and and, you know, to get to them the sample size number for UK, and then we'll just go through this through the application process, which in in theory is reasonably straightforward. It's just the time frame that's unknown. The next question is it was expected that GENEDRIVE's point of care test would be complete and CE Mark applied for it in October. Shareholders have not been updated on the progress.

50:01 So, again, I'll just go through that during the presentation. And as I mentioned, the the the issue has just been the recruitment of samples. So, traditionally, we would just buy samples in the market. But because our test uses its own customized buffer, right, you have to take the patient's nasal swab, put it into buffer, you need you need your starting material in that format. So it means that we have to proactively recruit samples at a clinical clinical lab, and the rate of collection is really just related to the rate of COVID infection. So we're almost there. As I mentioned, we used the word imminently. We we purposely chose that word, which we should be there very, very, very soon. Next question here.

50:52 In the it says in the recent open offer, GENEDRIVE stated that 2,000,000 will be used if sufficient funds received for US FDA approval of point of care. Our high throughput lab based COVID test, we spent money on to get approval since May 2020, has not got approvals. As such, is it worthwhile pulling the plug on this application? If so, is the money refundable given it was never processed? And then you could use this money for the point of care kit approval, which would give another shot at trying to put things right in regards to commercial sales. What are your thoughts on this? So the there's a maybe a slight confusion in the question. So the the open offer at the fundraise and and the ability to get at the FDA more quickly was was around point of care AIHL, not COVID.

51:46 So we didn't get ourselves to that point. We are very eager to get our product into the American market. We think it would be a a great opportunity, but that is gonna have to get funded off of off revenue. The FDA process for AIHL is a traditional premarket approval process. And normally, FDA so it's not there's no emergency status for that sort of thing. Normal FDA processes for a PMA are typically twelve to twenty four months. Yeah. So there's a significant time and financial investment there. Right? The FDA requires that you generate all of your performance data in America off American patients at American labs. So there's a there's a body of work to do there around data generation, and then there's a procedure to go through with the FDA just in terms of timing.

52:40 Okay? The the our next leg that question is a little bit on well, unfair. Don't know if that's the right word. If it's unfair, I guess, it's it's it's a sentiment, I suppose, and so that's that's fair enough. It says, why why do you continue to use Wallbrook as your PR company, which in your last presentation, you actively told investors to engage with, but they failed to add color or provide further clarity. So so we're a we're a small company, and we employ Wallbrook to manage private investor questions. Right? And that's what we've that's what we've asked everyone to do. We receive a lot of questions into the company, and we do try our best. A lot of them, we do come to us directly, and we we try to answer. Some we forward to Wallbrook and a lot go to Wallbrook directly.

53:28 Wallbrook often just provide shareholders with information that's already in the market, right, that they're unaware of. And they can clarify questions that aren't deemed to be to be price or market sensitive. Where they don't know the answers, Walbrook, you know, can revert to the company. I do get emails from them asking for clarification sometimes. But in most cases, the questions are are forward looking and price sensitive and therefore can't can't be answered, unfortunately. Right? And I think that's probably the primary source of frustration from private investors that they have questions and and the company won't answer them. Right? The reality is is is often we we can't answer them. But in the event that you believe Walbrock should be able to answer your question and they're not, ask them to reforward the question to the company. Right? And I and I do and I promise you, I'll ensure that the question gets reviewed. And if it can be answered, we'll give you an answer. Yeah?

54:22 The the best thing to do as well is to include a full name and a phone number is the is the really helpful thing for us to sort of just get back to you and and sort of talk through, you know, maybe in a bit of a bit of to really understand the question in in its entirety so that we can give you the proper answer that you're searching or maybe explain to you why we can't give you an answer where where you want them. And then the last thing, additionally, we also employ Wallbrook because several of our employees have been subject to quite abusive communication from people who claim to be private investors where they are or or not. I don't know. But, you know, either through email or or phone. Right? And and that's not good for our staff, and and it's not something that we we tolerate. So directing queries Wallbrook in the first instance really has allowed us to filter out some of that unfortunate communication.

55:15 Okay? But there will be times where we don't disclose information, frankly, because maybe we don't we don't why we don't want to. It's not in the interest of the company to disclose, and sometimes things are confidential. And and and, again, we don't we don't want to. But I'll just reiterate. If if if you think your your question is answerable and and and Walbrook, for whatever reason, doesn't think that it is, ask them before it is the company, and we'll take a look at it again. Still got time. We only have four minutes left, I think. I'm going to just move to this one. So this was a pre submitted question, and and I think it's important to answer because I think it encapsulates a lot of a lot of the tone of some of the questions that we had coming in. It says it says, basically, strong in r and d and and weak in sales and marketing.

56:05 This has been the major concern raised by some investors that GENEDRIVE is persistently failing to commercialize r and d opportunities effectively. While part of an explanation for this event is clearly outside of GENEDRIVE's control, The situation is also partly explained by systematic weaknesses within the marketing and sales operations of the company. Do you agree with the statement? And what further can you say to reassure investors that the company has the right people, processes, and culture to fully commercialize opportunities that are being created by a strong r and d. Okay. So it's a I think it's a good and it's a relevant question. And I don't I don't wanna sound defensive because I think there's some fair criticism in there. Right? We clearly can't say that we've done everything right. We had disappointing year.

56:51 We had a innovative product that we weren't able to get into market and generate revenue. So we accept the criticism. I think our r and d team will be pleased that you recognize the development capability that they have because they they have done a very good job. I think the the the conclusion isn't as simple as as maybe the question suggests. You know? We have we have partnered, you know, in my mind anyways, with some of the biggest, most successful diagnostic companies that exist. Right? We've got personalization agreements with Beck and Coulter, with SUSMAX, and commercializing is their daily bread and butter. Right? And and they haven't been successful either. They're we either working together on their own. So it isn't all about just the commercializing capability of of the GENEDRIVE team. And, again, I don't wanna I don't wanna sound sound defensive, but it is it is complicated.

57:53 I think what we what we wanna do is is we wanna take the lessons of last year and look forward to ensure that we don't repeat these things again. Right? So for example, register registration clearances were a huge problem for us. Right? We couldn't get our product into the markets that we needed to get registered in a timely fashion. Right? So going forward, when we look at the two product launches that we have ahead of us, we're focusing on Europe. Right? We've got CE marks. We don't have registration barriers there. We can get into our our market. Right? The commercial process is there. They're they're known and understood by us. You could argue that, you know, if we're trying to sell into Africa, you know, we don't understand commercial process there well enough. So let's focus on the markets where we we do.

58:47 And and may maybe there's a criticism of trying to partner with big diagnostic companies that have big portfolios and lots of things that they they could be doing. So I'm not a 100% sure that's that's a valid criticism. But nonetheless, think going forward, we are looking at more focused smaller companies that we can partner with and or going direct where we need to. Right? You know, there is a reality that in a in a big company, you know, salespeople can switch their efforts from one product to another without too much repercussion provided that they hit their revenue numbers. And and I think trying to work with smaller companies in the in the countries that are familiar to us without additional registration requirements will really help us in terms of commercializing effectively going forward.

59:39 Okay? David, I I I might just jump in for for no other reason than for every question that you're very generously answering. There's another one that that comes along. And, you know, I know that there are a significant number of presubmitted questions to which you've already provided a written response. So I guess for for the interest of time, and I know particularly that investor feedback is important to you, that that I maybe just jump in now. And and if there is a further question that you want to go on to, or as I say, you can provide any responses post this call. No. I think listen. I think it's I think it's okay. Listen. I I well, maybe I could just do a quick quick summary. Yeah. Think yeah. Is that okay? So I think, you know, just to just to finish off on what I was just saying there, you know, we we do have good innovative products on the market. Right? And and and new ones at the introduction stage.

1:00:29 We're well funded. You know, we're we're we're focusing again on the markets where we don't have regulatory hurdles. We're staying close to home. You know, we've we've increased the size now of our commercial team to work alongside these distributors and and, again, working with with smaller focused partners. So I think we have we have every reason to feel optimistic looking forward that we can make a success of what we have in hand. That's great, David. Matthew, thank you for updating investors. And and thank you to the investors for taking time to submit questions both ahead of today's event and during today's event. And as I said, we will make all these responses available to you where it's appropriate to do so, and we'll send you an email when it's ready for your review. Could I please ask investors now not to close this session as we'll now redirect you to provide your feedback in order the company can better understand your views and expectations?

1:01:18 This will only take a few moments to complete, but I'm sure will be greatly valued by the company. On behalf of the management team of GENEDRIVE PLC, we'd like to thank you for attending today's presentation. That now concludes today's session, and good afternoon to you all. Thank you.