CelLBxHealth plc (CLBX.L) Earnings Call Transcript & Summary
June 29, 2022
Earnings Call Speaker Segments
Operator
operatorGood afternoon, and welcome to the ANGLE plc Annual General Meeting proceedings. [Operator Instructions] I'd now like to hand you over to Garth Selvey, Chairman. Good afternoon.
Garth Selvey
executiveGood afternoon, everyone, and welcome to the 2022 Angle plc Annual General Meeting. Thank you all for attending. This is a hybrid event with some people attending and visiting Guildford and others joining online. My name is Garth Selvey, and I'm the Chair of the company. And I'm joined today by the executive Andrew Newland and Ian Griffiths as well as my common execs Brian Howlett and Jan Groen. Brian and I are attending online. You could see [indiscernible] and the other directors are physically present at Guildford. This has been a historic year in which we have achieved our De Novo FDA clearance. And my first comment is to thank our staff and investors for their help and support in achieving this, it is genuinely appreciated. I'll now briefly tell you what the format of the meeting is before handing over to Ian. And Ian Griffiths will -- when I finished speaking, present the votes received for each resolution and ask for the show of hands, when that is complete, Andrew will update you with a slide presentation covering the progress that the company is making in all areas. This presentation will subsequently be made available on our website. Following this, there will be answers given to various questions raised online, some of which will also be covered by Andrew's presentation. There will then be an opportunity to ask questions from the floor. At the end of this session, Andrew will formally close the meeting. I'm pleased to confirm that all resolutions have received a substantial vote in favor. And I will now pass you over to Ian, who will give you the full details. Ian?
Ian Griffiths
executiveGreat. Thanks, Garth. And obviously, sorry, Brian and Garth can't be with us, but Covid is still rearing its head in. But to those that are physically present, great to see many of you again. We haven't seen you for a few years. Obviously, the last 2 were virtual, so looking forward to that dialogue and interaction, and thanks for coming. And to those listening online, welcome. I will -- I propose that we take the notice as read. As I said, I will go with the formalities. I will repeat the individual resolutions, and we'll start off with Resolution 1, which was to receive the accounts. And before I put it for vote of the hands, just to advise that the company has received votes for of 89,327,733, representing 99.31%. Third parties discretion, another 0.69% that would be added to that. And essentially a de minimis amount against, 343 shares. So I'm not sure why those were received, but they were. Those in favor of the resolution in the room? Great. Thank you very much. Obviously, only members can vote in the room. I know there's a -- there's a couple of non-members here. That's duly -- Resolution 1 is duly carried by the necessary majority. Resolution 2, to approve the directors and the remuneration reports. And just to advise, the company's received votes as follows: for, 70,541,110, a 78.51%, with a further 0.69% of third parties discretion; against, 18,689,922, representing 20.8%. Again those in favor in the room? So I declare Resolution 2 carried by the necessary majority. Resolution 3, which is to reappoint PricewaterhouseCoopers. And the proxy voting received: for, 89,077,629, representing 99.06%. Third parties discretion, another 0.69%. Those against, 220,198, representing 0.24%. And those in favor in the room?
Unknown Shareholder
shareholderCan I ask a question?
Ian Griffiths
executiveYes.
Unknown Shareholder
shareholder[indiscernible]
Ian Griffiths
executivePwC, we brought on board 2 years ago after RSM.
Unknown Shareholder
shareholderRight. So [indiscernible]
Ian Griffiths
executivewell, we will review that at an appropriate time, but we've only recently appointed PwC. And so normally, unless there is a challenge of some form, you'd look at 5, maybe 10 years, depending on where the company is in its development and how it's going forward with it. If we can take questions after the formalities, that would be great. Thank you very much. So Resolution 3, as I said, just to reappoint PwC as auditors. Proxy votes received: those for, 89,077,629, representing 99.06%; another 0.69%, third parties discretion who votes for; against, 220,198, representing 0.24%. Those in the room? Thank you very much. I declare Resolution 3 carried by the necessary majority. Resolution 4, to reappoint myself, Ian Griffiths, is retiring by rotation. With the last -- appointed 3 years ago, so retiring by rotation in accordance with Article 91, which also applies to the rest of the directors who will be reappointed at the same time. And the proxy votes received: those for, 89,150,665, representing 99.87% of votes; third parties discretion, another 0.69%; those against, 212,088, 0.24%. Those in the room? Thank you very much. I declare Resolution 4 carried by the necessary majority. Resolution 5 is to reappoint Jan Groen, colleague to the right, you're all familiar, again retiring by rotation. Proxy votes received: those for, 85,134,082, representing 94.64%; third parties discretion, another 0.69%; those against, 4,197,271, representing 4.67%. Those in the room? Thanks very much. And so I declare Resolution 5 carried by the necessary majority. Resolution 6, to reappoint Brian Howlett who you saw earlier. He's again retiring by rotation. Those for, 82,378,551, representing 91.58%; the third-party discretion, another 0.69% voted for; those against, 6,949,202, representing 7.73%. Those in the room? Thank you very much. And so I declare Resolution 6 carried by the necessary majority. Our resolution 7, to appoint Andrew, again retiring by rotation. Those for, 89,209,368, representing 99.18% of the vote; third parties discretion, another 0.69%; those against, 180,385, representing 0.13%. Those in the room? Well, thank you very much. So our Resolution 7 carried by the necessary majority. Resolution 8, to reappoint Garth Selvey. Those for, 70,622,049, representing 88.51% of the votes; third parties discretion, another 0.78%; those against, 8,542,301, so 10.71%. Those in the room? Thank you very much. I declare Resolution 8 carried by the necessary majority. Resolution 9, the authority of the directors to grant issued shares in the capital representing about 1/3 of the company's issued share capital. Our proxy votes received: those for, 88,736,007, and it represents 98.68%. Third parties discretion was 0.69% who voted for. And then again, 561,051, representing 0.62%. Those in the room? Thank you very much. I declare Resolution 9 carried by the necessary majority. Only two more. Resolution 10, the ability of the company to disapply the statutory preemption rights representing about 10% of the issued share capital of the company. To note, this is a special resolution and that requires a 75% majority. The proxy votes received: those for, 88,552,147, representing 98.5% of votes; third parties discretion, another 0.69%; those against, 723,462, representing 0.8%. Those in the room? Thank you very much. I declare Resolution 10 carried by the necessary majority. And the last resolution, the ability of the company to make market purchases up to 10% of the ordinary issued share capital. Again, this is a special resolution requiring a 75% majority to pass. Those for, 88,175,018, representing 98.02%; third parties discretion, another 0.69%; voted for against, 1,155,214, representing 1.28% of the vote. Those in the room? Thank you very much. I declare our Resolution 11 carried by the necessary majority. I'd rattle through it because I know we're all here for the next part, which is the presentation and the Q&A. So on behalf of the Board, I'd like to thank you for your attendance and declare this formal part of the annual general meeting closed. Thank you.
Andrew David Newland
executiveGreat. Well, thank you very much, Ian. So now I'm going to do a presentation. So if you could put the slides up, please. Thank you very much. Great. Okay. So you are now looking at the Parsortix FDA-cleared platform, which is now going to be in full screen, hopefully. Yes, there we go. So today's presentation is going to be a little bit longer than usual for 2 reasons. First one is that I'm going to try and address a number of questions which should come in within the presentation. And the second one is very excitingly, we're now moving into the commercialization phase. And I want to explain some of the background as to the plans on commercialization. So I'm going to do that in a little bit more detail than might be expected in such a meeting. Before I do that, I'd like to add my welcome. It's great to see you guys in person -- having not been able to do so with COVID, very, very frustrating that, that was, but I'm glad that everybody has been able to come. And I'm also pleased to have the attendees online as well. So you're all very welcome. So as I said, this system is the first system ever cleared by FDA for harvesting cancer cells from patient blood for subsequent analysis. And we believe that, that will have a profound impact on the lives of cancer patients in the future. And very importantly for all of us, we make ANGLE a highly successful investment for its shareholders. And the backdrop to this is that the incidence of cancer is rising inexorably, unfortunately. The national cancer institution in the United States estimates that 40% of men and women will be diagnosed with cancer in their lifetime now. Obviously, that's a reflection of the fact that people are living longer and cancer is related to age, but it actually delivers a very, very important requirement, and that is to harness resources better to make sure that patients get a better outcome or do better and reduce the amount of money that's spent on health care expenditure. And a great deal of money is wasted in health care at the moment because of a lack of understanding of the individual's cancer at a particular time in point. and they therefore got given drugs and other therapies which won't work. It'd be far better if you could personalize cancer care. And that is the mission for ANGLE. And we've now gone a very long way towards achieving that mission by getting our product FDA-cleared, which means it can now be used in hospitals in the United States. And I should say also in Europe because we designed our studies to meet the European requirements for CE Mark. So we now have a product which can be used to recover cancer cells from blood for subsequent analysis. So that's the background to the company. In terms of the performance in the year in question, so the calendar year of 2021, we worked on multiple different parts of that program, which obviously has generated the outputs that we had earlier this year. And so we had intensive interaction with the Food and Drug Administration in the United States. We received from them an additional information request, which was a very detailed set of questions, which were complex and challenging to answer. And we developed a full and complete response to those questions. And that involves no extra clinical samples, thank goodness, so we didn't have to start a new patient study. But we did have to run another 1,000 analytical samples. So there was a substantial amount of work primarily in the first part of the year in relation to the FDA questions. And then we had an ongoing dialogue and interaction with them to clarify things throughout the second half of the year. Also during 2021, we moved forward with a key part of our commercialization strategy that I'm going to explain in a bit more detail, and that we set up 2 clinical laboratories. So we now have a laboratory on the Surrey Research Park, very close to where we are now, which is dedicated to dealing with patient samples, and we have a similar laboratory setup in the United States in Pennsylvania in the place called Plymouth Meeting, which is quite close to Philadelphia. And those 2 laboratories are being used to service our pharma services business, and I'll explain that in more detail. That's our near-term commercial revenue source where we can get large-scale revenues from working to pharmaceutical companies in cancer drug trials. So we set that business up from scratch starting last year and we've continued to grow it until now, and we're continuing to grow it going forward. We've worked on our ovarian cancer study, that was slowed up by some COVID impacts, but is now progressing very well, and I'll talk about that a little bit later as well. And we came -- and we developed some plans for prostate cancer development as well. And amongst all of that, we completed a fundraiser, which was well supported by existing and some new shareholders, both U.K. based and in the United States, to raise $20 million gross funding. And that put us into a reasonably strong cash position at the year-end. So at the year-end, we have GBP 32 million in cash reserves. By the way, we have no debt, so there's no debt in the company. And in addition to the GBP 32 million that we have at the year-end, we have a further receivable of GBP 4.5 million from U.K. government R&D tax credits. So that gave us a cash position, which is reasonable for what we're seeking to achieve. We also delivered an increase in revenue by 33% year-on-year. We consider these revenues still to be establishment revenues. So the primary purpose of the revenue at this point in time is to get leading cancer research centers to utilize the system. And I'll explain a little bit later on the impacts of that. So we've been talking about the FDA clearance. And why is that important? Okay. Well, the reason that's important is because it has a global credibility. So it's not just United States, every single cancer diagnostic company or a hospital in the world looks at an FDA product clearance if they want to buy a medical product. So it is absolutely literally the gold standard for getting a medical device approved. It took our company 6.5 years to achieve. So we processed 16,000 samples to do that, and we wrote 400 technical reports and documents in pursuit of that clearance. And I can tell you that at the outset, there were many people or at least some people who purported to understand this system and said we would never be successful. Well, we have been successful. And we also know that there are no other companies who are even trying to do this. So we're very well differentiated in a very large-scale market. The reason I know that is because we've asked the FDA, there have been other CTC companies who have approached them, but none of them have actually decided to go ahead when they realized how challenging this clearance is. The other thing that's important about this is the substance of the clearance. So the intended use is very broad. We asked FDA for a platform clearance. And by that, I mean that we didn't want to be specific about what the user does with the cancer cells. We wanted to get the clearance so that they can recover the cancer cells from patient blood, but that they can then decide what they want to do with those cells. And that was probably the single biggest challenge that we were concerned about with FDA as to whether they would accept that because normally, they go for 1 specific use and clear that only. So that would be, for example, looking at 1 protein on the cancer cell to advise on 1 particular drug that could be prescribed. And they accepted our argument, however, that we were seeking to provide a liquid biopsy alternative to tissue biopsy. So with tissue biopsy, they cut out the cancer and they get the cancer cells and it's up to the doctor and the clinical labs to decide what's the clinical question I want to answer and how do I do that on the cancer cells. It's not restricted. It's down to the laboratories. And we've got an exactly parallel clearance. So what that means is that any end user that buys our system for its intended use in metastatic breast cancer can then decide what they want to look at on the cancer cells. Now they do have the requirement to validate any test that they offer. So it's up to the clinicians to be sure that it is an appropriate test and it's an appropriate answer. But we believe that's the best way to get a broad adoption of the technology. And in terms of the impact that this has had, I was sort of noting that we've had a lot of incoming of congratulations and so on in some of the pre discussions before we started with the FDA clearance. Of greater note than that, we've had continued increased interaction from commercial companies about this. So we've had several large-scale medical diagnostic companies who have now spoken to us, and we're about to start conversations with them. And we've also had a significant number of biopharma companies, perhaps over a dozen who have approached us and said they'd like to talk about potentially using this in their cancer drug trials. That's a big change. So we've been trying to force doors open up until now. And now people are coming to us and asking us if we'd like to come through that door. So that's very encouraging. It doesn't mean that there's not a lot of steps between here and nirvana, but it is certainly the case that the credibility that we expected with FDA is, in fact, being shown to be the case. And clinical users are beginning to set out and look at this platform, whereas before they wouldn't. In addition to inbound, we've had an increased level of outbound. So we have a marketing team who are involved in directly spreading information about the system to potential users. We're also upping our game in terms of attending major clinical conferences. So there's a big one coming up later this month, which I will be at together with several of my colleagues, and that's a sort of changed because up until the FDA clearance, we didn't have a clinical product. So it was very difficult to justify going to the big clinical cancer conferences. Instead, we went to the big cancer research conferences. Now we can go to both. Our aim is to not be a small company with a few products. Our aim is to change the industry. So we want the whole health care industry to adopt this technology. We want it to be the de facto standard for recovering cancer cells for analysis. There are numerous companies that know how to analyze those cells, and they already do that with cells which come from tissue biopsy. Now we're giving them an opportunity to extend their reach to have repeat samples coming from blood. And that's very, very good for the patient because cancer changes over time. They can get -- now with our system, they're able to get real-time information on what's happening for the individual patient and that will improve their health care and also reduce costs. So why do people want circulating tumor cells? And what is the rest of the world doing in liquid biopsy? Well, the answer is that the rest of the world doesn't have a Parsortix system, at least not until they become a customer of ANGLE. They are instead focused on circulating tumor DNA. That's fragments of dead cancer cells simply because it's easy to get a hold of a fragment of dead cells, centrifuge the blood -- by centrifugal force, the blood cells go in 1 portion and the liquid is separated, remove the liquid with a PET and start sequencing it. That's how you can look at circulating tumor DNA, which is tiny fragments of dead cancer cells. Problem with that is it's a limited analyte. It can only be used to look at DNA. And DNA is only a very part -- small part of the picture. You want to look at RNA, you want to look at protein expression. So for example, most drugs target proteins, they don't target DNA. And there's a major benefit if you can actually look at the cells morphologically and look at the way that they're structured. So the circulating tumor cells are also a prospective assay. In other words, they're living cells spreading the disease. They give a prospective insight as to how the disease is progressing. Though circulating tumor DNA, by definitions, dead cells, you don't know why it died. Did it die because immune cell killed it? Did it die because the drug impacted it? Or was it neither of those? And actually, it's reflective of the ongoing growing cancer. So it's clearly a retrospective analyte. That said, we see the 2 analytes as being complementary, circulating tumor DNA and the CTCs. They both can come from the same tumor blood and we're seeking to work with a very large-scale clinical services labs that were in ctDNA. So if they buy a Parsortix a customer, they can do both analytes from the same blood sample. So we've shown the waste product of ctDNA can be put through Parsortix, recover the cancer cells and you can get more information. And that's one of the things which is quite outstanding about our technology is that we don't compete with anybody apart from a few small alternative CTC companies that don't have an FDA clearance. The whole industry can benefit from this. So med tech companies can benefit because they can extend the revenues that they have from their existing products by repeat testing. Pharmaceutical companies can benefit by improving the efficiency of their trials and also by potentially developing -- I mean diagnostics. So the circulating tumor cell, the living cancer cell recovered by Parsortix is actually the closest proxy analyte to the tissue biopsy. Broadly speaking, anything you can do with the tissue biopsy you can do with the blood test now that you've got Parsortix. And that clearly opens up a very large market, over USD 100 billion in the United States market alone, exactly the same across other parts of the world as well. And we believe that this technology can have a significant impact in the detection of cancer in high-risk groups, the selection of individual drugs for patients at different time points, assessing whether the treatment is being successful for the patient and monitoring patients in remission to guard against potential relapse. All these things can be done without modification of the Parsortix system. And whilst our FDA clearance is in metastatic breast cancer, we've had 31 independent cancer centers use this in 24 different cancer types. It works in all of them, and that's available in 63 peer review publications on ANGLE's website. So it's not just us saying it. There's a lot of information available to back up what I'm saying. We believe that our technology is unique and it's highly differentiated in this market and will enable us to build a dominant position in a very large marketplace. So this is where it comes to how we're going to do that. It's quite complex, so I'm going to go through a number of different parts to it. The main point is having an integrated strategy. This strategy has been in place for some time. But only now, we're really able to start putting our foot on the accelerator to deliver it. So it's a carefully developed strategy intended to leverage the entire industry. So stage 1 is providing the system and selling it into researchers. So that's already in place. That's what's driven the peer review publications. That's what you will have seen with numerous publications coming through most recently from the [ CTC ] lab yet again in Switzerland with the breakthrough technology about the impact of sleep on the spread of cancer. That work, which I believe will be groundbreaking could not have been achieved without Parsortix. That now has been working with Parsortix for 4 years now. They've been in nature 3x. So that's what I mean by the leveraged R&D. This is people who pay us to use our instrument and then they come up with groundbreaking applications. That's driving the next phase, which is the adoption by pharma companies. So it's very important to us to design a commercialization strategy, which can deliver substantial revenue in the relative near term, and that's going to come out of our Pharma Services business. And the reason I say that is because we have a known customer base, which is the pharmaceutical companies and the biopharma, we are developing new drugs. And they are in a position to pay for this test right now, and they want it. And I'll explain why on a later slide. We're also building out in our own clinical laboratories what's called lab-developed tests. So LDTs, as they're known, are tests offered by an accredited laboratory for patient management. And that process is a much quicker process and less involved process than getting an FDA clearance. So we've established these labs to be accelerators and demonstrators for new users. We've got 2 LDTs, which are developing, 1 in prostate and 1 in ovarian. And then finally, the fourth stage is the IVD CDx. So what I mean by that is, that is the very large-scale use in treating patients. There are 3 ways that we're addressing that. The first one is now we have an FDA clearance. We have an FDA-cleared product. We're starting to engage with some of the best-known high-quality reference labs in the United States. So these are top name cancer centers who may adopt this technology. We want to get it in their hands, and we want them to come up with some uses. So they will develop their own uses of the cancer cells, which they can start to deploy with their patients, and we want to use them as the -- essentially the opinion leaders to drive the marketplace. So that's the first part, and we're having direct contact with some of these leading cancer centers right now to discuss how they might do that. That will effectively sort of seed the market. The large-scale adoption, however, we want to do that via large-scale corporate partnerships -- so we've talked about the interaction with Abbott. So Abbott has a test for measuring HER2, a protein on cancer cells, which can indicate a patient will be given Herceptin as a drug. That is -- they're the market leaders in that, and that is a test which is their PathVysion test or somebody or competitor's test is done on every single breast cancer patient on presentation. They want to do repeat tests. The doctors would like to have a new HER2 test because it's known that HER2 status changes. They can't do that at the moment. So they will, in the future, be able to use Parsortix to recover cancer cells and then PathVysion could be used to assess HER2 status. So if we -- if plans go ahead as expected, we will do a deal with Abbott or 1 of their competitors to combine HER2 testing that already exists with Parsortix. And then this is the key point. Their sales and distribution channel, hundreds of people that they already have who are selling their tests will then work to sell Parsortix, not because they like us, but because it will enable sales of their own test. And that is a model that we want to replicate with every large-scale medical diagnostic company in the world that has a test that works on cancer cells. So it is not the idea that ANGLE will have 1,000 reps, and we will go out and sell Parsortix on our own. It is that we will pair up with people who have got downstream analysis and techniques to work with the cancer cells, and they will drive that adoption. So that's 1 major method of getting into the clinical market. The other one is the pharmaceutical companies. So I'm going to talk about the cancer drug trials in a minute. But the big macro picture is that pharma companies are developing new cancer drugs. They can be very effective but only for a limited number of patients. And the regulators are saying, well, we're not going to approve this drug unless you tell us who should have it. You can't just blanket give it to everybody because it's too expensive. It's got side effects, and it doesn't work for everybody. So those pharma companies need companion diagnostics, and we believe that Parsortix is an excellent platform to give them those companion diagnostics. So once those are available, the pharma company will have a requirement to actually sell our product around the world in order to sell their drugs. So again, it's about harnessing the industry. we're essentially trying to be a catalyst to get all of these things moving ahead. So that's how the commercialization strategy looks in overview. Now I'm going to talk about some of the details on the different elements. So the first one is about the Pharma Services offering. So first off, why do pharma companies want this? Well, the answer is that at the way that cancer drug trials are run at the moment, the pharma company will -- or the hospitals working for them will recruit a cohort of patients to be -- to try out a drug and then they will recruit a matched cohort to be given the placebo. So a standard drug trial, 1 lot has the drug, other lot has a placebo and then they look to see who does better, and essentially what they're measuring is overall survival and progression-free survival. Well, that has a number of -- and that's standard, that's the standard approach. That has a number of limitations. It's quite blunt. It just gives an overall result at the end, but doesn't give you any information as to what's happening during the process. And also, it can take quite a long time because you might have to wait several years to distinguish the 2 groups in terms of their outcome. So instead, what we've come up with is an alternative offering where they do a blood test on the patient before they have the drug. That blood is then sent to ANGLE's clinical labs and we analyze it. So what we can do is put the blood through a Parsortix system, then we can look at the cells that come out. We can work out how many cancer cells were present in that patient's blood? What type -- what phenotype of cancer cells were there? Were there any clusters? And if so, how large were they? What were they made up of? So that gives a set of baseline information as to the current status in the patient. Then they can repeat the blood test when the patient is having the drug and look at the difference. So if the drug is being -- having an impact, it should be reducing the number of cancer cells and the type of cancer cells that are present. And then they can repeat that again after they've had the drug to see if any responses continues or whether it dissipates. And they may want to do that several times. So actually, we've got 1 customer who's looking at 7 time points for each patient in their trial. And they're doing that not just in the ones who have the drug, but in the ones who have the placebo as well. So this is a new way of thinking about things, and that's what we started with about 12 months ago. Since then, it's become clear that we can add a lot of value to that already valuable service by targeting particular proteins of action of the individual pharma's drug. So if they say to us, our drug is targeting this particular protein, then we can do an assay development job to find a way to stay the individual cells, cancer cells to say, is that present or is that not present. So now we're giving them all the information about the cancer cells, but we're also indicating whether the target for their drug is present or not, and if so, how much. And that has been very well received. And bear in mind, I'm talking about proteins here. We cannot do that with circulating tumor DNA. The alternative liquid biopsy approach, you cannot do this at all. They can't even start on this. So from a standing start, we've built out now 4 customers. And 1 of them is what we announced as being a large-scale contract. So it's a $1.3 million contract. They jumped straight into a Phase III prostate cancer study, which was very unexpected. We thought we'd mainly be in the smaller studies initially and then progress through. That same customer has come back and has asked us to join another 1 of their studies, different drug altogether for $1.2 million. So what we've learned from that is what we were anticipating but it's now being borne out in practice is that it takes a significant effort to sign up a new customer. Some of these contracts are taking us 9 months to get from discussions with customers to signed up contract. But once they're in place, they can do a repeat contract very quickly because we signed a master services agreement with them. All the legals are in place. They just say, here's another contract, will you take this one? It's also extremely nice for us because these are longer-term contracts. So over time, we're selling now things that we're doing work in 3, 4, 5 years' time. And that's great because we're going to get visibility on growing revenues. It means we can plan out the capacity of our labs to address that. In terms of the assay development, we've got 2 customers who taken up on already. Both the assay developments are going really well. We get paid for the asset development, by the way, somewhere between $100,000 and $200,000 for each one depending on how difficult the work is. So we provide them with a quote, they accept that. And at the end of that process, we jumped straight into their clinical study. So we know there will be follow-on revenues. And that's what we expect with every one of these contracts as they start with a Phase Ia and then a Phase Ib, then a Phase II than a Phase III, et cetera. Getting more and more patients each time, so scaling out. So we really only need a handful of customers in order to make a very significant impact. So that's been a very exciting business development for us and is where we believe that we will get large-scale revenues. We're setting out to have the capacity of our 2 labs capable of running 50,000 samples per year. We can build out from that very easily if we want to, but that's what we're starting off with. Our base pricing is $1,000 a sample. So there's a tremendous opportunity just in those 2 clinical labs. Beyond that, we intend to stimulate other people to set up labs, and we'll be a product supplier to them. I can talk about that more later if appropriate. In terms of the pharma components, this slide may be a little bit difficult to see on our online presentation. But what it shows is 4 different cancer types. They just happen to be 4 that we're very active in, but the same thing applies across all the 24 cancers that I mentioned. And the highlights that we've got multiple peer-review publications by independent cancer centers showing that Parsortix works in these cancers. And then the critical point is that on clinicaltrials.gov, there are a lot of different studies that we can address. So in just in breast cancer, there are 950 clinical trials that might be appropriate for this that are logged on that system, including 247,000 patients. Each one of the -- if a pharma company signed us up, each 1 of those patients would have at least 3 blood samples and maybe 5 or even 7. So there's a very large scale opportunity. And just in these 4 cancers, we think the opportunity is up to $2 billion of revenue per annum. So this is where we're building out our near-term commercial revenue. So now I'm changing tack to talk about the first of our 2 lab developed tests that we intend to offer from ANGLE's labs. Now just to repeat, we're going to do that to accelerate early revenues to accelerate the commercialization process whereby we can go and get reimbursement codes and to prove out as exemplars for the rest of the industry what can be achieved. It's not our intention that we will become a clinical services company, and that will be the only thing we do. What we ideally want to do is prove out these tests and then have big clinical labs say, you know what, we want that. So you've got an ovarian cancer test, right, we'll take it on from there. So that's where we get the leverage. We continue to sell product to them. We make a very good margin on that and then we move on to the next area. So this is our first one. Ovarian cancer, we've done 2 clinical trials already. The last one -- both of them were successful. The last one was a highly successful area under the curve accuracy of 95% in detecting ovarian cancer from a blood test. This is targeted on women who have an abnormal pelvic mass. So they're known to have gotten the pelvic growth. But you can't tell from the symptoms whether they've got benign condition, which can be dealt with by a general surgeon quite easily, keyhole surgery or whether they've got ovarian cancer where it's essential that they have a very good cancer surgeon to do their operation. And those patients will typically be a 6-hour operation, and they'll end up in intensive care afterwards. Not knowing who's who before you start the work is very dangerous. And in this country, we don't have a good discrimination and many women who have ovarian cancer don't get appropriate surgery. So the status of this is that we're running a verification study at the moment. Following the COVID disruption to reagent supply, we are now analyzing the samples, and so within the next month or so, we will be able to get the headline results of that study coming through. And the aim is -- and no samples have been unblinded. So at the moment, we have no evidence either way on how this is going. But if we get good results like we had in the last study, the aim is to put this thing to our clinical labs in the first instance as a lab developed test and offer it. The addressable market in the United States is over $1 billion for that particular opportunity. The second one is in prostate cancer. This one is very notable for a number of reasons. The most important one is that we're setting it up with a commercial partner in place before we even start, which I think is a very smart way to address this market. We've done a deal with Solaris Health, the largest group of urology clinics in the United States. They work with over 700,000 men every year who have prostate conditions, and they want to work with us because they would like to offer these men a blood test. Now what the blood test can do potentially is pretty amazing. So we're getting, in the U.K. at the moment, a lot of press saying, go and have your PSA blood test because of risk of prostate cancer. Unfortunately, PSA is not a good test. And if you ever did have the misfortune of having a PSA test and it was positive, don't worry too much because 75% of the time it's a false positive and you don't actually have cancer. Nobody seems to realize that. And then you get forced into a standard of care pathway, which takes you into having very invasive tissue biopsies, firing needles into the prostate gland, which is at best very uncomfortable and at worst, can cause quite serious infection and potentially end up in serious hospitalization. So it's -- there's far too much invasive procedures going on from a very bad blood test, and it will be much better to have a more specific blood test, which have a lower level of false positivity and that's what we're seeking to achieve. The second half is even more impactful, which is a diagnosis of prostate cancer almost inevitably leads to a decision to have a surgery and to cut the prostate gland out. So obvious reaction, you've got cancer, let's cut it out. But unfortunately, the radical prostatectomy surgery has lifelong impact in terms of impotence and urinary incompetence. And when you know that the statistics are that 60% of men who have prostate cancer have a slow bone cancer that's not going to impact them. Unfortunately, that's not a good way to go forward. So it'll be far better to have a blood test to assess whether or not the cancer is aggressive. And if it's aggressive, take intervention and have the surgery. If it's low level, let's just watch it for a bit. Let's have another blood test in 3 months' time and just check if it's still low level. That's a far better alternative. And our market research suggests that many men, if they can afford it, would certainly like to pay for a blood test alternative to taking that unchangeable decision to take action. So that's what we're targeting with this. And the reason we think we've got a pretty good chance of success is that some leading researchers in Barts Cancer Institute have already published the use of Parsortix in prostate cancer and they showed that the ability to assess with a hazard ratio of over 10x serious aggressive prostate cancer versus indolent cancer. And we've looked into some statistics about men who have died not from cancer, and autopsies show that over the age of 70, up to 50% of men have prostate cancer, but they didn't know they have cancer. It's undiagnosed. They had no symptoms that really affected their life. So it is absolutely critical in my mind if you're going to do cancer diagnosis, you need to know, is it clinically significant, aggressive cancer that needs intervention. So we're hopeful that our tests will be able to achieve that. And it has a secret advantage on other tests. It is looking at living cancer cells in the blood. They cannot be there unless you have cancer. They won't be there by accident, and they're not like ctDNA because if your body has a malignant cell in it, the whole point of your immune system is to kill that and then you'll get fragments in your bloodstream. 10% of people over the age of 65 have ctDNA in their blood. They don't have cancer. That doesn't happen with living cancer cells in the blood. So we have the secret advantage that we're working with the actual cancer cells that spread the disease. I said it was going to be a bit longer than usual. I hope it's not too long. In terms of the IVD market, post FDA clearance, very large-scale market opportunity in the United States. It's driven by the fact that there are a lot of women who have breast cancer and who are living with the aftermath of having had breast cancer. And that opens up a $4 billion market in the U.S. We keep talking about U.S. markets, by the way. Rest assured, we're intending to market this in Europe and all over the world. We're working on setting up distributors, for example, to help us access the rest of the world. But we talk about the U.S. market because obviously, we've got U.S. FDA clearance and actually they provide very good data that you can use to work out these things. I've already really covered this slide, but it is very, very important. We sometimes get the odd sometimes tongue-in-cheek comment like it sounds too good to be true, are you sure you're not another Theranos. Well, the answer is Theranos never had a single peer review publication. We have 63 peer review publications. They're on our website, anyone can read them, and 31 world-leading cancer centers that have all tested to the performance of this system. So we've got in place a very clear strategy for commercialization. And over the next 12 to 18 months, there are some immediate priorities. So now we've got the FDA-cleared system. We're seeking to secure leading clinical customers as reference customers, and we're doing that in multiple locations. The Pharma Services business is in place. It's now established. We know what we're doing, and we're seeking to grow that business quite significantly. It's a wide open opportunity for us. And corporate deals, now that we've got the FDA clearance, we're reenergizing conversations that we'd already started, and we're starting new conversations with big corporates about working alongside with Parsortix. On the basis that, that can help them extend their tests and do multiple repeats. The 2 laboratories that we've got which are now trading under the brand Onc-AdaPT are in the process for accreditation, and we're hopeful that, that accreditation will come actually possibly a bit quicker than H1 calendar 2023, but they're dependent on us having a clinical test put into the accreditation in each of the categories. That's progressing well. In terms of the other sort of milestones that are coming through, the ovarian cancer results will be through later this year, prostate cancer results next year, launch of the laboratory-developed tests in both those areas. And we're also now moving into looking at molecular solutions for the tumor metastatic environment. We've learned now that the Parsortix system concentrates not only the living cancer cells. There's some very important immune cells, which are attacking those cancer cells. And I already mentioned the [ CTC lab ] once but will mention them again. They're looking at clusters and seeing white blood cells embedded in those clusters, a lot of information here that can be gained beyond just the cancer cells. Again, we're looking for third-party world-leading cancer researchers to do all the investigation on that. It's not going to be ANGLE scientists coming out with the next breakthrough. It's going to be these other people using our system. We're going to be starting work on reimbursement codes for Parsortix tests, and we're looking for the development of clinical applications by end users in multiple different areas using the system. So just in summary, we're in a strong -- we're in a very strong position now. The FDA clearance was a major breakthrough, and it has brought global recognition of our company and our product. And we have a first-mover advantage in a very large-scale market. The barriers to entry are quite phenomenal, not just our intellectual property, protecting how we do things. But the body of evidence published over many years now with these cancer centers and now an FDA clearance that took us 6.5 years to get to. So it's very, very difficult for us to be challenged by another CTC company. And all the other companies in the space we want to work with and enable them. And we've got the Pharma Services businesses up and running. We've got the first large contract. We've got a second repeat contract. The repeat contracts are much quicker to achieve, so very, very good news. And we're looking to expand that into other cancer types. So overall, we've got multiple potential catalysts over the next 12 to 18 months. So that concludes the presentation. Thank you very much. And we're going to move to questions and answers. So if colleagues would like to put their videos back on, and we can expand that out, that would be great. So Ian, you...
Ian Griffiths
executiveAnd as Garth mentioned at the start, we'll start off with some of the questions that have been received, which have been [indiscernible] those present here. I can start off with the first question to Garth and the question is, is the potential of NASDAQ listing still being considered? If so, when is it likely to happen? And what condition would be required?
Garth Selvey
executiveA very frequently asked question. All options are open is the answer. And the NASDAQ equally remains open. But our present focus is very much on the commercialization process and the development of revenue opportunities and you would, [ if you look at ] Andrew's presentation, be able to very, very clearly see the intensity of that process. We are working on a number of very positive fronts and making progress. The company is well prepared to pursue such a listing at an appropriate time. In the meantime, we just put things in place that are flexible and will help any decision that we take in that area, such things as the appointment of Berenberg and Jefferies as brokers and bankers as well as PricewaterhouseCoopers as auditors, just to ensure that should we wish to take such a decision, we have a very high caliber of advisers already in place and the systems in place that we would need to implement such a move. So that in a nutshell is a maybe, but we will have choices.
Ian Griffiths
executiveThank you, Garth. And I'd probably add to it given Bruce's point [ as we don't put ] in the formalities. The NASDAQ, there is only a choice of one of the big 4 auditors to take us through, and realistically the only 2 very strong ones in terms of the NASDAQ would be PwC and Ernst & Young. So that's, as Garth said, about lining our resources to take us forward. So I'm sure [ when that gets reviewed ] you may come back on later. But there are reasons why we work with some of the organizations to do that, [ it is to come up with ] decision as possible. The second question which I'll ask to myself in this case, is what is the current cash position. What is the route to profitability, the [ alternative ] and why, but I'm sure there's quite a few questions along those lines. What I would say is that we don't give out current cash position. Obviously, the last reported cash position was GBP 32 million as of December 31, along with another GBP 4.5 million R&D tax credits that were due in. We did a fundraise last June, July. That was designed to take us out to Q2 next year to meet certain milestones. We're on track with that. We can push it out a bit further than some of the discretionary spend. But we're deploying the capital that we raised for the activities we talked about and that includes the sample, obviously the newer areas here such as the prostate cancer and investing in the studies there as well as, in particular, developing out the clinical lab side of things and developing the lab developed tests as well. So we're in good shape financially, no immediate requirements. In terms of the route to profitability, Andrew has already described the various stages of the commercialization we're going through. There's a strong focus on building out pharma services at the moment. And that's where the nearer-term revenue is available. But we do have to focus on specific areas and activities. And so we can't just get out into all areas and so we've got a very tight focus plan. Following that tightly focused plan does affect when we get out to profitability or not. Obviously, keeping that tightly focused plan, we can get to profitability much earlier that we estimated by 2025. If we follow a more U.S.-based approach because we've got a platform technology that works across all different cancers, there's a lot of demand, for example, to develop lung, head and neck, melanoma and so forth, if we start investing in those areas there, obviously, it will increase the spend, which would push out the breakeven but actually gives us more of an opportunity to do a [indiscernible]. So we will need additional capital to get there. The question is what is the source of that capital. So obviously, we're progressing key corporate partnerships with the potential for some upfront milestone payments. And of course, historically, we've raised money from the capital markets. So we're in good shape, but we also have to keep the tight focused plan. Next question, which is to Andrew, is on the pharma services. The question is do the Board anticipate the onboarding of new pharma customers to be expedited post FDA approval? Or do you anticipate each new pharma inquiry to still take around 9 months.
Andrew David Newland
executiveSo the onboarding of pharma customers is a significant effort. So we're talking about customers who are not used to doing this approach. It's a new way of doing things. So they have to consider that. They have to ask for data suggesting that this might be successful, then they want to review our quality systems, and we have to agree with them, which centers are doing their studies, how the blood will be processed, et cetera. So there's a lot of different elements involved. And sometimes, we have to do some pilot work for them in order to demonstrate evidence that we're capable of giving a useful result. I don't anticipate that the onboarding of new customers will materially reduce in time scale. It is just a process you have to go through. However, what has changed is we've got more interest from customers coming in and approaching us. So the part of us going out and finding the customers and getting them to engage in the first place, that is getting quicker already. And the most notable point is that all of these customers have numerous different cancer drug trials. And once they've actually signed up with us then it's very easy to get repeat contracts because, as I think I mentioned in the presentation, they generally have a master services agreement with us. It sets out all the ins and outs, and that may have taken us a very long time to agree. But once it's in place, just adding an additional contract to it is very easy. So we're anticipating that over time we will have a cohort of a very solid large-scale repeat customers. And then that process will be much simplified. But in terms of brand new ones, I think it will continue to be a significant process that has to be followed.
Ian Griffiths
executiveThanks, Andrew. Next question was on clinical labs. In fact, there's 3 questions here, which, again, I'll put to you, Andrew. I'll read the 3 questions out first. Can you provide guidance on the likely timing of clinic accreditations in both the U.K. and U.S. and explain the processes involved? What LDTs will be offered by the clinical authorities once accredited and how will the offering develop over time? And is ANGLE planning on launching a website where private payers can order a testing kit pay and get their results?
Andrew David Newland
executiveWell, the first 2, I think probably were addressed, to an extent, in the presentation. So in terms of the timing of the accreditation, we've done all of the necessary work to get the quality control systems in place. We have the staff there. We've already registered with all the regulatory authorities, and we've gone through the first part. So the U.S. center, for example, is already registered. It's not fully accredited, but it was registered. To get the full accreditation, we have to, in each of the categories -- there are 2 main categories that we're interested in, one is imaging cells and the other one is doing molecular analysis of cells. So in each of those 2 categories, the first test that we're going to offer for patient management has to be submitted and approved by the regulatory agency. So it's a little bit of a chicken and egg situation. So for example, the first, molecular is going to be the ovarian test. So we have to finish the ovarian studies first, be satisfied that those are all in place and then submit that data for clearance. And similarly, with imaging, we're validating an imaging assay. And when we submit that, that will be part of the accreditation. So I would say the best guidance on that is somewhere around the end of the year. But to an extent, it's not a critical point because the most important use for those clinical labs is the pharma services work, and that is happening. It doesn't need the actual accreditation. It just needs the quality systems and controls to be in place, which we already have. So that's that one. In terms of the LDTs, the first 2 are expected to be ovarian cancer and then prostate cancer. And we're considering a number of other things. But at the moment, those are the first 2. In terms of a website where private payers can order a kit, that sort of implies can individuals come along and ask for a test. The answer to that is definitely no. We're not going to be dealing with cancer patients. We're not doctors. We're not approved for that, and we don't have the experience to do that. What we want to do is to interface with the clinics who deal with the patients. So that's why I thought the prostate cancer one is a really perfect example because we've got large-scale urology clinics who deal with many men who got prostate conditions, and they order the test from us, draw the blood from the patient, send it to us, and we get paid for the test to send them results back. But we never talk to the actual patient nor would we even know the patient's identity. In terms of having a website, there are -- we'll be using our LIMS management system from the laboratory to interface with clinics so that they will get sort of online access, assuming they've gone through authentication of who they are, et cetera, online access to test results and the ability to order up tests. But that will be business-to-business, not business to consumer.
Ian Griffiths
executiveThank you. Two questions on FDA here. But the first one to you, Andrew, the second to Jan. First one is can you explain the FDA labeling in more detail and what this means in practice.
Andrew David Newland
executiveYes. So that's the point about what we're allowed to do and the intended use. And what that is, is that we -- Parsortix system is intended to harvest cancer cells from the blood of metastatic breast cancer patients for subsequent analysis. And the good thing is, I mentioned in the presentation, it's a platform clearance. It does not limit what can be done on those cancer cells. It does, however, put the obligation on the end user to validate any test they do with those cells, and that's exactly parallel to what doctors have at the moment with a tissue biopsy. The doctor has to decide what we're going to look at in the cells and what they want to do as a result of that. Not ANGLE.
Ian Griffiths
executiveJan, a question for you is what other FDA clearances are likely? Will you be seeking clearance for ovarian cancer and prostate test? If so, how long would that take?
Jan Groen
executiveYes. I think during the presentation we stated that the initial focus of ANGLE will be on the laboratory-developed test. Of course, we will be engaging with the FDA regarding the processes for clearance, and it should go faster now. We have the cleared platform and what we presented, we will focus prominently on breast cancer, ovarian and prostate cancer, and we expect that the process will go faster since we have a cleared instrument.
Ian Griffiths
executiveThanks. And Brian, I don't know if you can put your microphone on. Hopefully, it will work. A question for you, is recruitment of qualified personnel proving to be an ongoing challenge.
Brian Howlett
executiveYes, that's a great question because ultimately a medic company depends on the quality of its workforce. And yes, recruitment and retention of highly qualified personnel is always a challenge for early-stage med tech ventures for obvious reasons. So far, I'm very happy to say that this company has successfully attracted a talented internationally-based diverse team that has marked a very, very significant achievements in its preliminary stages of commercialization, as you've heard from Andrew, i.e. demonstrating clinical utility of Parsortix, publications, highly relevant pioneer or establishment [ of regular users ], as Andrew called them. They are all the building blocks that has built a very, very solid foundation of the company. And last but not least, of course, this team has managed to achieve something very, very unusual indeed, which is an FDA clearance. And that plus all the steps that I know that the company takes to make sure that ANGLE is a great place to work. We'll ensure that we'll have the wherewithal to attracting the necessary additional skills and talent that we need to achieve the full financial potential of the Parsortix. And that goes throughout the company, and of course, including the Board, as the business develops and the skill sets that we need are additional, then that needs to be reflected in the Board. But I have great confidence in the company's HR approach to recruitment and retention of staff.
Ian Griffiths
executiveThank you, Brian. I'm conscious of the time, so I'm going to open questions to the room. Hopefully, it will pick up on the microphone well, but I will probably repeat the question that I'm asked us to make sure it does go through.
Andrew David Newland
executiveWe have been specifically asked to do that.
Ian Griffiths
executiveYes. All right. Bruce?
Unknown Shareholder
shareholderCan you just say what are your major obstacles to growth?
Ian Griffiths
executiveSo the question is, what are ANGLE's major obstacles to growth?
Andrew David Newland
executiveThat's always a very difficult question because we're in an extremely strong position. I would say the obstacles to growth relate around changing entrenched views, getting conservative clinicians to change their practice will be one. Clearly, the ability to have access to enough capital to take advantage of this opportunity. So we either will become a very large company ourselves or we will have partnered with multiple very large companies, which is the preferred strategy or will have been acquired by a very large company. And the only other alternative is we will fail to meet the objectives that we set out.
Unknown Shareholder
shareholderYes. On that point then, you delivered Parsortix, with [indiscernible] might be in 10 years. I'm sure [indiscernible] people here, and in pharma terms, on a shoestring budget, really. But how do you protect yourselves from people who haven't seen your vision and see it as cheap?
Andrew David Newland
executiveThat's probably one of the biggest risks. Do you want to comment on that, Ian? You got to repeat the question.
Ian Griffiths
executiveWell, I was going to repeat the question first.
Andrew David Newland
executiveOh, you got to repeat the question.
Ian Griffiths
executiveYes. The question is we put in a lot of effort over a lot of time on a shoestring. But with the overall market, how do we protect ourselves from a potential lowball offer. Well, obviously, we are a listed company and we're owned by the shareholders. So anybody can come in. And if there's an offer there. We -- the Board has a fiduciary responsibility to consider it and put it to the shareholders. What we've been trying to do, of course, is make sure we have the right shareholders on board that will long term buy into what we're trying to achieve, the value we're trying to be and would say, no, that is a lowball offer. And that, in particular, is why we've been trying to bring in some of the U.S. investors. They see liquid biopsy, it's coming, it's going to happen, it's going to change the market, right? There's going to be multiple winners in this space. It's a massive, massive market opportunity. Andrew already talked about the slide. We are incredibly well strongly differentiated. He's already explained ctDNA players are a commodity. It's a bigger play. So yes, we will be attractive to some of the companies, but we've also got that unique result proposition that we can create a massive value out of it. And if we've got the right backing and the right shareholders and they see that, a lowball offer is not of interest to them. What they're going to see is what we can do. It's a platform technology. It works with every cancer. It works across every part of the patient pathway. If we can deploy it, we will be, as Andrew said, a major, major company. So we don't want to see when an American company is just coming in and buying us cheap. There's a history in the U.K. of that happening all the time. We can't stop it if shareholders vote for that. What we're trying to do is make sure we've got the right shareholders who understand the potential they can create and therefore wouldn't accept such an offer.
Unknown Shareholder
shareholderYou mentioned during the presentation that the total addressable market for liquid biopsy was somewhere north of GBP 100 billion, I think. And then later on, you looked at subsets of ovarian, prostate and breast cancer. And those totals come to, I think, it looks like $14 billion or $15 billion. Could you explain the gap between those? Where is the remaining GBP 85 billion?
Ian Griffiths
executiveYes, that's fine. That's quite easy. The question is about the time we presented it, greater than $100 billion for the U.S. market alone and ANGLE's individual bottom up TAM, and in this case, that we described for breast cancer, prostate cancer and ovarian cancer. The main gap on the TAM, if you look at how that $100 billion is made up, it's around $50 billion is allocated towards early screening. ANGLE is not involved in early screening. So that is the biggest part of our bottom up. Our addressable -- because that's our real addressable market that we've described, okay? It doesn't mean we won't get into early screening at some point. We don't have plan. We'd like to support somebody else to do it. Then obviously, there are -- if you look at the other parts of the patient pathway, so we talked about high risk, we talked about the therapeutic decision-making, the remission monitoring and -- anyway, I'm sorry, residual disease, which is associated with the remission monitoring. So obviously, we're only looking at breast and prostate, 2 of the major cancers, hence, TAM is much larger and ovarian is one of the smaller. But look at all the other cancers there. Lung cancer, colorectal cancer, all these other cancers, they all make up constituent parts of that addressable market. So that is -- and that accounts for the rest of that difference. And so we -- as Andrew explained, we have an advantage over all of the other companies in the space because CTCs are very specific analyte and we think that will play out also in the remission monitoring because if you find a cell and they're rare, you shouldn't find it if the person is properly in remission. Now we're not doing studies in that area at the moment. That's an objective for us to get into that and prove that out, but we think we'll have a very strong role to play there because of the nature of the analyte that we have.
Unknown Shareholder
shareholderWe talked previously about reimbursement codes. I think you mentioned in the past that possibly you might be able to go in under the existing at a lower value. Perhaps if you could just remind us the situation on that? And what work needs to be done to get our future reimbursement codes at the top of value that's [indiscernible]?
Ian Griffiths
executiveYes. So the question is will we be able to leverage existing reimbursement codes during the process of securing the high-value codes that we think would be appropriate for our test.
Andrew David Newland
executiveYes. So there are some existing codes. The most notable one is in ovarian cancer where the current test, the best test for ovarian cancer gets reimbursed at $897 per test. It may be possible for us to seek to be paid against that code. It's not necessarily desirable, but it may be possible to do that. It doesn't stop the problem of having to actually go to all the insurance companies and persuade them to still to pay us. And the way that system works is you -- effectively, you accept the patient and then you apply against the reimbursement code, and then they will reject you and then you appeal. And unfortunately, it's a bit of a dysfunctional system, but that's how the approach works. The current ovarian test has approximately 4 false positives for each true positive, i.e., its positive predictive value is low because its specificity is low. We anticipate our test will be a much higher performing test. We also know that the way that ovarian cancer care is evolving is significant, which is where there's an expected ovarian cancer, they now are giving -- increasingly, they're giving neoadjuvant chemotherapy prior to surgery. So that means that the patient is given the cancer drug before they going to surgery to try and reduce down the ovarian cancer. And that is, in itself, a medical challenge because they don't know which chemotherapy will be most effective for the patient. And it happens at the way that we're detecting the cancer cells in ovarian cancer is by using our own molecular platform, which gives gene expression information on the cancer. And we look at that gene expression information to determine was cancer present? That -- it looks like that information, in its own right, is going to be valuable for choosing chemotherapy. So we may be best to start off by just staying with the initial code and then from that, go out and say, well, actually, we don't want that code. We want a different code because we've got a better test, and it gives more information and we want more money. So all of that work is extremely challenging. Getting reimbursement codes is not for the faint hearted. It's not quite as bad as it get, [indiscernible] but it's the same sort of idea. It can take a year or maybe even a couple of years of effort.
Unknown Shareholder
shareholder[indiscernible]
Andrew David Newland
executiveWell, this is what I was coming to. We strongly want to do -- the ovarian one, we are doing ourselves. So we've gone down those [ stats ], but we strongly want to do that kind of work with big companies. So for example, if we are successful with a deal with Abbott, they already have a reimbursement code for PathVysion. They already have a huge team of people that work on reimbursement who are already engaged with the necessary insurance companies. So clearly, that's easier to use that channel than it is for us to create a completely new one. There is a twist to the reimbursement codes. At the moment, MolDX, who is responsible for setting up the codes, but not for actually working out how much you get paid under the codes. That's 2 different things. They are focused on providing codes for specific tests end-to-end. And Parsortix is not a specific test end to end, which is the first part of a test which is then going to be added to another test that already exists. So what we're going to do is to see if we can engage with MolDX in exact same way we did with FDA to persuade them that actually maybe they should think about code for Parsortix. And if we could get that, that would be a breakthrough because then you wouldn't need to get a lot of extra codes because you've already got 1 for Parsortix. You've got 1 for imaging, you got 1 for molecular already. You just add the 2 together. At the moment, the position is that is not what they will do, and we will have to go and get codes for each individual test.
Ian Griffiths
executiveAny further questions?
Unknown Shareholder
shareholderSorry, just one more. [indiscernible] and probably getting a little bit ahead of ourselves. But obviously, in the resolutions, one of them was the potentially able to buy back shares which, obviously, with the capital position, I'm sure it's not on the short-term horizon. But just in conceptual terms, do you have any thoughts of where the priority be potentially if funds become available to buy back shares or providing a dividend is a [indiscernible].
Ian Griffiths
executiveSo the question is about sort of capital distribution policy at a point in the future. And I mean what we've seen, obviously, with quite a few of the larger sort of cash companies is they're going down a dual route these days. So you'll have some investors who prefer a dividend payback and then you'll obviously see a lot who prefer a share buyback. And so -- and the whole thing is if you've got certain of your people who've got it in a tax wrapper, they're probably happy with the dividend approach, but a share buyback, if it's outside, it may offer route for us as well because of the annual [indiscernible]. I mean, we will obviously -- we're focused on deploying the capital raise and creating larger value. For me, that's -- so when we're at that point, we'll consider the distribution policy in more detail.
Andrew David Newland
executiveThank you very much, Ian. I think we should draw things to a close. We will be here though, so we can talk to people who are present if they want to ask any additional questions. So I'd like to thank you all for the submitted questions and for the questions from the floor. We are extremely grateful for the support of all of our shareholders. And now with our historic first-ever FDA product clearance, we now have the platform in place to drive commercialization and, critically, to help thousands of cancer patients to receive personalized cancer care. This concludes the 2022 AGM. Thank you very much.
Operator
operatorThank you for updating attendees today. Can I please ask attendees not to close this session as you'll now automatically be redirected to provide your feedback in order for the Board can better understand your views and expectations. This will only take a few moments to complete and be greatly valued by the company. On behalf of the Board of ANGLE plc, we'd like to thank you for attending today's annual general meeting proceedings. Good afternoon to you all.
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